Item No. Detail of Item Pages: Minutes of 316 Meeting of Registration Board Held On 15, 16, 17 & 18 MARCH, 2022

MINUTES OF 316th MEETING OF REGISTRATION BOARD
HELD ON 15th, 16th, 17th & 18th MARCH, 2022

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Item Detail of Item Pages

No.
I. Confirmation of Minutes of Registration Board 3
II. Division of Pharmaceutical Evaluation & Registration -------------- 4
Pharmaceutical Evaluation Cell (PEC) --------------------------------- 4
Registration-I Section ----------------------------------------------------- 2060
Registration-II Section ---------------------------------------------------- 2133
Post Registration-I Section ----------------------------------------------- 2192
Post Registration-II Section ---------------------------------------------- 2208
Import & Vet-I Section --------------------------------------------------- 2220
Import & Vet-II Section -------------------------------------------------- 2296
RRR Section ---------------------------------------------------------------- 2337
III. Division of Biological Evaluation & Research 2403
IV. Division of Quality Assurance & Laboratory Testing 2496
V. Any Other Item with the permission of Chair 2517-
2611
Drug Regulatory Authority of Pakistan

T.F. Complex, 7-Mauve Area, G-9/4,
Islamabad
Minutes of 316th meeting of Registration Board (15-18 March, 2022) |1

316th meeting of Registration Board was held on 15th- 18th March, 2022 in the Committee Room,
Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by Dr.Obaidullah,
Director, Pharmaceutical Evaluation & Registration Division, DRAP. The meeting started with recitation
of the Holy Verses.
The meeting was attended by the following: -

1. Lt.Gen.(R) Prof. Dr. Karamat A.Karamat (HI-M.SI-M) Member
Former Surgeon General Pakistan
2. Maj.Gen. (R) Dr. Tahir Mukhtar Sayed, Member
Inspector General (Hospitals), Fauji Foundation, Rawalpindi
3. Mr. Iftikhar A. Choudhary, Member
Ex-Chief Pharmacist, Punjab University, Lahore
4. Dr. Qurban Ali, Former Director General, Member
National Veterinary Laboratories, Islamabad
5. Mr. Zohaib Abbas Khan, Director-Technical, Member
Drugs Testing Laboratory, Rawalpindi Government of the Punjab
6. Syed Adnan Rizvi, Director, Member
Drugs Testing Laboratory, Karachi Government of the Sindh
7. Mr. Ghulam Mujtaba, Deputy Director, Member
Representative of IPO, Islamabad.
8. Dr. Noor-us-Saba, Director, Member
Representative of Biological Evaluation & Research Division, DRAP
9. Mst. Mehwash Ansari, Deputy Director, Member
Representative of QA&LT Division, DRAP
10. Mr. Abdullah, Member/
Additional Director (PE&R), DRAP. Secretary
11. Dr. Muhammad Akram, Animal Husbandry Commissioner, Co-Opted
M/o National Food Security & Research, Islamabad Member
Mr. Asif Jalil, Incharge PEC and respective Assistant Directors, presented the agenda of PE&R
Division. Director, BE&R assisted by respective Assistant Directors to present the agenda of Biological
Evaluation & Research Division. Deputy Director, QA&LT was assisted by respective Assistant
Directors to present the agenda of QA & LT Division.
Mr.Jalal Ud Din Zaffar & Mr.Hamid Raza, Mr. Tipu Sultan Akram (PPMA); Mr. Nadeem
Alamgir (Pharma Bureau) and Mr. Zia-ul-Haq (PC&DA) attended the meeting as observers.

Item No. I: Confirmation of Minutes of 315th meetings of Registration Board.
315th meeting of Registration Board was held on 1st February, 2022. draft minutes of 315th meeting of
Registration Board were circulated among the members of Board on 2nd February, 2022 with the request
for perusal/approval/comments (if any) till 3rd February, 2022 at 10:00am. All members agreed the draft
minutes. Moreover, Dr. Muhammad Munawar Hayat, Director, DTL, Govt. of Punjab commented on
draft minutes. The comments of member are as under;
Dear Sir,
In case No.1; regarding compliance with pharmacopoeial specification, is under the Drugs
(Specification) Rules, 1978.
In my opinion, Registration Board is not competent to relax the compliance of pharmacopoeial
specification, as these are Rules made under the Drugs Act, 1976. The Federal Government is
empowered to relax this compliance of pharmacopeial specification.
Please acknowledge my descending not in the minutes.
Dr.Muhammad Munawar Hayat, Director, DTL Punjab
In view of the above, it is intimated that the same was not discussed by the officer during the
meeting, the officer intimated his thoughts after it.
Accordingly, Chairman, Registration Board approved the fair minutes of 315th meeting of
Registration Board which were circulated among concerned divisions/sections for implementation.
Decision: Registration Board confirmed the minutes of 315th meeting.

Item No. I Division of Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluation Cell (PEC)
Sr. No Name of Evaluator Title

1. Mr. Farooq Aslam Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst.Farzana Raja Evaluator PEC-IV
5. Mr. Muhammad Umar Latif Evaluator PEC-VI
6. Dr. Sidra Khalid Evaluator PEC-VII
7. Dr. Haneef Ullah Evaluator PEC-IX
8. Dr. Farhadullah Evaluator PEC-XI
9. Mr. Shahid Nawaz Evaluator PEC-XIII
10. Mr. Ahsan Hafiz Evaluator PEC-XIV
11. Mr. Akbar Ali Evaluator PEC-XVI
12. Mr. Zia Ullah Evaluator PEC-XVII
13. Mst. Saima AD PE&R
14. Mr. Syed Ajwad Bukhari AD PE&R

15. Mr. Hafiz Muhammad Ahsan Evaluator PEC-XIV
Sharif

Case No.I: Registration applications of newly granted DML of M/s Safina Pharmaceuticals
(Pvt) Ltd. 17-Km Lahore Sheikhupura Road, Lahore and M/s. Acumen Healthcare
(Pvt.) Ltd., Plot No. 39&40, Street No. S.02, RCCI Industrial Estate, Rawat.
Proceedings: Registration Board was apprised that various applications of M/s Safina Pharmaceuticals
(Pvt) Ltd. 17-Km Lahore Sheikhupura Road, Lahore and M/s. Acumen Healthcare (Pvt.) Ltd., Plot No.
39&40, Street No. S.02, RCCI Industrial Estate, Rawat were submitted against the category of New
DML. During evaluation of these applications and discussion among the evaluators it was observed that
similar data had been presented in the dossiers of both applicants.
For example, following few observations were noted in the applications of Cefixime capsule 400mg from
both applicants:
1. Same data had been presented for the method validation report of drug products.
2. Same results had been reported in the drug substance analysis performed by M/s Acumen & M/s
Safina for all the parameters, even the receiving date, sampled date and release date were the same.
3. Same results had been reported in the Pharmaceutical equivalence studies performed by M/s
Acumen & M/s Safina.
4. Submitted digital data logger records of stability chambers present the same values of temperature
& humidity.
Moreover, the signatures of QCM were the same between various dossiers of both applicants.
The above cited facts raised questions regarding the authenticity of submitted data by both applications
hence Chairman Registration Board constituted panel for on-site verification of authenticity of Product
development and Stability data submitted by both M/s Safina Pharmaceuticals (Pvt) Ltd. 17-Km Lahore
Sheikhupura Road, Lahore and M/s. Acumen Healthcare (Pvt.) Ltd., Plot No. 39&40, Street No. S.02,
RCCI Industrial Estate, Rawat.
Details of on-site inspection reports and registration applications is presented below:
I. Report of on-site verification of authenticity of Product development and Stability data of
M/s. Safina Pharmaceuticals (Pvt.) ltd. 17-Km, Lahore Sheikhupura Road
Reference No: F.1-2/2020-PEC dated 14th March, 2022.
Investigation Date and Time: 14th March, 2022.
Investigation Site: Factory premises of M/s. Safina Pharmaceuticals (Pvt.) ltd. 17-Km, Lahore
Sheikhupura Road.
Composition of Panel:
1. Mr. Akbar Ali (Assistant Director (PEC), PE&R Division)
2. Mr. Ammar Ashraf Awan, (Assistant Director (PEC), PE&R Division)
Scope of investigation:
• On-site verification of Authenticity of Product development and Stability data and associated
documents, import of API, quality, specifications, test analysis and facilities etc. of following
products:
Sr.# Product Composition
1. Sinocef 500mg Capsule Each Capsule Contains:
Cephradine as Monohydrate…500mg
2. Sinocef 250mg Capsule Each Capsule Contains:
3. S-Xime 400mg Capsule Each Capsule Contains:
Cefixime as Trihydrate…400mg
4. Omzole 20mg Capsule Each Capsule Contains:
Omeprazole…20mg
5. Omzole 40mg Capsule Each Capsule Contains:
Omeprazole…40mg
6. Esosef 20mg Capsule Each Capsule Contains:
Esomeprazole as Enteric Coated Pellets…20mg
7. Esosef 40mg Capsule Each Capsule Contains:
Esomeprazole as Enteric Coated Pellets…40mg

8. S-Xime 200mg/5ml Dry Each 5ml of Reconstituted Suspension Contains:
Suspension Cefixime as Trihydrate…200mg
9. Sinocef 125mg/5ml Suspension Each 5ml of Reconstituted Suspension Contains:
10. Sinocef 250mg/5ml Suspension Each 5ml of Reconstituted Suspension Contains:
11. S-Xime 100mg/5ml Dry Each 5ml of Reconstituted Suspension Contains:
Suspension Cefixime as Trihydrate…100mg
12. Safpain 200mg Tablet Each Tablet Contains:
Ibuprofen…200mg
13. Safiquin 500mg Tablet Each Tablet Contains:
Ciprofloxacin…500mg
14. Safiquin 250mg Tablet Each Tablet Contains:
Ciprofloxacin…250mg
The panel visited the premises of M/s. Safina Pharmaceuticals (Pvt.) ltd. 17-Km, Lahore Sheikhupura Road
on 14th of March,2022. Upon reaching the premises the panel observed a notice on the gate, stating that “no
production of medicine is being carried out & factory is closed”. The Gate keeper Mr. Zeeshan was available
initially while production manager Mr. Abdul Wahab Nasir came later and informed that Quality Control
Manager was on leave due to his personal engagement. The Production manager informed the panel that the
plant is non-operational and no sort of production activity is being carried out at the moment. The panel visited
the premises along with Production manager with reference to scope defined above. Details of the inspection
are as under:
Q.
Question Observation by panel
#
1. Do you have documents confirming the import of The production manager Mr. Abdul Wahab Nasir
API? informed that no API was procured and no record of API
procurement was available.
2. What was the rationale behind selecting the N/A
particular manufacturer of API?
3. Do you have documents confirming the import of No document confirming the import/procurement of
reference standard and impurity standards? reference standard & impurity standard was provided.
4. Do you have certificate of Analysis of the API, Not provided.

reference standards and impurity standards?
5. Do you have any approval of API or GMP -do-

certificate of API manufacturer issued by
regulatory authority of country of origin?
6. Do you use API manufacturer method of testing? -do-
7. Do you have stability studies reports on API? -do-
8. If yes, whether the stability testing has been -do-
performed as per SIM method and degradation
products have been quantified?
9. Do you have method for quantifying the -do-
impurities in the API?
10. Do you have some remaining quantities of the No API was available in the raw material stores & no
API, its reference standard and impurities reference standards were available in the QC lab.
standards?
11. Have you used pharmaceutical grade excipient? No excipient was available in the raw material stores. No
record was provided.
12. Do you have documents confirming the import of No document confirming the import of excipient was
the used excipient? provided.
13. Do you have test reports and other records on the Not provided.
excipient used?

14. Do you have written and authorized protocols for Not provided.
the development of product?
15. Have you performed Drug-excipient Not available.
compatibility studies?
16. Have you performed comparative dissolution Not provided.
studies?
17. Do you have product development (R&D) section R&D lab has not been established yet.
18. Do you have necessary equipments available in Manufacturing equipments were available in the area of
product development section for development of Capsule (Cephalosporin), Dry powder suspension
product? (Cephalosporin) and Tablet (General) section. While in
Capsule (General) section, capsule filling machine was not
available.
19. Are the equipments in product development R&D lab has not been established yet.
section qualified?
20. Do you have proper maintenance / calibration / R&D lab has not been established yet.
re-qualification program for the equipment used
in PD section?
21. Do you have qualified staff in product R&D lab has not been established yet.
development section with proper knowledge and
training in product development?
22. Have you manufactured three stability batches for The production manager informed that the product
the stability studies of product as required? development and stability studies along with preparation
of CTD dossier was outsourced.
23. What were the criteria for fixing the batch size of -do-
stability batches?
24. Do you have complete record of production of -do-
stability batches?
25. Do you have protocols for stability testing of -do-
stability batches?
26. Do you have developed and validated the method -do-
for testing of stability batches?
27. Do you have method transfer studies in case when -do-
the method of testing being used by your firm is
given by any other lab?
28. Do you have documents confirming the Qualification record was not provided.
qualification of equipments / instruments being
used in the test and analysis of API and the
finished drug?
29. Do your method of analysis stability indicating? The production manager informed that the product
development and stability studies along with preparation
of CTD dossier was outsourced.
30. Do your HPLC software is 21CFR compliant? One Schimadzu HPLC equipped with binary pump was
available. No evidence for performance of any analysis on
HPLC was provided.
31. Can you show Audit Trail reports on product No evidence for performance of any analysis on HPLC
testing? was provided.
32. Do you have some remaining quantities of No sample of any of the trial batch was available.
degradation products and stability batches?
33. Do you have commitment batches kept on No sample of any of the trial batch was available in the
stability testing? stability chambers.
34. Do you have valid calibration status for the Dissolution apparatus, Disintegration apparatus, One
equipments used in production in analysis Schimadzu HPLC equipped with binary pump and one
UV-spectrophotometer, were available. FTIR
spectrophotometer was not available. Calibration status of
all the equipments was due.

35. Do Proper and Continuous monitoring and Two stability chambers were placed in the incubation
control are available for stability chamber? room of the microbiology lab. Both the chambers were
found powered off. No sample of any of the trial batch was
available in the stability chambers.
36. Do related manufacturing area, equipment, No production activity observed.
personnel and utilities be rated as GMP
compliant?
Remarks:
I. Raw material Store (Cephalosporin/General)
The raw material store was empty & no any raw material/remaining raw material was present. No any
record/document of the import/procurement of raw materials for the above cited products was provided.
II. Production facility:
i. Dry powder suspension (Cephalosporin)
ii. Capsule (Cephalosporin)
The panel visited above production facilities, required manufacturing equipment were available however
no evidence/record for the trial batch manufacturing for the above cited products was provided.
i. Tablet (General)
ii. Capsule (General)
The panel visited above production facilities, required manufacturing equipment were available for tablet
section (general) however, capsule filling machine was not available. Furthermore, no evidence/record for
the trial batch manufacturing for the above cited products was provided.
III. Quality Control Lab:
At the time of inspection Quality Control Manager was not available and production manager informed
that he is on leave due to his personal engagement. Production In-charge accompanied the panel.
Dissolution apparatus, Disintegration apparatus, Schimadzu HPLC equipped with binary pump, UV-
spectrophotometer, were available. FTIR spectrophotometer was not available. Calibration status of all the
equipments was due.
No analytical record for the raw material analysis, method verification/validation studies, pharmaceutical
equivalence/CDP, trial batch analysis & stability studies for the above cited products was not provided
IV. Stability Chambers:
Two stability chambers were placed in the incubation room of the microbiology lab. Both the chambers
were found powered off. No sample of any of the trial batch was available in the stability chambers.
(Pictorial evidence is attached.)
V. Documentation:
Trial batch manufacturing record and analytical record of the products under verification was not provided
at the time of inspection. Equipment log books were not available, however some of the entries of analytical
log book were made. (Pictorial evidence is attached.)
Conclusion:
As per the on-site verification inspection of the premises conducted, the personnel met & the verification of
available production and analytical record, the authenticity of submitted Product development and Stability data,
by the firm for registration of above cited products could not be verified at the time of inspection.

Pictorial references:

Minutes of 316th meeting of Registration Board (15-18 March, 2022) | 10
Decision: Registration Board after threadbare deliberations and considering the findings and
recommendations of the panel inspection report decided to reject the below presented
registration applications of M/s Safina Pharmaceuticals (Pvt) Ltd. 17-Km Lahore Sheikhupura
Road, Lahore on following grounds:
• No API /Drug substance was procured and no record of API procurement was available.
• No API/Drug substance was available in the raw material stores & no reference standards
were available in the QC lab
• In Capsule (General) section, capsule filling machine was not available.
• Managing Director of the firm submitted that we outsource the CTD file making.
• No evidence for performance of any analysis on HPLC was provided.
• No sample of any of the trial batch was available in the stability chambers.
• Both the chambers were found powered off. No sample of any of the trial batch was available
in the stability chambers.
• As per the on-site verification inspection of the premises conducted, the personnel met & the
verification of available production and analytical record, the authenticity of submitted
Product development and Stability data, by the firm for registration of above cited products
could not be verified at the time of inspection.
Case No. 01: M/s Safina Pharmaceuticals (Pvt) Ltd. 17-Km Lahore Sheikhupura Road, Lahore.
Firm has submitted copy of DML by way of formulation (No. 000654) to M/s Safina Pharmaceuticals (Pvt) Ltd. 17-
Km Lahore Sheikhupura Road, Lahore dated 09-06-2021. Firm has also submitted a letter for issuance of DML dated
10-06-2021, the letter specifies that CLB in its 279th meeting held on 18th February 2021 has considered and approved
the re-grant of DML in the name of M/s Safina Pharmaceuticals (Pvt) Ltd. Lahore for following sections:
1. Tablet (General)
2. Capsule (General)
3. Topical Cream /ointment & Gel (General)
4. Oral dry powder suspension (cephalosporin) section
5. Capsule (Cephalosporin) section
Now the firm has submitted following applications as per the details mentioned in the table below:
Tablet (General) section: 01 Molecules / 01 Products
1. Name, address of Applicant / Marketing M/s Safina Pharmaceuticals (Pvt) Ltd. 17-Km Lahore
Authorization Holder Sheikhupura Road, Lahore.
Name, address of Manufacturing site. M/s Safina Pharmaceuticals (Pvt) Ltd. 17-Km Lahore
Sheikhupura Road, Lahore.
Status of the applicant ☒ Manufacturer
☐ Importer
☐ Is involved in none of the above (contract giver)
GMP status of the firm Firm has been granted new license (DML) dated 10-06-2021.
Evidence of approval of manufacturing Firm has submitted copy of letter for issuance of DML of M/s
facility Safina Pharmaceuticals (Pvt) Ltd dated 10-06-2021 specifying
capsule (cephalosporin) section. As per the contents of letter
CLB in its 279th meeting has considered and approved the re-
grant of DML by way of formulation.
Status of application ☐ New Drug Product (NDP)
☒ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☐ Domestic sale
☐ Export sale
☒ Domestic and Export sales
Dy. No. and date of submission Dy. No. 3132: 01-02-2022
Details of fee submitted PKR 30,000/-: 30-12-2021
The proposed proprietary name / brand name PARAD 500mg Tablet

Strength / concentration of drug of Active Each tablet contains
Pharmaceutical ingredient (API) per unit Paracetamol…………. 500mg
Pharmaceutical form of applied drug Tablet
Pharmacotherapeutic Group of (API) NSAID
Reference to Finished product specifications BP
Proposed Pack size 20 x 10’s
Proposed unit price As per SRO
The status in reference regulatory authorities (MHRA Approved)
For generic drugs (me-too status) Panadol Tablet by GSK
Name and address of API manufacturer. Saakh Pharma (Pvt) Ltd. C-7/1, North Western Industrial Zone
Port Qasim Karachi.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Firm
has summarized information related to nomenclature, structure,
general properties, solubilities, physical form, manufacturers,
description of manufacturing process and controls, impurities,
specifications, analytical procedures and its validation, batch
analysis and justification of specification, reference standard,
container closure system and stability studies of drug substance
and drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance data related
to nomenclature, structure, general properties, solubilities,
physical form, manufacturers, description of manufacturing
process and controls, impurities, specifications, analytical
procedures and its validation, batch analysis and justification of
specification, reference standard, container closure system and
stability studies of drug substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of drug
(Conditions & duration of Stability studies) substance at both accelerated as well as real time conditions. The
accelerated stability data is conducted at 40°C ± 2°C / 75% ± 5%
RH for 6 months. The real time stability data is conducted at 30°C
± 2°C / 65 ± 5% RH for 36 months.
Module-III Drug Product: Firm has submitted data of drug product including its description,
composition, pharmaceutical development, manufacture,
manufacturing process and process control, process validation
protocols, control of excipients, control of drug product,
specifications, analytical procedures, validation of analytical
procedures, batch analysis, justification of specifications,
reference standard or materials, container closure system and
stability.
Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence has been established against Panadol
Dissolution Profile 500mg tablets of GSK. CDP is with the Same Panadol 500mg
tablets of GSK at three pH i.e. Acidic (1.2), Acetate Buffer (4.5)
& Phosphate Buffer (6.8).
Analytical method validation/verification of Firm has submitted verification studies of the drug substance and
product the drug substance and drug product.
STABILITY STUDY DATA
Manufacturer of API Saakh Pharma (Pvt) Ltd. C-7/1, North Western Industrial Zone Port Qasim Karachi.
API Lot No. 21GN60084
Description of Pack 10x20’s tablets blistered in an Alu-Pvc Blister, then packed in a Unit Carton with leaf

(Container closure system) insert.
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. TR-060 TR-061 TR-062
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 04-2021 04-2021 04-2021
Date of Initiation 20-04-2021 20-04-2021 20-04-2021
No. of Batches 03
DOCUMENTS / DATA TO BE PROVIDED ALONG WITH STABILITY STUDY DATA
1. Reference of previous approval of applications
with stability study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API GMP certificate issued on basis of inspection conducted on
manufacturer issued by concerned regulatory 18-06-2020.
authority of country of origin.
3. Documents for the procurement of API with
approval from DRAP (in case of import).
4. Data of stability batches will be supported by
attested respective documents like
chromatograms, Raw data sheets, COA, summary
data sheets etc.
5. Compliance Record of HPLC software 21CFR &
audit trail reports on product testing
6. Record of Digital data logger for temperature and
humidity monitoring of stability chambers (real
time and accelerated)
2. Name, address of Applicant / Marketing M/s Safina Pharmaceuticals Private Limited., 17-Km Lahore-
Authorization Holder Sheikhupura Road, Sheikhupura.
Name, address of Manufacturing site. M/s Safina Pharmaceuticals Private Limited., 17-Km Lahore-
Sheikhupura Road, Sheikhupura.
☐ Importer
☐ Export sale
GMP status of the firm CLB in its 279th meeting held on 18th February, 2021 has
considered and approved the re-grant of drug manufacturing
license by way of formulation with following sections:
Tablet (General & General Antibiotic) section, General Capsule
Section,
Cream Ointment & Gel,
Cephalosporin (Capsule & Dry Suspension) Section

Dy. No. and date of submission Dy. No. 29547 dated 29-10-2021
Details of fee submitted PKR 30,000/-: dated 20-10-2021
The proposed proprietary name / brand name SINOCEF 125mg / 5ml Dry Suspension
Strength / concentration of drug of Active Each 5ml of reconstituted suspension contains: Cephradine as
Pharmaceutical ingredient (API) per unit monohydrate……….125mg
Pharmaceutical form of applied drug White to almost white granular powder
Pharmacotherapeutic Group of (API) Cephalosporin
Finished product specifications USP
Proposed Pack size 60ml
The status in reference regulatory authorities Velosef 125mg Dry Powder Suspension by M/s Apothecon,
USFDA Approved.
For generic drugs (me-too status) Velosef 125mg Dry Powder Suspension by M/s GSK, Pakistan
Reg. No. 001867
Name and address of API manufacturer. M/s Pharmagen Limited.,
Kot Nabi Bukhwala, 34 km Ferozepur Road Lahore
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template.
Summarized information related to nomenclature, structure,
specifications, analytical procedures and its verification, batch
and drug product is submitted.
Module III (Drug Substance) Official monograph of Cephradine is present in USP. The firm as
submitted detail of nomenclature, structure, general properties,
solubilities, physical form, manufacturers, description of
manufacturing process and controls, specifications, analytical
procedures and its verification, batch analysis and justification of
stability studies of drug substance
Stability studies Stability study conditions:
Real time: 5°C ± 3°C for 36 months
Accelerated: 25°C ± 2°C / 60% ± 5%RH for 6 months
Module-III (Drug Product): The firm has submitted detail of manufacturers, description of
manufacturing process and controls, impurities, specifications,
analytical procedure and its verification studies, batch analysis
and justification of specification, reference standard, container
closure system and stability studies of drug product.
Pharmaceutical equivalence and comparative The firm has submitted performance of pharmaceutical
dissolution profile equivalence of developed formulation Sinocef 125mg/5ml Dry
Suspension (Batch # TR-001) with reference product Velosef
125mg/5ml Dry suspension (Batch # 5V6P) by M/s GSK,
Pakistan by performing quality tests (Identification, Assay,
Uniformity of dosage form).
Analytical method validation/verification of Method verification studies have been submitted including
product linearity, range, accuracy, precision.
Manufacturer of API M/s Pharmagen Limited.,

API Lot No. 00203/186/2020
Description of Pack
Amber Pet Bottle Sealed with PP Cap in unit carton (60ml)
(Container closure system)
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
SINOCEF 125mg / 5ml Dry Suspension
Batch Size 250 Bottles 250 Bottles 250 Bottles
Manufacturing Date 05-03-2021 05-03-2021 05-03-2021
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
1. Reference of previous approval of The firm has not submitted any document.
applications with stability study data of the
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate No.
API manufacturer issued by concerned (06/2019/DRAP (AD/607409 /530) issued by Additional
regulatory authority of country of origin. Director DRAP. It is valid till 07-01-2022.
3. Documents for the procurement of API with The firm has submitted purchase invoice of cephradine
approval from DRAP (in case of import). (micronized) 5Kg from M/s Pharmagen Limited dated 01-03-
2021.
4. Data of stability batches will be supported by The firm has submitted data of stability batches supported by
attested respective documents like attested by respective documents like chromatograms, COA,
chromatograms, raw data sheets, COA, summary data sheets.
summary data sheets etc.
5. Compliance Record of HPLC software Not submitted
21CFR & audit trail reports on product testing
6. Record of Digital data logger for temperature The firm has submitted record of digital data logger for
and humidity monitoring of stability temperature and humidity monitoring of stability chambers (real
chambers (real time and accelerated) time and accelerated).
Sr.# Observations Response by the firm
1. Provide copy of Batch Manufacturing Record The firm has submitted copies of BMR of three
(BMR) for all the batches of drug product for which batches for which stability studies data have been
stability studies data is provided in Module 3 section submitted.
3.2.P.8.3.
2. Drug substance specifications performed by M/s The firm has submitted drug substance
Safina Pharma have not been submitted. specifications as per USP. However, the firm did
Reference for specifications of Assay test must be not submit clarification from drug substance
clarified by Drug substance manufacturer, whether manufacturer.
it is USP or BP, since both limits could not be
applied.
3. Analytical method verification studies submitted Not submitted.
from M/s Pharmagen limited does not include
performance of specificity parameter.

4. Analytical method verification studies including The firm has not submitted method verification of
specificity, accuracy and repeatability (method drug substance. Instead validation report of drug
precision) performed by the Drug Product product is attached.
manufacturer for both compendial as well as non-
compendial drug substance(s) shall be submitted.
5. Submitted COA of drug substance from M/s Safina The firm has submitted that we have performed all
Pharma does not include tests of “Crystallinity”, the tests as per USP monograph. Testing of related
“Related substances” & “Limit of cephalexin”. substances are not available at this time, therefore
we are relying on results of drug substance
manufacturer. COA by M/s Safina is attached which
includes all the compendial tests. However,
analytical procedures for tests of Crystallinity,
Limit of cephalexin, specific rotation were not
described.
6. Submitted COAs of cephradine were both of We have used cephradine micronized in the
compacted and micronized nature. Specify the type formulation of cephradine suspension.
of cephradine used in Oral suspension.
7. Equivalency factor of the Cephradine monohydrate Equivalency factor of 1.05 has been defined.
needs to be defined for cephradine in master
formulation.
8. Compatibility studies for the dry powder for Not submitted.
injections and dry powder for suspension shall be
performed as per the instructions provided in
individual label of the drug product.
9. Submitted specifications mention only Assay limit The firm has revised the assay limits in drug product
of 90% to 120%, whereas USP monograph of specifications as per USP.
“Cephradine for oral suspension” specifies Assay
limits of 90% - 125%.
10. Analytical method verification of drug product does
We have performed the specificity parameter but
not include performance of specificity parameter.the parameter was missed during compiling of the
report.
11. Submit raw data sheets reflecting the details of Not submitted
Standard weight, Sample weight, Potency of
standard and calculation formula applied for the
Assay test.
12. Compliance Record of HPLC software 21CFR & Not submitted.
audit trail reports on product testing.
13. Evidence of purchase of drug substance from M/s The firm has submitted purchase invoice of
Pharmagen limited. cephradine (micronized) 5Kg from M/s Pharmagen
Limited dated 01-03-2021.
☐ Importer
☐ Export sale

Section,
The proposed proprietary name / brand name SINOCEF 250mg / 5ml Dry Suspension
Strength / concentration of drug of Active Each 5ml of reconstituted suspension contains: Cephradine as
Pharmaceutical ingredient (API) per unit monohydrate……….250mg
Pharmaceutical form of applied drug White to almost white granular powder
The status in reference regulatory authorities Velosef 250mg Dry Powder Suspension by M/s Apothecon,
(USFDA Approved).
For generic drugs (me-too status) Velosef 250mg Dry Powder Suspension by M/s GSK, Pakistan
(Reg. No. 001867)
Module III (Drug Substance) Official monograph of Cephradine is present in USP. The firm
has submitted detail of nomenclature, structure, general
properties, solubilities, physical form, manufacturers, description
of manufacturing process and controls, specifications, analytical
Pharmaceutical equivalence The firm has submitted performance of pharmaceutical
equivalence of developed formulation Sinocef 250mg/5ml Dry
Suspension (Batch # TR-004) with comparator product Velosef
250mg/5ml Dry suspension (Batch # FF2W) by M/s GSK,

product linearity, range, accuracy, precision.
API Lot No. 00203/186/2020
Description of Pack
Amber Pet Bottle Sealed with PP Cap in unit carton (60ml)
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
SINOCEF 250mg / 5ml Dry Suspension
No. of Batches 03
firm (if any)
3. Documents for the procurement of API with Firm has submitted purchase invoice of cephradine (micronized)
approval from DRAP (in case of import). 5Kg from M/s Pharmagen Limited dated 01-3-2021.
1. Provide copy of Batch Manufacturing Record The firm has submitted copies of BMR of three
(BMR) for all the batches of drug product for which batches for which stability studies data have
stability studies data is provided in Module 3 section been submitted.
3.2.P.8.3.
Safina Pharma have not been submitted. Reference specifications as per USP. However, the firm
for specifications of Assay test must be clarified by did not submit clarification from drug substance
Drug substance manufacturer, whether it is USP or manufacturer.
BP, since both limits could not be applied.

4. Analytical method verification studies including The firm has not submitted method verification
specificity, accuracy and repeatability (method of drug substance. Instead validation report of
precision) performed by the Drug Product drug product is attached.
5. Submitted COA of drug substance from M/s Safina Firm has submitted that we have performed all
Pharma does not include tests of “Crystallinity”, the tests as per USP monograph. Testing of
“Related substances” & “Limit of cephalexin”. related substances are not available at this time,
therefore we are relying on results of drug
substance manufacturer. COA by M/s Safina is
attached which includes all the compendial tests.
However, analytical procedures for tests of
Crystallinity, Limit of cephalexin, specific
rotation were not described.
6. Submitted COAs of cephradine were both of We have used cephradine micronized in the
compacted and micronized nature. Specify the type formulation of cephradine suspension.
of cephradine used in Oral suspension.
needs to be defined for cephradine in master
formulation.
8. Details of batch numbers of applicant and Velosef 250mg / 5ml Suspension
comparator product in pharmaceutical equivalence Batch number: FF2W
are required to be provided. Sinocef 250mg / 5ml suspension
Batch number: TR-004
10. Submitted specifications mention only Assay limit The firm has revised the assay limits in drug
of 90% to 120%, whereas USP monograph of product specifications as per USP.
“Cephradine for oral suspension” specifies Assay
limits of 90% - 125%.
11. Analytical method verification of drug product does We have performed the specificity parameter
not include performance of specificity parameter. but the parameter was missed during compiling
of the report.
Assay test.
Pharmagen limited. cephradine (micronized) 5Kg from M/s
Pharmagen Limited dated 01-03-2021.
4. Name, address of Applicant / Marketing M/s Safina Pharmaceuticals Private Limited., 17-Km
Authorization Holder Lahore Sheikhupura Road, Sheikhupura.
Name, address of Manufacturing site. M/s Safina Pharmaceuticals Private Limited., 17-Km
Lahore Sheikhupura Road, Sheikhupura.
☐ Importer
☐ Is involved in none of the above

☐ Export sale
considered and approved the re-grant of drug
manufacturing license by way of formulation with
following sections:
Tablet (General & General Antibiotic) section, General
Capsule Section,
The proposed proprietary name / brand name SINOCEF Capsule 250mg
Strength / concentration of drug of Active Each capsule contains:
Pharmaceutical ingredient (API) per unit Cephradine as monohydrate………500mg
Pharmaceutical form of applied drug Hard gelatin capsule
Pharmacotherapeutic Group of (API) Cephalosporin antibiotic
Proposed Pack size 2 × 6’s
The status in reference regulatory authorities Cephradine 250mg hard Gelatin oral capsule of M/s Kent
Pharmaceuticals, MHRA Approved.
For generic drugs (me-too status) Velosef 250mg capsule of M/s GSK, Pakistan
Kot Nabi Bukshwala, 34 Km Ferozepur Road Lahore.
Module-II (Quality Overall Summary) The firm has submitted QOS as per WHO QOS-PD
template. Summarized information related to
nomenclature, structure, general properties, solubilities,
physical form, manufacturers, description of
manufacturing process and controls, impurities,
specifications, analytical procedures and its verification,
batch analysis and justification of specification, reference
standard, container closure system and stability studies of
drug substance and drug product is submitted.
Module III (Drug Substance) Official monograph of Cephradine is present in USP. The
firm has submitted detail of nomenclature, structure,
general properties, solubilities, physical form,
manufacturers, description of manufacturing process and
controls, specifications, analytical procedures and its
verification, batch analysis and justification of
specification, reference standard, container closure system
and stability studies of drug substance
Stability studies Stability study conditions of three batches:

Module-III (Drug Product): The firm has submitted detail of manufacturers, description
of manufacturing process and controls, impurities,
specifications, analytical procedure and its verification
studies, batch analysis and justification of specification,
reference standard, container closure system and stability
studies of drug product.
dissolution profile equivalence of developed formulation Sinocef 250mg
Capsule (Batch # TR-007) with comparator product
Velosef 500mg Capsule (Batch # JR9G) by M/s GSK,
Pakistan by performing quality tests (Identification,
Average weight, LOD, Dissolution, Assay).
The firm has submitted CDP data in 0.1N HCl, pH 4.5 and
buffer pH 6.8. Dissolution achieved 85% in 15% therefore
firm did not calculate similarity factor f2.
Analytical method validation/verification of Method verification studies of drug product have been
product submitted including linearity, range, accuracy, precision.
API Lot No. 00204/023/2021
Description of Pack
Alu-Alu Blister 2 × 6’s
SINOCEF Capsule 250mg
Batch Size 1500 Capsules 1500 Capsules 1500 Capsules
No. of Batches 03
1. Reference of previous approval of applications with The firm has not submitted any document.
stability study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate No.
manufacturer issued by concerned regulatory (06/2019/DRAP (AD/607409 /530) issued by Additional
authority of country of origin. Director DRAP. It is valid till 07-01-2022.
approval from DRAP (in case of import). (compacted) 5Kg from M/s Pharmagen Limited dated 01-
03-2021.
4. Data of stability batches will be supported by The firm has submitted data of stability batches supported
attested respective documents like chromatograms, by attested by respective documents like chromatograms,
raw data sheets, COA, summary data sheets etc. COA, summary data sheets.

5. Compliance Record of HPLC software 21CFR & Not submitted
6. Record of Digital data logger for temperature and The firm has submitted record of digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability chambers
time and accelerated) (real time and accelerated).
1. Therapeutic indications mentioned in introduction of The firm has corrected the therapeutic
QOS were following: indications in section 2.3.1.8 of Quality
Treatment of isotonic extracellular dehydration. overall summary.
Treatment of sodium depletion. Vehicle or diluent of
compatible drugs for parenteral administration.
Safina Pharma have not been submitted. specifications as per USP. However, the firm
Reference for specifications of Assay test must be did not submit clarification from drug
clarified by Drug substance manufacturer, whether it substance manufacturer.
is USP or BP, since both limits could not be applied.
4. Analytical method verification studies including The firm has not submitted method
specificity, accuracy and repeatability (method verification of drug substance. Instead
precision) performed by the Drug Product validation report of drug product is attached.
5. Submitted COA of drug substance from M/s Safina The firm has submitted that we have
Pharma does not include tests of “Crystallinity”, performed all the tests as per USP monograph.
“Related substances” & “Limit of cephalexin”. Testing of related substances are not available
at this time, therefore we are relying on results
of drug substance manufacturer. COA by M/s
Safina is attached which includes all the
compendial tests. However, analytical
procedures for tests of Crystallinity, Limit of
cephalexin, specific rotation were not
described.
6. Submitted COAs of cephradine were both of We have used cephradine compacted in the
compacted and micronized nature. Specify the type formulation of capsules.
of cephradine used in Hard gelatin capsule.
needs to be defined for cephradine in master However, assay value (98.95%) of cephradine
formulation. was not adjusted during dispensing.
8. Dissolution limits mentioned in specifications is The dissolution limit mentioned in
NLT 75% in 45 min while USP states dissolution specifications is same as in USP, only written
limit NLT 75% (Q) of the labeled amount of in shorter format.
cephradine in 45 min. Clarification is required.
9. Analytical method verification of drug product does We have performed the specificity parameter
not include performance of specificity parameter. but the parameter was missed during
compiling of the report.
Assay test.
11. Stability summary sheets include description as 1 × Corrected stability sheet is attached.
30ml bottle packed in unit formula applied for the
assay test.

Pharmagen limited. cephradine (compacted) 5Kg from M/s
☐ Importer
☐ Export sale
Section,
The proposed proprietary name / brand name SINOCEF Capsule 500mg
Pharmaceutical ingredient (API) per unit Cephradine as monohydrate………..500mg
Pharmacotherapeutic Group of (API) Cephalosporin antibiotic
The status in reference regulatory authorities Cephradine 500mg hard Gelatin oral capsule of M/s Kent
Pharmaceuticals, MHRA Approved.
For generic drugs (me-too status) Velosef 500mg capsule of M/s GSK, Pakistan (Reg. No. 030863)
Kot Nabi Bukshwala, 34 Km Ferozepur Road Lahore.

Module III (Drug Substance) Official monograph of Cephradine is present in USP. The firm
of manufacturing process and controls, specifications, analytical
Stability studies Stability study conditions of three batches:
dissolution profile equivalence of developed formulation Sinocef 500mg Capsule
(Batch # TR-010) with comparator product Velosef 500mg
Capsule (Batch # HP7J) by M/s GSK, Pakistan by performing
quality tests (Identification, Average weight, LOD, Dissolution,
Assay).
The firm has submitted CDP data in 0.1N HCl, pH 4.5 and buffer
pH 6.8. Dissolution achieved 85% in 15% therefore firm did not
calculate similarity factor f2.
Analytical method validation/verification of Method verification studies of drug product have been submitted
product including linearity, range, accuracy, precision.
API Lot No. 00204/023/2021
Description of Pack
Alu-Alu Blister 2 × 6’s
SINOCEF Capsule 500mg
No. of Batches 03
firm (if any)

approval from DRAP (in case of import). (compacted) 5Kg from M/s Pharmagen Limited dated 01-03-
2021.
Sr. Observations Response by the firm
No.
1. Therapeutic indications mentioned in introduction of QOS The firm has corrected the therapeutic
were following: indications in section 2.3.1.8 of Quality
Treatment of isotonic extracellular dehydration. Treatment overall summary.
of sodium depletion. Vehicle or diluent of compatible drugs
for parenteral administration.
2. Drug substance specifications performed by M/s Safina The firm has submitted drug substance
Pharma have not been submitted. specifications as per USP. However, the firm
Reference for specifications of Assay test must be clarified did not submit clarification from drug
by Drug substance manufacturer, whether it is USP or BP, substance manufacturer.
since both limits could not be applied.
3. Analytical method verification studies submitted from M/s Not submitted.
Pharmagen limited does not include performance of
specificity parameter.
4. Analytical method verification studies including The firm has not submitted method
specificity, accuracy and repeatability (method precision) verification of drug substance. Instead
performed by the Drug Product manufacturer for both validation report of drug product is attached.
compendial as well as non-compendial drug substance(s)
shall be submitted.
5. Submitted COA of drug substance from M/s Safina Pharma The firm has submitted that we have
does not include tests of “Crystallinity”, “Related performed all the tests as per USP monograph.
substances” & “Limit of cephalexin”. Testing of related substances are not available
at this time, therefore we are relying on results
of drug substance manufacturer. COA by M/s
Safina is attached which includes all the
compendial tests. However, analytical
procedures for tests of Crystallinity, Limit of
cephalexin, specific rotation were not
described.
6. Submitted COAs of cephradine were both of compacted We have used cephradine compacted in the
and micronized nature. Specify the type of cephradine used formulation of capsules.
in Hard gelatin capsule.
7. Equivalency factor of the Cephradine monohydrate needs Equivalency factor of 1.05 has been defined.
to be defined for cephradine in master formulation. However, assay value (98.95%) of cephradine
was not adjusted during dispensing.
8. Dissolution limits mentioned in specifications is NLT 75% The dissolution limit mentioned in
in 45 min while USP states dissolution limit NLT 75% (Q) specifications is same as in USP, only written
in shorter format.

of the labeled amount of cephradine in 45 min. Clarification
is required.
9. Analytical method verification of drug product does not We have performed the specificity parameter
include performance of specificity parameter. but the parameter was missed during
compiling of the report.
10. Submit raw data sheets reflecting the details of Standard Not submitted
weight, Sample weight, Potency of standard and
calculation formula applied for the Assay test.
11. Stability summary sheets include description as 1 × 30ml Corrected stability sheet is attached.
bottle packed in unit formula applied for the assay test.
12. Compliance Record of HPLC software 21CFR & audit trail Not submitted.
reports on product testing.
Pharmagen limited. cephradine (compacted) 5Kg from M/s
6. Name, address of Applicant / Marketing M/s Safina Pharmaceuticals (Pvt.) Ltd., 17 Km, Lahore
Name, address of Manufacturing site. M/s Safina Pharmaceuticals (Pvt.) Ltd., 17 Km, Lahore
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 29543: dated 29-10-2021.
Details of fee submitted PKR 30,000/-: dated 13/07/2021.
The proposed proprietary name / brand name Esosef 20mg Capsule.
Pharmaceutical ingredient (API) per unit Esomeprazole (as enteric coated pellets) ……….. 20mg
Pharmaceutical form of applied drug Oral capsule
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor.
Reference to Finished product specifications USP Specifications.
Proposed Pack size 2 x 7’s.
Proposed unit price As per SRO.
The status in reference regulatory authorities NEXIUM® 20mg & 40mg (esomeprazole magnesium) delayed-
release capsules, USFDA approved.
For generic drugs (me-too status) Xoleso DR capsules 20mg, CKD Pharmaceuticals, R.#089328
GMP status of the Finished product New license granted on 18/02/2021
manufacturer Tablet (General & General Antibiotic) section, General Capsule
Section, Cream Ointment & Gel and Cephalosporin (Capsule &
Dry Suspension) Section approved.
Evidence of section approval. Capsule general section vide No.F.1-43/2006-Lic (Vol-I) dated
10-06-2021.

Name and address of API manufacturer. Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle
Kahuta Road, Islamabad.
and drug product.
Module III (Drug Substance) Firm has submitted data of drug product including its description,
stability.
Stability studies (Drug substance.) Firm has submitted stability study data of 3 batches of drug
substance at both accelerated as well as real time conditions. The
± 2°C / 65 ± 5% RH for 36 months.
Batches: (EMZ044440, EMZ044265 & EMZ044152.)
Module-III (Drug Product): Firm has submitted data of drug product including its description,
stability.
Pharmaceutical equivalence and comparative Firm has submitted results of pharmaceutical equivalence for all
dissolution profile the quality tests for their product against Nexum 20mg Capsule.
Firm has submitted results of CDP for their product against
Nexium 20mg Capsule. The results of f2 factor in all dissolution
medium were within acceptable limit.
product the drug product
Manufacturer of API Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle Kahuta
Road Islamabad.
API Lot No. Could not be confirmed.
Description of Pack
Alu-Alu blister

Batch No. T-013 T-014 T-015
Batch Size 2000 2000 2000
No. of Batches 03
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board.
Administrative Portion
1. Reference of previous approval of applications with stability study data of the firm N/A.
(if any)
2. Approval of API/ DML/GMP certificate of API manufacturer issued by concerned Not submitted.
regulatory authority of country of origin.
3. Documents for the procurement of API with approval from DRAP (in case of
N/A
import).
4. Data of stability batches will be supported by attested respective documents like Submitted
chromatograms, Raw data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & audit trail reports on product Not submitted
testing
6. Record of Digital data logger for temperature and humidity monitoring of stability Submitted
chambers (real time and accelerated)
Remarks by the Evaluator:
Sr. Section Observation Submission by the firm.
No. number
1. 1.5.15 to Only one commitment is given in the module Submitted
1.5.20 which is also not signed and stamped.
2. 1.6.5 Approval of manufacturing facility/ latest GMP GMP certificate is not provided for the drug
certificate of API manufacturer. substance manufacturer.
3. 2.3.R.1.1 Copies of BMRs for those batches for which Submitted
stability studies has been conducted shall be
submitted.
4. Label claim in module 1, 2 & 3 are different from Firm has submitted that it was a drafting mistake.
each other. In module 1, only esomeprazole is The label claim is as under;
written without any salt form while in module 2, Each capsule contains:
label claim is esomeprazole as magnesium Esomeprazole (as magnesium trihydrate enteric
dihydrate is written and in module 3 esomeprazole coated pellets) ……………. 20mg.
as magnesium trihydrate is written. Justification is No fee for variation has been submitted by the firm.
required.
5. 3.2.S.4 • Detailed analytical procedure for the drug Detailed analytical procedure for the drug
substance by the drug product manufacturer substance by the drug product manufacturer is not
shall be provided. provided.
• Analytical method verification studies Submitted.
including specificity, accuracy and
repeatability (method precision) for drug
substance performed by the drug product
manufacturer shall be submitted.
6. 3.2.S.4.4 Batch number of submitted COA of drug Firm has submitted that COA attached in section
substance manufacturer is different from COA 3.2.S.4.4 is the one which is part of DMF. We are
submitted by M/s Safina pharmaceutical. submitting the COA of drug substance which was
Justification is required. used in in the manufacturing of trial batches.
7. 3.2.S.5 Submit COA of reference standard/working Not submitted.
standard use for the drug substance and drug
product stability studies by Safina pharma.

8. 3.2.P.2.2.1 Details of comparator product are not mentioned. Submitted.
Clarification is required.
9. 3.2.P.5 • Detailed method of analysis of drug product Submitted.
performed by the drug product manufacturer
shall be submitted.
• Analytical method for cefalexin is submitted
instead of esomeprazole. Justification is No justification provided.
required.
• Results of analysis of relevant batch(es) of
drug substance performed by drug product Not provided.
manufacturer used during product
development and stability studies along with
COA of the same batch from drug
substance/Active Pharmaceutical ingredient
manufacturer.
10. 3.2.P.5.3 Method validation protocol/studies has not been Validation studies provided by the firm has
submitted. omeprazole concentrations instead of
Esomeprazole.
11. 3.2.P.8.3 • Stability study data of 06 months shall be Firm has submitted 06 months stability studies data
submitted. for both real time and accelerated conditions. They
• API lot No. in stability data sheets have not have also mentioned API lot number in the summary
been mentioned. API lot used in stability data sheets.
could not be confirmed in the dossier. COA of the API lot number used in the stability data
provided by the drug substance manufacturer is not
provided.
Label claim provided in new raw data sheets is for
40mg capsule.
• Raw data sheets for assay provided by the
applicant are for omeprazole instead of Firm has submitted that omeprazole in the raw data
esomeprazole. Justification is required. sheets was mentioned mistakenly while compilation
• Salt factor is not adjusted in the product of data.
development. Justification is required. No reply is submitted by the firm for adjustment of
• Compliance Record of HPLC software 21CFR salt factor.
& audit trail reports on product testing shall be No record for compliance on HPLC software
submitted. 21CFR & audit trail reports on product testing
12. DML is re-granted vide No. F.1-43/2006-Lic No reply is submitted by the firm against this point.
(Vol-I) dated 10-06-2021 with effect from 18-02-
2021 while the analysis of drug substance has been
carried out on 11-02-2021 and the three batches
are manufactured on 17-02-2021. Clarification is
required.
13 • • Control of drug substance has mentioned 90- Firm has submitted that Esomeprazole magnesium
110% of esomeprazole Magnesium w/w by delayed release capsule contain an amount of
HPLC. Justification is required. esomeprazole magnesium equivalent to NLT 90.0%
and NMT 110.0% of the labelled amount of
esomeprazole.
However, no correction in the specification of drug
substance have been provided.
☐ Importer

☐ Export sale
The proposed proprietary name / brand name Esosef 40mg Capsule.
Pharmaceutical ingredient (API) per unit Esomeprazole (as enteric coated pellets) ……….. 40mg
Proposed unit price Rs. 260/-
The status in reference regulatory authorities NEXIUM® 20mg & 40mg (esomeprazole magnesium) delayed-
release capsules, USFDA approved.
For generic drugs (me-too status) Xoleso DR capsules 40mg, CKD Pharmaceutical, R.#089329.
10-06-2021.
and drug product.
Module III (Drug Substance) Firm has submitted detailed data for drug substance data related
to nomenclature, structure, general properties, solubility,
process & controls, impurities, specifications, analytical
± 2°C / 65 ± 5% RH for 36 months.
Batches: (EMZ044440, EMZ044265 & EMZ044152.)

stability.
Pharmaceutical equivalence and comparative Firm has submitted results of pharmaceutical equivalence for
dissolution profile quality tests (Description, identification, uniformity of dosage,
dissolution, assay) for their product against Nexum 40mg
Capsule.
product the drug product.
Road Islamabad.
Description of Pack
Alu-Alu blister
Batch No. T-016 T-017 T-018
Batch Size 2000 2000 2000
No. of Batches 03
1. Reference of previous approval of applications with stability study data of the firm (if N/A.
any)
3. Documents for the procurement of API with approval from DRAP (in case of import). N/A
5. Compliance Record of HPLC software 21CFR & audit trail reports on product testing Not submitted.

Sr.# Section Observation Response by the firm.
1. Label claim in module 1, 2 & 3 are different Firm has submitted that it was a drafting
from each other. In module 1, only mistake. The label claim is as under;
esomeprazole is written without any salt form Each capsule contains:
while in module 2, label claim is esomeprazole Esomeprazole (as magnesium trihydrate
as magnesium dihydrate is written and in enteric coated pellets) ……………. 40mg.
module 3 esomeprazole as magnesium No fee for variation has been submitted by
trihydrate is written. clarification is required. the firm.
2. 1.5.15 to Only one commitment is given in the module Submitted.
3. 1.6.5 Approval of manufacturing facility/ latest GMP GMP certificate is not provided for the
certificate of API manufacturer. drug substance manufacturer.
4. 2.3.R.1.1 Copies of BMRs for those batches for which Submitted.
submitted.
substance by the drug product manufacturer substance by the drug product
shall be provided. manufacturer is not provided.
• Analytical method verification studies
repeatability (method precision) for drug Submitted.
6. 3.2.S.4.4 Batch number of submitted COA of drug Firm has submitted that COA attached in
substance manufacturer is different from COA section 3.2.S.4.4 is the one which is part of
submitted by M/s Safina pharmaceutical. DMF. We are submitting the COA of drug
Justification is required. substance which was used in in the
manufacturing of trial batches.
8. 3.2.P.2.2.1 • Details of comparator product are not Submitted.
mentioned. Clarification is required.
• Comparative dissolution profile is not as per
WHO guidelines.
9. 3.2.P.5 • Detailed method of analysis of drug product Submitted.
performed by the drug product
• Analytical method for cefalexin is
submitted instead of esomeprazole.
Justification is required.
• Results of analysis of relevant batch(es) of No justification provided.
drug substance performed by drug product
manufacturer used during product
development and stability studies along Not provided.
with COA of the same batch from drug
manufacturer.
10. 3.2.P.5.3 Method validation protocol/studies has not been Validation studies provided by the firm has
submitted. omeprazole concentrations instead of
Esomeprazole.
11. 3.2.P.8.3 • Stability study data of drug product for 06 • Firm has submitted 06 months stability
months shall be submitted. studies data for both real time and
accelerated conditions. They have also

• API lot No. in stability data sheets have not mentioned API lot number in the
been mentioned. API lot used in stability summary sheets.
data could not be confirmed in the dossier. • COA of the API lot number used in the
stability data provided by the drug
substance manufacturer is not provided.
• Firm has submitted that omeprazole in
• Raw data sheets for assay provided by the the raw data sheets was mentioned
applicant are for omeprazole instead of mistakenly while compilation of data.
esomeprazole. Justification is required. • No reply is submitted by the firm for
• Salt factor is not adjusted in the product adjustment of salt factor.
development. Justification is required. • No record for compliance on HPLC
• Compliance Record of HPLC software software 21CFR & audit trail reports on
21CFR & audit trail reports on product product testing.
testing shall be submitted.
12. • DML is re-granted vide No. F.1-43/2006- No reply is submitted by the firm against
Lic (Vol-I) dated 10-06-2021 with effect this point.
from 18-02-2021 while the analysis of drug
substance has been carried out on 11-02-
2021 and the three batches are manufactured
on 17-02-2021. Clarification is required.
13. • Control of drug substance has mentioned 90- Firm has submitted that Esomeprazole
110% of esomeprazole Magnesium w/w by magnesium delayed release capsule
HPLC. Justification is required. contain an amount of esomeprazole
magnesium equivalent to NLT 90.0% and
NMT 110.0% of the labelled amount of
esomeprazole.
However, no correction in the
specification of drug substance have been
provided.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Omzole 20mg Capsule.
Pharmaceutical ingredient (API) per unit Omeprazole (as enteric coated pellets) ……….. 20mg

The status in reference regulatory authorities Omeprazole 20mg delayed release capsule, USFDA Approved.
For generic drugs (me-too status) Helezol 20mg Capsule, Focus & Rulz, Reg. No. 027104.
10-06-2021.
and drug product.
± 2°C / 65 ± 5% RH for 36 months.
Batches: (OMP073 only.)
stability.
dissolution, assay) for their product against Rizek 20mg Capsule.
Firm has submitted CDP against Losec in two different mediums.
However, no strength, Batch number, manufacturing date,
Expiry date etc. are mentioned.
Analytical method validation/verification of Not submitted.
product

Road Islamabad.
Description of Pack
Alu-Alu blister
Batch No. T-007 T-008 T-009
Batch Size 2000 2000 2000
No. of Batches 03
any)
5. Compliance Record of HPLC software 21CFR & audit trail reports on product testing Not submitted
No. number
1. 1.5.15 to Only one commitment is given in the module Submitted
2. 1.6.5 Approval of manufacturing facility/ latest GMP GMP certificate is not provided for the
certificate of API manufacturer. drug substance manufacturer.
3. 2.3 Table for literature references for the drug Firm has submitted revised literature
product does not declare the status in references with inclusion of BP and
pharmacopoeia other than USP. European pharmacopoeia.
No fee has been submitted.
submitted.
5. 3.2.S.4 • Detailed analytical procedure for the drug Detailed analytical procedure for the
substance by the drug product manufacturer drug substance by the drug product
shall be provided. manufacturer is not provided.

substance performed by the drug product Submitted
6. 3.2.S.4.4 • COA provided by the finished product • Firm has provided new COA of the
manufacturer has Omeprazole magnesium drug substance having omeprazole
EC pellets. Clarification is required. pellets 8.5% with same batch number
as that of the drug substance
• Batch number of submitted COA of drug manufacturer i.e. OMP792.
substance manufacturer is different from • Firm has submitted that COA attached
COA submitted by M/s Safina in section 3.2.S.4.4 is the one which is
pharmaceutical. Justification is required. part of DMF. We are submitting the
COA of drug substance which was used
in in the manufacturing of trial batches.
8. 3.2.S.7.3 Stability of drug substance is submitted for Stability studies data of only one batch is
Esomeprazole 22.5% submitted.
9. 3.2.P.2.2.1 • Justification for not performing CDP against • Firm has submitted CDP against
innovator product is required. Losec in two different mediums.
However, no strength, Batch number,
manufacturing date, Expiry date etc.
are mentioned.
• Submitted CDP results are for Brizole • No justification is submitted.
capsule of British pharmaceutical.
Furthermore, results are for esomeprazole
40mg is submitted instead of omeprazole
20mg. Clarification is required.
• Details of comparator product used in CDP • No details are provided.
& pharmaceutical equivalence are not
mentioned.
• Average weight in CDP is 138mg the weight • No justification/clarification is
of pellets per capsule is 235mg. clarification submitted.
is required.
• CDP is not as per WHO guidelines. • No justification is submitted.
10. 3.2.P.5 Detailed method of analysis of drug product Submitted.
shall be submitted.
11. 3.2.P.5.3 Method validation protocol/studies has not been Submitted.
submitted.
12. 3.2.P.8.3 • Justification/clarification of the formula used • The firm submitted that stability studies
in calculation of assay and dissolution tests were performed on the available
during stability studies in raw data sheets is resources i.e 10µL injection size, run
required. time and isocratic HPLC system.
• Raw data sheets provided by the firm has However, the variation in the USP
theoretical plates of 3642 to 3670 while the method were validated through method
official monograph has mentioned not less validation studies which are also
than 20,000 plates in column efficiency. provided.
• Run time for the assay in monograph is 25
minutes while the raw data sheets i.e.
chromatograms are for 14 minutes only.
Clarification is requited.
• Average content weight in the raw data sheet
is 87 to 88. Clarification is required. • No clarification is submitted.

• Injection size mentioned in USP monograph is
10µL while the raw data sheets have • No clarification is submitted.
mentioned 20µL. Clarification is required.
• Stability study data of 06 months shall be
submitted.
• API lot No. in stability data sheets have not Stability data is submitted.
been mentioned. API lot used in stability data Furthermore, the average weight
could not be confirmed in the dossier. mentioned in the raw data sheets of assay
• Compliance Record of HPLC software is 86.3mg instead of the actual weight of
21CFR & audit trail reports on product testing 235mg.
shall be submitted.
• This section should be as per the guidance
document.
13. DML is re-granted vide No. F.1-43/2006-Lic No reply is submitted against this point.
(Vol-I) dated 10-06-2021 with effect from 18-
02-2021 while the analysis of drug substance
has been carried out on 16-02-2021.
14. Provide specifications of HPLC system with its Not submitted.
model including information whether gradient
or isocratic column, 21 CFR compliance system.
15. Submitted application has documents of other Firm has submitted that since their
manufacturers. Clarification is required. technical team was compiling the CTD
dossier for the first time, therefore, they
have adopted the already set format of
other companies. Therefore, parts
mistakenly remained unchanged.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Omzole 40mg Capsule.
Pharmaceutical ingredient (API) per unit Omeprazole (as enteric coated pellets) ……….. 40mg

The status in reference regulatory authorities Omeprazole 40mg delayed release capsule, USFDA Approved.
For generic drugs (me-too status) Helezol 40mg Capsule, Focus & Rulz, Reg. No. 051054.
10-06-2021.
and drug product.
± 2°C / 65 ± 5% RH for 36 months.
Batches: (OMP073 only.)
stability.
dissolution, assay) for their product against Rizek 20mg Capsule.
Analytical method validation/verification of Not submitted.
product
Road Islamabad.

Description of Pack
Alu-Alu blister
Batch No. T-010 T-011 T-012
Batch Size 2000 2000 2000
No. of Batches 03
any)
No. number
1. 1.5.15 to Only one commitment is given in the Submitted
1.5.20 module which is also not signed and
stamped.
2. 1.6.5 Approval of manufacturing facility/ latest GMP certificate is not provided for the drug
GMP certificate of API manufacturer. substance manufacturer.
3. 2.3 Table for literature references for the drug Firm has submitted revised literature
product does not declare the status in references with inclusion of BP and European
pharmacopoeia other than USP. pharmacopoeia.
No fee has been submitted.
submitted.
substance by the drug product substance by the drug product manufacturer is
manufacturer shall be provided. not provided.
substance performed by the drug product Submitted

6. 3.2.S.4.4 • COA provided by the finished product • Firm has provided new COA of the drug
manufacturer has Omeprazole magnesium substance having omeprazole pellets 8.5%
EC pellets. Clarification is required. with same batch number as that of the drug
• Batch number of submitted COA of drug substance manufacturer i.e. OMP792.
substance manufacturer is different from • Firm has submitted that COA attached in
COA submitted by M/s Safina section 3.2.S.4.4 is the one which is part of
pharmaceutical. Justification is required. DMF. We are submitting the COA of drug
substance which was used in in the
manufacturing of trial batches.
standard use for drug substance and drug
8. 3.2.S.7.3 Stability of drug substance is submitted for Stability studies data of only one batch is
Esomeprazole 22.5% submitted.
Furthermore, the average weight mentioned in
the raw data sheets of assay is 86.3mg instead
of the actual weight of 235mg.
9. 3.2.P.2.2.1 • Firm has submitted CDP results for Firm has submitted CDP against Losec in two
Brizole capsule. Furthermore, results different mediums. However, no strength,
are for esomeprazole 40mg is submitted Batch number, manufacturing date, Expiry
instead of omeprazole 40mg. date etc. are mentioned.
• Details of comparator product are not
10. 3.2.P.5 Detailed method of analysis of drug product Submitted.
shall be submitted.
11. 3.2.P.5.3 Method validation studies has not been Submitted.
submitted.
12. 3.2.P.8.3 • Raw data sheets provided by the firm has The firm submitted that stability studies were
theoretical plates of 3642 to 3670 while performed on the available resources i.e 10µL
the official monograph has mentioned not injection size, run time and isocratic HPLC
less than 20,000 plates in column system. However, the variation in the USP
efficiency. method were validated through method
• Run time for the assay in monograph is 25 validation studies which are also provided.
minutes while the raw data sheets
(chromatograms are for 14 minutes only.)
• Average content weight in the raw data
sheet is 176 to 178. Clarification is
required.
• Injection size mentioned in USP
monograph is 10µL while the raw data
sheets have mentioned 20µL. Clarification
is required.
• Stability study data of 06 months shall be
submitted. Submitted.
• API lot No. in stability data sheets have Furthermore, the average weight mentioned in
not been mentioned. API lot used in the raw data sheets of assay is 86.3mg instead
stability data could not be confirmed in the of the actual weight of 235mg.
dossier.
13. Compliance Record of HPLC software Not submitted.
21CFR & audit trail reports on product
testing
14. DML is re-granted vide No. F.1-43/2006- Not submitted.
Lic (Vol-I) dated 10-06-2021 with effect
from 18-02-2021 while the analysis of drug
substance has been carried out on 16-02-
2021. Clarification is required.
15. Provide specifications of HPLC system Not submitted.
(elution condition) used during the
development of trial batches.

☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 1451; dated 17-01-2022.
The proposed proprietary name / brand name Safiquine 250mg Tablet.
Strength / concentration of drug of Active Each Film Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Ciprofloxacin HCl Eq. to Ciprofloxacin …… 250mg
Pharmaceutical form of applied drug Film coated Tablet
Pharmacotherapeutic Group of (API) Fluoroquinolones Antibiotic.
The status in reference regulatory authorities CIPRO® 250 mg, 500 mg (ciprofloxacin hydrochloride) film
coated tablets, USFDA Approved.
For generic drugs (me-too status) Ciplet 250mg Tablets, Indus Pharma, Reg. No. 044461.
Evidence of section approval. Tablet general section vide No.F.1-43/2006-Lic (Vol-I) dated 10-
06-2021.
Name and address of API manufacturer. M/s Citi Pharma (Pvt.) Ltd., 3.5 Km, Head Balloki Road, Phool
Nagar, Kasur, Pakistan.
and drug product.

± 2°C / 65 ± 5% RH for 24 months.
Batches: (CPH1904023, CPH2101001, CPH2001001)
stability.
dissolution profile quality tests i.e. (Description, identification, uniformity of
dosage units, dissolution, assay) for their product against
Ciproxin 250mg tablets manufactured by Bayer.
Firm has submitted CDP against the same brand i.e. Ciproxin
250mg tablets manufactured by Bayer pharmaceuticals in three
different mediums of KCl buffer pH 1.2, Acetate buffer pH 4.5
& Phosphate buffer pH 6.8.
and also, the similarity factor (f2) is calculated and found
satisfactory.
Manufacturer of API Zenith Chemical Industries (Pvt.) Limited., Moaza dhonday, Jia
Bagga, raiwind road, Lahore.
API Lot No. CPH2012009.
Description of Pack 1 x 10 film coated tablets blistered in an Alu-Alu Blister, then packed
(Container closure system) in a Unit Carton with leaf insert.
Batch No. TR051 TR052 TR059
Batch Size 1500 1500 1500
No. of Batches 03

1. Reference of previous approval of applications with stability study data of the firm Not submitted.
(if any)
N/A
import).
5. Compliance Record of HPLC software 21CFR & audit trail reports on product Not submitted
testing
Sr. Section Observation Response by the firm.
No. number
1. 1.5.15 to Only one commitment is given in the module Firm has submitted all the undertakings.
2. 1.6.5 Approval of manufacturing facility/ latest GMP Firm has submitted copy of DML of M/s Citi
certificate of drug substance manufacturer shall pharma, Kasur issued on 27-02-2013.
be submitted. However, Valid DML/latest GMP certificate of
the drug substance manufacturer is not
submitted
3. 3.2.S.4.2 • Analytical method for assay test is only Submitted.
provided. Detailed analytical method for all
the tests shall be provided.
• Analytical method for drug substance Safina has performed the testing as per latest
provided by the drug product manufacturer is USP43 whereas the tests performed by the
different from that of drug substance manufacturer based on USP 32.
manufacturer. Clarification is required.
4. 3.2.S.7.3 Real time stability studies of only 09 months for Only 09-month real time stability study for B#
the batch No. CPH21011001 has been provided. CPH21011001 has been provided.
Complete real time stability studies for all the Manufacturing date of the said batch is January,
three batches shall be submitted. 2021.
5. 3.2.P.R Justify the dispensing of drug substance for trial The substance carries the additional water
batch manufacturing as theoretical factor and content in addition to its salt form therefore the
actual water content both are applied. assay has been adjusted accordingly.
6. 3.2.P.2.2.1 • In comparative dissolution profile, KCl • The 1.2 HCl/KCl buffer which is mentioned
buffer pH 1.2 is used. Clarification is as KCl buffer. The composition is pH 1.2
required. HCl/KCl Buffer. Take 2 gm KCl in 1000ml
• CDP is not as per WHO guidelines. of water. Adjust pH with HCl.
• Justification of not performing CDP at 15 • No clarification submitted.
mint time point. • No clarification submitted.
7. 3.2.P.8.3 This section is not as per guidance document. Safina has been re-granted the DML hence no
Reference of previous approval of applications previous reference is available for approval of
with stability study data of the firm (if any) applications with stability data.
8. 3.2.P.8.3 • Analytical method used for assay test of drug • Both the formula are statistically similar and
product provided by the drug product used for normalization.
manufacturer has the same method as that of
USP. However, formula used for assay test in
the raw data sheets is completely different
from USP monograph.
• Justification/clarification of the formula
used in calculation of assay and dissolution
tests during stability studies in raw data
sheets is required.

• Concentration of standard solution in raw • Concentration used other than pharmacopeia
data sheets is not as per USP monograph. concentrations has been demonstrated
Clarification is required. through method verification studies
• Average content weight in the raw data sheet • Average weight of base was declared on raw
for assay test is 250. Clarification is required. data sheet.
Formula used for calculation of assay provided
• Compliance Record of HPLC software by the firm has mentioned average weight of the
21CFR & audit trail reports on product tablet instead of weight of the base.
testing shall be submitted. • Not submitted.
• Analytical record for dissolution test shall be • No record for dissolution is provided.
provided. • The acquired dates on calculation sheets may
• Two acquired dates are mentioned on the raw have been due to typographical mistakes.
data sheets for assay test. Clarification is
required.
9. Provide specifications of HPLC system with its Shimadzu LC-10Avp High pressure binary
model including information whether gradient or gradient with Lab solution software.
isocratic column, 21 CFR compliance system.
10. In method verification studies 0.5mg/ml The concentrations mentioned in the table in the
concentration has an area of 4236389 while in report were typographical error. Firm has
raw data sheets, same concentration has an area provided new verification studies.
of 8822063. Clarification is required.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Safiquine 500mg Tablet.
Pharmaceutical form of applied drug Film coated Tablet
The status in reference regulatory authorities CIPRO® 250 mg, 500 mg (ciprofloxacin hydrochloride) film
coated tablets, USFDA Approved.
For generic drugs (me-too status) Ciplet 500mg Tablets, Indus Pharma, Reg. No. 044462.
manufacturer

06-2021.
and drug product.
± 2°C / 65 ± 5% RH for 24 months.
Batches: (CPH1904023, CPH2101001, CPH2001001)
stability.
dissolution profile quality tests i.e. (Description, identification, uniformity of
dosage units, dissolution, assay) for their product against
Ciproxin 500mg tablets manufactured by Bayer.
Firm has submitted CDP against the same brand i.e. Ciproxin
500mg tablets manufactured by Bayer pharmaceuticals in three
and also, the similarity factor (f2) is calculated and found
satisfactory.
API Lot No. CPH2012009.

Description of Pack 1 x 10 film coated tablets blistered in an Alu-Alu Blister, then packed
(Container closure system) in a Unit Carton with leaf insert.
Batch Size 1500 1500 1500
No. of Batches 03
1. Reference of previous approval of applications with stability study data of the firm Not submitted.
(if any)
N/A
import).
No. number
1. 1.5.15 to Only one commitment is given in this Firm has submitted all the undertakings.
stamped.
2. 1.6.5 Approval of manufacturing facility/ latest Firm has submitted copy of DML of M/s Citi
GMP certificate of drug substance pharma, Kasur issued on 27-02-2013.
manufacturer shall be submitted. However, Valid DML/latest GMP certificate of the
drug substance manufacturer is not submitted
3. 3.2.S.4.2 • Analytical method for assay test is only Submitted.
provided. Detailed analytical method for
all tests shall be provided.
• Analytical method for drug substance
provided by the drug product Safina has performed the testing as per latest
manufacturer is different from that of USP43 whereas the tests performed by the
drug substance manufacturer. manufacturer based on USP 32.
4. 3.2.S.7.3 Real time stability studies of only 09 Only 09-month real time stability study for B#
months for the batch No. CPH21011001 CPH21011001 has been provided. Manufacturing
has been provided. Complete real time date of the said batch is January, 2021.
stability studies for all the three batches
shall be submitted.

5. 3.2.P.R Justify the dispensing of drug substance for The substance carries the additional water content
trial batch manufacturing as theoretical in addition to its salt form therefore the assay has
factor and actual water content both are been adjusted accordingly.
applied. Clarification is required.
6. 3.2.P.2.2.1 • In comparative dissolution profile, KCl The 1.2 HCl/KCl buffer which is mentioned as KCl
buffer pH 1.2 is used. Clarification is buffer. The composition is pH 1.2 HCl/KCl Buffer.
required. Take 2 gm KCl in 1000ml of water. Adjust pH with
• CDP is not as per WHO guidelines. HCl.
• Justification of not performing CDP at • No clarification submitted.
15 mint time point. • No clarification submitted.
7. 3.2.P.8.3 • This section is not as per guidance Safina has been re-granted the DML hence no
document. previous reference is available for approval of
• Reference of previous approval of applications with stability data.
applications with stability study data of
the firm (if any)
8. 3.2.P.8.3 • Analytical method used for assay test of • Both the formula are statistically similar and
drug product provided by the drug used for normalization.
product manufacturer has the same
method as that of USP. However,
formula used for assay test in the raw
data sheets is completely different from
USP monograph. • Concentration used other than pharmacopeia
• Justification/clarification of the concentrations has been demonstrated through
formula used in calculation of assay and method verification studies
dissolution tests during stability studies • Average weight of base was declared on raw
in raw data sheets is required. data sheet.
• Concentration of standard solution in Formula used for calculation of assay provided by
raw data sheets is not as per USP the firm has mentioned average weight of the tablet
monograph. Clarification is required. instead of weight of the base.
• Not provided.
sheet for assay test is 500. Clarification • Not submitted.
is required.
• Raw data sheets for assay test shall be • No record for dissolution test is provided.
provided. • The acquired dates on calculation sheets may
• Compliance Record of HPLC software have been due to typographical mistakes.
testing shall be submitted.
• Analytical record for dissolution test
shall be provided.
• Two acquired dates are mentioned on
the raw data sheets for assay test.
9. Provide specifications of HPLC system Shimadzu LC-10Avp High pressure binary
with its model including information gradient with Lab solution software.
whether gradient or isocratic column, 21
CFR compliance system.
10. In method verification studies 0.5mg/ml The concentrations mentioned in the table in the
concentration has an area of 4236389 while report were typographical error. Firm has provided
in raw data sheets, same concentration has new verification studies.
an area of 8822063. Clarification is
required.

☐ Importer
☐ Export sale
The proposed proprietary name / brand name Safpain 200mg Tablet.
Strength / concentration of drug of Active Each sugar-Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Ibuprofen …… …………….. 200mg
Pharmaceutical form of applied drug Oral Tablet
Pharmacotherapeutic Group of (API) NSAID.
Reference to Finished product specifications BP specifications.
The status in reference regulatory authorities Anadin Ibuprofen 200 mg Tablets, MHRA approved.
For generic drugs (me-too status) Arufen 200mg tablets, Progressive Laboratories, Reg. No.
10532.
06-2021.
Name and address of API manufacturer. Zenith Chemical Industries (Pvt.) Limited., Moaza dhonday, Jia
and drug product.

± 2°C / 65 ± 5% RH for 36 months.
Batches: (ZIBU11-001, ZIBU11-002, ZIBU11-003)
stability.
dissolution profile quality tests (Description, identification, uniformity of dosage
units, dissolution, assay) for their product against Brufen 200mg
tablets manufactured by Abbott.
Firm has submitted CDP against the same brand i.e. Brufen
200mg tablets manufactured by Abbott pharmaceuticals in three
API Lot No. ZIBU20-033.
Description of Pack
Alu-Pvc blister
Batch Size 1500 1500 1500
No. of Batches 03
1. Reference of previous approval of applications with stability study data of the firm (if Not submitted.
any)

No. number
1. 1.5.15 to Only one commitment is given in the Firm has submitted all the undertakings.
stamped.
2. 1.6.5 Approval of manufacturing facility/ latest Not submitted.
GMP certificate of drug substance
3. 3.2.S.4.4 • Justification shall be provided for The tests specified in the BP monograph were
incomplete analyses of the drug performed and are mentioned in the SAP
substance / API by Drug Product attached in module 3. COA of API with all the
manufacturer. i.e. Test for appearance performed tests and results is provided.
of solution, results of melting point & Initially all tests were not performed by the
optical rotation. finished product manufacturer.
4. 3.2.S.7.1 Condition mentioned on stability Mentioned conditions in a summary protocol
summary protocol are not as per zone IV- are an error. The stability reports provided of
A. the API batches shows the conditions as per
zone IV –A.
No new protocol is submitted by the firm.
5. 3.2.P.2.2.1 • In comparative dissolution profile, • The 1.2 HCl/KCl buffer which is
KCl buffer pH 1.2 is used. mentioned as KCl buffer. The composition
Clarification is required. is pH 1.2 HCl/KCl Buffer
Take 2 gm KCl in 1000ml of water. Adjust
pH with HCl.
• CDP has mentioned preparation of • No clarification is submitted.
standard solution for ciprofloxacin.
• CDP is not as per WHO guidelines. • No clarification is submitted.
• Justification of not performing CDP at • No clarification is submitted.
15 mint time point.
6. 3.2.P.4.2 Analytical method provided by the The analytical method is as per BP 2019. The
finished product manufacturer for assay BP monograph is also provided.
test is different from that in the However, no clarification is provided by the
pharmacopoeia. Clarification is required. firm.
7. 3.2.P.3.3 Manufacturing method provided by the Firm has provided new manufacturing method
finished product manufacturer has no with inclusion of coating process and also
coating step and also include some stated that some of the inactive were specified
inactive that are not included in the with brand names e.g. Promogel (Sodium
formulation development. Clarification is starch glycolate) which we have corrected with
required. generic nomenclature.
8. 3.2.P.8.3 This section is not as per guidance Firm has submitted that M/s Safina pharma has
document. been re-granted the DML hence no previous
Reference of previous approval of reference is available for approval of
applications with stability study data of the applications with stability data
firm (if any)
9. 3.2.P.8.3 • Justification/clarification of the • Both the formula are statistically similar and
formula used in calculation of assay used for normalization.

and dissolution tests during stability
studies in raw data sheets is required. • Concentration used other than pharmacopeia
• Concentration of standard solution in concentrations has been demonstrated
raw data sheets is not as per BP through method verification studies.
monograph. Clarification is required. • No justification is submitted.
sheet for assay test is 199 to 201.
Clarification is required. • Not provided.
• Raw data sheets for assay shall be
provided. • Not submitted.
• Compliance Record of HPLC software
21CFR & audit trail reports on product • No analytical record for dissolution is
testing shall be submitted. provided.
• Analytical record for dissolution test • The acquired dates on calculation sheets may
shall be provided. have been due to typographical mistakes.
• Two acquired dates are mentioned on
the raw data sheets for assay test.
10. Provide specifications of HPLC system Shimadzu LC-10Avp High pressure binary
with its model including information gradient with Lab solution software
whether gradient or isocratic column, 21
CFR compliance system.
Status of the applicant ☐ Manufacturer
☒ Importer
☐ Export sale
The proposed proprietary name / brand name S-XIME 400mg Capsule
Strength / concentration of drug of Active Each capsule Contains:
Pharmaceutical ingredient (API) per unit Cefixime as trihydrate………400mg
Pharmaceutical form of applied drug A white to slightly yellow granular powder filled in hard gelatin
capsule.
Pharmacotherapeutic Group of (API) Cephalosporin Antibiotic
Reference to Finished product specifications JP specification

Proposed Pack size 1x5’s
The status in reference regulatory authorities Cefixime 400mg capsule (MHRA Approved)
For generic drugs (me-too status) Cefim Capsule by Hilton
Name and address of API manufacturer. Pharmagen Limited. Kot Nabi Bukshwala, 34 Km, Ferozepur
Road, Lahore.
and drug product.
± 2°C / 65 ± 5% RH for 36 months.
stability.
Pharmaceutical Equivalence and Comparative Firm has submitted results of pharmaceutical equivalence of their
Dissolution Profile product against Cefspan 400mg capsule.
CDP studies are only conducted at one time point.
Manufacturer of API Pharmagen Limited. Kot Nabi Bukshwala, 34 Km, Ferozepur Road, Lahore.
API Lot No. 00244-020-2021
Description of Pack
Alu-alu blister
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH

Batch Size 1500 capsule 1500 capsule 1500 capsule
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate issued by
manufacturer issued by concerned regulatory Additional Director DRAP dated 11-01-2019 based on the
authority of country of origin. inspection dated 08-01-2019.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice dated 10-03-
approval from DRAP (in case of import). 2021 specifying purchase of 2.5Kg each of Cefixime
(compacted) Lot No. 00244/020/2021 and Cefixime
(micronized) Lot No. 00243/026/2021 from Pharmagen
Limited.
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches along with
attested respective documents like raw data sheets, COA and summary data sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted that we have already provided
audit trail reports on product testing compliance record of HPLC 21 CFR compliance however no
such data is provided by the firm
6. Record of Digital data logger for temperature and The record of data logger for temperature and humidity
humidity monitoring of stability chambers (real provided by the firm
Evaluation by PEC:
Shortcomings communicated Response by the firm
Submit data in section 3.2.S.4.1 as per the guidance Firm has submitted copy of drug substance specifications
document approved by Registration Board which and analytical method from both drug substance
specifies that “Copies of the Drug substance manufacturer and drug product manufacturer.
specifications and analytical procedures used for routine
testing of the Drug substance /Active Pharmaceutical
Ingredient by both Drug substance & Drug Product
manufacturer is required.”
You have claimed JP specifications for the drug product Drug substance specifications can be different from drug
and have used drug substance complying USP product specifications, provided that specifications are
specifications. Justification is required in this regard. present in official monograph. So drug product was tested
and released as per official USP specifications and drug
product is only available in JP so JP specifications were
adopted for drug product.
Submit data in section 3.2.S.4.3 as per the decision of The initially submitted data of verification studies
293rd meeting of Registration Board, which states that performed by Safina Pharma was evaluated and upon
“Analytical Method Verification studies including communication of observations.
specificity, accuracy and repeatability (method precision) Now in the firm has again submitted verification studies
performed by the Drug Product manufacturer for both in which the issue date of document has been changed
compendial as well as non-compendial drug substance(s) from 17-02-2021 to 14-02-2021 and the firm has also
shall be submitted”. Further justify how the analysis of changed some values in linearity however the results of
drug substance was conducted without performing accuracy and recovery is still the same. Firm has not
verification studies of the analytical method of drug submitted any justification for this.
substance.
Submit data in section 3.2.S.4.4 as per the guidance Firm has initially submitted COA from Safina Pharma for
document approved by Registration Board which batch No. 00244-020-2021 in which material was

specifies that “Provide results of analysis of relevant received on 12-03-2021 and the analysis was performed
batch(es) of Drug Substance performed by Drug Product on 13-03-2021 having GRN No. 605 and QC No. QC-
manufacturer used during product development and 004.
stability studies, along with Certificate of Analysis (CoA) Now M/s Safina Pharma has submitted a new COA of the
of the same batch from Drug Substance / /Active same drug substance having same batch number, same
Pharmaceutical Ingredient manufacture, since the date of receiving as well as testing and same QC and
submitted COA of three batches of API are of different GRN number but with different results for all tests. Firm
batches than that used in the manufacturing of stability has not submitted any justification for this change.
batches.
Submit COA of reference standard actually used in the Firm has submitted COA of working standard Batch No.
analysis of drug substance in section 3.2.S.5. WS/cefixime/074. Mfg date 15 February 2021 and use
before 14 May 2021. Firm has not justified how they will
perform the stability test for 3rd and 6th month time point
since they were in June 2021 and September 2021.
Justify why the developed formulation is qualitatively Since compacted form of cefixime has been used in the
different from the innovator product, the innovator formulation therefore only starch is used as a filler,
product has used colloidal silicon dioxide, crospovidone, furthermore the pharmaceutical equivalence with the
low substituted hydroxy propyl cellulose, magnesium reference product does not show any significant
stearate and mannitol as excipient while in your difference in physical and chemical parameters.
developed formulation only starch is used as excipient. The response of the firm is not scientifically justified
keeping in view the composition of innovator product.
Justify how 470mg drug substance per capsule in your Label claim: Each capsule contains cefixime as trihydrate
formulation is equivalent to 400mg of cefixime 400mg
Below are the adjustment which make he capsule
equivalent to 470mg
Water contents: 12%
Potency: 99%
Overage: 4%
The overage was added to overcome the process loss due
to small batch size. However, in commercial batches no
overage will be added.
Firm has still not justified how 470mg powder per
capsule will be equivalent to 400mg cefixime base as
well as the use of overage in trial batches.
Justify why all tests mentioned in JP monograph are not Related substances and impurities testing was not
performed during pharmaceutical equivalence studies. available.
However, firm has also not performed complete testing
other than these tests as well.
Submit comparative dissolution profile of your product Firm has submitted new results of CDP studies against
against the innovator product. the Cebosh Capsule of Bosch Pharma. The currently
submitted results show that 106.02% of the drug was
released in 90 minutes at 6.8pH while in previously
submitted data the drug released in 90 minutes at same
medium was 85.42%. Significant difference in the results
were not justified by the firm.
Justify the performance of comparative dissolution Multiple point testing was performed but in final report
profile in which the study design and protocols including only concluding results were added. Multiple point
dissolution medium and sampling time points are not in results are being attached.
line with the WHO guidelines. The multiple point results submitted by the firm are
completely different from that previously submitted as
concluding results.
Fill weight mentioned in section 3.2.P.1 is 470mg while The weight 625mg mentioned in process validation
the fill weight mentioned in process validation protocols protocol is the average weight of the capsule whereas
is 625mg. Justification is required in this regard. 470mg is the quantity of active material.
Justify the drug product specifications in light with JP Firm has submitted revised specifications without
monograph. Your specifications are not appropriately submission of fee.

written since it does not specify the criteria for uniformity
of dosage units, and complete acceptance criteria for
dissolution test and assay. Further you have mentioned
assay limits from 90 – 120% which is contrary to that
recommended in JP monograph. Revise your
specifications in line with official pharmacopoeia along
with submission of applicable fee.
Justify your analytical method and acceptance criteria for Analytical method variations as required are being
dissolution test since both parameters are different from justified with analytical method verification. Since UV
that specified in JP monograph. Further justify how you method was found in line with HPLC method data, hence
have performed dissolution test using UV method since UV method was adopted for dissolution test only.
HPLC method have been recommended in JP Firm has not any data which supports the claim of the
monograph. firm.
Justify your analytical method for assay testing of the Variations as per available resources has been justified
drug product which is different from that recommended due to analytical method verification.
in JP monograph. Firm has not any data which supports the claim of the
firm.
As per the analytical method validation report of the drug Firm has not submitted any response against this
product, the average area of standard solution at 100% observation
concentration is 13803191 while as per the stability study
data the average area of standard solution using the same
method is 5438419.6. Justify how this significant
difference in peak area can exist during the same analysis
using similar methods and how the analytical method can
be considered verified.
The accuracy studies have been performed at three Testing was performed as 80%, 100% and 120% in
different concentrations i.e. 80%, 100% and 120% in actual. Data was reported as normalized as 80% = 320mg,
which you have used 320mg, 400mg and 480mg instead 100% = 400mg and 120% = 480mg. So it is an only
of using 80%, 100% and 120% of the standard solution reporting convention.
as per applicable guidelines. Justification is required how
the method can be considered accurate when the accuracy The response of the firm is not justified as per the
studies are not conducted as per the guidelines. guidelines.
Submit complete protocols including analytical method Firm has again submitted the analytical method only,
for the testing, method including details of sample while the complete protocols are not yet submitted.
preparations for each step in the analytical method
verification studies.
Justify how the batch TR-019, TR-020 and TR-021 were Typo error.
released after signature of analyst and manager quality However firm has not submitted any corrected document.
control with remarks that “the product complies JP
specifications” while the dissolution acceptance criteria
is totally different from that specified in section 3.2.P.5.2
and that assay limit is also not as per JP monograph.
Furthermore the assay acceptance criteria specifies 90%
to 120% of the labelled amount of cephradine, instead of
cefixime.
The COA of Batch No. 00244/020/2021 issued by drug As drug substance specifications are available in both
substance manufacturer specifies that the product current BP & USP official monograph they can be used
complies BP specifications, while the COA generated by interchangeably.
Safina Pharma for the same batch specifies that the The response of the firm is not justified under any
product complies USP specifications and Safina pharma scientific guideline.
has also changed the limit for assay test. Justify how the
drug product manufacturer can release the batch of drug
substance using different specifications from that
claimed by drug substance manufacturer.
JP monograph specifies that the retention time should be Variations are being justified as method verification with
10 minutes, while the retention time in your submitted deliberate minor changes as per ICH guidelines.

results is 7 to 8 minutes. Justify how the method can be Firm has not any data which supports the claim of the
considered as per JP monograph. firm. Moreover, such difference is also not scientifically
justified.
Justify the broad peaks obtained in your stability studies Appearance of the said peak was due to reduced graph
and you have not determined system suitability using scale window. System suitability results were not added
number of theoretical plates and the symmetry factor as due to printing space constrains. Firm has now submitted
recommended by JP monograph. only 1 chromatograph.
Justify why the formula used for calculation of assay Formula used was normalized and is statistically
results of stability studies is different from that significant.
mentioned in section 3.2.P.5.2 and JP monograph.
In the formula for calculation of assay during stability Normalized label claim is used as 100% = 400mg, 100
studies, the label claim is mentioned as 100mg should be considered as 100% eq to 400mg label claim.
throughout all time points in all batches. Justify how the
results obtained for 100mg label claim can be considered
for 400mg label claim.
The average area of standard solution for batch TR019 at System variations at different time points if justified by
initial time point is 7792583.8 while the average area of applying 5 standard injections with each testing point.
standard solution for batch TR021 is 5680712.8. Justify
how such significant difference in peak area exist in
different batches at same concentration of standard
solution tested on same day.
Justify the dissolution specifications of NLT 80% in 90 Firm has replied that as innovator formulation was used,
minutes, since the JP monograph specifies this limit only and equivalency was justified so it was considered same
for 100mg potency capsule. for the 400mg potency capsule as well. However, firm
has not used the innovator formulation, neither the
equivalency was established against innovator product by
performing complete tests
The USFDA review of innovator product of cefixime Firm has replied that Comparative dissolution profile of
400mg capsule reveals that the acceptance criteria for innovator product is same and in line with S-xime 400mg
dissolution test should be NLT (Q) in 45 minutes using capsule, so equivalency can be established.
7.2pH phosphate buffer. Justify how your product may However, firm has not used the innovator product for
considered equivalent to the innovator product. studying CDP, moreover the dissolution medium is
different and therefore results of CDP cannot be related
to the dissolution test results..
Submit copy of commercial invoice for evidence of Firm has submitted copy of commercial invoice dated 10-
purchase of each batch of drug substance that have been 03-2021 specifying purchase of 2.5Kg each of Cefixime
used in the analysis of each batch of drug product. (compacted) Lot No. 00244/020/2021 and Cefixime
Limited.
Compliance Record of HPLC software 21CFR & audit Firm has submitted that we have already provided
trail reports on product testing. compliance record of HPLC 21 CFR compliance
however no such data is provided by the firm
Oral dry powder suspension (cephalosporin) section: 01 Molecules / 02 Products

☒ Importer

☐ Export sale
The proposed proprietary name / brand name S-XIME 100mg/5ml Dry suspension
Strength / concentration of drug of Active Each 5ml of reconstituted suspension Contains:
Pharmaceutical form of applied drug A slightly pink color granular powder filled in PET bottle
Reference to Finished product specifications USP specification
The status in reference regulatory authorities Cefixime 100mg/5ml suspension (USFDA Approved)
For generic drugs (me-too status) Cefim suspension by Hilton
Road, Lahore.
and drug product.
± 2°C / 65 ± 5% RH for 36 months.

stability.
Dissolution Profile product against Cefspan 100mg/5ml suspension.
API Lot No. 00243-026-2021
Description of Pack
Pet bottle
No. of Batches 03
Limited.
data sheets etc.
Evaluation by PEC:

293rd meeting of Registration Board, which states that performed by Safina Pharma.
“Analytical Method Verification studies including Now in the firm has again submitted verification studies
specificity, accuracy and repeatability (method precision) in which the issue date of document has been changed
performed by the Drug Product manufacturer for both from 17-02-2021 to 14-02-2021 and the firm has also
compendial as well as non-compendial drug substance(s) changed some values in linearity however the results of
shall be submitted”. Further justify how the analysis of accuracy and recovery is still the same. Firm has not
drug substance was conducted without performing submitted any justification for this.
verification studies of the analytical method of drug
substance.
batch(es) of Drug Substance performed by Drug Product on 13-03-2021.
manufacturer used during product development and
stability studies, along with Certificate of Analysis (CoA)
of the same batch from Drug Substance / /Active
Pharmaceutical Ingredient manufacture, since the
submitted COA of three batches of API are of different
batches than that used in the manufacturing of stability
batches.
perform the stability test for 3rd and 6th month time point
since they were in June 2021 and September 2021.
The developed formulation contains 704mg drug (6x100x1.12 as trihydrate factor) + assay adjustment +
substance per bottle of 30ml having 6 doses each of 5ml process loss during dispensing and mixing = 704mg of
of the drug after reconstitution. Justify how 704mg of cefixime trihydrate.
drug substance per 6 doses will make 100mg cefixime Firm has still not justified how 704mg of drug substance
per dose. per 6 doses will make 100mg cefixime per dose as well
as the use of overage in trial batches.
The developed formulation is available in 30ml bottle, Comparator products are with 30ml bottle
while the innovator product is available in 50ml, 75ml
and 100ml bottle size only. Justify how your formulation
will deliver equal number of doses as delivered by the
innovator product.
Provide details of the reconstitution of your product prior Measuring cup of 10mL capacity was added in unit pack.
to administration including details of type of diluent and So adding 1 cup = 10ml of previously boiled and cooled
exact volume of diluent. water reconstitutes to final volume of 30ml suspension.
The reconstitution volume mentioned by the firm does
not produce the same concentration of drug as that of the
innovator product.
Justify why pharmaceutical equivalence was not Related substances and impurities testing was not
performed by performing all tests as recommended in available.
USP monograph. However firm has also not performed complete testing

Justify why drug release studies / comparative CDP is not mandatory for suspension and drug release is
dissolution studies were not performed to justify your not included in USP monograph.
formulation development process.
Submit data of compatibility studies of the drug product Firm has submitted results of compatibility studies of the
with recommended diluent in section 3.2.P.2.6. drug product with diluent.
Justify why the test for deliverable volume is not added The test was performed and mentioned in the test reports
in specifications as recommended in USP monograph. attached with the stability studies data. However, it was
Revise your specifications as per USP monograph along mistakenly missed in the specifications provided in the
with submission of applicable fee. dossier. The detailed specifications and testing method is
submitted by the firm.
Provide detailed method of analysis of the drug product Firm has submitted detailed method of analysis of the
in section 3.2.P.5.2 instead of providing copy of USP-32 drug product.
monograph which is entirely different from that of USP-
43.
Provide detailed method of analysis as well as complete Firm has not submitted protocols for the verification
protocols for each test in the verification studies of the studies.
drug product. Submit detailed results for the verification
studies of the analytical method as per USP monograph.
method is 5547269. Justify how this significant
Justify how drug substance complying BP specifications Firm has not submitted any justification against this
can be used to develop a product complying USP point.
specifications.
JP monograph specifies that the retention time should be The product complies USP specifications.
10 minutes, while the retention time in your submitted
results is 7 to 8 minutes. Justify how the method can be
considered as per JP monograph.
Justify why you have not determined system suitability The submitted format of chromatogram does not depict
using number of theoretical plates and the symmetry the theoretical plates and the tailing factor. However, a
factor as recommended by USP monograph. typical chromatogram with all the parameters is now
provided by the firm.

standard solution for the same batch is 5547269. Justify
how such significant difference in peak area exist at same
concentration of standard solution.
The injection volume specified in USP monograph is The stability studies were performed on the available
10µL while the injection volume as per your analysis is resources i.e. 10μL injection size, However, the
20 µL. Justification is required in this regard. variations in the USP method were validated through
method validation studies which are also provided.
Limited.
☒ Importer
☐ Export sale
The proposed proprietary name / brand name S-XIME 200mg/5ml Dry suspension
Strength / concentration of drug of Active Each 5ml of reconstituted suspension Contains:
Pharmaceutical form of applied drug A slightly pink color granular powder filled in PET bottle
Reference to Finished product specifications USP specification
The status in reference regulatory authorities Cefixime 100mg/5ml suspension (USFDA Approved)
For generic drugs (me-too status) Cefim suspension by Hilton

Road, Lahore.
and drug product.
± 2°C / 65 ± 5% RH for 36 months.
stability.
Dissolution Profile product against Cefspan 100mg/5ml suspension.
API Lot No. 00243-026-2021
Description of Pack
Pet bottle
No. of Batches 03

Limited.
data sheets etc.
Evaluation by PEC:
293rd meeting of Registration Board, which states that performed by Safina Pharma.
“Analytical Method Verification studies including Now in the firm has again submitted verification studies
specificity, accuracy and repeatability (method precision) in which the issue date of document has been changed
performed by the Drug Product manufacturer for both from 17-02-2021 to 14-02-2021 and the firm has also
compendial as well as non-compendial drug substance(s) changed some values in linearity however the results of
shall be submitted”. Further justify how the analysis of accuracy and recovery is still the same. Firm has not
drug substance was conducted without performing submitted any justification for this.
verification studies of the analytical method of drug
substance.
batch(es) of Drug Substance performed by Drug Product on 13-03-2021.
manufacturer used during product development and
stability studies, along with Certificate of Analysis (CoA)
of the same batch from Drug Substance / /Active
Pharmaceutical Ingredient manufacture, since the
submitted COA of three batches of API are of different
batches than that used in the manufacturing of stability
batches.

perform the stability test for 3rd & 6th month time point
since they were in June 2021 & September 2021.
The developed formulation contains 1412mg drug (6x100x1.12 as trihydrate factor) + assay adjustment +
substance per bottle of 30ml having 6 doses each of 5ml process loss during dispensing and mixing = 1412mg of
of the drug after reconstitution. Justify how 14124mg of cefixime trihydrate.
drug substance per 6 doses will make 200mg cefixime Firm has still not justified how 704mg of drug substance
per dose. per 6 doses will make 100mg cefixime per dose as well
as the use of overage in trial batches.
The developed formulation is available in 30ml bottle, Comparator products are with 30ml bottle
while the innovator product is available in 25ml, 37.5ml,
50ml, 75ml and 100ml bottle size only. Justify how your
formulation will deliver equal number of doses as
delivered by the innovator product.
Provide details of the reconstitution of your product prior Measuring cup of 10mL capacity was added in unit pack.
to administration including details of type of diluent and So adding 1 cup = 10ml of previously boiled and cooled
exact volume of diluent. water reconstitutes to final volume of 30ml suspension.
The reconstitution volume mentioned by the firm does
not produce the same concentration of drug as that of the
innovator product.
Justify why pharmaceutical equivalence was not Related substances and impurities testing was not
performed by performing all tests as recommended in available.
USP monograph. However firm has also not performed complete testing
Justify why drug release studies / comparative CDP is not mandatory for suspension and drug release is
dissolution studies were not performed to justify your not included in USP monograph.
formulation development process.
Submit data of compatibility studies of the drug product Firm has submitted results of compatibility studies of the
with recommended diluent in section 3.2.P.2.6. drug product with diluent.
Justify why the test for deliverable volume is not added The test was performed and mentioned in the test reports
in specifications as recommended in USP monograph. attached with the stability studies data. However, it was
Revise your specifications as per USP monograph along mistakenly missed in the specifications provided in the
with submission of applicable fee. dossier. The detailed specifications and testing method is
submitted by the firm.
Provide detailed method of analysis of the drug product Firm has submitted detailed method of analysis of the
in section 3.2.P.5.2 instead of providing copy of USP-32 drug product.
monograph which is entirely different from that of USP-
43.
Provide detailed method of analysis as well as complete Firm has not submitted protocols for the verification
protocols for each test in the verification studies of the studies.
drug product. Submit detailed results for the verification
studies of the analytical method as per USP monograph.
method is 5547269. Justify how this significant

Justify how drug substance complying BP specifications Firm has not submitted any justification against this
can be used to develop a product complying USP point.
specifications.
JP monograph specifies that the retention time should be The product complies USP specifications.
10 minutes, while the retention time in your submitted
results is 7 to 8 minutes. Justify how the method can be
considered as per JP monograph.
Justify why you have not determined system suitability The submitted format of chromatogram does not depict
using number of theoretical plates and the symmetry the theoretical plates and the tailing factor. However, a
factor as recommended by USP monograph. typical chromatogram with all the parameters is now
provided by the firm.
standard solution for the batch TR017 is 5478729. Justify
how such significant difference in peak area exist at same
concentration of standard solution.
The injection volume specified in USP monograph is The stability studies were performed on the available
10µL while the injection volume as per your analysis is resources i.e. 10μL injection size, However, the
20 µL. Justification is required in this regard. variations in the USP method were validated through
method validation studies which are also provided.
Limited.

Report of on-site verification of authenticity of Product development and Stability data of M/s. Acumen
Healthcare (Pvt.) Ltd., Plot No. 39&40, Street No. S.02, RCCI Industrial Estate, Rawat.

Decision: Registration Board after thread bear deliberations and considering the findings and
recommendations of the panel inspection report decided to reject the below presented
registration applications of M/s. Acumen Healthcare (Pvt.) Ltd., Plot No. 39&40, Street No. S.02,
RCCI Industrial Estate, Rawat on following grounds:
• QC is not functional at the time of inspection.
• Dr. Nasreen Bibi (Quality Control Manager), Mr. Tahir Iqbal (Production Manager), Rehan
Ullah (Marketing Manager) informed that the product development and stability studies
along with preparation of CTD dossier was outsourced.
• Installation of stability chamber is in process.
• No information of trial batches available here.
• No API, no COA, no work in HPLC/ instability chamber observed by the panel.
• No tests conducted on the HPLC.
• Stability chambers are in the process of installation.
Applications of M/s Acumen

1. Name, address of Applicant / Marketing M/s. Acumen Healthcare (Pvt.) Ltd., Rawat
Authorization Holder
Name, address of Manufacturing site. M/s. Acumen Healthcare (Pvt.) Ltd., Plot No. 39&40, Street
No. S.02, RCCI Industrial Estate, Rawat.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.30776 dated 10-11-2021
Details of fee submitted PKR 30,000/-: fee deposit slip no.02450627990 dated
04/11/2021
The proposed proprietary name / brand name AGLOP 100mg/5ml Dry Suspension
Strength / concentration of drug of Active Each 5ml of reconstituted suspension contains:
Pharmaceutical ingredient (API) per unit Cefixime (as Trihydrate) ….100mg
Pharmaceutical form of applied drug Dry Suspension
Pharmacotherapeutic Group of (API) Cephalosporin Antibiotics
Reference to Finished product specifications USP
The status in reference regulatory authorities USFDA
For generic drugs (me-too status) Inficef 100mg/5ml Suspension of M/s. Davis Pharmaceutical
laboratories (Reg.no. 103422)
GMP status of the Finished product New License issue dated 02-06-2021 with following six
manufacturer sections:
1. Dry suspension section (General)
2. Tablet section (General)
3. Capsule section (General)
4. Dry Vial Injection Section (Cephalosporin)
5. Dry Suspension Section (Cephalosporin)
6. Capsule Section (Cephalosporin)

Name and address of API manufacturer. Pharmagen Limited Kot Nabi Bukshwala,34 Km Ferozepur
Road, Lahore.
container closure system and stability studies of drug
substance and drug product is submitted.
Module III (Drug Substance) Official monograph of Cefixime is present in USP. The firm
properties, solubilities, physical form, manufacturers,
description of manufacturing process and controls, tests for
impurity & related substances specifications, analytical
procedures and its verification, batch analysis and justification
of specification, reference standard, container closure system
Real time: 30°C ± 2°C / 75% ± 5%RH for 36 months
Batches:(00244/135/2010,00243/136/2010,00244/137/2010)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established against the
dissolution profile comparator product that is Cefspan 100mg Dry Suspension by
performing assay of drug products.
Analytical method validation/verification of Method verification studies have submitted including
product linearity, accuracy, precision, specificity.
Manufacturer of API Pharmagen Limited Kot Nabi Bukshwala,34 Km Ferozepur Road,
Lahore.
API Lot No. 00243-026-2021
Description of Pack
30ml pet bottle
Frequency Accelerated: 0,3,6 (Months)
Date of Initiation 04-2023 04-2023 04-2023

No. of Batches 03
1. Reference of previous approval of NA
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate Ref. No.06/2019-DRAP
API manufacturer issued by concerned (AD/607409-530) dated 11-01-2019 valid for 3 years.
3. Documents for the procurement of API with Not submitted

4. Data of stability batches will be supported by Submitted

chromatograms, Raw data sheets, COA,
6. Record of Digital data logger for temperature Submitted
and humidity monitoring of stability
Remarks OF Evaluator:
Batch manufacturing Record reflects that the batch has been Firm did not submit the reply.
manufactured prior to issuance of License by the Licensing
Division. Clarification is required in this regard.
• Provide the scientific justification of using 704mg of Firm replied that “(6x100x1.12 as Trihydrate
cefixime trihydrate with reference to the calculation of factor) +Assay adjustment + Process loss during
potency and moisture content of material. dispensing and mixing = 704mg of Cefixime
Trihydrate”.
Percentage of overage used for assay adjustment
and compensation for loss during manufacturing
process has not been mentioned.
• You have claimed JP specifications for the drug product Firm has submitted the reply that “Drug product
and have used drug substance complying USP is tested against latest USP monograph”.
specifications. Justification is required in this regard.
• Provide detailed analytical procedures for the testing of Firm submitted the analytical procedures for the
drug substance by the drug product manufacturer. testing of drug substance.
Firm did not provide the evidence of availability
of column oven to maintained the temperature of
column at 40°C as per USP chromatographic
condition.
• Provide analytical Method Verification studies including Firm has submitted the analytical method
specificity, accuracy and repeatability (method precision) verification report of drug substance performed
of drug substance performed by the Drug Product by drug product manufacturer.
manufacturer.
• Acceptance limit and result of assay of drug substance Firm has submitted the revised COA in which
performed by drug product manufacturer is not as per assay limits are in accordance with USP.
USP, clarification required in this regard. However, the COA of drug substance (Cefixime
micronized) by the drug substance manufacturer
evident that the substance complies with BP-
2020.

Following clarification has been required regarding stability Drug Substance Manufacturer concluded stability
data of drug substance: on raw API irrespective of physical attributes of
1. Same stability data has been submitted for cefixime raw material.
compacted and cefixime micronized while both of these However, the COA of drug substance by the drug
have different batch no. on the COA. substance manufacturer categorically mentioned
2. Acceptance criteria of the quality test has not been that the cefixime is micronized.
mentioned in the stability data sheet. Further, frim has not provide the justification for
3. Justification is required for not performing the not performing the identification test and
identification test, pH and determination of optical determination of pH during the stability study of
rotation during the stability study of drug substance. drug substance.
Provide the detail of diluent along with its quantity used for Firm submitted the reply that “Measuring cup of
reconstitution of suspension of 30ml. 10mL capacity was added and supplied with unit
pack. By adding 1 cup = 10 mL of water,
reconstitutes to 30mL Suspension.”
Clarification is required that either only 10ml of
water has been added in the suspension or make up
the volume up till 30ml. Further, as per the
innovator product “to reconstitute, suspend with 34
mL water. Method: Tap the bottle several times to
loosen powder contents prior to reconstitution.
Add approximately half the total amount of water
for reconstitution and shake well. Add the
remainder of water and shake well”.
Accordingly, for reconstitution of 30ml
suspension 20.4 ml water is required.
• Justification of choice of excipient as Inactive ingredients Firm has submitted the reply that in analytical
contained in the 100 mg/5ml suspension of innovator method validation studies no effect of placebo
product suprax suspension are: colloidal silicon dioxide, was recorded, showing zero to negligible effect
sodium benzoate, strawberry flavor, sucrose, and xanthan of excipients.
gum., while the applied drug product contains aerosil 200,
sugar, Xanthan gum, strawberry flavor, sodium benzoate,
strawberry red color.
• Compatibility studies of the Drug Substance(s) with
excipients shall be provided as the qualitative composition
of the formulation is not similar to innovator / reference
product.
• Submit details regarding batch number, manufacturing Firm has replied that “only parameters were tested
and expiry date of your as well as the comparator product which are available with us for testing”.
used in pharmaceutical equivalence and comparative Firm has not performed the test for determination
dissolution profile. of pH and quantitative acceptance limit and results
• Justify why all tests mentioned in USP monograph are not of content uniformity has not been mentioned.
performed during pharmaceutical equivalence studies. Further, similar assay results have been obtained
for 100mg/5ml and 200mg/5ml suspension as
evident in pharmaceutical equivalence report.
The selection and optimization of the manufacturing process Firm has replied that “Optimized manufacture
described in 3.2.P.3.3, in particular its critical aspects, shall method was used”.
be explained in this section instead of specified
manufacturing method.
• Formulation contain preservative sodium benzoate, so Profile of 7 days stability study after reconstitution
preservative effectiveness studies to be performed as per has been added already, which shows the stability
recommendations of pharmacopoeia and shall be submit. of the final product as per label claim. However,
• Compatibility studies of dry powder for suspension with firm has not submitted the 7 day in-use stability
its diluent shall be performed as per the instructions data. Further, Compatibility study of dry powder
provided in individual label of the drug product and for suspension with its diluent has also not been
submit the obtained results. submitted.

• If the drug product is formulated using an active moiety, Firm has submitted that “(6x100x1.12 as
then the composition for the drug substance shall be Trihydrate factor) +Assay adjustment + Process
clearly indicated (e.g. “1 kg of active ingredient base = loss during dispensing and mixing = 704mg of
1.075 kg active ingredient hydrochloride”). In the Cefixime Trihydrate”.
composition and batch formula of drug product active However, firm has not submitted the batch
ingredient has not been mentioned along with the formula mentioned the quantity of active
quantity of its anhydrous base. ingredient along with the quantity of its anhydrous
• Applied product contain 30ml of suspension consist of 6 base. Further, firm has not provided the
doses of 5ml, justify the claimed amount of cefixime per percentage of overage used for assay adjustment
5ml using the quantity of 704mg cefixime trihydrate as and quantity to compensate the losses during
mentioned in the batch formula. processing.
• Acceptance criteria of assay content has been changed Firm replied that, more strict range is applied
during the manufacturing steps as evident from the instead of given justification with reference to
submitted document, at the time of mixing it is 90-120% claimed specification i.e. USP.
and at the time of filling acceptance limit is 90-100%
clarification is required regarding the variation.
Following variations observed in process validation protocol, • Firm replied that More strict range was used
which need clarification during filling and total brim-full volume of the
• Average weight variation in section 3.2P.3.4 is 16g±5g bottle is 60mL, while reconstituted suspension
while average weight variation of filled bottle mentioned accounts for half of the volume which is 30mL
in process validation protocol is 16g±2g. per pack.
• Steps of manufacturing process given in the process • Firm did not give clear specification regarding
validation protocol specify that CMC sodium and vanilla the filled weight per bottle along with
flavor has been added in the cefixime mixture, while both acceptance criteria of weight variation.
of these excipients have not included in the batch formula • In section 3.2.P.7 description of primary
of applied product. container is 30ml DS pet bottle, while in their
• According to section 3.2 P.1 (d) product is packed in pet reply, firm claimed that they have used 60ml
bottle of 30ml while in the process validation protocol pet bottle, still clarification is required.
pack size of 60ml has been mentioned, clarification
required for the variation of pack size.
• Filled weight specified in the process validation protocol
30gm/bottle ± 2gm.
Justify the drug product specifications in light with USP • Firm has submitted the revised specification as
monograph. Your specifications are not appropriately written per USP but the requisite fee for
since it does not specify the criteria for uniformity of dosage variation/correction has not been submitted.
units, and complete acceptance criteria for assay. Revise your
specifications in line with official pharmacopoeia along with
submission of applicable fee.
Provide detailed analytical procedure of all the quality test of • Firm has submitted analytical procedure of all
drug product as per USP since the provided analytical the quality test of drug product as per USP.
procedures are not according to the claimed pharmacopeia.
• Perform the verification studies on compendial method • Firm has submitted the same verification
of assay and provide the data along with the raw data report for cefixime drug substance and for
sheet reflecting the sample, standard and placebo cefixime dry powder suspension 100mg/5ml
preparation procedure for performance of precision, and 200mg/5ml.
specificity and accuracy parameters.
• The accuracy studies have been performed at three
different concentrations i.e. 80%, 100% and 120% in
which you have used 160mg, 200mg and 240mg instead
of using 80%, 100% and 120% of the standard solution
the method can be considered accurate when the accuracy
studies are not conducted as per the guidelines.
• Repeatability should be assessed using a minimum of 6
determinations at 100% of the test concentration while
you have been using 100% concentration of standard

solution equivalent to 200mcg/ml, justification is
required that 100% of test concentration is eq. to
200mcg/ml along with raw data sheet reflecting the
preparation of sample solutions.
• You have not performed system suitability using number
of theoretical plates and the symmetry factor as
recommended by USP monograph. Justification is
required in this regard.
• Same verification studies have been submitted for
cefixime 100mg suspension and cefixime 200mg
suspension, how it was scientifically justified that the
verification studies of the 2 different strength with
different filled weight has same data.
• Submit copy of commercial invoice for evidence of • Firm has not submitted the reply of these
purchase of each batch of drug substance that have been queries.
used in the analysis of each batch of drug product.
• Submit stability study data in section 3.2.P.8.3 as per the
checklist approved by Registration Board in its 296th
meeting and the CTD guidance document, which
includes the following:
o Reference of previous approval of applications with
o Documents for the procurement of API with
o Compliance Record of HPLC software 21CFR &
o Record of Digital data logger for temperature and
humidity monitoring of stability chambers (real time
and accelerated).
• Submit protocols and results for in-use stability study,
including details whether the bottles are placed inverted
or upright and also specify the exact conditions at which
the bottles were kept along with claimed shelf life of
reconstituted solution.
• As per the submitted chromatogram the injection
volume of chromatographic system was 20 µl while as
per USP it should be 10 µl, justification is required for
this variation of chromatographic condition from USP
monograph.
• COA of same batch of active material which are used
during product development and stability studies.
☐ Importer
☐ Export sale

04/11/2021
The proposed proprietary name / brand name AGLOP 200mg/5ml Dry Suspension
Strength / concentration of drug of Active Each 5ml of reconstituted suspension contains:
Pharmaceutical ingredient (API) per unit Cefixime (as Trihydrate) ….200mg
For generic drugs (me-too status) Inficef 200mg/5ml Suspension of M/s. Davis Pharmaceutical
laboratories (Reg.no. 104580)
Road, Lahore.
Batches:(00244/135/2010,00243/136/2010,00244/137/2010)

Lahore.
API Lot No. 00243-026-2021
Description of Pack
30ml pet bottle
No. of Batches 03
1. Reference of previous approval of applications with NA
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate Ref. No.06/2019-DRAP
manufacturer issued by concerned regulatory authority of (AD/607409-530) dated 11-01-2019 valid for 3
country of origin. years.
3. Documents for the procurement of API with approval from Not submitted
DRAP (in case of import).
4. Data of stability batches will be supported by attested Submitted
respective documents like chromatograms, Raw data
sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & audit Not submitted

trail reports on product testing
6. Record of Digital data logger for temperature and humidity Submitted
monitoring of stability chambers (real time and
accelerated)
• Batch manufacturing Record reflects that the batch has been Firm did not submit the reply.
• Provide the scientific justification of using 704mg of cefixime Firm replied that “(6x100x1.12 as Trihydrate
trihydrate with reference to the calculation of potency and factor) +Assay adjustment + Process loss during
moisture content of material. dispensing and mixing = 704mg of Cefixime
Trihydrate.”

Percentage of overage used for assay
adjustment and compensation for loss during
manufacturing process has not been mentioned.
• You have claimed JP specifications for the drug product and Firm has submitted the reply that “Drug product
have used drug substance complying USP specifications. is tested against latest USP monograph”.
Justification is required in this regard.
• Provide detailed analytical procedures for the testing of drug Firm submitted the analytical procedures for the
substance by the drug product manufacturer. testing of drug substance.
Firm did not provide the evidence of availability
of column oven to maintained the temperature
of column at 40°C as per USP chromatographic
condition.
specificity, accuracy and repeatability (method precision) of verification report of drug substance performed
drug substance performed by the Drug Product by drug product manufacturer.
manufacturer.
performed by drug product manufacturer is not as per USP, assay limits are in accordance with USP.
clarification required in this regard. However, the COA of drug substance (Cefixime
micronized) by the drug substance
manufacturer evident that the substance
complies with BP-2020.
Following clarification has been required regarding stability data Drug Substance Manufacturer concluded
of drug substance: stability on raw API irrespective of physical
1. Same stability data has been submitted for cefixime attributes of raw material.
compacted and cefixime micronized while both of these However, the COA of drug substance by the
have different batch no. on the COA. drug substance manufacturer categorically
2. Acceptance criteria of the quality test has not been mentioned that the cefixime is micronized.
mentioned in the stability data sheet. Further, frim has not provide the justification
3. Justification is required for not performing the identification for not performing the identification test and
test, pH and determination of optical rotation during the determination of pH during the stability study
stability study of drug substance. of drug substance.
Provide the detail of diluent along with its quantity used for Firm submitted the reply that “Measuring cup
reconstitution of suspension of 30ml. of 10mL capacity was added and supplied with
unit pack. By adding 1 cup = 10 mL of water,
reconstitutes to 30mL Suspension.”
Clarification is required that either only 10ml
of water has been added in the suspension or
make up the volume up till 30ml. Further, as per
the innovator product “to reconstitute, suspend
with 34 mL water. Method: Tap the bottle
several times to loosen powder contents prior
to reconstitution. Add approximately half the
total amount of water for reconstitution and
shake well. Add the remainder of water and
shake well”.
Accordingly, for reconstitution of 30ml
suspension 20.4 ml water is required.
• Justification of choice of excipient as Inactive ingredients Firm has submitted the reply that in analytical
contained in the 100 mg/5ml suspension of innovator product method validation studies no effect of placebo
suprax suspension are: colloidal silicon dioxide, sodium was recorded, showing zero to negligible effect
benzoate, strawberry flavor, sucrose, and xanthan gum., of excipients.
while the applied drug product contains aerosil 200, sugar,
Xanthan gum, strawberry flavor, sodium benzoate,
strawberry red color.

• Compatibility studies of the Drug Substance(s) with
excipients shall be provided as the qualitative composition of
the formulation is not similar to innovator / reference product.
• Submit details regarding batch number, manufacturing and Firm has replied that “only parameters were
expiry date of your as well as the comparator product used in tested which are available with us for
pharmaceutical equivalence and comparative dissolution testing”.
profile. Firm has not performed the test for
• Justify why all tests mentioned in USP monograph are not determination of pH and quantitative
performed during pharmaceutical equivalence studies. acceptance limit and results of content
uniformity has not been mentioned. Further,
similar assay results have been obtained for
100mg/5ml and 200mg/5ml suspension as
evident in pharmaceutical equivalence
report.
described in 3.2.P.3.3, in particular its critical aspects, shall be method was used”.
explained in this section instead of specified manufacturing
method.
• Formulation contain preservative sodium benzoate, so Profile of 7 days stability study after
preservative effectiveness studies to be performed as per reconstitution has been added already, which
recommendations of pharmacopoeia and shall be submit. shows the stability of the final product as per
• Compatibility studies of dry powder for suspension with its label claim. However, firm has not submitted 7
diluent shall be performed as per the instructions provided in day in-use stability data. Further, Compatibility
individual label of the drug product and submit the obtained study of dry powder for suspension with its
results. diluent has also not been submitted.
• If the drug product is formulated using an active moiety, then Firm has submitted that “(6x100x1.12 as
the composition for the drug substance shall be clearly Trihydrate factor) +Assay adjustment + Process
indicated (e.g. “1 kg of active ingredient base = 1.075 kg loss during dispensing and mixing = 704mg of
active ingredient hydrochloride”). In the composition and Cefixime Trihydrate”.
batch formula of drug product active ingredient has not been However, firm has not submitted the batch
mentioned along with the quantity of its anhydrous base. formula mentioned the quantity of active
• Applied product contain 30ml of suspension consist of 6 ingredient along with the quantity of its
doses of 5ml, justify the claimed amount of cefixime per 5ml anhydrous base. Further, firm has not provided
using the quantity of 704mg cefixime trihydrate as the percentage of overage used for assay
mentioned in the batch formula. adjustment and quantity to compensate the
losses during processing.
• Acceptance criteria of assay content has been changed Firm replied that, more strict range is applied
during the manufacturing steps as evident from the instead of given justification with reference to
submitted document, at the time of mixing it is 90-120% and claimed specification i.e. USP.
at the time of filling acceptance limit is 90-100%
clarification is required regarding the variation.
Following variations observed in process validation protocol, • Firm replied that More strict range was used
which need clarification during filling and total brim-full volume of
• Average weight variation in section 3.2P.3.4 is 16g±5g while the bottle is 60mL, while reconstituted
average weight variation of filled bottle mentioned in process suspension accounts for half of the volume
validation protocol is 16g±2g. which is 30mL per pack.
• Steps of manufacturing process given in the process • Firm did not give clear specification
validation protocol specify that CMC sodium and vanilla regarding the filled weight per bottle along
flavor has been added in the cefixime mixture, while both of with acceptance criteria of weight variation.
these excipients have not included in the batch formula of • In section 3.2.P.7 description of primary
applied product. container is 30ml DS pet bottle, while in their
• According to section 3.2 P.1 (d) product is packed in pet firm claimed that they have used 60ml pet
bottle of 30ml while in the process validation protocol pack bottle, still clarification is required.
size of 60ml has been mentioned, clarification required for • Same process validation protocol with
the variation of pack size. similar specification of filled weight of
powder per bottle has been submitted in

• Filled weight specified in the process validation protocol 100mg/5ml suspension and 200mg/5ml
30gm/bottle ± 2gm. suspension registration dossier.
Justify the drug product specifications in light with USP • Firm has submitted the revised
monograph. Your specifications are not appropriately written specification as per USP but the requisite
since it does not specify the criteria for uniformity of dosage fee for variation/correction has not been
units, and complete acceptance criteria for assay. Revise your submitted.
specifications in line with official pharmacopoeia along with
Provide detailed analytical procedure of all the quality test of • Firm has submitted analytical procedure of
drug product as per USP since the provided analytical all the quality test of drug product as per
procedures are not according to the claimed pharmacopeia. USP.
• Perform the verification studies on compendial method of • Firm has submitted the same verification
assay and provide the data along with the raw data sheet report for cefixime drug substance and for
reflecting the sample, standard and placebo preparation cefixime dry powder suspension
procedure for performance of precision, specificity and 100mg/5ml and 200mg/5ml.
accuracy parameters.
• The accuracy studies have been performed at three different
concentrations i.e. 80%, 100% and 120% in which you have
used 160mg, 200mg and 240mg instead of using 80%, 100%
and 120% of the standard solution as per applicable
guidelines. Justification is required how the method can be
considered accurate when the accuracy studies are not
conducted as per the guidelines.
determinations at 100% of the test concentration while you
have been using 100% concentration of standard solution
equivalent to 200mcg/ml, justification is required that 100%
of test concentration is eq. to 200mcg/ml along with raw data
sheet reflecting the preparation of sample solutions.
• You have not performed system suitability using number of
theoretical plates and the symmetry factor as recommended
by USP monograph. Justification is required in this regard.
• Same verification studies have been submitted for cefixime
100mg suspension and cefixime 200mg suspension, how it
was scientifically justified that the verification studies of the
2 different strength with different filled weight has same
data.
• Submit copy of commercial invoice for evidence of • Firm has not submitted the reply of these
purchase of each batch of drug substance that have been queries.
used in the analysis of each batch of drug product. • Further the submitted chromatogram
• Submit stability study data in section 3.2.P.8.3 as per the mentioned that the concentration of sample
checklist approved by Registration Board in its 296th solution is 100, which also need clarification
meeting and the CTD guidance document, which includes from the firm.
the following:
o Reference of previous approval of applications with
o Documents for the procurement of API with approval
from DRAP (in case of import).
o Compliance Record of HPLC software 21CFR & audit
trail reports on product testing.
o Record of Digital data logger for temperature and
and accelerated).
• Submit protocols and results for in-use stability study,
including details whether the bottles are placed inverted or

upright and also specify the exact conditions at which the
bottles were kept along with claimed shelf life of
reconstituted solution.
• As per the submitted chromatogram the injection volume
of chromatographic system was 20 µl while as per USP it
should be 10 µl, justification is required for this variation
of chromatographic condition from USP monograph.
• COA of same batch of active material which are used
during product development and stability studies.
☐ Importer
☐ Export sale
04/11/2021
The proposed proprietary name / brand name AGLOP 400mg Capsule
Pharmaceutical ingredient (API) per unit Cefixime as trihydrate ….400mg
Reference to Finished product specifications JP
Proposed Pack size 5’s
For generic drugs (me-too status) Cefim capsule 400mg of M/s. Hilton Pharma (Pvt.) Ltd.
(Reg.no. 019818)
Road, Lahore.

Batches:(00244/135/2010,00243/136/2010,00244/137/2010)
Lahore.
API Lot No. 00243-026-2021
Description of Pack
30ml pet bottle
No. of Batches 03
firm (if any)

2. Approval of API/ DML/GMP certificate of Copy of GMP certificate Ref. No.06/2019-DRAP
API manufacturer issued by concerned (AD/607409-530) dated 11-01-2019 valid for 3 years.
• Batch manufacturing Record reflects that the batch has been Firm did not submit the reply.
• Provide the scientific justification of using 470mg of cefixime Trihydrate factor calculation + Process loss
trihydrate with reference to the calculation of potency and during dispensing/shifting and assay
moisture content of material. adjustments included (400mg base = 470 mg
Adjusted Trihydrate). Quantitative
calculation mentioning the trihydrate factor
and overage percentage used for assay
adjustment and compensation for process loss
has not been given by the firm.
• You have claimed JP specifications for the drug product and Firm has submitted the reply that “Drug
have used drug substance complying USP specifications. Substance Specifications can be different from
Justification is required in this regard. Drug Product Specifications, provided that
specifications are present in official
monograph. In this regard drug product was
tested and released as per official USP
specifications and Drug product is only
available in latest official JP XIIV monograph
hence, JP specifications were taken for Drug
Product release”.
• Provide detailed analytical procedures for the testing of drug Firm submitted the analytical procedures for
substance by the drug product manufacturer. the testing of drug substance.
Firm did not provide the evidence of
availability of column oven to maintained the
temperature of column at 40°C as per USP
chromatographic condition.
specificity, accuracy and repeatability (method precision) of verification report of drug substance
drug substance performed by the Drug Product performed by drug product manufacturer.
manufacturer.
performed by drug product manufacturer is not as per USP, assay limits are in accordance with USP.
clarification required in this regard. However, the COA of drug substance
(Cefixime compacted) by the drug substance
manufacturer evident that the substance
complies with BP-2020. Batch no.
00244/020/2021

Following clarification has been required regarding stability data Firm replied that Drug Substance
of drug substance: Manufacturer concluded stability on raw API
4. Same stability data has been submitted for cefixime irrespective of physical attributes of raw
compacted and cefixime micronized while both of these material.
have different batch no. on the COA. However, the COA of drug substance by the
5. Acceptance criteria of the quality test has not been drug substance manufacturer categorically
mentioned in the stability data sheet. mentioned that the cefixime is compacted,
6. Justification is required for not performing the identification which means that different batch of cefixime
test, pH and determination of optical rotation during the compacted has been manufactured by drug
stability study of drug substance. substance manufacturer.
Further, frim has not provide the justification
for not performing the identification test and
determination of pH during the stability study
of drug substance.
• Compatibility studies of the Drug Substance(s) with Firm has submitted the reply that in analytical
excipients shall be provided as the qualitative composition of method validation studies no effect of placebo
the formulation is not similar to innovator / reference product. was recorded, showing zero to negligible
effect of excipients.
• Submit details regarding batch number, manufacturing and Firm has replied that “only parameters were
expiry date of your as well as the comparator product used in tested which are available with us for testing”.
pharmaceutical equivalence and comparative dissolution Firm has not performed the test for
profile. determination of pH and quantitative results
• Justify why all tests mentioned in USP monograph are not of content uniformity has not been mentioned.
performed during pharmaceutical equivalence studies. Further, similar assay results have been
obtained for 100mg/5ml and 200mg/5ml
suspension as evident in pharmaceutical
equivalence report.
Following point regarding CDP needs clarification: • Firm has submitted the revised
• As per the CDP requirement, minimum of three time- Comparative dissolution profile report of
points (zero excluded) should be included, the time- 15 minutes,30 minutes ,45 minutes and
points for both innovator / reference and test product 90minutes. Further replied that, drug
being the same. While the submitted data has only been product was in line with both JP and
mentioned the release profile at 90 minutes. Provide the USFDA innovator product
release profile of minimum three time-points (zero recommendations. But only JP complying
excluded) for both innovator / reference and test results were reported.
product. • UV methods complying parallel to HPLC
• Dissolution profile of test product and the innovator / method is used only for dissolution. Rest
reference product should be performed by using 12 units of all test during stability studies were
of each. While six unit has been used in the submitted performed HPLC method.
dissolution summary. • In CDP testing zero interference from
• Dissolution test has not been performed as per the excipients concludes quantitative change
experimental condition of JP. of excipient has no effect on qualitative
• Justify the performance of comparative dissolution parameters.
profile using UV method while JP has recommended However, the CDP report evident that the
HPLC method for dissolution testing. more than 85% drug dissolved in 90 minutes
• Justify the dissolution specifications of NLT 80% in 90 in 6.8 phosphate buffer medium while the firm
minutes, since the JP monograph specifies this limit did not calculate the f2 factor which is
only for 100mg potency capsule. mandatory as per the decision of Registration
• The USFDA review of innovator product of cefixime Board if the drug release is less than 85% in
400mg capsule reveals that the acceptance criteria for 15 minutes.
dissolution test should be NLT (Q) in 45 minutes using Further, at least 12 units should be used for
7.2pH phosphate buffer. Justify how your product may determination of each profile, while the firm
considered equivalent to the innovator product. used 6 units.
As per innovator product the dissolution
medium in which maximum drug release has
been achieved is 0.05M phosphate buffer, pH

7.2, while the applicant did not perform
dissolution in this medium.
Firm did not provide any justification for
using different dissolution condition than
innovator.
described in 3.2.P.3.3, in particular its critical aspects, shall be method was used”.
explained in this section instead of specified manufacturing
method.
• If the drug product is formulated using an active moiety, then Trihydrate factor calculation + Process loss
the composition for the drug substance shall be clearly during dispensing/shifting and assay
indicated (e.g. “1 kg of active ingredient base = 1.075 kg adjustments included (400mg base = 470 mg
active ingredient hydrochloride”). In the composition and Adjusted Trihydrate)
batch formula of drug product active ingredient has not been • Quantitative calculation mentioning the
mentioned along with the quantity of its anhydrous base. trihydrate factor and overage percentage
used for assay adjustment and
compensation for process loss has not
been given by the firm.
• Further, firm has not submitted the batch
formula mentioned the quantity of active
ingredient along with the quantity of its
anhydrous base. Further, firm has not
provided the percentage of overage used
for assay adjustment and quantity to
compensate the losses during processing.
• Fill weight mentioned in section 3.2.P.1 is 470mg while the Firm replied that Revised and updated
fill weight mentioned in process validation protocols is attached herewith. 470mg API+55mg
625mg. Justification is required in this regard. Starch+100mg Shell Weight = 625 mg fill
weight.
Firm has not provided the percentage of
overage used for assay adjustment and
quantity to compensate the losses during
processing.
Justify the drug product specifications in light with JP • Firm has submitted the Specifications and
monograph. Your specifications are not appropriately written test method in line with JP XIIV.
since it does not specify the criteria for uniformity of dosage • However, the dissolution criteria as per JP
units, and complete acceptance criteria for dissolution test and is, the dissolution rates in 60 minutes of 50-
assay. Further you have mentioned assay limits from 90 – 120% mg (potency) capsule and in 90 minutes of
which is contrary to that recommended in JP monograph. Revise 100-mg (potency) capsule are not less than
your specifications in line with official pharmacopoeia along 80%, respectively. While dissolution
with submission of applicable fee. acceptance criteria as per the specification
submitted by the firm is NLT 80% of drug
release in 45 minutes.
Provide detailed analytical procedure of all the quality test of • Firm has submitted analytical procedure
drug product as per the JP Pharmacopeia since the provided of all the quality test of drug product as
analytical procedures are not according to the claimed per JP.
pharmacopeia.
• Perform the verification studies on compendial method of • Firm has submitted the same verification
assay and provide the data along with the raw data sheet report for cefixime drug substance and
reflecting the sample, standard and placebo preparation for cefixime dry powder suspension
procedure for performance of precision, specificity and 100mg/5ml & 200mg/5ml and for
accuracy parameters. cefixime capsule 400mg.
• The accuracy studies have been performed at three different
concentrations i.e. 80%, 100% and 120% in which you have
used 160mg, 200mg and 240mg instead of using 80%, 100%

and 120% of the standard solution as per applicable
guidelines. Justification is required how the method can be
considered accurate when the accuracy studies are not
conducted as per the guidelines.
determinations at 100% of the test concentration while you
have been using 100% concentration of standard solution
equivalent to 200mcg/ml, justification is required that 100%
of test concentration is eq. to 200mcg/ml along with raw data
sheet reflecting the preparation of sample solutions.
• You have not performed system suitability using number of
theoretical plates and the symmetry factor as recommended
by USP monograph. Justification is required in this regard.
• Same verification studies have been submitted for cefixime
suspension and capsule, how it was scientifically justified
that the verification studies of the 2 different dosage form
have same data.
• Specifications of all the quality test on the drug product • Firm has submitted the revised batch
analysis report were not as per JP clarification is required in analysis report as per JP.
this regard.
• Stability data sheet of accelerated and real time study • Firm has submitted revised COA of each
data claimed that JP specifications has been comply time point of stability study following
while the analytical report of same batches on the same variation still has been observed in the
time point reflects that the product complied USP revised COA.
specifications. Clarification required in this regard. • Quantitative results of content uniformity
• Acceptance criteria of quality test performed while test have not been mentioned.
stability study was not as per JP. • Acceptance criteria of dissolution test is not
• Submit copy of commercial invoice for evidence of in accordance with JP monograph neither
purchase of each batch of drug substance that have been in accordance with innovator.
used in the analysis of each batch of drug product. • Further dissolution test results are not in
• Provide Compliance Record of HPLC software 21CFR accordance with international guidelines.
& audit trail reports on product testing. • Moreover, firm did not submit the
following:
• Copy of commercial invoice for
evidence of purchase of each batch of
drug substance that have been used in
analysis of each batch of drug product.
• Compliance Record of HPLC software
testing.
4. Name, address of Applicant / Marketing M/s Acumen Healthcare Private Limited, Islamabad
Name, address of Manufacturing site. M/s Acumen Healthcare Private Limited
Plot # 39-40, Street #2, RCCI, Industrial Estate, Rawat.
☐ Importer
Intended use of pharmaceutical product ☐Domestic sale
☐ Export sale

Dy. No. and date of submission Dy. No 30783 dated 10-11-2021
Details of fee submitted Rs.30,000/- dated 04-11-2021
The proposed proprietary name / brand name Esticef 1g IM Injection
Strength / concentration of drug of Active Each Vial Contains:
Pharmaceutical ingredient (API) per unit Ceftriaxone Sodium Eq. to Ceftriaxone…1gm
Pharmaceutical form of applied drug Sterile Powder for IM Injection use, in clear glass vial, rubber
stoppered with flip off seal.
Proposed Pack size 1×1’s
The status in reference regulatory authorities Ceftriaxone 250mg Powder for Solution for Injection or Infusion
Manufacturer: Wockhardt UK Ltd (MHRA approved)
For generic drugs (me-too status) Bioxone mg Injection by M/s Biolabs,
GMP status of the Finished product The firm was Inspected on 12/04/2021 & 15/04/2021 and new
manufacturer license granted on 02/06/2021
Tablet, Capsule, Dry Suspension (General) and Capsule, Dry
Suspension, Dry Injection (Cephalosporin) section approved.
Name and address of API manufacturer. M/s Pharmagen Ltd, 5 Kot Nabi Bukshwala, 34 Km Ferozepur
Road, Lahore.
Stability studies Firm has submitted stability study data of 3 batches of drug
RH for 6 months. The real time stability data is conducted at
30°C ± 2°C / 65 ± 5% RH for 36 months.
stability
Pharmaceutical equivalence and comparative --
dissolution profile

Manufacturer of API M/s Pharmagen Ltd, 5 Kot Nabi Bukshwala, 34 Km Ferozepur Road, Lahore.
API Lot No. 00421/029/2021
Description of Pack Sterile Powder for IM Injection use, in clear glass vial, rubber stoppered with flip off
(Container closure system) seal, packed in unit carton (1×1’s)
Batch Size 500 Vials 500 Vials Vials
No. of Batches 03
7. Reference of previous approval of N/A
firm (if any)
8. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. 06/2019-DRAP (AD/607409-530)
API manufacturer issued by concerned issued by DRAP valid till 08/01/2022.
9. Documents for the procurement of API with N/A
--
11. Compliance Record of HPLC software
--
12. Record of Digital data logger for temperature
and humidity monitoring of stability --
☐ Importer
☐ Export sale

The proposed proprietary name/brand name Esticef IM 250mg Injection
Strength / concentration of drug of Active Each vial Contains:
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium equivalent to ceftriaxone ….……250mg
Pharmaceutical form of applied drug Sterile Powder for IM Injection use, in clear glass vial, rubber
For generic drugs (me-too status) Bioxone 250 mg Injection by M/s Biolabs,
Road, Lahore.
30°C ± 2°C / 65 ± 5% RH for 36 months.
stability

dissolution profile brand leader that is Rocephin 250mg Injection by Roche Pakistan
Ltd,
API Lot No. 00421/029/2021
Description of Pack Sterile Powder for IM Injection use, in clear glass vial, rubber stoppered with flip off
No. of Batches 03
1. Reference of previous approval of applications with stability N/A
study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API manufacturer Copy of GMP certificate No. 06/2019-DRAP
issued by concerned regulatory authority of country of origin. (AD/607409-530) issued by DRAP valid till
08/01/2022.
3. Documents for the procurement of API with approval from N/A
4. Data of stability batches will be supported by attested respective
documents like chromatograms, Raw data sheets, COA, --
5. Compliance Record of HPLC software 21CFR & audit trail
--
reports on product testing
6. Record of Digital data logger for temperature and humidity
--
monitoring of stability chambers (real time and accelerated)
Name, address of Manufacturing site. M/s Acumen Healthcare Private Limited, Plot # 39-40, Street #2,
RCCI, Industrial Estate, Rawat.
☐ Importer
☐ Export sale

The proposed proprietary name / brand name Esticef 500mg IM Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium equivalent to Ceftriaxone… 500mg
Pharmaceutical form of applied drug Sterile Powder for IV Injection use, in clear glass vial, rubber
For generic drugs (me-too status) Bioxone 500 mg Injection by M/s Biolabs
manufacturer license granted on 02/06/2021 Tablet, Capsule, Dry Suspension
(General) and Capsule, Dry Suspension, Dry Injection
(Cephalosporin) section approved.
Road, Lahore.
30°C ± 2°C / 65 ± 5% RH for 36 months.
stability
dissolution profile

API Lot No. 00421/029/2021
Description of Pack Sterile Powder for IV Injection use, in clear glass vial, rubber stoppered with flip off
No. of Batches 03
08/01/2022.
documents like chromatograms, Raw data sheets, COA, summary Submitted
data sheets etc.

Submitted
monitoring of stability chambers (real time and accelerated) Submitted
☐ Importer
☐ Export sale

details of fee submitted PKR 30,000/-: dated 04/11/2021
The proposed proprietary name/brand name Tradix IV 250mg Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone Sodium Eq. to Ceftriaxone…250mg
For generic drugs (me-too status) Bioxone mg Injection by M/s Biolabs
Road, Lahore.
30°C ± 2°C / 65 ± 5% RH for 36 months.
stability
dissolution profile

API Lot No. 00421/029/2021
No. of Batches 03
08/01/2022.
data sheets etc.
Submitted
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy.No 30780 dated 10-11-2021

etails of fee submitted Rs.30,000/- dated 04-11-2021
The proposed proprietary name/brand name Tradix IV 1gm Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone Sodium Eq. to Ceftriaxone……..1gm
For generic drugs (me-too status) Bioxone mg Injection by M/s Biolabs
Road, Lahore.
30°C ± 2°C / 65 ± 5% RH for 36 months.
stability
dissolution profile

API Lot No. 00421/029/2021
No. of Batches 03
1. Reference of previous approval of applications with stability study N/A
data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API manufacturer issued Copy of GMP certificate No. 06/2019-
by concerned regulatory authority of country of origin. DRAP (AD/607409-530) issued by
DRAP valid till 08/01/2022.
3. Documents for the procurement of API with approval from DRAP (in N/A
case of import).
documents like chromatograms, Raw data sheets, COA, summary data Submitted
sheets etc.
5. Compliance Record of HPLC software 21CFR & audit trail reports on
Submitted
product testing
Submitted
Remarks of Evaluator:
Section# Observations Firm’s response
1.1 Covering letter has not been signed.
2.3.P.1 The section declares the equivalency statement as “Ceftriaxone sodium
286mg is equivalent to 500mg ceftriaxone base.” Justification shall be
submitted.
2.3. P.3.2 The quantity of 10 Kg against the batch size of 8389 vials is not justified
against the weight per vial given in section 3.2. P.1
2.3. P.3.4 Fill weight per vial has been declared as 286mg.
2.3. P.5.1 Specifications of average weight per vial is not as per the composition
declared in 2.3. P.1
3.2. S.4.1 Drug substance specification proposed by drug substance manufacturer refer
to both USP & BP for Assay limit. Justification shall be submitted in this
regard.
3.2.S.4.2 M/s Pharmagen has proposed analytical procedure both as per BP & USP.
Clarification shall be submitted which method is applied for the batch release.
Drug substance specifications & analytical procedure applied by Drug product

3.2.S.4.3 Analytical Method Verification studies including specificity, accuracy and
repeatability (method precision) performed by the Drug Product manufacturer
shall be submitted.
3.2.S.4.4 • Assay limits declared in the COA from M/s Acumen are not as per USP.
• COA from M/s Pharmagen of the relevant batch used for the
manufacturing of drug product stability batches shall be submitted.
3.2.S.5 Submitted COA of working standard from M/s Pharmagen declares the use
before date as “19-11-2016”, whereas the analysis has been performed
subsequent to this date.
3.2.S.7 Submitted stability data does not include tests of sterility.
3.2.P.1 Justify the equivalency factor of Ceftriaxone sodium for Ceftriaxone.
3.2.P.3.5 • Submitted protocol mentions the details of Cefoperazone/sulbactam
injection.
• The specification mentioned in the protocol are not as per USP
monograph.
3.2.P.5.1 Average weight is not as per the master formulation submitted for per vial in
section 3.2. P.1
3.2. P.5.2 Submit signed copy of drug product analysis method.
3.2. P.5.3 • Analytical method verification studies have bene conducted even before
the manufacturing of trial batches.
• Detailed analytical method applied for verification studies shall be
submitted.
3.2. P.5.4 • Submitted COAs have not been signed.
• Submitted COAs does not reflect the performance of Bacterial Endotoxin
test.
3.2. P.6 Details of reference standard shall be submitted.
3.2. P.7.1 This section mentions primary packaging as ampoule.
3.2. P.8 • It is evident from the submitted Assay calculation sheet that the standard
and sample dilutions have not been prepared as per USP monograph of
“Ceftriaxone for injection”. Justification shall be submitted in this regard.
• Average content weight mentioned in Assay calculation sheet.
• Submitted HPLC chromatograms declare the Sample ID as
“Ceftriaxone250-STD” for the standard solution injections, whereas
applied product is of 500mg strength.
• Reference of the potency value applied in assay calculation sheet, shall be
submitted.
• Submitted data logger record of stability chambers does not cover the all
calendar days of stability studies.
• Microbiological analysis record for the performance of sterility test &
Bacterial Endotoxin test shall be submitted.
Firm has submitted reply which still include details of other drugs than that is applied.
9. Name, address of Applicant / Marketing M/s Acumen Healthcare Private Limited
Authorization Holder Plot # 39-40, Street #2, RCCI Industrial Estate, Rawat.
Plot # 39-40, Street #2, RCCI Industrial Estate, Rawat.
☐ Importer

☐ Export sale
Dy. No. and date of submission Dy. No. 30951 dated 11/11/2021
Details of fee submitted PKR 30,000/-: dated 04/11/2021
The proposed proprietary name/brand name Bactowin 2g Injection
Strength / concentration of drug of Active Each vial contains:
Pharmaceutical ingredient (API) per unit Cefoperazone as sodium………1g
Sulbactam as sodium………….1g
Pharmaceutical form of applied drug Sterile Powder for IV/IM Injection use, in clear glass vial, rubber
The status in reference regulatory authorities Sulperazon Injection by Pfizer Inc. PMDA Approved
For generic drugs (me-too status) Ceflactam 2g Injection by M/s Barret Hodgson,
manufacturer license granted on 02/06/2021 Tablet, Capsule, Dry Suspension
(General) and Capsule, Dry Suspension, Dry Injection
(Cephalosporin) section approved.
Name and address of API manufacturer. M/s Qilu Antibiotics Pharmaceutical Co., Ltd.
No.849 Dongjia Town, Licheng District, Jinan, Shandong
Province, China Post Code: 250105
Module III (Drug Substance) Firm has submitted detailed data for drug substance data
related to nomenclature, structure, general properties,
solubility, physical form, manufacturers, description of
specifications, analytical procedures and its validation,
drug substance.
substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted at
40°C ± 2°C / 75% ± 5% RH for 6 months. The real time
stability data is conducted at 30°C ± 2°C / 65 ± 5% RH for
36 months.
Module-III (Drug Product): Firm has submitted data of drug product including its
description, composition, pharmaceutical development,
manufacture, manufacturing process and process control,

process validation protocols, control of excipients, control
of drug product, specifications, analytical procedures,
validation of analytical procedures, batch analysis,
justification of specifications, reference standard or
materials, container closure system and stability
dissolution profile brand leader that is Q-bact 2g Injection by M/s High-Q
Pahrmaceuticals
Analytical method validation/verification of Firm has submitted verification studies of the drug
product substance and the drug product.
Manufacturer of API M/s M/s Qilu Antibiotics Pharmaceutical Co., Ltd.
No.849 Dongjia Town, Licheng District, Jinan, Shandong Province,China
Post Code: 250105
API Lot No. 0044LJ81NE
Description of Pack Sterile Powder for IM/IV Injection use, in clear glass vial, rubber stoppered
(Container closure system) with flip off seal, packed in unit carton (1×1’s)
Batch Size 500 Vials 500 Vials 500 Vials
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. SD20160497 issued by China food
API manufacturer issued by concerned and Drug administration valid till 25/08/2021.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice no. 2734 dated
approval from DRAP (in case of import). 31/03/2021. Firm has also submitted the copy of DHL Invoice.
Submitted
Submitted
and humidity monitoring of stability Submitted
chambers (real time & accelerated)

The moisture limit is ≤ 4% with results of 1.9 of the drug substances reported by DSM.
The JP product is lyophilized in final container.
10. Name, address of Applicant / Marketing M/s Acumen Healthcare Private Limited Plot # 39-40, Street #2,
Authorization Holder RCCI Industrial Estate, Rawat.
Plot # 39-40, Street #2, RCCI Industrial Estate, Rawat.
☐ Importer
☐ Export sale
The proposed proprietary name/ brand name Bactowin 2g Injection
Pharmaceutical ingredient (API) per unit Cefoperazone as sodium………500mg
Sulbactam as sodium………….500mg
Pharmaceutical form of applied drug Sterile Powder for IV/IM Injection use, in clear glass vial, rubber
The status in reference regulatory authorities Sulperazon Injection by Pfizer Inc. PMDA Approved
For generic drugs (me-too status) Ceflactam 2g Injection by M/s Barret Hodgson,

30°C ± 2°C / 65 ± 5% RH for 36 months.
stability
dissolution profile brand leader that is Q-bact 2g Injection by M/s High-Q
Pahrmaceuticals
Manufacturer of API M/s M/s Qilu Antibiotics Pharmaceutical Co., Ltd. No.849 Dongjia Town, Licheng
District, Jinan, Shandong Province,China Post Code: 250105
API Lot No. 0044LJ81NE
Description of Pack Sterile Powder for IM/IV Injection use, in clear glass vial, rubber stoppered with flip
(Container closure system) off seal, packed in unit carton (1×1’s)
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API manufacturer Copy of GMP certificate No. SD20160497
issued by concerned regulatory authority of country of origin. issued by China food and Drug administration
valid till 25/08/2021.
3. Documents for the procurement of API with approval from Firm has submitted copy of commercial invoice
DRAP (in case of import). no. 2734 dated 31/03/2021. Firm has also
submitted the copy of DHL Invoice.

4. Data of stability batches will be supported by attested
respective documents like chromatograms, Raw data sheets, Submitted
COA, summary data sheets etc.

Submitted
The moisture limit is ≤ 4% with results of 1.9 of the drug substances reported by DSM.
The JP product is lyophilized in final container.
☐ Importer
☐ Export sale
The proposed proprietary name/brand name Betapime 500mg Injection
Pharmaceutical ingredient (API) per unit Cefepime (as hydrochloride) with L-arginine….……500mg
Pharmaceutical form of applied drug Sterile Powder for Injection use, in clear glass vial, rubber
The status in reference regulatory authorities Renapime 500mg Powder for solution for injection/infusion
Manufacturer: Renascience Pharma Ltd (MHRA approved)
For generic drugs (me-too status) Maxipime 500 mg Injection by M/s Novartis,

30°C ± 2°C / 65 ± 5% RH for 36 months.
stability
dissolution profile brand leader that is Maxipime 500 mg Injection by M/s Novartis
Manufacturer of API M/s Qilu Antibiotics Pharmaceutical Co., Ltd. No.849 Dongjia Town, Licheng
District, Jinan, Shandong Province, China Post Code: 250105
API Lot No. 0025CJ86DB
No. of Batches 03

firm (if any)
Submitted
Submitted
☐ Importer
☐ Export sale
The proposed proprietary name/brand name Betapime 1g Injection
Pharmaceutical ingredient (API) per unit Cefepime (as hydrochloride) with L-arginine….……1g
Pharmaceutical form of applied drug Sterile Powder for Injection use, in clear glass vial, rubber
The status in reference regulatory authorities Renapime 500mg Powder for solution for injection/infusion
Manufacturer: Renascience Pharma Ltd (MHRA approved)
For generic drugs (me-too status) Maxipime 500 mg Injection by M/s Novartis,

Name and address of API manufacturer. M/s Qilu Antibiotics Pharmaceutical Co., Ltd. No.849 Dongjia
Town, Licheng District, Jinan, Shandong Province, China
Post Code: 250105
30°C ± 2°C / 65 ± 5% RH for 36 months.
stability
dissolution profile brand leader that is Maxipime 500 mg Injection by M/s Novartis
Manufacturer of API M/s Qilu Antibiotics Pharmaceutical Co., Ltd. No.849 Dongjia Town, Licheng
District, Jinan, Shandong Province,China Post Code: 250105
API Lot No. 0025CJ86DB

No. of Batches 03
firm (if any)
Submitted
Submitted
chambers (real time & accelerated)
Name, address of Manufacturing site. M/s Acumen Healthcare Private Limited, Plot # 39-40, Street
#2, RCCI, Industrial Estate, Rawat.
☐ Importer
☐ Export sale
etails of fee submitted PKR 30,000/-: dated 04/11/2021
The proposed proprietary name / brand name Tradix IV 500mg Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium equivalent to Ceftriaxone ….…… 500mg
The status in reference regulatory authorities Ceftriaxone 500mg Powder for Solution for Injection or
Infusion

For generic drugs (me-too status) Bioxone 500 mg Injection by M/s Biolabs
Name and address of API manufacturer. M/s Pharmagen Ltd, 5 Kot Nabi Bukshwala, 34 Km
Ferozepur Road, Lahore.
solubility, physical form, manufacturers, description of
drug substance.
Stability studies Firm has submitted stability study data of 3 batches of
drug substance at both accelerated as well as real time
40°C ± 2°C / 75% ± 5% RH for 6 months. The real time
stability data is conducted at 30°C ± 2°C / 65 ± 5% RH
for 36 months.
materials, container closure system and stability
dissolution profile brand leader that is Rocephin 1g Injection by Roche
Pakistan Ltd,
Analytical method validation/verification of Firm has submitted verification studies of the drug
product substance and the drug product.
API Lot No. 00421/029/2021
Description of Pack Sterile Powder for IV Injection use, in clear glass vial, rubber stoppered with
(Container closure system) flip off seal, packed in unit carton (1×1’s)

No. of Batches 03
1. Reference of previous approval of applications with stability study N/A
2. Approval of API/ DML/GMP certificate of API manufacturer Copy of GMP certificate No. 06/2019-
issued by concerned regulatory authority of country of origin. DRAP (AD/607409-530) issued by DRAP
valid till 08/01/2022.
3. Documents for the procurement of API with approval from DRAP N/A
(in case of import).
data sheets etc.
5. Compliance Record of HPLC software 21CFR & audit trail reports
Submitted
on product testing
1.1 Covering letter has not been signed.
2.3.P.1 The section declares the equivalency statement as “Ceftriaxone sodium
286mg is equivalent to 500mg ceftriaxone base.” Justification shall be
submitted.
2.3. P.3.2 The quantity of 10 Kg against the batch size of 8389 vials is not justified
against the weight per vial given in section 3.2. P.1
2.3. P.3.4 Fill weight per vial has been declared as 286mg.
2.3. P.5.1 Specifications of average weight per vial is not as per the composition
declared in 2.3. P.1
3.2. S.4.1 Drug substance specification proposed by drug substance manufacturer
refer to both USP & BP for Assay limit. Justification shall be submitted in
this regard.
3.2.S.4.2 M/s Pharmagen has proposed analytical procedure both as per BP & USP.
Clarification shall be submitted which method is applied for the batch
release.
Drug substance specifications & analytical procedure applied by Drug
product manufacturer shall be submitted.
3.2.S.4.3 Analytical Method Verification studies including specificity,
accuracy and repeatability (method precision) performed by the Drug
Product manufacturer shall be submitted.
3.2.S.4.4 • Assay limits declared in the COA from M/s Acumen are not as per USP.
• COA from M/s Pharmagen of the relevant batch used for the
manufacturing of drug product stability batches shall be submitted.
3.2.S.5 Submitted COA of working standard from M/s Pharmagen declares the use
before date as “19-11-2016”, whereas the analysis has been performed

3.2.S.7 Submitted stability data does not include tests of sterility.
3.2.P.1 Justify the equivalency factor of Ceftriaxone sodium for Ceftriaxone.
3.2.P.3.5 • Submitted protocol mentions the details of Cefoperazone/sulbactam
injection.
• The specification mentioned in the protocol are not as per USP
monograph.
3.2.P.5.1 Average weight is not as per the master formulation submitted for per vial
in section 3.2. P.1
3.2. P.5.2 Submit signed copy of drug product analysis method.
3.2. P.5.3 • Analytical method verification studies have bene conducted even
before the manufacturing of trial batches.
• Detailed analytical method applied for verification studies shall be
submitted.
3.2. P.5.4 • Submitted COAs have not been signed.
• Submitted COAs does not reflect the performance of Bacterial
Endotoxin test.
3.2. P.6 Details of reference standard shall be submitted.
3.2. P.7.1 This section mentions primary packaging as ampoule.
3.2. P.8 • It is evident from the submitted Assay calculation sheet that the
standard and sample dilutions have not been prepared as per USP
monograph of “Ceftriaxone for injection”. Justification shall be
submitted in this regard.
• Average content weight mentioned in Assay calculation sheet.
• Submitted HPLC chromatograms declare the Sample ID as
“Ceftriaxone250-STD” for the standard solution injections, whereas
applied product is of 500mg strength.
• Reference of the potency value applied in assay calculation sheet, shall
be submitted.
• Submitted data logger record of stability chambers does not cover the
all calendar days of stability studies.
• Microbiological analysis record for the performance of sterility test &
Bacterial Endotoxin test shall be submitted.
Firm has submitted reply which still include details of other drugs than that is applied.
Agenda of Evaluator PEC-V

Case No. 1: Priority Consideration of drugs for Covid-19
1. Name, address of Applicant / Importer M/s Pfizer Pakistan Limited,
12 Dockyard Road West Wharf, Karachi.
Details of Drug Sale License of importer DHOKW(Drugs)/148/License No. 029
Address: 12 Dockyard Road West Wharf, Karachi.
Address of go-down
12 Dockyard Road West Wharf, Karachi.
Validity: 25-02-2023
Status: License to sell drugs by way of Whole sale.
Name and address of marketing authorization M/s Pfizer Limited
holder (abroad) Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Name, address of manufacturer(s) Ritonavir Tablets
Bulk Tabs. Manufacturer, Testing and Release
M/s. Hetero Labs Limited,
Unit-III, 22-110,
Industrial Development Area, Jeedimetla, Hyderabad-500055,
Telangana, India

Nirmatrelvir Tablets
Manufacturer,Primary Packaging,Secondary Packaging,Testing,
Stability,Release of co-packs
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg,Mooswaldallee 1,79090 Freiburg,
Germany
Name of exporting country Germany
Detail of certificates attached (CoPP, Freesale • Firm has submitted copy GMP Certificate (No. DE_BW-
certificate, GMP certificate) 01_GMP_2021_0006 dated 21-02-2021 valid till 07-10-2023
issued by Germany. The GMP certificate specifies the GMP
status of the manufacturer.
• Firm has submitted Original and Legalized CoPP
(PP10175835) dated 18-02-2022 valid for five years issued by
Medicine and Healthcare Products Regulatory Agency United
Kingdom. The CoPP specifies free sale status of the product in
country of origin along with its availability.
Details of letter of authorization / sole agency Original LOA has been submitted by firm dated 10-02-2022
agreement
☒ Importer
Status of application ☒ New Drug Product (NDP)
☐ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☒ Domestic sale
☐ Export sale
☐ Domestic and Export sales
For imported products, specify one the these ☒ Finished Pharmaceutical product import
☐ Buk import and local repackaging
☐ Buk import and local repackaging for export purpose only
Dy. No. and date of submission Dairy No. 6640 Dated 10-03-2022
The proposed proprietary name / brand name PAXLOVID 150 mg/100mg Film-Coated Tablets
Strength / concentration of drug of Active Each Pink Coloured Film coated tablet contains:
Pharmaceutical ingredient (API) per unit Nirmatrelvir…………150mg
Each White Coloured Film coated tablet contains:

Ritonavir……………100mg
Pharmaceutical form of applied drug Film Coated Tablets
Pharmacotherapeutic Group of (API) Protease Inhibitor Antiviral
PF-07321332 and ritonavir, in two different tablets. PF-
07321332 works by reducing the ability of SARS-CoV-2 (the
virus that causes COVID-19) to multiply in the body while
ritonavir prolongs the action of PF-07321332 enabling it to
remain longer in the body at levels that affect the multiplication
of the virus.
Reference to Finished product specifications Pfizer Specs
Proposed unit price Firm has stated it will be provided later.

The status in reference regulatory authorities MHRA approved (Conditional Grant)
EMA:Conditional marketing authorisation
For generic drugs (me-too status) NA
Module-II (Quality Overall Summary) Firm has not provided QOS.
Firms response
An up-to-date Quality Overall Summary (QOS) that summarizes
the complete module 3 content is not available currently. Due to
accelerated development timelines in response to the pandemic,
the dossier was submitted to MHRA and subsequently updated as
part of a rolling submission process. The QOS included with this
dossier is intended to provide a brief introduction to the product
only.
Nirmatrelvir (PF-07321332)
Name, address of drug substance The following commercial sites are involved in manufacturing of
manufacturer drug substance:
Pfizer Ireland Pharmaceuticals, Ringaskiddy Active
Site 1
Pharmaceutical Ingredient Plant Ringaskiddy County Cork,
Ireland
Site 2 Jilin Asymchem Laboratories Co. Ltd, No. 99, Hongda
Road, Economic Development Zone, Dunhua, Jilin 133700,
China (CHN)
Changzhou SynTheAll Pharmaceutical Co. Ltd No.589,
Site 3
North Yulong Road, Xinbei District, Changzhou, CH

213127, China (CHN)
Module-III Drug Substance: General Information
• Nirmatrelvir was formally known as PF-07321332.
• Polymorphism: Form 1 is the thermodynamically most
stable form at relevant temperatures and humidity and is
used for development and emergency application
supplies.
• Chirality: PF-07321332 has 6 asymmetric centers, giving
32 possible stereoisomers.
• There are no cis-trans isomers for PF-07321332.
• White to pale colored powder.
Manufacture, characterisation and process controls
A total of six synthetic routes have been used to manufacture
supplies of PF-07321332. There are two processes used in the
manufacture of PF-07321332, Synthetic Route F and Synthetic
Route G.
There is no process validation as there is no aseptic processing or
sterilization in the manufacture of PF-07321332.
Specification
Provisional Specifications have been provided for synthetic route
F and G.
Provisional analytical procedures used to control the manufacture
of PF-07321332. The final analytical methods for registration
will be validated in accordance with ICH guidelines.
Container Closure System
PF-07321332 is packaged in two sealed, low density
polyethylene (LDPE) anti-static liners.The bagged material is
then inserted in a high density polyethylene (HDPE) drum or
equivalent secondary container.
Stability Studies of Drug Substance The stability of PF-07321322 synthetic routes C and D are
(Conditions & duration of Stability studies) supportive of synthetic routes F and G as all synthetic routes have

the same polymorph, similar synthetic chemistry, and same final
solvents.
Condition (6months)
40°C/75% RH
25°C/60% RH
Shelf life
A retest date has been assigned to be 12 months at 15 – 30°C.
Emergency supply batches of PF-07321332 drug substance
manufactured at the commercial site will be placed on stability at
30°C/75% RH and 40°C/75% RH in support of this storage
condition.
The stability data sheets of synthetic route F and G are not
available.
Ritonavir
Name, address of drug substance The following commercial sites are involved in manufacturing of
manufacturer ritonavir:
M/s. Hetero Drugs Limited, Unit-IX,
Plot No. 1, Hetero Infrastructure SEZ Ltd.,
N. Narasapuram (Village), Nakkapalli (Mandal),
Visakhapatnam District-531081, Andhra Pradesh, INDIA.
Module-III Drug Substance: General Information
• Polymorphism : Ritonavir exhibits polymorphism.
Hetero produces crystalline Form-I.
• Isomerism : Ritonavir (Form-I) exhibits isomerism. It
contains four chiral centers.
• White or almost white powder.
Manufacture, characterisation and process controls
The molecular structure of Ritonavir (Form-I) (B. No.
RI0020410) was investigated and confirmed by IR, UV, NMR
(Proton & Carbon), Mass spectroscopic techniques.
Specification
• The specification limits followed for drug substance is
fixed based on process capability, Ph. Eur. monograph
of Ritonavir (Form-I) and ICH recommendations.
• The analytical methods used in the analysis of Ritonavir
(Form-I) are Related compounds (By HPLC), Assay (By
HPLC, on anhydrous basis), Residual solvents (By GC).
These methods were qualified for regular analysis.
Container Closure System
The API is packed in transparent polythene bags placed in an
HDPE drum.
Stability Studies of Drug Substance Accelerated
(Conditions & duration of Stability studies) 40±2°C/75±5% RH
0, 1, 2, 3, 4, 5, 6
Intermediate
30±2°C/65±5% RH
0, 1, 3, 6, 9, 12
Long Term
25±2°C/60±5%RH
0, 1, 2, 3, 4, 5, 6, 9,12, 18, 24, 36, 48, 60
Shelf life/Retest
Retest period of 60 months

Paxlovid finished medicinal product
The proposed medicinal product Paxlovid consists of PF-07321332 150 mg film-coated tablets and ritonavir 100
mg film-coated tablets, which are separately manufactured, but co-packaged on the same blister for ease of daily
co-administration.
Nimatrelvir film-coated tablets
Module-III Drug Product: Description of the product and pharmaceutical development
Nimatrelvir film-coated tablets The proposed dosage form for PF-07321332 is an immediate
release (IR) film-coated tablet in dosage strength of 150 mg. The
dosage form is presented as an oval, pink, film-coated tablet with
“PFE” debossed on one tablet face and “3CL” debossed on the
opposite tablet face.
Manufacture of the product and process controls
Manufacturing Site
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg,Germany
Process validation: The manufacturing process for PF-07321332
150 mg film-coated tablets use conventional manufacturing
techniques and equipment. The manufacturing & packaging
process validation will be completed and provided as part of a
forthcoming submission when final process and controls will
have been identified and appropriate process understanding has
been developed.
Stability data
Manufacture Site:Pfizer ,Freiburg, PPD
Container:Foil blister
3 months data submitted
Pharmaceutical Equivalence and Comparative Nirmatrelvir: Not applicable for innovator products.
Dissolution Profile
Analytical method validation/verification of Nirmatrelvir:
product Firm has submitted that analytical method validation studies for
drug product has been performed. These analytical procedures
were verified and confirmed suitable for their intended use. Non-
compendial analytical procedures used for batch release and
stability studies.
Ritonavir Film coated Tablets
Module-III Drug Product: Description of the product and pharmaceutical development
Ritonavir film-coated tablets White to off white, capsule shaped, film-coated tablets, debossed
with ‘H’ on one side and ‘R9’ on other side.
Manufacture of the product and process controls
Manufacturing Site
Ritonavir:
I. Bulk tablet manufacturing M/s. Hetero Labs Limited,
Unit-III, 22-110, Industrial Development Area,
Jeedimetla, Hyderabad-500055, Telangana, India
II. Ritonavir Premix (Amorphous) manufacturing M/s.
Hetero Drugs Limited, Unit-IX, Plot No. 1, Hetero
Infrastructure Ltd.- SEZ, Narasapuram Village,
Nakkapally Mandal, Visakhapatnam District-531081,
Andhra Pradesh, India.
Stability data of bulk Tablets is available.

Pharmaceutical Equivalence and Comparative Ritonavir tablets were developed in reference to NORVIR®
Dissolution Profile Manufactured by Abbott Laboratories Ltd., (Manufactured by
Abbott laboratories. North Chicago, IL 60064, U.S.A).
The dissolution methods developed indicated good comparison
with Norvir®.
Analytical method validation/verification of The method validations were performed for Related compounds
product (By HPLC), Assay (By HPLC), Residual solvents (By GC).
Paxlovid finished medicinal product
The proposed medicinal product Paxlovid consists of PF-07321332 150 mg film-coated tablets and ritonavir 100
mg film-coated tablets, which are separately manufactured, but co-packaged on the same blister for ease of daily
co-administration.
Container closure system of the co-pack Paxlovid is packaged in cartons containing 5 daily-dose
OPA/Al/PVC foil blister cards of 30 tablets.
Each daily blister card contains 4 Nirmatrelvir tablets (Pink) and
2 ritonavir tablets (White).
The container closure system for PF-07321332 150 mg film-
coated tablets and externally sourced ritonavir 100 mg film-
coated tablets consists of a foil/foil blister system made from a
composite Oriented PolyAmide/Aluminium
Foil/Polyvinylchloride (OPA/Al/PVC) foil blister with
aluminium foil lidding where each tablet is placed into an
individual blister cavity.
Stability study data of Co-pack drug product, Stability data for Ritonavir 100 mg Tablets in the Pfizer co-
shelf life and storage conditions packaged foil/foil blister system is currently not available.
Stability studies for the co-packaged drug product (containing
both Nirmatrelvir and ritonavir tablets) in commercial packaging
are currently scheduled to start between March and May 2022.
Stability studies will be performed at long term storage
conditions of 30 °C/75% RH and 25°C/60% RH and accelerated
conditions of 40 °C/75% RH.
Stability data for the individual tablets are provided.
Nirmatrelvir film coated tablets Shelf life
Due to the accelerated pharmaceutical development, limited
primary stability data is currently available for the PF-07321332
150 mg film-coated tablet.
Preliminary stability data for three primary batches of the 150 mg
tablets were reported for three months at the long-term storage
conditions of 30°C/ 75% RH and 25°C/60% RH and at the
accelerated storage conditions of 40°C/ 75% RH.

To support the proposed 12-month shelf life, six months of
stability data for PF-07321332 tablets from the three primary
stability batches will be available in March 2022.
Ritonavir Film coated shelf life
The commercially available Hetero Ritonavir 100 mg tablet in
foil/foil blister container closure system has an approved shelf
life of 24 months.
Copack Shelf Life
The final shelf life and storage condition for co-package product
will be based on the more stringent shelf-life and storage
condition
Based on the 3 months stability data for 3 batches of Nirmatrelvir
150 mg film-coated tablets from the primary registration stability
program and up to 6 months stability data for supportive stability
batches, the proposed shelf-life is 12 months when “Stored at
room temperature 20°C to 25°C (68°F to 77°F); excursions
permitted between 15°C and 30°C (59°F and 86°F)” for product
packaged in foil/foil blisters.
Remarks of the evaluator
Shortcomings Query Firms response
1. QOS is not available. It is not available currently. Due to accelerated development
timelines in response to the pandemic, the dossier was
submitted to MHRA and subsequently updated as part of a
rolling submission process.
2. Total 6 synthetic routes have been A total 6 synthetic routes have been used in the manufacturing
used in manufacture of Nirmatrelvir of Nirmatrelvir.
(A,B,C,D,.E.F.G) but the submitted The routes that will provide supplies to emergency supply are
stability data is of route C and D route F(Pfizer Ireland Current Source) and route G (China,
only. Clarification regardingfuture assessment).These routes have been used for initial
synthetic route, manufacturing and manufacturing of Nirmatrelvir.
stability site is required? Five previous routes A,B,C,D and E(China)were used to
• Pfizer Ireland Pharmaceuticals, provide earlier development ,preclinical and clinical supplies.
Ringaskiddy Active Pharmaceutical Stability studies at Pfizer Ireland Pharmaceuticals,
Ingredient Plant Ringaskiddy Ringaskiddy are ongoing. The 3-month interval stability
County Cork, Ireland analysis is under progress. The data will be made available by
• Jilin Asymchem Laboratories Co. April 2022.
Ltd, No. 99, Hongda Road, Given stability of 6 months of another site Wuxi Apptec
Economic Development Zone, China(route C and D) is available. STA Pharmaceutical
Dunhua, Jilin 133700, China (CHN) (WuXi STA), a subsidiary of WuXi AppTec.
• Changzhou SynTheAll
Pharmaceutical Co. Ltd No.589,
North Yulong Road, Xinbei
District, Changzhou, CH 213127,
China (CHN).
3. 3.2.P.3.5. Process validation has not The manufacturing process for PF-07321332 150 mg film-
been performed for Nirmatrelvir coated tablets uses conventional manufacturing techniques
Tablets? and equipment. The manufacturing & packaging process
validation will be completed and provided as part of a
forthcoming submission when final process and controls will
have been identified and appropriate process understanding
has been developed.
Manufacturing site is expected to complete the protocol
development by July 2022.
4. Stability Data of co-pack has not Stability studies for the co-packaged drug product (containing
been submitted? both nirmatrelvir and ritonavir tablets) in commercial
packaging are currently scheduled to start between March and

May 2022 at all three sites, depending on site packaging
schedules.
Stability studies will be performed at long term conditions
30°C/75% RH ,25°C/60% RH and accelerated conditions of
30°C/75%.
To support 12 months shelf life ,six months stability for
nirmatrelvir tablets from the three primary stability batches
will be available in March 2022.
We commit to monitor stability data according to ICH
guidelines and will inform the authorities according to GMP
processes in the case of OOS results.
5. Clarification for Final release site for Germany site is responsible for manufacturing and final
drug product with respect to COPP release of drug product. MHRA can mention a site name once
as it mentions Germany site as only.
manufacturer and at release site
Ireland and Italy.
Decision: Registration Board deliberated the case in details and opined that as MHRA of UK and US FDA has
approved EUA (Emrgency Use Authorisation) with certain post-marketting conditions and Registration Board
may also consider on same pattern / conditions. However, the Board referred the case to DRAP Authority for
priority consideration of registration applications or otherwise considering the current situation of COVID-19
pandemic in Pakistan.
Case No 2 Veterinary Deferred Case
2. Name and address of manufacturer / "M/s Selmore Pharmaceuticals Pvt Ltd.
Applicant 36-Km, Multan Road Lahore."
Brand Name +Dosage Form + Strength Amino Vita Injection 250ml
Composition "Each ml contains:
L-Arginine HCL...1.42mg
L-Cysteine HCL...0.02mg
Monosodium Glutamate...0.08mg
L-Histidine HCL...0.02mg
L-Isoleucine HCL...0.525mg
L-Leucine...0.6mg
L-Lysine HCL...0.525mg
DL-Methionine...0.525mg
L-Threonine...0.35mg
L-Tryptophan...0.175mg
L-Phenylaline...0.35mg
L-Valine...0.525mg
Thiamine HCL...0.1mg
Riboflavin...0.05mg
Pyridoxine HCL...0.1mg
Nicotinamide ...3mg
Dextrose...50mg
Calcium Chloride...2mg
Potassium Chloride...2mg
Magnesium sulphate...2mg
Sodium acetate...7.5mg
D-Pantothenol...0.1mg"
Diary No. Date of R& I & fee Dy.No 8789 dated 27-02-2019 Rs.20,000/- 26-02-2019
Pharmacological Group Vitamins,Aminoacid, Mineral Supplement
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 250ml glass vial. As per SRO.
Me-too status Me too 020083 AMINOVITAL HIGH INJECTION
GMP status 05-03-2018,17-08-2018 & 16-10-2018 Conclusion:

In the light of the inspection conducted by the panel and based on
the findings the panel of inspectors recommends grant of renewal of
drug manufacturing license by way of formulation of M/s Selmore
Pharma Lahore for following sections:
1- Veterinary Bolus
2- Veterinary Aerosal
3- Veterinary Oral powder
4- Veterinary Oral Liquid
5- Veterinary Liquid Injection
6- Veterinary Penicillin oral powder
7- Veterinary Penicillin dry powder for injection
8- Veterinary Penicillin liquid injection
9- Veterinary Hormone Liquid injection
10- Human Penicillin capsule
11- Human Penicillin dry powder suspension
12- Human Penicillin dry powder injection.
Remarks of the Evaluator-V Evidence of Me Too is required.
th
Decision of 297 Meeting: Deferred for the evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) along with registration number, brand name and name of firm.
Evaluation by PEC-V:
Firm has submitted following Me too 020083 AMINOVITAL HIGH INJECTION and their applied
formulation is as per ME too but there was typographical error in agenda, that has been verified from dossier.
Strength mentioned in previous Agenda Applied formulation
L-Tryptophan...0.165mg L-Tryptophan...0.175mg
L-Phenylaline...0.45mg L-Phenylaline...0.35mg
Riboflavin...3mg Riboflavin...0.05mg
Decision of M-307: Deferred for the evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) along with registration number, brand name and name of firm.
Firms Reply
Firm has submitted following Me too 020083 AMINOVITAL HIGH INJECTION
Decision of M-313: The Board deferred the case for revision of strength of L-Arginine in the formulation as per
me-too reference (i.e from 1.425mg to 1.42mg) along with the submission of applicable fee for revision of
formulation as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Evaluation:
Firm has revised the formulation and submitted the requisite fee Rs.30,000/-.
Decision: Approved as per following label claim with innovators specification:
"Each ml contains:
L-Arginine HCL...1.42mg
L-Cysteine HCL...0.02mg
Monosodium Glutamate...0.08mg
L-Histidine HCl...0.02mg
L-Isoleucine HCL...0.525mg
L-Leucine...0.6mg
L-Lysine HCL...0.525mg
DL-Methionine...0.525mg
L-Threonine...0.35mg
L-Tryptophan...0.175mg
L-Phenylaline...0.35mg
L-Valine...0.525mg
Thiamine HCL...0.1mg
Riboflavin...0.05mg
Pyridoxine HCL...0.1mg
Nicotinamide ...3mg
Dextrose...50mg
Calcium Chloride...2mg
Potassium Chloride...2mg

Magnesium sulphate...2mg
Sodium acetate...7.5mg
D-Pantothenol...0.1mg"
Agenda of Evaluator PEC-XIV
Case no. 01 Registration applications for local manufacturing of (Human) drugs
a. Deferred cases
3. Name and address of manufacturer / M/ s Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi Industrial Area
Applicant Karachi Pakistan
Brand Name +Dosage Form + Strength Cefexol capsule 200mg
Composition Each Capsule contains:
Cefixime USP.…….200mg
Diary No. Date of R& I & fee Dy. No: 429 dated 28-01-2013, Rs.20,000/-
Pharmacological Group 3rd Generation Cephalosporin Antibiotic
Type of Form Form-5
Finished product Specifications Manufacturer’s Specifications
Pack size & Demanded Price 10’s, 30’s / As per SRO
Approval status of product in Reference Cefixime Normon 200mg Capsule of M/s Laboratories Normon, S.A.
Regulatory Authorities Madrid Spain (CIMA Approved)
Me-too status Cefosch capsule 200mg of M/s Bosch (Reg#050513)
GMP status The firm was inspected on 05-08-2019 and conclusion of inspection
was as below:
Based on the areas inspected, the people met and the documents
reviewed, and considering the findings of the inspection M/s
NabiQasim Karachi is considered to be operating at an acceptable
level of compliance of GMP requirements.
Previous remarks of the Evaluator.
Previous Decision Deferred for submission of correct salt form of API as per reference
product (M-279).
Evaluation by PEC The firm has submitted revised form-5 with correct salt form of
applied formulation as below:
Each Capsule contains:
Cefixime as trihydrate…….…….200mg
Fee challan of Rs. 7500/- (Slip # 49088576668)
Initially the firm claimed JP specifications, subsequently the firm
submitted finished product specifications as approved by Registration
Board in 313th meeting. The firm has submitted fee challan of Rs.
7500/- (Slip # 9812969033) dated 09-03-2022.
Decision: Approved with Manufacturer’s specifications notified vide letter No.F.14-1/2022-PEC dated 14th
March 2022.
The firm shall submit the fee of Rs. 7500/- for correction/pre-approval change in product specifications as
per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
4. Name and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt) Ltd., 21 -Km, Feroz Pur Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Zupenth IM Injection
Composition Each ml contains:
Zuclopenthixol decanoate (B.P) …………….50mg
Diary No. Date of R& I & fee Dy no. 617 dated 31-3-2014, Rs.20,000/-
Pharmacological Group Typical antipsychotic drug of thioxanthene class
Type of Form Form-5
Finished product Specifications BP specifications
Pack size & Demanded Price As Per SRO/1×2ml ampoule
Approval status of product in Reference Clopixol Acuphase zuclopenthixol acetate 100mg/2ml injection
Regulatory Authorities ampoule of M/s Lundbeck Australia (TGA approved).
Me-too status Clopixol Acuphase Injection of Lundbeck (Reg# 008023)

GMP status GMP certificate issued to M/s Shrooq Pharma based upon evaluation
conducted on 29-10-2021.
Previous Decision Deferred for confirmation of approval status in reference authorities
for same unit volume (M-265).
Evaluation by PEC The firm has revised the salt form of applied formulation as per
reference product as below:
Each ml contains:
Zuclopenthixol acetate …………….50mg
Fee challan of Rs. 30,000/- (slip # 3724987167) dated 03-03-2022 has
been submitted for correction in composition.
Me-too status has been verified against reference of “Zulcopen

Acuphase Injection 100mg” of M/s The Schazoo Pharmaceuticals
Laboratories (Pvt) Ltd. (Reg.#065846).
Decision: Approved.
5. Name and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt) Ltd., 21 -Km, Feroz Pur Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Muco Gel
Composition Each 5gm contains
Mucopolysaccharide ………. 0.01g (0.2% w/w)
Salicylic Acid ……………….0.1g (2.0% w/w)
Diary No. Date of R& I & fee Dy. No. 411, 31.03.2015, Rs. 8,000, Rs.12000/-, 31.03.2015
Pharmacological Group ATC code: M02AC, Topical Products for Joint and Muscular Pain
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 15gm, 40gm; As per SRO
Approval status of product in Reference Movelat Gel of M/s Genus Pharmaceuticals Ltd, Huddersfield, UK
Regulatory Authorities (MHRA approved)
Me-too status Hi-Velet Gel by Highnoon Labs (Reg # 074326)
GMP status GMP certificate issued to M/s Shrooq Pharma based upon evaluation
Previous Decision Deferred for confirmation of approval of applied formulation in
reference regulatory authorities and me-too status (M-265).
Evaluation by PEC Revision of formulation as per reference is required since the reference
formulation in MHRA contains mucopolysaccharide polysulphate
(MPS) while applied formulation contains Mucopolysaccharide.
Decision: Approved with innovator’s specifications.
The firm shall submit revised formulation with correct salt form as per the innovator drug product before
issuance of registration letter, along with submission fee of Rs. 30,000/- for correction/pre-approval change
in product composition (correction/pre-approval change in salt form of drug substance) as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
6. Name and address of manufacturer / M/s Weatherfolds Pharmaceuticals, Plot # 69, Phase-II,
Applicant Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Fusid 250mg Tablet
Composition Each film coated tablet contains:
Sodium Fusidate………………250mg
Diary No. Date of R& I & fee 1882, 04-01-2018, 20,000/-, 04-01-2018
Pharmacological Group Steroid Antibacterials;
ATC code: J01XC01
Type of Form Form-5
Finished product Specifications In-house
Pack size & Demanded Price As per SRO; As per SRO

Approval status of product in Reference Approved in MHRA
Regulatory Authorities
Me-too status Fucidin Tablet of LEO Pharma
GMP status GMP inspection conducted on 15-09-2017 concluded that overall the
firm was GMP compliant as per DRAP
Guidelines.
Previous Decision Deferred for submission of correct pharmacological group (M-288).
Evaluation by PEC The firm has submitted Form-5 with revised pharmacological group
as “Anti-infective”.
Decision: Deferred for further deliberation regarding pharmacological group of applied products and
required manufacturing facility.
7. Name and address of manufacturer / M/s Shawan Pharmaceuticals, Plot # 37, Road: NS-1, National
Applicant Industrial Zone, Rawat, Rawalpindi.
Brand Name +Dosage Form + Strength Omeyz 40mg Capsule
Composition Each capsule contains:
Omeprazole (as enteric coated pellets 22.5%)…..40mg
Diary No. Date of R& I & fee 01-03-2011 vide diary # 3030, Rs.15000 & 19-08-2013
diary # 1917, Rs.5000
Pharmacological Group Proton pump inhibitors
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price As per SRO
Approval status of product in Reference Omeprazole 40mg Capsules of M/s Sandoz Limited (MHRA
Regulatory Authorities approved)
Me-too status Omega 40mg by M/s Ferozsons
GMP status GMP inspection report dated 21 & 26-10-2021 concluded that overall
GMP compliance found good, the company is working at proper
hygienic conditions. The management has been advised to continue
the process of up gradation.
Previous Decision Deferred for following (M-254)
Finished product specifications are not provided.
Source of pellets is not provided.
Commitment as per decision of RB is not provided.
Fresh inspection report conducted within the period of 1 year need to
be submitted.
Evaluation by PEC The firm has claimed USP specifications.
Source of pellets: M/s Vision Pharmaceuticals
Fee for variance to Registration application: 7,500/- (slip #
522607571992) dated 24-01-2022.
Differential fee: Rs. 10,000/- (slip # 9766019413) dated 24-01-2022.
Decision: Approved.
8. Name and address of manufacturer / M/s High-Q Pharmaceuticals,
Applicant Plot No.224, Sector 23, Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Pramadol Plus Tablet
Composition Each film coated Tablet Contains:
Tramadol hydrochloride……75mg
Paracetamol………………….650mg
Diary No. Date of R& I & fee Dy.No 13099, 09-04-2018, Rs.20,000/- 09-04-2018
Pharmacological Group Opioids in combination with non-opioid analgesics
Type of Form Form-5

Approval status of product in Reference Tramadol/Paracetamol 75 mg / 650 mg Tablets by M/s Aspire Pharma
Regulatory Authorities Ltd. UK. (MHRA Approved)
Me-too status Not confirmed
GMP status Inspection dated 10-04-18 concluded that the firm was considered to
be operating at an acceptable level of compliance with good
manufacturing practices for Pharma products.
Previous Decision Deferred for evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith registration number,
brand name and name of firm (M-290).
Evaluation by PEC The firm has submitted following me-too reference:
Tonoflex-P Forte Tablets of M/s Sami Pharmaceuticals (Reg #
094798).
Stability study data as per guidelines of 293rd meeting of Registration
Board is required to be submitted.
Decision: Deferred for submission of stability study data as per guidelines of 293rd meeting of Registration
Board.
9. Name and address of manufacturer / M/s Schazoo Zaka (Pvt) Ltd.,
Applicant Lahore Kalalwala, Zakaur Rehman State, Plot No.1, 20-km Lahore -
Jaranwala Road, Shikhupura
Brand Name +Dosage Form + Strength Parotin CR 12.5mg Tablet
Composition "Each enteric coated tablet contains:
Paroxetine as hydrochloride…………12.5mg"
Diary No. Date of R& I & fee Dy.No. 30866,13-09-2018, Rs.20,000/-, 13-09-2018
Pharmacological Group Anti-depressants, SSRI
Type of Form Form-5
Finished product Specifications USP specifications
Approval status of product in Reference PAXIL CR (paroxetine) extended-release tablets
Regulatory Authorities USFDA Approved with box warning.
Me-too status Panox CR Tablet 12.5 mg of M/s Regal (Reg # 081953)
GMP status GMP certificate issued on 24-07-2018 with following sections:
1- Tablet (Gen, Anti TB)
2- Capsule (General)
3- Dry Powder suspension (Gen, Anti Tb)
4- Sachet (Gen, Anti Tb).
Previous remarks of the Evaluator. The applied formulation is internationally approved as
enteric coated controlled release tablet whereas, firm has applied for
only enteric coated.
The innovator product consists of two layers. One layer of the tablet
consists of a degradable barrier layer and the other contains the active
material in a hydrophilic matrix.
Previous Decision Deferred for the following (M-296):
• Submit label claim of applied formulation in line with reference
product which is approved as enteric coated controlled release tablet.
• Submit manufacturing method of applied formulation in line with
the innovator product which consists of two layers. One layer of the
tablet consists of a degradable barrier layer and the other contains
the active material in a hydrophilic matrix.
Evaluation by PEC The firm has submitted revised Form-5 with following label claim:
Each enteric film coated controlled release tablet contains:
Paroxetine hydrochloride eq. to Paroxetine……12.5mg
Fee of Rs. 7500/- (deposit slip # 6250592774) dated 27-10-2021 has
been submitted.
Decision: Approved as per following label claim:

The firm shall submit differential fee of Rs. 22,500/- for correction/pre-approval change in product
composition (correction/pre-approval change from enteric coated to enteric film coated controlled release
tablet) as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
10. Name and address of manufacturer / M/s Schazoo Zaka (Pvt) Ltd.,
Brand Name +Dosage Form + Strength Parotin CR 25mg Tablet
Paroxetine as hydrochloride…………25mg"
Diary No. Date of R& I & fee Dy.No. 30867, 13-09-2018, Rs.20,000/-13-09-2018
Type of Form Form-5
Finished product Specifications USP extended release monograph
Me-too status Panox CR Tablet 25 mg of M/s Regal (Reg # 081954)
Paroxetine hydrochloride eq. to Paroxetine……25mg
Fee of Rs. 7500/- (deposit slip # 05540439825) dated 27-10-2021 has
been submitted.
Decision: Approved with following label claim:
Paroxetine hydrochloride eq. to Paroxetine………25mg
11. Name and address of manufacturer / M/s Schazoo Zaka (Pvt) Ltd.
Brand Name +Dosage Form + Strength Parotin CR 37.5mg Tablet
Paroxetine as hydrochloride…………37.5mg"
Diary No. Date of R& I & fee Dy.No. 30868, 13-09-2018, Rs.20,000/-13-09-2018

Type of Form Form-5
Finished product Specifications USP extended release monograph
Me-too status Paraxyl CR Tablet 37.5 mg of M/s CCL (Reg # 060323)
Fee of Rs. 7500/- (deposit slip # 20552806) dated 27-10-2021 has been
submitted.
Paroxetine hydrochloride eq. to Paroxetine………37.5mg
12. Name and address of manufacturer / M/s Wezen Pharmaceuticals., plot 23 -24, phase S-1 , industrial estate
Applicant , Rawat
Brand Name +Dosage Form + Strength Esowen 40mg Capsule
Esomeprazole as magnesium trihydrate (Enteric coated
pellets)…………………..40mg
Diary No. Date of R& I & fee Dy. No. dated 07/03/2019 Fee 20,000/-
Pharmacological Group Proton pump inhibitor
Type of Form Form 5
Finished product Specifications USP Specifications
Approval status of product in Reference Nexium 40mg Capsule USFDA APPROVED
Me-too status Esorid 40mg Capsules. Reg. No. 033097
GMP status Panel Inspection for Grant of Additional sections on 4th Dec, 2020.
Panel recommends Grant of Additional sections.
Previous remarks of the Evaluator. Detail regarding source of pellets, COA, GMP of manufacturer of
pellets and stability studies according to zone IV-A is required.
Previous Decision Deferred as DML has been suspended by CLB (M-312)

Evaluation by PEC The firm has submitted following documents;
GMP: Certificate No. F.3-26/2019-Addl. Director (QA&LT) dated
31/07/2019.
Stability studies:
36 months real time stability data at 30°C ± 2°C / 65% ± 5%RH of 03
batches
06 month accelerated stability data 40°C ± 2°C / 75% ± 5%RH of 03
batches
Certificate of analysis of pellets
The firm has submitted document from licensing division vide letter
No. F.1-30/2014-Lic dated 15th November, 2021 wherein the CLB has
ceased the operation of suspension order for further period with
immediate effect.
Decision: Approved.
Applicant , Rawat
Brand Name +Dosage Form + Strength Esowen 20mg Capsule
Esomeprazole as magnesium trihydrate (enteric coated pellets)
……………20mg.
Diary No. Date of R& I & fee Dy. No. 16298 Dated 07-03-2019, Rs. 20,000/-
Type of Form Form 5
Approval status of product in Reference Nexium 20mg Capsule USFDA APPROVED
Me-too status Esorid 20mg Capsules. Reg. No. 033097
Previous Decision Deferred as DML has been suspended by CLB (M-312)
31/07/2019.
Stability studies:
batches
batches
immediate effect.
Decision: Approved.
Applicant , Rawat
Brand Name +Dosage Form + Strength Omewen 40mg Capsule
Omeprazole (as enteric coated pellets) ……...40mg

Type of Form Form 5
Approval status of product in Reference Losec 40 mg hard gastro-resistant capsules
Regulatory Authorities (Approved by MHRA)
Me-too status Omecap Capsule. Reg. No. 084494
Previous Decision Deferred as DML has been suspended by CLB (M-312).
31/07/2019.
Stability studies:
batches
batches
immediate effect.
Decision: Approved.
Applicant , Rawat
Brand Name +Dosage Form + Strength Omewen 20mg Capsule
Omeprazole (as enteric coated pellets) ……...20mg
Type of Form Form 5
Approval status of product in Reference Losec 20 mg hard gastro-resistant capsules
Regulatory Authorities (Approved by MHRA)
Me-too status Omecap Capsule. Reg. No. 084494
Previous Decision Deferred as DML has been suspended by CLB (M-312).
31/07/2019.
Stability studies:
batches
batches

immediate effect.
Decision: Approved.
16. Name and address of manufacturer / M/s Cibex (Pvt.) Ltd., F-405, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form + Strength Klegg Dry suspension
Composition Upon reconstitution each 5ml contains:
Clarithromycin (as taste masked Pellets 27.5%)…….…250mg
Diary No. Date of R& I & fee Dy. No.1376; 29-09-2016; Rs.20,000/- (28-09-2016)
Pharmacological Group Macrolide antibiotic
Type of Form Form-5
Pack size & Demanded Price 60ml; As per SRO
Approval status of product in Reference Biaxin Suspension (USFDA approved)
Me-too status Maclacin of M/s Bosch
GMP status Certificate of cGMP based on evaluation conducted on 20-09-17 is
provided.
Previous remarks of the Evaluator. Fee challan of Clarithromycin 500mg tablets is attached instead of
clarithromycin 250mg dry suspension. However, an undertaking has
also been submitted that the challan number 0520918, dated
September 2, 2016 for Rs.20,000/- is intended to be used for Klegg
(Clarithromycin 250mg/5ml) dry suspension only, and will not be
used for any other product.
Previous Decision Deferred for confirmation from B & A Division for submitted fee for
applied formulation (M-281).
Evaluation by PEC The firm has submitted photocopy of fee challan of Rs. 20,000/-
(Deposit slip # 0229232) dated 17-01-2018 stating correct strength of
clarithromycin 250 mg dry suspension.
Remarks of AD Revenue (B & A) regarding fee challan are as below:
The said challan No. 0229232 has already been endorsed by the
Division of Budget & Accounts in original and handed over to M/s
Cibex (Pvt.) Ltd. As per SOP, copy of challan(s) cannot be endorsed.
The firm has also submitted yellow copy of fee challan for the applied
formulation.
Decision: Approved with USP specifications.
The firm shall submit the fee of Rs. 7,500/- for correction/pre-approval change in product specifications
as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
17. Name and address of manufacturer / M/s The Searle Company Limited (Formerly Searle Pak Ltd), F-319,
Applicant SITE, Karachi.
Brand Name +Dosage Form + Strength Spingab capsule 225mg
Pregabalin………………………225mg
Diary No. Date of R& I & fee Dy.No 2023, 03-04-2017, Rs.20,000/- 03-04-2017
Pharmacological Group Antiepileptic
Type of Form Form-5
Pack size & Demanded Price 2 × 7’s; As per SRO
Approval status of product in Reference USFDA approved.
Me-too status Not available in the applied strengths
(50,75,100,150,200 & 300 available)

GMP status GMP certificate issued on 13-08-2020 on the basis of inspection
Previous Decision Deferred for evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith registration number,
Evaluation by PEC The firm has submitted me-too reference:
Nurica 225mg Capsule of M/s Macter international (Reg # 086889).
However, the submitted me-too could not be verified from available
database.
Decision: Approved with Innovator specifications.
18. Name and address of manufacturer / M/s Werrick Pharmaceuticals, I-10/3, Industrial Area Islamabad.
Applicant
Brand Name +Dosage Form + Strength Pine XR tablets 50mg
Composition Each Extended release film coated tablet contains:
Quetiapine Fumarate eq to Quetiapine……..50mg
Diary No. Date of R& I & fee Dy. No.1828; 21-1-2011; Rs.12,000/- (10-4-2015);
Rs.8,000/- (21-01-2011)
Pharmacological Group Anti-psychotic
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s
Approval status of product in Reference Not provided
Me-too status Not provided
GMP status Last inspection report 09-11-2018 The panel unanimously
recommends for the grant of renewal of DML by way of formulation.
Previous Decision Deferred for submission of evidence of approval in reference
regulatory authorities and me-too status (M-274).
Evaluation by PEC The firm has submitted following:
Me-too status: Qupin XR 50mg Tablet of M/s Genome
International availability: Seroquel XR 50mg Tablet of M/s Astra
Zenenca Pharmaceuticals (USFDA approved)
• Firm shall submit fee of Rs. 7,500 for correction/pre-approval change/ in product specifications,
• Registration letter will be issued after submission of GMP audit report from QA&LT Division,
valid within last three years.
19. Name and address of manufacturer / "M/s Kanel Pharma. Plot # 6, St # SS-3, National Industrial Zone,
Applicant Rawat, Islamabad"
Brand Name +Dosage Form + Strength Kaxine-XR 75mg Capsule
Composition "Each Capsule Contains:
Extended Release Pellets of Venlafaxine Hydrochloride Eq. to
Venlafaxine…75mg"
Diary No. Date of R& I & fee Dy.No. 17216, 09-05-2018 Rs.20,000/- 08-05-2018
Pharmacological Group Serotonin and norepinephrine reuptake inhibitor
Type of Form Form-5
Approval status of product in Reference Approved by MHRA of UK
Me-too status Venflax XR 75mg Capsule by M/s Regal Pharmaceuticals
(Reg#081978)
GMP status Firm has submitted copy of GMP inspection report

conducted on 06-03-2019 concluding as under:
Keeping in view the above stated observations during inspection, areas
visited, documents reviewed it is concluded that M/s Kanel Pharma
Rawat is operating in compliance to GMP guidelines as of today.
However, the points of improvements have been discussed and agreed
by the representatives of the firm.
Previous Decision Deferred for source of pellets, along with stability studies data, GMP
certificate of supplier and differential fee in case of import of pellets
(M-290).
Evaluation by PEC The firm has submitted documents of following source:
Source of pellets: M/s Vision Pharmaceuticals (Pvt) Ltd.
Decision: Approved.
Deferred cases of M/s Obsons Pharmaceuticals 209-S, Industrial Estate, Kotlakhpat, Lahore
The Central Licensing Board in its 280th meeting held on 26th & 27th April 2021 has cancelled the Drug
Manufacturing License No. 000416 by way of (formulation) of M/s Obsons Pharmaceuticals, 209-S, Quaid-e-
Azam Industrial Estate, Kot lakhpat, Lahore, conveyed vide letter No. F.1-5/84-Lic (Vol-IV) dated 25th May 2021
by Secretary Central Licensing Board. Later on, the Appellate Board in its meeting No. 156th held on 31st August,
2021 decided as: The Board after hearing the arguments and pursuing record of case, decided to give final
opportunity of two years period to the firm for submission of new lay out plan for approval of the Central
Licensing Board. The decision of cancellation of Drug Manufacturing License by the Central Licensing Board
is set aside.
Furthermore, the firm has been granted GMP certificate dated 07-03-2022 based on inspection conducted on
22-02-2022.
20. Name and address of manufacturer / M/s Obsons Pharmaceuticals 209-S, Industrial Estate, Kotlakhpat,
Applicant Lahore
Brand Name +Dosage Form + Strength Obsamide Capsule 2mg
Loperamide hydrochloride………...….2mg
Diary No. Date of R& I & fee Dy. No. 1366: 4-11-2015 Fee. 20,000/-: 4-11-2015
Pharmacological Group Anti-propulsive
Type of Form Form 5
Finished product Specification USP specifications
Pack size & Demanded Price 60’s: Rs. 190/-
Approval status of product in Reference Imodium 2mg Capsule by M/s McNeil Products limited (MHRA
Regulatory Authorities. Approved)
Me-too status Imodium 2mg Capsule by M/s Aspin pharma (Reg#006159)
GMP status The firm has been granted GMP certificate based on inspection
Previous remarks of the Evaluator. • Latest GMP inspection report (which should have been conducted
within the period of last one year)
Previous decision(s) Deferred for GMP inspection report conducted within a period of last
1 year. (M-273)
Evaluation by PEC Inspection conducted on 19th July, 2017 concluded that most of the
shortcomings pointed out during last inspection had been rectified by
the firm. Some advises were also given for further improvements and
up-gradations and management showed positive approach towards
compliance.
Decision: Approved.
Applicant Lahore
Brand Name +Dosage Form + Strength Obmycin Capsule 500mg
Lincomycin as hydrochloride…….500mg
Diary No. Date of R& I & fee Dy. No. 1365: 4-11-2015 Fee. 20,000/-: 4-11-2015

Pharmacological Group Antibiotic
Type of Form Form 5
Pack size & Demanded Price 12’s: Rs. 80/-
Approval status of product in Reference Lincocin 500mg Capsule by M/s pharmacia and upjohn
Regulatory Authorities. (Discontinued in FDA)
Me-too status Lincocin capsule 500mg by M/s Pfizer Pakistan (Reg#000602)
• Evidence of approval of applied formulation in reference regulatory
authorities which were approved by Registration Board in its 249th
meeting
Previous decision(s) Deferred for following submissions:
GMP inspection report conducted within a period of last 1 year.
Evidence of approval in reference regulatory authorities (M-273).
Evaluation by PEC • Inspection conducted on 19th July, 2017 concluded that most of the
shortcomings pointed out during last inspection had been rectified
by the firm. Some advises were also given for further improvements
and up-gradations and management showed positive approach
towards compliance.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory authority
adopted by Registration Board in 275th meeting.
Applicant Lahore
Brand Name +Dosage Form + Strength Obsartan-K 50mg Tablets
Losartan potassium………..….50mg
Diary No. Date of R& I & fee Dy. No.1368: 4-11-2015 Fee. 20,000/-: 4-11-2015
Pharmacological Group Antihypertensive
Type of Form Form 5
Pack size & Demanded Price 1 x 20’s: Rs. 220/-
Approval status of product in Reference Cozaar 50mg Film coated tablet by MSD (MHRA Approved)
Regulatory Authorities.
Me-too status Cozaar 50mg Tablet of M/s OBS Pakistan (Reg#022067)
Previous decision(s) Deferred for GMP inspection report conducted within a period of last
1 year. (M-273)
compliance.
Decision: Approved.
Applicant Lahore
Brand Name +Dosage Form + Strength Vomson Suspension
Composition Each 5ml contains:
Domperidone…………..1mg/ml

Pharmacological Group Propulsives (WHO ATC code: A03FA03)
Type of Form Form 5
Finished product Specification Manufacturer specifications
Me-too status Domel 1mg/ml Oral Suspension by M/s Barrett Hodgson
(Reg#028758)
Previous remarks of the Evaluator. • Wrong pharmacological group has been mentioned in the dossier.
• Firm has claimed manufacturer’s specifications.
• No USP or BP monograph is available for applied formulation.
• Commitments as per 251st meeting of Registration Board shall be
submitted.
• Latest inspection report conducted within last one year by DRAP
shall be submitted.
Previous decision(s) Deferred due to paucity of time (M-273)
Evaluation by PEC • Inspection conducted on 19th July, 2017 concluded that most of the
shortcomings pointed out during last inspection had been rectified
by the firm. Some advises were also given for further improvements
and up-gradations and management showed positive approach
towards compliance.
• The firm has submitted commitments as per 251st meeting of
Registration Board.
• The firm has stated correct pharmacological group.
• The firm has submitted revised Form-5 with correct label claim and
master formulation as follows
Each ml contains:
Domperidone………..1mg
• The firm has submitted fee challan of Rs. 20,000/- (deposit slip #
0770641) dated 07-12-2018.
Decision: Approved with innovator’s specifications and with following label claim:
Each ml contains:
Domperidone………….1mg
• The firm shall submit the fee of Rs. 7500/- for correction/pre-approval change in product
specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Applicant Lahore
Brand Name +Dosage Form + Strength Obstan 500mg Tablet
Composition Each film coated tablet Contains:-
Mefenamic Acid………..500mg
Pharmacological Group NSAID
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price Rs. 432 per 200 tables or As per SRO/
Rs. 404 per 100 tablets or As per SRO
Approval status of product in Reference Approved by MHRA
Me-too status Ponsic Forte Tablet of M/s Safe Pharmaceuticals (Pvt.) Limited,
Karachi (Reg.#058208)
GMP status Last inspection report conducted on 27-04-2017 with remarks as
under:

“The management agreed and requested for some time to overcome
the shortcomings and will inform to the authorities and the re-
inspection will be conducted accordingly.”
Previous remarks of the Evaluator. •
Previous decision(s) Deferred for latest inspection report conducted within one year by
DRAP as the submitted inspection report does not conclude GMP
compliant status. (M-274)
Evaluation by PEC The firm has been granted GMP certificate based on inspection
Decision: Approved.
Applicant Lahore
Brand Name +Dosage Form + Strength D-Cyclox Capsule
Doxycycline (as hyclate) ………..100mg
Type of Form Form-5
Pack size & Demanded Price Rs. 140 per 50 caps or As per SRO
Rs. 200 per 50 caps or As per SRO
Approval status of product in Reference Approved by MHRA
Me-too status Vibramycin 100mg capsule by M/s Pfizer Pharma (Reg#000456)
under:
Previous remarks of the Evaluator. Last inspection report conducted within last one year by DRAP shall
be submitted.
Decision: Approved.
Applicant Lahore
Brand Name +Dosage Form + Strength Obstatin 40mg Tablet
Composition Each tablet contains:-
Atorvastatin………..40mg
Pharmacological Group HMG-CoA reductase inhibitors
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s tablets; As per SRO
Me-too status Lipica Tablets 40mg of M/s CSH, Pharmaceuticals-North (Pvt.) Ltd.
(Reg.#064428)
GMP status Last inspection report conducted on 22-07-2013.
Previous remarks of the Evaluator. • Salt form of API has not been mentioned in master formulation.
• Firm has claimed manufacturer’s specifications.

• Finished product specifications and testing method submitted by
firm does not state test of dissolution.
• No USP & BP monograph is available for applied formulation.
• Commitments as per 251st meeting of Registration Board shall be
submitted.
• Latest inspection report conducted within last one year by DRAP
shall be submitted.
Previous decision(s) Deferred due to paucity of time (M-274)
compliance.
The firm has submitted commitments as per 251st meeting of
Registration Board.
The firm has submitted revised Form-5 with correct label claim and
master formulation as follows:
Each film coated tablet contains:
Atorvastatin as calcium trihydrate …………...40mg
Fee challan of Rs. 5000/- (Deposit slip # 0770642) dated 07-12-2018
has been submitted.
The firm has been granted GMP certificate based on inspection
Atorvastatin as calcium trihydrate.…………...40mg
• The firm shall submit fee of Rs. 25,000/- for correction/pre-approval change in product composition
Applicant Lahore.
Brand Name +Dosage Form + Strength Obetenol 50mg Tablets
Composition Each tablet contains:
Atenolol ………….50mg
Diary No. Date of R& I & fee Dy. No.1052 (R&I); 24-02-2016; Rs.20,000/- (24-02-2016) Dy. No
589 (Reg-V)
Pharmacological Group β1 receptor blocker
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price Rs. 74 per 20 tablets or as per SRO
Me-too status Hetolol Tablets of M/s Healers Pharmaceuticals, Peshawar. (Reg #
069749)
under:

compliance.
The firm has submitted commitments as per 251st meeting of
Registration Board.
The firm has submitted revised master formulation from coated to
uncoated tablet.
Fee challan of Rs. 5000/- (Deposit slip # 0770644) dated 07-12-2018
has been submitted.
The firm has been granted GMP certificate based on inspection
• The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product specifications
Applicant Lahore
Brand Name +Dosage Form + Strength Obaxostat 40mg Tablet
Febuxostat…….………..40mg
Pharmacological Group Anti-Gout
Type of Form Form 5
Pack size & Demanded Price 20’s: As per SRO
Approval status of product in Reference Approved by USFDA
Me-too status Febuxin by M/s AGP, Karachi (Reg. No. 081104)
under:
• The firm shall submit the fee of Rs. 7500/- for correction/pre-approval change in product
Applicant Lahore
Brand Name +Dosage Form + Strength Obsozole 40mg Capsule
Composition Each Capsule Contains:
Enteric coated pellets of Omeprazole 8.5%w/w equivalent to
Omeprazole ………….40mg
Source of pellets: M/s Titan laboratories Pvt. Ltd., Dist. Raigad,
India
Diary No. Date of R& I & fee Dy. No.1052 (R&I); 24-02-2016; Rs.20,000/- (24-02-2016) Dy. No
590 (Reg-V)
Type of Form Form 5
Pack size & Demanded Price Rs. 259 per 14 capsules or as per SRO
Rs. 225 per 14 capsules or as per SRO

Me-too status Risek 40mg capsule by M/s Getz Pharma Pvt.Ltd. (Reg#022109)
under:
Previous remarks of the Evaluator. Differential fee of Rs. 80,000/- for import of pellets shall be
submitted.
Previous decision(s) Deferred for following:
Latest inspection report conducted within one year by DRAP as the
submitted inspection report does not conclude GMP compliant status.
Submission of differential fee of Rs. 80,000/- for import of pellets.
(M-274)
compliance.
The firm has submitted that we are now changing the source of pellets
to M/s Vision Pharma, Islamabad as it is available locally.
The firm has submitted COA of pellets, GMP certificate of supplier
and stability data of three batches.
• The firm shall submit the fee of Rs. 30,000/- for correction/pre-approval change in source of
pellets, as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Applicant Lahore
Brand Name +Dosage Form + Strength Obnol 300mg Tablets
Allopurinol ………….300mg
Diary No. Date of R& I & fee Dy. 1059; 24-02-2016; Rs.20,000/- (24-02-2016)
Pharmacological Group Antigout
Type of Form Form 5
Pack size & Demanded Price 20 tablets; As per SRO
Me-too status Zyuric-300 Tablet of M/s Rasco Pharma. (Reg.#067966)
under:
Previous remarks of the Evaluator. In contrary to reference product approved by USFDA & MHRA of
UK, which is available as uncoated tablet, firm has applied for film
coated tablet.
Previous decision(s) Deferred for followings:
(M-275) Updated status of GMP from QA&LT Division as submitted
inspection report does not conclude GMP compliant status.
Clarification of dosage form as reference product is available as
uncoated tablet whereas firm has applied for film coated tablet.

compliance.
The firm has submitted revised master formulation without coating.
Decision: Approved with USP specifications. The firm shall submit fee of Rs. 7500/- for correction/pre-
approval change in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021
Case no. 02 Registration applications for local manufacturing of (Veterinary) drugs
a. Deferred cases
31. Name and address of manufacturer / M/s Zakfas Pharmaceutical (Pvt) Ltd.12 Km Bosan Road,
Applicant Multan.
Brand Name +Dosage Form + Strength NICLOZAK Bolus
Composition Each bolus contains:
Niclosamide………….1250mg
Diary No. Date of R& I & fee Dy.No. dated 12-03-2014, Rs. 20,000, 12-03-2014
Pharmacological Group Anthelmintic
Type of Form Form-5
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 1 × 5, 1 × 10, 1 × 50, 1 × 100; Decontrolled
GMP status Copy of panel inspection report dated 15-06-2021 recommended for
renewal of drug manufacturing license.
Previous remarks of the Evaluator. The firm has provided Bolus & Granule section.
Previous decision(s) Deferred for evidence of applied formulation/drug already approved
(M-248) by DRAP (generic/me-too status) alongwith registration number,
brand name & name of firm.
Evaluation by PEC The firm has submitted me-too reference as follows:
Niclover Bolus of M/s Selmore Pharmaceuticals (Reg # 046572)
which is verified from available database.
The firm has claimed BP specifications while the product is not
available in BP.
Decision: Approved with innovator’s specifications. The firm shall submit fee of Rs. 7500/- for
correction/pre-approval change in product specifications as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021.
32. Name and address of manufacturer / M/s Mylab Pvt Ltd., Khankah Sharif, Bahawalpur.
Applicant
Brand Name +Dosage Form + Strength Vitamax K3 Water Soluble Powder
Composition Each Kg contains:
Vitamin K3……………….515gm
Diary No. Date of R& I & fee Dy.No. 13033 dated 06-04-2018, Rs. 20,000, 27-02-2018
Pharmacological Group Vitamin K supplement
Type of Form Form-5
Finished product Specification Innovator’s specifications
Pack size & Demanded Price 100g, 500g, 1kg, 10kg, 25kg; Decontrolled
Me-too status MSB Powder of UM Enterprises (Reg#016224)
GMP status GMP inspection report conducted on 24-02-2021 to 25-02-2021
concluded that the firm was found to be operating at a satisfactory
level of GMP compliance.
Previous decision(s) Deferred for evidence of applied formulation/drug already approved
by DRAP (generic/me-too status) alongwith registration number,
Deferred for submission of fee for revision of formulation (M-293)
Evaluation by PEC The firm has submitted Form-5 with revised strength of applied
formulation alongwith fee challan of PKR 30,000/- (slip #
2447234655) dated 30-12-2021 has been submitted.

Decision: Approved.
33. Name and address of manufacturer / M/s Mylab Pvt Ltd., Khankah Sharif, Bahawalpur.
Applicant
Brand Name +Dosage Form + Strength DEXUM INJECTION
Dexamethasone sodium phosphate………….0.265gm
Diary No. Date of R& I & fee Dy.No. 14090, 16-04-2018, 20,000/-, 19-02-2018
Pharmacological Group Corticosteroid
Type of Form Form-5
Finished product Specification Innovator’s specifications
Pack size & Demanded Price 100ml glass vial; Decontrolled
Me-too status Dexacare Injection of M/s Vety care (Reg # 026528)
Previous remarks of the Evaluator. The firm has provided Liquid Injectable (Steroid) Section.
Previous decision(s) Registration Board referred the case to QA & LT to update GMP
status of the firm on priority (M-293).
Evaluation by PEC The firm has submitted Form-5 with revised strength of applied
formulation as follows:
Each ml contains:
Dexamethasone sodium phosphate………….2mg
Me-too: Dexamethasone sodium phosphate injection of M/s Orient
Laboratories (Reg # 041253)
Fee challan of PKR 30,000/- (slip # 2447234655) dated 30-12-2021
has been submitted.
Decision: Deferred for review of formulation by expert working group on veterinary drugs.
34. Name and address of manufacturer / M/s Mylab Pvt Ltd., Khankah Sharif, Bahawalpur
Applicant
Brand Name +Dosage Form + Strength Tetramide Spray
Composition Each 100gm Contains:
Chlortetracycline hydrochloride…………..367000IU
Sulphanilamide………………………..…5.963mg
Diary No. Date of R& I & fee Dy.No. 2024, 16-01-2018 Rs. 20,000, 15-01-2018
Pharmacological Group Insecticide
Type of Form Form-5
Finished product Specification In-house specifications
Pack size & Demanded Price 210 ml; Decontrolled
Me-too status Orospray External Spray of M/s ABL International Faisalabad (Reg
# 027453)
Previous remarks of the Evaluator. • The firm has provided Aerosol vet section.
Previous decision(s) Deferred for clarification of manufacturing of powder formulation
in aerosol section (M-288).
Deferred for further deliberation regarding clarification of
manufacturing of powder formulation in aerosol section
(M-296).
The Board deferred the case for confirmation whether applied
product is spray or aerosol and then required manufacturing facility
including filling of carrier / propellant gas for aerosol formulation
(M-313).
Evaluation by PEC: The firm has submitted the product for registration is an “Aerosol Preparation”. This
preparation comprises of active pharmaceutical ingredient (API) dissolved in liquefied propellant. we have

separate Manufacturing and Filling Areas for aerosol products in our premises that is a Registered Aerosol
Section. In manufacturing area, a manufacturing vessel is available for the preparation of product concentrate.
A “3 in 1 semi-automatic aerosol filling machine” has been installed in the Filling Room that has three main
functions i.e. filling the liquid, crimping/ sealing the valve assembly and filling the propellant gas
simultaneously.
The product also known as product concentrate in the form of liquid which contains all of the active
ingredients, solvents and co-solvents as per formulation except for the propellant. First, we determine weight
per milliliter (g/mL) of our product concentrate and then we determine a specific weight of the product
concentrate that must be filled into each and every container in order to meet the pre-defined criteria.
The firm has submitted IQ, OQ, PQ of semi-automatic aerosol filling and sealing machine. Moreover, the
commercial invoice for the purchase of machine is enclosed.
The firm shall submit the fee of Rs. 7500/- for correction/pre-approval change in product specifications
Applicant
Brand Name +Dosage Form + Strength Roximax Topical Spray
Composition Each 170 gm Bottle Contains:
Rifaximin…………….0.5gm
Diary No. Date of R& I & fee Dy.No 2008 dated 16-01-2018 Rs. 20,000 Dated 15-01-2018
Type of Form Form-5
Finished product Specification In house
Pack size & Demanded Price 170gm can; Decontrolled
Me-too status Fatroximin Topical Spray of Prix Pharma (Reg#021263)
manufacturing of powder formulation in aerosol section (M-296).
The Board deferred the case for confirmation whether applied
product is spray or aerosol and then required manufacturing facility
including filling of carrier / propellant gas for aerosol formulation
(M-313).
simultaneously.
The product also known as product concentrate in the form of liquid which contains all of the active
ingredients, solvents and co-solvents as per formulation except for the propellant. First, we determine weight
per milliliter (g/mL) of our product concentrate and then we determine a specific weight of the product
concentrate that must be filled into each and every container in order to meet the pre-defined criteria.
The firm has submitted IQ, OQ, PQ of semi-automatic aerosol filling and sealing machine. Moreover, the
commercial invoice for the purchase of machine is enclosed.
The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product specifications as
Applicant
Brand Name +Dosage Form + Strength Anti-Mastitis Spray

Composition Each 15gm Contains:
Rifaximina………….…….0.100gm
Cefacetrile Sodium…..…0.200gm
Diary No. Date of R& I & fee Dy.No 2006, 16-01-2018 Rs. 20,000, 15-01-2018
Pharmacological Group Anti-Mastitis
Type of Form Form-5
Pack size & Demanded Price 4×15gm can; Decontrolled
Me-too status Cefaximin-l Anti Mastitis Spray of M/s Prix Pharma (R# 019906)
Deferred for following submission (M-313):
Confirmation whether the applied product is spray or aerosol and
accordingly required manufacturing facility including filling of
carrier / propellant gas for aerosol formulation.
Rationale for application of topical spray dosage form for the
treatment of Mastitis.
Section. A “3 in 1 semi-automatic aerosol filling machine” has been installed in the Filling Room that has
three main functions i.e. filling the liquid, crimping/ sealing the valve assembly and filling the propellant gas
simultaneously.
Mastitis is a condition characterized by the persistent and inflammatory reaction of the udder tissue in animals
due to either physical trauma or infections caused by microorganisms. It is a potentially fatal mammary gland
infection that is most common in dairy cattle worldwide.
This spray is intended to kill bacteria that get on the teat during milking before they colonize the teat end &
reduces the maximum infection with immediate effect.
The product is having strong anti-microbial and anti-inflammatory qualities. It does not contaminate the milk
and acts as excellent fly repellant with distinctive therapeutic effectiveness.
Decision: Deferred for evidence of approval of required manufacturing facility “Cephalosporin section”
from CLB, for applied product.
Applicant
Brand Name +Dosage Form + Strength Alspray Pressurized Suspension
Composition Each gm Contains:
Aluminum Powder…………….40mg
Diary No. Date of R& I & fee Dy. No. 2005, 16-01-2018 Rs. 20,000 dated 15-01-2018
Pharmacological Group Antiseptic & Cicatrizing drug
Type of Form Form-5
Pack size & Demanded Price 210 ml; Decontrolled
Me-too status Aluspray Pressurized suspension of ABL International (R#028560)

Deferred for following submission (M-313):
Confirmation whether the applied product is spray or aerosol and
accordingly required
manufacturing facility including filling of carrier / propellant gas for
aerosol formulation.
Confirmation of aluminium salt to be used in the applied
formulation.
preparation comprises of Active Pharmaceutical Ingredient (API) dissolved in liquefied propellant. we have
simultaneously.
Furthermore, it is to clarify you that we will use Aluminium Powder in our formulation. It is also mentioned in
British Pharmacopoeia 2021 (VOL 1, Page #127) with the same name.
Aluminium Powder consists mainly of metallic aluminium mainly in the form of very small flakes, usually with
an appreciable proportion of aluminium oxide. It is lubricated with stearic acid to prevent oxidation. It contains
not less than 86.0% of Aluminium calculated with reference to the substance freed from lubricant and volatile
matter.
Applicant
Brand Name +Dosage Form + Strength Roximax Intrauterine Foam
Composition Each 13.4gm Bottle Contains:
Rifaximin…………..0.10gm
Diary No. Date of R& I & fee Dy.No 2009 dated 16-01-2018, Rs. 20,000 Dated 15-01-2018
Type of Form Form-5
Pack size & Demanded Price 13.4g; Decontrolled
Me-too status Fatroximin Intrauterine Foam of M/s Prix Pharmaceutica
(R#048129)
Registration Board deferred the case for confirmation/clarification
of required manufacturing facility for intrauterine foam (M-313).
Evaluation by PEC: The firm has submitted that the Roximax intrauterine foam for the registration of which
we are applying, is an aerosol preparation with the addition of surfactants in its formulation. Therefore, we will
use the same AEROSOL SECTION for the manufacturing of intrauterine foam.
A foam aerosol is an emulsion containing one or more active Pharmaceutical Ingredients, surfactants, aqueous
and non-aqueous liquids and the propellants. If the propellant is in the internal (discontinuous) phase (i.e. of the
oil-in-water type), stable foam is discharged and if the propellant is in the external (continuous) phase (i.e. of
water-in-oil type), a spray or quick-breaking foam is discharged.
Foaming type nozzles are used in this case that tend to produce fewer, but larger, drops than conventional type
pressure nozzles.

Case No.03: Registration applications of drugs for which stability study data is submitted
a. Verification of stability study data
39. Name and address of manufacturer / M/s Hudson Pharma (pvt.) Ltd., D-93, North Western industrial
Applicant Zone, Port Qasim, Karachi
Brand Name +Dosage Form + Strength LULISON CREAM 1%
Composition Each gm contains:
Luliconazole……..…10mg
Diary No. Date of R& I & fee Dy No. 3791, 30-01-2018, Rs. 50,000/-,17-01-2018
Pharmacological Group Antifungal agent
Type of Form Form-5D
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 10gm; As per SRO
Approval status of product in Reference LUZU Cream of Medicis (USFDA approved)
Me-too status Not available
GMP status Routine GMP inspection conducted on 11-12-2017 concluded that
the overall cGMP compliance of the firm with respect to building,
facilities and procedures demonstrated at the time of inspection
found at acceptable level.
Drug LULISON CREAM 1%
Name of Manufacturer M/s Hudson Pharma (pvt.) Ltd., D-93, North Western industrial Zone, Port Qasim,
Karachi
Manufacturer of API M/s Viwit Pharmaceutical Co., Ltd. 88 Weizhi Road, Tengzhou Biopharma Park,
Shandong, China
API Lot No. 333001-201705001
Description of Pack Plastic tubes
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 06 (months)
Real Time: 06 (months)
Frequency Accelerated: 0,1,3,6 (Months)
Real Time: 0,1,3,6 (Months)
Batch No. LCS04 LCS05 LCS06
Batch Size 200 tubes 200 tubes 200 tubes
No. of Batches 03
Date of Submission 29340 (03-09-2018)
Sr. Documents To Be Provided Status
No.
1. COA of API. Copy of COA from M/s Viwit Pharmaceutical Co., Ltd.,
Shandong, China is submitted.

2. Approval of API by regulatory authority of Copy of GMP certificate for M/s Viwit Pharmaceutical Co.,
country of origin or GMP certificate of API Ltd., Shandong, China issued by Tengzhou Food and Drug
manufacturer issued by regulatory authority of Administration of People’s Republic of China. It is valid until
country of origin. 24-09-2017.
3. Protocols followed for conduction of stability Yes
study and details of tests.
4. Data of 03 batches will be supported by attested Yes
respective documents like chromatograms,
laboratory reports, data sheets etc.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice attested
by ADC, DRAP, Karachi dated 19-06-2017.
6. All provided documents will be attested (name, Yes
sign and stamp) for ensuring authenticity of data
/ documents.
7. Commitment to continue real time stability study Yes
till assigned shelf life of the product.
8. Commitment to follow Drug Specification Rules, Yes
1978.
REMARKS OF EVALUATOR
● The firm has submitted 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Batches.
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Date of submission: 03-09-2018 vide diary no. 29340
1. Reference of last onsite panel inspection Registration Board decided to approve the registration of “Acneson
for instant dosage form conducted during Gel 5% (Dapsone)” by M/s Hudson Pharma (Pvt.) Ltd., D-93, North
last two years. Western Industrial Zone, Port Qasim-Karachi. Manufacturer will
place first three production batches of both products on long term
stability studies throughout proposed shelf life and on accelerated
studies for six months.
Date of Inspection: 10-05-2018.
• The HPLC software is 21 CFR compliant
• Audit trail reports on testing of finished product are available.
2. Documents for the procurement of API The firm has submitted copy of commercial invoice attested by ADC,
with approval from DRAP (in case of DRAP, Karachi dated 19-06-2017.
import).
3. Documents for the procurement of The firm has not submitted copy of invoice of working standard.
reference standard & impurity standards.
4. Approval of API/ DML/GMP certificate Copy of GMP certificate for M/s Viwit Pharmaceutical Co., Ltd.,
of API manufacturer issued by regulatory Shandong, China issued by Tengzhou Food and Drug Administration
authority of country of origin. of People’s Republic of China. It is valid until 24-09-2017.
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for Evaluation of Vendors.
6. Certificate of analysis of the API, • Copy of COA of API submitted.
reference standards and impurity • Copy of COA of working standard has been submitted
standards • Copy of COA of impurity standard has not been submitted.
7. Documents for the procurement of The firm has not submitted photocopy of Commercial invoices/COAs
excipients used in product development? of the excipients used in the formulation of applied product.
8. List of qualified staff involved in product The firm has not submitted List of qualified staff involved in R&D
development with relevant experience. department.

Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of “Protocols/SOPs for the
development & stability testing of trial Pharmaceutical Development of Product.”
batches.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing Records
three stability batches. of following 03 Batches:
Batch No. Batch Size Mfg. Date
LCS01 200 Tubes -----
LCS02 200 Tubes -----
LCS03 200 Tubes -----
LCS04 200 Tubes 11-09-2017
LCS05 200 Tubes 13-09-2017
LCS06 200 Tubes 28-10-2017
11. Record of remaining quantities of stability
batches. Trial Batch size Consumed Remaining Quantity,
No. in stability Lab trials, QC
batches sample and retention
LCS01 200 Tubes 20g 10g,
LCS02 200 Tubes 20g 10g,
LCS03 200 Tubes 20g 10g
LCS04 200 Tubes 20g
LCS05 200 Tubes 20g
LCS06 200 Tubes 20g
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of digital data logger record of
temperature and humidity monitoring of Accelerated stability chamber and real time chamber from 01-08-
stability chambers (real time and 2017 to 28-02-2018.
accelerated)
13. Method used for analysis of API along The firm has submitted photocopy of Raw Material Specifications,
with COA. Raw Material Testing Procedures along with COA for Luliconazole.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product Testing
complete record of testing of stability Procedure for Luliconazole Cream 1% along with Stability Study
batches (i.e. chromatograms, lab reports, Reports.
raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted reports of real time stability studies (25 oC ±
manufacturer. 2oC/65 ± 5% RH) for 6 months and accelerated stability studies (40oC
± 2oC/75 ± 5% RH) for 36 months of Luliconazole.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports of excipients
used.
17. Drug-excipients compatibility studies. Not submitted
18. Record of comparative dissolution data. The firm has performed comparative dissolution studies with Lulimac
Cream manufactured by M/s. Optimus Pharma Pvt. Limited, Solan
India with Batch No.OA7012B. The firm‘s product results are
comparable to that of the comparator product.
19. Compliance Record of HPLC software Audit trail on testing reports of Luliconazole Cream 1% from 13-09-
21CFR & audit trail reports on product 2017 to 19-07-2018 has been submitted.
testing.
The firm has initiated stability studies on 13-09-2017 whereas firm was granted section approval letter for
Cream/Ointment/Gel section from licensing on 21-02-2018.
Finished product specifications do not mention dissolution test for applied formulation. Similarly, comparative
Dissolution Profile does not dissolution conditions under which dissolution was performed.

Decision: Registration Board after thorough discussion decided to reject the stability data on the basis of following
reasons (M-287):
“Manufacturing of batches of applied formulation i.e. Cream before the approval of relevant section i.e.
Cream/Ointment/ Gel section by Licensing Division, DRAP.
Evaluation by PEC: The firm has submitted that we have re-manufactured 03 stability batches and kept them on
accelerated and ambient stability which is enclosed herewith.
Drug LULISON CREAM 1%
Name of Manufacturer M/s Hudson Pharma (pvt.) Ltd., D-93, North Western industrial Zone, Port Qasim,
Karachi
Manufacturer of API M/s Viwit Pharmaceutical Co., Ltd. 88 Weizhi Road, Tengzhou Biopharma Park,
Shandong, China
API Lot No. 333001-201705001
Description of Pack Plastic tubes
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 06 (months) Real Time: 06 (months)
Frequency Accelerated: 0,1,3,6 (Months) Real Time: 0,1,3,6 (Months)
Batch No. LCS07 LCS08 LCS09
No. of Batches 03
Date of Submission 21937 (25-10-2019)
Sr.# Documents To Be Provided Status
1. Certificate of analysis of drug substance Copy of COA from M/s Viwit Pharmaceutical Co., Ltd.,
Shandong, China is submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate for M/s Viwit Pharmaceutical Co.,
country of origin or GMP certificate of API Ltd., Shandong, China issued by Tengzhou Food and Drug
manufacturer issued by regulatory authority of Administration of People’s Republic of China. It is valid until
country of origin. 24-09-2017.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice attested
by ADC, DRAP, Karachi dated 19-06-2017.
sign and stamp) for ensuring authenticity of data
/ documents.
7. Commitment to continue real time stability study Yes
till assigned shelf life of the product.
8. Commitment to follow Drug Specification Rules, Yes
1978.

● The firm has submitted 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Batches.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of LULISON CREAM
1% (Luliconazole), Pack Size 1x10g by M/S. Hudson Pharma (Pvt) Ltd., D-93, North Western Industrial Zone,
Post Qasim, Karachi.
Reference No: F.1-2/2020-PEC dated 29th March, 2021.
Investigation Date and Time: 05th January, 2022 (Morning).
Investigation Site: Factory premises of M/S. Hudson Pharma (Pvt) Ltd., Port Qasim Industrial
Zone, Karachi.
Background:
Chairman Registration Board considered the applications of M/S. Hudson Pharma (Pvt) Ltd., Port Qasim, Karachi for
registration of LULISON CREAM 1% (Luliconazole) 10mg and constituted a two member panel to investigate the
authenticity / genuineness of data (import of raw material and stability data). Panel was advised to conduct inspection
of the firm and to submit report for further consideration.
1. Dr. Saif-ur-Rehman Khattak, Director/ FGA, CDL, Karachi.
2. Mr. Awais Ahmad, Assistant Director, CDL, DRAP, Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing of
stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved, ongoing
studies, printed data and integrity and security of data in respective databases were also audited. The details of
investigation may be summarized as under:
Sr.# Question Observation
1. Do you have documents confirming Luliconazole imported from Optrix laboratories Pvt Ltd, India with
the import of Luliconazole API proper approval from DRAP Karachi with following details.
including approval from DRAP?
Batch No. Date of Invoice Quantity Imported
Import No.
OT-
27/10/201
LCZ/04/17/00 035 150 g
7
2
As per PEC observation the firm to adjust the pH again
manufactured 3 new batches of Lulison cream for which they
procured API Luliconazole from same source, Optrix laboratories
Pvt Ltd, India, with following details:
Batch No. Date of Import Invoice Quantity
No. Imported
1/OT- SS-
29/07/21 110 g
LCZ/S2/013/21 02482
2. What was the rationale behind selecting The rationale for selection of API manufacturer is the vendor
the particular manufacturer of API? qualification criteria as per SOP # QA/GN/OP/023 that contains
GMP Certificate, DMF, SMF, API, Impurity standards etc.
3. Do you have documents confirming the The firm has imported Luliconazole working standard and impurity
import of Luliconazole reference standards from Optrix laboratories India.
standard and impurity standards?

4. Do you have a certificate of Analysis of The firm has COA for the API, working standards and impurity
the API, reference standards and standards.
impurity standards?
5. Do you have any approval of API or The firm has a copy of GMP certificate of Optrix Laboratories Pvt
GMP certificate of API manufacturer Ltd India issued by regulatory authority of India valid upto
issued by regulatory authority of 02/06/2025.
country of origin?
6. Do you use API manufacturer methods The firm has used an in-house method for testing of Luliconazole
of testing? based on API manufacturer method of testing.
7. Do you have stability studies reports on The firm has real time & accelerated stability study reports of
API? Luliconazole conducted by the API manufacturer.
8. If yes, whether the stability testing has The stability testing has been performed as per SIM method.
been performed as per SIM method and
degradation products have been
quantified?
9. Do you have a method for quantifying The firm has a method for quantifying the impurities in the API based
the impurities in the API? on manufacturer specification.
10. Do you have some remaining quantities The firm has some remaining quantity of API, impurities and
of the API, its reference standard and reference standard procured for the new batches.
impurities standards?
11. Have you used pharmaceutical grade The firm has used the following pharma grade excipients.
excipients? Benzyl alcohol from Sigma Aldrich, USA.
Butylated Hydroxy toluene from Hangzhou Zhongbao Import &
Export Corp Ltd, China.
Cetostearyl alcohol from Emery, Malaysia.
Isopropyl myristate from KLK Oleo, Malaysia.
Caprylic Capric Triglyceride from KLK Oleo, Malaysia.
Methylparaben from UENO Fine Chemicals, Japan.
Polysorbate 60 (tween 60) from Croda, India.
Propylene glycol from Merck, Germany.
Sorbitan monostearate (Span 60) from Croda, India.
12. Do you have documents confirming the All the excipients have been locally purchased, with proper invoice
import of the used excipients? and COAs.
13. Do you have test reports and other The firm has test reports & other records on the excipients used.
records on the excipients used?
14. Do you have written and authorized The firm has written & authorized protocols for the development of
protocols for the development of Lulison 1% cream.
Lulison cream 1%?
15. Have you performed Drug-excipients Since the firm has used the same excipient as used by innovator (Luzu
compatibility studies? 1% Cream), therefore compatibility studies are not needed.
16. Have you performed comparative The firm has not performed comparative studies, with innovator
studies? product.
17. Do you have a product development The firm has a product development section.
(R&D) section?

18. Do you have necessary equipment The firm has necessary equipment is PD section for manufacturing
available in the product development while for QC routine QC equipment are used.
section for development of Lulison
cream 1%?
19. Are the equipment in the product All the equipment are qualified.
development section qualified?
20. Do you have a proper maintenance / There is a proper maintenance & calibration / re-qualification
calibration / re-qualification program program for the equipment used in the PD section.
for the equipment used in the PD
section?
21. Do you have qualified staff in the The firm has 2 Pharmacists assisted by the staff of manufacturing &
product development section with QC, in product development.
proper knowledge and training in
product development?
22. Have you manufactured three stability The firm has manufactured three stability batches for the stability
batches for the stability studies of study of Lulison cream(pH:3-4.5), with details as below:
Lulison cream 1% as required?
Batch No. Mfg. Date Batch Size
LCS07 09-04-2019 200 tubes each of 10g

The firm has further manufactured three stability batches for the
stability study of Lulison cream (pH:5-7) as per PEC
recommendations with details as below:
Batch No. Mfg. Date Batch Size
SB-LUL-CR-01 07-09-2021 250 tubes each of 10g
23. Do you have any criteria for fixing the The firm has manufactured stability batches based on number of tests
batch size of stability batches? & frequency of testing.
24. Do you have a complete record of The firm has a complete record of production of stability batches.
production of stability batches?
25. Do you have protocols for stability The firm has developed protocol for stability testing of stability
testing of stability batches? batches (Doc#QC/GN/OP/015).
26. Do you have developed and validated The firm has developed & validated methods for testing of stability
the method for testing of stability batches of Lulison 1% cream.
batches?
27. Do you have method transfer studies in N/A

case when the method of testing being
used by your firm is given by any other
lab?

28. Do you have documents confirming the The firm has proper documents confirming the qualification of
qualification of equipments / equipment/instruments being used in the test & analysis of
instruments being used in the test and Luliconazole & the finished product (Lulison 1% Cream).
analysis of Luliconazole and the
finished drug?
29. Does your method of analysis stability The firm has performed analytical method validation on their product
indicating? forced degradation studies from basis for the method to be stability
indicating.
30. Does your HPLC software is 21CFR The firm has HPLC software is 21CFR compliant.
compliant?
31. Can you show Audit Trail reports on Audit trail reports on testing of API and finished product is available.
Luliconazole testing?
32. Do you have some remaining quantities Impurities studies are available.
of degradation products and stability
batches?
33. Do you have stability batches kept on The three new batches manufactured in July 2021 have been kept for
stability testing? stability testing. Currently three months studies are complete with
satisfactory results.
34. Do you have valid calibration status for The firm has valid calibration status for the equipment used in the
the equipments used in Lulison cream production & analysis of lulison cream 1%.
1% production & analysis?
35. Do proper and continuous monitoring Adequate monitoring & controls are available for stability chambers.
and control are available for the Chambers are controlled & monitored through data loggers.
stability chamber?
36. Do related manufacturing area, Related manufacturing area, equipment, personnel & utilities are
equipments, personnel and utilities be GMP compliant.
rated as GMP compliant?
37. Queries of PEC: Firm has shown studies on two different formulations manufactured
Results of pH of applied formulation in
at pH specs as 3.0 to 4.5 and 5.0 to 7.0. respectively. Six months
the light of innovator product (LUZU studies conducted at real time and accelerated conditions on three
1% w/w cream) having pH accepting batches of the first formulation have been already submitted to
criteria ranging from 5.0 to 7.0. Islamabad. Three batches of the second formulation having pH specs
5.0 to 7.0 have been kept on real time and accelerated condition.
Currently three months studies are complete which are being
evaluated by the panel. The studies with both the formulation
demonstrate that the product is stable within a pH range of 3.0 to 7.0.
The firm has also submitted their safety testing on both formulations
for acute dermal irritant test. The results of the test show that no sign
of irritation / inflammation were found during the observation period
of (optimized test conditions). (Copy of Reports Attached).
Firm has also performed viscosity testing on the manufactured
Performance of test of viscosity and batches from PCSIR. The results are within the range i.e. 20,000 to
homogeneity for evaluation of topical 40,000 (common ranges for cream formulation). (Copy of Report
formulation. Attached).
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Lulison 1% Cream Pack Size 1x10g are verifiable to satisfactory level.

2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suited for the
manufacturing of Lulison 1% Cream Pack Size 1x10g.
Recommendations:
1. The panel recommends registration of Lulison 1% Cream (Luliconazole).
Decision: Deferred for submission of following:
• Stability data, upto 6th month time point, of the trial batches which were presented before inspection panel
with pH specifications of 5.0 to 7.0.
• Pharmaceutical equivalence with innovator / reference drug product shall also be submitted.
• Firm shall also submit fee of Rs. 30,000 for revision in stability data, as per notification No.F.7-11/2021-
B&A/DRAP dated 13-07-2021.
40. Name and address of manufacturer / "M/s Wilshire Laboratories Pvt Ltd.,
Applicant 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore"
Brand Name +Dosage Form + Strength Dexpra 30mg Capsule
Dexlansoprazole (as DDR pellets)………30mg
Diary No. Date of R& I & fee Dy No. 21257: date 13-06-18: Rs. 20,000
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 40’s, 50’s: As per SRO
Approval status of product in Reference Approved in US-FDA
Regulatory Authorities Dexilant Capsule
Me-too status (with strength and dosage Razodex of Getz Pharma
form)
GMP status Last GMP inspection was conducted on 06-11-2018 and the
report concludes satisfactory level of GMP compliance.
Drug Dexpra 30mg Capsule
Name of Manufacturer "M/s Wilshire Laboratories Pvt Ltd.
124/1, Quaid-e-Azam Industrial Estate, KotLakhpat, Lahore"
Manufacturer of API M/s Vision Pharmaceutical (Pvt) Ltd. Islamabad.
API Lot No. Dexlansoperazole pellets w/w. (Batch. # )
Description of Pack
Alu-Alu blister
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH
Accelerated:40°C ±2°C / 75% ± 5%RH
Time Period Real Time: 12 Months Accelerated:06Months
Frequency Real Time: 0,3,6,9,12 Months (on going)
Accelerated: 0,1,2,3,4,6 Months
Batch No. T#001 T#002 T#003
Batch Size 0.200kg Capsule 0.200kg Capsule 0.200kg Capsule
No. of Batches 03
Date of Submission 23-12-2019
No.

1. COA of API
2. Approval of API by regulatory authority of Applicant has submitted GMP certificate having following
country of origin or GMP certificate of API information on it:
manufacturer issued by regulatory authority of Certificate No. F.3-26/2019-Addl. Dir. (QA&LT-1)
country of origin. Issued to: M/s. Vision Pharmaceuticals
Validity: 10-02-2022.
5. Documents confirming import of API etc. Applicant has submitted Copy Of Invoice having following
information on it:
Dexlansoprazole pellets
Batch No: DLP363
Quantity: 2kg
Manufactured by: M/s Vision Pharmaceuticals
sign and stamp) for ensuring authenticity of
data / documents.
7. Commitment to continue real time stability Yes
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification Yes
Rules, 1978.
Evaluation by PEC:
41. Name and address of manufacturer / "M/s Wilshire Laboratories Pvt Ltd.
Brand Name +Dosage Form + Strength Dexpra 60mg Capsule
Dexlansoprazole (as DDR pellets)………60mg
Diary No. Date of R& I & fee Dy No. 21258: date 13-06-18: Rs. 20,000
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 40’s, 50’s: As per SRO
Approval status of product in Reference Approved in US-FDA
Me-too status (with strength and dosage Razodex of Getz Pharma
form)
GMP status Last GMP inspection was conducted on 06-11-2018 and the
report concludes satisfactory level of GMP compliance.
Drug Dexerid Capsule 60mg
Name of Manufacturer "M/s Wilshire Laboratories Pvt Ltd.
124/1, Quaid-e-Azam Industrial Estate, KotLakhpat, Lahore"
Manufacturer of API M/s Vision Pharmaceutical (Pvt) Ltd. Islamabad.
API Lot No. Dexlansoperazole DDR pellets w/w. (Batch. # DLP363)
Description of Pack
Alu-Alu blister
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH

Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 09 Months Accelerated:06Months
Frequency Real Time: 0,3,6,9,12 Months (on going)
Accelerated: 0,1,2,3,4,6 Months
Batch No. T#001 T#002 T#003
Batch Size 0.400kg Capsule 0.400kg Capsule 0.400kg Capsule
No. of Batches 03
Date of Submission 23/12/2019
No.
1. Certificate of analysis of API
2. Approval of API by regulatory authority of Applicant has submitted GMP certificate having following
country of origin or GMP certificate of API information on it:
manufacturer issued by regulatory authority of Certificate No. F.3-26/2019-Addl. Dir. (QA&LT-1)
country of origin. Issued to: M/s. Vision Pharmaceuticals
Validity: 10-02-2022.
5. Documents confirming import of API etc. Applicant has submitted Copy of Invoice having following
information on it:
Dexlansoprazole pellets
Batch No: DLP363
Quantity: 2kg
Manufactured by: M/s Vision Pharmaceuticals
sign and stamp) for ensuring authenticity of
data / documents.
7. Commitment to continue real time stability Yes
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification Yes
Rules, 1978.
Evaluation by PEC:
Name of Manufacturer M/s. Wilshire Labs (Pvt.) Ltd.
Physical Address 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
Drug Manufacturing license No. and Validity 000232 valid till 20-07-2025
(Date of application for DML renewal)
Contact Address 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
Date of inspection 01-12-2021

Purpose of inspection Panel inspection for verification of authenticity of stability data for
purpose of registration of drugs with reference to DRAP, Islamabad
letter No. F.1-2/2020-PEC dated 01-09-2020.
Name of inspector (s) 1. Mr. Zaka-ur-Rehman, COO.
2. Ms. Aisha Irfan, Area Federal Inspector of Drugs, DRAP,
Lahore.
3. Ms. Maham Misbah, Assistant Director, DRAP, Lahore.
Name of Firm’s Representative (s) Mr. Ghazanfar Ali Jawa (Chief Executive Officer)
accompanying during inspection Dr. Aqil Husnain (COO BD & Regulatory)
Mr. M. Faisal Javid, Plant Head.
Ms. Anita Mehdi (Production Manager)
Mr. Usman Shoukat (Quality Assurance Manager).
Mr. Akhter Hussain (Quality Control Incharge) and Mr. Ah$@n
Sabir (R&D Manager)
Panel Inspection of M/s. Wilshire Labs (Pvt) Ltd., was conducted with reference to DRAP Letter No. F.1-
2/2020-PEC dated 01-09-2020, for verification of authenticity of stability data of following products. The panel
evaluated the relevant documents and also visited the required facility and quality control laboratory of the company.
The data of both products was evaluated in accordance with the checklist provided as given below:
1. Dexpra 30mg Capsule
2. Dexpra 60mg Capsule
1. Do you have documents confirming the The firm has locally purchased 2kg Dexlansoprazole
import of Dexlansoprazole including DDR Pellets 22.5% (API) from Vision Pharmaceutical (Pvt)
approval from DRAP? Ltd.
Invoice No. 500679 dated: 25.09.2017. ( B a t c h N o
DLP363, Mfg 07-17, Expiry 06-20).
2. What was the rationale behind selecting The rationale behind selecting the particular manufacturer of
the particular manufacturer of API? API is the in-house vender evaluation process.
3. Do you have documents confirming the Firm had locally purchased the working standard from M/s.
import of reference standard and impurity Vision Pharmaceuticals.
standards?
4. Do you have certificate of Analysis of the Firm had CoA of API and working standard. Additionally,
API, reference standards and impurity In house Raw material Testing data is also attached.
standards? .
5. Do you have GMP certificate of API Yes
manufacturer issued by regulatory
authority of country of origin?
6. Do you use API manufacturer method of Yes, as per method of testing shown to the panel.
testing for testing API?
7. Do you have stability studies reports on Yes
APIs?
8. If yes, whether the stability testing has Impurities had been quantified.
been performed as per SIM method and .
degradation products have been
quantified?
9. Do you have method for quantifying the Method of quantifying the impurities in API was provided by
impurities in the API? M/s. Vision Pharmaceuticals (Pvt.) Ltd. However, the firm had
not run sample for impurity testing according to the time
specified in the method.

10. Do you have some remaining quantities of The firm informed the panel that they had destroyed remaining
the API, its reference standard and quantity of pellets after expiry.
impurities standards?
11. Have you used pharmaceutical grade Excipients were not used.
excipients?
12. Do you have documents confirming the Not applicable.
import of the used excipients?
13. Do you have test reports and other records Not applicable.
on the excipients used?
14. Do you have written and authorized Yes
protocols for the development of Dexpra
Capsules?
15. Have you performed Drug-excipient Not applicable
compatibility studies?
16. Have you performed comparative The firm had performed comparative Dissolution studies using
dissolution studies? Dexilant capsules manufactured by M/s Takeda Pharma Co.
Ltd. Japan as reference product.
17. Do you have product development Yes
(R&D) section
18. Do you have necessary equipments Manual capsule filling machine was available in the product
available in product development section development/ R&D section. The firm’s management informed
for development Dexpra Capsules? the panel that filling dexlansoprazole pellets was done using the
automatic capsule filling machine in commercial production
facility.
19. Are the equipment in product Equipment.
development section qualified?
20. Do you have proper maintenance / Yes
calibration / re-qualification program for
the equipment used in PD section?
21. Do you have qualified staff in product Yes
development section with proper
knowledge and training in product
development?
22. Have you manufactured three stability Yes
batches for the stability studies of Dexpra
Capsules as required?
23. Do you have any criteria for fixing the Firm had fixed batch size according to DRAP guidelines, as
batch size of stability batches? informed by the firm’s management.

24. Do you have complete record of The firm had complete record of production of stability
production of stability batches? batches. Complete Batch Manufacturing records of
Dexlansoprazole 30mg & 60mg were shown to the
Panel.
Trial # Mfg date Exp B. size

date
Dexpra Capsule 30mg
T001 04-18 03-20 1500
caps
T002 04-18 03-20 -do-
T003 04-18 03-20 -do-
Dexpra Capsule 60mg
T001 04-18 03-20 -do-
T002 04-18 03-20 -do-
T003 04-18 03-20 -do-
25. Do you have protocols for stability testing Yes
of stability batches? The firm had protocol for stability testing.
26. Do you have developed and validated Testing Method was provided by M/s. Vision Pharma was
the method for testing of stability batches? validated in-house by the firm and report was shown to the
panel.
27. Do you have method transfer studies in No
case when the method of testing being
used by your firm is given by any other
lab?
28. Do you have documents confirming the Yes
qualification of equipment / instruments
being used in the test and analysis of
Dexlansoprazole and the finished drug?
29. Do your method of analysis stability Impurities could be quantified according to testing method
indicating? provided by M/s. Vision Pharma. Firm had performed forced
degradation studies with reference to the parameters of
temperature humidity and photolysis, according to the
documents shown to the panel.
30. Do your HPLC software 21CFR HPLC software was 21CFR Compliant as per documents
Compliant? shown to the panel. However, some of the testing data / results
had been transferred to the main server, as informed by the
firm’s management and could not be retrieved at the time of
inspection. However, hard copies of chromatograms were
available and shown to the panel at the time of inspection.
31. Can you show Audit trail reports on Audit trail reports were available for testing of trial batches. The
Dexlansoprazole testing? data of assay testing Dexlansoprazole pellets could not be verified
from HPLC.
32. Do you have some remaining quantities No
of degradation products and stability
33. batches?
Do you have stability batches kept on Stability Study had been completed at the time of inspection.
stability testing?
34. Do you have valid calibration status for Yes.

the equipment used in Dexpra Capsules
production and analysis?
35. Do proper and continuous monitoring Yes

and control are available for stability
chamber?
36. Do related manufacturing area, Firm has valid GMP certificate from DRAP.
equipment, personnel and utilities be rated
as GMP compliant?
Verification of additional points:-
Firm had used dissolution method provided by M/s. Vision Pharmaceutical at pH 7 and sampling time 120
minutes, according to the in-house analytical test method for Dexpra 60mg capsules shown to the panel at the
time of inspection.
In-house dissolution testing data of Dexlansoprazole pellets could not be verified from the HPLC at the time of
inspection as the firm’s management informed that the testing data/results had been transferred to the main server
and hence could not be retrieved at the time of inspection.
Submitted for further necessary action.
Decision: Registration Board decided to defer the case for submission of either of the following:
a. Documented evidence based upon an IT report, to verify firm’s claim regarding transfer of
analytical data of assay & dissolution testing of Dexlansoprazole pellets.
Or
b. Fresh analysis of the Dexlansoprazole pellets performed by M/s Wilshire Laboratories including
analytical record i..e, chromatograms, raw data sheets etc. for the assay & dissolution testing.
42. Name and address of manufacturer / "M/s Wilshire Laboratories Pvt Ltd.
Brand Name +Dosage Form + Strength Dapawil-M XR 5/500mg Tablet
Composition "Each extended release tablet contains:
Dapagliflozin (as propanediol monohydrate) …..…5mg
Metformin hydrochloride…..…500mg"
Diary No. Date of R& I & fee Dy.No 41225 dated 07-12-2018, Rs.50,000/-, 07-12-2018
Pharmacological Group Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Finished product Specification Manufacturer’s Specifications
Approval status of product in Reference USFDA Approved
GMP status The firm is granted GMP certificate based on inspection conducted
on 08-08-2019.
Previous Decision Registration Board deferred the case for submission of stability
study data as per the guidelines provided in 278th meeting of
Registration Board along with submission of differential fees (M-
295).
Manufacturer of API Dapagliflozin propanediol Monohydrate: M/s Jiangsu Yongan Pharmaceutical Co.,
Ltd. No.18, 237, Provincial Road, Economic Development Zone, Huaian, Jiangsu,
China
Metformin hydrochloride: M/s IPCA Laboratories Limited, Aurangabad, India
API Lot No. Dapagliflozin propanediol Monohydrate: DGF-201608001
Metformin hydrochloride: 6417 ML2RMI
Description of Pack
Alu Alu Blister, 3 × 10’s
Frequency Accelerated: 0, 1, 3, 6 months
Real Time: 0,3,6,9 months
Batch No. T001 T002 T003

No. of Batches 03
Date of Submission 22-09-2020 (Dy. No. 24643)
Documents To Be Provided Status
Certificate of analysis of API. Yes
Approval of API by regulatory authority of country of Dapagliflozin propanediol Monohydrate: The firm has
origin or GMP certificate of API manufacturer issued submitted copy of GMP certificate issued by Huaian Market
by regulatory authority of country of origin. Supervision Administration, China. It is valid till 31-12-2020.
Metformin hydrochloride: The firm has submitted copy of
GMP certificate issued by Food and Drugs Administration
Madhya Pradesh. It is valid till 25-04-2022.
Protocols followed for conduction of stability study and
Yes
details of tests.
Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory Yes
reports, data sheets etc.
Documents confirming import of API etc. Dapagliflozin propanediol monohydrate: The firm has copy
of invoice for the purchase of Dapagliflozin (0.5412Kg) dated
10-09-2016 not attested by AD (I&E). Instead the firm has
submitted copy of DHL as evidence of purchase.
commercial invoice for the import of metformin
hydrochloride (2000Kg, 6417ML2RMI) attested by AD (I&E)
Lahore dated 02-01-2017.
All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data / Yes
documents.
Commitment to continue real time stability study till
Yes
assigned shelf life of the product.
Commitment to follow Drug Specification Rules, 1978. Yes
• The firm has submitted 06 months Accelerated and 06 months Real Time Stability Data for 03 Batches.
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Date of submission: 03-03-2020 (Dy. No.3334)
1. Reference of last onsite panel inspection Firm has referred to onsite inspection report of their product
for instant dosage form conducted during “Velbuvir 400/100mg Tablet”, which was presented in 292nd meeting
last two years. of Registration board.
Date of inspection: 23-05-2019
According to the report, following points were confirmed
a) The HPLC software is 21CFR Compliant as per record available
with the firm.
b) Continuous monitoring and power supply are available for stability
chambers.

2. Documents for the procurement of API Dapagliflozin propanediol Monohydrate: The firm has submitted
with approval from DRAP (in case of copy of GMP certificate for M/s Jiangsu Yongan Pharmaceutical Co.
import). Ltd issued by Jiangsu Food and Drug Administration, China. It is
valid till 03-03-2021.
Metformin hydrochloride: The firm has submitted copy of GMP
certificate for M/s IPCA Laboratories Limited, Aurangabad, India
issued by Food and Drugs Administration Madhya Pradesh. It is valid
till 25-04-2022.
3. Documents for the procurement of Dapagliflozin propanediol monohydrate: The firm has copy of
reference standard and impurity standards. invoice for the purchase of Dapagliflozin (0.5412Kg) dated 10-09-
2016 not attested by AD (I&E). Instead the firm has submitted copy
of DHL as evidence of purchase.
commercial invoice for the import of metformin hydrochloride
(2000Kg, 6417ML2RMI) attested by AD (I&E) Lahore dated 02-01-
2017.
4. Approval of API/ DML/GMP certificate of Dapagliflozin propanediol Monohydrate: The firm has submitted
API manufacturer issued by regulatory copy of GMP certificate for M/s Jiangsu Yongan Pharmaceutical Co.
authority of country of origin. Ltd issued by Jiangsu Food and Drug Administration, China. It is
Metformin hydrochloride: The firm has submitted copy of GMP
certificate for M/s IPCA Laboratories Limited, Aurangabad, India
issued by Food and Drugs Administration Madhya Pradesh. It is valid
till 25-04-2022.
5. Mechanism for vendor pre-qualification The firm has submitted SOP for Evaluation of Vendors.
6. Certificate of analysis of the API, reference Dapagliflozin propanediol Monohydrate: Copy of COA of API from
standards and impurity standards M/s Jiangsu Yongan Pharmaceutical Co., China is submitted.
Impurity A
Impurity B
Metformin hydrochloride: Copy of COA of API from M/s IPCA
Laboratories Limited, Aurangabad, India is submitted.
Working standard
7. Documents for the procurement of The firm has submitted documents for the procurement of excipients
excipients used in product development? used in product development
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved in R&D
development with relevant experience. department.
Production Data
9. Authorized Protocols/SOP for The firm has submitted photocopy of “Protocols/SOP for
development & stability testing of trial Pharmaceutical Product Development”.
batches.
10. Complete batch manufacturing record of The firm has submitted photocopy of manufacturing trials of
three stability batches. following 03 Batches:
T001 2520 Tabs 05-2018
T002 2520 Tabs 05-2018
T003 2520 Tabs 05-2018
11. Record of remaining quantities of stability Trial No Batch Size Tablets used Remaining
batches. for stability Quantities of
testing tablets
T001 2520 Tabs 25 packs 59 packs
QA / QC DATA

12. Record of Digital data logger for Firm has submitted photocopies of data logger record for chambers
temperature and humidity monitoring of used in Real Time & Accelerated stability studies of applied product.
stability chambers (real time and
accelerated)
13. Method used for analysis of API along with The firm has submitted photocopy of Raw Material Specifications,
COA. Raw Material Testing Procedures along with COAs for APIs used.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product Testing
complete record of testing of stability Procedure for “Dapawil M XR 5/500mg Tablet” along with Stability
batches (i.e. chromatograms, lab reports, Study Reports.
raw data sheets etc.)
15. Reports of stability studies of API fromDapagliflozin propanediol Monohydrate: The firm has submitted
manufacturer. 6 months accelerated and 36months real time stability study data of
three batches. Storage conditions for real time data were conducted
at 25oC ± 2oC / 60% ± 5% RH which was not as per Zone IV-A.
Metformin hydrochloride: The firm has submitted 6 months
accelerated and 60months real time stability study data of three
batches as per Zone IV-A.
16. Analysis reports for excipients used. The firm has submitted analytical reports of excipients used.
17. Drug-excipients compatibility studies. The firm has submitted that applied formulation is same as per
innovator.
18. Record of comparative dissolution data. The firm has submitted CDP of developed formulation DAPAWIL-
M XR 5/500mg (T-001) and reference formulation Xigduo XR
5/500mg Tab (Batch # L3H1468) of M/s AstraZeneca in 0.1 N HCl,
acetate buffer pH 4.5, phosphate buffer pH 6.8 and water. The results
showed both products are comparable in dissolution profile.
19. Compliance Record of HPLC software The firm has submitted certificate of 21 CFR compliance and audit
21CFR & audit trail reports on product trail reports of applied product.
testing.
Decision of 297th meeting of RB Response by the Firm
1. The submitted copy of GMP certificate of The firm has submitted copy of GMP certificate for M/s
API manufacturer for Dapagliflozin Jiangsu Yongan Pharmaceutical Co. Ltd issued by
propanediol monohydrate is expired. Jiangsu Food and Drug Administration, China. It is valid
Updated copy of GMP certificate is required. till 03-03-2021
2. The storage conditions under which stability The firm has submitted 06 months accelerated and 36
study data of Dapagliflozin propanediol months real time stability study data of Dapagliflozin
monohydrate were not as per Zone IV-A. Propanediol monohydrate as per Zone-IVA conditions.
3. Documents confirming import of APIs were Dapagliflozin propanediol monohydrate: The firm has
not attested by AD (I & E) of concerned copy of invoice for the purchase of Dapagliflozin
office. Clarification is required. Moreover, (0.5412Kg) dated 10-09-2016 not attested by AD (I&E).
exact quantity of Dapagliflozin API imported Instead the firm has submitted copy of DHL as evidence
is not mentioned in submitted document. of purchase.
Metformin hydrochloride: The firm has submitted copy
of commercial invoice for the import of metformin
hydrochloride (2000Kg, 6417ML2RMI) attested by AD
(I&E) Lahore dated 02-01-2017.

4. Complete batch manufacturing records of The firm has submitted batch manufacturing record of
trials of applied product including steps of three batches.
manufacturing procedure are required.
Trial Batch Size Tablets used Remaining
No for stability Quantities
testing of tablets
5. Results of comparative dissolution profile The firm has submitted CDP of developed formulation
conducted in three BCS media across the DAPAWIL-M XR 5/500mg (T-001) and reference
physiological pH range along with formulation Xigduo XR 5/500mg Tab (Batch #
calculation of similarity factor f2 shall be L3H1468) of M/s AstraZeneca in 0.1 N HCl, acetate
submitted and discussed. buffer pH 4.5, phosphate buffer pH 6.8 and water. The
results showed both products are comparable in
dissolution profile.
6. Audit trail reports on product testing are The firm has submitted audit trail record of product
required. testing.
7. Stability study data alongwith supporting The firm has submitted stability study data of three
documents like summary sheets, batches alongwith chromatograms and raw data sheets.
chromatograms and raw data of applied
formulation is required.
Decision: Deferred for the justification of applied formulation against the innovator product since innovator
drug product approved by US FDA is a bilayer compressed tablet (Immediate release layer of
Dapagliflozin and Extended relase layer of Metformin HCl) whereas firm has manufactured trial
batches as a mono-layer comprerssed tablet.
Case No. 4 Registration applications for local manufacturing of human drugs submitted on CTD
format (New License)
The Central Licensing Board in its 271st meeting held on 12th September, 2019 has considered and approved the
grant of Drug Manufacturing License to M/s Himark Laboratories Pvt Ltd. Plot 37-A, Sundar Industrial Estate,
Lahore by way of Formulation vide approval letter No. F. 1-67/2005-Lic dated 29th Sep, 2019 with following (06)
sections.
Name of Section Considered till 313th RB Freshly applied
meeting
No of No of No of No of
molecules products molecules products
Tablet (General & General Antibiotic) Section 2 5 2 2
Capsule (General & General Antibiotic) Section 4 9 1 2
Dry Powder Suspension (General & General 3 5 1 1
Antibiotic) Section
Sachet (General) Section - - 1 1
Oral Liquid Syrup Section 2 3 2 3
Cream/Ointment (General) Section - - - -
43. Name, address of Applicant / Marketing M/s Himark Laboratories Private Limited, Plot 37-A, Sunder
Authorization Holder Industrial Estate Lahore.
Name, address of Manufacturing site. M/s Himark Laboratories Private Limited, Plot 37-A, Sunder
Industrial Estate Lahore.
☐ Importer

☐ Export sale
Dy. No. and date of submission Dy. No.30582; Dated: 08-11-2021
Details of fee submitted PKR 20,000/-: Dated 31-12-2020
PKR 10,000/- Duplicate challan date not mentioned
manufacturer Capsule (General & General Antibiotic) section approved.
The proposed proprietary name / brand name Dicmark 50 mg DR capsule
Pharmaceutical ingredient (API) per unit Diclofenac sodium (as Diclofenac sodium EC Pellets
24%)………………50 mg
Pharmaceutical form of applied drug Hard Gelatin capsule
Reference to Finished product specifications Innovator’s specifications
Proposed Pack size 2 ×10’s
The status in reference regulatory authorities Deflamat 50 mg – Kapseln, Astellas Pharma GmbH Linzer
Straße 221/E02 1140 Vienna Austria, AGES (Austria)
Approved.
For generic drugs (me-too status) Phlogin 50 mg cap (Enteric coated pellets) by M/s Brookes
Pharma, Reg. No. 009128
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad-
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure,
description of manufacturing process and controls,
Identification, water determination, Assay and tests for total
impurities, specifications, analytical procedures and its
verification, batch analysis and justification of specification,
studies of drug substance.
Batches:(DE-161, DE-469, DE-597)
process validation protocols and report, control of drug
product, specifications, analytical procedures, validation of

analytical procedures, batch analysis, justification of
specifications, reference standard or materials, container
closure system and stability.
dissolution profile brand leader that is Phlogin 50 mg capsule by Brookes
Pharma by performing quality tests (Identification, Assay,
Dissolution, Uniformity of dosage form).
product linearity, range, accuracy, precision, specificity.
Manufacturer of API M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan
API Lot No. DE706
Description of Pack
Alu-PVC blister packed in unit carton (2 x 10’s)
Frequency Accelerated: 0, 2, 4, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. T-49 T-50 T-51
Batch Size 1500 capsules 1500 capsules 1500 capsules
No. of Batches 03
13. Reference of previous approval of applications The firm has not submitted any document.
14. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate issued by
manufacturer issued by concerned regulatory Additional Director DRAP, Islamabad. It is valid till 10-02-
authority of country of origin. 2022.
15. Documents for the procurement of API with The firm has submitted copy of invoice for the purchase of
approval from DRAP (in case of import). Diclofenac sodium EC pellets 24 % (Batch # DE706, 1Kg)
dated 11-03-2020.
16. Data of stability batches will be supported by Data of stability batches have been submitted by UV method
attested respective documents like alongwith respective documents like COA, summary data
chromatograms, Raw data sheets, COA, sheets.
17. Compliance Record of HPLC software 21CFR The firm has submitted that testing of Dicmark 50mg DR
& audit trail reports on product testing capsule has been performed on UV spectrophotometer.
18. Record of Digital data logger for temperature Record of data logger for temperature and humidity
and humidity monitoring of stability chambers monitoring of stability chambers (real time and accelerated)
(real time and accelerated) has been submitted.
No.
1. Copies of the Drug substance specifications and The firm has submitted copies of the Drug substance
analytical procedures used for routine testing of specifications and analytical procedures used for
the Drug substance / Active Pharmaceutical routine testing of the Drug substance by both Drug
Ingredient by both Drug substance & Drug substance & Drug Product manufacturer.
Product.

2. Analytical method verification reports of The firm has submitted analytical method
parameters like specificity, accuracy and verification reports of drug substance performed by
repeatability (method precision) performed by drug product manufacturer. However, relevant
the Drug Product manufacturer for both chromatograms of tested parameters were not
compendial as well as non-compendial drug provided.
substance(s) shall be submitted.
3. Provide results of analysis of relevant batch(es) The firm has provided results of analysis of relevant
of Drug Substance performed by Drug Product batch(es) of Drug Substance performed by Drug
manufacturer used during product development Product manufacturer used during stability studies,
and stability studies, along with Certificate of along with certificate of analysis (CoA) of the same
Analysis (CoA) of the same batch from Drug batch.
Substance / /Active Pharmaceutical Ingredient
manufacture.
4. Pharmaceutical equivalence of the applied drug The firm has submitted pharmaceutical equivalence
shall be established with the innovator product data of developed formulation (batch # T-49)
and results of all the quality tests of the against comparator brand Phlogin DR 50mg
developed formulation and the innovator Capsule (Batch # 09519) of M/s Brookes pharma.
product shall be submitted and discussed. Reference of WHO technical report series No. 902,
2002 has been given to justify the selection of
market brand leader if innovator is not available.
5. Details of batch numbers of applicant and The firm has provided details of applicant and
comparator product in pharmaceutical comparator product.
equivalence are required to be provided.
6. Justification is required for performing assay Dicmark 50mg DR Capsule is a non-compendial
testing by UV method instead of HPLC method. product. We have performed method validation on
UV spectrophotometer, hence we performed assay
testing by UV method.
7. Justification is required for setting dissolution The firm has submitted that 70% in 45min is a
limit in phosphate buffer stage as NLT 70% in typographic mistake. Actual limit is NLT 80% in 45
45 min which is different from that mentioned min in phosphate buffer in Dissolution test as
in Stability study protocol i.e., NLT 80% in 45 written in stability protocol.
min.
8. Analytical method verification of drug product The firm has submitted revised reports of
includes performance of test of Detection limit performance of test of Detection limit and
and Quantitation limit by HPLC method. Quantitation limit by UV method.
9. Documents for the procurement of the API The firm has submitted copy of invoice for the
including purchase invoice from M/s M/s Vision purchase of Diclofenac sodium EC pellets 24 %
Pharmaceuticals (Pvt.) Ltd. (Batch # DE706, 1Kg) dated 11-03-2020.
10. Compliance Record of HPLC software 21CFR The firm has submitted that testing of Dicmark
& audit trail reports on product testing. 50mg DR capsule has been performed on UV
spectrophotometer.
11. Record of Digital data logger for temperature Record of data logger for temperature and humidity
and humidity monitoring of stability chambers monitoring of stability chambers (real time and
(real time and accelerated). accelerated) has been submitted.
• Analytical method verification report of drug substance performed by drug product manufacturer as
per requirement of section 3.2.S.4.3 of Form-5F.
• Justification of adopting UV-visible spectrophotometric method for assay testing of applied formulation.
• Performance of pharmaceutical equivalence and CDP studies with innovator/reference product.
• Analytical method verification reports of drug product performed by drug product manufacturer.

☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 30583: Dated: 08-11-2021
PKR 10,000/- Duplicate challan date not mentioned
The proposed proprietary name / brand name Dicmark 100 mg SR capsule
Strength / concentration of drug of Active Each Sustained Release capsule contains:
Pharmaceutical ingredient (API) per unit Diclofenac sodium (as Diclofenac sodium SR Pellets 32%)
......................100 mg
Pharmaceutical form of applied drug Red /Transparent (Shell # 1) containing SR pellets of Diclofenac
sodium (32%).
Reference to Finished product specifications BP specifications
The status in reference regulatory authorities Rhumalgan XL 100 mg Cap, Sandoz Ltd, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR, United
Kingdom, MHRA approved
For generic drugs (me-too status) Phlogin SR 100 mg cap by M/s Brookes Pharma (Reg. No.
009129)
GMP status of the Finished product manufacturer New license granted on 26-09-2019.
Capsule (General & General Antibiotic) section.
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Pakistan
controls, impurities, specifications, analytical procedures and
its verification, batch analysis and justification of
and stability studies of drug substance and drug product is
submitted.
Module III (Drug Substance) The firm has submitted details of nomenclature, structure,
controls, Identification, water determination, Assay and tests
for total impurities, specifications, analytical procedures and

Batches: (DE062ER, DE160ER, DE230ER)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established against
dissolution profile comparator products that is Biodic SR Capsule by Biorex
Pharma, by performing quality tests (Identification, Assay,
CDP has been performed against the same brand that is
Biodic SR Capsule by Biorex Pharma in Acid media (pH
1.0-1.2) & Phosphate Buffer (pH 6.8). The values for f1 and
f2 are in the acceptable range.
Manufacturer of API M/s Vision Pharmaceuticals (Pvt.) Ltd.,
API Lot No. DE695ER
Description of Pack
Alu-PVC blister packed in unit carton (2 x 10’s)
Frequency Accelerated: 0, 2, 4, 6 (Months)
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate issued by DRAP on the basis
manufacturer issued by concerned regulatory of inspection conducted on 11-02-2019.

approval from DRAP (in case of import). Diclofenac sodium SR pellets 32 % (Batch # DE695ER, 2Kg)
dated 23-12-2019.
4. Data of stability batches will be supported by Data of stability batches have been submitted by UV method
attested respective documents like alongwith respective documents like COA, summary data
chromatograms, Raw data sheets, COA, summary sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & The firm has submitted that HPLC software 21 CFR is not
audit trail reports on product testing applicable as testing of Dicmark 100mg SR Capsule has been
performed on UV-spectrophotomer.
6. Record of Digital data logger for temperature and Record of data logger for temperature and humidity
humidity monitoring of stability chambers (real monitoring of stability chambers (real time and accelerated)
time and accelerated) has been submitted.
No.
1. Copies of the Drug substance specifications and The firm has submitted copies of the Drug
analytical procedures used for routine testing of the substance specifications and analytical procedures
Drug substance / Active Pharmaceutical Ingredient used for routine testing of the Drug substance by
by both Drug substance & Drug Product. both Drug substance & Drug Product manufacturer.
parameters like specificity, accuracy and verification parameter of drug substance performed
repeatability (method precision) performed by the by drug product manufacturer. However, the
Drug Product manufacturer for both compendial as specificity results were not presented. The relevant
well as non-compendial drug substance(s) shall be spectra of tested parameter were not provided.
submitted.
3. Provide results of analysis of relevant batch(es) of The firm has provided results of analysis of relevant
Drug Substance performed by Drug Product batch(es) of Drug Substance performed by Drug
Analysis (CoA) of the same batch from drug batch.
substance manufacturer.
4. Pharmaceutical equivalence of the applied drug Pharmaceutical Equivalence have been established
shall be established with the innovator product and against comparator products that is Biodic SR
results of all the quality tests of the developed Capsule by Biorex Pharma, by performing quality
formulation and the innovator product shall be tests (Identification, Assay, Dissolution, Uniformity
submitted and discussed. of dosage form).
CDP has been performed against the same brand
that is Biodic SR Capsule by Biorex Pharma in
Acid media (pH 1.0-1.2) & Buffer medium (pH
7.2). Reference of WHO technical report series No.
902, 2002 has been given to justify the selection of
market brand leader if innovator is not available.
5. Details of batch numbers of applicant and Applicant batch no. Comparator batch
comparator product in pharmaceutical equivalence no.
are required to be provided. Dicmark 100mg SR Phlogin 100mg SR
Capsule = T-16 capsule = 329G9
6. Scientific justification is required for performing The firm has submitted that BP allows to perform
comparative dissolution profile conducted in acidic dissolution test as per manufacturer and here
media for 1 h followed by phosphate buffer pH 6.8 manufacturer’s specification has been followed. BP
since applied formulation is sustained release statement as below:
capsule. “A suitable dissolution test is carried out to
demonstrate the appropriate release of Diclofenac
sodium. The dissolution profile reflects the in-vivo
performance which in-turn is compatible with

dosage schedule recommended by the
manufacturer”.
7. Justification of method of specificity test in The firm has not submitted results for specificity
analytical method verification studies shall be test.
submitted. Clarification is required.
8. Documents for the procurement of the API The firm has submitted copy of invoice for the
including purchase invoice from M/s M/s Vision purchase of Diclofenac sodium SR pellets 32 %
Pharmaceuticals (Pvt.) Ltd. (Batch # DE695ER, 2Kg) dated 23-12-2019.
9. Data of stability batches should be supported by The firm has submitted raw data sheets without
submission of attested respective documents like relevant UV scans of assay testing at each time
chromatograms/spectra, Raw data sheets. point of 3 batches during stability studies.
10. Compliance Record of HPLC software 21CFR & The firm has submitted that HPLC software 21 CFR
audit trail reports on product testing. is not applicable as testing of Dicmark 100mg SR
Capsule has been performed on UV-
spectrophotomer.
11. Record of Digital data logger for temperature and Record of data logger for temperature and humidity
humidity monitoring of stability chambers (real monitoring of stability chambers (real time and
time and accelerated). accelerated) has been submitted.
Decision: Approved.
Firm shall submit following before issuance of registration letter:
• Analytical method verification report of drug substance performed by drug product manufacturer.
• UV spectra for Assay testing, as recommended by the BP monograph of applied formulation, at each time
point of stability studies.
• Analytical method verification reports for testing of drug product as per requirements of section 3.2.P.5.3
of Form-5F.
☐ Importer
☐ Export sale
GMP status of the Finished product New license granted on 26-09-2019.
manufacturer Dry powder Suspension (General & general antibiotics)
section approved.
PKR 10,000/-: Duplicate challan date not mentioned
The proposed proprietary name / brand name Hitek 125 mg / 5mL granules for oral suspension
Strength / concentration of drug of Active Each 5 ml after reconstitution contains:
Pharmaceutical ingredient (API) per unit Clarithromycin as taste masked micro pellets……….125 mg
Pharmaceutical form of applied drug Granules for oral suspension

Pharmacotherapeutic Group of (API) Macrolide antibiotic

Proposed Pack size 1 × 60 mL
The status in reference regulatory authorities Clarithromycin 125 mg/5ml suspension by M/s Sandoz Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16
7SR, (USFDA Approved).
For generic drugs (me-too status) Rithmo 125 mg / 5 ml Suspension by M/s Sami Pharma, Reg.
No. 057746
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22-23,
Industrial Triangle, Kahuta Road, Islamabad- Pakistan
Module-II (Quality Overall Summary) The firm has submitted QOS as per WHO QOS-PD template.
control drug substance, specifications, analytical procedures
and its verification, batch analysis and justification of
submitted.
Identification, Assay and tests for related substances,
substance
Batches:
(STRHB 170001, STRHB 170002, STRHB 170003)
dissolution profile brand leader that is Rithmo 125 mg /5 mL granules for oral
suspension by Sami Pharmaceuticals by performing quality
tests (Identification, Assay, pH, Uniformity of dosage unit &
loss on drying and dissolution test).
CDP – Not applicable
Manufacturer of API M/s Vision Pharmaceuticals (Pvt.) Ltd.
API Lot No. CTM 0613

Description of Pack Granular powder for oral suspension, prepares white to off white suspension when
(Container closure system) constituted as per label instructions,packed in amber glass bottles sealed with aluminium
caps.
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate issued by DRAP on the basis of
manufacturer issued by concerned regulatory inspection conducted on 11-02-2019.
3. Documents for the procurement of API with The firm has not submitted relevant invoice.
attested respective documents like attested respective documents like chromatograms, raw data
chromatograms, Raw data sheets, COA, sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR The firm has not submitted compliance record of HPLC
& audit trail reports on product testing software and audit trail reports.
6. Record of Digital data logger for temperature The firm has submitted record of data logger for temperature
and humidity monitoring of stability chambers and humidity monitoring of stability chambers (real time and
(real time and accelerated) accelerated
analytical procedures used for routine testing of the substance specifications and analytical
Drug substance / Active Pharmaceutical Ingredient by procedures used for routine testing of the Drug
both Drug substance & Drug Product. substance by both Drug substance & Drug
Product manufacturer.
2. Analytical method verification reports of parameters The firm has submitted analytical method
like specificity, accuracy and repeatability (method verification parameter of drug substance
precision) performed by the Drug Product performed by drug product manufacturer.
manufacturer for both compendial as well as non- However, the specificity results were not
compendial drug substance(s) shall be submitted. presented. The relevant chromatograms of tested
parameter were not provided.
3. Provide results of analysis of relevant batch(es) of The firm has provided results of analysis of
Drug Substance performed by Drug Product relevant batch(es) of Drug Substance performed
manufacturer used during product development and by Drug Product manufacturer used during
stability studies, along with Certificate of Analysis stability studies, along with certificate of analysis
(CoA) of the same batch from Drug Substance / (CoA) of the same batch.
/Active Pharmaceutical Ingredient manufacture.

4. Justify dissolution test of clarithromycin micro pellets Dissolution test of clarithromycin micro pellets in
in acid stage and buffer stage since the same are not acid stage and buffer stage is performed because
enteric coated. taste masking of the same has been done by way
of enteric coating.
5. Pharmaceutical equivalence of the applied drug shall The firm has submitted pharmaceutical
be established with the innovator product and results equivalence of applied formulation with
of all the quality tests of the developed formulation and comparator product by performing quality tests
the innovator product shall be submitted and discussed. (Identification, assay, uniformity of dosage units,
Deliverable volume, pH and loss on drying).
Reference of WHO technical report series No.
902, 2002 has been given to justify the selection
of market brand leader if innovator is not
available.
6. Details of batch numbers of applicant and comparator Applicant batch no. Comparator batch no.
product in pharmaceutical equivalence are required to Hitek 125 mg/ 5ml Rithmo 125 mg/ 5ml
be provided. granules for oral granules for oral
suspension = T-22 suspension = 069E
7. Justification of method of specificity test in analytical The firm has not submitted results for specificity
method verification studies shall be submitted. test.
8. Provide raw data sheets wherein details of sample The firm has submitted raw data sheets for the
solution preparation and standard solution and assay test.
calculation formula for the assay test shall be
mentioned.
9. Documents for the procurement of the API including The firm has not provided relevant invoice
purchase invoice from M/s Vision Pharmaceuticals instead invoice of diclofenac sodium EC pellets
(Pvt.) Ltd. has been submitted.
10. Record of Digital data logger for temperature and The firm has submitted record of data logger for
humidity monitoring of stability chambers (real time temperature and humidity monitoring of stability
and accelerated). chambers (real time and accelerated
Decision: Approved.
Firm shall submit following before issuance of registration letter:
• Performance of pharmaceutical equivalence and CDP studies with innovator product i.e., Klaricid
125mg /5ml Paediatric suspension of M/s Abbott.
• Documents for the procurement of the API with approval from DRAP (in case of import).
☐ Importer
☐ Export sale
GMP status of the Finished product manufacturer New license granted on 26-09-2019.
Tablet (General & General Antibiotic) section approved.
Dy. No. and date of submission Dy. No.30581: Dated 08-11-2021

The proposed proprietary name / brand name Lorak 10 mg Tablet
Strength / concentration of drug of Active Each tablet contains:
Pharmaceutical ingredient (API) per unit Loratadine ...................10 mg
Pharmaceutical form of applied drug White to off white round uncoated tablet
Pharmacotherapeutic Group of (API) Antihistamines –H1 antagonists
Reference to Finished product specifications USP specifications
The status in reference regulatory authorities Clarityn Allergy 10mg Tablets by M/s UCB Pharma,
(MHRA Approved).
For generic drugs (me-too status) Softin 10 mg Tablet by M/s Werrick Pharmaceuticals, (Reg
# 012026)
Name and address of API manufacturer. M/s. Vasudha Pharma Chem Limited., 78/A,
VENGALRAO NAGAR, HYDERABAD –500038, INDIA.
submitted.
Module III (Drug Substance) The firm has submitted detail of nomenclature, structure,
controls, Identification, Assay and tests for total impurities,
drug substance
Real time: 30°C ± 2°C / 65% ± 5% RH for 60 months
Accelerated: 40°C ± 2°C / 75% ± 5% RH for 6 months
(BLRD/001/11, BLRD/002/11, BLRD/003/11)
Module-III (Drug Product): The firm has submitted data of drug product including its
process validation protocols and report, control of excipients,
control of drug product, specifications, analytical procedures,
materials, container closure system and stability.

Pharmaceutical equivalence and comparative Pharmaceutical equivalence has been established against the
dissolution profile brand leader that is Tirlor Tablet of Novartis Pharma by
performing quality tests (Identification, Assay, Dissolution,
CDP has been performed against the same brand that is Tirlor
Tablet by Novartis Pharma in Acid media (pH 1.0-1.2),
phosphate buffer (pH 4.5 & pH 6.8).

Manufacturer of API M/s Vasudha Pharma Chem Limited.,
78/A, VENGALRAO NAGAR, HYDERABAD – 500038, INDIA
API Lot No. BLRD/1911023
Description of Pack
Alu-Alu blister packed in unit carton (1×10’s)
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate No. L. Dis.
manufacturer issued by concerned regulatory No. 5741/P&B/2001 issued by Drugs Control Administration
authority of country of origin. (Govt. of Andhra Pradesh) India valid till 20-11-2022.
3. Documents for the procurement of API with The firm has submitted copy of letter No.17133/2019/
approval from DRAP (in case of import). DRAP-AD-CD(I&E) dated 26-12-2019 is submitted wherein
the permission to import different APIs Loratadine for the
purpose of test/analysis and stability studies is granted.
4. Data of stability batches will be supported by The firm has submitted stability data supported by respective
attested respective documents like documents like chromatograms, and summary data sheets etc.
chromatograms, raw data sheets, COA, summary
data sheets etc.
6. Record of Digital data logger for temperature and The firm has submitted record of data logger sheets for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability chambers
time and accelerated) (real time and accelerated.

No.
1. Copies of the Drug substance specifications and The firm has submitted copies of the Drug substance
analytical procedures used for routine testing of specifications and analytical procedures used for
the Drug substance / Active Pharmaceutical routine testing of the Drug substance by both Drug
Ingredient by both Drug substance & Drug substance & Drug Product manufacturer.
Product.
2. Analytical method verification reports of The firm has submitted analytical method verification
parameters like specificity, accuracy and parameter of drug substance performed by drug
repeatability (method precision) performed by product manufacturer. However, the specificity
the Drug Product manufacturer for both results were not presented. The relevant
compendial as well as non-compendial drug chromatograms of tested parameter were not
substance(s) shall be submitted. provided.
3. Provide results of analysis of relevant batch(es) The firm has provided results of analysis of relevant
of Drug Substance performed by Drug Product batch(es) of Drug Substance performed by Drug
Analysis (CoA) of the same batch from Drug batch.
Substance manufacturer.
4. Pharmaceutical equivalence of the applied drug Pharmaceutical equivalence has been established
shall be established with the innovator product against the brand leader that is Tirlor Tablet of
and results of all the quality tests of the Novartis Pharma by performing quality tests
developed formulation and the innovator (Identification, Assay, Dissolution, Uniformity of
product shall be submitted and discussed. dosage form).
5. Details of batch numbers of applicant and Applicant batch no. Comparator batch no.
comparator product in pharmaceutical Lorak 10 mg Tablet Tirlor 10mg tablet of M/s
equivalence are required to be provided. = T-28 Novartis pharma = 102
6. Submit date of analysis of pharmaceutical The firm has stated date of analysis 27-01-2020 and
equivalence and comparative dissolution profile relevant chromatograms / spectra were not provided.
alongwith chromatograms / spectra.
7. Control of excipients is missing. The firm has submitted that excipients used in the
formulation are of pharmacopoeial grade and we are
using BP specifications.
8. Justification of method of specificity test in The firm has not submitted results for specificity test.
analytical method verification studies shall be
9. Analytical method verification reports of each The firm has submitted raw data sheets for the assay
parameter like specificity, accuracy and test.
repeatability (method precision) performed by
the Drug Product manufacturer for drug product
shall be submitted.
10. The submitted chromatograms in stability The firm has not submitted chromatograms of all time
studies (3.2.P.8) do not differentiate between points of real time and accelerated stability studies.
real time or accelerated stability studies time
points of different batches.
11. Submit copies of Batch Manufacturing Record The firm has submitted copies of BMRs for three
(BMR) for all the batches of drug product for batches.
which stability studies data is provided in
Module 3 section 3.2.P.8.3.
12. Record of Digital data logger for temperature The firm has submitted record of data logger for
and humidity monitoring of stability chambers temperature and humidity monitoring of stability
(real time and accelerated). chambers (real time and accelerated.

• HPLC chromatograms of all time points of real time and accelerated stability studies.
• Analytical method verification reports for testing of drug product as per requirements of section
3.2.P.5.3 of Form-5F.
☐ Importer
☐ Export sale
manufacturer Oral Liquid Syrup section approved.
Dy. No. and date of submission Dy. No. 30580: Dated 08-11-2021
The proposed proprietary name / brand name Lorak 5 mg / 5 mL oral solution
Strength / concentration of drug of Active Each 5 ml contains:
Pharmaceutical ingredient (API) per unit Loratadine….................5 mg
Pharmaceutical form of applied drug Transparent to yellowish sweet taste orange flavor oral solution
Pharmacotherapeutic Group of (API) Anti-histamine
The status in reference regulatory authorities Loratadine 5 mg / 5 ml syrup by M/s Generics [UK] Limited
t/a Mylan, MHRA Approved.
For generic drugs (me-too status) Lorel 1mg/mL Syrup by M/s Standpharm (Reg # 020951)
Name and address of API manufacturer. M/s Vasudha Pharma Chem Limited.,78/A, VENGALRAO
NAGAR, HYDERABAD – 500038, INDIA
Module III (Drug Substance) Official monograph of Loratadine is present in USP. The firm
as submitted detail of nomenclature, structure, general
Identification, Assay and tests for total impurities,

substance
(BLRD/001/11, BLRD/002/11, BLRD/003/11)
justification of specifications, reference standard or materials,
container closure system and stability.
dissolution profile brand leader that is Lorel Syrup by Standpharm by performing
quality tests (Identification, Assay, pH, microbial
enumeration tests & tests for specified micro-organisms).
Manufacturer of API M/s Vasudha Pharma Chem Limited.,
78/A, Vengalrao Nagar, Hyderabad – 500038, INDIA
API Lot No. BLRD/1911023
Description of Pack Clear & transparent solution with sweet taste & tutti-fruiti flavor filled in amber glass
(Container closure system) bottles in packs of 60 mL, further packed in unit carton provided with leaflet insert and a
spoon.
Batch Size 100 bottles 100 bottles 100 bottles
No. of Batches 03
manufacturer issued by concerned regulatory 5741/P&B/2001 issued by Drugs Control Administration,
authority of country of origin. Government of Andhra Pradesh, India valid till 20-11-2022.

3. Documents for the procurement of API with The firm has submitted copy of letter No.17133/2019/ DRAP-
approval from DRAP (in case of import). AD-CD(I&E) dated 26/12/2019 is submitted wherein the
permission to import different APIs Loratadine for the purpose
of test/analysis and stability studies is granted.
4. Data of stability batches will be supported by The firm has submitted stability data supported by respective
attested respective documents like documents like chromatograms, and summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Not submitted.
& audit trail reports on product testing.
6. Record of Digital data logger for temperature The firm has submitted record of data logger sheets for
and humidity monitoring of stability chambers temperature and humidity monitoring of stability chambers
(real time and accelerated) (real time and accelerated.
No.
Drug substance / Active Pharmaceutical Ingredient procedures used for routine testing of the Drug
by both Drug substance & Drug Product. substance by both Drug substance & Drug
parameters like specificity, accuracy and verification parameter of drug substance
repeatability (method precision) performed by the performed by drug product manufacturer.
Drug Product manufacturer for both compendial as However, the specificity results were not
well as non-compendial drug substance(s) shall be presented. The relevant chromatograms of tested
submitted. parameter were not provided.
(CoA) of the same batch from Drug Substance (CoA) of the same batch.
manufacturer.
4. Pharmaceutical equivalence of the applied drug The firm has performed pharmaceutical
shall be established with the innovator product and equivalence studies with comparator product.
results of all the quality tests of the developed The details are below:
formulation and the innovator product shall be
submitted and discussed.
comparator product in pharmaceutical equivalence Lorak 5 mg /5ml Lorel 5mg /5ml oral
are required to be provided. Oral solution = T- solution of M/s
31 StandPharma = 004G
6. Submit date of analysis of pharmaceutical The firm has stated date of analysis 12-02-2020,
equivalence and comparative dissolution profile however relevant chromatograms / spectra were
alongwith chromatograms / spectra. not provided.
formulation are of pharmacopoeial grade and we
are using BP specifications.
9. Analytical method verification reports of each The firm has not submitted analytical method
parameter like specificity, accuracy and verification reports of parameters like specificity,
repeatability (method precision) performed by the accuracy and repeatability (method precision) for
drug product.

Drug Product manufacturer for drug product shall
be submitted.
10. The submitted chromatograms in stability studies The firm has not submitted chromatograms of all
(3.2.P.8) do not differentiate between real time or time points of real time and accelerated stability
accelerated stability studies time points of different studies.
batches.
(BMR) for all the batches of drug product for which batches.
stability studies data is provided in Module 3
section 3.2.P.8.3.
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability
time and accelerated). chambers (real time and accelerated.

3.2.P.5.3 of Form-5F.
☐ Importer
☐ Export sale
PKR 10,000/-: Date not mentioned
The proposed proprietary name / brand name Hitran Paediatric Suspension
Strength / concentration of drug of Active Each 5 mL suspension contains:
Pharmaceutical ingredient (API) per unit Trimethprim........................40 mg
Sulfamethoxazole...............200 mg
Pharmaceutical form of applied drug Clear sweet strawberry flavored homogeneous oral suspension
filled in amber glass bottle sealed with aluminium cap and
packed in printed unit cartons.
Pharmacotherapeutic Group of (API) Antibiotic

The status in reference regulatory authorities Bactrim Suspension by M/s Sun Pharm industries, USFDA
Approved.
For generic drugs (me-too status) Septran Paediatric Suspension by M/s GSK Pharma (Reg. No.
000384)
Name and address of API manufacturer. M/s Shouguang Fukang Pharmaceutical company Ltd.,
North-East of Dongwaihuan Road, Dongcheng Industrial Area,
Shouguang City, Shandong Province, China.
Module III (Drug Substance) Trimethoprim:
The firm has submitted details of nomenclature, structure,
substance.
Sulfamethoxazole:
substance.
Batches of Trimethoprim:
(201103504, 201103505, 201103506)
Batches of Sulfamethoxazole:
Accelerated: (200604001, 200604002, 200604003)
Real Time: (2007706001, 2007706002, 2007706003)
validation of analytical procedures, batch analysis, justification
of specifications, reference standard or materials, container
dissolution profile brand leader that is Septran Paediatric Suspension by GSK

Pharma by performing quality tests (Identification, Assay, pH,
Deliverable volume).
Analytical method validation/verification of Method verification studies have submitted including linearity,
product range, accuracy, precision, specificity.
Manufacturer of API M/s Shouguang Fukang Pharmaceutical company Ltd.,
North-East of Dongwaihuan Road, Dongcheng Industrial Area, Shouguang City,
Shandong Province, People’s Republic of China.
API Lot No. Trimethoprim: A-50112007004-0500
Sulfamethoxazole: A-50212005029
Description of Pack Hitran Paediatric Suspension is filled in amber glass bottle sealed with pilfer proof
(Container closure system) aluminium cap and packed in a box board unit carton.
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate (Certificate #
manufacturer issued by concerned regulatory 20190888) for M/s Shouguang Fukang Pharmaceutical Co.
authority of country of origin. Ltd. issued by China Food and Drug Administration valid till
12-03-2024.
3. Documents for the procurement of API with The firm has submitted copy of letter No.17133/2019/DRAP-
approval from DRAP (in case of import). AD-CD (I&E) dated 26-12-2019 wherein the permission to
import different APIs Trimethoprim & Sulfamethoxazole for
the purpose of test/analysis and stability studies is granted.
Invoice for the purchase of materials is not submitted.
4. Data of stability batches will be supported by The firm has submitted data of stability batches alongwith raw
attested respective documents like data sheets, COA, summary data sheets. Relevant UV scans
chromatograms, Raw data sheets, COA, were not provided.
5. Compliance Record of HPLC software 21CFR The testing of applied product is performed on UV
& audit trail reports on product testing spectrophotometer and audit trail reports not submitted.
and humidity monitoring of stability chambers and humidity monitoring of stability chambers (real time and
(real time and accelerated) accelerated).

The firm has claimed BP specifications however, the product is also present in USP monograph.
No.
Drug substance / Active Pharmaceutical Ingredient procedures used for routine testing of the Drug
by both Drug substance & Drug Product. substance by both Drug substance & Drug
2. Submit evidence of equipments required for The firm has not provided evidence of
potentiometric titration and electrometric titration availability of potentiometer.
required for analysis of trimethoprim and
sulfamethoxazole, respectively.
parameters like specificity, accuracy and verification parameter of drug substance
repeatability (method precision) performed by the performed by drug product manufacturer.
Drug Product manufacturer for both compendial as However, the specificity results were not
well as non-compendial drug substance(s) shall be presented. The relevant chromatograms of tested
submitted. parameters were not provided.
(CoA) of the same batch from drug substance (CoA) of the same batch.
manufacturer.
comparator product in pharmaceutical equivalence Hitran Paediatric Septran paediatric
are required to be provided. suspension = T-88 Suspension = KR5B
6. Discussion of microbiological attributes of the The firm has not submitted preservative
Drug Product (e.g. preservative effectiveness effectiveness studies as recommended by
studies to be performed as per recommendations of Pharmacopoeia.
pharmacopoeia) shall be provided.
formulation are of pharmacopoeial grade and we
are using BP specifications and analytical
methods for all tests except Flavor Banana &
Flavor Vanilla for which analytical procedures
are attached.
repeatability (method precision) performed by the accuracy and repeatability (method precision) for
Drug Product manufacturer for drug product shall drug product.
be submitted.
10. Provide raw data sheets wherein details of sample The firm has submitted raw data sheets for the
solution preparation and standard solution and assay test.
calculation formula for the assay test shall be
mentioned
11. Submitted DHL invoice is for M/s Scilife Pharma The firm has submitted that M/s Scilife Pharma
(Pvt.) Ltd. Clarification is required. (pvt.) Ltd was written mistakenly by DHL. The
materials were directly delivered to our plant.
12. Supportive documents like chromatograms / The testing of Hitran Pediatric Suspension has
spectra are not submitted. Clarification is required. been performed on UV-Spectrophotometer.

However, relevant UV scans have not been
submitted.
(BMR) for all the batches of drug product for which batches.
stability studies data is provided in Module 3
section 3.2.P.8.3.
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability
time and accelerated). chambers (real time and accelerated.

• Preservative effectiveness studies performed as per recommendations of pharmacopoeia.
• Evidence of availability potentiometer including purchase invoice and IQ, OQ, PQ of the equipment
3.2.P.5.3 of Form-5F.
• Relevant UV spectra for assay testing as recommended by the BP monograph of applied formulation
• Evidence of procurement of drug substance with approval from DRAP.
☐ Importer
☐ Export sale
GMP status of the Finished product New license granted on 26-09-2019
The proposed proprietary name / brand name Hitran DS Suspension
Strength / concentration of drug of Active Each 5 mL suspension contains:
Pharmaceutical ingredient (API) per unit Trimethprim ........................80 mg

Sulfamethoxazole ...............400 mg
Pharmaceutical form of applied drug Clear sweet strawberry flavored homogeneous oral suspension
filled in amber glass bottle sealed with aluminium cap and
packed in printed unit cartons along with a patient information
leaflet.
The status in reference regulatory authorities Sulfatrim Suspension by M/s Pharm Assoc, (USFDA Approved).
For generic drugs (me-too status) Septran DS Suspension by M/s GSK Pharma (Reg # 008752)
Name and address of API manufacturer. M/s Shouguang Fukang Pharmaceutical company Ltd.
North-East of Dongwaihuan Road, Dongcheng Industrial Area,
Shouguang City, Shandong Province, People’s Republic of
China
Module III (Drug Substance) Official monograph of Trimethoprim and Sulfamethoxazole is
present in BP.
Trimethoprim:
The firm as submitted detail of nomenclature, structure, general
Identification, Assay and tests for related substances, impurity K,
heavy metals, specifications, analytical procedures and its
reference standard, container closure system and stability studies
of drug substance
Sulfamethoxazole:
Identification, Assay and tests for related substances (impurities
A, C, D, E) & impurity B, impurity F, unspecified impurities and
total impurities, specifications, analytical procedures and its
of drug substance
Batches of Trimethoprim:
(201103504,201103505, 201103506)
Batches of Sulfamethoxazole:

Accelerated: (200604001,200604002, 200604003
Real Time: (2007706001, 2007706002, 2007706003)
manufacture, manufacturing process and process control, process
validation protocols and report, control of excipients, control of
drug product, specifications, analytical procedures, validation of
specifications, reference standard or materials, container closure
system and stability.
dissolution profile brand leader that is Septran DS Suspension by GSK Pharma by
performing quality tests (Identification, Assay, pH, Uniformity
of dosage unit).
Analytical method validation/verification of Analytical method verification reports have not been submitted
product including linearity, accuracy, precision, specificity.
Manufacturer of API M/s Shouguang Fukang Pharmaceutical company Ltd.,
North-East of Dongwaihuan Road, Dongcheng Industrial Area, Shouguang City,
Shandong Province, People’s Republic of China
API Lot No. Trimethoprim: A-50112007004-0500
Sulfamethoxazole: A-50212005029
Description of Pack Hitran DS Suspension is filled in amber glass bottle sealed with pilfer proof aluminium
(Container closure system) cap and packed in a in box board unit carton.
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate (Certificate #
API manufacturer issued by concerned 20190888) for M/s Shouguang Fukang Pharmaceutical Co. Ltd.
regulatory authority of country of origin.issued by China Food and Drug Administration valid till 12-03-
2024.
approval from DRAP (in case of import). AD-CD (I&E) dated 26-12-2019 wherein the permission to
import different APIs Trimethoprim & Sulfamethoxazole for the
purpose of test/analysis and stability studies is granted. Invoice
for the purchase of materials is not submitted.

4. Data of stability batches will be supported by The firm has submitted data of stability batches alongwith raw
attested respective documents like data sheets, COA, summary data sheets. Relevant UV scans were
chromatograms, Raw data sheets, COA, not provided.
5. Compliance Record of HPLC software The testing of applied product is performed on UV
21CFR & audit trail reports on product testing spectrophotometer and audit trail reports not submitted.
6. Record of Digital data logger for temperature The firm has submitted record of data logger for temperature and
and humidity monitoring of stability humidity monitoring of stability chambers (real time and
chambers (real time and accelerated) accelerated).
The firm has claimed BP specifications while the product is also present in available USP.
Evidence of approval of applied formulation in reference regulatory authority could not be confirmed.
No.
1. Copies of the Drug substance specifications The firm has submitted copies of the Drug substance
and analytical procedures used for routine specifications and analytical procedures used for
testing of the Drug substance / Active routine testing of the Drug substance by both Drug
Pharmaceutical Ingredient by both Drug substance & Drug Product manufacturer.
substance & Drug Product.
2. Submit evidence of equipments required for The firm has not provided evidence of availability of
potentiometric titration and electrometric potentiometer.
titration required for analysis of trimethoprim
and sulfamethoxazole, respectively.
repeatability (method precision) performed product manufacturer. However, the specificity
by the Drug Product manufacturer for both results were not presented. The relevant
compendial as well as non-compendial drug chromatograms of tested parameters were not
4. Provide results of analysis of relevant The firm has provided results of analysis of relevant
batch(es) of Drug Substance performed by batch(es) of Drug Substance performed by Drug
Drug Product manufacturer used during Product manufacturer used during stability studies,
product development and stability studies, along with certificate of analysis (CoA) of the same
along with Certificate of Analysis (CoA) of batch.
the same batch from Drug Substance
manufacturer.
comparator product in pharmaceutical Hitran DS Septran DS Suspension
equivalence are required to be provided. suspension = T-88 = HR8P
6. Discussion of microbiological attributes of The firm has not submitted preservative effectiveness
the Drug Product (e.g. preservative studies as recommended by Pharmacopoeia.
effectiveness studies to be performed as per
recommendations of pharmacopoeia) shall be
provided.
using BP specifications and analytical methods for all
tests except Flavor Banana & Flavor Vanilla for
which analytical procedures are attached.
8. Justification of method of specificity test in The firm has not submitted results for specificity test.
analytical method verification studies shall be
9. Analytical method verification reports of The firm has not submitted analytical method
each parameter like specificity, accuracy and verification reports of parameters like specificity,
repeatability (method precision) performed

by the Drug Product manufacturer for drug accuracy and repeatability (method precision) for
product shall be submitted. drug product.
10. Provide raw data sheets wherein details of The firm has submitted raw data sheets for the assay
sample solution preparation and standard test.
solution and calculation formula for the assay
test shall be mentioned
11. Submitted DHL invoice is for M/s Scilife The firm has submitted that M/s Scilife Pharma (pvt.)
Pharma (Pvt.) Ltd. Clarification is required. Ltd was written mistakenly by DHL. The materials
were directly delivered to our plant.
12. Supportive documents like chromatograms / The testing of Hitran DS Suspension has been
spectra are not submitted. Clarification is performed on UV-Spectrophotometer. However,
required. relevant UV scans have not been submitted.
13. Submit copies of Batch Manufacturing The firm has submitted copies of BMRs for three
Record (BMR) for all the batches of drug batches.
product for which stability studies data is
provided in Module 3 section 3.2.P.8.3.
14. Record of Digital data logger for temperature The firm has submitted record of data logger for
and humidity monitoring of stability temperature and humidity monitoring of stability
chambers (real time and accelerated). chambers (real time and accelerated.

• Preservative effectiveness studies performed as per recommendations of pharmacopoeia.
• Evidence of availability potentiometer including purchase invoice and IQ, OQ, PQ of the equipment
3.2.P.5.3 of Form-5F.
• Relevant UV spectra for assay testing of applied formulation.
☐ Importer
☐ Export sale
manufacturer Sachet (General) section approved.
The proposed proprietary name / brand name Oestolos 2 g Sachet
Strength / concentration of drug of Active Each Sachet contains:
Pharmaceutical ingredient (API) per unit Strontium Ranelate……..... 2 g

Pharmaceutical form of applied drug Granules in sachet pack
Pharmacotherapeutic Group of (API) Anti-osteoporosis
The status in reference regulatory authorities Strontium ranelate Aristo 2 g granules for oral suspension by M/s
Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin
Germany, MHRA Approved.
For generic drugs (me-too status) ONITA SACHET by M/s PHARM-EVO (PVT) LTD,
(Reg. No. 057746)
Name and address of API manufacturer. M/s Suntril Pharmaceuticals Pvt. Ltd.,
Plot # 219, Phase-1, HSIIDC, Alipur Tehsil Barwala District
Panchkula (Haryana), India.
Module III (Drug Substance) The firm has submitted detail of nomenclature, structure, general
Identification, Assay and tests for related substances (unspecified
and total impurities), specifications, analytical procedures and its
of drug substance
Batches:
(STRHB 170001, STRHB 170002, STRHB 170003)
validation protocols and report, control of excipients, control of
dissolution profile brand leader that is Osstium sachet by Atco Pharma by
performing quality tests (Identification, Assay, pH, Uniformity
of dosage unit & loss on Drying).
Manufacturer of API M/s Suntril Pharmaceuticals Pvt. Ltd.,

Plot # 219, Phase-1, HSIIDC, Alipur Tehsil Barwala District Panchkula (Haryana), India.
API Lot No. STRHB200003
Description of Pack
Aluminium Foil, 1 × 7’s
Batch No. T-100 T-101 T-102
Batch Size 100 Sachet 100 Sachet 100 Sachet
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate No. 1/151-2
API manufacturer issued by concerned Drug-1-2019/7839 issued by Food and Drug Administration
regulatory authority of country of origin. Haryana Panchkula (India) valid till 22-10-2021.
3. Documents for the procurement of API with The firm has submitted copy of letter No. 17133/2019/DRAP-
approval from DRAP (in case of import). AD-CD(I&E) dated 26-12-2019 is submitted wherein the
permission to import different API Strontium Ranelate for the
4. Data of stability batches will be supported by The firm has submitted data of stability batches alongwith
attested respective documents like chromatograms, Raw data sheets, COA, summary data sheets etc.
chambers (real time and accelerated). time and accelerated).
No.

3. Provide results of analysis of relevant The firm has submitted analytical method verification
batch(es) of Drug Substance performed by parameter of drug substance performed by drug
Drug Product manufacturer used during product manufacturer. However, the specificity
product development and stability studies, results were not presented. The relevant
along with Certificate of Analysis (CoA) of chromatograms of tested parameters were not
the same batch from Drug Substance / /Active provided.
Pharmaceutical Ingredient manufacture.
4. The reference formulation states granules for The firm has submitted that granules are prepared in-
oral suspension for applied formulation. house by sieving the materials from appropriate mesh.
Clarification is required in manufacturing
process and process control whether granules
will be prepared in-house or otherwise.
5. Pharmaceutical equivalence of the applied The firm has submitted pharmaceutical equivalence
drug shall be established with the innovator with comparator product Osstium Sachet of M/s Atco
product and results of all the quality tests of Labs.
the developed formulation and the innovator
product shall be submitted and discussed.
comparator product in pharmaceutical Oestolos 2g Sachet Osstium Sachet =
equivalence are required to be provided. = T-100 UJ006FM1
using BP specifications
8. Analytical method verification reports of The firm has not submitted analytical method
each parameter like specificity, accuracy and verification reports of parameters like specificity,
repeatability (method precision) performed accuracy and repeatability (method precision) for
by the Drug Product manufacturer for drug drug product.
product shall be submitted.
test shall be mentioned
10. Submitted invoice for the procurement of The firm has not submitted invoice for the
drug substance is not attested by AD (I & E). procurement of drug substance.
11. Justification is required for submission of The firm has not submitted chromatograms for real
single chromatogram as test result of each time and accelerated stability studies at different time
batch at different time intervals. intervals. Instead, single chromatogram for each test
interval is submitted.
3.2.P.5.3 of Form-5F.
☐ Importer

☐ Export sale
manufacturer Tablet (General & General Antibiotic) section approved.
Dy. No. and date of submission Dy. No. 24085 Dated: 01-09-2021
Details of fee submitted PKR 30,000/-: Dated 21/06/2021
The proposed proprietary name / brand name Trox 10 mg Tablet
Strength / concentration of drug of Active Each film coated tablet contains:
Pharmaceutical ingredient (API) per unit Cetirizine Dihydrochloride……………….. 10 mg
Pharmaceutical form of applied drug White to off white round shaped without any score film coated tablet
Pharmacotherapeutic Group of (API) Anti-histamine

The status in reference regulatory authorities Zirtek Allergy Relief 10 mg film-coated tablets by M/s UCB
Pharma, MHRA Approved.
For generic drugs (me-too status) Avec 10mg Tablet by M/s Platinum Pharma, (Reg # 025506)
Name and address of API manufacturer. M/s Supriya Life sciences Ltd., Mumbai, INDIA. A-5/2, Lote
Parshuram Industrial Area, M.I.D.C Taluka – Khed, District –
Ratnagiri, Maharashtra, India 415 722.
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure, general
container closure system and stability studies of drug substance.
Batches: (SLL/CTR/0309047, SLL/CTR/0309048,
SLL/CTR/0309047).
Module-III (Drug Product): The firm has submitted details of manufacturers, description of
analytical procedure (including dissolution testing at acidic and
buffer medium) and its verification studies, batch analysis and
justification of specification, reference standard, container

Pharmaceutical equivalence and comparative Pharmaceutical equivalence has been established against that is
dissolution profile Zyrtec 10 mg Tab by GSK Pharma by performing quality tests
(Identification, Assay, Dissolution, Uniformity of dosage form).
CDP has been performed against the same brand that is Zyrtec
10 mg Tab by GSK Pharma in acidic media (pH 1.2) &
phosphate buffer (pH 4.5 & 6.8). The values for f2 are in the
acceptable range.
Manufacturer of API M/s Supriya Life science Ltd., Mumbai, INDIA. A-5/2, Lote Parshuram Industrial Area,
M.I.D.C Taluka – Khed, District – Ratnagiri, Maharashtra, India 415 722.
API Lot No. CTZ/083/20-21
Description of Pack
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate No. NEW-
API manufacturer issued by concerned WHO-GMP/CERT/KD/67649/2018/11/25185 issued by Food
regulatory authority of country of origin. and Drug Administration India valid till 04-10-2021.
approval from DRAP (in case of import). AD-CD(I&E) dated 26/12/2019 wherein the permission to import
different APIs Cetirizine Dihydrochloride for the purpose of
test/analysis and stability studies is granted.
4. Data of stability batches will be supported by The firm has submitted data of stability batches alongwith
attested respective documents like chromatograms, Raw data sheets, COA, summary data sheets etc.
chambers (real time and accelerated). time and accelerated).
No.

3. Provide results of analysis of relevant The firm has submitted analytical method verification
batch(es) of Drug Substance performed by parameter of drug substance performed by drug
Drug Product manufacturer used during product manufacturer. However, the specificity
product development and stability studies, results were not presented. The relevant
along with certificate of Analysis (CoA) of chromatograms of tested parameters were not
the same batch from Drug Substance / /Active provided.
Pharmaceutical Ingredient manufacture.
4. Pharmaceutical equivalence of the applied The firm has submitted pharmaceutical equivalence
drug shall be established with the innovator with comparator product Osstium Sachet of M/s Atco
product and results of all the quality tests of Labs.
the developed formulation and the innovator
5. Details of batch numbers of applicant and Applicant batch Comparator batch no.
comparator product in pharmaceutical no.
equivalence are required to be provided. Trox 10mg Tab = Zyrtec 10mg Tab = 354 E
T-94
using BP specifications
repeatability (method precision) performed by accuracy and repeatability (method precision) for
the Drug Product manufacturer for drug drug product.
test shall be mentioned.
9. Submitted invoice for the procurement of Not submitted.
drug substance is not attested by AD (I & E).
10. UV spectra of dissolution data are required to Not submitted.
be provided.
11. Justification is required for submission of The submitted chromatograms do not differentiate
single chromatogram as test result for each between real time or accelerated stability studies time
batch at different time intervals. points of different batches.
• UV spectra of dissolution testing, as recommended by the BP monograph of applied formulation, at all
time points of stability study data.
3.2.P.5.3 of Form-5F.

Registration applications of local manufacturing of human drugs submitted on CTD format (New Section)
On the recommendations of panel of experts, the CLB in its 276th meeting held on 03rd September, 2020 has
considered and approved the grant of Drug Manufacturing License in the name of M/s Alpenglow pharmaceuticals
(Pvt) Ltd, Plot No. A7, Risalpur Export processing Zone, Risalpur.
i. Capsule (Cephalosporin)
ii. Dry Powder injection section (Cephalosporin) (1 molecule / 6 products)
iii. Dry powder suspension section (Cephalosporin)
iv. Tablet (Psychotropic)
52. Name, address of Applicant / Marketing M/s Alpenglow Pharmaceuticals Plot # A/7, Export
Authorization Holder Processing Zone Risalpur, District Nowshera (KP) Pakistan.
Name, address of Manufacturing site. M/s Alpenglow Pharmaceuticals Plot # A/7, Export
Processing Zone Risalpur, District Nowshera (KP) Pakistan.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 5231 Dated 24-02-2022
The proposed proprietary name / brand name CIAXON 250mg IV Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as Sodium……………..250mg
Pharmaceutical form of applied drug Dry Powder Injection
Pharmacotherapeutic Group of (API) Anti-bacterials for systemic use, Third-generation
cephalosporins.
The status in reference regulatory authorities Rocephin 250mg IV Injection
USFDA Approved.
For generic drugs (me-too status) AVENTRIAX 250mg IV Injection
manufacturer
Name and address of API manufacturer. M/s Sinopharm Weiqida Pharmaceutical Co., Ltd. Address:
First Medical Zone, Economic & Technological
Development Zone, Datong, Shanxi, China.
studies of drug substance and drug product is submitted.

Module III (Drug Substance) Official monograph of ceftriaxone sodium is present in USP.
impurity D, G & related substances (impurity A &
unspecified), specifications, analytical procedures and its
studies of drug substance
Batches: (011302001, 011302002, 011302003).
specifications, analytical procedure (including dissolution
testing at acidic and buffer medium) and its verification
Pharmaceutical equivalence and comparative Pharmaceutical equivalence has been established against
dissolution profile comparator product Aventrix 250mg Injection by Sanofi
Aventis Pharma by performing quality tests (Identification,
Assay, Dissolution, Uniformity of dosage form).
product linearity, range, accuracy, precision, specificty.
Manufacturer of API M/s Sinopharm Weiqida Pharmaceutical Co., Ltd., First Medical Zone, Economic &
Technological Development Zone, Datong, Shanxi, China.
API Lot No. Q0121039028
Description of Pack Transparent PVC tray Sealed with printed A.foil filled with Dry Sterile Powder
(Container closure system) ceftriaxone in clear glass vial One Ampoule of water for injection and aluminum Foil
with embossed board unit carton UV coated. (1’s)
Batch No. 001 002 003
No. of Batches 03
DOCUMENTS/DATA ALONG WITH STABILITY STUDY DATA

manufacturer issued by concerned regulatory SX20180229 issued by CFDA valid till 05-06-2023.
approval from DRAP (in case of import). CPS/1330 CD(I&E) dated 16/04/2021 wherein the
permission to import different APIs like ceftriaxone sodium
for the purpose of test/analysis and stability studies is granted.
AHPAO505150 dated 04-05-2021.
attested respective documents like Submitted
data sheets etc.
11. Compliance Record of HPLC software 21CFR & The firm has submitted that our current HPLC system is not
audit trail reports on product testing 21 CFR compliant, we will try to upgrade our system as soon
as possible.
12. Record of Digital data logger for temperature and Submitted
Sr.# Observations communicated Response by the firm
1. Copies of the Drug substance specifications Copies of drug substance specifications and analytical
and analytical procedures used for routine procedures were provided by drug substance manufacturer.
testing of the Drug substance /Active However, copies of drug substance specifications and
Pharmaceutical Ingredient by both Drug analytical procedures were not provided by drug product
substance & Drug Product manufacturer is manufacturer.
required.
2. Analytical method verification studies The submitted analytical method verification studies were
including specificity, accuracy and performed by drug substance manufacturer. Method
repeatability (method precision) performed verification studies were not performed by drug product
by the Drug Product manufacturer for both manufacturer.
compendial as well as non-compendial drug
3. The tests for crystallinity and particulate Not submitted.
matter are not performed by drug product
manufacturer.
The assay limit specified by drug substance Assay limit as specified by drug substance manufacturer >
manufacturer (>84.0%) is different from 84% is according to CP 2010 as provided by Sinopharm.
that specified by drug product manufacturer While QC department of Alpenglow has followed USP 43
(NLT 79%). Justification is required. which specifies assay limit = NLT 79%.
4. Provide COA of reference standard which Instead of providing CoA from drug substance manufacturer,
is actually used in the analysis of drug the firm has provided CoA of working standard of FPP
substance. manufacturer.
5. Submit master formulation including The firm has provided theoretical fill weight of ceftriaxone
theoretical fill weight per vial. sodium per vial.
injections and dry powder for suspension
shall be performed as per the instructions
provided in individual label of the drug
product.
7. Justify your process validation protocols Not submitted.
without any process for optimization of
sterilization process and sealing of vials etc.
8. Specifications of the drug product does not Not submitted.
include tests as recommended by USP

including test for constituted solution,
crystallinity and complete assay test.
9. Provide detailed testing method for the The firm has provided testing method of ceftriaxone sodium
applied drug product instead of submitting raw material. The chromatographic conditions are different
copy of USP monograph. from USP.
Parameters Submitted USP monograph
monograph
Column 4mm × 15cm 4.6-mm × 25-cm; 5-μm
packing L1 packing
Flow rate 2.0 ml/min 1.5 ml/min
Detector 270nm UV 254 nm
Mobile Tetraheptyl Tetradecyl ammonium
phase ammonium bromide and tetraheptyl
bromide in ammonium bromide in a
400ml of mixture of 440 mL of water,
acetonitrile 55 mL of Buffer, 5.0 mL of
Solution C, and 500 mL of
acetonitrile.
10. Provide standard and sample preparation Not submitted.
method used in analytical method
11. Specify the details of the accuracy and Not submitted
specificity test including the details of
concentration of 80%, 100% and 120%
solutions. Test method for Empazin 25mg
Tablet is provided in analytical method
12. Justification of method of specificity test in The firm has submitted analytical method verification studies
analytical method verification studies shall of drug product including specificity, accuracy and precision.
be submitted. Clarification is required.
Analytical method verification reports of
each parameter like specificity, accuracy
and repeatability (method precision)
performed by the Drug Product
manufacturer shall be submitted. Not submitted.
The peak area of standard solution
concentration in analytical method
verification studies is approximately
6472293 while the peak area of the standard
solution of same concentration in stability
studies is 436282 approximately. Clarify
the difference in peak areas.
13. Provide COA of reference standard actually The firm has submitted COA of working standard from drug
used in the analysis of drug product. product manufacturer.
14. • In-use studies for drug products which are Not submitted
to be reconstituted before use, along with
proposed in-use storage statement and in-
use shelf-life shall be provided.
• The tests for water contents, constituted
solution etc are not performed during Not provided
stability studies since these tests are
required to make assessment of the stability
profile.
• Submit compliance Record of HPLC The firm has submitted that our current HPLC system is not
software 21CFR & audit trail reports on 21 CFR compliant, we will try to upgrade our system as soon
product testing. Reference of previous as possible.

approval of applications with stability study
data of the firm (if any).
15. • Pharmaceutical equivalence of the The firm has submitted pharmaceutical equivalence data
developed formulation and the innovator / against Rocephin 250mg IV injection (batch # 4121z015) by
reference / comparator product including performing quality tests.
the results of all the quality tests shall be
submitted.
Decision: Deferred for following:
• Performance of tests of crystallinity and particulate matter by drug product manufacturer.
• Justify the difference in assay limit specified by drug substance manufacturer (>84.0%) and drug
product manufacturer (NLT 79%).
• Justify the chromatographic conditions in the submitted analytical procedures which are different from
USP monograph.
• Submit master formulation including details of potency adjustment as per assay results on certificate of
analysis.
• Justification of submission of pharmaceutical equivalence data with Rocephin 250mg IV Injection since
the formulation in the same strength is not available.
• Performance of compatibility studies for the dry powder for injections as per the instructions provided
in individual label of the drug product.
• Provide standard and sample preparation method used in analytical method verification studies.
• Specify the details of the accuracy and specificity test including the details of concentration of 80%, 100%
and 120% solutions.
• Analytical method verification protocol and reports for testing of drug product as per requirements of
section 3.2.P.5.3 of Form-5F.
• Clarify the difference in peak area for standard solution concentration in analytical method verification
studies which is approximately 6472293 while the peak area of the standard solution of same
concentration in stability studies is 436282 approximately.
• Provide COA of reference standard actually used in the analysis of drug product.
• Provide in-use studies for drug products which are to be reconstituted before use, along with proposed
in-use storage statement and in-use shelf-life.
• Performance of tests for water contents, constituted solution etc during stability studies since these tests
are required to make assessment of the stability profile.
• Evidence of procurement of API with approval from DRAP.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.5233 Dated 24-02-2022
The proposed proprietary name / brand name CIAXON 250mg IM Injection

Pharmaceutical ingredient (API) per unit Ceftriaxone as Sodium……………250mg
Pharmaceutical form of applied drug Intramuscular Injection
cephalosporins.
The status in reference regulatory authorities Rocephin 250mg IM Injection USFDA Approved.
For generic drugs (me-too status) AVENTRIAX 250mg IM inj
Module III (Drug Substance) Official monograph of Ceftrioxone Sodium is present in USP.
The firm as submitted detail of nomenclature, structure,
Batches: (011302001, 011302002, 011302003)
dissolution profile the brand leader that is Aventrix 250mg Injection by Sanofi

Manufacturer of API M/s Sinopharm Weiqida Pharmaceutical Co., Ltd., First Medical Zone, Economic &
API Lot No. Q0121039028
Description of Pack Transparent PVC tray Sealed with printed Alu foil filled with Dry Sterile Powder
Batch No. 004 005 006
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. SX20180229 issued by CFDA
manufacturer issued by concerned regulatory valid till 05/06/2023.
3. Documents for the procurement of API with Copy of letter No.0090/2021/DRAP-CPS/1330 CD(I&E)
approval from DRAP (in case of import). dated 16/04/2021 is submitted wherein the permission to
import different APIs ceftriaxone as sodium for the purpose
AHPAO505150 dated 04/05/2021
5. Compliance Record of HPLC software 21CFR The firm has submitted that our current HPLC system is not
& audit trail reports on product testing 21 CFR compliant, we will try to upgrade our system as soon
as possible.
and humidity monitoring of stability chambers
(real time and accelerated)
Sr. Observations communicated Response by the firm
No.
1. Copies of the Drug substance specifications and Copies of drug substance specifications and
analytical procedures used for routine testing of analytical procedures were provided by drug
the Drug substance /Active Pharmaceutical substance manufacturer.
Ingredient by both Drug substance & Drug
Product manufacturer is required.
2. Analytical method verification studies including The submitted analytical method verification
specificity, accuracy and repeatability (method studies were performed by drug substance
precision) performed by the Drug Product manufacturer. Method verification studies were
manufacturer for both compendial as well as not performed by drug product manufacturer.
non-compendial drug substance(s) shall be
submitted.

3. The tests for crystallinity and particulate matter Not submitted.
are not performed by drug product
manufacturer.
The assay limit specified by drug substance Assay limit as specified by drug substance
manufacturer (>84.0%) is different from that manufacturer > 84% is according to CP 2010 as
specified by drug product manufacturer (NLT provided by Sinopharm.
79%). Justification is required. While QC department of Alpenglow has
followed USP 43 which specifies assay limit =
NLT 79%.
4. Provide COA of reference standard which is Instead of providing CoA from drug substance
actually used in the analysis of drug substance. manufacturer, the firm has provided CoA of
working standard of FPP manufacturer.
5. Submit master formulation including theoretical The firm has provided theoretical fill weight of
fill weight per vial. ceftriaxone sodium per vial.
6. Compatibility studies for the dry powder for Not submitted
injections and dry powder for suspension shall
be performed as per the instructions provided in
7. Justify your process validation protocols Not submitted
8. Specifications of the drug product does not Not submitted
include tests as recommended by USP including
test for constituted solution, crystallinity and
complete assay test.
9. Provide detailed testing method for the applied The firm has provided testing method of
drug product instead of submitting copy of USP ceftriaxone sodium raw material. The
monograph. chromatographic conditions are different from
USP.
monograph
Column 4mm × 15cm 4.6-mm × 25-
packing L1 cm; 5-μm
packing
Mobile Tetraheptyl Tetradecyl
phase ammonium ammonium
bromide in bromide and
400ml of tetraheptyl
acetonitrile ammonium
bromide in a
mixture of 440
mL ofwater, 55
mL of Buffer,
5.0 mL of
Solution C, and
500 mL of
acetonitrile.
method used in analytical method verification
studies.
11. Specify the details of the accuracy and
concertation of 80%, 100% and 120% solutions.

Test method for Empazin 25mg Tablet is
provided in analytical method verification
studies.
12. Justification of method of specificity test in The firm has submitted analytical method
analytical method verification studies shall be verification studies of drug product including
submitted. Clarification is required. specificity, accuracy and precision.
Analytical method verification reports of each
parameter like specificity, accuracy and
the Drug Product manufacturer shall be
submitted.
The peak area of standard solution Not submitted.
concentration in analytical method verification
studies is approximately 6472293 while the
peak area of the standard solution of same
concentration in stability studies is 436282
approximately. Clarify the difference in peak
areas.
13. Provide COA of reference standard actually The firm has submitted COA of working
used in the analysis of drug product. standard from drug product manufacturer.
14. • In-use studies for drug products which are to be Not submitted
reconstituted before use, along with proposed
in-use storage statement and in-use shelf-life
shall be provided.
• Provide raw data sheets to justify the calculation Not submitted
of results for assay testing at each time point
during the stability testing of each batch.
• The tests for water contents, constituted solution
etc are not performed during stability studies Not provided
since these tests are required to make
assessment of the stability profile.
• Submit compliance Record of HPLC software
21CFR & audit trail reports on product testing. The firm has submitted that our current HPLC
Reference of previous approval of applications system is not 21 CFR compliant, we will try to
with stability study data of the firm (if any). upgrade our system as soon as possible.
15. • Pharmaceutical equivalence of the developed The firm has submitted pharmaceutical
formulation and the innovator / reference / equivalence data against Rocephin 250mg IM
comparator product including the results of all injection (batch # 4121z015) by performing
the quality tests shall be submitted. quality tests.
• Analytical method verification protocol and report of drug substance performed by drug product
manufacturer as per requirement of section 3.2.S.4.3 of Form-5F.
• Justify the chromatographic conditions in the submitted analytical which are different from USP
monograph.
analysis.
• Justification of submission of pharmaceutical equivalence data with Rocephin 250mg IV Injection since
the formulation in the same strength is not available.

and 120% solutions.
Authorization Holder Processing Zone Risalpur, District Nowshera (KP) Pakistan
Processing Zone Risalpur, District Nowshera (KP) Pakistan
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.5234 Dated 24-02-2022
The proposed proprietary name / brand name CIAXON 500mg IM Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as Sodium…………..500 mg
Pharmaceutical form of applied drug Dry Powder for Injection
cephalosporins.
The status in reference regulatory authorities Rocephin 500mg IM Injection
USFDA Approved.
For generic drugs (me-too status) AVENTRIAX 500mg IM injection
manufacturer

Batches: (011302001, 011302002, 011302003)
Module-III (Drug Product): The firm has submitted details of manufacturers, description
dissolution profile comparator product Aventrix 500mg IM Injection by Sanofi
Manufacturer of API M/S Sinopharm Weiqida Pharmaceutical Co. Ltd., First Medical Zone, Economic &
API Lot No. Q0121039028
Batch No. 010 011 012
No. of Batches 03

with stability study data of the firm (if any).
manufacturer issued by concerned regulatory SX20180229 issued by CFDA valid till 05/06/2023.
approval from DRAP (in case of import). CPS/1330 CD (I&E) dated 16-04-2021 wherein the
permission to import different APIs including ceftriaxone
sodium for the purpose of test/analysis and stability studies is
granted.
AHPAO505150 dated 04-05-2021.
5. Compliance record of HPLC software 21CFR & The firm has submitted that our current HPLC system is not
audit trail reports on product testing. 21 CFR compliant, we will try to upgrade our system as soon
as possible.
time and accelerated).
No.
1. Copies of the Drug substance specifications and Copies of drug substance specifications and analytical
analytical procedures used for routine testing of procedures were provided by drug substance
the Drug substance /Active Pharmaceutical manufacturer.
2. Analytical method verification studies including The submitted analytical method verification studies were
specificity, accuracy and repeatability (method performed by drug substance manufacturer. Method
precision) performed by the Drug Product verification studies were not performed by drug product
manufacturer for both compendial as well as manufacturer.
submitted.
are not performed by drug product manufacturer.
The assay limit specified by drug substance
manufacturer (>84.0%) is different from that Assay limit as specified by drug substance manufacturer
specified by drug product manufacturer (NLT > 84% is according to CP 2010 as provided by
79%). Justification is required. Sinopharm.
While QC department of Alpenglow has followed USP
43 which specifies assay limit = NLT 79%.
actually used in the analysis of drug substance. manufacturer, the firm has provided CoA of working
standard of FPP manufacturer.

7. Justify your process validation protocols without Not submitted
any process for optimization of sterilization
process and sealing of vials etc.
9. Provide detailed testing method for the applied The firm has provided testing method of ceftriaxone
drug product instead of submitting copy of USP sodium raw material. The chromatographic conditions are
monograph. different from USP.
monograph
Column 4mm × 15cm 4.6-mm × 25-cm; 5-μm
packing L1 packing
Mobile Tetraheptyl Tetradecyl ammonium
phase ammonium bromide and tetraheptyl
bromide in ammonium bromide in a
400ml of mixture of 440 mL
acetonitrile ofwater, 55 mL of
Buffer, 5.0 mL of
Solution C, and 500 mL
of acetonitrile.
10. Provide standard and sample preparation method Not submitted.
used in analytical method verification studies.
11. Specify the details of the accuracy and specificity
test including the details of concertation of 80%,
100% and 120% solutions. Test method for
Empazin 25mg Tablet is provided in analytical
method verification studies.
12. Justification of method of specificity test in The firm has submitted analytical method verification
analytical method verification studies shall be studies of drug product including specificity, accuracy
submitted. Clarification is required. and precision.
repeatability (method precision) performed by the
Drug Product manufacturer shall be submitted.
The peak area of standard solution concentration
in analytical method verification studies is Not submitted.
approximately 6472293 while the peak area of the
standard solution of same concentration in stability
studies is 436282 approximately. Clarify the
difference in peak areas.
13. Provide COA of reference standard actually used The firm has submitted COA of working standard from
in the analysis of drug product. drug product manufacturer.
14.• In-use studies for drug products which are to be Not submitted
reconstituted before use, along with proposed in-
use storage statement and in-use shelf-life shall be
provided. The tests for water contents, constituted
solution etc are not performed during stability
studies since these tests are required to make Not provided
assessment of the stability profile. Submit
compliance Record of HPLC software 21CFR &
audit trail reports on product testing. Reference of

previous approval of applications with stability The firm has submitted that our current HPLC system is
study data of the firm (if any). not 21 CFR compliant, we will try to upgrade our system
as soon as possible.
15.• Pharmaceutical equivalence of the developed The firm has submitted pharmaceutical equivalence data
formulation and the innovator / reference / against Rocephin 500mg IM injection (batch # 4121z015)
comparator product including the results of all the by performing quality tests.
quality tests shall be submitted.
• Analytical method verification protocol and report of drug substance performed by drug product
manufacturer as per requirement of section 3.2.S.4.3 of Form-5F.
monograph.
analysis.
and 120% solutions.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name CIAXON 500mg IV Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium………….500 mg

cephalosporins.
The status in reference regulatory authorities Rocephin 500mg IV Injection of M/s Roche (MHRA
Approved).
For generic drugs (me-too status) AVENTRIAX 500mg IV Injection of M/s Sanofi Aventis
manufacturer
Batches: (011302001, 011302002, 011302003)
Pharmaceutical equivalence and comparative Pharmaceutical equivalence has been established with
dissolution profile comparator product Aventrix 500mg Injection by Sanofi
assay, dissolution, uniformity of dosage form).

Manufacturer of API M/S Sinopharm Weiqida Pharmaceutical Co. Ltd., First Medical Zone, Economic &
API Lot No. Q0121039028
Batch No. 007 008 009
No. of Batches 03
manufacturer issued by concerned regulatory SX20180229 issued by CFDA valid till 05-06-2023.
approval from DRAP (in case of import). CPS/1330 CD(I&E) dated 16-04-2021 wherein the
permission to import different APIs ceftriaxone sodium for
the purpose of test/analysis and stability studies is granted.
AHPAO505150 dated 04-05-2021.
audit trail reports on product testing. 21 CFR compliant, we will try to upgrade our system as soon
as possible.
humidity monitoring of stability chambers (real Submitted
analytical procedures used for routine testing of analytical procedures were provided by drug
the Drug substance /Active Pharmaceutical substance manufacturer.
manufacturer for both compendial as well as not performed by drug product manufacturer.
submitted.

3. The tests for crystallinity and particulate matter
Not submitted.
are not performed by drug product Assay limit as specified by drug substance
manufacturer. manufacturer > 84% is according to CP 2010 as
The assay limit specified by drug substance provided by Sinopharm.
manufacturer (>84.0%) is different from that While QC department of Alpenglow has
specified by drug product manufacturer (NLT followed USP 43 which specifies assay limit =
79%). Justification is required. NLT 79%.
actually used in the analysis of drug substance. manufacturer, the firm has provided CoA of
9. Provide detailed testing method for the applied The firm has provided testing method of
drug product instead of submitting copy of USP ceftriaxone sodium raw material. The
monograph. chromatographic conditions are different from
USP.
monograph
Column 4mm × 15cm 4.6-mm × 25-
packing L1 cm; 5-μm
packing
Mobile Tetraheptyl Tetradecyl
phase ammonium ammonium
bromide in bromide and
400ml of tetraheptyl
acetonitrile ammonium
bromide in a
mixture of 440
mL ofwater, 55
mL of Buffer,
5.0 mL of
Solution C, and
500 mL of
acetonitrile.
studies.
11. Specify the details of the accuracy and Not submitted.
studies.

submitted. The peak area of standard solution
concentration in analytical method verification Not submitted.
areas.
13. Provide COA of reference standard actually The firm has submitted COA of working
used in the analysis of drug product. standard from drug product manufacturer.
shall be provided.
Reference of previous approval of applications system is not 21 CFR compliant, we will try to
with stability study data of the firm (if any). upgrade our system as soon as possible.
15. • Pharmaceutical equivalence of the developed The firm has submitted pharmaceutical
formulation and the innovator / reference / equivalence data against Rocephin 500mg IV
comparator product including the results of all injection (batch # 6121z31) by performing
the quality tests shall be submitted. quality tests.
monograph.
analysis.
and 120% solutions.

• Performance of tests for water contents, constituted solution etc. during stability studies since these tests
☐ Importer
☐ Export sale
The proposed proprietary name / brand name CIAXON 1 gm IM Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium ……………. 1 gm
cephalosporins
The status in reference regulatory authorities Rocephin 1gm IM Injection of M/s Hoffman LA Roche
(USFDA Approved).
For generic drugs (me-too status) AVENTRIAX 1 gm IM injection
manufacturer

Batches: (011302001, 011302002, 011302003)
dissolution profile the brand leader that is Aventrix 1g Injection by Sanofi
assay, dissolution, uniformity of dosage form).
Manufacturer of API M/s Sinopharm Weiqida Pharmaceutical Co., Ltd.
API Lot No. Q0121039028
Batch No. 016 017 018
No. of Batches 03
AHPAO505150 dated 04/05/2021

as possible.
1. Copies of the Drug substance specifications and Copies of drug substance specifications and analytical
analytical procedures used for routine testing of procedures were provided by drug substance
the Drug substance /Active Pharmaceutical manufacturer.
2. Analytical method verification studies including The submitted analytical method verification studies
specificity, accuracy and repeatability (method were performed by drug substance manufacturer.
precision) performed by the Drug Product Method verification studies were not performed by
manufacturer for both compendial as well as drug product manufacturer.
submitted.
are not performed by drug product Assay limit as specified by drug substance
manufacturer. The assay limit specified by drug manufacturer > 84% is according to CP 2010 as
substance manufacturer (>84.0%) is different provided by Sinopharm.
from that specified by drug product While QC department of Alpenglow has followed USP
manufacturer (NLT 79%). Justification is 43 which specifies assay limit = NLT 79%.
required.
actually used in the analysis of drug substance. manufacturer, the firm has provided CoA of working
standard of FPP manufacturer.
9. Provide detailed testing method for the applied The firm has provided detailed testing method for the
drug product instead of submitting copy of USP applied drug product.
monograph.
studies.
11. Specify the details of the accuracy and Not submitted

studies.
12. Justification of method of specificity test in The firm has submitted analytical method verification
analytical method verification studies shall be studies of drug product including specificity, accuracy
submitted. Clarification is required. and precision.
submitted.
The peak area of standard solution Not submitted.
concentration in analytical method verification
areas.
13. Provide COA of reference standard actually The firm has submitted COA of working standard from
used in the analysis of drug product. drug product manufacturer.
shall be provided.
21CFR & audit trail reports on product testing. The firm has submitted that our current HPLC system
Reference of previous approval of applications is not 21 CFR compliant, we will try to upgrade our
with stability study data of the firm (if any). system as soon as possible.
15. • Pharmaceutical equivalence of the developed The firm has submitted pharmaceutical equivalence
formulation and the innovator / reference / data against Rocephin 1g IM injection (batch #
comparator product including the results of all 6121z015) by performing quality tests.
the quality tests shall be submitted.
monograph.
analysis.
and 120% solutions.

☐ Importer
☐ Export sale
The proposed proprietary name / brand name CIAXON 1 gm IV Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as Sodium………….1 gm
Pharmacotherapeutic Group of (API) Antibacterials for systemic use, Third-generation
cephalosporins.
The status in reference regulatory authorities Rocephin 1gm IV Injection of M/s Hoffman LA Roche
(USFDA Approved).
For generic drugs (me-too status) AVENTRIAX 1 gm IV Injection
manufacturer
Name and address of API manufacturer. Sinopharm Weiqida Pharmaceutical Co., Ltd. Address: First
Medical Zone, Economic & Technological Development
Zone, Datong, Shanxi, China Tel: 0352-7698888 Fax: 0352-
7695555 Post Code: 037300 E-mail: [email protected]

Module III (Drug Substance) Official monograph of Ceftrioxone Sodium is present in USP.
Batches: (011302001, 011302002, 011302003)
dissolution profile the brand leader that is Aventrix 250mg Injection by Sanofi
Manufacturer of API M/S Sinopharm Weiqida Pharmaceutical Co., Ltd.
API Lot No. Q0121039028
Batch No. 013 014 015
No. of Batches 03

AHPAO505150 dated 04/05/2021
as possible.
analytical procedures used for routine testing of the analytical procedures were provided by drug
Drug substance /Active Pharmaceutical Ingredient substance manufacturer.
by both Drug substance & Drug Product
manufacturer is required.
manufacturer for both compendial as well as non- not performed by drug product manufacturer.
3. The tests for crystallinity and particulate matter are Not submitted.
not performed by drug product manufacturer. Assay limit as specified by drug substance
The assay limit specified by drug substance manufacturer > 84% is according to CP 2010 as
manufacturer (>84.0%) is different from that provided by Sinopharm.
specified by drug product manufacturer (NLT 79%). While QC department of Alpenglow has followed
Justification is required. USP 43 which specifies assay limit = NLT 79%.
4. Provide COA of reference standard which is actually Instead of providing CoA from drug substance
used in the analysis of drug substance. manufacturer, the firm has provided CoA of
5. Submit master formulation including theoretical fill The firm has provided theoretical fill weight of
weight per vial. ceftriaxone sodium per vial.
7. Justify your process validation protocols without Not submitted
any process for optimization of sterilization process
and sealing of vials etc.
8. Specifications of the drug product does not include Not submitted
tests as recommended by USP including test for
constituted solution, crystallinity and complete
assay test.
9. Provide detailed testing method for the applied drug The firm has provided detailed testing method for
product instead of submitting copy of USP the applied drug product.
monograph.
10. Provide standard and sample preparation method Not submitted.
used in analytical method verification studies.

11. Specify the details of the accuracy and specificity Not submitted
test including the details of concertation of 80%,
100% and 120% solutions. Test method for Empazin
25mg Tablet is provided in analytical method
Drug Product manufacturer shall be submitted.
The peak area of standard solution concentration in
analytical method verification studies is Not submitted.
approximately 6472293 while the peak area of the
standard solution of same concentration in stability
studies is 436282 approximately. Clarify the
difference in peak areas.
13. Provide COA of reference standard actually used in The firm has submitted COA of working standard
the analysis of drug product. from drug product manufacturer.
reconstituted before use, along with proposed in-use
storage statement and in-use shelf-life shall be
provided.
• The tests for water contents, constituted solution etc
are not performed during stability studies since these Not provided
tests are required to make assessment of the stability
profile.
Reference of previous approval of applications with system is not 21 CFR compliant, we will try to
stability study data of the firm (if any). upgrade our system as soon as possible.
• Pharmaceutical equivalence of the developed The firm has submitted pharmaceutical
formulation and the innovator / reference / equivalence data against Rocephin 1g IV injection
comparator product including the results of all the (batch # 6121z015) by performing quality tests.
quality tests shall be submitted.
monograph.
analysis.
and 120% solutions.

Case no. 05: Registration applications of locally manufacturing drugs (human) submitted on CTD format
a. New cases
58. Name, address of Applicant / Marketing M/s Sami Pharmaceuticals (Pvt.) Ltd., F-95, off hub River Road,
Authorization Holder S.I.T.E, Karachi.
Name, address of Manufacturing site. M/s Sami Pharmaceuticals (Pvt.) Ltd., F-95, off hub River Road,
S.I.T.E, Karachi.
☐ Importer
☐ Export sale
GMP status of the firm The firm is granted GMP certificate based on inspection
The proposed proprietary name / brand name BALOXA 20MG TABLET
Pharmaceutical ingredient (API) per unit Baloxavir Marboxil…………..20mg
Pharmaceutical form of applied drug White to off-white colored, oval shaped film coated tablets, plain
on one side and break line on other side.
Pharmacotherapeutic Group of (API) Antiviral (WHO ATC code: J05AX25)
Reference to Finished product specifications Innovator’s Specifications
The status in reference regulatory authorities XOFLUZA ™ (Baloxavir marboxil) Tablets 20mg of M/s
Genetech USA, Inc (USFDA approved)
For generic drugs (me-too status) Not applicable
Name and address of API manufacturer. M/s Fujian Jinshan Zhundian Pharmaceutical Co. Ltd,
Address: Jintang Industry Zone, Shaowu City, Fujian Province,
China.
characterization, impurities, specifications, analytical procedures
and its validation, batch analysis and justification of

stability studies of drug substance and drug product is submitted.
general properties, solubility, physical form, manufacturers,
impurity A, B, individual impurity and total impurity,
analysis and justification of specification, working standard,
Batches: (180801, 180802, 180803)
validation protocols, control of excipients, control of drug
Pharmaceutical equivalence and comparative Pharmaceutical equivalence and CDP studies could not be
dissolution profile performed due to the unavailability of innovator products,
justification regarding the comparative studies and innovator
pack procurement have been submitted.
Analytical method validation/verification of Method validation studies have been submitted including
product precision, accuracy and specificity studies.
Manufacturer of API M/s Fujian Jinshan Zhundian Pharmaceutical Co. Ltd.,
Address: Jintang Industry Zone, Shaowu City, Fujian Province, China
API Lot No. 200101
Description of Pack
BALOXA 20MG TABLET
Batch No. Lab-01 Lab-02 Lab-03
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted reference of last onsite panel inspection
with stability study data of the firm (if any) for instant dosage form conducted during last two years i.e.
EMPOLI (Empagliflozin) 10mg & 25mg Tablets which was

presented in 290th meeting of the registration board & hence
approved & registered by registration board Date of inspection:
13th June 2019. The inspection report confirms following points
The HPLC software is 21CFR Compliant.
• Audit trail on the testing reports is available.
• Adequate monitoring and control are available for stability
chamber. Chambers are controlled and monitored through
software having alarm system for alerts as well.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. FJ20160009 issued by Food and
API manufacturer issued by concerned Drug Administration of china valid till 22/02/2021.
regulatory authority of country of origin. As per Chinese Government website no more GMP certificates
are being issued after December 2019.
3. Documents for the procurement of API with The firm has submitted copy of commercial invoice (Invoice#
approval from DRAP (in case of import). WIS200028 MAR 18, 2020 with received quantity i.e. 300 g) for
the purchase of Baloxavir Marboxil by M/s Fujian Jinsahn
Zhundian Pharmaceutical Co., Ltd attested by DRAP dated 25-
03-2020.
4. Data of stability batches will be supported by Firm has submitted complete record of testing of all batches along
with chromatograms, raw data sheets, COA and summary data
5. Compliance Record of HPLC software 21CFR The Firm has submitted audit trail record of product testing of
& audit trail reports on product testing. HPLC for all test intervals.
and humidity monitoring of stability chambers humidity monitoring of stability chambers (real time and
(real time and accelerated). accelerated).
1. Submit differential fee for the registration of Differential fee deposit slip # 772863043 of Rs. 25000/-
applied product since the applied product since has been submitted.
the application was received in R&I section of
DRAP after 7th May 2021.
2. The reference product literature showed that the The structure and absolute stereochemistry of Baloxavir
structure and absolute stereochemistry of Marboxil is verified by single crystal x-ray determination
Baloxavir marboxil is verified by single is mentioned on COA as polymorphic form, i.e: form I.
crystal x-ray determination. The submitted Revised COA and XPRD Spectra is attached for your
COA from drug substance manufacturer does reference.
not contain this test.
3. Give a detailed account on polymorphic form of Description of polymorphic form of material is defined
drug substance used in drug product in DMF (3.2.S.3.1.9 summary) as material is
development since several polymorphic forms polymorphic form I.
of drug substance are possible as per reference
literature.
4. Elaborate the test of "Microbial limit Test" Microbial examination of non-sterile products is
mentioned in certificate of analysis of Baloxavir performed as per following USP method given in the
Marboxil. texts on Microbial Enumeration Test <61>, Tests for
Specified Microorganisms <62> and Microbiological
examination of non-sterile products (acceptance criteria
for pharmaceutical preparations and substances for
pharmaceutical use) <1111>.
As per pharmacopeia the acceptance criteria for non-
sterile pharmaceutical products based on the total aerobic
microbial count (TAMC), total yeast and molds count

(TYMC) and objectionable microorganisms which must
be absent and these are called as Microbial Limit Tests.
We followed the same practice and set restricted
microbiological limits as per SAMI’s Specs, that is
TAMC: NMT 100 cfu/g, TYMC: NMT 10 cfu/g as well
as absence of pathogenic organisms including E. Coli,
Salmonella, S. Aureus in our raw material.
5. The submitted acceptance criteria for release We develop the product specifications according to the
and shelf life specifications are same. Scientific general monograph of USP and from the chemistry
justification is required for adopting such reviews of USFDA, EMA. In addition, ICH Q6A states
acceptance criteria. that the acceptance criteria are the same from release
throughout shelf life of product. Therefore, we have also
set the same specification limits for release and shelf life.
6. The submitted process validation protocol does Existing protocol captures the required information and
not describe the critical process steps and describes critical process parameters along with process
controls in defined ranges. controls. However, to make this more elaborative, we
have revised these sections and version 2 of protocol is
attached.
7. Since the strategy for product development is The innovator of Baloxavir Marboxil Tablet i.e.
planned according to identified QTPP which is XOFLUZA 40mg & 20mg Tablets, already published a
based on evaluation of the innovator/reference detailed characterization of API (Baloxavir Marboxil) in
product therefore, justify the authenticity of FDA chemistry review as well product assessment report
product development studies for applied of European Medicine Agency (EMA). This part of
formulation without comparison with QTPP was derived from FDA chemistry review & EMA
innovator/reference product. assessment report.
Appearance of API, its solubility, pKa, partition
coefficient, stereoisomerism and polymorphic form etc.
were mentioned in detail by the innovator, therefore, all
these required details are gathered from literature data.
As the reference finished product is presented as
immediate-release film-coated tablets for oral
administration containing 20mg or 40mg of Baloxavir
Marboxil as the active substance, therefore, we have
designed our product same as reference product to ensure
pharmaceutical equivalency.
Product dissolution parameters and other related
specification are already disclosed by the manufacturer
of the reference product. Due to poor solubility of API,
to ensure reproducible dissolution results, we have
selected micronized grade of API for development of our
product as suggested by the reference brand in FDA
chemistry review.
Due to unavailability of innovator samples, the
dissolution profile in different pH mediums i.e., pH 1.2,
4.5 and 6.8 buffers as recommended in WHO for CDP is
checked and the release profile found similar to that of
innovator product “Xofluza Tablet” in FDA chemistry
review publically available.
Information related to product packaging, storage and
labeling were also gathered from the above mentioned
product assessment reports i.e. FDA chemistry review as
well product assessment report of European Medicine
Agency.
Decision: Registration Board decided to defer the case for submission of pharmaceutical equivalence and CDP
studies with innovator / reference product.

59. Name, address of Applicant / Marketing M/s Sami Pharmaceuticals (Pvt.) Ltd., F-95, off hub River Road,
Authorization Holder S.I.T.E, Karachi.
Name, address of Manufacturing site. M/s Sami Pharmaceuticals (Pvt.) Ltd., F-95, off hub River Road,
S.I.T.E, Karachi.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. dated 27-07-2021
The proposed proprietary name / brand name BALOXA 40MG TABLET
Pharmaceutical ingredient (API) per unit Baloxavir Marboxil…………..40mg
Pharmaceutical form of applied drug White to off-white colored, oval shaped film coated tablets, plain
on one side and break line on other side.
Pharmacotherapeutic Group of (API) Antiviral (WHO ATC code: J05AX25)
The status in reference regulatory authorities XOFLUZA ™ (baloxavir marboxil) Tablets 40mg of M/s
Genetech USA, Inc (USFDA approved)
Name and address of API manufacturer. M/s Fujian Jinshan Zhundian Pharmaceutical Co. Ltd, Address:
Jintang Industry Zone, Shaowu City, Fujian Province, China
Module III (Drug Substance) The firm as submitted details of nomenclature, structure, general
properties, solubility, physical form, manufacturers, description
of manufacturing process and controls, tests for impurity D, G &
related substances (impurity A & unspecified), specifications,
analytical procedures and its verification, batch analysis and
justification of specification, working standard, container closure
system and stability studies of drug substance.

Batches:( 180801, 180802, 180803)
Pharmaceutical equivalence and comparative Pharmaceutical equivalence and CDP studies could not be
dissolution profile performed due to the unavailability of innovator products,
justification regarding the comparative studies and innovator
pack procurement have been submitted.
product Linearity, accuracy, precision, robustness and specificity studies.
Manufacturer of API M/s Fujian Jinshan Zhundian Pharmaceutical Co. Ltd,
Address: Jintang Industry Zone, Shaowu City, Fujian Province, China
API Lot No. 200101
Description of Pack
Alu-Alu blister packed in unit carton (10’s)
BALOXA 40MG TABLET
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted reference of last onsite panel inspection
with stability study data of the firm (if any) for instant dosage form conducted during last two years i.e.
EMPOLI (Empagliflozin) 10mg & 25mg Tablets which was
approved & registered by registration board Date of inspection:
13th June 2019. The inspection report confirms following points
The HPLC software is 21CFR Compliant.
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate No. FJ20160009
API manufacturer issued by concerned issued by Food and Drug Administration of china valid till 22-
regulatory authority of country of origin. 02-2021.
As per Chinese Government website no more GMP certificates
are being issued after December 2019.

3. Documents for the procurement of API with The firm has submitted copy of commercial invoice (Invoice#
approval from DRAP (in case of import). WIS200028 MAR 18, 2020 with received quantity i.e. 300 g) for
the purchase of Baloxavir Marboxil by M/s Fujian Jinsahn
Zhundian Pharmaceutical Co., Ltd attested by Assistant Director
(I & E) DRAP, dated 25-03-2020.
attested respective documents like with chromatograms, raw data sheets, COA and summary data
5. Compliance Record of HPLC software 21CFR The Firm has submitted audit trail record of product testing of
& audit trail reports on product testing. HPLC for all test intervals.
1. Submit differential fee for the registration of Differential fee deposit slip # 5700633630 of Rs.
applied product since the applied product since 25,000/- has been submitted.
the application was received in R&I section of
DRAP after 7th May 2021.
2. The reference product literature showed that the The structure and absolute stereochemistry of
structure and absolute stereochemistry of Baloxavir Marboxil is verified by single crystal x-ray
Baloxavir marboxil is verified by single determination is mentioned on COA as polymorphic
crystal x-ray determination. The submitted form, i.e: form I. Revised COA and XPRD Spectra is
COA from drug substance manufacturer does attached for your reference.
not contain this test.
3. Give a detailed account on polymorphic form of Description of polymorphic form of material is defined
drug substance used in drug product in DMF (3.2.S.3.1.9 summary) as material is
development since several polymorphic forms polymorphic form I.
of drug substance are possible as per reference
literature.
4. Elaborate the test of "Microbial limit Test" Microbial examination of non-sterile products is
mentioned in certificate of analysis of Baloxavir performed as per following USP method given in the
Marboxil. texts on Microbial Enumeration Test <61>, Tests for
Specified Microorganisms <62> and Microbiological
examination of non-sterile products (acceptance
criteria for pharmaceutical preparations and
substances for pharmaceutical use) <1111>.
As per pharmacopeia the acceptance criteria for non-
sterile pharmaceutical products based on the total
aerobic microbial count (TAMC), total yeast and molds
count (TYMC) and objectionable microorganisms
which must be absent and these are called as Microbial
Limit Tests.
We followed the same practice and set restricted
microbiological limits as per SAMI’s Specs, that is
TAMC: NMT 100 cfu/g, TYMC: NMT 10 cfu/g as well
as absence of pathogenic organisms including E. Coli,
Salmonella, S. Aureus in our raw material.
5. The submitted acceptance criteria for release We develop the product specifications according to the
and shelf life specifications are same. Scientific general monograph of USP and from the chemistry
justification is required for adopting such reviews of USFDA, EMA. In addition, ICH Q6A states
acceptance criteria. that the acceptance criteria are the same from release
throughout shelf life of product. Therefore, we have

also set the same specification limits for release and
shelf life.
6. The submitted process validation protocol does Existing protocol captures the required information and
not describe the critical process steps and describes critical process parameters along with
controls in defined ranges. process controls. However, to make this more
elaborative, we have revised these sections and version
2 of protocol is attached.
7. Since the strategy for product development is The innovator of Baloxavir Marboxil Tablet i.e.
planned according to identified QTPP which is XOFLUZA 40mg & 20mg Tablets, already published
based on evaluation of the innovator/reference a detailed characterization of API (Baloxavir Marboxil)
product therefore, justify the authenticity of in FDA chemistry review as well product assessment
product development studies for applied report of European Medicine Agency (EMA). This part
formulation without comparison with of QTPP was derived from FDA chemistry review &
innovator/reference product. EMA assessment report.
Appearance of API, its solubility, pKa, partition
coefficient, stereoisomerism and polymorphic form etc.
were mentioned in detail by the innovator, therefore, all
these required details are gathered from literature data.
As the reference finished product is presented as
immediate-release film-coated tablets for oral
administration containing 20mg or 40mg of Baloxavir
Marboxil as the active substance, therefore, we have
designed our product same as reference product to
ensure pharmaceutical equivalency.
Product dissolution parameters and other related
specification are already disclosed by the manufacturer
of the reference product. Due to poor solubility of API,
to ensure reproducible dissolution results, we have
selected micronized grade of API for development of
our product as suggested by the reference brand in FDA
chemistry review.
Due to unavailability of innovator samples, the
dissolution profile in different pH mediums i.e., pH 1.2,
4.5 and 6.8 buffers as recommended in WHO for CDP
is checked and the release profile found similar to that
of innovator product “Xofluza Tablet” in FDA
chemistry review publically available.
Information related to product packaging, storage and
labeling were also gathered from the above mentioned
product assessment reports i.e. FDA chemistry review
as well product assessment report of European
Medicine Agency.
Decision: Registration Board decided to defer the case for submission of pharmaceutical equivalence and CDP
studies with innovator / reference product.
60. Name, address of Applicant / Marketing M/s Arsons Pharmaceutical Industries (Pvt) Ltd., 22 Km Multan
Authorization Holder Road off, 2.5 Km, Defence Road, Lahore
Name, address of Manufacturing site. M/s Arsons Pharmaceutical Industries (Pvt) Ltd., 22 Km Multan
Road off, 2.5 Km, Defence Road, Lahore
☐ Importer

☐ Export sale
The proposed proprietary name / brand name Peflam 50mg Tablet
Pharmaceutical ingredient (API) per unit Diclofenac potassium………….50mg
Pharmaceutical form of applied drug Light brown colored round biconvex film coated tablet
Pharmacotherapeutic Group of (API) NSAIDs
Reference to Finished product specifications USP Specifications
The status in reference regulatory authorities Cataflam 50mg Tablet of M/s Novartis (USFDA approved)
For generic drugs (me-too status) Voltaflam Tablet of M/s Platinum pharma (Reg# 021621)
Name and address of API manufacturer. M/s Henan Dongtai Pharm Co. Ltd., East Changhong Road,
Tangyin, Henan, China.
general properties, solubility, physical form, manufacturers,
analysis and justification of specification, working standard,
Batches: (131118-5, 131118-6, 131119-5)
Pharmaceutical equivalence and comparative The firm has submitted comparative dissolution studies Peflam
dissolution profile 50mg Tablet (B#PF001) with comparator product Caflam 50mg
tablet (B#PK3R) in three media pH 1.2, acetate buffer pH 4.5 and
phosphate buffer pH 6.8.

product accuracy, precision, robustness and specificity studies.
Manufacturer of API M/s Henan Dongtai Pharmaceutical Co. Ltd.,
No. 2, East Kangtai Road, Tangyin County, Anyang city, China.
API Lot No. 0303191005-5
Description of Pack
Alu-PVC blister packed in unit carton (2 × 10’s)
Peflam-50 Tablet
Batch No. PF-001 PF-002 PF-003
No. of Batches 03
The firm has not submitted any document.
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate (Certificate #
API manufacturer issued by concerned HA20190077) of M/s Henan Dongtai Pharmaceutical Co., Ltd.
regulatory authority of country of origin.China issued by He Nan Province Drug administration, China. It
is valid till 05-11-2024.
attested respective documents like with chromatograms, raw data sheets, COA and summary data
5. Compliance Record of HPLC software 21CFR The firm has submitted compliance record of HPLC software and
& audit trail reports on product testing. audit trail record of product testing.
1. Copies of the drug substance specifications The firm has submitted that drug substance specifications are
and analytical procedures used for routine part of analytical procedure.
testing of the drug substance / active The firm has submitted copies of analytical procedure from
pharmaceutical ingredient by both drug both drug substance and drug product manufacturer.
substance & drug Product manufacturer.
Moreover, analytical procedure for assay
testing has not been provided.
parameters like specificity, accuracy and protocol and reports for assay method by titration method.

repeatability (method precision) performed The verification study does not include accuracy and
by the Drug Product manufacturer for both specificity parameters.
3. Provide results of analysis of relevant The firm has submitted certificate of analysis of drug
batch(es) of Drug Substance performed by substance from both drug substance and drug product
drug Product manufacturer used during manufacturer.
product development and stability studies,
along with certificate of Analysis (CoA) of
the same batch from Drug Substance
manufacturer.
4. Pharmaceutical equivalence of the applied The firm has provided comparative dissolution profile
drug shall be established with the innovator / studies with Anti-flam Tablet 50mg.
reference / comparator product and results of The performance of pharmaceutical equivalence studies with
all the quality tests of the developed innovator product was not provided.
formulation and the innovator / reference /
comparator product shall be submitted and
discussed.
5. Submit acceptance criteria for release and The firm has submitted that release limit and shelf life
shelf life specifications. specifications comply USP monograph. Both the limits are
exactly the same.
6. Justify method verification studies without The firm has submitted performance of linearity and
performance of specificity studies. precision studies.
Moreover, relevant chromatograms for each
studied parameter are required.
7. Reference of previous approval of No approvals have been granted so far with stability studies,
applications with stability study data of the however, we have 21 CFR compliant HPLC alongwith audit
firm (if any). trail enabled. Further our stability chambers are also attached
with UPS and 24-h monitoring record.
8. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate (Certificate
API manufacturer issued by concerned # HA20190077) of M/s Henan Dongtai Pharmaceutical Co.,
regulatory authority of country of origin. Ltd. China issued by HeNan Province Drug administration,
China. It is valid till 05-11-2024.
9. Documents for the procurement of API with Not submitted.
• Submission of complete analytical method verification studies including results of specificity and accuracy
parameters as per requirement of section 3.2.S.4.3 of Form-5F.
• Justification for adopting same acceptance criteria for release and shelf life specifications.
• Performance of pharmaceutical equivalence and CDP studies with innovator/reference product.
• Analytical method verification protocol and reports of drug product as per requirements of section
3.2.P.5.3 of Form-5F.
61. Name, address of Applicant / Marketing M/s Hudson Pharma Private Limited., D-93, North Western
Authorization Holder Industrial Zone, PQA, Karachi 75020, Pakistan.
Name, address of Manufacturing site. M/s Hudson Pharma Private Limited., D-93, North Western
Industrial Zone, PQA, Karachi 75020, Pakistan.
☐ Importer

☐ Export sale
GMP status of the Finished product The firm has submitted copy of inspection report conducted on
manufacturer 24-09-2020 wherein the buildings, facilities and procedures
were found at good level of GMP compliance.
The firm is granted GMP certificate based on inspection
The firm has provided Plastic ampoule (BFS technology)
section.
The proposed proprietary name / brand name Feever Injection 400mg/3ml
Strength / concentration of drug of Active Each 3ml solution contains:
Pharmaceutical ingredient (API) per unit Ibuprofen Lysine………400mg
Pharmaceutical form of applied drug A clear and colorless to pale solution for intra muscular
injection.
Reference to Finished product specifications Innovator’s Specification
The status in reference regulatory authorities ARFEN 400mg/3ml solution for intramuscular injection by M/s
Laboratorio Italiano Biochimico Farmaceutico Lisa Pharma
S.p.A, AIFA Approved.
Name and address of API manufacturer. M/s Solara Active Pharma Sciences Limited A1/B, SIPCOT
Industrial Complex Kudikadu Village, Cuddalore – 607 005,
Tamil Nadu, India.
Module III (Drug Substance) Ibuprofen Lysine is not present in any pharmacopeia.
Therefore, its specifications develop with the compendial
monograph of European pharmacopeia & In-house test
parameters. The firm has submitted details of nomenclature,
structure, general properties, solubilities, physical form,
controls, tests for specified impurity J, A, N & unspecified B,
D, E, L & M, specifications, analytical procedures and its
validation, batch analysis and justification of specification,
Accelerated: 40°C±2°C / 75% ± 5%RH for 6 months

Batches: (PILD19001V, PILD19002V, PILD19003V)
procedure and its validation studies, batch analysis and
Pharmaceutical equivalence and comparative Firm has submitted pharmaceutical equivalence against the
dissolution profile reference product Arfen Injection 400mg/3ml by M/s
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA
S.p.A. Italy.
Analytical method validation/verification of Firm has submitted analytical method validation studies for the
product applied product.
Manufacturer of API M/s Solara Active Pharma Sciences Limited A1/B, SIPCOT Industrial Complex
Kudikadu Village, Cuddalore – 607 005, Tamil Nadu, India.
API Lot No. CIBL200003
Description of Pack
LDPE ampoule which is then placed in PVC tray and packed in unit carton (1×10’s)
Feever Injection 400mg/3ml
Batch No. SB-IL-IN-001 SB-IL-IN-002 SB-IL-IN-003
Batch Size 20 L 20 L 20 L
No. of Batches 03
manufacturer issued by concerned regulatory 8550/D14/2018 issued by Department of Food Safety and
authority of country of origin. Drugs Control Administration, Government of Tamil Nadu
3. Documents for the procurement of API with Firm has submitted copy of invoice (invoice # 1107300629 /
approval from DRAP (in case of import). 20.08.2020) cleared by DRAP Karachi office dated 09-09-2020
specifying import 1.5 Kg Ibuprofen Lysine (Batch #
CIBL200003).
4. Data of stability batches will be supported by Firm has submitted complete record of testing of all batches
attested respective documents like along with chromatograms, raw data sheets, COA and summary
chromatograms, Raw data sheets, COA, data sheets.
5. Compliance Record of HPLC software 21CFR The firm has submitted audit trail record of product testing of
& audit trail reports on product testing HPLC for all test intervals.

6. Record of Digital data logger for temperature Firm has submitted record of digital data logger for temperature
and humidity monitoring of stability chambers and humidity monitoring of real time and accelerated stability
(real time and accelerated). chambers.
1. Submit differential fee for the registration of Original deposit slip of differential fee of Rs. 25,000
applied product since the application was received via challan No. 6155948409 dated 24-01-2022 has
in R&I section DRAP after 7th May, 2021. been submitted.
2. Provide summarized tabulated results of Attached tabulated summary of analytical method
verification studies including specificity, accuracy validation studies of API including specificity,
and repeatability (method precision) studies accuracy and repeatability (method precision) of
performed by the Drug Product manufacturer for Ibuprofen Lysine
both compendial as well as non-compendial drug
substance(s).
3. For in-house methods, analytical method validation Attached tabulated summary of analytical method
of drug product shall be required to be submitted. validation studies including specificity, accuracy and
repeatability (method precision) of drug product.
4. Clarification is required why analytical method M/s Strides Shasun Limited change their name to
validation studies were performed by M/s Shasun M/s Solara Active Pharma Sciences & name change
pharmaceuticals since drug substance manufacture intimation note attached for your reference.
is M/s Solara Active Pharma Sciences
5. Provide results of analysis of relevant batch(es) of Attached copy of certificate of analysis from Drug
Drug Substance performed by Drug Product Substance manufacturer & Drug Product
manufacturer used during product development and manufacturer of the same batch used during product
stability studies, along with Certificate of Analysis development and stability studies.
(CoA) of the same batch from Drug Substance
manufacturer.
6. The submitted stability study data of different The firm has submitted stability study data of 3
batches of Ibuprofen lysine manufactured at batches of Ibuprofen lysine.
different facilities were not arranged in a sequence. Real time: 30°C ± 2°C/65%±5%RH for 12 months
Submit data with clarity. Accelerated: 40°C±2°C/75%±5%RH for 6 months
Batches: (PILD19001V, PILD19002V,
PILD19003V)
7. Pharmaceutical equivalence study does not include We have performed all the test methods as per the
complete testing of drug product and innovator innovator product. Please note that there is no
product including the tests recommended by the official pharmacopeial monograph available for this
official pharmacopeia. product.
8. Process validation report that does not include We aseptically fill all our injectable products using
important steps like optimization of the sterilization the BFS technology. We have validated and
process. Justification is required. optimized our sterilization process for all of them.
Ibuprofen lysine injection is also filled aseptically &
sterilized using 0.2micron filter which is mentioned
on page no.12 of process validation report of
Ibuprofen lysine injection 400mg/3ml i.e. after
manufacturing the solution is transferred to the
filling machine through 0.2micron filter.
9. The submitted copy drug product specifications We have performed all the test methods as per the
does not include complete tests as recommended by innovator product.
the innovator product as well as by the official
pharmacopeia.
10. Reference of previous approval of applications with The firm has submitted copy of previous approval of
stability study data of the firm. application Bufen injection 400mg/4ml PE ampoule
dated 11-05-2018 which showed that
The HPLC software is 21 CFR compliant.
Adequate monitoring and controls are available for
stability chambers.

11. You have not calculated potential water loss during The firm has submitted % water loss data performed
stability study as mentioned in ICH Q1A (R2) during stability study as per ICH guidelines.
(2.2.7.3. Drug products packaged in semi-
permeable containers). Justification is required.
12. Submit documents for the procurement of API with
The firm has submitted copy of invoice for the
approval from DRAP for the relevant batch of API
import of Ibuprofen lysine (Batch # CIBL200003)
used in the manufacturing of stability batches.
from M/s Solara Active pharma Sciences limited,
India cleared by Assistant Director (I & E), Karachi
dated 09-09-2020.
Decision: Approved. The Board further decided that the firm shall submit testing/assessment of Extractables
<USP chapter 1663> and Leachables <USP chapter 1664> associated with LDPE packaging before issuance of
registration letter.
62. Name, address of Applicant / Marketing M/s Daneen Pharma (Pvt.) Limited., 27-Sundar Industrial
Authorization Holder Estate, Sundar Raiwind Road, Lahore.
Name, address of Manufacturing site. M/s Daneen Pharma (Pvt.) Limited., 27-Sundar Industrial
Estate, Sundar Raiwind Road, Lahore.
☐ Importer
☐ Export sale
GMP status of the Finished product License granted on 03-04-2019 wherein sterile Dry Powder
manufacturer Injection (Cephalosporin) Section has been approved.
PKR 25,000/-: Dated 07-06-2021
The proposed proprietary name / brand name Avizid Injection 2.5g
Pharmaceutical ingredient (API) per unit Ceftazidime pentahydrate eq. to Ceftazidime.….2gm
Avibactam sodium eq. to Avibactam………...0.5gm
Pharmaceutical form of applied drug Powder for Injection
White to pale-yellow sterile dry powder for injection filled in
15ml glass vials sealed with rubber stopper and grey flip-of
aluminum seal.
Pharmacotherapeutic Group of API Antibiotic
Reference to Finished product specifications Innovator specification
Proposed Pack size 1’s & 10’s
The status in reference regulatory authorities AVYCAZ 2.5g (Ceftazidime and avibactam) for injection by M/s
GlaxoSmithKline Manufacturing Italy (USFDA Approved)
For generic drugs (me-too status) Zavicefta 2.5g Injection of M/s GSK
Name and address of API manufacturer. M/s Chifeng Addisun Pharmaceutical Co., Ltd.
No.3 Minsheng Street, Economic Development Zone of
Hongshan District, Chifeng, Inner Mongolia, China.

Module III (Drug Substance) (Ceftazidime and avibactam) both drug substances are tested at
in-house specifications. The firm has submitted details of
process and controls, tests for impurity (Ceftazidime) A, B, &
G & other single impurity & (Avibactam) impurity A & other
single impurity, specifications, analytical procedures and its
Batches: (180601, 180602, 180603)
analytical procedure and its validation studies, batch analysis
Pharmaceutical equivalence and comparative The firm has submitted pharmaceutical equivalence of their
dissolution profile developed formulation Avizid Injection (Batch # 001I) against
the reference product AVYCAZ 2.5g (Lot No. 2004EO) of M/s
GlaxoSmithKline Manufacturing Italy by performing quality
tests (Identification & Assay).
CDP is not applicable.
Analytical method validation/verification of The firm has submitted analytical method validation studies
product including linearity, range, accuracy, precision, specificity.
Manufacturer of API M/s Chifeng Addisun Pharmaceutical Co., Ltd., No.3 Minsheng Street, Economic
Development Zone of Hongshan District, Chifeng, Inner Mongolia, China.
API Lot No. Batch No: 20200522
Description of Pack
Glass type I with rubber stopper and aluminum seal in a bleach board unit carton. (1’s)
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH Accelerated: 40°C ± 2°C / 75% ± 5%RH
Frequency Accelerated: 0, 1,2, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 001I 002I 003I
No. of Batches 03

2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate (No.
manufacturer issued by concerned regulatory NM20170098) issued by china Food and Drug Administration
authority of country of origin. valid till 21-02-2022.
3. Documents for the procurement of API with The firm has imported CEFTAZIDIME (as Ceftazidime
approval from DRAP (in case of import). pentahydrate/sodium carbonate) AVIBACTAM (as avibactam
sodium) manufactured by M/s Chifeng Addisun
Pharmaceuticals Co. Ltd. from M/S WIS PHARMATECH CO.
LTD through invoice number WIS190129 dated: 22-06-2020
duly verified by AD (I & E) Lahore dated 27-07-2020.
attested respective documents like chromatograms, raw data sheets, COA and summary data
5. Compliance Record of HPLC software 21CFR Compliance Record of HPLC software 21CFR & Audit trail on
& audit trail reports on product testing. testing reports of product submitted.
6. Record of Digital data logger for temperature Firm has submitted record of data logger for temperature and
and humidity monitoring of stability chambers humidity monitoring of real time and accelerated stability
No.
1. Copies of Drug substance specifications and The firm has submitted following:
analytical procedures used for routine testing of the -Drug Substance specifications & analytical procedure
Drug substance /Active Pharmaceutical by Drug substance manufacturer.
Ingredients by both Drug substance & Drug - Drug Substance specifications & analytical
product manufacturer. procedure by drug product manufacturer.
2. Analytical method verification reports of Avizid Powder for injection 2.5g is a sterile dry
parameters like specificity, accuracy and powder which has same composition as that of its raw
repeatability (method precision) performed by the material.
Drug product manufacturer for both compendial as -Manufacturing process of Avizid do not involve any
well as non-compendial drug substance(s) shall be addition of excipient or manufacturing step and it
submitted. consists of aseptic filling only. So, method of analysis
for finished product is same as that of raw material
which is in-house method of drug substance
manufacturer.
-Hence analytical method validation performed on
drug product is valid for both raw material and
finished product.
- Summary of important features of both methods
along with detailed Analytical Method Validation of
finished product performed by drug product
manufacturer is enclosed in support.
3. Details of impurity standards are required to be Details of impurities standards used for testing are
provided since Ceftazidime & Avibactam attached along with COA.
standards are mentioned only.
4. Compatibility studies for the dry powder for Avizid dry powder for injection is initially constituted
injections shall be performed as per the instruction with 10ml of water for injection. This solution was
provided in individual label of the drug product. further diluted in various diluents and tested over the
period of time.
• 0.9% sodium chloride injection, USP
• 5% Dextrose Injection
• Lactated ringer’s Injection

5. Submit date of analysis of pharmaceutical Analysis Dates:
equivalence along with chromatogram / spectra. AVIZID: 03-10-20 & 05-10-20
AVYCAZ: 10-10-20 & 12-10-20
Following documents are submitted,
-Chromatograms for the testing of AVYCAZ 2004E0
-Chromatograms for the testing of AVIZID 001I
6. Justification / clarification is required regarding Justification is as follows,
target filled weight of ceftazidime Avibactam as Label Claim:
3100mg in batch formula. Ceftazidime: 2g (Ceftazidime pentahydrate /sodium
carbonate)
Avibactam: 0.5g (Avibactam sodium)
Potency of Ceftazidime in raw material = 64.93%
Calculation of proposed weight on the basis of
ceftazidime potency:
Fill weight = label claim x 100 / Potency (%)
Fill weight = 2000 x 100 /64.93
Fill weight = 3080mg/ vial.
Potency of Avibactam in raw material = 16.13%
Calculation of proposed weight on the basis of
ceftazidime potency:
Fill weight = label claim x 100 / Potency (%)
Fill weight = 500 x 100 /16.13
Fill weight = 3099.8mg ≈ 3100mg/ vial
Fill weight of AVIZID injection has been selected
3100mg/vial to calculate batch size which is
maximum of both and have both API > 100%
(Avibactam 100.00%, Ceftazidime 100.6%).
-COA is also enclosed for potency evidence.
7. -Scientific justification /rational for not performing -Sodium carbonate is an excipient and its role is to
the test of sodium carbonate content. stabilize ceftazidime. So, its content is not tested as
API. Furthermore, there is no specific limit for its
assay claimed by innovator. Hence, following
innovator, (AVYCAZ) approximate content of
sodium carbonate per vial may be mentioned on leaflet
which are Approx. 236.1mg.
For the determination of sodium carbonate content, an
agreement has been made with TTI labs (Third party
testing service) due to the unavailability of specific
equipment required for this test.
Stability batches have been tested by Atomic
absorption for the evaluation of sodium carbonate
contents per vial. The analysis of sodium carbonate
performed by Atomic absorption Spectrometer (AAS)
are as:
Sample # Results (mg/vial)
001I 236.24
002I 236.93
003I 234.90
This is only an informative test and no acceptance
limits are applicable.
8. Justify the weights taken for ceftazidime and In analytical method validation, weights on as is bases
avibactam in different sets of accuracy parameter has been considered and not on the proposed fill
in analytical method validation studies. Moreover, weight. To avoid excess use of mobile phase, working
basis for setting 100% theoretical contents are standards and samples reduced amounts of dilutions
required to be clarified. have been prepared i.e., 50ml instead of 100ml and

weights have been reduced accordingly. So the actual
ratio of solute to solvent is same.
9. Documents for the procurement of drug substance The firm has submitted copy of invoice for the import
with approval from DRAP (In case of import) shall of Ceftazidime avibactam (1.5Kg) attested by AD (I &
be submitted. E) DRAP Lahore dated 27-07-2020.
Decision: Approved.
• Manufacturer will place first three commercial batches on long term stability studies throughout proposed shelf
life and on accelerated studies for six months as per the commitment submitted in the registration application.
• Manufacturer will perform process validation of first three commercial batches as per the commitment
submitted in the registration application.
63. Name, address of Applicant / Marketing M/s Islam Pharmaceuticals, 7KM Pasrur Road Sialkot, from
Authorization Holder M/s Bio-Labs (Pvt) Ltd
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No 145 Industrial Triangle,
Kahuta road, Islamabad.
☐ Importer
☒ Is involved in none of the above (contract giver)
☐ Export sale
GMP status M/s Islam Pharmaceutical: The firm is granted GMP
certificate based on inspection conducted on 01-02-2020.
M/s Bio-Labs (Pvt) Ltd. The firm is granted GMP certificate
based on inspection conducted 23-04-2019.
The proposed proprietary name / brand name Espharm Injection 40mg IV
Pharmaceutical ingredient (API) per unit Esomeprazole as sodium……..40mg (Lyophilized powder)
Pharmaceutical form of applied drug Almost white colored lyophilized, hygroscopic powder filled
in glass vial.
Pharmacotherapeutic Group of (API) Proton pump inhibitors
Reference to Finished product specifications In-house
The status in reference regulatory authorities Nexium IV 40mg Injection of M/s AstraZeneca (USFDA
approved).
For generic drugs (me-too status) Esomine 40mg Injection of M/s Lawari International (Reg #
069703)
GMP status of the Finished product GMP certificate issued based upon inspection conduct 23-4-
manufacturer 2019, valid upto 22-4-2022.
Name and address of API manufacturer. M/s. Sterile India Pvt. Ltd.
Plot No. 100, Sec-56 Phase -4, Kundli Sonipat (Haryana)
India

Firm has summarized information related to nomenclature,
manufacturers,
Characterization, specifications, analytical procedures and its
studies of drug substance. The firm has summarized
information of drug product including its description,
manufacturing process and process control, process
product, specifications, analytical procedures,
validation/verification of analytical procedures, batch
analysis, justification of specifications, reference standard or
Module III (Drug Substance) Firm has submitted detailed data for both drug substance data
substance.
substance at both accelerated as well as real time conditions.
The accelerated stability data is conducted at 40°C ± 2°C
/75% ± 5% RH for 6 months. The real time stability data is
conducted at 30°C ± 2°C / 65% ± 5% RH for 36 months.
(Batch No. SI/EPZ/0010312, SI/EPZ/0020312 &
SI/EPZ/0030312).
Pharmaceutical equivalence and comparative Firm has submitted pharmaceutical equivalence study report
dissolution profile of trial formulation (Batch # L-315) with Nexum 40mg
injection (Batch # 137P07) of M/s Getz pharma by
performing quality tests (Description, water contents, pH,
Sterility, assay).
CDP- Not applicable
Analytical method validation/verification of Analytical method validation studies have been submitted
Manufacturer of API M/s. Sterile India Pvt. Ltd.
Plot No. 100, Sec-56 Phase -4, Kundli Sonipat (Haryana) India
API Lot No. SI/EPZ/00061217
Description of Pack
Glass vial

Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
E-Zole 40mg Injection
Batch No. L-315 L-287 L-283
Batch Size 5,000 vials 5,000 vials 5,000 vials
No. of Batches 03
DOCUMENTS / DATA TO BE PROVIDED WITH STABILITY STUDY
1. Reference of previous approval of applications NA
2. Approval of API/ DML/GMP certificate of GMP certificate of M/s. Sterile India Pvt. Ltd.
API manufacturer issued by concerned Plot No. 100, Sec-56 Phase -4, Kundli Sonipat (Haryana)
regulatory authority of country of origin. India valid upto 21-5-2021
3. Documents for the procurement of API with Firm has submitted attested copy of invoice (invoice#
approval from DRAP (in case of import). E/161/SIPL/19-20)
5. Compliance Record of HPLC software 21CFR The firm has not submitted audit trail reports on product
& audit trail reports on product testing testing.
(real time and accelerated) chambers.
1. Analytical Method Verification studies including Firm has submitted reports of verification studies of
specificity, accuracy and repeatability (method the analytical method of drug substance.
precision) performed by the Drug Product
2. Provide COA of reference standard which is Firm has submitted COA of working standard from
actually used in the analysis of drug substance in the API manufacturer which is standardized against
section 3.2.S.5. USP reference standard.
3. Pharmaceutical equivalence study does not Firm has submitted pharmaceutical equivalence
include complete testing of the drug product and study report of trial formulation (Batch # L-315)
the comparator product including the tests with Nexum 40mg injection (Batch # 137P07) of
recommended by innovator product as well as the M/s Getz pharma by performing quality tests
tests recommended in general monographs of (Description, water contents, pH, Sterility, assay).
official pharmacopoeia.
4. Pharmaceutical equivalence studies were not We are using market lead product Nexum 40mg
conducted against the innovator product. injection by M/s Getz Pharmaceuticals Ltd which is
approved by DRAP.
5. Justify the pH of your product between 9 to 12 Initially we followed in house specifications that’s
since the pH of the innovator product is between why pH limit was 9-12. Now we are following
9 to 11. Revise your specifications along with innovator’s specification and accordingly revised
submission of requisite fee. our specifications.

6. Justify analytical method based on UV The firm has submitted that we have revised our
spectrophotometric method for assay testing of E-method as per innovator’s specifications and adopted
Zole 40mg Injection IV while that of innovator / HPLC method for the assay testing of the drug
reference product is based on HPLC. product. We have also performed validation studies
of the analytical method and therefore the HPLC
method has been validated.
7. Justify your validation studies of the drug product Firm has submitted revised validation studies of the
in the light of ICH guidelines, since your analysis analytical method of the drug product using HPLC
and reporting of the results is not exactly in line testing as per the ICH guidelines.
with the ICH recommendations.
8. Justify why the stability study data of three Firm has initially submitted stability study data of
different batches is submitted from those for three batches (Batch No. L-234, L-142, L-180)
which batch analysis is provided in section manufactured in 02-2019, 04-2018 and 09-2018 in
3.2.P.5.4. which the assay testing of stability batches was
carried out through UV method. Now the firm has
submitted stability study data of three new batches
manufactured in 2020 where the assay testing was
conducted using HPLC method.
9. Tests for water contents, constituted solution etc These tests have been performed as per revised
were not performed during stability studies since specifications on the submitted data of the stability
these tests are critical and are required to make batches.
assessment of the stability profile and shelf life.
10. Submit documents for the procurement of API Firm has submitted copy of commercial invoice
with approval from DRAP for the relevant batch specifying import of 5Kg Esomeprazole sodium
of API which is used in the manufacturing of sterile powder dated 02-12-2019. The invoice is
stability batches. cleared by AD (I&E) DRAP.
11. Submit Batch Manufacturing Record of three Firm has submitted copy of batch manufacturing
batches for which stability study data is submitted. record of three stability batches.
Decision: Deferred for submission of Pharmaceutical equivalence studies against innovator/reference product,
manufactured by way of lyophilization. Moroever, firm shall submit the fee of Rs. 7500/- for correction/pre-
approval change in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
64. Name, address of Applicant / Marketing M/s Gray’s Pharmaceuticals., 7 km, Pasrur Road, Sialkot.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt.) Ltd., Plot # 145 Industrial Triangles, kahuta
Road, Islamabad.
☐ Importer
The firm has submitted copy of agreement between M/s Islam
Pharmaceuticals and M/s Bio-Labs (Pvt.) Ltd, Islamabad made
on 21-01-2020.
GMP status of the firm M/s Gray’s Pharmaceuticals: The firm has submitted copy of
GMP certificate based on inspection conducted on 14-09-2021.
M/s Bio-Labs Pvt Ltd: The firm is granted GMP certificate
based on inspection conducted on 23-04-2019.
Evidence of approval of manufacturing facility The manufacturer has provided Lyophilized vial (General)
section.
☐ Export sale

The proposed proprietary name / brand name Epra 40mg IV Injection
Pharmaceutical ingredient (API) per unit Omeprazole sodium eq. to Omeprazole.…….40mg
Pharmaceutical form of applied drug Lyophilized Powder for injection
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor
The status in reference regulatory authorities Omeprazole powder for solution for infusion of M/s Sandoza
Novartis (MHRA approved)
For generic drugs (me-too status) Risek Injection 40mg of M/s Getz Pharma Pakistan
Name and address of API manufacturer. M/s Rajasthan Antibiotics Ltd., Plot no A-619 & 630, Rico
Industrial Area Bhiwadi-301019 Rajasthan, India
Characterization, impurities, specifications, analytical
The firm has summarized information of drug product including
its description, composition, pharmaceutical development,
Module-III Drug Substance: The firm has submitted detailed drug substance data related to
nomenclature, structure, general properties, solubilities, physical
form, manufacturers, description of manufacturing process and
controls, impurities, specifications, analytical procedures and its
of drug substance.
Stability Studies of Drug Substance The firm has submitted stability study data of 6 months
(Conditions & duration of Stability studies) accelerated and 36 months real time data of 3 batches of API as
per Zone-IV A.
protocols and report, control of excipients, control of drug
Pharmaceutical Equivalence The firm has performed pharmaceutical equivalence of their
developed formulation Delka 40mg IV Injection (B # L 289) with

comparator product Risek 40mg Injection IV (B # 788P06) of
M/s GETZ Pharma, Karachi. Quality tests of both products
including description, identification, pH, assay, Sterility and
bacterial endotoxins were performed and compared.
Analytical method validation/verification of Firm has submitted analytical method validation report of drug
product substance.
Firm has submitted analytical method validation report of
applied product.
Manufacturer of API M/s Rajasthan Antibiotics Ltd., Plot no A-619 & 630, Rico Industrial Area Bhiwadi-
301019 Rajesthan, India
API Lot No. AOSS19032
Description of Pack
Glass vial
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH Accelerated: 40°C ± 2°C / 75% ± 5%RH
Delka 40mg IV Injection
Batch No. L-140 L-163 L-197
Batch Size 25000 vials 20,000 vials 15,000 vials
No. of Batches 03
# Documents To Be Provided Status
2. Approval of API/ DML/GMP certificate of Not submitted

API manufacturer issued by concerned
3. Documents for the procurement of API with The firm has submitted copy of invoice for the import of
approval from DRAP (in case of import). Omeprazole sodium.
attested respective documents like chromatograms, raw data sheets, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR Audit trail on testing reports of product submitted.
S.# Observations communicated Response by the firm
1. Provide results of analysis of relevant batch(es) of The firm has submitted that API lot used in stability
Drug Substance used during product studies procured from Rajasthan Antibiotics while
development and stability studies, along with provided DMF was from Metrochem. We are submitting
Certificate of Analysis (CoA) of the same batch DMF from Rajasthan antibiotics and COAs accordingly.
from Drug Substance manufacturer.

2. Details of applicant batch number and comparator Revised pharmaceutical equivalence report has been
product batch number used for pharmaceutical submitted.
equivalence studies are required.
3. Data of commercial batches with different batch We do not perform process validation on all manufactured
numbers was given in process validation reports, batches. We performed stability study and process
batch analysis of finished product and stability validation on different batches however we are submitting
studies. revised batch analysis of stability batches.
4. Pharmaceutical equivalence of the applied drug The firm has submitted we used market leader product
shall be established with the innovator product and (Risek 40mg Injection) of GETZ pharma which was
results of all the quality tests (mentioned in any approved by DRAP.
official pharmacopoeia or section 3.2.P.5.1 of this
application) of the developed formulation and the
innovator product should be submitted and
discussed as per requirements of section 3.2.P.2.
5. Justification is required for using UV The firm has submitted that since product is of in-house
spectrophotometric method in place of HPLC specifications and in-house validated method is applied
method for assay testing of Delka 40mg Injection for testing which is UV-visible spectrophotometer.
IV. Validation of analytical method is provided in module 3.
6. Approval of API/ DML/GMP certificate of API Response not submitted against this point.
manufacturer issued by concerned regulatory
7. Evidence of procurement of drug substance with Response not submitted against this point.
approval from DRAP is required.
• Scientific justification of manufacturing of applied formulation by way of lyophilization using pre-lyophilized
omeprazole sodium from M/s Rajasthan Antibiotics, India.
• Justification of adopting UV-visible spectrophotometric method for assay testing of applied formulation.
• Approval of API/ DML/GMP certificate of API manufacturer (Rajasthan antibiotics) issued by concerned
• Submission of Pharmaceutical equivalence studies against innovator/reference product, manufactured by way
of lyophilization.
65. Name, address of Applicant / Marketing M/s Cherwel Pharmaceuticals (Pvt) Ltd. plot # 20, Phase 4,
Authorization Holder Hattar Industrial Estate, Hattar KPK from M/s Bio-Labs (Pvt)
Ltd
☐ Importer
☐ Export sale
GMP status M/s Cherwel Pharmaceuticals: The firm is granted GMP
certificate based on inspection conducted on 04-02-2019.
M/s Bio-Labs (Pvt) Ltd. The firm is granted GMP certificate

The proposed proprietary name / brand name Esocare Injection 40mg IV
Pharmaceutical ingredient (API) per unit Esomeprazole as sodium………………40mg
(Lyophilized powder)
Pharmaceutical form of applied drug Almost white colored lyophilized, hygroscopic powder filled
in glass vial.
Pharmacotherapeutic Group of (API) Proton pump inhibitor
Reference to Finished product specifications In-house specifications
approved)
For generic drugs (me-too status) Esomine 40mg Injection Lawari International (R# 069703)
Name and address of API manufacturer. M/s. Sterile India Pvt. Ltd. Plot No. 100, Sec-56 Phase -4,
Kundli Sonipat (Haryana) India
manufacturers,
substance.
The accelerated stability data is conducted at 40°C± 2°C
SI/EPZ/0030312)

Sterility, assay).
Analytical method validation/verification of Method validation studies have submitted including linearity,
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. L-315 L-287 L-283
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API GMP certificate of M/s. Sterile India Pvt. Ltd.
manufacturer issued by concerned regulatory Plot No. 100, Sec-56 Phase -4, Kundli Sonipat (Haryana)
authority of country of origin. India valid upto 21-05-2021.
5. Compliance Record of HPLC software 21CFR The firm has not submitted audit trail reports on product
& audit trail reports on product testing testing.

No.
1. Analytical Method Verification studies Firm has submitted reports of verification studies of
including specificity, accuracy and repeatability the analytical method of drug substance.
(method precision) performed by the Drug
Product manufacturer for both compendial as
well as non-compendial drug substance(s) shall
be submitted.
2. Provide COA of reference standard which is Firm has submitted COA of working standard from the
actually used in the analysis of drug substance API manufacturer which is standardized against USP
in section 3.2.S.5. reference standard.
3. Pharmaceutical equivalence study does not Firm has submitted pharmaceutical equivalence study
include complete testing of the drug product and report of trial formulation (Batch # L-315) with Nexum
the comparator product including the tests 40mg injection (Batch # 137P07) of M/s Getz pharma
recommended by innovator product as well as by performing quality tests (Description, water
the tests recommended in general monographs contents, pH, Sterility, assay).
of official pharmacopoeia.
conducted against the innovator product. injection by Getz Pharma Ltd which is approved by
DRAP.
5. Justify the pH of your product between 9 to 12 Initially we followed in house specifications that’s
since the pH of the innovator product is between why pH limit was 9-12. Now we are following
9 to 11. Revise your specifications along with innovator’s specification and accordingly revised our
submission of requisite fee. specifications.
6. Justify analytical method based on UV The firm has submitted that we have revised our
spectrophotometric method for assay testing of method as per innovator’s specifications and adopted
E-Zole 40mg Injection IV while that of HPLC method for the assay testing of the drug product.
innovator / reference product is based on HPLC. We have also performed validation studies of the
analytical method and therefore the HPLC method has
been validated.
7. Justify your validation studies of the drug Firm has submitted revised validation studies of the
product in the light of ICH guidelines, since analytical method of the drug product using HPLC
your analysis and reporting of the results is not testing as per the ICH guidelines.
exactly in line with the ICH recommendations.
8. Justify why the stability study data of three Firm has initially submitted stability study data of three
different batches is submitted from those for batches (Batch No. L-234, L-142, L-180)
3.2.P.5.4. which the assay testing of stability batches was carried
out through UV method. Now the firm has submitted
stability study data of three new batches manufactured
in 2020 where the assay testing was conducted using
HPLC method.
were not performed during stability studies specifications on the submitted data of the stability
since these tests are critical and are required to batches.
make assessment of the stability profile and
shelf life.
with approval from DRAP for the relevant batch specifying import of 5Kg Esomeprazole sodium sterile
of API which is used in the manufacturing of powder dated 02-12-2019. The invoice is cleared by
stability batches. AD (I&E) DRAP.
11. Submit Batch Manufacturing Record of three Firm has submitted copy of batch manufacturing
batches for which stability study data is record of three stability batches.
submitted.

66. Name, address of Applicant / Marketing M/s Munawar Pharma (Pvt) Ltd., 31km, Ferozpur Road Lahore
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No 145 Industrial Triangle, Kahuta
road, Islamabad.
☐ Importer
☐ Export sale
GMP status M/s Bio-Labs (Pvt) Ltd. The firm is granted GMP certificate
M/s Munawar Pharma: The firm is granted GMP certificate
The proposed proprietary name / brand name Someper Injection 40mg IV
Pharmaceutical ingredient (API) per unit Esomeprazole as sodium……………….……40mg
Pharmaceutical form of applied drug Almost white colored lyophilized, hygroscopic powder filled in
glass vial.
Pharmacotherapeutic Group of (API) Proton pump inhibitor
approved)
For generic drugs (me-too status) Esomine 40mg Injection Lawari International 069703
Name and address of API manufacturer. M/s. Sterile India Pvt. Ltd.,
Plot No. 100, Sec-56 Phase -4, Kundli Sonipat (Haryana) India.
manufacturers,
of drug substance. The firm has summarized

specifications, analytical procedures, validation/verification of
accelerated stability data is conducted at 40°C ± 2°C /75% ± 5%
30°C ± 2°C / 65% ± 5% RH for 36 months. (Batch No.
SI/EPZ/0010312, SI/EPZ/0020312 & SI/EPZ/0030312)
process validation protocols and reports, control of excipients,
Pharmaceutical equivalence and comparative Firm has submitted pharmaceutical equivalence study report of
dissolution profile trial formulation (Batch # L-315) with Nexum 40mg injection
(Batch # 137P07) of M/s Getz pharma by performing quality
tests (Description, water contents, pH, Sterility, assay).
Description of Pack
Glass vial
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. L-315 L-287 L-283
No. of Batches 03

manufacturer issued by concerned regulatory Plot No. 100, Sec-56 Phase -4, Kundli Sonipat (Haryana)
authority of country of origin. India valid upto 21-5-2021
5. Compliance Record of HPLC software 21CFR Audit trail not provided.
& audit trail reports on product testing
1. Analytical Method Verification studies Firm has submitted reports of verification studies of the
including specificity, accuracy and repeatability analytical method of drug substance.
be submitted.
recommended by innovator product as well as by performing quality tests (Description, water contents,
the tests recommended in general monographs pH, Sterility, assay).
DRAP.
5. Justify the pH of your product between 9 to 12 Initially we followed in house specifications that’s why
since the pH of the innovator product is between pH limit was 9-12. Now we are following innovator’s
9 to 11. Revise your specifications along with specification and accordingly revised our specifications.
submission of requisite fee.
6. Justify analytical method based on UV The firm has submitted that we have revised our method
spectrophotometric method for assay testing of as per innovator’s specifications and adopted HPLC
E-Zole 40mg Injection IV while that of method for the assay testing of the drug product. We
innovator / reference product is based on HPLC. have also performed validation studies of the analytical
method and therefore the HPLC method has been
validated.
manufactured in 02-2019, 04-2018 and 09-2018 in

which batch analysis is provided in section which the assay testing of stability batches was carried
3.2.P.5.4. out through UV method. Now the firm has submitted
HPLC method.
shelf life.
of API which is used in the manufacturing of powder dated 02-12-2019. The invoice is cleared by AD
stability batches. (I&E) DRAP.
11. Submit Batch Manufacturing Record of three Firm has submitted copy of batch manufacturing record
batches for which stability study data is of three stability batches.
submitted.
67. Name, address of Applicant / Marketing M/s Davis Pharmaceutical, 121 industrial Triangle area,
Authorization Holder Kahuta Road Islamabad contract manufacturing from M/s
Bio-Labs (Pvt) Ltd.
☐ Importer
☐ Export sale
GMP status M/s Davis Pharmaceutical: The firm is granted GMP
certificate based on inspection conducted 02-02-2022.
M/s Bio-Labs (Pvt) Ltd. The firm is granted GMP
certificate based on inspection conducted 23-04-2019.
The proposed proprietary name / brand name Esset Injection 40mg IV
Pharmaceutical ingredient (API) per unit Esomeprazole as sodium………………40mg
Pharmaceutical form of applied drug Almost white colored lyophilized, hygroscopic powder
filled in glass vial.
Pharmacotherapeutic Group of (API) Proton pump inhibitors

approved)
For generic drugs (me-too status) Esomine 40mg Injection Lawari International (Reg #
069703).
Name and address of API manufacturer. M/s. Sterile India Pvt. Ltd.,
Plot No. 100, Sec-56 Phase -4, Kundli Sonipat (Haryana)
India
manufacturers,
Characterization, specifications, analytical procedures and
its validation, batch analysis and justification of
and stability studies of drug substance. The firm has
summarized
analysis, justification of specifications, reference standard
or materials, container closure system and stability.
Module III (Drug Substance) Firm has submitted detailed data for both drug substance
data related to nomenclature, structure, general properties,
drug substance.
The accelerated stability data is conducted at 40°C ± 2°C
SI/EPZ/0030312)
process validation protocols and report, control of
excipients, control of drug product, specifications,
analytical procedures, validation of analytical procedures,
batch analysis, justification of specifications, reference
standard or materials, container closure system and stability.
Sterility, assay).

Analytical method validation/verification of Method validation studies have submitted including
Plot No. 100, Sec-56 Phase -4, Kundli Sonipat (Haryana) India.
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. L-315 L-287 L-283
No. of Batches 03
manufacturer issued by concerned regulatory Plot No. 100, Sec-56 Phase -4, Kundli Sonipat
authority of country of origin. (Haryana) India valid upto 21-5-2021
4. Data of stability batches will be supported by attested Firm has submitted record of testing of all batches along
respective documents like chromatograms, Raw data with chromatograms, raw data sheets, COA and
sheets, COA, summary data sheets etc. summary data sheets.
5. Compliance Record of HPLC software 21CFR & Audit trail not provided.
6. Record of Digital data logger for temperature and Firm has submitted record of data logger for
humidity monitoring of stability chambers (real time temperature and humidity monitoring of real time and
and accelerated) accelerated stability chambers.
1. Analytical Method Verification studies Firm has submitted reports of verification studies of the
including specificity, accuracy and repeatability analytical method of drug substance.
be submitted.

recommended by innovator product as well as by performing quality tests (Description, water contents,
the tests recommended in general monographs pH, Sterility, assay).
DRAP.
5. Justify the pH of your product between 9 to 12 Initially we followed in house specifications wherein the
since the pH of the innovator product is between pH limit was 9-12. Now we are following innovator’s
9 to 11. Revise your specifications along with specifications and accordingly revised specifications.
submission of requisite fee.
6. Justify analytical method based on UV The firm has submitted that we have revised our method
spectrophotometric method for assay testing of as per innovator’s specifications and adopted HPLC
E-Zole 40mg Injection IV while that of method for the assay testing of the drug product. We
innovator / reference product is based on HPLC. have also performed validation studies of the analytical
method and therefore the HPLC method has been
validated for assay testing.
3.2.P.5.4. which the assay testing of stability batches was carried
out through UV method. Now the firm has submitted
HPLC method.
shelf life.
of API which is used in the manufacturing of powder dated 02-12-2019. The invoice is cleared by AD
stability batches. (I&E) DRAP.
11. Submit Batch Manufacturing Record of three Firm has submitted copy of batch manufacturing record
batches for which stability study data is of three stability batches.
submitted.
68. Name, address of Applicant / Marketing M/s W. Woodward Pakistan (Pvt) Ltd, F-275, S.I.T.E, Karachi.
Name, address of Manufacturing site. M/s W. Woodward Pakistan (Pvt) Ltd, F-275, S.I.T.E, Karachi.
☐ Importer
GMP status of the firm The firm has submitted copy of GMP inspection report
conducted on 02-07-2020 wherein the firm was found to be
maintaining good level of GMP compliance with commitment
for continuous improvement.

Evidence of approval of manufacturing The manufacturer has provided Capsule (General & Antibiotics)
facility section.
☐ Export sale
The proposed proprietary name / brand name DELKA 20mg Capsule
Pharmaceutical ingredient (API) per unit Omeprazole enteric coated pellets eq. to Omeprazole.…….20mg
(ATC code: A02BC01)
The status in reference regulatory authorities Prilosec capsule 20mg of M/s AstraZeneca (USFDA Approved)
For generic drugs (me-too status) Ruling 20mg Capsule of M/s High-Q pharma (Reg # 044191)
Name and address of API manufacturer. M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle,
Kahuta Road, Islamabad-Pakistan.
process validation protocols, control of excipients, control of
of drug substance.
(Conditions & duration of Stability studies) accelerated (40°C ± 2°C/75% ± 5%) and 36 months real time
data (30°C ± 2°C/65% ± 5%) of 3 batches of Omeprazole pellets.
Module-III Drug Product: Firm has submitted data of drug product including its

Pharmaceutical Equivalence and comparative The firm has submitted results of pharmaceutical equivalence
dissolution profile with comparator product by performing the quality tests.
The firm has submitted data of comparative dissolution profile
of trial formulation Delka 20mg Capsule (B # D2001) with
comparator product Ruling 20mg Capsue (B # 2RU134) of M/s
High-Q Pharma, Karachi in 0.1N HCl for 2 h and phosphate
buffer pH 6.8. The similarity factor f2 was found to be 64.01
which shows that the Delka 20mg Capsule is equivalent to
Ruling 20mg Capsule.
Analytical method validation/verification of The firm has submitted analytical method validation report of
Manufacturer of API M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle, Kahuta Road,
Islamabad-Pakistan.
API Lot No. OMP780
Description of Pack
Alu Alu Blister (2 × 7’s)
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH Accelerated: 40°C ± 2°C / 75% ± 5%RH
DELKA 20mg Capsule
Batch No. PD-167 PD-168 PD-169
Batch Size 1276 Capsule 1276 Capsule 1276 Capsule
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate issued by
API manufacturer issued by concerned Additional Director DRAP, Islamabad. It is valid till 10-02-
regulatory authority of country of origin. 2022.
approval from DRAP (in case of import). Omeprazole pellets 8.5%.
4. Data of stability batches will be supported by Firm has submitted record of testing of batches along with
attested respective documents like chromatograms, raw data sheets, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR Audit trail on testing reports of product were not submitted.

6. Record of Digital data logger for temperature Firm has not submitted record of data logger for temperature and
1. Analytical method verification studies The firm has submitted protocol and report of analytical
including specificity, accuracy and method verification studies of HPLC method. Verification
repeatability (method precision) performed parameters for assay included specificity, accuracy, and
by the Drug Product manufacturer for both repeatability studies.
compendial as well as non-compendial
drug substance(s) shall be submitted.
2. Pharmaceutical equivalence of the applied The firm has submitted results of pharmaceutical
drug shall be established with comparator / equivalence with comparator product by performing the
reference / innovator product and results of quality tests.
all the quality tests should be submitted and The firm has submitted data of comparative dissolution
discussed as per requirements of section profile of trial formulation Delka 20mg Capsule (B #
3.2.P.2. D4001) with comparator product Ruling 20mg Capsule of
M/s High-Q Pharma, Karachi in 0.1N HCl for 2 h and
phosphate buffer pH 6.8. The similarity factor f2 was found
to be 79.56 which shows that the Delka 20mg Capsule is
equivalent to Ruling 20mg Capsule.
3. Justification is required for using UV The firm has submitted that the UV method for the testing
spectrophotometric method in place of of the said product was established successfully and then
HPLC method as per USP for assay testing complete validation studies were performed and any
of applied product. validated method is acceptable for its intended use
(Reference ICH Guidelines Q2 (R1) Part II, USP validation
chapter <1225>, EMA ICH Q6A, Manual of drug law and
Guidance for industry Q2B validation for analytical
procedures. However, it is informed that we have tested our
product by HPLC method at 23rd month (attached testing
reports with chromatograms) and found result satisfactory.
We assure that we will follow the HPLC method on our
commercial batches for testing.
4. Evidence of procurement of omeprazole The firm has submitted evidence of sample dispatch from
pellets from local source is required. M/s Vision Pharmaceuticals.
Decision: Registration Board decided to reject the application of Delka 20mg Capsule of M/s W. Woodward
Pakistan (Pvt) Ltd, F-275, S.I.T.E, Karachi due to the following reasons:
• Firm has performed assay test of drug product on UV-Visible spectrophotometer although it was required to
be performed on HPLC method as recommended by USP monograph of drug product.
• Firm adopted HPLC method at 23-month testing point which cannot be representative of accelerated stability
studies for the whole 6 months period and real time stability studies till 23rd month time point.
69. Name, address of Applicant / Marketing M/s W. Woodward Pakistan (Pvt) Ltd, F-275, S.I.T.E, Karachi.
Name, address of Manufacturing site. M/s W. Woodward Pakistan (Pvt) Ltd, F-275, S.I.T.E, Karachi.
☐ Importer
GMP status of the firm The firm has submitted copy of GMP inspection report
conducted on 02-07-2020 wherein the firm was found to be
maintaining good level of GMP compliance with commitment
for continuous improvement.
Evidence of approval of manufacturing The manufacturer has provided Capsule (General & Antibiotics)
facility section.

☐ Export sale
The proposed proprietary name / brand name DELKA 40mg Capsule
Pharmaceutical ingredient (API) per unit Omeprazole enteric coated pellets eq. to Omeprazole.…….40mg
(ATC code: A02BC01)
The status in reference regulatory authorities Prilosec capsule 40mg of M/s AstraZeneca (USFDA Approved)
For generic drugs (me-too status) Ruling 40mg Capsule of M/s High-Q pharma (Reg # 058484)
Name and address of API manufacturer. M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle,
Kahuta Road, Islamabad-Pakistan.
of drug substance.
(Conditions & duration of Stability studies) accelerated (40°C ± 2°C/75% ± 5%) and 36 months real time
data (30°C ± 2°C/65% ± 5%) of 3 batches of Omeprazole pellets.

Pharmaceutical Equivalence and comparative The firm has submitted results of pharmaceutical equivalence
dissolution profile with comparator product by performing the quality tests.
comparator product Ruling 40mg Capsue (B # 4RU063) of M/s
High-Q Pharma, Karachi in 0.1N HCl for 2 h and phosphate
Analytical method validation/verification of Firm has submitted analytical method validation report of
Manufacturer of API M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle, Kahuta Road,
Islamabad-Pakistan.
API Lot No. OMP780
Description of Pack
Alu Alu Blister (2 × 7’s)
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH
DELKA 40mg Capsule
Batch No. PD-170 PD-171 PD-172
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate issued by
API manufacturer issued by concerned Additional Director DRAP, Islamabad. It is valid till 10-02-
regulatory authority of country of origin. 2022.
3. Documents for the procurement of API with The firm has submitted copy of sample dispatch for the purchase
approval from DRAP (in case of import). for Omeprazole pellets 8.5%.
4. Data of stability batches will be supported by Firm has submitted record of testing of batches along with UV
attested respective documents like spectra, raw data sheets, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR Not submitted.

No.
1. Analytical method verification studies The firm has submitted protocol and report of analytical method
including specificity, accuracy and verification studies of HPLC method. Verification parameters
repeatability (method precision) performed for assay included specificity, accuracy, and repeatability
by the Drug Product manufacturer for both studies.
drug substance(s) shall be submitted.
2. Pharmaceutical equivalence of the appliedThe firm has submitted results of pharmaceutical equivalence
drug shall be established with comparator /
with comparator product by performing the quality tests.
reference / innovator product and results of
all the quality tests should be submitted and
discussed as per requirements of section comparator product Ruling 40mg Capsue (B # 4RU063) of M/s
3.2.P.2. High-Q Pharma, Karachi in 0.1N HCl for 2 h and phosphate
3. Justification is required for using UV The firm has submitted that the UV method for the testing of the
spectrophotometric method in place of said product was established successfully and then complete
HPLC method as per USP for assay testing validation studies were performed and any validated method is
of applied product. acceptable for its intended use (Reference ICH Guidelines Q2
(R1) Part II, USP validation chapter <1225>, EMA ICH Q6A,
Manual of drug law and Guidance for industry Q2B validation
for analytical procedures. However, it is informed that we have
tested our product by HPLC method at 23rd month (attached
testing reports with chromatograms) and found result
satisfactory. We assure that we will follow the HPLC method
on our commercial batches for testing.
4. Evidence of procurement of omeprazole The firm has submitted evidence of sample dispatch from M/s
pellets from local source is required. Vision Pharmaceuticals.
Decision: Registration Board decided to reject the application of Delka 40mg Capsule of M/s W. Woodward
Pakistan (Pvt) Ltd, F-275, S.I.T.E, Karachi due to the following reasons:
• Firm has performed assay test of drug product on UV-Visible spectrophotometer although it was required to
be performed on HPLC method as recommended by USP monograph of drug product.
• Firm adopted HPLC method at 23-month testing point which cannot represent the accelerated stability studies
for the whole 6 months period and real time stability studies till 23rd month time point.
70. Name, address of Applicant / Marketing M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Authorization Holder Plot # 22-23, Industrial triangle, kahuta road, Islamabad-44000.
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt.) Ltd.
Plot # 22-23, Industrial triangle, kahuta road, Islamabad-44000.
☐ Importer
☐ Export sale

manufacturer The firm has provided Liquid Ampoule General section.
The proposed proprietary name / brand name Vision DS Injection 600mg/2ml
Strength / concentration of drug of Active Each 2ml contains:
Pharmaceutical ingredient (API) per unit Lincomycin as hydrochloride………….600mg
Pharmaceutical form of applied drug Clear to slightly yellow colour liquid injection
Pharmacotherapeutic Group of (API) Antibiotics
Proposed Pack size 10’s, 50’s & 100’s
The status in reference regulatory authorities LINCOMYCIN SXP 600mg/2ml solution for injection ampoule
by M/s Southem XP IP Pty Ltd, (TGA Approved).
For generic drugs (me-too status) Olinc 600mg/2ml Injection by M/s Bosch Karachi, Reg. No.
025416
Name and address of API manufacturer. M/s Topfond Pharmaceutical Co., Ltd., No.2, Guangming
Road, Zhumadian City, 463000, Henan P.R. China.
impurity & related substances, specifications, analytical
and stability studies of drug substance.
Real time: 30°C ± 2°C / 65%±5%RH for 48 months
Accelerated: 40°C ± 2°C /75%±5%RH for 6 months
Batches: (081101, 081102, 081103)
Pharmaceutical equivalence and comparative The firm has submitted comparative assay data of trial
dissolution profile formulation (Batch # NPD 213 T-01) against the comparator
product Lincocin Injection (Batch # C151) by Sanofi – Aventis
Pakistan Ltd. Karachi by performing quality tests (Physical
appearance, Assay, pH, Liquid Particle Count).

Manufacturer of API M/s Topfond Pharmaceutical Co., Ltd., No.2, Guangming Road, Zhumadian City,
463000, Henan P.R. China.
API Lot No. 1907025
Description of Pack
2 ml Glass Type II Ampoule
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. NPD213-T01 NPD213-T02 NPD213-T03
Batch Size 1587 Amp 1587 Amp 1587 Amp
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to onsite inspection report of their product
with stability study data of the firm (if any) Calador 400mg/100ml Infusion which was conducted on 24-08-
2021 and was presented in 312th meeting of Registration Board
held on 14-16th September, 2021.
According to the report following points were confirmed.
•The firm has 21 CFR compliant HPLC software
•The firm has audit trail reports available.
The firm possesses stability chambers with digital data loggers.
manufacturer issued by concerned regulatory HA20160021 issued by CFDA valid till 17-10-2021.
3. Documents for the procurement of API with The firm has submitted copy of commercial Invoice to import
approval from DRAP (in case of import). Lincomycin HCl (Invoice # XX17026) dated Jul-28-2017
attested by AD (I & E) DRAP Islamabad dated 20-09-2019.
4. Data of stability batches will be supported by The firm has submitted Data of stability batches supported by
chromatograms, raw data sheets, COA, sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR The firm has submitted Compliance Record of HPLC software
& audit trail reports on product testing 21CFR & audit trail reports on product testing.
and humidity monitoring of stability chambers temperature and humidity monitoring of stability chambers (real
(real time and accelerated). time and accelerated)
1. Copies of the drug substance specification and Copies of the drug substance specification and analytical
analytical procedures used for routine testing of procedures used for routine testing of the Drug substance
the Drug substance / Active Pharmaceutical / Active Pharmaceutical Ingredient by both Drug
Ingredient by both Drug substance & Drug substance & Drug Product manufacturer are attached.

2. Submitted drug substance specifications are as As we have used material by Topfond pharmaceutical Co.
per Indian Pharmacopoeia while monograph of Ltd which is as per USP monograph. We have revised
drug substance is available in USP. documents and complete DMF & QOS is attached here.
Initially the firm had provided DMF from Henan
Xinxiang Huaxing Pharmaceutical factory. However, the
limits provided by FPP manufacturer for pH, specific
optical rotation, water contents and assay are different
from API manufacturer.
3. Analytical method verification reports of Analytical method verification reports of parameters like
parameters like specificity, accuracy & specificity, accuracy & repeatability (method precision)
repeatability (method precision) performed by performed by the drug product manufacturer are attached.
the drug product manufacturer for both
4. Submitted certificate of analysis is from API used for manufacturing & testing is by Topfond
Topfond pharmaceutical Co. Ltd while drug pharmaceutical Co. Ltd. accidently DMF of Henan
substance manufacturer is M/s Henan Xinxiang Xinxiang Huaxing Pharmaceutical factory is provided in
Huaxing Pharmaceutical Factory. dossier.
5. Reference standard was not from drug substance Not submitted.
manufacturer.
6. Details of batch numbering of reference product The firm has submitted comparative assay profile
and test formulation used for Pharmaceutical protocol as well as report of trial formulation with
equivalence are required. comparator product Linocin Injection 600mg/2ml.
Pharmaceutical equivalence should contain However, pharmaceutical equivalence results containing
results of all the quality tests mentioned in all the tests have not been submitted.
official pharmacopoeia of the developed
formulation and the reference product.
7. In section 3.2.P.2.4, type II glass vial has been It is a typing error, container closure used is Glass
chosen as container closure system while in ampoule
manufacturing process development glass
ampoule has been mentioned
8. Justification/Clarification is required regarding It is error occurred during typing, the actual quantity
target fill weight of Lincomycin hydrochloride dispensed is 1.031kg instead of 1031.0kg. As per trial
as 1031.0kg in batch formula for preparing 1587 card, the quantity dispensed is 1.119 Kg.
ampoules.
9. Justification shall be submitted for not The firm has submitted that we performed the autoclave
performing terminal sterilization in applied on all trials.
injection. Moreover, step of aseptic filling Highlighted trial card is also attached.
process has also not been mentioned.
10. Justify the weight taken for Lincomycin As per USP, standard concentration is 1.2 mg per ml, so
hydrochloride in different sets of accuracy we have prepared the sample also as 2ml containing
parameter in analytical method validation 600mg of Lincomycin so we pipette 2 ml and transfer to
studies. Moreover, basis for setting 100% 50ml volumetric flask. In second dilution, we transfer 5ml
theoretical contents are required to be clarified. from it to another 50ml volumetric flask, making final
concentration of 1.2mg / ml. For other concentration
spiking was done as per protocol.
11. Chromatograms of Lincomycin injection Chromatograms of Lincomycin injection samples contain
samples contain two principle peaks. two principle peaks.
Clarification is required for these two peaks As this finished product only containing API
(Lincomycin HCl) and excipient (Benzyl Alcohol)
Peak at 16.443 minutes is of LINCOMYCIN and peak on
11.396 minutes is of BENZYL ALCOHOL. Secondly,
210nm of wavelength is used for analysis.

• Clarification of dispensed quantity of Lincomycin hydrochloride for manufacturing of 1587 ampoules of each
trial batch since the quantity mentioned on master formulation is different from trial card.
• Provide COA of primary / secondary reference standard including source and lot number.
71. Name, address of Applicant / Marketing M/s Werrick Pharmaceuticals, Plot # 216-217, Sector I-10/3
Authorization Holder Industrial area, Islamabad
Name, address of Manufacturing site. M/s Werrick Pharmaceuticals, Plot # 216-217, Sector I-10/3
Industrial area, Islamabad
☐ Importer
☐ Export sale
GMP status of the Finished product Panel inspection report conducted on 09-11-2018 wherein the
manufacturer panel unanimously recommended grant of GMP certificate.
Details of fee submitted PKR 20,000/-: Dated: 09-04-2021
PKR 10,000/-: Dated: 10-06-2021
The proposed proprietary name / brand name Wardy Tablets 10mg
Strength / concentration of drug of Active Each film coated tablet Contains:
Pharmaceutical ingredient (API) per unit Empagliflozin……………..10mg
Pharmaceutical form of applied drug Film coated tablet
Pharmacotherapeutic Group of (API) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
The status in reference regulatory authorities Jardiance Tablets 10mg of M/s BOEHRINGER INGELHEIM
(USFDA Approved).
For generic drugs (me-too status) Diampa Tablets 10mg by M/s Getz Pharma Reg. No. 093073
Name and address of API manufacturer. M/s Kaifeng Pharmaceutical (Group) Company
Limited.,
Address: No. 1, Yunan Street, Kaifeng, Henan Province, China.
Module-II (Quality Overall Summary) The firm has submitted QOS as per WHO QOS-PD template. The
firm has summarized information related to nomenclature,
of drug substance and drug product is submitted.
of manufacturing process and controls, assay, tests for related
substance and specifications, analytical procedures and its
of drug substance.
Real time: 30°± 2°C & 65± 5% RH for 24 months
Accelerated: 40°± 2°C & 75± 5% RH for 6 months
Batches: (180205, 180227, 180325)

procedure, content uniformity, impurities, assay and its batch
container closure system and stability studies of drug product.
Pharmaceutical equivalence The firm has submitted pharmaceutical equivalence has been
established against innovator product Jardiance Tablets 10mg
(Batch No. 707214A) by Boehringer Ingelheim by performing
quality tests (Identification, Assay, and Dissolution).
CDP has been performed of developed formulation with
Jardiance Tablets 25mg by Boehringer Ingelheim in Phosphate
Buffer (pH 6.8), Acetate Buffer (pH 4.5) & Acid media (0.1N
HCl).
Analytical method validation/verification of The firm has submitted method validation studies including
product system suitability, specificity, linearity, limit of detection (LOD)
and limit of quantification (LOQ), accuracy, precision and
robustness.
Manufacturer of API M/s Kaifeng Pharmaceutical (Group) Company Limited.
API Lot No. HF180721
Description of Pack
Alu-Alu / Alu-PVC blister pack of 14’s, 28’s Tablets.
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6, 9 (Months)
No. of Batches 03
1. Reference of previous approval of applications The firm has given reference of previous inspection for Xetine
with stability study data of the firm (if any) Tablet 10mg & 20mg dated 3rd march, 2020 and Registration
Board approved products in 294th meeting.
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of DML certificate No. Yu20150031
API manufacturer issued by concerned issued by FDA (Henan Province) valid till 31-12-2025.
3. Documents for the procurement of API with The firm has submitted copy of invoice No. CIN20180726G02
approval from DRAP (in case of import). dated 26-07-2018 wherein the permission to import
Empagliflozin for the purpose of test / analysis / stability studies
and manufacturing is granted.
The firm has submitted copy of clearance certificate showing
import of 1Kg Empagliflozin invoice no 2326/20218 attested by
Assistant director (I&E) dated 10-08-2018.
chromatograms, Raw data sheets, COA, sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR The firm has submitted compliance record of HPLC software 21
& audit trail reports on product testing CFR and audit trail reports on product testing.

6. Record of Digital data logger for temperature The firm has submitted Record of Digital data logger for
(real time and accelerated) time and accelerated).
Sr. # Observations communicated Response by the applicant
1. Provide summarized tabulated results of The firm has provided summarised tabulated results of
verification studies including specificity, analytical method verification studies of drug substance.
accuracy and repeatability (method
precision) performed by the Drug
Product manufacturer for both
drug substance(s).
2. Justification is required for setting the Wardy 10mg is film coated tablet, and the limit for
limit of disintegration time as NMT disintegration time is not more than 30min for coated tablets
30min while dissolution limit as NLT according to British Pharmacopoeia Vol.III, General
85% after 15 min. Moreover, Monographs page III-39, Edition 2021.
clarification is required for the phrase Moreover, Empagliflozin belongs to BCS III class (high
“NLT 85% after 15 min” in dissolution solubility, low permeability) drug according to EUROPEAN
test specifications. MEDICINE AGENCY Assessment report for Jardiance tablets
(Assessment report #EMA/CHMP/137741/2014, Page#11). For
highly soluble and rapidly dissolving drug products (BCS
classes 1 & III, a single point dissolution test specification of
NLT 85% (Q=80%) is recommended by DRAP Guidance
document for setting dissolution specification of immediate
release solid oral dosage form. While the value of time i.e.,
15min “T” is adopted by innovator/reference product.
3. Justification is required for choosing two The FDA Reference for Empagliflozin 10mg, JARDIANCE
different container closure systems as Tablet, is supplied in the Bottles of both 30 (NDC 0597-0152-
Alu-Alu / Alu-PVC Blister Strips while 30) and 90 (NDC 0597-0152-90) packaging, and Institutional
innovator has used Alu-PVC container pack containing 3 blister cards of 10 tablets each (NDC 0597-
closure system. 0153-37). Because of the variability in the packaging of the
FDA Reference, we listed both, ALU-ALU and ALU-PVC, as
our packaging media. The stability studies of Wardy 10mg
claimed the product to be stable in ALU-ALU packaging.
The market competitor of Empagliflozin 10mg, Diampa 25mg
Tablet by Getz Pharma, is available in the market in ALU-ALU
packaging. Thereby, we will also package our product in ALU-
ALU packaging. Also, our product remains stable in ALU-ALU
packaging (as per stability testing), hence further leading
towards ALU-ALU packaging as mentioned in Module 2
Section 2.3.P.8.1.
4. Analytical method verification studies The firm has submitted analytical method validation studies of
including specificity, accuracy and drug substance performed by drug product manufacturer.
repeatability (method precision)
manufacturer for both compendial as
well as non-compendial drug
5. Only dissolution test is mentioned with Dissolution test is mentioned with innovator’s specifications
innovator’s specifications while all other because drug product dissolution specifications of the
test including assay test are mentioned in- innovator/reference product are publicly available in FDA
house. Clarification is required. Clinical pharmacology and Biopharmaceutics review of
Jardiance Tablets, reference ID: 3401482 page 6. While in house
method is used for analysis of our product wardy tablets 10mg
and complete validation of method is performed.

6. Submit date of analysis of The date of analysis of pharmaceutical equivalence of wardy
pharmaceutical equivalence alongwith tablets 10mg with Jardiance tablets 10mg B. #707214A is 18th
chromatograms / spectra. July 2020. Respective chromatograms are attached. While
dissolution results are compared in three different media i.e.,
0.1N HCl, Acetate Buffer pH 4.5, & Phosphate Buffer pH 6.8.
7. Approval of API/ DML/GMP certificate The firm has submitted copy of DML certificate No.
of API manufacturer issued by concerned Yu20150031 issued by FDA (Henan Province) valid till 31-12-
regulatory authority of country of origin 2025.
is required.
Decision: Approved.
• Manufacturer will perform process validation of first three batches as per the commitment submitted in the
registration application.
• Registration letter will be issued after submission of GMP audit report from QA&LT Division, valid within last
three years.
72. Name, address of Applicant / Marketing M/s Werrick Pharmaceuticals, Plot # 216-217, Sector I-10/3
Authorization Holder Industrial area, Islamabad
Name, address of Manufacturing site. M/s Werrick Pharmaceuticals, Plot # 216-217, Sector I-10/3
Industrial area, Islamabad
☐ Importer
☐ Export sale
GMP status of the Finished product Panel inspection report conducted on 09-11-2018 wherein the
manufacturer panel unanimously recommended grant of GMP certificate.
Dy. No. and Date of submission Dy. No.17504 Dated: 23-06-2021
PKR 10,000/-: Dated: 10-06-2021
The proposed proprietary name / brand name Wardy Tablets 25mg
Pharmaceutical ingredient (API) per unit Empagliflozin…………….. 25mg
The status in reference regulatory authorities Jardiance Tablets 25mg
USFDA Approved.
For generic drugs (me-too status) Diampa Tablets 25mg by M/s Getz Pharma Reg. No. 093074
Name and address of API manufacturer. M/s Kaifeng Pharmaceutical (Group) Company
Limited.,
Address: No. 1, Yunan street, Kaifeng, Henan Province, China.
is submitted.

The firm has summarized information related to description and
composition of the drug product, pharmaceutical development,
manufacture, control of excipients, control of drug product,
procedures, its batch analysis and justification of specification,
of drug product.
of manufacturing process and controls, assay, tests for related
substance and specifications, analytical procedures and its
of drug substance.
Real time: 30°C ± 2°C & 65± 5% RH for 24 months
Accelerated: 40° C ± 2°C & 75± 5% RH for 6 months
Batches: (180205, 180227, 180325)
Module-III (Drug Product): The firm has submitted details of description and composition of
the drug product, pharmaceutical development, manufacture,
control of excipients, control of drug product, specifications,
analytical procedures, validation of analytical procedures, its
standard, container closure system and stability studies of drug
product.
Pharmaceutical equivalence The firm has submitted pharmaceutical equivalence has been
established against innovator product Jardiance Tablets 25mg
(Batch No. 707650) by Boehringer Ingelheim by performing
quality tests (Identification, Assay, and Dissolution).
CDP has been performed of developed formulation with
Jardiance Tablets 25mg by Boehringer Ingelheim in Phosphate
Buffer (pH 6.8), Acetate Buffer (pH 4.5) & Acid media (0.1N
HCl).
Analytical method validation/verification of The firm has submitted method validation studies including
product system suitability, specificity, linearity, limit of detection (LOD)
and limit of quantification (LOQ), accuracy, precision and
robustness.
Manufacturer of API M/s Kaifeng Pharmaceutical (Group) Company Limited.,
API Lot No. HF180721
Description of Pack
Alu-Alu / Alu-PVC blister pack of 14’s, 28’s Tablets.
No. of Batches 03
1. Reference of previous approval of applications The firm has given reference of previous inspection for Xetine
with stability study data of the firm (if any) Tablet 10mg & 20mg dated 3rd march, 2020 and Registration
Board approved products in 294th meeting.

2. Approval of API/ DML/GMP certificate of The firm has submitted copy of DML certificate No. Yu20150031
API manufacturer issued by concerned issued by FDA (Henan Province) valid till 31-12-2025.
3. Documents for the procurement of API with The firm has submitted copy of invoice No. CIN20180726G02
approval from DRAP (in case of import). dated 26-07-2018 wherein the permission to import
Empagliflozin for the purpose of test / analysis / stability studies
and manufacturing is granted.
The firm has submitted copy of clearance certificate showing
import of 1Kg Empagliflozin invoice no 2326/20218 attested by
Assistant director (I&E) dated 10-08-2018.
chromatograms, raw data sheets, COA, sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR The firm has submitted compliance record of HPLC software 21
& audit trail reports on product testing CFR and audit trail reports on product testing.
6. Record of Digital data logger for temperature The firm has submitted Record of Digital data logger for
(real time and accelerated). time and accelerated).
Sr.# Observations communicated Response by the applicant
1. Provide summarized tabulated results of The firm has provided summarised tabulated results of
verification studies including specificity, analytical method verification studies of drug substance.
accuracy and repeatability (method precision)
performed by the Drug Product manufacturer
for both compendial as well as non-compendial
drug substance(s).
2. Justification is required for setting the limit of
Wardy 10mg is film coated tablet, and the limit for
disintegration time as NMT 30min while disintegration time is not more than 30min for coated
dissolution limit as NLT 85% after 15 min. tablets according to British Pharmacopoeia Vol.III,
Moreover, clarification is required for the General Monographs page III-39, Edition 2021.
phrase “NLT 85% after 15 min” in dissolution Moreover, Empagliflozin belongs to BCS III class (high
test specifications. solubility, low permeability) drug according to
EUROPEAN MEDICINE AGENCY Assessment report
for Jardiance tablets (Assessment report
#EMA/CHMP/137741/2014, Page#11). For highly
soluble and rapidly dissolving drug products (BCS
classes 1 & III, a single point dissolution test
specification of NLT 85% (Q=80%) is recommended by
DRAP Guidance document for setting dissolution
specification of immediate release solid oral dosage
form. While the value of time i.e., 15min “T” is adopted
by innovator/reference product.
3. Justification is required for choosing two The FDA Reference for Empagliflozin 25mg,
different container closure systems as Alu-Alu JARDIANCE Tablet, is supplied in the Bottles of both
/ Alu-PVC Blister Strips while innovator has 30 (NDC 0597-0152-30) and 90 (NDC 0597-0152-90)
used Alu-PVC container closure system. packaging, and Institutional pack containing 3 blister
cards of 10 tablets each (NDC 0597-0153-37). Because
of the variability in the packaging of the FDA Reference,
we listed both, ALU-ALU and ALU-PVC, as our
packaging media. The stability studies of Wardy 25mg
claimed the product to be stable in ALU-ALU
packaging.
The market competitor of Empagliflozin 10mg, Diampa
25mg Tablet by Getz Pharma, is available in the market

in ALU-ALU packaging. Thereby, we will also package
our product in ALU-ALU packaging. Also, our product
remains stable in ALU-ALU packaging (as per stability
testing), hence further leading towards ALU-ALU
packaging as mentioned in Module 2 Section 2.3.P.8.1.
4. Analytical method verification studies The firm has submitted analytical method validation
including specificity, accuracy and studies of drug substance performed by drug product
repeatability (method precision) performed by manufacturer.
the Drug Product manufacturer for both
5. Only dissolution test is mentioned with Dissolution test is mentioned with innovator’s
innovator’s specifications while all other test specifications because drug product dissolution
including assay test are mentioned in-house. specifications of the innovator/reference product are
Clarification is required. publicly available in FDA Clinical pharmacology and
Biopharmaceutics review of Jardiance Tablets, reference
ID: 3401482 page 6. While in house method is used for
analysis of our product wardy tablets 25mg and complete
validation of method is performed.
6. Submit date of analysis of pharmaceutical The date of analysis of pharmaceutical equivalence of
equivalence alongwith chromatograms / wardy tablets 25mg with Jardiance tablets 10mg B.
spectra. #707214A is 18th July 2020. Respective chromatograms
are attached. While dissolution results are compared in
three different media i.e., 0.1N HCl, Acetate Buffer pH
4.5, & Phosphate Buffer pH 6.8.
7. Approval of API/ DML/GMP certificate of The firm has submitted copy of DML certificate No.
API manufacturer issued by concerned Yu20150031 issued by FDA (Henan Province) valid till
regulatory authority of country of origin is 31-12-2025.
required.
Decision: Approved.
• Registrationletter will be issued after submission of GMP audit report from QA&LT Division, valid within last
three years.
73. Name, address of Applicant / Marketing M/s Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129, North
Authorization Holder Western Industrial Zone, Bin Qasim, Karachi-75020, Pakistan.
Name, address of Manufacturing site. M/s Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129, North
Western Industrial Zone, Bin Qasim, Karachi-75020, Pakistan.
☐ Importer
☐ Export sale
GMP status of the Finished product GMP inspection report dated 11-08-2020 concluded that overall
manufacturer GMP compliance of the firm with respect to building, facilities

and procedures demonstrated was satisfactory at the time of
inspection.
The proposed proprietary name / brand name Rebamide 100mg tablet
Strength / concentration of drug of Active Each film coated tablet contains
Pharmaceutical ingredient (API) per unit Rebamipide…………….100mg
Pharmaceutical form of applied drug White round biconvex tablet coated plain on both sides.
Pharmacotherapeutic Group of (API) Gastro-protective drug
Reference to Finished product specifications JP specifications
Proposed Pack size 10’s, 20’s, 30’s
The status in reference regulatory authorities Mucosta Tablets 100mg of M/s Otsuka Pharmaceutical Co., Ltd
(PMDA approved)
For generic drugs (me-too status) Mucosta 100mg tablet by Otsuka (Reg # 078129)
Name and address of API manufacturer. M/s Jiangxi synergy pharmaceutical, Co., Ltd
Jiangxi fengxin Industrial part, fengxin, Jiangxi province, P.R.
China
Module III (Drug Substance) Official monograph of Rebamipide is present in JP. The firm
has submitted details of nomenclature, structure, general
Real time: 30°C ±2°C /65% ±5%RH for 60 months
Accelerated: 40°C ±2°C / 75% ±5%RH for 6 months
Batches: (20100704, 20100705, 20100706)
dissolution profile innovator product Mucosta 100mg tablet (batch # 7B79MT3)
by Otsuka Pharmaceutical Co., Ltd by performing quality tests
(Physical appearance, thickness, hardness, disintegration,
Dissolution, Assay).
CDP has been performed with Mucosta 100mg Tablet by otsuka
Pharma in acidic media (pH 0.1N HCl) & Phosphate Buffer (pH
6.8, 4.5, 6.0). The values for f1 and f2 are in the acceptable range.

product accuracy, precision, LOD, LOQ)
Manufacturer of API M/s Jiangxi synergy pharmaceutical, Co., Ltd
Jiangxi fengxin industrial part, fengxin, Jiangxi province, P.R.China
API Lot No.
Description of Pack
Alu / PVC Blister pack (10’s, 20’s, 30’s)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. TF-01 TF-02 TF-03
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted reference of previous inspection report
with stability study data of the firm (if any) of Rofair 500 mcg Tablet which is conducted on 25-06-2019.
The report confirms that:
HPLC system is 21 CFR part II compliant.
Digital data logger was present.
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of DML No. GAN 20160125
manufacturer issued by concerned regulatory issued by Jiangxi province FDA valid till 15-02-2021.
authority of country of origin. The firm has submitted copy of GMP certificate (No. 2017001)
issued by Jiangxi CCD valid till 23-07-2022.
3. Documents for the procurement of API with The firm has submitted copy of Form 6 license no. 2782 cleared
approval from DRAP (in case of import). by AD (I & E) DRAP, dated 12-10-2017. However, invoice is
not attested.
5. Compliance Record of HPLC software 21CFR The firm has submitted compliance Record of HPLC software
& audit trail reports on product testing 21CFR & Audit trail on testing reports of product submitted.
No.
1. Copies of the Drug substance specifications and The firm has submitted copies of drug substance
analytical procedures used for routine testing of specifications and analytical procedures from both drug
the drug substance / active pharmaceutical substance manufacturer and drug product manufacturer.
ingredient by both drug substance & drug Product
manufacturer.

parameters like specificity, accuracy and report of Rebamipide by titration method.
Drug Product manufacturer for both compendial
as well as non-compendial drug substance(s) shall
be submitted.
3. COA of primary / secondary reference standard The firm has submitted copy of CoA of working
including source and lot number shall be standard of Rebamipide (lot # 201639).
provided.
4. List of all components of the dosage form, and The firm has submitted qualitative and quantitative
their amount on a per unit basis, the function of composition alongwith function of components and
the components, and a reference to their quality reference to their quality standards.
standards (e.g. compendial monographs or
manufacturer’s specifications) shall be submitted.
5. Details of batch numbers of reference product and Details of pack of innovator product Mucosta Tablet
test formulation used for Pharmaceutical 100mg (Batch # 7B79MT3) of M/s Otsuka
equivalence are required. pharmaceutical Co., Ltd have been submitted.
6. The results of analytical method verification The firm has provided summarized tabulated results for
studies need to be summarized in tabulated form linearity, accuracy, precision and specificity.
for each parameter since only chromatograms are
presented for each parameter.
7. The copies of complete analysis of at least two Batch analysis of two batches of Rebamipide tablet
batches shall be provided. 100mg were provided.
8. Those impurities that are degradation product Details of related substances were included in finished
shall be included in the specifications. product specifications.
9. Justification of specification of non-
Since the monograph of Rebamipide Tablet 100mg is
pharmacopeial product shall be based on batch available in Japanese pharmacopoeia. Therefore, no
analysis results. justification of specifications is required.
10. Description of the primary container closure The firm has provided specifications of PVC film clear
systems shall be submitted. transparent and Aluminium Foil Blister.
11. The results of stability data of B. No.: 002 (TF-
The firm has submitted 6-month accelerated and 24-
02) are lying borderline limit of 95% at 18 month real time stability study data of applied product.
months. Result of 24-month stability time point is
The assay result of 24-month time point is 95.09% for
not submitted. B. No. 002 which is lying at borderline limit of 95% -
105%.
12. Submitted chromatograms do not reflect the UV Details of UVProbe software containing wavelength of
detector wavelength at which analysis has been 326 nm have been provided.
conducted.
13. The submitted copy of DML is expired and The firm has submitted copy of GMP certificate of M/s
submitted copy of GMP certificate is not issued Jiangxi Synergy Pharmaceutical Co., Ltd, china issued
by concerned regulatory authority of country of by Jiangxi Food and Drug Administration. The
origin. certificate is valid till 23-07-2022.
14. Documents for the procurement of API with The firm has submitted copy of invoice for the import
approval from DRAP including commercial of Rebamipide JP17 (260g) dated 18-07-2017 received
invoice. through DHL courier. The invoice is not cleared by AD
(I&E) of field office.
Decision: Deferred for submission of aanny document confirming that material (Rebamipide (260g)) has been
imported and cleared by Custom authorities against the submitted invoice.
74. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-205
Authorization Holder Industrial Triangle, kahuta Road, Islamabad-25000, Pakistan.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-205
Industrial Triangle, kahuta Road, Islamabad-25000, Pakistan.
☐ Importer

☐ Export sale
GMP status of the Finished product The firm is granted GMP certificate based on inspection
manufacturer conducted on 24-10-2018 and it is valid till 23-10-2021.
Request for GMP inspection of premises is submitted by firm,
R&I dated: 10-06-2021.
Dy. No. and date of submission Dy No. 17052: Dated: 18-06-2021
The proposed proprietary name / brand name Pain Void Gel 1%
Strength / concentration of drug of Active Each 50g contains:
Pharmaceutical ingredient (API) per unit Diclofenac sodium……….………500 mg
(in the form of Diclofenac epolamine……. 646.4mg)
Pharmaceutical form of applied drug Topical gel
Pharmacotherapeutic Group of (API) NSAIDs
Reference to Finished product specifications Innovator specifications
The status in reference regulatory authorities FLECTOR 1% GEL of IBSA Institute Biochimique SA
(ANSM approved)
For generic drugs (me-too status) N/A
Name and address of API manufacturer. M/s AMOLI ORGANICS Pvt. Ltd.,
Plot No. 322/4, 40 Shed Area, G.I.D.C., VAPI – 396 195,
District- Valsad, Gujarat State, India.
impurity & related substances, specifications, analytical
Real time: 30°C±2°C/65% ± 5%RH for 60 months
Accelerated: 40°C ± 2°C/75% ± 5%RH for 6 months
Batches: (DAP/1012/0003A, DAP/1012/0004A,
DAP/1012/0004A).

Pharmaceutical equivalence and comparative The firm has performed pharmaceutical equivalence profile of
dissolution profile their developed formulation Pain Void 1% Gel (B
#ST19H042) with reference product Flector Gel 1% (B #
136708) of M/s IBSA pharmaceuticals. The results showed
that release profile of both test and comparator products were
comparable.
CDP is not applicable.
Manufacturer of API M/s AMOLI ORGANICS Pvt. Limited.,
Plot No. 322/4, 40 Shed Area, G.I.D.C., Vapi, District- Valsad, State-Gujarat, India.
API Lot No. DAP/1803/0003A
Description of Pack
Aluminium Tube packed in unit carton (1’s)
Real Time: 0, 3, 6, 9, 12, 18 (Months)
Batch No. ST19H042 ST19H043 ST19H044
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to previous inspection of stability data of
with stability study data of the firm (if any) the same dosage form on the basis of which Registration Board
in 288th meeting decided to approve registration of Cordin Gel
4% (Chlorhexidine Gluconate 7.1% eq. to
Chlorhexidine………4%w/w).
Inspection date: 9-10th Jan 2019.
The report shows that:
The HPLC software is 21 CFR compliant.
The firm has provided data loggers with stability chambers.
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate (No.
manufacturer issued by concerned regulatory 20031925) issued by Food & drug Control Administration
authority of country of origin. valid till 16-03-2023.

3. Documents for the procurement of API with The firm has submitted copy of invoice for the import of
approval from DRAP (in case of import). Diclofenac Epolamine (02 Kg, Invoice # 18-19/VAP/00517)
and attested copy of form 6 by AD (I&E) DRAP, Islamabad
dated 08-11-2018.
chromatograms, raw data sheets, COA, summary sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & The firm has submitted compliance Record of HPLC software
audit trail reports on product testing. 21CFR & Audit trail on testing reports of product submitted.
6. Record of Digital data logger for temperature and Firm has submitted record of data logger for temperature and
humidity monitoring of stability chambers (real humidity monitoring of real time and accelerated stability
time and accelerated) chambers.

1. Justification/clarification is required As per innovator, the active substance of Flector 1% gel
regarding fill weight of Diclofenac epolamine is Diclofenac sodium as Diclofenac epolamine salt,
as 646.5mg in applied composition. corresponding to 1g per 100g Diclofenac sodium as drug
substance.
Molecular weight of Diclofenac epolamine = 411.3
Molecular weight of Diclofenac Sodium = 318.1
This means
318.1grams of Diclofenac Sodium = 411.3g Diclofenac
Epolamine
So,
01gram Diclofenac Sodium= (411.3/318.1) = 1.293grams
For 1% Gel
Each 100grams of the Gel will contain 1.293grams
Diclofenac Epolamine corresponding to 1g Diclofenac
sodium.
As each tube contains 50grams gel, so
each tube will contain= 1.293/2=0.64649grams or
646.5mg
2. Pharmaceutical equivalence should contain Due to limited quantity of innovator sample only all major
results of all the quality tests of the developed quality tests have been performed.
formulation and the reference product.
3. Drug product specification does not include • Assay of isopropyl alcohol in GC based test.At the time
tests of assay of isopropyl alcohol, content of of product development lab was not equipped with
dione impurity, viscosity and microbial purity GC.At the moment we are in the process of purchasing
as specified in reference formulation. GC.This test will be included in commercial batches.
The same tests should include in • Assay of dione impurity has been performed in the name
pharmaceutical equivalence and stability of impurity-A (1-(2,6-dichlorophenyl)-1,3-dihydro-2H-
study data results. indol-2-one)-, impurity mentioned in DMF.
See Annexure III
• Viscosity being a parameter required for smooth filling
of Gel tubes, which has been fixed at pre-formulation
batches. Results are attached for your concern in
Annexure IV.
• Microbial purity was performed initially and after 6
months only. Results are attached in Annexure V.
We followed the specification parameters of
Diclofenac Gel as per European Pharmaceopeia, which
doesn’t mention this test in its monograph but
innovator mentions in its SmPC.

Moreover, these parameters have been updated in
specifications for future working.
4. Submitted chromatograms do not reflect the The Analysis of Pain Void Gel 1% is performed on two
UV detector wavelength at which analysis has different HPLC systems. Analysis of first 6 months &
been conducted. 24th month has been performed on one HPLC (with
software version 7.4.1.95) and 9th ,12th, and 18th month is
performed on second HPLC (with clarity software
version 6.1.0.130)
The older version does not show wavelength on
chromatograms.
Photographic evidence of Techrom by clarity attached.
Decision: Approved. The Board further decided that the firm shall submit performance of assay test of isopropyl
alcohol, content of “dione impurity” by GC method and viscosity, as recommended by Public assessment report
of innovator product, before issuance of registration letter.
Case No.06: Registration applications of local manufacturing of human drugs submitted on CTD format
a. Deferred Cases
75. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (Pvt.) Ltd.
Authorization Holder Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt.) Ltd.
Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad
☐ Importer
GMP status of the firm The Firm has submitted copy panel inspection dated 24-12-
2018 wherein renewal of DML was granted.
Evidence of approval of manufacturing facility Firm has submitted copy of Section approval letter dated 13th
June, 2107 specifying Tablet General section.
☐ Export sale
Details of fee submitted PKR 20,000/-: 21-02-2020, 30,000/- 10-03-2020
The proposed proprietary name / brand name Asprala 81mg/40mg Tablet
Strength / concentration of drug of Active Each Film coated delayed release tablet contains:
Pharmaceutical ingredient (API) per unit Aspirin…………..81mg (Delayed release)
Omeprazole……….40mg (Immediate release)
Pharmaceutical form of applied drug Film coated delayed release Tablet
Pharmacotherapeutic Group of (API) Antiplatelet agent and proton pump inhibitor
Reference to Finished product specifications Innovators specifications
Proposed Pack size 1 x10’s
The status in reference regulatory authorities YOSPRALA Tablets 81mg /40mg by Arelez
Pharmaceuticals (USFDA approved)
For generic drugs (me-too status) OMO/ASPER Tablets 81mg /40mg by M/s Helix

Name and address of API manufacturer. Aspirin: M/s Shangdong Xinhua Pharmaceutical Co. Ltd. 14
Dongyi Road, Zhangdian District, Zibo city, Shangdong
province, China
Omeprazole: M/s Everest Organics Limited, Sadasivpet
(Mandal) Medak, Andra Pradesh, India
its validation, batch analysis and justification of specification,
Module-III Drug Substance: Firm has submitted detailed drug substance data related to
procedures and its validation, batch analysis and justification
Stability Studies of Drug Substance Aspirin: The Firm has submitted 6months accelerated (40oC
(Conditions & duration of Stability studies) ± 2oC/75%± 5% RH) and 60months real time (30oC ± 2
o
C/60%± 5% RH) stability study data of 3 batches.
Omeprazole: The Firm has submitted 6months accelerated
(40oC ± 2oC/75%± 5% RH) and 48months real time (30oC ±
2 oC/60%± 5% RH) stability study data of 3 batches.
drug product, specifications, analytical procedures, validation
of analytical procedures, batch analysis, justification of
Pharmaceutical Equivalence and Comparative Firm has submitted comparative dissolution study of their
Dissolution Profile Batch No. TT-001 with the innovator product i.e. Yosprala
325/40mg Tablets. Firm has performed CDP in 0.1 N HCl,
acetate buffer and phosphate buffer. Comparison of results
indicate that omeprazole releases more than 85% in 10
minutes in pH 1.2 and 6.8, therefore calculation for f2 factor
was not made. However, for aspirin F2 factor is 58.42, hence
dissolution profile of both products found comparable.
Analytical method validation/verification of Firm has submitted protocols and reports of validation studies
product of analytical method.
Manufacturer of API Aspirin: M/s Shangdong Xinhua Pharmaceutical Co. Ltd. 14 Dongyi Road, Zhangdian
District, Zibo city, Shangdong province, China
Omeprazole: M/s Everest Organics Limited, Sadasivpet (Mandal) Medak, Telangana,
India
API Lot No. Aspirin: 171315
Omeprazole: OME/E-222/16
Description of Pack
Alu-Alu Blister

Frequency Accelerated: 0, 1, 2, 3,4, 6 (Months) Real Time: 0, 3, 6 (Months)
ASPRALA 81MG/40MG TABLET
Batch No. TT-001 TT-002 TT-003
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to last onsite panel inspection for instant
with stability study data of the firm (if any) dosage form conducted during last two years Promig plus
Tablets on 13th & 14th March, 2019 which confirms that:
HPLC is 21 CFR II compliant.
Digital data loggers were available for continuous
monitoring of temperature and humidity.
2. Approval of API/ DML/GMP certificate of API Aspirin: The firm has submitted copy of GMP certificate for
manufacturer issued by concerned regulatory M/s Shangdong Xinhua Pharmaceutical Co. Ltd. 14 Dongyi
authority of country of origin. Road, Zhangdian District, Zibo city, Shangdong province,
China issued by Shangdong Food and Drug Administration.
It is valid till 18-10-2022.
Omeprazole: The firm has submitted copy of GMP
certificate for M/s Everest Organics Limited, Sadasivpet
(Mandal) Medak, Telangana, India issued by Government of
Telangana, Drugs Control administration. It was valid till 31-
03-2017.
3. Documents for the procurement of API with Aspirin: Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). specifying import of 5Kg of Aspirin. The invoice is attested
by AD (I&E) DRAP Islamabad office dated 11-06-2018.
Omeprazole: Firm has submitted copy of commercial
invoice specifying import of 100Kg of Aspirin. The invoice
is attested by AD (I&E) DRAP Islamabad office dated 13-
05-2016.
attested respective documents like along with chromatograms, raw data sheets, COA and
chromatograms, Raw data sheets, COA, summary data sheets.
5. Compliance Record of HPLC software 21CFR Firm has submitted certificate of compliance along with
& audit trail reports on product testing audit trail record of product testing of HPLC for all test
intervals.
6. Record of Digital data logger for temperature Firm has submitted record of digital data logger for
and humidity monitoring of stability chambers temperature and humidity monitoring of real time and
(real time and accelerated). accelerated stability chambers.
Evidence of import of API including copy Evidence of import of both APIs attested by AD (I&E),
of commercial invoice cleared by DRAP Islamabad is submitted
field office.

GMP certificate of API manufacturer issued The firm has submitted copy of GMP certificate of M/s
by regulatory authority of country of origin Everest Organics Limited, India issued by Drugs control
needs to be submitted. administration, Government of Telangana, India. The
certificate is valid till 08-08-2022.
Provide certificate of analysis of each batch Submitted
of API used in the stability studies of the
three submitted batches.
Provide data of pharmaceutical equivalence The firm has submitted that we performed pharmaceutical
against innovator product including data of equivalence against comparator product that is Yosprala
comparative dissolution profile to justify 325mg/40mg tablet. But unfortunately, we are unable to
your formulation development as per the arrange innovator pack / comparator of one of its strength
requirement of section 3.2.P.2.2.1. i.e., Yosprala 81mg/40mg Tablet. Being same dosage form
and same kind of release profile of both strengths, the firm
has requested to accept the study of higher strength of same
product against its lower strength also.
Submit data to comply the decision of 293rd The firm has submitted analytical method validation
meeting of Registration Board, which states studies.
that “Analytical Method Verification
studies including specificity, accuracy and
by the Drug Product manufacturer for both
substance(s) shall be submitted”.
The drug substance and drug product part of The firm has submitted details of drug substance and drug
Module III needs to be submitted as per product as per 293rd meeting of Registration Board.
293rd meeting of registration covering all the
sections mentioned in that document.
Previous Decision: Registration Board decided to defer registration application of Asprala 81mg/40mg Tablet for
submission of pharmaceutical equivalence and comparative dissolution profile with innovator / comparator product of
same strength (M-296).
Evaluation by PEC: The firm has submitted pharmaceutical equivalence data of applied formulation Asprala 81/40mg
tablet (Batch # ST21G029) against innovator product Yosprala 81/40mg tablet (Batch # 3146104) of M/s Aralez
Pharmaceutical US Inc.
The firm has submitted CDP data of test and reference formulation in pH 1.2, buffer pH 4.5 and phosphate buffer pH
6.8 and found similarity factor f2.
Decision: Approved.
Manufacturer will place first three production batches on long term stability studies throughout proposed shelf
Manufacturer will perform process validation of first three batches as per the commitment submitted in the
Case No. 07 Registration applications of import human drugs submitted on CTD format
a. New cases
76. Name, address of Applicant / Importer M/s Al-Habib Pharmaceuticals, Plot # 81-B, Block B,
SMCHS, Karachi.
Details of Drug Sale License of importer DSL No.: 1245
Address: Al-Habib Pharmaceuticals, 81-B, Block B,
SMCHS, Karachi.
Address of Godown:
1. Plot No. 10, sector 25 KIA, Karachi
2. HT-8, Landhi Industrial Area, Karachi
Status: Drug License by way of wholesale

Name and address of marketing authorization M/s Laboratorios IMA S.A.I.C, Palpa 2862, Ciudad
holder (abroad) Autonoma de Buenos Aires, Argentina.
Name, address of manufacturer(s) M/s Laboratorios IMA S.A.I.C, Palpa 2862, Ciudad
Autonoma de Buenos Aires, Argentina.
Name of exporting country Argentina
Detail of certificates attached (CoPP, Freesale CoPP:
certificate, GMP certificate) Original legalized CoPP (certificate No. 191105) valid till
12-10-2021 issued by National Institute of Drugs Avenida
Caseros 2161, Ciudad Autonoma de buemos Aires -
Republica Argentina. The applied product is available for
free sale in exporting country. The facilities and operations
conform to WHO-GMP.
Details of letter of authorization / sole agency Notarized copy of sole agency agreement is submitted
agreement whereby M/s Laboratorios IMA S.A.I.C, authorizes M/s Al-
Habib Pharmaceuticals to Import and commercialize
different products including Paclitaxel 30mg injection
☒ Importer
☐ Export sale
Details of fee submitted PKR 100,000: Dated: 29-03-2021
Differential fee: PKR 50,000: Dated: 05-07-2021
The proposed proprietary name / brand name PACLITAXEL AHP 30MG/VIAL
Pharmaceutical ingredient (API) per unit Paclitaxel concentrated solution for injection…………….
30mg
Pharmaceutical form of applied drug Concentrated Solution for injection
Pharmacotherapeutic Group of (API) Anti-Cancer (L01CD03)
Proposed Pack size 1 Vials
The status in reference regulatory authorities Taxol® Paclitaxel 30 mg injection by Bristol-Myers Squibb
(USFDA Approved)
For generic drugs (me-too status) Taxol 30 mg Injection by Bristol-Myers Squibb
(Reg#016180)

controls, impurities, specifications, analytical procedures
Name, address of drug substance manufacturer M/s Shanghai Cdymax Pharmaceuticals Co., Ltd. (Huinan
Site) No.9125 Hunan Road, Shanghai 201300, China.
Module-III Drug Substance: Firm has submitted detailed drug substance data for both
sources related to nomenclature, structure, general
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of API
(Conditions & duration of Stability studies) at accelerated as well as real time conditions. The real time
stability data is conducted at 25°C ± 2°C / 60% ± 5% RH.
The stability study data is till 36 months.
drug product, specifications, analytical procedures,
Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence data of test product of M/s IMA
Dissolution Profile Laboratories (Batch # Pacli/30/01) has been submitted
against the reference product Taxol® Paclitaxel 30 mg
injection (Batch # 1G00216-1) by M/s Bristol-Myers Squibb.
Analytical method validation/verification of Firm has submitted analytical method validation studies for
product the applied product.
Container closure system of the drug product Type I glass vial, colorless × 5mL;
Bromobutyl elastomeric with Teflon treatment Stopper.
Aluminum capsule with green flip off closure.
It has a label which includes: identificatory data,
composition, route of administration, storage conditions,
expiration date and batch number.
Stability study data of drug product, shelf life and Firm has submitted 6-months accelerated and 24 month real
storage conditions time stability study data of 3 batches.
24 months real time stability data at 30°C ± 2°C, 65% ±
5%RH.
06 month accelerated stability data 40°C ± 2°C / 75% ±
5%RH of 03 batches.
Batch Batch size Starting date
number
6135/A 2000 vials 06-2012
6138/A 2000 vials 06-2012
6143/A 2000 vials 06-2012
Evaluation by PEC:

1. Applied product is developed as per innovator’s The firm has submitted that the applied product is
specifications while the product is available in developed as per USP specifications. The details of
USP. Clarification is required. analytical procedures and specifications were provided
to confirm that the product is developed as per USP.
2. Submitted copy of COPP is expired on 12-10- We submitted the CTD dossier in DRAP in the month of
2021. Updated copy of COPP is required. July-2021. The COPP expired during evaluation period
after submission in DRAP whereas the COPP was valid
at the time of R&I therefore it is requested to proceed the
registration process.
3. Submit copy of the drug product specification(s) The complete details of specifications, acceptance
including tests, acceptance criteria and reference criteria and reference to analytical procedure alongwith
to analytical procedure shall be provided. details of impurities and degradable substances were
Specifications shall also include the details of provided.
impurities (as applicable) as per requirement of
Section 3.2.P.5.1.
4. Submit detailed analytical procedures used for Complete analytical procedures for drug product,
testing the drug product as per Section 3.2.P.5.2. microbial limits as well as sterility test submitted.
5. Justify the storage conditions under which Firm has submitted 6-months accelerated and 24-month
stability study data has been performed since the real time stability study data of 3 batches.
innovator product has recommended the storage 24 months real time stability data at 30°C ± 2°C, 65% ±
of 25 °C for the said product. 5%RH.
5%RH of 03 batches.
Batch Batch size Starting date
number
6135/A 2000 vials 06-2012
6138/A 2000 vials 06-2012
6143/A 2000 vials 06-2012
Decision: Approved with shelf life of 18 months as per Policy for inspection of Manufacturer abroad and
verification of local storage facility.
77. Name, address of Applicant / Importer M/s Al-Habib Pharmaceuticals, Plot #81, block B, SMCHS,
Karachi.
Address: Al-Habib Pharmaceuticals, 81-B, block B,
SMCHS, Karachi.
Godown: 1. Plot No. 10 sector 25 KIA, Karachi
Validity: 18/05/2022
Detail of certificates attached (CoPP, Freesale CoPP: Copy of CoPP (certificate No. 191105) valid till 12-
certificate, GMP certificate) 10-2021 issued by National Institute of Drugs, Argentina.
The applied product is available for free sale in exporting
country. The facilities and operations conform to WHO-
GMP.
Details of letter of authorization / sole agency Sole Agency Agreement: Notarized copy of sole agency
agreement agreement is submitted whereby M/s M/s Laboratorios IMA
S.A.I.C, authorizes M/s Al-Habib Pharmaceuticals to Import

and commercialize different products including Paclitaxel
100mg injection.

☒ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 20440 _Dated: 27-07-2021
Details of fee submitted PKR 100,000 Dated: 29-03-2021
Differential fee: PKR 50,000 Dated: 05-07-2021
Strength / concentration of drug of Active Each Vial contains:
Pharmaceutical ingredient (API) per unit Paclitaxel concentrated solution for Injection……. 100mg
Proposed Pack size 1 Vials
The status in reference regulatory authorities Paclitaxel 100mg / 16.7 ml injection by Hospira Inc.
(USFDA Approved)
For generic drugs (me-too status) Taxol Injection 100 mg / 16.7 ml injection by Bristol-Myers
Squibb (Reg#021106)
Name, address of drug substance manufacturer Shanghai Cdymax Pharmaceuticals Co., Ltd. (Huinan Site)
No.9125 Hunan Road, Shanghai 201300, China

(Conditions & duration of Stability studies) substance at accelerated as well as real time conditions. The
real time stability data is conducted at 25°C ± 2°C. The
stability study data is till 36 months.
Dissolution Profile Laboratories (Batch # Pacli/100/01) have been submitted
injection (Batch # 1H00216-1) by M/s Bristol-Myers Squibb.
Container closure system of the drug product Type I glass vial, colorless × 16.7mL;
Stability study data of drug product, shelf life and Firm has submitted 6-months accelerated and 24-month real
storage conditions time stability study data of 3 batches.
24 months real time stability data at 30°C ± 2°C, 65% ±
5%RH.
5%RH of 03 batches.
Batch number Batch size
6136/B 2000 vials
6137/B 700 vials
6141/B 700 vials
Evaluation by PEC:
Section 3.2.P.5.1.

5. Justify the storage conditions under which The firm has submitted 6-months accelerated and 24-
stability study data has been performed since the month real time stability study data of 3 batches.
5%RH of 03 batches.
Batch number Batch size Starting date
6136/B 2000 vials 06-2012
6137/B 700 vials 06-2012
6141/B 700 vials 06-2012
Karachi.
SMCHS, Karachi.
Godown: Plot No. 10 sector 25 KIA, Karachi
Detail of certificates attached (CoPP, Freesale CoPP: Original legalized CoPP (certificate No. 191105)
certificate, GMP certificate) valid till 12-10-2022 issued by National Institute of Drugs,
Argentina. The applied product is available for free sale in
exporting country. The facilities and operations conform to
WHO-GMP.
agreement whereby M/s M/s Laboratorios IMA S.A.I.C, authorizes M/s
Al-Habib Pharmaceuticals to Import and commercialize
different products including paclitaxel 150mg injection
☒ Importer
☐ Export sale
Details of fee submitted PKR 100,000; Dated: 29-03-2021
Differential fee: PKR 50,000 Dated : 05-07-2021

Pharmaceutical ingredient (API) per unit Paclitaxel concentrated solution for Injection …………….
150mg
Proposed Pack size 1’s Vial
The status in reference regulatory authorities Taxol® Paclitaxel 150 mg injection by Bristol-Myers Squibb
(USFDA Approved).
For generic drugs (me-too status) Paclitaxel 150mg / 25mL Injection by Novartis Pharma
Pakistan (Reg # 066170)
Name, address of drug substance manufacturer Shanghai Cdymax Pharmaceuticals Co., Ltd. (Huinan Site)
No.9125 Hunan Road, Shanghai 201300, China
stability data is conducted at 25°C ± 2°C. The stability study
data is till 36 months.
Dissolution Profile Laboratories (Batch # Pacli/150/01) has been submitted
injection (Batch # 1K00216-1) by M/s Bristol-Myers Squibb.
Container closure system of the drug product Type I glass vial, colorless × 25mL;

Stability study data of drug product, shelf life and The firm has submitted 6-months accelerated and 24-
storage conditions month real time stability study data of 3 batches.
24 months real time stability data at 30°C ± 2°C, 65%
± 5%RH.
06 month accelerated stability data 40°C ± 2°C / 75%
± 5%RH of 03 batches.
6139/C 400 vials 05-2012
6140/C 400 vials 06-2012
6142/B 400 vials 07-2012
Evaluation by PEC:
Section 3.2.P.5.1.
5. Justify the storage conditions under which The firm has submitted 6-months accelerated and 24-
stability study data has been performed since the month real time stability study data of 3 batches.
5%RH of 03 batches.
6139/C 400 vials 05-2012
6140/C 400 vials 06-2012
6142/B 400 vials 07-2012
79. Name, address of Applicant / Importer M/s CSM Pakistan Guarantee Ltd, 23-C Old Sunset
Boulevard Phase II, DHA Karachi.
Details of Drug Sale License of importer License No: 545
Address: Ground Floor, Plot No. A-65, Sec: 6F, Mehran
Town, Korangi Industrial Area, Karachi
Status: By way of Wholesale

Name and address of marketing authorization M/s China Resources Zizhu Pharmaceutical Co. Ltd. Plot
holder (abroad) No. 27, Chaoyang North Road, Chaoyang District, Beijing,
P. R 100024, China.
Name, address of manufacturer(s) M/s China Resources Zizhu Pharmaceutical Co. Ltd. Plot
No. 27, Chaoyang North Road, Chaoyang District, Beijing,
P. R 100024, China.
Name of exporting country China
Detail of certificates attached (CoPP, Free sale CoPP: The firm has submitted original, legalized copy of
certificate, GMP certificate) CoPP certificate (No. Beijing 20200407) dated 13-10-2020
issued by Beijing Municipal Medical Products
Administration for Mifepristone 0.2g Tablet. The CoPP
confirms free sale status of the product in exporting country
as well as GMP status of the manufacturing site through
periodic inspection every 3 year.
The name of importing country on CoPP is mentioned as
Pakistan. Furthermore, the CoPP is valid till 11-10-2022.
Details of letter of authorization / sole agency The firm has submitted copy of agreement of distribution
agreement from China Resources Zizhu Pharmaceutical Co. Ltd. The
agreement specifies that the manufacturer appoints M/s CSM
Pakistan (Guarantee) Ltd to register their products in
Pakistan. The authorization agreement is valid till 31-03-
2024.
☒ Importer
☐ Export sale
☐ Bulk import and local repackaging
☐ Bulk import and local repackaging for export purpose
only
Dy. No. and date of submission Dy. No. 17347: Dated:22-06-2021
The proposed proprietary name / brand name Mi-Safe 200 Tablet
Pharmaceutical ingredient (API) per unit Mifepristone………...200mg
Pharmaceutical form of applied drug Mifepristone 200mg 1 tablet/blister/box.
Pharmacotherapeutic Group of (API) Other sex hormone and modulator of the reproductive
function/antiprogestogen, ATC code: G03XB01
Reference to Finished product specifications In-house specifications
Proposed unit price Rs 3,000/- single tablet / box
The status in reference regulatory authorities MIFEPREX 200mg tablet of M/s Danco Labs LLC (USFDA
Approved)

Mifepristone 200mg tablet of M/s China Resources Zizhu
Pharmaceutical Co (WHO prequalified product).
Name, address of drug substance manufacturer M/s Qinhuangdao Zizhu Pharmaceutical Co., Ltd
No.10, Longhai Road, Economic and Technological
Development Zone, Qinhuangdao City, Hebei Province,
China.
Module-II (Quality Overall Summary) The applied product is present in WHO prequalified
medicine list (WHO reference number, RH052).
Firm has submitted QOS as per WHO QOS-PD template.
manufacturers, characterization, impurities, specifications,
analytical procedures and its validation, batch analysis and
closure system and stability studies of drug substance.
The firm has summarized information of drug product
including its description, composition, pharmaceutical
development, manufacture, manufacturing process and
process control, process validation protocols, control of
excipients, control of drug product, specifications, analytical
procedures, validation of analytical procedures, batch
Module-III (Drug Substance) The firm has submitted information related to nomenclature,
manufacturers, characterization, impurities, specifications,
Stability Studies of Drug Substance Accelerated testing: 40°C ± 2°C and 75% RH ± 5% RH for
(Conditions & duration of Stability studies) 06 months.
Long-term testing: 30°C ± 2°C and 65% RH ± 5% RH for 72
months.
Module-III Drug Product: The firm has submitted details of manufacturers, description
specifications, analytical procedure, analytical method
validation studies, batch analysis and justification of
and stability studies of drug product.
Pharmaceutical Equivalence and Comparative The firm has submitted pharmaceutical equivalence study of
Dissolution Profile test formulation with reference product Mifegyne 200mg
tablet (Batch # 11071) of M/s Macors-89000 Auxerre –
France in by performing quality tests (Appearance,
Identification (HPLC), Dissolution and assay).
The firm has submitted CDP data of test formulation with
reference product Mifegyne 200mg tablet (Batch # 11071) of
M/s Macors-89000 Auxerre – France in pH 1.2 Buffer, pH
4.5 Buffer with 0.1% SLS and pH 6.8 Buffer with 0.2% SLS.
Analytical method validation/verification of The firm has submitted analytical method validation reports
product of assay, identification, related substances, dissolution of
Mifepristone 200mg tablets.

Container closure system of the drug product Each carton box contains 1 tablet of mifepristone 200 mg
packed in a PVC/Al blister.
Stability study data of drug product, shelf life and The firm has submitted stability study data of accelerated and
storage conditions long-term stability for primary batch (20120828, 36M),
primary/BE batch (45130401, 36M) and validation batches
(45160103, 45160104, 45160105, 24M)
Evaluation by PEC:
Sr. Observations communicated Response by the applicant
No
1. Copy of valid drug sale license shall be The firm has provided details of drug sale license as below:
submitted since already submitted drug License No: 545
sale license is expired. Address: Ground Floor, Plot No. A-65, Sec: 6F, Mehran
Town, Korangi Industrial Area, Karachi
2. The stability studies of the Drug substance The firm has submitted stability studies of five batches of
shall be submitted as per Zone IVA Drug substance as per Zone IVA conditions as per the
conditions as per the requirement of requirement of 3.2.S.7.
3.2.S.7. 20801108001
20801108002
20801108003
20801108010
20801108011
20801108012
3. Pharmaceutical equivalence of the applied The firm has submitted pharmaceutical equivalence study of
drug shall be established with the test formulation with reference product Mifegyne 200mg
innovator / reference product and results of tablet (Batch # 11071) of M/s Macors-89000 Auxerre –
all the quality tests of the developed France in by performing quality tests (Appearance,
formulation and the innovator / reference Identification (HPLC), Dissolution and assay).
product shall be submitted and discussed
as per section 3.2.P.2.
4. Submit analytical method validation report The firm has submitted analytical method validation report
of assay and identification as per section of assay and identification of Mifepristone 200mg tablets as
3.2.P.5.3. per section 3.2.P.5.3.
5. Details of stability batch sizes, date of Batch no. Batch size Manufacturing
manufacturing of batches, date of initiation date
of stability studies are required to be 20120828 75,000 Tablets 28th Aug, 2012
mentioned.
45130401 75,000 Tablets 8th April, 2013
45160103 75,000 Tablets 29th Dec, 2015
45160104 75,000 Tablets 05th Jan, 2016
45160105 75,000 Tablets 12th Jan, 2016
Decision: Registration Board deliberated the case in detail regarding the clinical indications and potential abuse
of the product. The Board after thread bare delibeartions decided to refer the case to DRAP Authority with
submission that drug qualifies criteria for grant of Registration. However Registration Board referred the case
to DRAP Authority whether Registration Board should proceed for grant of registration or otherwise due to its
potential for abuse. Director DTL Sindh opined not to register the product due to its potential abuse as
abortifacient drug.
b. Deferred Cases
80. Name, address of Applicant / Importer M/s Amgomed Office # 4, First Floor Ghausia Plaza, Jinnah Avenue
Blue Area Islamabad.

Details of Drug Sale License of importer License No: 002-ICT/2013
Address: Office No. 4, 1st Floor Ghousia Plaza, Main Jinnah
Avenue, Blue Area Islamabad.
Address of Godown: Office No. 5, first Floor, Rose-I Plaza, I-8
Markaz Islamabad.
Validity: 30-01-2022.
Status: License to sell drugs in a whole sale distributor.
Name and address of marketing PT Fonko International Pharmaceuticals Kawasan Industri Jababeka
authorization holder (abroad) II, JI. Industri Selatan V, Block PP No. 7, Cikarang Selatan, Bekasi,
Jawa Barat. Indonesia.
Name, address of manufacturer(s) PT Fonko International Pharmaceuticals Kawasan Industri Jababeka
II, JI. Industri Selatan V, Block PP No. 7, Cikarang Selatan, Bekasi,
Jawa Barat. Indonesia.
Name of exporting country Indonesia
Detail of certificates attached (CoPP, Free CoPP: The firm has submitted legalized CoPP certificate (No.
sale certificate, GMP certificate) RG.01.05.32.321.03.21.2589) issued by Badan Pengawas Obat dan
Makanan (Google translation name: National Agency of Drug and
Food Control) for Fonkozomib 3.5mg Injection. The CoPP confirms
free sale status of the product in exporting country as well as GMP
status of the manufacturing site through periodic inspection every 2
years.
Details of letter of authorization / sole Firm has submitted letter of authorization from Fonko International
agency agreement Pharmaceuticals. The letter specifies that the manufacturer appoints
M/s Amgomed Islamabad to register their products in Pakistan.
Authorization letter is issued on 24-09-2020.
☒ Importer
☐ Export sale
For imported products, specify one of ☒ Finished Pharmaceutical product import
these ☐ Bulk import and local repackaging
☐ Bulk import and local repackaging for export purpose only
Dy. No. and date of submission Form-5F Dy.No 25922 dated 17-09-2021
Proposed proprietary name / brand name FONKOZOMIB 3.5mg Injection
Strength/concentration of drug of Active Each vial contains:
Pharmaceutical ingredient (API) per unit Bortezomib…..……3.5mg
Pharmaceutical form of applied drug Lyophilized Powder for injection
Pharmacotherapeutic Group of (API) Antineoplastic and immunomodulating agent
(ATC code: L01XG01)
Finished product specification In-house Specifications
Proposed Pack size 1’s vial

The status in reference regulatory VELCADE for injection 3.5mg per vial of Millenium pharms
authorities (USFDA approved)
For generic drugs (me-too status) 3.5mg Bortezomib Lyophilized Powder for injection of M/s. Revive
Pharma (Reg # 090738)
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Firm has
summarized information related to nomenclature, structure, general
properties, solubilities, physical form, manufacturers, description of
justification of specification, reference standard, container closure
The firm has summarized information of drug product including its
validation protocols, control of excipients, control of drug product,
procedures, batch analysis, justification of specifications, reference
Name, address of drug substance M/s Hetero Labs Limited, Unit-I, Survey No. 10, I.D.A,
manufacturer Gaddapotharam Village, Jinnaram Mandal, Sangareddy District -
502319, Telangana, India.
form, manufacture, description of manufacturing process &
controls, characterization, impurities, specifications, analytical
specification, reference standard, container closure system &
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of API at
(Conditions & duration of Stability accelerated and real time conditions. It was concluded that
studies) Bortezomib is stable upto 6 months under accelerated conditions
(5±3°C) & 60 months under long term conditions (-20°C) and also
stable up to 6 months under accelerated conditions (25°C ± 2°C /
60% ± 5% RH) and 60 months under long term conditions.
report, control of excipients, control of drug product, specifications,
analytical procedures, validation of analytical procedures, batch
Pharmaceutical Equivalence and The firm has submitted pharmaceutical equivalence of Velcade®
Comparative Dissolution Profile 3.5mg powder for solution for injection (batch # BILS000) of M/s
Jassen Pharmaceutica NV with Bortezomib lyophilized powder for
Injection 3.5mg (batch # E0009EB, F0011CA, F0079AA).
Analytical method validation/verification Firm has submitted validation of HPLC method for identification of
of product Bortezomib in Bortezomib 3.5mg powder for Solution for injection.
Analytical methods were developed and transferred PT Fonko
International Pharmaceuticals. The analytical method validation
was established to determine the Assay (By HPLC), Tertiary butyl
alcohol (By HPLC), Related substance (By HPLC), in drug product
validated as per the ICH.

Container closure system of the drug Vial size and type: Type-I clear Glass vial, 10ml clear with 20 mm
product neck
Rubber stopper: Bromobutyl grey rubber stopper 20 mm
Flip off seal: White flip off seal 20 mm.
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches of Bortezomib
life and storage conditions 3.5mg Powder for solution for injection of 10ml vial (Upright):
Batch No. Batch Mfg. Initiation date
size Date
D0009 2619 vials 02-2017 April-2017
E0009 2619 vials 01-2018 Feb-2018
F0011 2619 vials 02-2019 Feb-2018
Remarks of Evaluator
Pharmaceutical equivalence of the applied drug with the reference product should include results of all the quality tests
of the developed formulation and the reference product.
Submit stability study data of 3 batches of Bortezomib 3.5mg Injection 10ml vial in horizontal and inverted position.
Evaluation by PEC:
Sr.# Decision of 313th meeting of RB Response by the applicant from principal
1. Performance of pharmaceutical Reference product of Fonkozomib (Bortezomib lyophilized
equivalence data of applied drug with the powder for injection 3.5mg) is Velcade for injection 3.5mg,
innovator product including results of all manufactured by Janssen Pharmaceutical N.V., Belgium.
the quality tests. The firm has submitted comparison of specifications of
Bortezomib Lyophilized powder for Injection 3.5mg (Batch
# F0079AA) and reference product (batch # BILS000 &
KEZTQ00).
2. Stability study data of 3 batches of Fonkozomib is a lyophilized product, therefore the cake of
Bortezomib 3.5mg Injection 10ml vial in product will have less contact to rubber compared to liquid
horizontal and inverted position. injection product (possibility of incompatibility of product
with rubber is low). Furthermore, referring to Guidance for
industry ANDA’s: Stability testing of Drug substances and
product: that “For primary batches of liquids, solution, semi-
solids and suspensions, the product should be placed into an
inverted (or horizsontal) position and upright (or vertical)
position. For routine stability studies, the applicant should
pick the worst case orientation for the study.” There is no
statement that lyophilized product should be placed into an
inverted position in stability study, therefore we decided that
stability in inverted condition is not necessary.
Decision: Approved as per Policy for inspection of Manufacturer abroad and verification of local storage
facility.
81. Name, address of Applicant / Importer M/s Punjab Medical Services, Office # 4,5, 2nd floor Jalal
center opposite OPD Sir Gangaram Hospital, Lahore
Details of Drug Sale License of importer License No: 05-352-0063-041061D
Address: Office No. 4/5 2nd Floor Jalal Center opposite OPD
Gate Sir Gangaram Hospital Mozang Road Lahore.
Go-down(s) address: NA
Status: License to sell drugs as a distributor
Name and address of marketing authorization Onko Ilac San ve. Tic. A.S
holder (abroad) Kosuyolu Cad. No. 34 34718, Kosuyolu Kadikoy / Istanbul
Turkey.
Name, address of manufacturer(s) Onko Ilac Sanayi ve Ticaret A.S
Gebze Organize Sanayi Bolgesi, 1700 Sokak, No. 1703 Gebze,
Kocaeli, Turkey

Name of exporting country Turkey
Detail of certificates attached (CoPP, Freesale CoPP: Firm has submitted Original Legalized CoPP
certificate, GMP certificate) (Certificate#. 2019/3819) issued on 10-12-2019 by Turkish
Medicines and Medical Devices Agency, Ministry of Health,
Republic of Turkey for Cytu 1000mg/10mL solution for
injection and infusion. The CoPP confirms free sale status of
the product in Turkey as well as GMP status of the
manufacturing site through periodic inspection in every 3
years. The certificate is valid till 10-12-2021.
Details of letter of authorization / sole agency Firm has submitted a copy of letter of authorization from
agreement General Director of Onko Ilac San ve. Tic. A.S located at
Kosuyolu Cad. No. 34 34718, Kadikoy / Istanbul Turkey.
According to the letter, the firm authorizes “Punjab Medical
Services” with registered address at Office No. 4/5 2nd Floor
Jalal Center, opposite OPD Gate Sir Gangaram Hospital,
Lahore, Mozang Road, Lahore to perform the registration
procedures, sales and other similar activities concerning
medicinal products for territory of Pakistan. The letter was
issued on 28-11-2019 and it is valid for three years from date
of issue.
The appendix 1 of the letter of authorization contains products
list containing Cytu 500mg, 1000mg.
☒ Importer
☐ Export sale
Dy. No. and date of submission Dy. No 26223: 06-10-2020
Proposed proprietary name / brand name Cytu 1000mg / 10ml solution for injection
Strength/concentration of drug of Active Each ml contains:
Pharmaceutical ingredient (API) per unit Cytarabine.……….100mg
Pharmaceutical form of applied drug Solution for injection or infusion
Pharmacotherapeutic Group of (API) Pyrimidine analogues (ATC code: L01BC01)
Reference to Finished product specifications Ph. Eur. Specifications
Proposed Pack size 1’s vial
The status in reference regulatory authorities CYTARABINE ACCORD 100 mg / ml, solution for injection
or infusion of HEALTHCARE FRANCE SAS AGREEMENT,
45 RUE DU FAUBOURG DE ROUBAIX 59000 LILLE
(ANSM approved)
For generic drugs (me-too status) Cytarine 1g Injection of Atco laboratories (045710)
has summarized information related to nomenclature,

Firm has submitted data of drug product including its
process validation report, control of excipients, control of drug
Name, address of drug substance manufacturer Name of license holder: M/s EUTICALS SPA, Viale Bianca
Maria, 25 Italy – 20122 Milano
Site of production: M/s EUTICALS SPA Via Valverde 20/22
Italy – 21100 Varese.
Firm has also referred to certificate of suitability (R1-CEP
2000-048-Rev 02) issued by EDQM for cytarabine, active
substance which is verified from EDQM database.
(Conditions & duration of Stability studies) accelerated (6months) and real time conditions (60 months).
The real time stability data is conducted as per 25°C ± 2°C /
60% ± 5% RH for 60 months.
process validation protocol and report, control of excipients,
Pharmaceutical Equivalence The firm has submitted pharmaceutical equivalence of applied
formulation Cytu 1000mg/10ml solution for Injection with
Cytarabine injection (Batch # D3367).
Analytical method validation/verification of Firm has submitted that the product was initially registered as
product an import license product and manufactured in Intas
Pharmaceuticals India in 2013. After that they file a variation
application for replacement of manufacturing site to Onko Ilac
Turkey in 2016. During this variation application
manufacturing method transfer and analytical method transfer
studies were performed. Process validation, batch analysis and
stability studies were also performed. The application of this
variation was approved from MoH in 2017.
The analytical method validation studies performed by Intas
Pharmaceuticals Limited/ India, the analytical method
transferring and T-test report are given in 3.2.P.5.3.

Container closure system of the drug product Container: 10 R Transparent glass vial Type-I (mouth 20mm)
Stopper: 20mm Chlorobutyl grey rubber stopper
Seal: 20mm aluminium flip-off orange seal.
Stability study data of drug product, shelf life Firm has submitted stability study data of 3 batches 51107800,
and storage conditions 51107900 and 80102110. The accelerated stability study data
is conducted at 40⁰C ±2⁰C / 75% ± 5% RH for 6 months. The
real time stability study data is conducted at 30°C ±2°C / 65%
± 5% RH for 12 months.
1. Performance of pharmaceutical equivalence of the The firm has submitted pharmaceutical equivalence of
applied product with innovator / reference or applied formulation Cytu 1000mg/10ml solution for
comparator product shall be submitted and Injection with Cytarabine injection (Batch # D3367).
discussed.
2. Only two batches of cytarabine drug substance were Data of three batches of cytarabine drug substance has
subjected to accelerated stability testing. been submitted.
3. Provide copy of Batch Manufacturing Record The firm has submitted copy of batch manufacturing
(BMR) for all the batches of drug product for which record of all the batches.
stability studies data is provided in Module 3 section
3.2.P.8.3.
Previous Decision: Registration Board deferred the case for confirmation of details of reference product for
performance of pharmaceutical equivalence studies (M-307).
Evaluation by PEC: The firm has submitted that samples of innovator product Cytarabine 100mg/mL of M/s Pfizer
were not available and hence the impurity profile comparison was done between Accord Healthcare Ltd. product
Cytarabine Injection BP 100mg/mL, 10mL (Batch # D3367) and ARA-cell 5g/50mL, ARA-cell 10g/100mL of M/s
Cell Pharm GmbH, Germany. The results showed that accord’s product and the EU reference product have comparable
impurity profile.
The sample of European reference product has been tested for description, pH, assay of cytarabine and related
substances. The comparison of quality tests with applied product Cytu 1000mg/10mL and European reference product
has been presented in tabulated form. The comparison of physicochemical characterization showed comparable results.
However, strengths of European reference product were different from that applied product in the instant application.
Previous Decision: Registration Board deferred the case for submission of data of pharmaceutical equivalence with
innovator / reference product having the same strength and volume as per the applied formulation (M-312).
Evaluation by PEC: The firm has submitted data of pharmaceutical equivalence with reference product Accord
Healthcare Ltd. product Cytarabine Injection BP 100mg/mL, 10mL (Batch # D3548). The comparison of
physicochemical characterization showed comparable results.
facility.
82. Name, address of Applicant / Importer M/s GRATON PHARMA, Office # 501, 502, 5th Floor Plot #
42C/2, Lane # 08, Bukhari Commercial, DHA phase - VI, Karachi
Details of Drug Sale License of importer Address: Office no. 501,502 ,5th floor Plot no IV 42c/2 Lane 08,
Bukhari Commercial Phase, D.H.A Karachi
Status: Drug license by the way of wholesale
Name and address of marketing M/s JODAS EXPOIM PVT. LTD.,
authorization holder (abroad) Plot No. 55, Phase-III, Biotech Park, Karkapatla (v), Markook
(Mandal), Siddipet District, Telangana-502279, India.
Name, address of manufacturer(s) M/s JODAS EXPOIM PVT. LTD.,
Plot No. 55, Phase-III, Biotech Park, Karkapatla (v), Markook
(Mandal), Siddipet District, Telangana-502279, India.
Name of exporting country India

Detail of certificates attached (CoPP, Free CoPP: Firm has submitted legalized copy of CoPP certificate
sale certificate, GMP certificate) (No.2750 /E1/2020) dated 19 Nov 2020 issued by Drugs Control
Administration Hyderabad india for Abiraterone Tablet 250mg.
The CoPP confirms free sale status of the product in exporting
country as well as GMP status of the manufacturing site through
periodic inspection every year.
The name of importing country on CoPP is mentioned.
Furthermore, the CoPP was valid till 26-02-2023.
Details of letter of authorization / sole Firm has submitted copy of letter of distribution certificate from
agency agreement Jodas Expoim Pvt Ltd, India. The letter species that the
manufacturer appoints M/s Graton Pharma, to register their
products in Pakistan. The authorization letter is valid till 31-12-
2025.
☒ Importer
☐ Export sale
Dy. No. and date of submission Form-5F Dy.No. 27702 dated 06-10-2021
Details of fee submitted PKR 75,000/-: 14 July 2021
Proposed proprietary name / brand name XABITON Tablet 250mg
Strength/concentration of drug of Active Each tablet contains:
Pharmaceutical ingredient (API) per unit Abiraterone Acetate.…….250mg
Pharmaceutical form of applied drug Immediate release tablet
Pharmacotherapeutic Group of (API) Hormone antagonists and related agents (ATC code: L02BX03)
Proposed Pack size Bottle Pack: 60’s Tablets are packed in one HDPE bottle
The status in reference regulatory authorities Zytiga® Tablet 250mg of M/s Janssen-Cilag international NV
Turnhoutseweg 30, B-2340 Beerse Belgium (USFDA
Approved).
For generic drugs (me-too status) Not confirmed.

Name, address of drug substance M/s Mac Chem Products (India) Pvt. Ltd. 304, Town centre,
manufacturer Andheri – Kurla Road, Andheri (East), Mumbai – 400 059, India.
form, manufacture, characterization, control of API, analytical
procedures and its validation, batch analyses, justification of
(Conditions & duration of Stability studies) accelerated conditions (40°C ± 2°C/ 75% ± 5% RH) for 6 months
and at real time conditions (30°C ± 2°C / 65% ± 5% RH) for 36
months.
stability.
Pharmaceutical equivalence and The firm has submitted comparative dissolution profile data of
Comparative Dissolution Profile developed formulation Abiraterone acetate 250mg tablet (Batch #
XGZY) with reference product Zytiga tablet 250mg (Batch #
ABT/T-01/021) of M/s Janssen-Cilag in the following dissolution
conditions:
Apparatus: USP II (paddle)
Medium: 025% SLS in 56.5mM phosphate buffer pH 4.5, Run:
50 RPM, Volume: 900ml.
Container closure system of the drug PVC / PE/PVdC-Alu Blister Pack:
product 10 tablets are packed in one PVC/PE/PVdC-Alu blister.
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches:
life and storage conditions Batch No. Batch size Mfg. Date
ON-E18019 12,000 Tablets 12-2018
ON-E18020 12,000 Tablets 12-2018
ON-E18021 12,000 Tablets 12-2018
The firm has performed accelerated stability study at 40
o
C±2oC/75%±5%RH for 6 months and real time stability study at
30 oC±2 oC/75%±5%RH for 24 months.
Sr. Decision of 313th meeting of RB Response by the firm

No.
1. Performance of pharmaceutical equivalence The firm has submitted that our manufacturer provides us
data of applied drug with the innovator bioequivalence studies instead of pharmaceutical
product including results of all the quality equivalence through comparative dissolution profile so we
tests. have submitted bioequivalence report in module 3.
However, no such bioequivalence studies could be found in
the dossier. Instead, pharmaceutical equivalence through
comparative dissolution profile is provided.

2. Details of batches of developed formulation The firm has submitted comparative dissolution profile data
and reference product Zytiga 250mg tablet of developed formulation Abiraterone acetate 250mg tablet
used in comparative dissolution profile. (Batch # XGZY) with reference product Zytiga tablet
250mg (Batch # ABT/T-01/021) of M/s Janssen-Cilag SpA
in three BCS media with following dissolution conditions:
Apparatus: USP II (paddle)
Medium: 025% SLS in 56.5mM phosphate buffer pH 4.5,
pH 6.8 and 0.01 N HCl
Run: 50 RPM,
Volume: 900ml.
3. Stability study data (real time) in relevant The firm has submitted real time stability study data of 3
container closure system till claimed shelf batches in PVC / PE/PVdC-Alu Blister Pack as per Zone
life under conditions of Zone- IVA. IV-A conditions for following 3 batches:
Batch No. Batch size Mfg. Date
ON-E18019 12,000 Tablets 12-2018
ON-E18020 12,000 Tablets 12-2018
ON-E18021 12,000 Tablets 12-2018
4. Updated copy of drug sale license of Address: Office no. 501, 502 ,5th floor Plot no: 42-C/2 Lane
importer. 08, Bukhari Commercial Phase-VI, D.H.A Karachi
facility. The firm shall submit performance of pharmaceutical equivalence with innovator / reference product
before issuance of registration letter.
Agenda of Evaluator PEC-XIII

Registration applications of locally manufactured (Human) drugs on Form 5F.
A; New Licenses/sections.
M/s Cure Laboratories (Pvt.) Ltd., Plot # 11-12, Street No. NS-2 RCCI, Industrial Estate, Rawat, Islamabad was
granted following additional sections vide letter No. F. 1-13/2017-Lic dated 08-10-2020 in 276th meeting of Central
Licensing Board held on 03-09-2020;
i. Tablet section general.
ii. Capsule section general.
83. Name, address of Applicant / Marketing M/s Cure Laboratories (Pvt.) Ltd., Plot # 11-12, Street
Authorization Holder No. NS-2 RCCI, Industrial Estate, Rawat, Islamabad.
Name, address of Manufacturing site. M/s Cure Laboratories (Pvt.) Ltd., Plot # 11-12, Street
No. NS-2 RCCI, Industrial Estate, Rawat, Islamabad.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No 28728 dated 20-10-2021.
Details of fee submitted Rs.30,000/- dated 11-10-2021.
The proposed proprietary name / brand name P-Pram 10mg Tablet.
Strength / concentration of drug of Active Each film coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Escitalopram as Oxalate …………………..10mg
Pharmaceutical form of applied drug Oral tablets.

Pharmacotherapeutic Group of (API) Selective serotonin reuptake inhibitors.
Reference to Finished product specifications USP specifications.
The status in reference regulatory authorities Lexapro® (escitalopram oxalate) film coated Tablets,
USFDA approved.
For generic drugs (me-too status) Espram 10mg Tablets, Pharmatec Pakistan, Reg. No.
036113.
GMP status of the Finished product manufacturer GMP certificate issued on 18-02-2021 on the basis of
inspection conducted on 12-08-2020.
Evidence of section approval. Tablet section general vide letter No. F. 1-13/2017-Lic
dated 08-10-2020.
Name and address of API manufacturer. Zhejiang Haisen Pharmaceutical Co., Ltd.
Address: Xiangtan Village, Liushi Street, Dongyang
City, Zhejiang Province, China.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD
specifications, analytical procedures and its
Validation/verification, batch analysis and justification
of specification, reference standard, container closure
system and stability studies of drug substance and drug
product is submitted.
Module III (Drug Substance) Official monograph of Escitalopram Oxalate is present
in USP. The firm as submitted detail of nomenclature,
manufacturers, description of manufacturing process
and controls, tests for impurities & related substances
specification, reference standard, container closure
system and stability studies of drug substance as per
Zone-IV B.
Stability studies (Drug substance.) Stability study conditions:
Stability Batches: (3619102201, 3619102202,
3619102203)
Module-III (Drug Product): The firm has submitted detail of manufacturers,
impurities, specifications, analytical procedures as per
USP Monograph and its verification studies, batch
analysis and justification of specification, reference
standard, container closure system and stability studies
of drug product as per Zone-IV A.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been established
dissolution profile against Zavget 10mg tablets by Getz Pharma (Pvt.) Ltd.
by performing quality tests (Description, Identification,

Avg. Weight, Dissolution, and Assay, as per USP
Monograph).
CDP is with the Same Brand Zavget 10mg Tablets by
Getz Pharma (Pvt.) Ltd. at three pH Acid (1.2), Acetate
Buffer (4.5) & Phosphate Buffer (6.8) and also the
similarity factor (f2) is calculated and found
satisfactory.
Analytical method validation/verification of product Method validation studies have been submitted
including System Suitability, Accuracy, and Precision.
Manufacturer of API Zhejiang Haisen Pharmaceutical Co., Ltd.
Address: Xiangtan Village, Liushi Street, Dongyang City,
Zhejiang Province, China.
API Lot No. 3620120201 (01-02-2021)
Description of Pack 10 white colored round, biconvex film coated tablets blistered in
(Container closure system) an Alu-Alu Blister, then packed in a Unit Carton with leaf insert.
Real Time: 0, 3, 6, 9,12, 18 & 24 (Months)
Batch No. T21003 T21004 T21005
Batch Size 17,000 Tablets 17,000 Tablets 17,000 Tablets
No. of Batches 03
1. Reference of previous approval of applications with Seven Products are approved in 307th Meeting of
stability study data of the firm (if any) Registration Board with stability Data. Loxiten 20mg
Capsules, Loxiten 30mg Capsules, Loxiten 60mg
Capsules, Omexa 20mg Capsules, Omexa 40mg
Capsules, Lansasure 15mg Capusles and Lansasure
30mg Capsules.
2. Approval of API/ DML/GMP certificate of API GMP certificate # ZJ20190082 issued by CHINA
manufacturer issued by concerned regulatory FOOD AND DRUG ADMINISTRATION to M/s
authority of country of origin. Zhejiang Haisen pharmaceutical Co., Ltd. Issued on 22-
07-2019 and valid until 21-07-2024.
3. Documents for the procurement of API with approval Invoice No. ZJHP821022 with diary No: 427 dated
from DRAP (in case of import). 01/02/2021 cleared by I&E DRAP, Islamabad is
submitted.
4. Data of stability batches will be supported by attested
respective documents like chromatograms, Raw data Submitted.

5. Compliance Record of HPLC software 21CFR & audit
Submitted.
humidity monitoring of stability chambers (real time Submitted.
and accelerated)
Sr. Section. Observation Reply by the firm.
No.
1. 2.3 • In QOS molecular formula and molecular Firm has corrected the molecular mass as per USP.
mass for some other molecule is provided. i.e. 414.43.
Clarification is required. Firm has submitted that inhouse specification was
• Inhouse specification are mentioned in typographic error and actual specifications are USP.
module II. Firm has provided correct information without
• In module II, it is also mentioned that submission of applicable fee.
applied formulation available in BP.
2. 3.2 S.4.2 Signed copy of analytical method of drug Submitted.
substance shall be submitted.
3. 3.2.S.7. Both accelerated and real time stability of drug Real time stability studies of drug substance from
substance provided by the firm is only for 06 drug substance manufacturer for 24 months are
months. submitted.
4. 3.2 P.2.1.2 For use of primojel and aerosol 200, their Submitted.
compatibility studies shall be submitted as
they are not used by the reference product.
5. 3.2 P.2.2.1 • Justification for not performing CDP • We tried to arrange innovator pack but unable to
against the innovator product. arrange it. Therefore, we performed CDP against
zavget 10mg which is brand leader in Pakistan.
• Firm has provided CDP result including 15
• Justification of not performing CDP at 15 minutes time point.
mint time point.
• Details of comparator product are not
provided. Dissolution medium for pH 1.2 is KCl.
• Detailed method for CDP shall be
provided.
6. 3.2 P.4.2 Signed copy of analytical method of drug Submitted.
7. 3.2.P.8.3 • In analytical method validation data 100% In stability studies base normalized concentration
concentration of the sample has an area of was used adding oxalate factor while in method
33952 while the raw data sheets of validation 100% concentration was normalized as
stability study data have an area of 43572 escitalopram oxalate as whole.
for the same concentration. Clarification is
required.
• Raw data sheets provided by the firm has Raw data sheets have potency without oxalate and
mentioned a potency of 78.43 while the COA of working standard is with oxalate for
COA of working standard has 99.7%. calculation normalization. Without oxalate the
Clarification is required. potency of working standard in raw data sheets also
99.7%.
This was typographic error. Actually, average
• Average weight in the raw data sheets weight should be 170 ± 3%.
claimed is 110. Clarification is required. However, upon calculation of the assay in raw data
sheets with 170, the assay of the formulation was
162%.
Firm once again submitted that weight of sample in
the calculation of assay was also mistakenly written
as 550 while the actual weight is 850mg.
8. Analytical method validation protocol has not Submitted.
been submitted.
9. 3.2.P.8.3 Analytical record for dissolution test shall be Not provided
provided.
10. 2% of overage is mentioned in the executed This must be a typographical mistake that 2%
BMR. Clarification is required. overage is mentioned on the executed BMR. No

overage is being used for this formulation. Kindly
consider the formulation without overage.
Decision: Deferred for the following;
• Submission of comparative dissolution profile against the innovator’s product.
• Justifications for using KCl buffer of pH 1.2 as dissolution medium in Comparative dissolution profile.
• Submission of analytical record for dissolution test for complete stability studies.
• Justification of applying tablet average weight of 110mg instead of 170mg for the calculation of Assay
results for the stability studies.
• Clarification regarding authenticity of Assay results which have been calculated by applying wrong
sample weight and average tablet weight.
B; Deferred cases of locally manufactured (Human) drugs Form 5F.
M/s Cure Laboratories (Pvt.) Ltd., Plot # 11-12, Street No. NS-2 RCCI, Industrial Estate, Rawat, Islamabad was
granted following additional sections vide letter No. F. 1-13/2017-Lic dated 08-10-2020 in 276th meeting of Central
Licensing Board held on 03-09-2020;
i. Tablet section general.
ii. Capsule section general.
84. Name, address of Applicant / Marketing M/s Cure Laboratories (Pvt.) Ltd., Plot # 11-12, Street No. NS-
Authorization Holder 2 RCCI, Industrial Estate, Rawat, Islamabad.
Name, address of Manufacturing site. M/s Cure Laboratories (Pvt.) Ltd., Plot # 11-12, Street No. NS-
2 RCCI, Industrial Estate, Rawat, Islamabad.
☐ Importer
☐ Export sale
proposed proprietary name / brand name P-Cip 250mg Tablet.
Reference to Finished product
USP specifications.
specification
The status in reference regulatory CIPRO® 250 mg, 500 mg (ciprofloxacin hydrochloride) film
authorities coated tablet, for oral use.
USFDA Approved,
Bayer Healthcare Pharmaceuticals Inc. USA
For generic drugs (me-too status) Ciplet 250mg Tablets, Indus Pharma Karachi, R. No. 044461.
GMP status of the Finished product GMP certificate issued on 18-02-2021 on the basis of inspection
manufacturer conducted on 12-08-2020.

Evidence of section approval. Tablet section general vide letter No. F. 1-13/2017-Lic dated 08-
10-2020.
specifications, analytical procedures and its Validation/
Module III (Drug Substance) Official monograph of Ciprofloxacin Hydrochloride is present
in USP. The firm as submitted detail of nomenclature, structure,
impurities & related substances specifications, analytical
and stability studies of drug substance as per Zone-IV A.
Batches: (CPH1402007, CPH1402008 & CPH 1403009)
analytical procedures as per USP Monograph and its verification
of drug product for three trial batches as per Zone-IV A.
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established against

comparative dissolution profile Ciproxin 250mg tablets of Bayer Pakistan (Pvt.) Ltd., by
performing quality tests (Description, Identification, Avg.
Weight, Dissolution, and Assay, as per USP Monograph).
CDP is with the Same Brand Ciproxin 250mg Tablets by Bayer
Pakistan (Pvt.) Ltd. at three pH i.e. Acidic (1.2), Acetate Buffer
(4.5) & Phosphate Buffer (6.8) and also the similarity factor (f2)
is calculated and found satisfactory.
Analytical method validation/verification Method verification studies have submitted including linearity,
of product range, accuracy, precision, specificity.
Manufacturer of API M/s Citi Pharma (Pvt.) Ltd., 3.5 Km, Head Balloki Road, Phool Nagar, Kasur,
Pakistan.
API Lot No. CPH-2011069
Description of Pack 10 white colored oblong film coated tablets blistered in an Alu-Alu Blister,
(Container closure system) then packed in a Unit Carton with leaf insert.

Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6, 9,12, 18 & 24 (Months)
No. of Batches 03
1. Reference of previous approval of Seven Products are approved in 307th Meeting of Registration
applications with stability study data of Board with stability Data. Loxiten 20mg Capsules, Loxiten
the firm (if any) 30mg Capsules, Loxiten 60mg Capsules, Omexa 20mg
Capsules, Omexa 40mg Capsules, Lansasure 15mg Capusles and
Lansasure 30mg Capsules.
2. Approval of API/ DML/GMP certificate Citi Pharma (Pvt.) Ltd., Semi Basic (000429) has a GMP
of API manufacturer issued by concerned Certificate Ref. No. 01/2021-DRAP(FID-2036001-5101) Dated:
regulatory authority of country of origin. 6th January 2021.
Valid Till: 17th December 2022.
3. Documents for the procurement of API The Material is locally purchased from Citi Pharma (Pvt.) Ltd.
with approval from DRAP (in case of 3.5-km, Head Balloki Road, Phool Nagar, Kasur- Pakistan.
import).
4. Data of stability batches will be supported
by attested respective documents like
Submitted.
21CFR & audit trail reports on product Submitted.
testing
6. Record of Digital data logger for
temperature and humidity monitoring of
Submitted.
accelerated)
Sr# Section Observation Submission by the firm.
1. 1.3 Latest GMP certificate/inspection report Firm has provided GMP certificate issued on 18-02-2021
conducted within last three years could not on the basis of inspection conducted on 12-08-2020.
be confirmed.
2. 1.5.3 This section has mentioned 500mg of Firm has corrected the said section with 250mg of
ciprofloxacin. ciprofloxacin.
3. 2.3 Table for literature references for the drug Corrected table is submitted by the firm with required
product does not declare the status in information.
pharmacopoeia other than USP.
4. 3.2 S.4.2 Signed copy of analytical method of drug Submitted
5. 3.2 S.4.3 • Limits provided by the finished product • Firm has submitted new limits for drug substance i.e
manufacturer in verification of 98% -102%.
analytical procedure of drug substance
is 90-110%. Justification is required.
• Performance of repeatability studies
has not been done in the verification Submitted
studies by finished product
manufacturer.

6. 3.2 Use of primojel and its compatibility Submitted.
P.2.1.2 studies shall be submitted as it is not used
by the reference product.
7. 3.2 Justification of not performing CDP at 15 Firm has referred an article from FDA wherein at page 4,
P.2.2.1 mint time point. under heading “Approaches for setting Dissolution
specifications for new Chemical Entity” for highly soluble
and rapidly dissolving drugs products (BCS Classes 1 & 3),
generation of an adequate profile sample at 5- or 10-minute
intervals may be necessary, and with reference to WHO
document, Ciprofloxacin HCl come under BCS class 1&3.
BCS classification of ciprofloxacin HCl is IV. Firm has
claimed that it falls in Class I & III.
8. 3.2 P.4.2 Signed copy of analytical method of drug Submitted.
9. Justify the dispensing of drug substance We have dispensed our trial batches on basis of factor
for trial batch manufacturing, on the basis calculation for HCL salt because the COA of API Lot #
of theoretical factor instead of the actual CPH-2011069 of Ciprofloxacin was showing the
potency determined in Assay analysis of Assay above 100%. We have checked for assay as well in
drug substance. our own lab and found 100.1%. Due to this reason we have
only calculated factor for salt only.
The firm has not adjusted the potency considering the
percentage water content.
10. As per submitted raw data sheets the Firm has submitted that we have performed all the studies
dissolution medium is not as per that with 0.01M HCl as mentioned in USP, However, 0.1M HCl
recommended by the USP monograph of was erroneously written in some raw data sheets.
ciprofloxacin tablets.
11. As per submitted analytical record of Firm has submitted that
stability studies the dissolution test at “An amount of Ciprofloxacin Hydrochloride equivalent to
various time points does not qualify S1 NLT 80% (Q) of the labeled amount of ciprofloxacin is
stage criteria as recommended by USP dissolved”.
general chapter 711. Statement is clear that drug release should be not less than
80% at the end of test. If we go in General chapter
“Dissolution <711>, the first line in
“INTERPRETATION” states “Unless otherwise specified
in the individual monograph”.
Accordingly, I have performed the test, and it is qualifying
the limits (NLT 80%).
The interpretation of firm is not in accordance with
pharmacopoeial recommendations.
Decision of 313th meeting of Registration Board: Deferred for following;
• Justify the dispensing of drug substance for trial batch manufacturing, on the basis of theoretical factor instead of the
actual potency determined in Assay analysis of drug substance.
• As per submitted analytical record of stability studies the dissolution test at various time points does not qualify S1
stage criteria as recommended by USP general chapter 711.
• Submission of 7500/- fee for revision of finished product specifications as per notification No. F. 7-11/2012-
Submission by the firm:
Sr. Reason for deferment. Submission/Justification by the firm.
No.
1. Justify the dispensing of drug substance for trial We have dispensed our trial batches on basis of factor
batch manufacturing, on the basis of theoretical calculation for HCl salt because the COA of API Lot No. CPH-
factor instead of the actual potency determined 201169 of ciprofloxacin was showing the assay on anhydrous
in Assay analysis of drug substance. basis as 102.49%. We have checked the assay (on anhydrous
basis) as well in our lab and found 100.1%. Due to this reason
we have only calculated factor for salt only.
Water content of 4.7% has not been adjusted in the
formulation. Potency of anhydrous basis is used in trial
batches instead of as is basis.
2. As per submitted analytical record of stability We have used the dissolution limits in stability studies as (Q)
studies the dissolution test at various time points 80+5%. All the dissolution results of stability studies are above
85% except in one reading. That’s why we have checked the

does not qualify S1 stage criteria as stability samples of the respective batches again in our QC lab
recommended by USP general chapter 711. and the dissolution results of all these batches showing results
of above 85%. Hence our product complies the USP
dissolution limit of results (Q) 80+5%= 85%.
Firm has provided 09th month time point dissolution results as
follows;
B# Time point Real time
T001 09th 87.99%
T002 09th 87.58%
T003 09th 88.16%
Two trial batches T001 & T003 at 6th month time point real
time stability study were having 84.53% & 84.90% of
dissolution results respectively. One trial batch T001 at 6 th
month time point accelerated stability study was having
83.10% of dissolution results.
3. Submission of 7500/- fee for revision of finished Fee of 7500/- vide slip number 1590109558 dated 30-12-2021
product specifications as per notification No. F. for revision finished product specifications.
7-11/2012-B&A/DRAP dated 07-05-2021.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months as per the commitment submitted in
the registration application.
• Manufacturer will perform process validation of first three batches as per the commitment
85. Name, address of Applicant / Marketing M/s Cure Laboratories (Pvt.) Ltd., Plot # 11-12, Street No. NS-
Authorization Holder 2 RCCI, Industrial Estate, Rawat, Islamabad.
Name, address of Manufacturing site. M/s Cure Laboratories (Pvt.) Ltd., Plot # 11-12, Street No. NS-
2 RCCI, Industrial Estate, Rawat, Islamabad.
☐ Importer
☐ Export sale
proposed proprietary name / brand name P-Cip 500mg Tablet.
Strength/ concentration of drug of Active Each Film Coated Tablet Contains:
USP specifications.
specification
The status in reference regulatory CIPRO® 250 mg, 500 mg (ciprofloxacin hydrochloride) film
authorities coated tablet, for oral use.
USFDA Approved,

Bayer Healthcare Pharmaceuticals Inc. USA
For generic drugs (me-too status) Ciplet 500mg Tablets, Indus Pharma Karachi, Reg. No. 044462.
GMP status of the Finished product GMP certificate issued on 18-02-2021 on the basis of inspection
Evidence of section approval. Tablet section general vide letter No. F. 1-13/2017-Lic dated 08-
10-2020.
specifications, analytical procedures and its Validation/
Module III (Drug Substance) Official monograph of Ciprofloxacin Hydrochloride is present
in USP. The firm as submitted detail of nomenclature, structure,
impurities & related substances specifications, analytical
and stability studies of drug substance as per Zone-IV A.
Batches: (CPH1402007, CPH1402008 & CPH 1403009)
analytical procedures as per USP Monograph and its verification
of drug product for three trial batches as per Zone-IV A.

comparative dissolution profile Ciproxin 500mg tablets of Bayer Pakistan (Pvt.) Ltd., by
performing quality tests (Description, Identification, Avg.
Weight, Dissolution, and Assay, as per USP Monograph).
CDP is with the Same Brand Ciproxin 500mg Tablets by Bayer
Pakistan (Pvt.) Ltd. at three pH i.e. Acidic (1.2), Acetate Buffer
(4.5) & Phosphate Buffer (6.8) and also the similarity factor (f2)
is calculated and found satisfactory.
Manufacturer of API M/s Citi Pharma (Pvt.) Ltd., 3.5 Km, Head Balloki Road, Phool Nagar, Kasur,
Pakistan.
API Lot No. CPH-2011069
Description of Pack 10 white colored oblong film coated tablets blistered in an Alu-Alu Blister,
(Container closure system) then packed in a Unit Carton with leaf insert.

Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6, 9,12, 18 & 24 (Months)
Batch Size 20,000 Tablets 20,000 Tablets 20,000 Tablets
No. of Batches 03
1. Reference of previous approval of Seven Products are approved in 307th Meeting of Registration
applications with stability study data of Board with stability Data. Loxiten 20mg Capsules, Loxiten
the firm (if any) 30mg Capsules, Loxiten 60mg Capsules, Omexa 20mg
Capsules, Omexa 40mg Capsules, Lansasure 15mg Capusles and
Lansasure 30mg Capsules.
2. Approval of API/ DML/GMP certificate Citi Pharma (Pvt.) Ltd., Semi Basic (000429) has a GMP
of API manufacturer issued by concerned Certificate Ref. No. 01/2021-DRAP(FID-2036001-5101) Dated:
regulatory authority of country of origin. 6th January 2021.
Valid Till: 17th December 2022.
3. Documents for the procurement of API The Material is locally purchased from Citi Pharma (Pvt.) Ltd.
with approval from DRAP (in case of 3.5-km, Head Balloki Road, Phool Nagar, Kasur- Pakistan.
import).
Submitted.
21CFR & audit trail reports on product Submitted.
testing
Submitted.
accelerated)
Sr.# Section Observation Submission by the firm.
1 1.3 Latest GMP certificate/inspection report Firm has provided GMP certificate issued on 18-02-
conducted within last three years could not 2021 on the basis of inspection conducted on 12-08-
be confirmed. 2020.
2 1.5.12 SOP for batch numbering is for capsule SOP for batch numbering of general tablet is provided
dosage form. by the firm.
3 2.3 Table for literature references for the drug Corrected table is submitted by the firm with required
product does not declare the status in information.
pharmacopoeia other than USP.
4 3.2 S.4.2 Signed copy of analytical method of drug Submitted
5 3.2 S.4.3 • Limits provided by the finished product Firm has submitted new limits for drug substance i.e
manufacturer in verification of 98% -102%.
analytical procedure of drug substance is
90-110%. Justification is required.

• Performance of repeatability studies has
not been done in the verification studies
by the finished product manufacturer.
6 3.2 P.2.1.2 Use of primojel and its compatibility studies Submitted.
shall be submitted as it is not used by the
reference product.
7 3.2 P.2.2.1 Justification of not performing CDP at 15 Firm has referred an article from FDA wherein at page
mint time point. 4, under heading “Approaches for setting Dissolution
specifications for new Chemical Entity” for highly
soluble and rapidly dissolving drugs products (BCS
Classes 1 & 3), generation of an adequate profile sample
at 5- or 10-minute intervals may be necessary, and with
reference to WHO document, Ciprofloxacin HCl come
under BCS class 1&3.
BCS classification of ciprofloxacin HCl is IV. Firm has
claimed that it falls in Class I & III.
8 3.2 P.4.2 Signed copy of analytical method of drug Submitted.
9 Justify the dispensing of drug substance for We have dispensed our trial batches on basis of factor
trial batch manufacturing, on the basis of calculation for HCL salt because the COA of API Lot #
theoretical factor instead of the actual CPH-2011069 of Ciprofloxacin was showing
potency determined in Assay analysis of the Assay above 100%. We have checked for assay as
drug substance. well in our own lab and found 100.1%. Due to this
reason we have only calculated factor for salt only.
The firm has not adjusted the potency considering the
percentage water content.
10 As per submitted raw data sheets the Firm has submitted that we have performed all the
dissolution medium is not as per that studies with 0.01M HCl as mentioned in USP,
recommended by the USP monograph of However, 0.1M HCl was erroneously written in some
ciprofloxacin tablets. raw data sheets.
11 As per submitted analytical record of Firm has submitted that;
stability studies the dissolution test at various “An amount of Ciprofloxacin Hydrochloride equivalent
time points does not qualify S1 stage criteria to NLT 80% (Q) of the labelled amount of ciprofloxacin
as recommended by USP general chapter is dissolved”.
711. Statement is clear that drug release should be not less
than 80% at the end of test. If we go in General chapter
“Dissolution <711>, the first line in
“INTERPRETATION” states “Unless otherwise
specified in the individual monograph”.
Accordingly, I have performed the test, and it is
qualifying the limits (NLT 80%).
The interpretation of firm is not in accordance with the
pharmacopoeial recommendations.
Decision of 313th meeting of Registration Board: Deferred for following;
• Justify the dispensing of drug substance for trial batch manufacturing, on the basis of theoretical factor
instead of the actual potency determined in Assay analysis of drug substance.
• As per submitted analytical record of stability studies the dissolution test at various time points does not
qualify S1 stage criteria as recommended by USP general chapter 711.
• Submission of 7500/- fee for revision of finished product specifications as per notification No. F. 7-11/2012-
Submission by the firm;
No.
1. Justify the dispensing of drug substance for trial We have dispensed our trial batches on basis of factor calculation
batch manufacturing, on the basis of theoretical for HCl salt because the COA of API Lot No. CPH-201169 of
factor instead of the actual potency determined ciprofloxacin was showing the assay on anhydrous basis as
in Assay analysis of drug substance. 102.49%. We have checked the assay (on anhydrous basis) as well
in our lab and found 100.1%. Due to this reason we have only
calculated factor for salt only.

Water content of 4.7% has not been adjusted in the formulation.
Potency of anhydrous basis is used in trial batches instead of as is
basis.
2. As per submitted analytical record of stability We have used the dissolution limits in stability studies as (Q)
studies the dissolution test at various time points 80+5%. All the dissolution results of stability studies are above 85%
does not qualify S1 stage criteria as except in one reading. That’s why we have checked the stability
recommended by USP general chapter 711. samples of the respective batches again in our QC lab and the
dissolution results of all these batches showing results of above
85%. Hence our product complies the USP dissolution limit of
results (Q) 80+5%= 85%.
Previously the stability studies were performed by junior analyst
and he was not trained. Therefore, there might be chances of wrong
dilutions or mishandling during dissolution studies. So, we have
decided to retest the dissolution of stability studies of the trial
batches with our senior & well-trained analyst and the dissolution
results are above 85% and the product is qualifying S1 stage.
Firm has provided 09th month time point dissolution results as
follows;
B# Time point Real time
T001 09th 86.15%
T002 09th 87.11%
T003 09th 85.66%
Two trial batches T20001 & T20002 at 03rd month time point
accelerated stability study were having 84.59% & 84.04% of
dissolution results respectively. Three trial batch T20001 T20002 &
T20003 at 06th month time point accelerated stability study were
having 84.33%, 83.86% & 84.61% of dissolution results
respectively.
3. Submission of 7500/- fee for revision of finished Fee of 7500/- vide slip number 54547452800 dated 30-12-2021 for
product specifications as per notification No. F. revision finished product specifications.
7-11/2012-B&A/DRAP dated 07-05-2021.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies throughout proposed
shelf life and on accelerated studies for six months as per the commitment submitted in the registration
application.
• Manufacturer will perform process validation of first three batches as per the commitment submitted in
86. Name, address of Applicant / Marketing M/s Davis Pharmaceutical Laboratories, Plot No. 121
Authorization Holder industrial Triangle area, Kahuta Road, Islamabad.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt.) Ltd., Plot No. 145 Industrial Triangle,
☐ Importer
☐ Export sale
Details of fee submitted PKR 50,000/-: dated 26-01-2021.
The proposed proprietary name / brand name Kerolac 30mg IV/IM Injection.
Strength / concentration of drug of Active Each ampoule contains:
Pharmaceutical ingredient (API) per unit Ketorolac Tromethamine ……………….. 30mg

Pharmaceutical form of applied drug Clear colorless liquid filled in glass ampoule
Reference to Finished product specifications Innovator’s
Proposed Pack size 1ml x 5’s
The status in reference regulatory authorities US FDA approved.
For generic drugs (me-too status) Tekac 30mg/ml Injection, Sami Pharmaceuticals, Reg. No.
092855.
GMP status of the Applicant. GMP certificate issued on 08-10-2020 on the basis of
inspection conduct 01-10-2019.
GMP status of the Finished product GMP certificate issued on 21-05-2019 on the basis of
manufacturer inspection conduct 23-4-2019, valid up to 22-04-2022.
Evidence of section approval of the Finished Liquid ampoule (from GMP certificate.)
product manufacturer. Ampoule general vide letter No. F. 1-12/89-Lic (Vol-II)
dated 23-07-2012.
Name and address of API manufacturer. M/s. Saurav Chemicals Limited
370 Industrial Area, Phase II Panchkula, Haryana, 134109
– India.
Manufacturing site address:
M/s. Saurav Chemicals Limited,
Bhagwanpura, Derabassi – Barwala Road, Mohali District
Punjab India
manufacturers,
summarized information of drug product including its
drug substance.
Stability studies (Drug substance) Firm has submitted stability study data of 3 batches of drug
substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted at 40
O
± 2 O C /75% ± 5% RH for 6 months. The real time
stability data is conducted at 30OC ± 2 O C / 65% ± 5% RH

for 60 months. (Batch No. KTM06130016, KTM06130017
& KTM06130018)
specifications, analytical procedure, verification studies,
drug product.
Pharmaceutical equivalence and comparative Firm has performed pharmaceutical equivalence against the
dissolution profile product Toradol Ampoule 30mg, B. No. C2436, Mfg. date
01, 2020 by Barrett Hodgson by performing quality tests
(Description, Identification, pH, Assay, Sterility, Bacterial
endotoxin.)
Manufacturer of API M/s. Saurav Chemicals Limited
370 Industrial Area, Phase II Panchkula, Haryana, 134109 – India.
Manufacturing site address:
M/s. Saurav Chemicals Limited,
Bhagwanpura, Derabassi – Barwala Road, Mohali District Punjab India
API Lot No. KM-0100918, KTM-180015 & KTM180015.
Description of Pack
Glass ampoule
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. A-439 A-596 A-611
Batch Size 46,200 16,000 Ampoules 33,000 Ampoules
Ampoules
No. of Batches 03
2. Approval of API/ DML/GMP certificate of GMP certificate of M/s. Saurav Chemicals Limited,
API manufacturer issued by concerned Bhagwanpura, Derabassi – Barwala Road, Mohali District
regulatory authority of country of origin. Punjab India Valid till 25-06-2023.
approval from DRAP (in case of import). SCL2018/18-19 dated 29-01-2019.
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches along
attested respective documents like with chromatograms, raw data sheets, COA and summary
chromatograms, Raw data sheets, COA, data sheets.

5.
Compliance Record of HPLC software 21CFR N/A
6. Record of Digital data logger for temperature Firm has submitted record of data logger for temperature
and humidity monitoring of stability chambers and humidity monitoring of real time and accelerated
(real time and accelerated) stability chambers.
Sr. Section Observations Firm’s Response
No. Number
1 1.4.3 Total number of approved registered products Applicant has 07 approved sections and applicant
on contract basis could not be confirmed. has also submitted that they no product is registered
Complete details of products registered on on contract manufacturing.
contract basis shall be submitted.
2 1.5.6 Official monograph is available in USP. Firm Firm has provided new Form 5F wherein they have
has claimed innovator’s specifications in revised their specifications from innovator’s
“1.5.6” section of form 5F. specifications to USP specifications without
3 1.6.5 Valid GMP certificate of API manufacturer Valid GMP certificate of API manufacturer is
issued by regulatory body of country shall be provided.
submitted. Valid till 25-06-2023.
4 3.2. S.4 • Results of analysis of relevant batch(es) of Batch No. A-439 has been manufactured by API lot
drug substance performed by drug product No. KM-0100918 while COA has only been
manufacturer used during product submitted for API Lot No. KTM-180015
development and stability studies along with
COA of the same batch from drug
manufacturer.
• Detailed analytical procedure for the drug Submitted.
substance by the drug product manufacturer
shall be provided.
• Analytical method verification studies Firm has submitted analytical method verification
including specificity, accuracy and studies but chromatograms for finished product has
repeatability (method precision) for drug been submitted.
5 3.2. P.8.3 ADC attested invoices of the drug substance ADC attested invoice for API Lot No. KM-0100918
used during product development and stability used in Batch No. A-439 has not been provided by
studies shall be submitted. the firm.
6 3.2. P.2.3 Justification of not performing terminal Firm has submitted that we cannot perform terminal
sterilization of the drug product. sterilization of ketorolac injection because it is heat
sensitive product.
Melting point of the API mentioned in DMF is 165-
170 oC.
7 3.2. P.5.2 Detailed analytical procedure for the drug Submitted.
product by the drug product manufacturer shall
be provided.
8 3.2. P.5.3 In process validation protocol 30.45mg of Firm has submitted that it is potency adjustment.
ketorolac tromethamine is used. Justification is The potency as per COA of drug substance on as is
required whether overage or potency basis is 98.5%. On the basis of as is potency the
adjustment. quantity of powder to be dispensed is calculated as
30.45mg {(100/98.5) x 30 = 30.45}
9 3.2. P.8.3 Submit raw data sheets for stability studies, Submitted.
reflecting the details of Standard weight,
Sample dilution preparation, Potency of
Reference standard and Calculation formula
applied for the Assay test.
Decision of 313th meeting of the Registration Board: Deferred for following;
• Submission of documents/commercial invoice for the procurement of API Lot No. KM-0100918 with
approval from DRAP.
• Submission of scientific justification for not performing terminal sterilization of the drug product.

• Submission of 7500/- fee for revision of finished product specifications as per notification No. F. 7-
11/2021-B&A/DRAP dated 13-07-2021.
Submission by the firm;
No.
1. Submission of documents/commercial invoice Firm has submitted clearance certificate attested by AD -
for the procurement of API Lot No. KM- I&E, DRAP, Islamabad dated 27-04-2018 for the ketorolac
0100918 with approval from DRAP. tromethamine B# KM-0100918.
2. Submission of scientific justification for not Firm has submitted that we were not performing terminal
performing terminal sterilization of the drug sterilization earlier but now we started terminal
product. sterilization. They have also attached review document.
3. Submission of 7500/- fee for revision of finished Firm has submitted fee of 7500/- vide slip No.
product specifications as per notification No. F. 31868295920 dated 06-01-2022 for revision of
7-11/2021-B&A/DRAP dated 13-07-2021. specifications.
Decision: Deferred for scientific rationale of performing terminal sterilization, with reference to the innovator
product.
Registration applications of locally manufactured (Human) drugs on Form 5F (New cases).
Registration Board in its 292nd meeting held on 1st & 2nd October, 2019, rejected the applications of Felixia Tablets
97/103mg, Felixia Tablets 49/51mg and Felixia Tablets 24/26mg of M/s Tabros Pharma (Pvt.) Ltd., Karachi due to
following reasons:
(i) Re-processing of tablets already used in tests of “Friability” & “Hardness” for compensating the batch
yield, since firm could not submit any rationale for this practice to compensate the yield.
(ii) Manual feeding of the powder in dies cavity of tablet compression machine, since this practice does not
simulate the manufacture procedure applied for commercial production.
(iii) Submitted record of tablets declare that firm does not have sufficient number of tablets to conduct real
time stability studies till claimed shelf life.
The firm didn’t agree with the decision of the Registration Board and decided to appeal against the above said decision
in the Appellate Board as provided under section 09 of the Drugs Act, 1976.
The Appellate Board in its 158th sitting held on 21st October, 2021 decided to dismiss the instant appeals (16/2020,
17/2020 and 18/2020) being without merit and directed the Pharmaceutical Evaluation and Registration (PE&R)
Division to evaluate the CTD applications submitted by the appellant for registration of Flixia Tablets 24mg/26mg,
49mg/51mg and 97mg/103mg (Sacubitril + Valsartan) on priority basis and place the same before the Registration
Board for consideration on merit.
As per directions of the Appellate Board, the above said applications are submitted for consideration of the
Registration Board.
87. Name, address of Applicant / Marketing M/s Tabros Pharma (Pvt.) Ltd., L-20/B, Sector-22, F.B.
Authorization Holder Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Tabros Pharma (Pvt.) Ltd., L-20/B, Sector-22, F.B.
Industrial Area, Karachi.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 24065 dated 01-09-2021.
Details of fee submitted PKR 30,000/- dated 17-07-2021.
The proposed proprietary name / brand name Felixia Tablet 24mg/26mg.
Pharmaceutical ingredient (API) per unit Sacubitril……….………………24mg
Valsartan……………………….26mg
(As sacubitril valsartan sodium salt complex)
Pharmaceutical form of applied drug Film coated tablets.

Pharmacotherapeutic Group of (API) Angiotensin II receptor blockers (ARBs), other combinations.
Reference to Finished product specifications
Tabros Specifications.
Proposed unit price As per DPC.
The status in reference regulatory authorities
ENTRESTO® 24/26mg (sacubitril and valsartan) tablets,
USFDA approved.
For generic drugs (me-too status) Savesto 50 Tablet, Getz Pharma, Reg. No. 093110.
GMP status of the Finished product GMP certificate issued based upon inspection conducted on
manufacturer 28-02-2020
Evidence of section approval. Tablet section vide letter No. F.2-5/87-Lic. (Vol-III) 30-06-
2020.
Name and address of API manufacturer. M/s Zhuhai Rundu Pharmaceutical Co. Ltd., No. 6, North
Airport Road, Sanzao Town, Jinwan District, Zhuhai city,
Guangdong Province, China.
Valid GMP certificate of API manufacturer is required. (13-
11-2021)
Module-II (Quality Overall Summary) Firm has submitted QOS as per template provided in 293 DRB
meeting. Firm has submitted summarized information related
to general information, nomenclature, structure, general
properties, solubilities, physical description, manufacturer,
and stability studies of drug substance. Firm has summarized
manufacturing process and process control, control of critical
steps and intermediate, process validation protocols, control of
materials, container closure system and stability. Firm has also
submitted data for facilities, equipments and regional
information.
Module III (Drug Substance) Firm has submitted detailed drug substance data related to
general information, nomenclature, structure, general
Characterization, impurities, Specifications, analytical
Stability studies (Drug Substance) Stability study conditions:
Real time: 30°C ± 2°C / 75% ± 5%RH for 24 months.
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months.
Batches: (57319010802, 57319010803, 57319010804)
Module-III (Drug Product): Firm has summarized information of drug product including
control of critical steps and intermediate, process validation
stability.

dissolution profile brand leader UPERIO tablet 50mg, Batch No. TER92, mfg.
date Jun-20 manufactured by Novartis Pharma by performing
quality tests (Identification, disintegration time, water content,
Assay, Dissolution, content uniformity).
UPERIO tablet 50mg by Novartis Pharma in Acid media (pH
1.2), acetate buffer pH 4.5 & Phosphate Buffer pH 6.8. The F2
values are in the acceptable range.
Analytical method validation /verification of Method validation studies for finished product have submitted
product including following parameters: Linearity & range, Accuracy,
Precision, Specificity, Detection limit, Quantitation limit,
Robustness, Stability indicating, Solution stability.
Analytical method validation for drug substance performed by
drug product manufacturer also submitted including following
parameters:
Linearity & Range, Accuracy, Precision, Specificity.
Manufacturer of API M/s Zhuhai Rundu Pharmaceutical Co. Ltd., No. 6, North Airport Road, Sanzao
Town, Jinwan District, Zhuhai city, Guangdong Province, China.
API Lot No. 57319070802
Description of Pack
Time Period Real time: 09months
Real Time: 0, 3, 6, 9 (Months)
Batch No. TR004-1/FEL TR005-1/FEL TR006-1/FEL
Batch Size 1500 tablets 1500 tablets 1500 tablets
No. of Batches 03
1. Reference of previous approval of applications Firm has referred last onsite panel inspection for instant dosage
with stability study data of the firm (if any) form conducted during last two years BAXIB (Apixaban)
2.5mg & 5mg Tablets on 5th January, 2021 by following panel:
1. Prof. Dr. Rafeeq Alam Khan, Dean, Faculty of Pharmacy,
Zia Uddin University, Karachi. (Member Registration Board).
2. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP,
Karachi.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. GD20160649 issued by China
manufacturer issued by concerned regulatory Food and Drug Administration valid till 13/11/2021.
3. Documents for the procurement of API with The firm has imported 2.5Kg API from M/s Zhuhai Rundu -
approval from DRAP (in case of import). China, bearing invoice number RD2020030202-1 dated March
12, 2020. ADC signed Form 6, & invoice is available. Form 3
and form 7 also available.
chromatograms, Raw data sheets, COA, Submitted

5. Compliance Record of HPLC software 21CFR
& audit trail reports on product testing Submitted
and humidity monitoring of stability chambers Submitted
Sr. Section Observation Response by the firm
No. No.
1. 1.3 Valid GMP certificate/inspection report Firm has submitted GMP certificate issued on 09-06-2020
of the finished product manufacturer on the basis of inspection conducted on 28-02-2020.
conducted within last three years shall be
provided. of the
2. 1.6.5 Valid GMP certificate issued by the GMP certificate issued on 16-09-2021 valid till 15-09-2026
concerned regulatory authority of drug issued by the Zhuhai Association for Pharmaceutical &
substance manufacturer shall be Medical Equipment is provided by the firm.
provided. Not issued by the China Food and Drug Administration.
3. 3.2.S.4.2 Mobile phase gradient program Mobile phase gradient program used by Tabros is similar to
mentioned by Drug product manufacturer that applied by the drug substance manufacturer except on
is different form that applied by the drug one point of 18 minute where the ratio of mobile phase was
substance manufacturer, for the Assay adjusted to improve resolution between peaks.
test. The minor adjustment improved the resolution and
subsequently validated during analytical method validation
studies.
This adjustment is also in line with the allowances of
gradient adjustment mentioned in USP chapter <621>
chromatography.
4. 3.2.P.6 Analytical record for the re-test Firm has submitted analytical record for the re-test
/standardization analysis shall be /standardization for the reference standard.
provided.
5. 3.2.P.7 This section has mentioned pack size of 1 In this section the description of primary container closure
x 14’s while all the other annexures has system is mentioned and 1 x 14’s is the unit count of primary
mentioned 2 x 14’s. Clarification is container i.e. of one Alu-Alu blister strip.
required. Whereas one pack contains two blister strips so the pack size
is 2 x 14’s.
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as
• Registration Board further decided that registration letter will be issued after submission of valid GMP
certificate of drug substance manufacturer, issued by the relevant regulatory authority of the country
of origin.
proposed shelf life and on accelerated studies for six months as per the commitment submitted in the
• Manufacturer will perform process validation of first three batches as per the commitment submitted
in the registration application.
☐ Importer
☐ Export sale

The proposed proprietary name/brand name Felixia Tablet 49mg/51mg.
Reference to Finished product specifications Tabros Specifications.
The status in reference regulatory authorities ENTRESTO® 49/51mg (sacubitril and valsartan) tablets,
USFDA approved.
2020.
11-2021)
information.
Batches: (57319010802, 57319010803, 57319010804)

stability.
dissolution profile brand leader UPERIO tablet 100mg, Batch No. TCY41, mfg.
date Nov-19 manufactured by Novartis Pharma by performing
parameters:
API Lot No. 57319070802
Description of Pack
Time Period Real time: 09months Accelerated: 6 months
No. of Batches 03
Karachi.

No. No.
1. 1.3 Valid GMP certificate/inspection report of Firm has submitted GMP certificate issued on 09-06-2020
the finished product manufacturer on the basis of inspection conducted on 28-02-2020.
conducted within last three years shall be
provided. of the
2. 1.6.5 Valid GMP certificate issued by the GMP certificate issued on 16-09-2021 valid till 15-09-2026
concerned regulatory authority of drug issued by the Zhuhai Association for Pharmaceutical &
substance manufacturer shall be provided. Medical Equipment is provided by the firm.
Not issued by the China Food and Drug Administration.
3. 3.2.S.4.2 Mobile phase gradient program mentioned Mobile phase gradient program used by Tabros is similar to
by Drug product manufacturer is different that applied by the drug substance manufacturer except on
form that applied by the drug substance one point of 18 minute where the ratio of mobile phase was
manufacturer, for the Assay test. adjusted to improve resolution between peaks.
The minor adjustment improved the resolution and
subsequently validated during analytical method validation
studies.
chromatography.
/standardization analysis shall be provided. /standardization for the reference standard.
5. 3.2.P.7 This section has mentioned pack size of 1 x In this section the description of primary container closure
14’s while all the other annexures has system is mentioned and 1 x 14’s is the unit count of
mentioned 2 x 14’s. Clarification is primary container i.e. of one Alu-Alu blister strip.
required. Whereas one pack contains two blister strips so the pack
size is 2 x 14’s.
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product specifications,
• Registration Board further decided that registration letter will be issued after submission of valid
GMP certificate of drug substance manufacturer, issued by the relevant regulatory authority of the
country of origin.
☐ Importer

☐ Export sale
The proposed proprietary name / brand name Felixia Tablet 97mg/103mg.
Reference to Finished product specifications Tabros Specifications.
The status in reference regulatory authorities ENTRESTO® 97/103mg (sacubitril and valsartan) tablets,
USFDA approved.
2020.
11-2021)
information.

Batches: (57319010802, 57319010803, 57319010804)
stability.
dissolution profile brand leader UPERIO tablet 200mg, Batch No. TT213, mfg.
date June-18 manufactured by Novartis Pharma by performing
parameters:
API Lot No. 57319070802
Description of Pack
Time Period Real time: 09months
Real Time: 0, 3, 6, 9 (Months)
Batch Size 1500 tab 1500 tab 1500 tab
No. of Batches 03
Karachi.

No. No.
1. 1.3 Valid GMP certificate/inspection report of the Firm has submitted GMP certificate issued on 09-06-2020
finished product manufacturer conducted on the basis of inspection conducted on 28-02-2020.
within last three years shall be provided. of the
2. 1.6.5 Valid GMP certificate issued by the GMP certificate issued on 16-09-2021 valid till 15-09-
concerned regulatory authority of drug 2026 issued by the Zhuhai Association for Pharmaceutical
substance manufacturer shall be provided. & Medical Equipment is provided by the firm.
Not issued by the China Food and Drug Administration.
3. 3.2.S.4.2 Mobile phase gradient program mentioned by Mobile phase gradient program used by Tabros is similar
Drug product manufacturer is different form to that applied by the drug substance manufacturer except
that applied by the drug substance on one point of 18 minute where the ratio of mobile phase
manufacturer, for the Assay test. was adjusted to improve resolution between peaks.
The minor adjustment improved the resolution and
subsequently validated during analytical method
validation studies.
chromatography.
/standardization analysis shall be provided. /standardization for the reference standard.
5. 3.2.P.7 This section has mentioned pack size of 1 x In this section the description of primary container closure
14’s while all the other annexures has system is mentioned and 1 x 14’s is the unit count of
mentioned 2 x 14’s. Clarification is required. primary container i.e. of one Alu-Alu blister strip.
Whereas one pack contains two blister strips so the pack
size is 2 x 14’s.
GMP certificate of drug substance manufacturer, issued by the relevant regulatory authority of the
country of origin.
90. Name, address of Applicant / M/s Martin Dow Limited, Plot No. 37, Sector 19, Korangi Industrial
Marketing Authorization Holder Area, Karachi.

Name, address of Manufacturing site. M/s Martin Dow Limited, Plot No. 37, Sector 19, Korangi Industrial
Area, Karachi.
☐ Importer
Intended use of pharmaceutical ☐ Domestic sale
product ☐ Export sale
The proposed proprietary name / brand Duvel Plus XR Tablet 50mg + 1000mg.
name
Strength / concentration of drug of Each tablet contains:
Active Pharmaceutical ingredient Sitagliptin Phosphate Monohydrate Eq. to Sitagliptin
(API) per unit ………………………………. 50mg
Metformin HCl (as extended release) ……….. 1000mg
Pharmaceutical form of applied drug Film-coated Extended-release tablet
Pharmacotherapeutic Group of (API) Combinations of oral blood glucose lowering drugs.
Reference to Finished product Martin Dow specifications.
specifications
Proposed Pack size 7’s, 10’s, 14’s, 20’s & 28’s.
The status in reference regulatory JANUMET® XR (sitagliptin and metformin hydrochloride extended
authorities release) tablets, USFDA approved.
For generic drugs (me-too status) Inosita Plus XR Tab 50/1000 Tablet, PharmEvo (Pvt) Ltd., Reg. No.
090991.
GMP status of the Finished product GMP certificate issued 11-06-2020 on the basis of inspection
Evidence of section approval. Tablet (general) section approved vide letter No. F. 2-6/86-Lic (Vol-
V) dated 30-07-2018.
Name and address of API Sitagliptin phosphate monohydrate:
manufacturer. Lianyungang Jari Pharmaceutical Co., Ltd.
No. 18, Zhenhua Road, Lianyungang, China.
Validity 11-04-2024.
Metformin HCl:
IPCA Laboratories Limited.
H-4, MIDC, WALUJ Aurangabad, Aurangabad 431136, Maharashtra
State, India.
Validity 27-08-2021.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO QOS PD template.
manufacturing process and controls, tests for impurities & related
substances, specifications, analytical procedures and its verification,
batch analysis and justification of specification, reference standard,

container closure system and stability studies of in APIMFs of both
drug substances.
Sitagliptin Phosphate Monohydrate.
Batches: (20160301, 20160302, 20160303)
Metformin HCl.
Batches: (9002 ML2RMI, 9003 ML2RMI, 9004 ML2RMI,
Module-III (Drug Product): The firm has submitted detail of manufacturer, description of
analytical procedure (including dissolution testing at acidic and buffer
medium) and its validation studies, batch analysis and justification of
stability studies of drug product.
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established against the
comparative dissolution profile Innovator product that is Janumet XR tablet 50mg+1000mg by Merck
Sharp & Dohme Corp, USA by performing quality tests
(Identification, Disintegration, Assay, Dissolution, Uniformity of
dosage form).
CDP has been performed against the same brand that is Janumet XR
tablet 50mg+1000mg by Merck Sharp & Dohme Corp, USA in Acid
media (pH 1.2), Acetate buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
The values for f1 and f2 are in the acceptable range.
Analytical method Method Validation studies have submitted including linearity, range,
validation/verification of product accuracy, precision, specificity.
Manufacturer of API Sitagliptin:
Lianyungang Jari Pharmaceuticals Co., Ltd.
No. 18, Zhenhua Road, Lianyungang City, Jiangsu province, China
Metformin HCl:
IPCA Laboratories Limited.
H-4, MIDC, WALUJ Aurangabad, Aurangabad 431136, Maharashtra State,
India.
API Lot No. Sitagliptin phosphate monohydrate;
2005000020 (20200401), 2008000002 (20200602),
Metformin HCl:
1908000095 (19370ML2ARMI), 2011000079 (20212ML2ARMI).
Description of Pack
Alu-Alu blister packed in unit carton (2x7’s)
Batch No. NPD-T-1228-L NPD-T-1351-P NPD-T-1352-P

No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of their product Empator
applications with stability study data of 10mg Tablets which was conducted on 6th August 2019 and was
the firm (if any) presented in 291st meeting of Registration Board held on 02nd – 4th
September 2019.
• The firm has 21 CFR compliant HPLC software.
• The firm has audit trail reports available.
The firm possesses stability chambers with digital data loggers.
2. Approval of API/ DML/GMP Sitagliptin: Copy of GMP certificate for Lianyungang Jari
certificate of API manufacturer issued Pharmaceuticals Co., Ltd issued by Lianyungang Drug Administration
by concerned regulatory authority of & Valid up to 11-April-2024 is submitted.
country of origin. Metformin HCl: Copy of GMP Certificate for IPCA Laboratories
Limited (Certificate: New-
WHOGMP/CERT/AD/67318/2018/11/24741) dated 31-08-2018 valid
till 27-08-2021 issued by Food and Drug Administration, M.S.
Bandra-kurla Complex, Bandra (E), Mumbai-400051 Maharashtra,
India is submitted.
3. Documents for the procurement of API Submitted.
with approval from DRAP (in case of
import).
4. Data of stability batches will be Submitted

supported by attested respective
documents like chromatograms, Raw
data sheets, COA, summary data sheets
etc.
5. Compliance Record of HPLC software Submitted
testing
6. Record of Digital data logger for Submitted
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
Sr. Section Observation. Response by the firm.
No. number
1. 1.3.4 Valid copy of DML of the applicant shall be Firm has submitted valid copy of DML w.e.f. 09-02-
submitted. 2021.
2. 1.6.5 Valid GMP certificate of the API Firm has submitted Copy of GMP Certificate for IPCA
manufacturer of metformin HCl, issued by Laboratories Limited (Certificate No.: New-WHO-
the relevant regulatory authority shall be GMP/CERT/AD/104179/2021/11/37725) dated 28-
submitted. 10-2021 valid till 27-10-2024 issued by Food and
Drug Administration, M.S. Bandra-kurla Complex,
Bandra (E), Mumbai-400051 Maharashtra, India.
3. 3.2.S.4.2 Analytical procedure submitted by the drug Firm has submitted that Manufacturer has adopted the
substance manufacturer for the Assay test of test method Assay by Titration based on USP old
Metformin HCl is different from that version that was official at the time of manufacturing
adopted by the drug product manufacturer. (Lot No. 20212 ML2ARMI/Mfg. Date: Feb.2020)
and also the assay limits were set accordingly.

The API lot was tested at Martin Dow in December
2020 and method adopted Assay by HPLC along with
revised limits according to updated versions of USP
monograph (Official as of November 2020).
4. 3.2.S.4.4 • Provide results of analysis of relevant Firm has provided COA’s of the drug substances with
batch(es) of Sitagliptin performed by batch number of Martin Dow. The same COA has also
Drug Product manufacturer used during the supplier lot number.
product development and stability
studies, along with Certificate of Analysis
(CoA) of the same batch from Drug
Substance manufacture.
• Provide results of analysis of relevant
batch(es) of Metformin HCl performed Submitted.
by Drug Product manufacturer used
during product development and stability
studies, along with Certificate of Analysis
(CoA) of the same batch from Drug
Substance manufacture.
• Assay limits for Metformin HCl provided Firm has submitted that Manufacturer has adopted the
by the drug product manufacturer is test method Assay by Titration based on USP old
different from that declared by the drug version wherein the limits were 98.5% - 101.0% while
substance manufacturer. we have adopted Assay by HPLC along with revised
limits according to updated versions of USP
monograph i.e. 98.0% - 102.0%
5. 3.2.P.8.3 • ADC attested invoices of the both drug Firm has provided attested invoices of both the drug
substance used during product substances for the lot numbers used during stability
development and stability studies shall be studies.
submitted.
• Date of manufacturing of B # NPD-T- Batch was manufactured on 19/11/2020 and was
1228-L is 19-11-2020 while the analysis processed after each stage satisfactory testing result to
date id 25-02-2021. Justification for this finished product with final coat. The finished product
delay shall be submitted. was received by 07/01/2021 in the lab for final testing
and after satisfactory test results of 02 other batches
manufactured in February 2021 initiated on stability
along with the other two batches on 25/02/2021.
6. • USP monograph of Metformin HCl Firm has submitted that it is a typo error. The actual
mentions use of 25-cm column in the column used is 250 instead of 25.
Assay test, while the applicant has
declared use of 250cm column for the
same. Justification is required. • The 50% excess quantity mentioned in the BPR is
• Justification of 50% extra amount of for the clarity of the reviewer and the document
Sitagliptin in master formulation (which itself.
is required to be based on study/scientific • Excess quantity was added in coating material i.e.,
rationale) for which firm has stated that it Propyl gallate, Polyethylene Glycol 6000,
was taken to compensate the loss during Hydroxyprop.Methylcell.2910/6CP, Kaolin along
coating. with it is the API Sitagliptin Phosphate
Monohydrate to compensate for the process loss
faced while Coating operation is being carried out,
as it is an API coated tablet.
• As it’s a universal truth, losses are
observed/experienced during coating and thus extra
quantities are added as a recompense. These extra
quantities do not become part of the final film
coated product, as is evident in the Assay results of
Sitagliptin which are well within limits as per label
claim.
• Actual quantity of water used for the The actual water quantity mentioned in the Batch
preparation of Active coating solution Production Record is a typographical error while the
does not equate to the 50% extra than that calculation is correct as of 50% excess quantity to
mentioned for each tablet. match with rest of the formulation.

• The submitted BMR does not reflect The dissolution testing was performed at final stage
performance of dissolution for Metformin and results were well within specified limits. Since the
HCl before proceeding for seal & active trial were satisfactory at core stage, a decision was
coating step. Justification shall be made on risk basis to perform the dissolution testing at
submitted for proceeding further without final stage after multiple coating to better evaluate the
establishing the Dissolution profile of impact on all stability batches. Satisfactory initial and
Metformin HCl. stability results are also evident on Metformin HCl
dissolution performance.
• The submitted product development The uniformity of content for sitagliptin was
record does not reflect performance of performed at final stage as per procedure and results
Uniformity of dosage units test by way of were found well within specified limits. The assay
Assay for Sitagliptin before proceeding (Sitagliptin) was performed on API coat stage before
for final film coating step. Justification proceeding the next final stage of film coating while it
shall be submitted for proceeding further was decided to perform the uniformity of dosage units
without establishing the content of (Sitagliptin) on finished stage on risk basis and later
Sitagliptin. results were found satisfactory.
Decision Approved with innovator’s specifications.
• Manufacturer will perform process validation of first three production batches as per the
commitment submitted in the registration application.
91. Name, address of Applicant / Wilson’s Pharmaceuticals, Plot No. 387-388, Sector I-9, Industrial
Marketing Authorization Holder Area, Islamabad.
Name, address of Manufacturing site. Wilson’s Pharmaceuticals, Plot No. 387-388, Sector I-9, Industrial
Area, Islamabad.
☐ Importer
☒ Domestic and Export sales.
Dy. No. and date of submission Form-5F Dy. No. 16902 dated 17-06-2021.
Details of fee submitted PKR 20,000/-: dated 30-03-2021 & Rs.10,000/- dated 26-05-2021.
The proposed proprietary name / brand
Metwil-S 50/850mg tablets.
name
Strength / concentration of drug of Each film coated tablet contains;
Active Pharmaceutical ingredient Sitagliptin (as Phosphate Monohydrate) ……. 50mg
(API) per unit Metformin Hydrochloride ……………………. 850mg
Pharmaceutical form of applied drug Oral tablet.
Pharmacotherapeutic Group of (API) Combinations of oral blood glucose lowering drugs.
Manufacturer specifications.
specifications
Proposed Pack size 7’s, 14’s & 28’s.

The status in reference regulatory Janumet® 50 mg/850 mg film coated tablets, MHRA approved.
authorities
For generic drugs (me-too status) Inosita Plus 50/850 Tablet, PharmEvo Pvt. Ltd., Reg. No. 083004.
GMP status of the Finished product Inspection report of 24-01-2018.
manufacturer Not valid.
Evidence of section approval. Tablet (general) section approved vide No. F. 1-19/92-Lic (P1) dated
27-07-2015.
Name and address of API Metformin hydrochloride.
manufacturer. Abhilasha Pharma Pvt. Limited 1408, 1409, GID, EST. Anklishwar,
393 002, Gujrat state India.
Zhejiang Tianu Pharmaceuticals Co. Ltd., No. 15, Dongai 5th Avenue,
Zhejiang provincial chemical and medical Raw materials Base Linhai
Zone, Taizhou City, Zhejiang province, China.
Valid till 02-06-2022.
Issued by Zhejiang medicine center for economic development
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Summarized
information related to nomenclature, structure, general properties,
system and stability studies of drug substance and drug product is
submitted.
Module III (Drug Substance) Sitagliptin Phosphate Monohydrate:
The firm submitted detail of nomenclature, structure, general
manufacturing process and controls, tests for related substances
(impurity A & unspecified), specifications, analytical procedures and
its validation, batch analyses and justification of specification,
reference standard, container closure system and stability studies of
drug substance.
Metformin HCl:
The firm submitted detail of nomenclature, structure, general
manufacturing process and controls, tests for related substances
(impurity A & unspecified), specifications, analytical procedures and
its validation, batch analyses and justification of specification,
drug substance
Batches: (12300-160101, 12300-160102 & 12300-160103)
Metformin HCl.
Batches: (MET099/13, MET100/13 & MET101/13)

Module-III (Drug Product): The firm has submitted detail of description, composition,
pharmaceutical development, manufacturers, description of
analytical procedure and its validation studies, batch analysis and
system and stability studies of drug product.
Pharmaceutical equivalence and Pharmaceutical equivalence against has been established against the
comparative dissolution profile reference product Inosita Plus 50/850mg tablet manufactured by
Pharma Evo (Pvt.) Ltd., by performing quality tests (Identification,
Comparative dissolution test is carried out in three different mediums
i.e. pH 1.2 in 0.1 N HCl, pH 4.5 Acetate buffer & pH 6.8 Phosphate
buffer against the Inosita Plus 50/850mg tablet, B# 0F043,
manufactured by Pharma Evo (Pvt.) Ltd at different time points with
f2 value of greater than 50.
Analytical method Method validation studies have been submitted including: system
validation/verification of product suitability, accuracy, and precision.
Manufacturer of API Metformin hydrochloride.
Abhilasha Pharma Pvt. Limited 1408, 1409, GID, EST. Anklishwar, 393 002, Gujrat
state India.
Zhejiang Tianu Pharmaceuticals Co. Ltd., No. 15, Dongai 5th Avenue, Zhejiang
provincial chemical and medical Raw materials Base Linhai Zone, Taizhou City,
Zhejiang province, China.
API Lot No. 12301-17030101 (Sitagliptin)
MET 136/15 (Metformin)
Description of Pack
Alu-Alu strip packed in card box unit carton of 4 x 7’s (28’s)
Batch No. Trial 01 Trial 02 Trial 03
Batch Size 1500 tabs 1500 tabs 1500 tabs
No. of Batches 03
1. Reference of previous approval of Firm has submitted Reference of previous approval of applications
applications with stability study data of with stability study data.
the firm (if any)

2. Approval of API/ DML/GMP Firm has submitted GMP certificates of:
certificate of API manufacturer issued
Sitagliptin Phosphate Monohydrate: GMP Certificate No:
by concerned regulatory authority of201904044 valid up to Jun. 02, 2022 issued by Zhejiang Medicine
country of origin. Center for Economic Development, China.
Metformin HCl: GMP Certificate No: 19081546 valid up to
25/08/2022 issued by Food & Drugs Control Administration by
Gujarat State, India.
3. Documents for the procurement of API Firm has submitted copy of commercial invoice of:
with approval from DRAP (in case of Sitagliptin Phosphate Monohydrate: Commercial Invoice No:
import). TY117433 dated Jun. 05, 2017.
Metformin HCl: Commercial Invoice No: AST/EXP/158/15-16 dated
04-09-2015.
etc.
testing
accelerated)
No. No.
1. 1.3 Valid copy of DML and latest GMP Firm has submitted receipt for renewal of DML dated
certificate/inspection report conducted within 03-02-2021.
last three years of the finished product Firm has also submitted GMP inspection report dated
manufacturer shall be provided. 24-01-2018.
Provided GMP inspection report is not within last
three years.
2. 1.6.5 GMP certificate for drug substance (Sitagliptin Firm has submitted copy of GMP Certificate No:
phosphate monohydrate) from concerned / 201904044 valid up to Jun. 02, 2022 issued by
relevant regulatory authority shall be submitted. Zhejiang Medicine Center for Economic
Development, China.
3. 3.2.S.4.2 Detailed method of analytical procedure for Submitted
drug substance performed by the drug product
4. 3.2.S.4.3 Verification studies of drug substance Submitted.
shall be submitted.
5. 3.2.S.7 Real time stability study data of drug substance Submitted.
(metformin HCl) provided by the firm is not in
readable form. Clear and readable copies shall
be submitted.
6. 3.2.P.2.2.1 CDP and pharmaceutical equivalence are not Firm submitted that at the time of submission,
established against innovator brand. reference product was not available in Pakistan; even
Clarification is required. after exhaustive effort we were unable to arrange the
reference product from the local market.
Firm further submitted that Registration Board has
decided that CDP must be carried out with innovator
brand available in Pakistan and in case the
originator/innovator is not available then the CDP
with me-too is a must.

They further undertake that they shall perform the PE
& CDP with the reference product in future.
7. 3.2.P.6 Details of working standard for sitagliptin Submitted.
phosphate monohydrate have not been provided.
8. 3.2.P.8.3. ADC attested invoices of the drug substance ADC attested invoices i.e. 12301-17030101
used during product development and stability (Sitagliptin), MET 136/15 (Metformin) are
studies shall be submitted. provided by the firm.
9. In EMA public assessment report, limits for the Firm has revised their finished product specifications
assay test for drug product are 95% - 105% in accordance with innovator’s product i.e. (Assay:
while the specification of the drug product 95.0% - 105.0%) with submission of 7500/- fee vide
provided by the drug product manufacturer is slip No. 15760546695 dated 24-01-2022.
90% - 110%. Clarification is required.
• Registration letter will be issued after submission of GMP audit report from QA&LT Division, valid
within last three years.
92. Name, address of Applicant / Marketing M/s Wilson's Pharmaceuticals, 387-388, Sector I-9, Industrial
Authorization Holder Area, Islamabad.
Name, address of Manufacturing site. M/s Wilson's Pharmaceuticals, 387-388, Sector I-9, Industrial
Area, Islamabad.
☐ Importer
☐ Export sale
☒Domestic and Export sales
Differential Fee PKR 10,000/-: dated 26/05/2021.
Mefo 4mg Tablet.
name
Strength / concentration of drug of Active Each Film Coated Tablet contains:
Pharmaceutical ingredient (API) per unit Lornoxicam ………………4mg
Pharmaceutical form of applied drug Yellow color, Round shaped, Film Coated Tablet Plain on both
sides.
Pharmacotherapeutic Group of (API) Anti-inflammatory and Antirheumatic Products, Non-Steroids.
Manufacturer’s Specifications.
specifications
Proposed Pack size 10’s, 20’s and 30’s.
Proposed unit price As per S.R.O.
The status in reference regulatory Xefo 4mg Film-Coated Tablet, Takeda Austria GmbH, Austria
authorities approved.
For generic drugs (me-too status) Acabel Tablets 4mg, S.J & G Fazul Ellahie, Reg. No. 061603.

Evidence of section approval. Tablet (general) section approved vide No. F. 1-19/92-Lic (P1)
dated 27-07-2015.
Name and address of API manufacturer. Glenmark Life Sciences Limited (701214), A-80, MIDC,
Kurkumbh, Tal. Daund-413802, Dist_Pune-Zone4, India.
Issued by Food & Drug Administration Pune division India.
Module III (Drug Substance) Official monograph of Lornoxicam does not exist in any
Pharmacopoeia. The firm has submitted detail of nomenclature,
manufacturers, description of manufacturing process and controls,
tests for impurity A, B, C & D, specifications, analytical
procedures and its Validation, batch analyses and justification of
substances (accelerated and real time) according to Zone IV-A
conditions:
Batches: (AB12013007, AB12013008, AB12013009)
manufacturing process and process control, specifications,
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established against the
comparative dissolution profile brand leader that is Acabel Tablets 4mg by M/s S. J & G Fazul
Ellahie (Pvt.) Ltd., Karachi by performing quality tests
(Appearance, Assay, Dissolution and Disintegration Time).
CDP has been performed against the same brand that is Acabel
Tablets 4mg by M/s M/s S. J & G Fazul Ellahie (Pvt.) Ltd.,
Karachi in 3 medias i.e; 0.1N HCl, Acetate Buffer pH4.5 &
Phosphate Buffer pH 6.8.The values for f2 are in the acceptable
range.
Analytical method validation/verification Method validation studies have been submitted including System
of product. Suitability, Accuracy, and Precision.
Manufacturer of API Glenmark Life Sciences Limited (701214), A-80, MIDC, Kurkumbh, Tal. Daund-
413802, Dist_Pune-Zone4, India.
API Lot No. 83181111.
Description of Pack Alu-Alu blister packed in unit carton (10’s, 20’s and 30’s)

Batch No. Trial No. 01 Trial No. 02 Trial No. 03
No. of Batches 03
applications with stability study data of the with stability study data.
firm (if any)
2. Approval of API/ DML/GMP certificate of Firm has submitted Copy of GMP certificate No. 6097419 issued
API manufacturer issued by concerned by Food & Drug Administration, PUNE Division, Maharashtra
regulatory authority of country of origin. State India valid till 10/01/2022.
3. Documents for the procurement of API Firm has submitted copy of Clearance Certificate attested by AD
with approval from DRAP (in case of (I&E), DRAP, Islamabad dated 27-02-2019 and copy of
import). commercial invoice No. F30000000068 mentioning batch No.
83181111 dated 06-02-2019 is also submitted.
4. Data of stability batches will be supported Submitted.
5. Compliance Record of HPLC software Submitted.
testing
6. Record of Digital data logger for Submitted.
accelerated)
Sr. Section No. Observation Response by the firm
No.
1. 1.3 • Valid copy of DML of drug product Firm has submitted receipt for renewal of DML
manufacturer shall be submitted. dated 03-02-2021.
• Latest GMP certificate/inspection report Firm has also submitted GMP inspection report
conducted within last three years of the dated 24-01-2018.
finished product manufacturer shall be Provided GMP inspection report is not within last
submitted. three years.
2. 1.6.5 Valid copy of GMP certificate for drug Firm has provided copy of GMP certificate No.
substance manufacturer from concerned / 6104231 valid till 24-01-2023 issued by Food &
relevant regulatory authority shall be submitted. Drug Administration Pune division, Maharashtra
state, India.
3. 2.3.R.2 Justify the dispensing of drug substance for trial Firm has submitted that their product results for
batch manufacturing without potency trial batches ranges from 99.0% - 102.84%,
adjustment. whereas the release limits for finished drug

product are 90.0% - 110.0%. as per
manufacturer’s specifications.
They further undertake that they will adjust the
potency of drug substance in formulation of
commercial batches.
4. 3.2.S.2 Address of drug substance manufacturer is Due to typographic error, the address of drug
different on GMP certificate from that given in substance manufacturer was written wrong. Firm
3.2.S.2. Clarification is required. has also corrected the address of the
manufacturer in 3.2.S.2.
5. 3.2.S.4.2 Detailed analytical procedures for the testing of Submitted.
drug substance performed by the drug substance
manufacturer shall be provided.
shall be submitted.
7. 3.2.P.2.1.2 Povidone is used by the reference product while Firm submitted that innovator brand has adopted
the applied formulation has no povidone as wet granulation method that’s why povidone has
excipient. Clarification is required. been used as a wet binder.
While we have tested and stabilized or product on
direct compression method, where there is no
need of adding any binder (povidone) in wet
form.
established against innovator product. reference product was not available in Pakistan;
Clarification is required. even after exhaustive effort we were unable to
arrange the reference product from the local
market.
Firm further submitted that Registration Board
has decided that CDP must be carried out with
innovator brand available in Pakistan and in case
the originator/innovator is not available then the
CDP with me-too is a must.
They further undertake that they shall perform
the PE & CDP with the reference product in
future.
• Manufacturer will submit comparative dissolution profile against the innovator product before
issuance of registration letter.
Area, Islamabad.
☐ Importer

☐ Export sale
Mefo 8mg Tablet.
name
Strength / concentration of drug of Active Each Film Coated Tablet contains:
Pharmaceutical form of applied drug Orange colored, Round shaped, Film Coated Tablet Plain on both
sides.
specifications
The status in reference regulatory Xefo 8mg Film-Coated Tablet, Takeda Austria GmbH, Austria
authorities approved.
For generic drugs (me-too status) Acabel Tablets 8mg, S.J & G Fazul Ellahie, Reg. No. 061604.
dated 27-07-2015.
conditions:

Batches: (AB12013007, AB12013008, AB12013009)
comparative dissolution profile Spedicam 8mg by M/s PharmEvo (Pvt.) Ltd., Karachi by
performing quality tests (Appearance, Assay, Dissolution and
Disintegration Time).
CDP has been performed against the same brand that is Spedicam
8mg by M/s PharmEvo (Pvt.) Ltd., Karachi in 3 medias i.e; 0.1N
HCl, Acetate Buffer pH4.5 & Phosphate Buffer pH 6.8.The values
for f2 are in the acceptable range.
Manufacturer of API Glenmark Life Sciences Limited (701214), A-80, MIDC, Kurkumbh, Tal. Daund-413802,
Dist_Pune-Zone4, India.
API Lot No. 83181111.
Description of Pack
(Container closure Alu-Alu blister packed in unit carton (10’s, 20’s and 30’s)
system)
Stability Storage Real time: 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
No. of Batches 03
firm (if any)

testing
accelerated)
No.
state, India.
adjustment. whereas the release limits for finished drug product
are 90.0% - 110.0%. as per manufacturer’s
specifications.
commercial batches.
3.2.S.2. Clarification is required. has also corrected the address of the manufacturer
in 3.2.S.2.
shall be submitted.
7. 3.2.P.2.1.2 Povidone is used by the reference product while Firm submitted that innovator brand has adopted
the applied formulation has no povidone as wet granulation method that’s why povidone has
excipient. Clarification is required. been used as a wet binder.
While we have tested and stabilized or product on
direct compression method, where there is no need
of adding any binder (povidone) in wet form.
established against innovator product. reference product was not available in Pakistan;
market.
decided that CDP must be carried out with

They further undertake that they shall perform the
PE & CDP with the reference product in future.
Area, Islamabad.
☐ Importer
☐ Export sale
Mefo Rapid 8mg Tablet.
name
Strength / concentration of drug of Active Each Rapid Film Coated Tablet contains:
Pharmaceutical form of applied drug Pear shaped, Red color film coated tablet with bisect line on one
side and plain on other.
specifications
The status in reference regulatory Xefo Rapid 8mg film coated tablets, Takeda Austria GmbH,
authorities Austria approved.
For generic drugs (me-too status) Xika Rapid 8mg tablet, Hilton Pharma, Reg. No. 061612.
dated 27-07-2015.

conditions:
Batches: (AB12013007, AB12013008, AB12013009)
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established against Xica
comparative dissolution profile 8mg Rapid tablets by M/s Hilton Pharma (Pvt.) Ltd., Karachi by
performing quality tests (Appearance, Assay, Dissolution and
Disintegration Time).
CDP has been performed against the same brand that is Xica 8mg
Rapid tablets by M/s Hilton Pharma (Pvt.) Ltd., Karachi in 3
medias i.e; 0.1N HCl, Acetate Buffer pH4.5 & Phosphate Buffer
pH 6.8.The values for f2 are in the acceptable range.
Manufacturer of API Glenmark Life Sciences Limited (701214), A-80, MIDC, Kurkumbh, Tal. Daund-413802,
Dist_Pune-Zone4, India.
API Lot No. 83181111.
Description of Pack
(Container closure Alu-Alu blister packed in unit carton (10’s, 20’s and 30’s)
system)

No. of Batches 03
firm (if any)
testing
accelerated)
No.
state, India.
adjustment. whereas the release limits for finished drug product
are 90.0% - 110.0%. as per manufacturer’s
specifications.
commercial batches.
3.2.S.2. Clarification is required.

has also corrected the address of the manufacturer
in 3.2.S.2.
shall be submitted.
7. 3.2.P.2.1.1 Effer soda has been used as in-active in the The chemical name of effer soda is sodium
formulation. However, its composition is not bicarbonate
known. Calcium stearate is a lubricant that is used for
Calcium stearate is used by the innovator enhancing the flow properties of the material. Our
product while the applied formulation has no formulation does not contain any lubricant as the
calcium stearate. Clarification is required. material already had excellent flow properties.
Therefore, addition of calcium stearate as flow
promoter in our product is not required.
established against innovator brand. reference product was not available in Pakistan;
market.
decided that CDP must be carried out with
They further undertake that they shall perform the
PE & CDP with the reference product in future.
9. You are hereby advised to clarify the difference • The innovator data attached in mefo 8mg Rapid
between two applied formulations of tablets states in section 5.1
lornoxicam 8mg film coated tablet & “In a clinical study in patients with pain after
Lornoxicam 8mg rapid tablet, based upon their surgical removal of an impacted third molar
pharmacokinetic profiles and also elaborate the lornoxicam Rapid film coated tablets showed a
in-vitro tests applied for establishing the said faster onset of action compared to lornoxicam film
difference. coated tablets”.
• The innovator data attached in mefo 8mg Rapid
tablets states in section 5.1
“The Cmax for Xefo rapid film coated tablets is
higher than Cmax for Xefo film coated tablets and
equivalent to Cmax for the parenteral formulation
of lornoxicam”
The above stated two points show the difference in
two applied formulations i.e. Mefo 8mg and Mefo
8mg Rapid tablets.
Decision: Deferred for clarification of difference between two applied formulations of lornoxicam 8mg film
coated tablet and Lornoxicam 8mg rapid tablet, based upon their pharmacokinetic profiles and also elaborate
the in-vitro tests applied for establishing the said difference.
Registration applications of locally manufactured (Human) drugs on Form 5.
95. Name and address of manufacturer/ Qintar Pharmaceuticals, 14-A, P.S.I.E Lahore Road, Sargodha.
Applicant
Brand Name + Dosage Form + Strength Seratase 10mg Tablets.
Composition Each enteric coated tablet contains:
Serratiopeptidase ……………… 10mg
Diary No. Date of R & I & fee Dy.No.12997 dated 05-03-2019; Rs.20,000/- Dated 04-03-2019.
Pharmacological Group Anti-Inflammatory agent.
Type of Form Form-5.
Finished product Specification Manufacturer Specifications.
Pack size & Demanded Price 20’s & as per policy of DRAP.

Approval status of product in Reference Could not be confirmed.
Me-too status Danzen DS Tab, Helix pharma, Reg. No. 028173.
GMP status Conclusion: 04-09-2019.
Firm has improved a lot of observations and showed good
intentions to rectify further.
Remarks of the Evaluator • Evidence of section approval for the applied formulation.
• Valid copy of drug manufacturing license.
• Analytical method for finished drug product.
• Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved
by the Registration Board in its 275th meeting.
Decision: Deferred for the followings;
• Evidence of section approval for the applied formulation.
• Valid copy of drug manufacturing license.
• Analytical method for finished drug product.
• Evidence of approval of applied formulation in reference regulatory authorities/agencies which
were declared/approved by the Registration Board in its 275th meeting.
96. Name and address of manufacturer/ M/s Linta Pharmaceuticals (Pvt.) Ltd., Plot No. 03, Street No S-5,
Applicant National Industrial Zone, Rawat, Islamabad (Capsule section
general).
Brand Name + Dosage Form + Strength Dulox 20mg Capsule.
Composition Each Hard Gelatin Capsule Contains:
Enteric Coated Pellets of Duloxetine Hydrochloride Eq. To
Duloxetine ……… 20mg
(Source of pellets is M/s Vision pharma, Islamabad)
Diary No. Date of R & I & fee Dy. No 31554 dated 18-09-2018; Rs.20,000/- dated 18-09-2018.
Pharmacological Group Antidepressants.
Pack size & Demanded Price 1 x 10’s, 4 x 7’s, 2 x 7’s & As per SRO.
Approval status of product in Reference CYMBALTA (duloxetine delayed-release capsules), USFDA
Regulatory Authorities approved.
Me-too status Duprex capsule 20mg, CCL Pharmaceuticals, Reg. No. 054410.
GMP status Concluding Remarks (10-07-2019):
Keeping in view the above it may be concluded that M/s Linta
Pharmaceuticals is operating at acceptable level of GMP standard.
Remarks of the Evaluator • Firm has also provided stability studies data of pellets for three
batches along with GMP certificate of supplier.
• Firm has also provided Duloxet, Duloxy capsules 20mg as
alternative brand names.
Decision: Approved.
97. Name and address of manufacturer/ M/s Linta Pharmaceuticals (Pvt.) Ltd., Plot No. 03, Street No S-5,
Applicant National Industrial Zone, Rawat, Islamabad (Tablet Section
general).
Brand Name + Dosage Form + Strength K-Flam 50mg Tablets.
Composition Each Film Coated Tablet Contains:
Diclofenac Potassium ……………… 50mg
Pharmacological Group Anti-inflammatory and Antirheumatic Products, Non-Steroids
Finished product Specification USP Specifications.
Pack size & Demanded Price 2 x 10’s, 3 x 10 & As per SRO.
Approval status of product in Reference Voltarol® Rapid 50mg coated tablets, MHRA approved.

Me-too status Maxit Tablets, Hilton Pharma, Reg. No. 010867.
GMP status Same as above.
Remarks of the Evaluator • Firm has also provided Nsaidic, Linko & Diron-K 50mg tablets
as alternative brand names.
Decision: Approved.
98. Name and address of manufacturer/ Pharmedic laboratories 16KM, Multan Road, Lahore (Tablet
Applicant Antibiotic).
Brand Name + Dosage Form + Strength Nyxia 550mg tablets.
Rifaximin ……………………. 550mg
Diary No. Date of R & I & fee Dy. No 1224 dated 21-10-2015; Rs. 20,000/- dated 21-10-2015.
Duplicate File Bearing Dy No. 1311 dated 21-05-2021.
Pharmacological Group Antibiotic.
Pack size & Demanded Price 2 x 10’s & as per SRO.
Approval status of product in Reference XIFAXAN® (rifaximin) film coated Tablets, USFDA approved.
Me-too status Nimixa Tablets 550mg, Getz pharma, Reg. No. 070733.
Remarks of the Evaluator • Firm has revised their master formulation and manufacturing
process by adding coating process with submission of 30,000/-
fee vide deposit slip No. 45411916 dated 20-09-2021.
99. Name and address of manufacturer/ Pharmedic laboratories 16KM, Multan Road, Lahore (Liquid
Applicant injectable Ampoule & vial).
Brand Name + Dosage Form + Strength Patron 0.25mg/5ml injection.
Palonosetron as HCl ………………..0.25mg
Duplicate File Bearing Dy No. 1314 dated 19-05-2021.
Pharmacological Group Serotonin (5HT3) antagonists.
Type of Form Form-5D.
Pack size & Demanded Price As per SRO.
Approval status of product in Reference Palonosetron as hydrochloride 250 microgram/5 mL solution for
Regulatory Authorities injection, TGA approved.
Me-too status Arista Injection 0.25mg/5ml, S.J & G. Fazul Ellahie, Reg. No.
070580.
Remarks of the Evaluator • Firm has revised the pharmacological group from Antidiabetic
to Serotonin (5HT3) antagonists with submission of 7530/- fee
vide slip No. 941335307 dated 20-09-2021.
• Firm has also provided Palon & Oron as alternative brand
names.
100. Name and address of manufacturer/ Valor pharmaceuticals, 124/A, Industrial Triangle, Kahuta Road,
Applicant Islamabad.
Brand Name + Dosage Form + Strength Mometaval Nasal Spray
Composition Each actuation of spray contains:
Mometasone Furoate as monohydrate ………. 50mcg
Diary No. Date of R & I & fee Dy. No. 38586 dated 23-11-2018; Rs. 20,000/- dated 23-11-2018.

Pharmacological Group Corticosteroids, Plain.
Type of Form Form-5
Finished product Specification BP specifications.
Pack size & Demanded Price 60 doses, 120 doses, 140 doses of spray per plastic bottle.
Approval status of product in Reference Nasonex 50 micrograms/actuation Nasal Spray, Suspension,
Regulatory Authorities MHRA approved.
Me-too status Rinelon Aqueous Nasal Spray, Imported by OBS Pakistan, Reg.
No. 087691.
GMP status Could not be confirmed.
Remarks of the Evaluator • Latest GMP certificate/Inspection report conducted within last
three years could not be confirmed.
• Section approval/manufacturing facility could not be confirmed.
Decision: Deferred for following;
• Latest GMP certificate/Inspection report conducted within last three years.
• Section approval/manufacturing facility for the applied formulation.
101. Name and address of manufacturer/ M/s Winilton Pharmaceuticals (Pvt.) Ltd., Plot # 45, Street # S-5,
Applicant National Industrial Zone, Rawat, Islamabad (Tablet general).
Brand Name + Dosage Form + Strength Oxitine CR 25mg Tablet.
Composition Each Controlled Release Tablet Contains:
Paroxetine as HCl …………………25mg
Diary No. Date of R & I & fee Dy. No. 8247 dated 25-02-2019; Rs.20,000/- dated 25-02-2019.
Duplicate File Bearing Dy No. 15463 dated 03-06-2021 Verified
by R & I Section.
Pharmacological Group Selective serotonin reuptake inhibitors.
Finished product Specification USP specifications.
Pack size & Demanded Price 10’s, 20’s, 30’s & as per SRO.
Approval status of product in Reference PAXIL CR (paroxetine as HCl) 25 mg, USFDA approved.
Me-too status Deroxat CR 25mg Tablets, Global Pharmaceuticals, Reg. No.
069949.
Remarks of the Evaluator • Firm has revised their label claim in line with reference product
with submission of 30,000/- fee vide slip No. 886454433 dated
03-11-2021.
Revised label claim is as under;
Each enteric film coated controlled release Tablet Contains:
Paroxetine as HCl …………………25mg
Decision: Approved with following label claim;
Each enteric film coated controlled release Tablet Contains:
Paroxetine as HCl …………………25mg.
Applicant National Industrial Zone, Rawat, Islamabad (Contract giver)
M/s Vision Pharmaceuticals, Plot # 22,23, Industrial Triangle,
Kahuta Road, Islamabad (Contract acceptor) (Dry powder
injection general)
Brand Name + Dosage Form + Strength Omeprazole 40mg IV Injection.
Composition Each Vial Contains
Omeprazole as Sodium ……………………40mg
Diary No. Date of R & I & fee Dy. No 10128 dated 04-03-2019; Rs.50,000/- dated 01-03-2019
Pharmacological Group Proton pump inhibitor.
Finished product Specification Innovator’s specifications.
Pack size & Demanded Price 1’s & as per SRO.

Approval status of product in Reference Omeprazole 40 mg Powder for Solution for Infusion, Sandoz
Regulatory Authorities Limited, MHRA approved.
Me-too status Zolpro Injection 40mg, Safe pharma, Reg. No. 067427.
GMP status Vision Pharma:
GMP certificate issued on 25-02-2019 on the basis of inspection
Winilton pharma:
Conclusion 07-03-2019:
Overall the Evaluation of Inspection report is Good.
Remarks of the Evaluator • Firm has provided section approval letter wherein they have
three approved sections and they also submitted that no product
is registered on contract basis.
Decision: Deferred as already deferred for capacity assessment (manufacturing and testing facility etc)
of M/s vision in 313th meeting of Registration Board, For “Dry Powder Injection section (General)” &
“Dry Powder Injection section (Steroid )”, notified vide letter No. F.15-1/2022-PEC dated 08-03-2022.
Kahuta Road, Islamabad (Contract acceptor) (Dry powder
injection general)
Brand Name + Dosage Form + Strength Somicid 40mg IV Injection.
Composition Each Vial Contains
Esomeprazole as Sodium …………… 40mg
Finished product Specification Manufacturer specifications.
Pack size & Demanded Price 1’s & as per SRO.
Approval status of product in Reference Nexium IV 40mg/vial injection, ASTRAZENECA PHARMS,
Regulatory Authorities USFDA approved.
Me-too status Somezol Injection, Bosch pharma, Reg. No. 045386.
Remarks of the Evaluator • Firm has provided section approval letter wherein they have
Kahuta Road, Islamabad (Contract acceptor) (Liquid vial general)
Brand Name + Dosage Form + Strength Mecowin Injection 500mcg.
Composition Each 1ml Ampoule Contains:
Mecobalamin ………………… 500mcg.
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues)
Pack size & Demanded Price 1ml x 10’s & as per SRO.
Approval status of product in Reference Mecobalamin Injection 500 mcg, PMDA Japan Approved.
Me-too status Minbala Injection 500mcg/ml, Munawar Pharma, Reg. No.
042657.

Remarks of the Evaluator • Firm has submitted that we cannot perform terminal
sterilization of Mecowin injection because it is sensitive to
heat.
• Firm has provided section approval letter wherein they have
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product
specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Registration Board further decided that Registration letter will be issued after submission of
valid GMP certificates of both the contract giver and contract acceptor.
Brand Name + Dosage Form + Strength Irowin 100mg Injection.
Composition Each 5ml Ampoule Contains:
Iron as Iron Sucrose ……..…..… 100mg
Pharmacological Group Iron, parenteral preparations.
Approval status of product in Reference Venofer (50mg/2.5mL, 100mg/5mL, 200mg/10mL) (20mg/mL) in
Regulatory Authorities single-dose vials. Injection USFDA Approved
Me-too status Irofit Injection 100mg/5ml, Zafa Pharma, Reg. No. 082291.
sterilization of Irowin injection because it is sensitive to heat.
“Each 5ml contains:
Iron sucrose (iron(III)-hydroxide sucrose complex) eq. to elemental Iron …….. 100mg”
• Firm shall submit fee of Rs. 75,000 for each product for standardization of label claim, as per
notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
GMP certificates of both the contract giver and contract acceptor. Moroever firm shall submit
evidence of performance of assay test on atomic absorption spectrophotometry, as recommended by
USP monograph, by M/s Vision pharmaceuticals.
Brand Name + Dosage Form + Strength Ketroq 30mg Injection.
Composition Each Ampoule Contains:
Ketorolac Tromethamine ………..… 30mg
Pharmacological Group Anti-inflammatory and Antirheumatic Products, Non-Steroids
Approval status of product in Reference Toradol Injection 30mg/ampoule of 1ml by M/s Atnahs Pharma,
Regulatory Authorities UK (MHRA Approved)

Me-too status Tromit Injection 30mg/ml, Standpharm Pakistan, Reg. No.
049958.
Remarks of the Evaluator • Firm has revised their manufacturing outline wherein they have
added terminal sterilization with submission of fee of 7500/-
vide slip no. 51343740442 dated 12-11-2021.
Decision: Deferred for scientific rationale of performing terminal sterilization, with reference to the
innovator product.
Brand Name + Dosage Form + Strength Win D3 5mg Injection.
Cholecalciferol ……….… 5mg
Pharmacological Group Vitamin D and analogue.
Approval status of product in Reference Vitamin D3 Good 200,000 IU / 1 ml IM solution for
Regulatory Authorities injection of (ANSM France approved)
Me-too status Cara-IN-D, Caraway Pharmaceuticals, Reg. No. 052731.
sterilization of Cholecalciferol injection because crodamol oil
is used in the manufacturing of it and have oily phase.
• Firm has claimed BP specifications. However, BP has the
strength of 7.5 mg and Ethyl Oleate as vehicle.
Decision: Deferred for justification of claiming BP specifications for applied product, since the applied
strength and composition is different form that specified by BP monograph of cholecalciferol injection.
108. Name and address of manufacturer/ M/s Safe Pharmaceuticals (Pvt.) Ltd., Plot No. C.I-20, Sector 6-B,
Applicant North Karachi Industrial Area, Karachi (Tablet general).
Brand Name + Dosage Form + Strength Safefoxtin 20mg Tablet.
Composition Each Film coated Tablet Contains:
Paroxetine Hydrochloride Hemihydrate Eq. To Paroxetine
………………………………….…. 20mg
Diary No. Date of R & I & fee Dy. No 10726 dated 05-03-2019; Rs.20,000 dated 04-03-2019.
Pharmacological Group Selective serotonin reuptake inhibitors
Type of Form. Form-5.
Finished product Specification. USP specifications.
Pack size & Demanded Price 1 x 10’s, 3 x 10’s & as per DRAP policy.
Approval status of product in Reference Paxil (10mg, 20mg, 30mg, 40mg) film coated tablet USFDA
Regulatory Authorities. Approved
Me-too status. Frais Tablet 20mg, Bio-Mark Pharmaceuticals (Reg. No. 082658.
GMP status. GMP certificate issued on 13-08-2020 on the basis of inspection

Remarks of the Evaluator. • Firm has provided revised master formulation and complete
manufacturing process with submission of 7500/- fee vide slip
No. 36148200412 dated 07-10-2021.
Decision: Approved.
Brand Name + Dosage Form + Strength Saferoxtin CR 12.5mg Tablet.
Composition Each Enteric film coated Controlled Release Tablet Contains:
………………………………..…..12.5mg
Approval status of product in Reference Paxil CR extended-release Tablet (12.5mg, 25mg, 37.5mg)
Regulatory Authorities. (USFDA Approved)
Me-too status. Panox CR Tablet 12.5mg, Regal Pharma, Reg. No. 081953.
GMP status. Same as above.
No. 764984817260 dated 07-10-2021.
Decision: Approved.
Brand Name + Dosage Form + Strength Saferoxtin CR 25mg Tablet.
…………………………………..…..25mg
Me-too status. Panox CR Tablet 25 mg, Regal Pharmaceuticals, R.No. 081954.
No. 4239509157 dated 07-10-2021.
Decision: Approved.
Brand Name + Dosage Form + Strength Saferoxtin CR 37.5mg Tablet.
……………………………….…..37.5mg

Me-too status. Deroxat CR 37.5mg Tablet, Global Pharmaceuticals, Reg. No.
069948.
No. 1630992548 dated 07-10-2021.
Decision: Approved.
Brand Name + Dosage Form + Strength Leveron 250mg Tablet.
Composition Each Tablet Contains:
Levetiracetam ……………………. 250mg
Pack size & Demanded Price 1 x 10’s & as per DRAP policy.
Approval status of product in Reference KEPPRA 250mg (levetiracetam) film coated tablets,
Regulatory Authorities. USFDA approved.
Me-too status. Levep 250mg Tablet, Hilton Pharma, Reg. No. 053348.
Remarks of the Evaluator. • Firm has revised their label claim from uncoated tablets to film
coated tablets and provided revised master formulation and
complete manufacturing process with submission of 7500/- fee
Revised label claim is as under:
Each film coated Tablet Contains:
Levetiracetam …………. 500mg

Brand Name + Dosage Form + Strength Leveron 1gm Tablet.
Levetiracetam ……………………. 1gm.
Approval status of product in Reference KEPPRA 1000mg (levetiracetam) film coated tablets,USFDA
Regulatory Authorities. approved.
Levetiracetam …………. 1gm
Levetiracetam …………. 1gm.
Brand Name + Dosage Form + Strength Alitra SR 200mg Tablet.
Composition Each Sustained Release Tablet Contains:
Aceclofenac …………….200mg
Pharmacological Group Anti-inflammatory and anti-rheumatic products, non-steroids.

Finished product Specification. Manufacturer specifications.
Me-too status. Alkeris SR 200mg Tablet, Sami Pharmaceuticals, R.No. 61066.
Remarks of the Evaluator. • Evidence of approval of applied formulation in reference
regulatory authorities as decided by the Registration Board in
275th meeting.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory authorities
as adopted by the Registration Board in 275th meeting.
Applicant North Karachi Industrial Area, Karachi (Capsule general).
Brand Name + Dosage Form + Strength Alitra SR 200mg Capsule.
Composition Each Sustained Release Capsule Contains:
Aceclofenac …….………..200mg
Pharmacological Group Anti-inflammatory and anti-rheumatic products, non-steroids.
Finished product Specification. BP specifications.
Me-too status. Acelonac-SR 200mg Capsule, Maple pharma, Reg. No. 057742.
275th meeting.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory authorities
as adopted by the Registration Board in 275th meeting.
Brand Name + Dosage Form + Strength Saglip 2.5mg Tablet.
Saxagliptin as Hydrochloride …….…. 2.5mg
Pharmacological Group Blood Glucose Lowering Drugs, Excl. Insulin.
Approval status of product in Reference Onglyza 2.5 mg (as hydrochloride) film-coated tablets, MHRA
Me-too status. Saxagen 2.5mg Tablet, Genix pharma, Reg. No. 076644.
No. 73733703379 dated 07-10-2021.
Decision: Deferred for review of applied formulation with reference to the innovator product.
Brand Name + Dosage Form + Strength Saglip 5mg Tablet.
Saxagliptin as Hydrochloride ……….…. 5mg

Pharmacological Group Blood Glucose Lowering Drugs, Excl. Insulin.
Approval status of product in Reference Onglyza 5 mg (as hydrochloride) film-coated tablets, MHRA
Me-too status. Saxagen 5mg Tablet, Genix pharma, Reg. No. 076643.
No. 4637889738 dated 07-10-2021.
• Stability study data as per guidelines provided in 293rd meeting
of Registration Board is required.
Decision: Deferred for review of applied formulation with reference to the innovator product.
Brand Name + Dosage Form + Strength Gliben M 1.25/250 Tablet.
Glibenclamide ……………..…1.25mg
Metformin HCl ………….…… 250mg
Pharmacological Group Sulphonylurea.
Approval status of product in Reference GLUCOVANCE 250/1.25 (metformin hydrochloride 250 mg and
Regulatory Authorities. glibenclamide 1.25 mg), film coated tablets, TGA approved.
Me-too status. Glimetica Tablet 1.25/250, Mega Pharmaceuticals, Reg. No.
057539.
No. 66653944382 dated 07-10-2021.
Brand Name + Dosage Form + Strength Gliben M 2.5/500 Tablet.
Glibenclamide ……………..…2.5mg
Pharmacological Group Sulphonylurea.
Approval status of product in Reference GLUCOVANCE 500/2.5 (metformin hydrochloride 500 mg and
Regulatory Authorities. Glibenclamide 2.5 mg), film coated tablets, TGA approved.
Me-too status. Glimetica Tablet 2.5/500, Mega Pharmaceuticals, Reg. No.
057540.
No. 1015412924 dated 07-10-2021.

Brand Name + Dosage Form + Strength Gliben M 5/500 Tablet.
Glibenclamide ………………..…5mg
Pharmacological Group Sulphonyl urea.
Approval status of product in Reference GLUCOVANCE 500/5 (metformin hydrochloride 500 mg and
Regulatory Authorities. Glibenclamide 5 mg), film coated tablets, TGA approved.
Me-too status. Glimetica Tablet 5/500, Mega Pharmaceuticals, Reg. No. 057541.
No. 944910897099 dated 07-10-2021.
Brand Name + Dosage Form + Strength Safoni 12.5/15 Tablet.
Alogliptin ………………. 12.5mg
Pioglitazone ……………... 15 mg
Pharmacological Group Combination of oral blood glucose lowering drugs.
Type of Form. Form-5
Finished product Specification. Innovator specifications.
Pack size & Demanded Price 1x10’s, 2x10’s, 3x10’s, 2x7’s, 4x4’s & as per DRAP policy.
Approval status of product in Reference OSENI 12.5 mg/15 mg (alogliptin and pioglitazone) film coated
Regulatory Authorities. tablets, USFDA approved.
Me-too status. Could not be confirmed/not provided.
Remarks of the Evaluator. • Reference product contains alogliptin as benzoate &
pioglitazone as hydrochloride while the applied formulation
contains base of active ingredients
• Evidence of approval of already approved generic/me too
product by DRAP with registration number, Brand name and
manufacturer name.
• Master formula does not depict the coating material.
• Label claim needs revision as per reference product with
applicable fee.
• Complete manufacturing process including all the steps be
provided.
• Reference product contains Alogliptin as benzoate & Pioglitazone as hydrochloride while the
applied formulation contains base of active ingredients.
• Master formula does not include the coating material.
• Complete manufacturing process including all the steps shall be provided.
• Evidence of approval of already approved generic/me too product by DRAP with registration
number, Brand name and manufacturer name or else submit stability study data as per guidelines
provided in 293rd meeting of Registration Board.

Alogliptin ………….…. 12.5mg
Pioglitazone …………... 30 mg
manufacturer name.
applicable fee.
provided.
• Stability study data as per guidelines provided in 293rd
meeting of Registration Board is required.
number, Brand name and manufacturer name or else submit stability study data as per
guidelines provided in 293rd meeting of Registration Board.
Alogliptin ……….….…. 12.5mg
Pioglitazone …………... 45 mg

manufacturer name.
applicable fee.
provided.
Brand Name + Dosage Form + Strength Logmet 12.5/500mg Tablet.
Composition Each Film tablet Contains:
Alogliptin ………….….…. 12.5mg
Metformin HCl ………… …500 mg
Approval status of product in Reference KAZANO 12.5/500mg (alogliptin and metformin HCl) film coated
Remarks of the Evaluator. • Reference product contains alogliptin as benzoate while the
applied formulation contains base of Alogliptin. Label claim
needs revision as per reference product with applicable fee.
manufacturer name.
• Label claim and master formula needs revision as per
reference product with applicable fee.
provided.
• Reference product contains Alogliptin as benzoate while the applied formulation contains base
of Alogliptin.

Alogliptin ………………. 12.5mg
Metformin HCl ………… …850 mg
275th meeting.
manufacturer name.
• Evidence of approval of applied formulation in reference regulatory authorities as decided by the
Registration Board in 275th meeting.
number, Brand name and manufacturer name.
Alogliptin …………….…. 12.5mg
Metformin HCl ………… ..1000 mg
Approval status of product in Reference KAZANO 12.5/1000mg (alogliptin and metformin HCl) film
Regulatory Authorities. coated tablets, USFDA approved.
Remarks of the Evaluator. • Reference product contains alogliptin as benzoate & while the
applied formulation contains base of Alogliptin. Label claim
needs revision as per reference product with applicable fee.
manufacturer name.
provided.
applicable fee.

• Reference product contains Alogliptin as benzoate while the applied formulation contains base
of Alogliptin.
129. Name and address of manufacturer/ M/s Horizon Healthcare, Plot No. 35, Small Industrial Estate,
Applicant Taxila (Liquid injection ampoule general).
Brand Name + Dosage Form + Strength Water for Injection (5ml)
Sterilized Water for Injection ……………5ml
Diary No. Date of R & I & fee Dy. No. 34137 dated 15-10-2018; Rs.20,000/- dated 15-10-2018.
Duplicate File Bearing Dy. No 6449 Dated 26th Feb, 2021.
Pharmacological Group Solvent
Type of Form Form-5
Pack size & Demanded Price 1’s, 5’s, 10’s, 50’s, 100’s & as per SRO.
Approval status of product in Reference Sterile water for injection (1ml, 2ml, 3.2ml, 5ml and 10ml) ampule
Regulatory Authorities Glass class I. MHRA approved
Me-too status Sterile Water for injection 5ml, Otsuka Pakistan Ltd, Reg. No.
081541.
Remarks of the Evaluator XIII • Firm has revised their manufacturing outline without
• Terminal sterilization has been added in the manufacturing
process.
Decision: Approved.
• Firm shall submit fee of Rs.7,500 for correction/pre-approval change in the method of manufacture,
130. Name and address of manufacturer/ M/s High-Q Pharmaceuticals, Plot No.224/23, Korangi Industrial
Applicant Area, Karachi (Tablet general).
Brand Name + Dosage Form + Strength Myrdron 25mg Prolonged release tablet.
Composition Each prolonged release tablet contains:
Mirabegron ……………………. 25mg
Duplicate File Bearing Dy. No.1863 dated 13-07-2021.
Pharmacological Group Drugs for urinary frequency and incontinence.
Type of Form Form-5 D.
Approval status of product in Reference BETMIGA mirabegron 25 mg film-coated prolonged release
Regulatory Authorities tablet, TGA approved.
Me-too status Mibega Tablets 25mg, Getz Pharma, Reg. No. 089375
Remarks of the Evaluator • Firm was communicated that master formulation for the
applied formulation does not depict any ingredient for prolong
release of the active. Master formulation needs revision along
with applicable fee.

• They replied that Methocel K100 is used as an extended
release agent in master formulation. However, no Methocel
K100 has been used in master formulation.
• Stability studies data as per requirement determined in 293rd
• Revision of master formulation for inclusion of excipient for prolonged release profile.
• Submission of stability study data as per the guidelines approved in 293rd meeting of Registration
Board.
Brand Name + Dosage Form + Strength Myrdron 50mg Prolonged release tablet.
Composition Each prolonged release tablet contains:
Mirabegron ……………………. 50mg
Pharmacological Group Drugs for urinary frequency and incontinence.
Type of Form Form-5 D.
Approval status of product in Reference BETMIGA mirabegron 50 mg film-coated prolonged release
Regulatory Authorities tablet, TGA approved.
Me-too status Mirabet 50mg tablets, CCL Pharma, Reg. No. 090503.
Remarks of the Evaluator • Firm was communicated that master formulation for the
applied formulation does not depict any ingredient for prolong
release of the active. Master formulation needs revision along
with applicable fee.
• They replied that Methocel K100 is used as an extended
release agent in master formulation. However, no Methocel
K100 has been used in master formulation.
• Stability studies data as per requirement determined in 293rd
• Revision of master formulation for inclusion of excipient for prolonged release profile.
• Submission of stability study data as per the guidelines approved in 293rd meeting of Registration
Board.
Brand Name + Dosage Form + Strength Sildomet 50/850mg tablets.
Sitagliptin as phosphate monohydrate ……… 50mg
Metformin HCl ……………………………..850mg
Pharmacological Group Combinations of oral blood glucose lowering drugs.
Approval status of product in Reference Janumet 50 mg/850 mg film coated tablets, TGA approved.
Me-too status S-Gliptin Plus 50mg+850mg Tablet, Barrett Hodgson, Reg. No.
081619.

Remarks of the Evaluator • Firm has revised their master formulation with submission of
fee of 7500/- vide slip No. dated 05174943974 dated 09-09-
2021.
Applicant Area, Karachi (Dry powder injection vials Cephalosporin).
Brand Name + Dosage Form + Strength Cefrinex 1gm Dry powder for injection.
Composition Each vial contains:
1gm sterile cephradine with sterile arginine.
Pharmacological Group Cephalosporin Antibiotic.
Pack size & Demanded Price 1’s & As per SRO.
Me-too status Cefrinex vial 1000mg, Reg. No. 015129.
Remarks of the Evaluator • Firm has provided Velosef 1gm injection in HPRA (Ireland)
which could not be verified.
regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting. Provided evidence is
discontinued.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
134. Name and address of manufacturer/ Derma techno Pakistan 528 Sundar Industrial Estate, Lahore.
Applicant
Brand Name + Dosage Form + Strength Scalpvate liquid (Topical lotion).
Clobetasol propionate ……………… 0.5mg
Duplicate File Bearing Dy. No. 30484 dated 16-11-2020
Pharmacological Group Corticosteroids, Plain.
Type of Form Form-5
Pack size & Demanded Price 60ml & as per SRO.
Approval status of product in Reference CLOBEX® (clobetasol propionate) Lotion, 0.05%, USFDA
Regulatory Authorities approved.
Me-too status Clodrm Lotion, Jawa Pharmaceuticals, Reg. No. 088791.
GMP status DML renewal report conducted on 21-01-2019.
Recommended for renewal of DML for Tablet, capsule,
Cream/ointment general, topical lotion/solution and
cream/ointment steroidal section.
Remarks of the Evaluator • Firm has revised their master formulation in line with reference
product & finished product specification with submission of
7500/- fee vide slip No. 354559800 dated 08-09-2021.
• Firm has provided an undertaking that they have segregated
dispensing area, dispensing booth for steroidal preparation and
adequate system to minimize the potential risk of cross
contamination.
Decision: Approved.

135. Name and address of manufacturer/ Derma techno Pakistan 528 Sundar Industrial Estate, Lahore
Applicant Cream/ointment general).
Brand Name + Dosage Form + Strength Benzal cream
Composition Each gram contains:
Benzoyl peroxide ………………….. 40mg
Duplicate File Bearing Dy. No. 30485 dated 16-11-2020
Pharmacological Group Anti-Acne Preparations for Topical Use.
Type of Form Form-5
Pack size & Demanded Price 20gm & as per SRO.
Approval status of product in Reference Brevoxyl 4% Cream by M/s GSK consumer healthcare,
Regulatory Authorities MHRA Approved.
Me-too status Prayzid Cream 4%, Prays Pharma, Reg. No. 072415.
Remarks of the Evaluator • Firm has revised their finished product specification with
submission of 7500/- fee vide slip No. 22474170038 dated 08-
09-2021.
Decision: Approved.
136. Name and address of manufacturer/ Derma techno Pakistan 528 Sundar Industrial Estate, Lahore
Applicant (Topical lotion general).
Brand Name + Dosage Form + Strength Zarnol HC lotion
Hydrocortisone ……………….10mg
Camphor ………………………5mg
Menthol ……………………….5mg
Phenol …………………………5mg
Duplicate File Bearing Dy No. 30492 dated 16-11-2020
Pharmacological Group corticosteroids
Type of Form Form-5
Pack size & Demanded Price 60ml & as per SRO.
Me-too status Could not be confirmed.
Remarks of the Evaluator • Firm has provided an undertaking that they have segregated
dispensing area, dispensing booth for steroidal preparation and
adequate system to minimize the potential risk of cross
contamination.
• Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) along with registration number,
brand name and name of firm.
regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting.
• Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along
with registration number, brand name and name of firm.
were adopted by the Registration Board in its 275th meeting.

137. Name and address of manufacturer/ M/s Avant Pharmaceuticals (Pvt.) Ltd., Plot No. M-28 Hub
Applicant Industrial Estate, Hub Pakistan (contract giver).
Mediate pharmaceutical (Pvt.) Ltd., Plot No. 150-151, Sector 24,
Korangi Industrial Area Karachi (Contract acceptor) Dry Powder
(general) Injection.
Brand Name + Dosage Form + Strength Navis 40mg Injection.
Composition Each Glass Vial Contains:
Esomeprazole sodium…………………..40mg
Type of Form. Form-5A.
Pack size & Demanded Price As per DRAP policy.
Approval status of product in Reference NEXIUM® I.V. (esomeprazole sodium) for injection, USFDA
Me-too status. Nexum IV 40mg Injection, Getz Pharma, Reg. No. 050651
GMP status. Conclusion (Mediate Pharmaceuticals 02-04-2019):
Keeping in view the areas inspected, people met, documents
reviewed and the considering findings of the inspection M/s
Mediate Karachi was considered to be operating at an acceptable
level of good compliance with GMP guidelines.
Avant Pharma Lab Hub 29-09-2020.
The CLB in its 276th meeting held on 3rd September, 2020 Renewal
of DML under the Drug Act,1976 following section.
i. Tablet (General)
ii. Capsule (General)
Remarks of the Evaluator. • Firm has revised their label claim with submission of 7500/-
fee vide slip no. 9254805267 dated 05-10-2021.
Each Glass Vial Contains:
Esomeprazole sodium eq. to Esomeprazole …………..40mg
• Total number of registered products on contract
manufacturing of the applicant provided are 08.
138. Name and address of manufacturer/ M/s Wilshire Laboratories (Pvt.) Ltd., 124/1, Quaid-e-Azam
Applicant Industrial Estate, Kot Lakhpat, Lahore (Capsule general).
Brand Name + Dosage Form + Strength Lespra Capsule 15mg.
Composition Each Delayed Release Capsule Contains:
Lansoprazole ………………… 15mg
Pack size & Demanded Price 5’s, 7’s, 10’s, 20’s, 30’s, 40’s, 50’s & as per SRO.
Approval status of product in Reference Lansoprazole 15 mg Gastro-Resistant Capsules, MHRA approved.
Me-too status Arcozol Capsules 15mg, Pakistan Pharmaceutical Product, Reg.
No. 032239.
GMP status GMP issued on 05-09-2019 on the basis of inspection conducted
on 08-08-2019.
Remarks of the Evaluator • Firm has revised their label claim with submission of 30,000/-
fee vide slip No. 27284285703 dated 22-22-2021 &
7601965104 dated 01-12-2021.

• Firm has also provided their source of pellets which is Vision
pharma Islamabad along with stability studies data of 3 batches,
GMP certificate of supplier & COA of pellets.
Each Delayed Release Capsule Contains:
Lansoprazole enteric coated pellets eq. to Lansoprazole
………………… 15mg
Each Delayed Release Capsule Contains:
Lansoprazole enteric coated pellets eq. to Lansoprazole ………………… 15mg
139. Name and address of manufacturer/ M/s. Fynk Pharma, 19Km G.T. Road, Kalashah Kaku Lahore
Applicant (Sachet general).
Brand Name + Dosage Form + Strength Fymezole 20/1680 mg Insta Sachet.
Composition Each sachet contains:
Omeprazole …………….. 20mg
Sodium Bicarbonate ………………1680mg
Diary No. Date of R & I & fee Dy. No. 790 dated 08-02-2016 Rs. 20,000/-14-01-2016
Duplicate File Bearing Dy No.11783 dated 20-04-2021
Pack size & Demanded Price 1 x 10’s & as per SRO.
Approval status of product in Reference ZEGERID® (omeprazole and sodium bicarbonate) for oral
Regulatory Authorities suspension, USFDA approved.
Me-too status Omega Rapid Dry Suspension, Ferozesons Labs, Reg. No. 064268.
GMP status Conclusion 16-07-2019:
Keeping in view of the above improvements by the firm, the
members of the panel are of the opinion to recommend the grant of
renewal of DML (000494) of M/s Fynk pharmaceuticals 19Km
G.T. Road, Kalashah Kaku Lahore.
Remarks of the Evaluator • Firm has revised their master formulation as per reference
product and also removed 5% of overage with submission of
30000/- vide slip No. 8960352294 dated 28-01-2022.
140. Name and address of manufacturer/ M/s. Fynk Pharma, 19Km G.T. Road, Kalashah Kaku Lahore
Applicant (Cream/ointment steroids).
Brand Name + Dosage Form + Strength Fcort-D cream
Diflucortolone valerate …………… 1mg
Isoconazole nitrate …………………10mg
Diary No. Date of R & I & fee Dy. No. 1379 dated 04-03-2015: Rs. 20,000/-03-03-2015
Duplicate File Bearing Dy No.11782 dated 20-04-2021
Pharmacological Group Corticosteroid, Antifungal
Pack size & Demanded Price 1 x 10 gm & as per SRO.
Approval status of product in Reference Travocort 0.1 + 1% w/w Cream (AIFA Italy Approved)
Me-too status Broadzole-D 0.1/1% w/w Cream, Atco Laboratories, Reg. No.
088956.
Remarks of the Evaluator

Deferred cases of Human Drugs (Local Manufacturer):
141. Name and address of manufacturer/ M/s Pharma Lord (Pvt.) Ltd., 12 KM, Lahore Road, Layyah,
Applicant Punjab (Tablet general).
Brand Name + Dosage Form + Strength DOM Tablet
Domperidone …………………10mg
Diary No. Date of R & I & fee Dy. No 10370 dated 05-03-2019; Rs.20,000 dated 05-03-2019
Pharmacological Group Propulsive.
Finished product Specification. BP Specifications.
Pack size & Demanded Price 1 x 10’s, 3 x 10’s; 10 x 10’s.
Approval status of product in Reference Motilium 10 mg (domperidone maleate 12.72 mg equivalent to
Regulatory Authorities. domperidone 10 mg) film-coated tablets, MHRA approved.
Me-too status. Epodom 10mg Tablets, Atlantic Pharmaceutical, R.No 062326.
Remarks of the Evaluator. • Reference product contains domperidone maleate 12.72 mg
equivalent to domperidone 10 mg while the applied
formulation has domperidone only. Label claim needs
revision along with applicable fee.
• Firm has also provided D-one, Novom, Vomrid & Dilium as
alternative brand names.
Decision of 312th meeting of Registration Deferred as the reference product contains domperidone maleate
Board. 12.72 mg equivalent to domperidone 10 mg while the applied
formulation has domperidone only. Label claim needs revision
along with applicable fee.
Submission by the firm: • Firm has submitted the revised label claim with submission
of 7500/- fee vide slip no. 12220696389 date d27-12-2021.
Each Film Coated Tablet Contains:
Domperidone as maleate ……10mg
Remarks of the Evaluator PEC-XIII • Firm has neither submitted revised form-5 nor master
formula for revised label claim.
“Each film coated tablet contains:
Domperidone as maleate ……10mg.”
• Firm will submit Form-5 for the revised label claim as mentioned above.
142. Name and address of manufacturer/ M/s Pharma Lord (Pvt.) Ltd., 12 KM, Lahore Road, Layyah,
Applicant Punjab.
Brand Name + Dosage Form + Strength DMET XR Tablet
Metformin Hydrochloride ……………750mg
Pharmacological Group Biguanides.
Finished product Specification. USP specifications
Pack size & Demanded Price 3 x10’s, 10 x 10’s.
Approval status of product in Reference Glucophage XR 750mg tablets, USFDA approved.
Regulatory Authorities. **Federal Register determination that product was not
discontinued or withdrawn for safety or efficacy reasons**
Me-too status. Glucophage XR Tablet, Merck, Reg. No. 061799.
Remarks of the Evaluator. • Label claim of the applied formulation needs revision as per
reference product.
• Master formula has no ingredients for XR formulation.

• Firm has also provided Diamet XR, Metlor XR, Metfin XR
& Diafor XR as alternative brand names.
Decision of 312th meeting of Registration Deferred for following:
Board. • Master formula has no ingredients for XR formulation.
• Label claim and master formulation of the applied
formulation needs revision as per reference product with
Submission by the firm: • Firm has submitted the revised label claim with submission
of 7500/- fee vide slip no. 74824381343 dated 27-12-2021.
Each Film Coated extended release Tablet Contains:
Metformin Hydrochloride ……………750mg
formula for revised label claim.
“Each film coated extended release tablet contains:
Metformin hydrochloride ……………750mg”
• Firm shall submit differential fee of Rs. 22,500 for correction/pre-approval change in
composition (correction/change of formulation from film-coated tablet to film coated extended
release tablet), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also submit Form 5 for the revised label claim as mentioned above.
143. Name and address of manufacturer/ M/s Maxitech Pharma (Pvt.) Ltd., Plot No. E-178, S.I.T.E. Super
Applicant Highway, Phase II, Karachi (Contract giver).
M/s Safe Pharmaceuticals (Pvt.) Ltd., Plot No. C.I-20, Sector 6-
B, North Karachi Industrial Area, Karachi (Contract acceptor).
Brand Name + Dosage Form + Strength Claritide 500mg Injection
Composition Each Vial Contains:
Clarithromycin dihydrate………..500mg
Pharmacological Group Antibacterial for systemic use.
Finished product Specification Innovator’s specifications.
Approval status of product in Reference Clarithromycin 500 mg Powder for concentrate for solution for
Regulatory Authorities infusion, MHRA approved.
Me-too status Maclacin 500mg Injection, Bosch pharma, Reg. No. 061080.
Remarks of the Evaluator XIII • Reference product contain clarithromycin (as clarithromycin
lactobionate) while the applied formulation has dihydrate
salt form. Label claim needs revision along with applicable
fee.
• M/s Maxitech has 09 approved sections as per section
approval letter. They further submitted that no product is
registered in contract manufacturing.
• They also clarified they their product Claritide 500mg
Injection is ready to fill lyophilized powder.
• M/s safe pharma is having sterile dry powder Injection
(Lyophilized) section.
• Firm has also provided Saber & Maxiclar injection as
alternative brand name.
Board. • Reference product contain clarithromycin (as clarithromycin
lactobionate) while the applied formulation has dihydrate
salt form. Label claim needs revision along with applicable
fee.

• Submission of evidence of manufacturing facility/section
approval for the applied formulation. (1. Klaricid IV 500 mg,
White to off-white caked, lyophilized powder) (2.
Clarithromycin 500mg, White to off white cake or powder.)
Submission by the firm: • Firm has revised their formulation with submission of 7500/-
fee vide slip number 5171016093 dated 10-09-2021 &
67500/- fee vide slip No. 84422520 date d24-11-2021.
Revised formulation is as under;
Each Vial Contains:
Clarithromycin as lactobionate………... 500mg.
• Firm has submitted that M/s Safe pharma has section for dry
powder injection (for pre-lyophilized powders). They further
requested to consider their applications for registration.
• They further submitted that in 308th meeting of Registration
Board, different products are approved in the dry powder
injection section of M/s safe pharma.
Remarks of the Evaluator PEC-XIII
Decision: Deferred for the submission of capacity enhancement plan from M/s Safe Pharmaceuticals
regarding Quality control lab.
144. Name and address of manufacturer/ M/s Maxitech Pharma (Pvt.) Ltd., Plot No. E-178, S.I.T.E. Super
Applicant Highway, Phase II, Karachi (Contract giver).
M/s Safe Pharmaceuticals (Pvt.) Ltd., Plot No. C.I-20, Sector 6-
B, Industrial Area, North Karachi (Contract acceptor).
Brand Name + Dosage Form + Strength Lancid 30mg/Vial Injection.
Lansoprazole Sodium …….…30mg
(Duplicate).
Finished product Specification. Innovator’s specifications.
Pack size & Demanded Price As per DRAP policy.
Approval status of product in Reference Takepron for intravenous injection 30 mg, PMDA approved.
Me-too status. Anso Injection, Shaigan Pharmaceuticals, Reg. No. 069893.
Remarks of the Evaluator XIII • Reference product contain lansoprazole while the applied
formulation has lansoprazole sodium equillant to
lansoprazole. Label claim needs revision along with
requisite fee.
• M/s Maxitech has 09 approved sections as per section
approval letter. They further submitted that no product is
registered in contract manufacturing.
• They also clarified thay their product Lancid 30mg Injection
is ready to fill lyophilized powder.
• M/s safe pharma is having sterile dry powder Injection
(Lyophilized) section.
Board. • Reference product contain lansoprazole while the applied
formulation has lansoprazole sodium equivalent to
lansoprazole. Label claim needs revision along with
requisite fee.
• Submission of evidence of manufacturing facility/section
approval for the applied formulation.

Submission by the firm: • Firm has revised their formulation with submission of 7500/-
fee vide slip number 120859868817 dt:10-9-2021.
Each Vial Contains:
Lansoprazole ………... 30mg.
• Firm has submitted that M/s Safe pharma has section for dry
powder injection (for pre-lyophilized powders). They further
requested to consider their applications for registration.
• They further submitted that in 308th meeting of Registration
Board, different products are approved in the dry powder
injection section of M/s safe pharma.
Remarks of the Evaluator PEC-XIII •
Decision: Deferred for the submission of capacity enhancement plan from M/s Safe Pharmaceuticals
regarding Quality control lab.
• Firm will submit the differential fee of Rs. 67,500 for correction/pre-approval change in composition
(correction/change of salt form of the drug substance), as per notification No.F.7-11/2021-
145. Name and address of manufacturer/ M/s Eros Pharmaceuticals Pvt. Ltd., Plot # 94-95, Sector 23,
Applicant Korangi Industrial Area Karachi.
Contract Manufacturer: M/s Mediate Pharmaceutical Pvt. Ltd.,
Plot No. 150-151, Sector 24, Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Ezone Injection 1000mg
Cefoperazone as Sodium……….…....….500mg
Sulbactam as Sodium………….……..…500mg
Diary No. Date of R & I & fee Dy.No.10977 dated 05-03-2019; Rs.50,000/- 04-03-2019
Pharmacological Group Cephalosporin/ Beta Lactam Inhibitor
Type of Form. Form- 5
Finished product Specification. Manufacturers
Pack size & Demanded Price 1 vial dry substance + 5ml ampoule water for injection & As
per SRO
Approval status of product in Reference Sulperazon Injection by Pfizer Inc. PMDA Approved
Me-too status. Ectafin Injection 1gm I/V of M/s Hi-Medic Pharma (Pvt.) Ltd,
19- KM link Multan Road, Lahore 080028
GMP status. M/s Eros Pharma:
Last GMP inspection was conducted on 11-12-2018 and the
report concludes:
Keeping in view the request of the firm, the competent Authority
is pleased to constitute the panel for thorough cGMP
inspection of the Ophthalmic section of the firm and for the
verification of improvements before resumption of production.
M/s Mediate Pharma:
report concludes acceptable level of good compliance.
Remarks of the Evaluator • Manufacturer firm has Dry powder injection Cephalosporin
section as mentioned in the submitted DML.
• The official monograph for the applied formulation is
available in USP.
• No. of sections of applicant needs to be submitted.
• No. of approved drugs on contract basis needs to be
submitted.
• Section approval letter of applicant needs to be submitted.
Previous Decision. Deferred in 296th DRB meeting for following:
• Number of sections of applicant needs to be submitted.

• Number of approved drugs of applicant on contract basis
needs to be submitted.
Evaluation by PEC-XIII (a) • Firm has submitted incomplete reply as instead of submitting
section approval letter, approval of layout plan of 13
approved sections dated: 29-10-2010 is submitted.
• Number of approved drugs of applicant on contract basis is
03.
th
Decision of 297 meeting of Registration Deferred for confirmation of sections of M/s Eros, Karachi.
Board.
Submission by the firm. Firm has submitted that they have approved layout of Dry
Powder injection (Cephalosporin) but we don’t have any
production facility of Dry Powder injection (Cephalosporin)
that’s why we need to manufacture our products from mediate
pharmaceuticals.
They further requested to consider their applications as per
DRAP Policy contract manufacturing 2021 SRO No. 1347/21
and grant us registration.
XIII
Remarks of the Evaluator PEC- Number of sections of the applicant were required to calculate
the total number of approved products on contract
manufacturing.
Decision: Approved with JP specifications.
• Firm will submit the fee of Rs. 7,500 for correction/pre-approval change in product specifications,
Brand Name + Dosage Form + Strength Maxpime 500mg Injection I/V, I/M
Cefepime HCl with L- Arginine…………………..500mg
Diary No. Date of R & I & fee Dy.No.10981, 05-03-2019; Rs.50,000/- Dated 04-03-2019.
Pharmacological Group Anti- infective.
Approval status of product in Reference TGA Australia Approved as Cefepime hydrochloride
Regulatory Authorities. monohydrate equivalent to Cefepime 500 mg, powder for
injection.
Me-too status. Cefstar Injection 500mg of M/s Barrett Hodgson Pakistan (Pvt.)
Ltd, S.I.T.E, Karachi 030953
report concludes:
M/s Mediate Pharma:
Remarks of the Evaluator • The official monograph for the applied formulation is
available in USP.
• Revise the label claim and master formulation as Cefepime
hydrochloride monohydrate equivalent to Cefepime as in

TGA, Australia. Correction along with adjustment of its
weight as per salt factor needs to be submitted.
submitted.
• Volume of injection and pack size needs to be submitted.
• Revision of label claim along with adjustment of weight of
salt factor in master formulation
03.
Decision of 297th meeting of Registration Deferred for confirmation of sections of M/s Eros, Karachi.
Board.
pharmaceuticals.
Remarks of the Evaluator PEC-XIII Number of sections of the applicant were required to calculate
manufacturing.
• Firm will submit the fee of Rs. 7,500 for correction/pre-approval change in product specifications,
Brand Name + Dosage Form + Strength Maxpime 1000mg Injection.
Cefepime HCl with L- Arginine………………....1000mg
Diary No. Date of R & I & fee Dy.No.10982 dated 05-03-2019 Rs.50,000/- Dated 04-03-2019.
Pharmacological Group Anti- infective.
Approval status of product in Reference TGA Australia Approved as Cefepime hydrochloride
Regulatory Authorities. monohydrate equivalent to Cefepime 1g, powder for injection

Me-too status. Cefstar Injection 1g of M/s Barrett Hodgson Pakistan (Pvt.) Ltd,
S.I.T.E, Karachi. 030954.
report concludes:
M/s Mediate Pharma:
Remarks of the Evaluator • The official monograph for the applied formulation is
available in USP.
submitted.
• Revision of label claim along with adjustment of weight of
salt factor in master formulation
03.
Board.
pharmaceuticals.
manufacturing.
• Firm will submit the fee of Rs. 7,500 for pre-approval change in product specifications, as per

Brand Name + Dosage Form + Strength Ferofer Injection 100mg
Iron sucrose complex eq. to elemental iron….…100mg
Diary No. Date of R & I & fee Dy.No.10974 dated 05-03-2019; Rs.50,000/- Dated 04-03-
2019.
Pharmacological Group Anti- Anaemic.
Approval status of product in Reference Approved in USFDA as single dose vial.
Me-too status. Ferotein- S Injection of M/s Getz Pharma, (Reg. # 055440).
report concludes:
M/s Mediate Pharma:
Remarks of the Evaluator • Manufacturer firm has Liquid ampoule General injection
section as mentioned in the submitted DML.
• The official monograph for the applied formulation is
available in USP.
submitted.
• Ampoule or vial what is applied not confirmed.
• Submission of details of primary packaging whether vial or
ampoule.
03.
• Submit details of primary packaging whether vial or
ampoule.
th
Decision of 297 meeting of Registration Deferred for confirmation of sections of M/s Eros, Karachi.
Board.

pharmaceuticals.
manufacturing.
Decision: Approved.
• Firm will submit the declaration for drug product specifications either USP or BP along with fee of
Rs. 7,500 for pre-approval change in product specifications, as per notification No.F.7-11/2021-
Brand Name + Dosage Form + Strength P-Zac Infusion 40mg (powder for infusion).
Composition Each amber glass vial contains:
Pantoprazole ……………40mg
Diary No. Date of R & I & fee Dy.No.10978, 05-03-2019; Rs.50,000/- Dated 04-03-2019.
Pharmacological Group PPI
Finished product Specification. Innovators.
Pack size & Demanded Price Amber glass vial as per SRO.
Approval status of product in Reference MHRA Approved.
Me-too status. Zentro Injection of M/s Bosch, Karachi 045388.
report concludes:
M/s Mediate Pharma:
Remarks of the Evaluator • Approved in MHRA as Pantoprazole as sodium
sesquihydrate
• General infusion section is available in the manufacturers
firm as mentioned in the submitted DML.
submitted.
• Strength of infusion is not mentioned.
• Revision of salt form as per reference product.
• Number of products already approved on contract
manufacturing.

• Number of sections approved for M/s Eros Pharmaceuticals
Pvt. Ltd., Karachi.
03.
• Revision of salt form as per reference product needs to be
submitted.
Board.
pharmaceuticals.
manufacturing.
Decision: Approved.
150. Name and address of manufacturer/ M/s Demont Research Laboratories, 20km, Lahore-Sharikpur
Applicant Road, Sheikhupura, Pakistan.
Brand Name + Dosage Form + Strength Aspril 75/75mg Tablet.
Composition Each film- coated tablet contains:
Clopidogrel as hydrogen sulphate (core enteric coated)
……………………………………..…75mg
Aspirin (outer immediate core) ……………….75mg
Diary No. Date of R & I & fee Dy.No.41393 dated 07-12-2018; Rs.20,000/- Dated 07-12-2018
Pharmacological Group Anti- thrombotic.
Type of Form. Form- 5.
Finished product Specification. Manufacturers.
Approval status of product in Reference TGA; Australia Approved.
Me-too status. Clopido Plus 75 Tablet of M/s Platinum Pharma, Karachi 055740
GMP status. Last GMP inspection was conducted on 26-02-2018 satisfactory
and the report concludes satisfactory level of GMP compliance.
Remarks of the Evaluator. In EMA, the product has been developed as film-coated bilayer
tablets containing two active substances while the firm has applied
only film- coated tablets.
th
Decision of 297 meeting of Deferred for correction of formulation along with fee and evidence
Registration Board. requisite bilayer machine.
Submission by the firm: Firm has submitted that they have dual core compression machine
(ZP-33) and already have a registered bilayer product Mastador
75mg/200mcg tablets, Reg. No. 109304 which was registered after
online stability data verification where the same machine was also
the part of inspection.
Firm has also provided registration letter of Mastador
75mg/200mcg tablets.

Remarks of the Evaluator PEC-XIII • Firm neither changed their label claim nor submitted any fee for
change of label claim.
• Latest GMP could not be confirmed.
Decision: Deferred for revision of formulation to bi-layer tablet as per the innovator product along with
submission of full fee.
Deferred cases veterinary drugs (Local Manufacturer):

151. Name and address of manufacturer / M/s Bio-Oxime Pharmaceuticals, Plot 31-32 Millat Garment City
Applicant Faisalabad, Pakistan.
Brand Name +Dosage Form + Strength Fencol oral solution
Florfenicol …………….....230g
Diary No. Date of R& I & fee Dy. No.72, R&I Dated 14-07-2012, Rs. 20,000/- (30.06.2015)
Pharmacological Group Antibiotic/anti-bacterial
Type of Form Form -5
Finished product Specifications Manufacturers
Pack size & Demanded Price 500ml, 1000ml & Decontrolled price
Approval status of product in Reference Not Available
Me-too status (with strength/dosage Neflox solution of M/s Selmore Pharmaceuticals.
form)
GMP status Last GMP inspection was conducted on 23-11-2017 and the firm is
found GMP compliant.
Remarks of the Evaluator PEC • International reference couldn’t be searched. targeted species is
Poultry.
• Targeted species is Poultry.
• Firm has oral liquid general section.
th
Decision of 277 meeting of Registration Registration Board referred the case to QA & LT division to
Board. confirm GMP status of the firm as critical observations are
mentioned in submitted inspection report.
Submission by the firm. Firm has submitted DML renewal report conducted on 24-02-2021
wherein the panel of inspectors recommends the renewal of DML
bearing number 000812 by the way of formulation (Vet) in respect
of Oral liquid (veterinary & Oral powder (Veterinary) sections
issued in favor of M/s Bio-Oxime Pharmaceuticals, Situated at plot
No. 31, 32, Millat Garment city, Dry Port road, Faisalabad.
152. Name and address of manufacturer / M/s Bio-Oxime Pharmaceuticals, Plot 31-32 Millat Garment City
Applicant Faisalabad, Pakistan.
Brand Name +Dosage Form + Strength T-Dox Extra Oral Powder 1kg
Composition Each 1000g contains:
Doxycycline…………….....200g
Tylosin Tartrate………….100g
Bromhexine…………………..4g
Colistin sulphate ………450MIU
Diary No. Date of R& I & fee Dy. No.73, R&I Dated 14-07-2015, Rs. 20,000/- (30.06.2016)
Finished product Specifications Manufacturers
Pack size & Demanded Price 10g, 30g, 50g, 100g, 500g, 1000g, 5000g & Decontrolled price
Approval status of product in Reference Not Available

Me-too status (with strength and dosage Betadox powder of M/s Attabak Pharmaceuticals.
form)
GMP status Last GMP inspection was conducted on 23-11-2017 and the firm is
found GMP compliant.
Remarks of the Evaluator PEC • International reference couldn’t be searched.
• Targeted Species are: Calves, goats, sheep & Poultry.
Decision of 277th meeting of Registration Registration Board referred the case to QA & LT division to
Board. confirm GMP status of the firm as critical observations are
mentioned in submitted inspection report.
Submission by the firm. Firm has submitted DML renewal report conducted on 24-02-2021
wherein the panel of inspectors recommends the renewal of DML
bearing number 000812 by the way of formulation (Vet) in respect
of Oral liquid (veterinary & Oral powder (Veterinary) sections
issued in favor of M/s Bio-Oxime Pharmaceuticals, Situated at plot
No. 31, 32, Millat Garment city, Dry Port road, Faisalabad.
Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as
153. Name and address of manufacturer/ M/s Selmore Pharmaceuticals (Pvt.) Ltd., 36-Km, Multan Road
Applicant Lahore.
Brand Name + Dosage Form + Strength Cynosel Forte 1000mcg Injection 100ml.
Composition Each 2ml Contains:
Cyanocobalamin ……………1000mcg.
Pharmacological Group Vitamin B12
Pack size & Demanded Price Decontrolled.
Approval status of product in Reference
Me-too status Cyanoco Injection (50ml), International Pharma, Reg. No. 041242.
Remarks of the Evaluator Evidence of applied formulation/drug already approved by DRAP
in applied fill volume (generic / me-too status) along with
registration number, brand name and name of firm.
Decision of 312th meeting of Registration Deferred for evidence of applied formulation/drug already
Board. approved by DRAP in applied fill volume (generic / me-too status)
along with registration number, brand name and name of firm.
Submission by the firm. • Firm has revised their composition in line with the already
registered product with submission of 30,000/- fee vide slip
No. 21751641 dated 14-01-2022.
• Firm has provided reference of already approved drug of M/s
Prix pharmaceutical, Reg. No. 074021 with brand name of
Cyanocob 1000 injection (100ml).
Cynosel Forte 1000mcg Injection 100ml.
Each ml Contains:
Cyanocobalamin ……………1000mcg.
“Each ml Contains:
Cyanocobalamin ……………1000mcg.”
154. Name and address of manufacturer / M/s Attabak Pharmaceutical, 5-C Industrial Area, I-10/3 Islamabad
Applicant (Oral powder (Penicillin)- Veterinary).

Brand Name +Dosage Form + Strength ASL-20 Powder
Composition Each kg contains
Amoxicillin trihydrate 200gm eq. to amoxicillin base
………………………….. 173.92gm
Lincomycin HCl ………………88mg
Spectinomycin sulphate ………..88mg
Vitamin-E 50% ………………30mg
Diary No. Date of R& I & fee Dy. No. 13861 dated 24-05-2021; Rs. 30,000/- vide slip No.
51411031100 dated 20/05/2021
Finished product Specifications Innovator’s Specification
Pack size & Demanded Price 100gm, 500gm, 1kg, 2.5kg, 5kg & Decontrolled.
Me-too status (with strength and dosage Tritin-Le powder, Leeds pharma, Reg. No. 082795.
form)
GMP status New Section granted vide Letter No. F.1-5/96-Lic Dated 12-03-
2021 On basis of Inspection conducted on dated 08-2-2021
Remarks of the Evaluator PEC- XIII
• Submitted me too contain 88 grams of each of both Lincomycin
HCl & Spectinomycin sulphate while the applied formulation
has 88 milligrams of both the actives.
• Evidence of approval of applied formulation (generic/me too)
already approved by DRAP with brand name, Reg. No. and
name of the firm OR revise label claim with applicable fee.
Decision of 307th meeting of Deferred for Evidence of approval of applied formulation
Registration Board. (generic/me too) already approved by DRAP with brand name, Reg.
No. and name of the firm.
Submission by the firm. Firm has provided their revised formulation with submission of
Revised formulation is as under:
Each kg contains
Amoxicillin trihydrate 200gm eq. to amoxicillin base.. 173.92gm
Lincomycin HCl ………………88gm
Spectinomycin sulphate ………..88gm
formulation for revised formulation.
• Full fee is required for change of formulation.
Decision of 313th meeting of • Revised form 5, master formulation and manufacturing process.
Registration Board. • For correction/standardization of composition as per
RRA/Innovator’s product, full fee is required as per notification
No. F. 7-11/2021-B&A/DRAP dated 13-07-2021.
Submission by the firm. • Firm has submitted a differential fee of 22500/- vide slip No.
788024950770 dated 20-01-2022.
• Firm has also provided form 5, master formulation and
manufacturing process.
Decision: Approved with innovator’s specifications up to 1kg pack size and following label claim;
Each kg contains
Amoxicillin trihydrate 200gm eq. to amoxicillin base ……….. 173.92gm
Lincomycin HCl ………………88gm
Spectinomycin sulphate ………..88gm

Applicant (Oral powder (Penicillin)- Veterinary).
Brand Name +Dosage Form + Strength Amox-T Powder
…………………43.48mg
9773518678 dated 20/05/2021
Pharmacological Group Penicillin Antibiotic
Type of Form Form-5
Me-too status (with strength and dosage D-Mox Powder, Leads pharma, Reg. No. 082796.
form)
Remarks of the Evaluator PEC XIII
• Submitted me too product contains Amoxicillin trihydrate
50gm eq. to amoxicillin base 43.48gm while the applied
formulation is having 43.48mg.
Decision of 307th meeting of Deferred for following:
Registration Board. • Submitted me too product contains Amoxicillin trihydrate 50gm
eq. to amoxicillin base 43.48gm while the applied formulation is
having 43.48mg.
They also revised their specifications from innovator to BP
specifications.
Each 100gm contains
…………………43.48gm
Remarks of the Evaluator PEC XIII • Firm has neither submitted revised form-5 nor master
Decision of 313th meeting of Deferred for following;
Registration Board. • Revised form 5, master formulation and manufacturing process.
• For correction/standardization of composition as per
No. F. 7-11/2021-B&A/DRAP dated 13-07-2021.
6784564383 dated 20-01-2022.
•
Decision: Approved with BP specifications up to 1kg pack size and following label claim;
Each 100gm contains
Amoxicillin trihydrate 50gm eq. to amoxicillin base …………………43.48gm

Applicant (Oral powder (Penicillin) - Veterinary).
Brand Name +Dosage Form + Strength Amox-C Powder.
Composition Each gm contains
Amoxicillin trihydrate ……..20,000 mg
Colistin sulphate ………200,000,00 IU
45999735407 dated 20/05/2021.
Me-too status Anzah-Mox, Bio labs Islamabad, Reg. No. 034568.
Remarks of the Evaluator PEC XIII Submitted generic product and applied formulation are not same.
Each 1000gm Contains: -
Amoxycillin …. 20,000mg.
Colistine Sulphate … 2000,0000IU
Evidence of approval of applied formulation (generic/me too)
already approved by DRAP with brand name, Reg. No. and name
of the firm.
Decision of 307th meeting of Deferred for Evidence of approval of applied formulation
Registration Board. (generic/me too) already approved by DRAP with brand name,
Reg. No. and name of the firm.
Amoxycillin …….…. 20,000mg.
Colistine Sulphate ………… 2000,0000IU
No. F. 7-11/2021-B&A/DRAP dated 13-07-2021.
4431422045 dated 20-01-2022.
Amoxycillin …….…. 20,000mg.
Colistin Sulphate ………… 2000,0000IU
Brand Name +Dosage Form + Strength Amox 10% Powder
Amoxicillin trihydrate …………..100mg

Colistin sulphate ………500,000 IU
81974677578 dated 20/05/2021.
Type of Form Form-5
Me-too status Colimoxin Powder, Selmore Pharmaceutical (034583)
Remarks of the Evaluator PEC XIII Submitted me too contain Amoxicillin base 100mg while the
applied formulation contains Amoxicillin trihydrate. Label claim
needs revision along with applicable fee.
Decision of 307th meeting of Deferred for revision of label claim in line with the reference
Registration Board. generic product along with applicable fee.
Each gm contains
Amoxicillin base …………...100mg
Colistin sulphate ……………500,000 IU
Remarks of the Evaluator PEC XIII Firm has neither submitted revised form-5 nor master formulation
for revised formulation.
Decision of 313th meeting of Deferred for submission of revised form 5, master formulation and
Registration Board. manufacturing process.
Submission by the firm. Firm has provided form 5, master formulation and manufacturing
process.
Each gm contains
Amoxicillin base …………...100mg
Colistin sulphate ……………500,000 IU
Brand Name +Dosage Form + Strength LSA PLUS Powder.
Amoxicillin Trihydrate …………200mg
Lincomycin HCl ……………88mg
Spectinomycin 2HCl …………….88mg
76700977 dated 20/05/2021.
Type of Form Form-5
Me-too status (with strength+dosage Amoxy LS powder, Inshal pharma, Reg. No. 063887.
form)

Remarks of the Evaluator PEC XIII Submitted me too contain Amoxicillin Trihydrate 20mg/gm while
the applied formulation contains Amoxicillin Trihydrate
200mg/gm.
Decision of 307th meeting of Deferred for revision of label claim in line with reference product
Registration Board. along with submission of applicable fee.
Each 100gm contains
Amoxicillin Trihydrate …………20gm
Lincomycin HCl …….…………… 8.8gm
Spectinomycin 2HCl ….…………. 8.8gm.
No. F. 7-11/2021-B&A/DRAP dated 13-07-2021.
09029685211 dated 20-01-2022.
•
Each 100gm contains
Amoxicillin Trihydrate …………20gm
Lincomycin HCl …….…………… 8.8gm
Spectinomycin 2HCl ….…………. 8.8gm.
Brand Name +Dosage Form + Strength COLBAK Powder.
Amoxicillin Trihydrate …………………….16gm
Clavulanic Acid as potassium clavulanate….4gm
7259289940 dated 20/05/2021.
Type of Form Form-5
Me-too status Clavet Powder, Selmore pharmaceuticals, (034582)
XIII
Remarks of the Evaluator PEC Submitted me too contains Amoxycillin as Trihydrate 160mg/gm
and Clavulanic Acid 40mg/gm while the applied formulation has
Amoxicillin Trihydrate & Clavulanic Acid as potassium
clavulanate respectively. Label claim needs revision as per
reference product along with applicable fee.
th
Decision of 307 meeting of Deferred for revision of label claim in line with reference generic
Registration Board. product along with applicable fee.

Each gram contains
Amoxicillin as Trihydrate ……………. 160mg
Clavulanic Acid ………………………..….4mg
Decision of 313th meeting of • Deferred for submission of revised form 5, master formulation
Registration Board. and manufacturing process.
Submission by the firm. • Firm has submitted revised form 5, master formulation and
• In previous meeting concentration of clavulanic acid was
mistakenly written as 4mg while the applied concentration is
40mg.
Revised & correct formulation is as under:
Each gram contains
Clavulanic Acid ………………………..….40mg
“Each gram contains
Clavulanic Acid ………………………..….40mg”
Brand Name +Dosage Form + Strength Amoxi-PB Powder
Amoxicillin Trihydrate 20gm eq. To Amoxicillin Base
……..17.392gm
Clavulanic Acid as potassium clavulanate …..4gm
Bromhexine HCl …………..0.5gm
0574359455 dated 20/05/2021.
Type of Form Form-5
Me-too status Clavmox-Forte Oral Water-Soluble Powder, Sanna Laboratories,
Reg. No. 081697.
Remarks of the Evaluator PECXIII • Submitted me too contain Amoxicillin as Amoxicillin
Trihydrate 16gm/100gm while the applied formulation contains
Amoxicillin Trihydrate 20gm eq. To Amoxicillin Base
17.392gm/100gm.
Evidence of approval of applied formulation (generic/me too)
already approved by DRAP with brand name, Reg. No. and name
of the firm OR
Revise formulation as per reference product with applicable fee.
th
Decision of 307 meeting of Deferred for Evidence of approval of applied formulation
Registration Board. (generic/me too) already approved by DRAP with brand name,
Reg. No. and name of the firm OR
Revise formulation as per reference product with applicable fee.

Each 100gm contains
Amoxicillin as Trihydrate …….. 16gm
No. F. 7-11/2021-B&A/DRAP dated 13-07-2021.
1958876106 dated 20-01-2022.
Remarks of the Evaluator PEC XIII •
Decision: Approved with innovator’s specifications up to 1kg pack size as per following label claim;
Each 100gm contains
Amoxicillin as Trihydrate …….. 16gm
Agenda of Evaluator PEC-IV

a. New cases Form 5-F
161. Name, address of Applicant / Marketing M/s Getz Pharma (Pvt.) Ltd.,
Authorization Holder Plot No. 29-30, Sector 27, Korangi Industrial Area, Karachi.
Name, address of Manufacturing site M/s Getz Pharma (Pvt.) Ltd.,
☐ Importer
☐ Export sale
Details of fee submitted PKR 20,000/- dated 19/05/2021
PKR 10,000/- Deposit slip No#32398365505
The proposed proprietary name / brand name ONITERON Tablets 8mg
Strength / concentration of drug of Active Each film-coated tablet contains:
Pharmaceutical ingredient (API) per unit Ondansetron hydrochloride (as dihydrate) USP equivalent to
Ondansetron…8mg
Pharmaceutical form of applied drug Green colored, oval shaped, film coated tablet, engraved
“GETZ” on one side and break line on other side.
Pharmacotherapeutic Group of (API) Serotonin (5HT3) antagonist

The status in reference regulatory authorities Zofran Tablets 8mg by M/s Novartis Pharmaceuticals Co.,
USA.
For generic drugs (me-too status) Zofran Tablets 8mg by M/s Novartis (Reg. No.: 020668)
GMP status of the Finished product cGMP certificate based on the Evaluation conducted on 07th
manufacturer January, 2019
Name and address of API manufacturer. M/s CTX Lifesciences Pvt. Ltd.
Block No. 251-252, Sachin- Magdalla Road
GIDC, Sachin, Surat – 394 230, Gujarat, INDIA
and drug product.
Module III (Drug Substance) Official monograph of Ondansetron hydrochloride is present in
USP. Firm has submitted detailed data for drug substance data
Batches: (ON130001, ON130002, ON130003)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been established against the
dissolution profile brand leader that is Zofran Tablets 8mg by Novartis (Pakistan)
Ltd (manufactured by Aspen Bad Oldesloe GmbH, Germany)..
Batch No. B44519L.
CDP has been performed against the same brand that is Zofran
Tablets 8mg by Novartis (Pakistan) Ltd. in Acidic media (pH
1.2), Acetate buffer (pH 4.5) & Phosphate Buffer (pH 6.8). The
values of f2 are in the acceptable range.
product specificity, linearity, accuracy, precision repeatability, stability
of solution and range.
Manufacturer of API M/s CTX Lifesciences Pvt. Ltd. Block No. 251-252, Sachin- Magdalla Road GIDC,
Sachin, Surat – 394 230, Gujarat, India
API Lot No. 20ON00013
Description of Pack
Alu-Alu blister packed in unit carton (1’s, 10’s & 12’s)

Batch No. 548DS01 548DS02 548DS03
Manufacturing Date 23.09.2020 09.10.2020 09.10.2020
Date of Initiation 03.11.2020 03.11.2020 03.11.2020
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of their product for
applications with stability study data of the Estine (Ebastine) Tablets 10mg & 20mg on 6th May, 2019.
firm (if any) Further, the said panel inspection report was discussed in 289th
Drug Registration Board meeting held on 14th – 16th May 2019.
The case was approved and the inspection report confirms
following points:
• The HPLC software is 21CFR Compliant as per record
available with the firm.
Related manufacturing area, equipment, personnel and utilities
are GMP compliant.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. 19061470 issued by Food & Drugs
API manufacturer issued by concerned Control Administration, Gujrat valid till 01/07/2022.
3. Documents for the procurement of API with Firm has submitted copy of Form 6 from 7 & invoice (invoice#
approval from DRAP (in case of import). EI/3002100158) dated: 25-06-2020 cleared by DRAP Karachi
office dated 30-06-2020 specifying import 0.600kg

Firm has submitted data of stability batches along with batch
chromatograms,
manufacturing record and analytical record.
Raw data sheets, COA, summary data sheets
etc.
Firm has submitted audit trail reports on product testing.
6. Record of Digital data logger for temperature Firm has submitted Record of Digital data logger for
and humidity monitoring of stability temperature & humidity monitoring of stability chambers (real
S.No Section Shortcomings Reply
Communicated
1. 2.3.R.1.2 For applications of locally Blank batch manufacturing record to be used during the
manufactured drug commercial manufacturing Submitted
product(s), provide blank
master production
document
/ batch manufacturing
record to be used during
the commercial
manufacturing of the
applied product

2. 3.2.S.4.1 Copies of the Specifications of the Drug substance by M/s Getz Pharma
specifications of the (Pvt.) Ltd Submitted
Drug substance /Active
Pharmaceutical Ingredient
by Drug Product
manufacturer is required
3. 3.2.S.4.1 Detailed analytical Analytical procedures for routine testing of the Drug substance
procedures used for by M/s Getz Pharma (Pvt.) Ltd submitted
routine testing of the
Drug Product
4. 3.2.S.4.1 Analytical Method Firm has submitted Analytical method verification studies,
Verification studies without performance of accuracy parameter. Firm has
including specificity, submitted following justification:
accuracy and repeatability “This is to bring to your kind attention that we have used 100%
(method API without any placebo in Analytical Method Verification
precision) performed by Studies of Ondansetron, therefore, requirement of accuracy is
the Drug Product not applicable. Further, we have performed linearity to check
manufacturer for drug area response of the sample as the concentration of the sample
substance(s) shall be raised within working range of sample i.e., 50% - 150%.”
submitted.
5. 3.2.P.2.2.1 Provide details This is to bring to your kind information that we have
comparator product established Pharmaceutical Equivalence of Oniteron tablets
against which 8mg (manufactured by Getz Pharma) with Zofran Tablets
Pharmaceutical (manufactured by Aspen Bad Oldesloe GmbH, Germany).
Equivalence was
established.
6. 3.2.P.5.1 Time for Q not mentioned Revised Updated Finished Product Specifications of Oniteron
in specifications. (Ondansetron) Tablets 8mg submitted
• Manufacturer will place first three commercial batches on long term stability studies throughout
☐ Importer
☐ Export sale
PKR 10,000 Deposit Slip # 29801065

The proposed proprietary name / brand name ONITERON Injection 4mg/2ml
Strength / concentration of drug of Active Each 2ml ampoule contains:
Ondansetron….4mg
Pharmaceutical form of applied drug A clear colorless liquid, free from turbidity and foreign matter;
filled in a sterilized USP Type-I ampoule.
Proposed Pack size 2ml x 1’s & 2ml x 5’s
The status in reference regulatory authorities Zofran Injection 2mg/ml by M/s Novartis Pharmaceuticals UK
Ltd., MHRA Approved.
For generic drugs (me-too status) Zofran Injection 4mg/2ml by M/s Novartis (Pakistan), Ltd.
(Reg. No.: 052259)
GMP status of the Finished product cGMP certificate based on the Evaluation conducted on 07th
manufacturer January, 2019
GIDC, Sachin, Surat – 394 230, Gujarat, India
and drug product.
Batches: (ON130001, ON130002 and ON130003)
Pharmaceutical equivalence and comparative • Initially Pharmaceutical Equivalence has been
dissolution profile established against the brand leader that is Zofran
Injection 8mg/4ml Batch No. A44W by M/s Novartis
(Pakistan) Ltd.
• Later Pharmaceutical Equivalence has been established
against the brand leader that is Onseron Injection
4mg/2ml Batch # 010008 (manufactured by Indus
Pharma (Pvt Ltd.)

product specificity, linearity, accuracy, precision, repeatability,
intermediate precision, robustness, stability of solution and
range.
Manufacturer of API M/s CTX Lifesciences Pvt. Ltd.
GIDC, Sachin, Surat – 394 230, Gujarat, India
Description of Pack
2ml Ampoule packed in unit carton (1’s & 5’s)
Batch No. 546DS01 546DS02 546DS03
Batch Size 700 Ampoules 700 Ampoules 700 Ampoules
No. of Batches 03
following points:
are GMP compliant.

chromatograms,
etc.

Communicated
1. 2.3.R.1.2 For applications of Blank batch manufacturing record to be used during the
locally manufactured commercial manufacturing Submitted
drug product(s), provide
blank master production
document / batch
manufacturing record to
be used during the
commercial
applied product
specifications of the (Pvt.) Ltd Submitted
Pharmaceutical
Ingredient by Drug
Product manufacturer is
required
3. 3.2.S.4.1 Detailed analytical Analytical procedures for routine testing of the Drug
procedures used for substance by M/s Getz Pharma (Pvt.) Ltd submitted
Pharmaceutical
Ingredient Drug Product
accuracy and “This is to bring to your kind attention that we have used
repeatability (method 100% API without any placebo in Analytical Method
precision) performed by Verification Studies of Ondansetron, therefore, requirement of
the Drug Product accuracy is not applicable. Further, we have performed
manufacturer for drug linearity to check area response of the sample as the
substance(s) shall be concentration of the sample raised within working range of
submitted. sample i.e., 50% - 150%.”
5. 3.2.P.2.2.1 Pharmaceutical This is to bring to your kind information that we established
equivalence with the Pharmaceutical Equivalence of Oniteron Injection
8mg/4ml established. 4mg/2ml with 8mg/4ml since content of API per ml in both
Justification is required. product is same i.e. 2mg/ml and at that time comparator
product with 4mg/2ml strength was not available.
Submitted Pharmaceutical Equivalence Studies of Oniteron
Injection 4mg/2ml with Onseron Injection 4mg/2ml Batch No
080001 (manufactured by Indus Pharma (Pvt.) Ltd.) for your
record.

☐ Importer
☐ Export sale
PKR 10,000/- Deposit Slip # 01809107
The proposed proprietary name / brand name ONITERON Injection 8mg / 4ml
Ondansetron….8mg
Pharmaceutical form of applied drug A clear colorless liquid, free from turbidity and foreign matter;
filled in a sterilized USP Type-I ampoule.
Proposed Pack size 4ml x 1’s & 4ml x 5’s
The status in reference regulatory authorities Zofran Injection 2mg/ml by M/s Novartis Pharmaceuticals UK
Ltd., MHRA Approved.
For generic drugs (me-too status) Zofran Injection 8mg/4ml by M/s Novartis (Pakistan), Ltd.
(Reg. No.: 020669)
GMP status of the Finished product Last GMP Inspection dated 03-12-2021 concludes that M/s Getz
manufacturer Pharma Pvt. Ltd. is considered to be operating at an acceptable
level of compliance of GMP requirements.
Liquid Injectable (General) section approved.
and drug product.

Batches: (ON130001, ON130002 and ON130003)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been established against the
dissolution profile brand leader that is Zofran Injection 8mg/4ml Batch No. A44W
by M/s Novartis (Pakistan) Ltd.
product specificity, linearity, accuracy, precision, repeatability,
intermediate precision, robustness, stability of solution and
range.
Manufacturer of API M/s CTX Lifesciences Pvt. Ltd.
Description of Pack
4ml Ampoule packed in unit carton
Batch No. 547DS01 547DS02 547DS03
No. of Batches 03
following points:
are GMP compliant.


chromatograms,
etc.
Communicated
1. 2.3.R.1.2 For applications of locally Blank batch manufacturing record to be used during the
manufactured drug commercial manufacturing Submitted
product(s), provide blank
master production
document
/ batch manufacturing
record to be used during
the commercial
applied product
specifications of the Drug (Pvt.) Ltd Submitted
substance /Active
by Drug Product
3. 3.2.S.4.1 Detailed analytical Analytical procedures for routine testing of the Drug
procedures used for substance by M/s Getz Pharma (Pvt.) Ltd submitted
Drug Product
accuracy and repeatability “This is to bring to your kind attention that we have used
(method precision) 100% API without any placebo in Analytical Method
performed by the Drug Verification Studies of Ondansetron, therefore, requirement of
Product manufacturer for accuracy is not applicable. Further, we have performed
drug substance(s) shall be linearity to check area response of the sample as the
submitted. concentration of the sample raised within working range of
sample i.e., 50% - 150%.”

5. 3.2.P.2.2.1 Provide details This is to bring to your kind information that we have
comparator product established Pharmaceutical Equivalence of Oniteron Injection
against which 8mg/4ml (manufactured by Getz Pharma) with Zofran
Pharmaceutical Injection 8mg/4ml (manufactured by GSK S.p.A, Italy).
Equivalence was
established.
164. Name, address of Applicant / Marketing M/s. SAMI Pharmaceuticals (Pvt.) Ltd. F-95, Off Hub River
Authorization Holder Road, S.I.T.E. Karachi.
Name, address of Manufacturing site. M/s Sami Pharmaceuticals (Pvt) Ltd. F-95, Off Hub River
Road, S.I.T.E. Karachi.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 19160 dated :08-07-2021
Details of fee submitted PKR 30,000/-: Deposit slip #887056162198
PKR 120,000/-: Deposit slip #12835367 dated:20-01-2022
The proposed proprietary name / brand name Mevulak MR 200mg Capsule
Strength / concentration of drug of Active Each Capsule contains:
Pharmaceutical ingredient (API) per unit Modified release Mebeverine HCl Pellets Equivalent to
Mebeverine HCl….200mg
(Innovator’s Specifications)
Pharmaceutical form of applied drug Modified Release Capsule
Pharmacotherapeutic Group of (API) Synthetic anticholinergics
ATC Code: A03AA04
Proposed Pack size 10’s, 20’s, & 30’s
The status in reference regulatory authorities Colofac® MR. Modified release capsule by M/s MHRA
Approved.
For generic drugs (me-too status) Mebever MR 200mg Capsule by M/s Getz
Pharma,Registration No. 050747
GMP status of the Finished product GMP Certificate issued date 11-08-2020 on the basis of
manufacturer inspection conducted on 28-08-2019
Name and address of API manufacturer. M/s RA Chem Pharma Limited (FDF)

Plot No: A-19/C, A-23A 7 A-23B, Road No0 18, IDA
Nancharam, Nancharm Village , Uppal Manda, Medchal-
malkajgiri district, Hyderabad, Telegana, India.
Stability studies of Drug substance Stability study conditions:
Batches:(MBPJ16007,MBPJ16008,MBPJ16009,)
individual impurity and total impurity, specifications,
analytical procedure (including dissolution testing at acidic
and buffer medium) and its validation studies, batch analysis
and justification of specification, reference standard,
product.
dissolution profile the Competitor that is Mebever MR® 200mg Tablets by M/s
Getz Pharma by performing quality tests (Appearance,
average weight, Assay, Dissolution, impurity profiling,
Microbiological limit test ).
CDP has been performed against the same brand that is A
Mebever MR® 200mg Tablets by M/s Getz Pharma in Acid
media (pH 1.2-4.5) & Phosphate Buffer (pH 6.8). The
values for f1 and f2 are in the acceptable range.
product linearity, accuracy, precision (including intermediate
precession , Repeatability), Robustness, specificity
Manufacturer of API M/s RA Chem Pharma Limited (FDF)
Plot No: A-19/C, A-23A 7 A-23B, Road No0 18, IDA Nancharam, Nancharm
Village , Uppal Manda, Medchal- malkajgiri district, Hyderabad, Telegana, India.
API Lot No. DMBPJ19049
Description of Pack
Alu-Alu blister
Time Period Real time: 06th months Accelerated: 6th months

No. of Batches 03
1. Reference of previous approval of applications Reference of our last onsite panel inspection for instant
with stability study data of the firm (if any) dosage form conducted during last two years i.e. DELANZO
DR (Dexlansoprazole) 30mg & 60mg Capsules which was
approved & registered by registration board
Date of inspection: 02nd April, 2018.The inspection report
confirms following points
• The HPLC software is 21CFR Compliant
• Related manufacturing area, equipment, personnel and
utilities are GMP compliant.
2. Approval of API/ DML/GMP certificate of API Copy of DML for M/s RA Chem Pharma Limited (FDF)
manufacturer issued by concerned regulatory (License No# 23/RR/AP/2007/F/R/CC, Dt:07/07/2013)
authority of country of origin. issued by Drug Control Administration Government of
Telegana, valid upto 26-10-2025 is submitted
3. Documents for the procurement of API with Detail of Loan material from S.J & G Fazul Elahie (Pvt.)
approval from DRAP (in case of import). Karachi along with the Copy of form 3, form 7 &
commercial invoice (Invoice# RATG/19-20/812 02-03-
2020 with received quantity i.e. 250 kg) for the purchase
Mebeverine HCl SR Pellets by RA CHEM PHARMA
LIMITED (FDF Division) with attestation of DRAP dated:
13 -02- 2020
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Submitted.
Fee submitted PKR 120,000/-: Deposit slip #12835367, Dated: 20-01-2022
S.No Section Shortcomings Communicated Reply
1. 3.2.P.8 Clarify why you take loan of Pellets Mebeverine HCL pellets of good quality could be
from S.J & G Fazul Elahie (Pvt.) sourced from good Indian manufacturers at reasonable
Karachi instead of purchase from rates.
direct pellets maufacturer In order to conduct Stability Studies, we requested few
manufacturers to supply required quantity of Mebeverine
Hcl SR pellets to which they agreed.

Unfortunately no Courier company was willing to lift
sample quantity from India for delivery to us; copies of
emails exchanged with them are annexed herewith.
M/s S.J. & G Fazul Ellahie Pvt. Ltd. Karachi fortunately
had sufficient stock of imported Mebeverine Hcl pellets
and were willing to provide required quantity on loan.
We accordingly obtained required quantity on loan from
them.
Decision: Deferred for further deliberation regarding regarding use of drug substance pellets by M/s Sami
Pharmaceuticals (Pvt.) Ltd, for the manufacturing of stability batches, which had been procured and imported
by M/s S.J. & G Fazul Ellahie Pvt. Ltd. Karachi.
165. Name, address of Applicant / Marketing M/s Scotman Pharmaceuticals
Authorization Holder 5-D, I-10/3, Industrial Area, Islamabad- Pakistan
Name, address of Manufacturing site. M/s Scotman Pharmaceuticals
5-D, I-10/3, Industrial Area, Islamabad- Pakistan
☐ Importer
☐Generic Drug Product (GDP)
☐ Export sale
Details of fee submitted PKR 20,000/-: 15-03-2021 & PKR 10,000/-: 28-05-2021
The proposed proprietary name / brand name Balit 8mg Tablet
Strength / concentration of drug of Active Each Tablet Contains:
Pharmaceutical ingredient (API) per unit Betahistine Dihydrochloride.………8mg
Pharmaceutical form of applied drug uncoated tablet

Pharmacotherapeutic Group of (API) Histamine H1 Receptor antagonist
Proposed Pack size 10’s, 14’s, 20’s, 28’s, & 30’s,
The status in reference regulatory authorities Betahistine Dihydrochloride 8mg tablet of France approved
For generic drugs (me-too status) SERC tablet 8mg of M/S Abbot (Reg # 006653)
GMP status of the Finished product cGMP certificate on the basis of inspection and evaluation
manufacturer conducted on 09-11-2020 and valid till 08-11-2022
Name and address of API manufacturer. Ami Lifesciences Private Limited.
2nd Floor, Prestige Plaza, 40, Urmi Society, Nr, Urmi Cross
Road, BPc Road, Akota, Baroda-390 020. Gujrat, India
Module-II (Quality Overall Summary) Firm has summarized information related to nomenclature,
structure, general properties, solubility, physical form,
and stability studies of drug substance. Firm has submitted

data of drug product including its description, composition,
pharmaceutical development, manufacture, manufacturing
process and process control, process validation protocols,
nomenclature, structure, general properties, solubility,
procedures and its validation, batch analysis and
closure system and stability studies of drug substances.
Pharmaceutical equivalence and comparative Firm has performed comparative dissolution profile against
dissolution profile the product i.e Serc tablet 8mg Batch No# 182136 of Abbot
Laboratories and the results are within acceptable limit
product linearity, accuracy, precision, robustness, specificity.
Manufacturer of API Ami Lifesciences Private Limited.
2nd Floor, Prestige Plaza, 40, Urmi Society, Nr, Urmi Cross Road, BPc Road, Akota,
Baroda-390 020. Gujrat, India
API Lot No. BTI/20070518
Description of Pack
Alu-Alu
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH Accelerated: 40°C ± 2°C / 75% ± 5%RH
Frequency Accelerated: 0,3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. Trial # 01 Trial # 02 Trial # 03
Manufacturing Date 10.2018 10.2018 10.2018
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to onsite inspection report of their product
with stability study data of the firm (if any) “Dascot (Daclatasvir) 30mg Tablets” which was presented

in 278th meeting of Registration Board wherein the Board
decided to approve registration of this product
Date of inspection: 26th January, 2018.
According to inspection report, following points were
confirmed.
• The firm has 21CFR compliant HPLC software.
• Adequate monitoring and control are available for
stability chamber
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No19041306 issued by Food and
manufacturer issued by concerned regulatory Drug control administration Gandhinagar, Gujrat Stat,
authority of country of origin. India valid till 24/04/2022.
3. Documents for the procurement of API with Firm has submitted copy of form 3, form 7, commercial
approval from DRAP (in case of import). invoice No # EXP/I/18-19/0164 dated: 12-07-2018
specifying import of 300g of Betahistine Dihydrochloride
(Batch # BTI/20070518). attested by AD (I&E), Islamabad
dated 30-07-2018
chromatograms,
Raw data sheets, COA, summary data sheets etc.
1. 1.4.1 Fee submitted 30000/- while in this This is metoo product available in the market with
section New Drug Product mentioned the name of Serc Tablets 8mg, Serc Tablets 16mg
and Serc Tablets 24mg manufactured by Abbott
Laboratories (Pakistan) Limited.
It was mistakenly tick on New Drug product instead of
Generic Drug Product. Correction submitted.
2. 1.5.5 Indicate Pharmacological class of the Pharmacological class of the API is mentioned in
API (drug substance) with proper prescribed form
reference.
3. Modul II Do not refer for any detail to Module Detail of Module II is attached
III.
4. 2.3.R.2 Provide analytical method validation Analytical method validation/ verification results are
/ verification results in the table attached.
given in the guidelines
5. 3.2.S.4.1 Copies of the Drug substance Copies of the drug substance specifications is attached.
specifications by Drug Product
6. 3.2.S.4.2 Analytical procedures used for Analytical procedures used for routine testing of the
routine testing of the Drug substance drug substance/ Active Pharmaceutical ingredient by
/Active Pharmaceutical Ingredient drug product manufacturer is attached.
by Drug Product manufacturer is
required
7. 3.2.S.4.3 Analytical Method Verification Analytical method verification studies including
studies including specificity, specificity, accuracy and repeatability (method
accuracy and repeatability (method

precision) performed by the Drug precision) performed by the drug product manufacturer
Product manufacturer of drug of drug substance(s) is attached
substance(s) shall be submitted
8. 3.2.S.4.8 The Drug substance stability data In terms of drug substance API stability studies at
submitted in form 5-F and stability various temperatures, we are presenting an undertaking
studies of drug product is same but from the supplier, who has stated that the stability study
different conditions i.e 25°C ± 2°C / of API delivered at 25°C was typographically error and
60% ± 5% and 30°C ± 2°C / 65% ± actual temperature is 30 °C is attached
5%. Clarification is required.
9. 3.2.P.5.1 • Justify the dissolution acceptance During product development, stages dissolution profile
criteria of value of Q = 80% in 45 at different time intervals that is 15, 30, and 45 minutes
min while in CDP in acidic are recorded. But at registration, dissolution for an
medium at 15 minutes more than immediate release tablet becomes a single time point.
85% dissolution achieved. According to the USP GENERAL MONOGRAPH
“THE DISSOLUTION PROCEDURE:
DEVELOPMENT AND VALIDATION” the majority
of immediate-release products typically show a gradual
increase reaching 85%–100% at about 30–45 min. As a
result, to characterize the performance of most
immediate-release products, sufficient dissolution time
points are chosen. This is why 45 minutes was chosen
as the time limit. However, the acceptance criteria have
been revised/updated to Q 80% in 30 minutes attached.
10. 3.2.P.5.3 • Submit Analytical test method • Submitted
validation protocols and report in • Complete method for preparation of these dilutions
detail is not provided.
• The calibration curve is • As per the USP General monograph “Validation of
established with acceptable value Compendial Procedure”
for r2 by preparing the dilutions
from 80% to 120%. Since “The range of the procedure is validated by verifying that
complete method for preparation the analytical procedure provides acceptable precision,
of these dilutions is not provided accuracy, and linearity when applied to samples
in the dossier, therefore, you are containing analyte at the extremes of the range as well as
required to submit the complete within the range.”
method for the said testing.
• Moreover, the dilutions for We performed the accuracy-test in extreme ranges of 50
testing of accuracy parameter to 150 % based on the above guidelines. The recovery
have been prepared from 50% to results in the 50-150% and 80-120 % ranges are well
150% while the calibration curve within the limits, indicating that the method is more
was constructed by taking the accurate and reliable in both ranges. We have, however,
dilutions of 80% to 120% into conducted accuracy tests ranging from 80% to 120 %.
account, please justify whether The recovery limits of 97-103% in accordance with the
accuracy parameter can be reference as attached
established by taking the dilutions “FOOD AND DRUG ADMINISTRATION OFFICE OF
outside the calibration curve or REGULATORY AFFAIRS ORA LABORATORY
otherwise, refer the relevant MANUAL VOLUME II GUIDELINE
guideline as well..
• Justification is required for setting
up the criteria for accuracy
parameter of validation studies
from 97% to 103%, please refer
the guideline as well.
Firm submitted fee of Rs: 7500/- Deposit slip # 29803207324 Dated: 09-03-2022 for change of dissolution
specifications
Decision: Approved with BP specifications.

☐ Importer
☐ Export sale
The status in reference regulatory authorities Betahistine Dihydrochloride 24mg tablet of France
approved

dissolution profile the product i.e Serc tablet 16mg Batch No# 182149 of
Abbot Laboratories and the results are within acceptable
limit
Description of Pack
Alu-Alu
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to onsite inspection report of their
with stability study data of the firm (if any) product “Dascot (Daclatasvir) 30mg Tablets” which was
presented in 278th meeting of Registration Board wherein
the Board decided to approve registration of this product

confirmed.
stability chamber
dated 30-07-2018
data sheets etc.
1. 1.4.1 Fee submitted 30000/- while in this This is meetoo product available in the market with
reference.
III.
4. 2.3.R.2 Provide analytical method validation Analytical method validation/ verification results are
/ verification results in the table attached.
given in the gudlines
6. 7. 3.2.S.4. Analytical procedures used for Analytical procedures used for routine testing of the
2 routine testing of the Drug substance drug substance/ Active Pharmaceutical ingredient by
/Active Pharmaceutical Ingredient drug product manufacturer is attached.
by Drug Product manufacturer is
required
accuracy and repeatability (method precision) performed by the drug product manufacturer
precision) performed by the Drug of drug substance(s) is attached
Product manufacturer of drug

5%. Clarification is required..
• The calibration curve is • As per the USP General monograph “Validation of
established with acceptable value Compendial Procedure”
for r2 by preparing the dilutions
from 80% to 120%. Since “The range of the procedure is validated by verifying
complete method for preparation that the analytical procedure provides acceptable
of these dilutions is not provided precision, accuracy, and linearity when applied to
in the dossier, therefore, you are samples containing analyte at the extremes of the range
required to submit the complete as well as within the range.”
method for the said testing.
• Moreover, the dilutions for We performed the accuracy-test in extreme ranges of
testing of accuracy parameter 50 to 150 % based on the above guidelines. The
have been prepared from 50% to recovery results in the 50-150% and 80-120 % ranges
150% while the calibration curve are well within the limits, indicating that the method is
was constructed by taking the more accurate and reliable in both ranges. We have,
dilutions of 80% to 120% into however, conducted accuracy tests ranging from 80%
account, please justify whether to 120 %.
accuracy parameter can be The recovery limits of 97-103% in accordance with the
established by taking the dilutions reference as attached
outside the calibration curve or “FOOD AND DRUG ADMINISTRATION OFFICE
otherwise, refer the relevant OF REGULATORY AFFAIRS ORA LABORATORY
guideline as well.. MANUAL VOLUME II GUIDELINE
from 97% to 103%, please refer
the guideline as well.
Firm submitted fee of Rs: 7500/- Deposit slip # 736226187 Dated: 09-03-2022 for change of dissolution specifications

☐ Importer
☐ Export sale
The status in reference regulatory authorities Betahistine Dihydrochloride 24mg tablet of France
approved

dissolution profile the product i.e Serc tablet 24mg Batch No# 182569 of
Abbot Laboratories and the results are within acceptable
limit
Description of Pack
Alu-Alu
No. of Batches 03
with stability study data of the firm (if any) “Dascot (Daclatasvir) 30mg Tablets” which was presented
confirmed.

stability chamber
dated 30-07-2018
data sheets etc.
1. 1.4.1 Fee submitted 30000/- while in this This is meetoo product available in the market with
reference.
III.
4. 2.3.R.2 Provide analytical method validation / Analytical method validation/ verification results are
verification results in the table given attached.
in the gudlines
6. 3.2.S.4.2 Analytical procedures used for routine Analytical procedures used for routine testing of the
testing of the Drug substance /Active drug substance/ Active Pharmaceutical ingredient by
Pharmaceutical Ingredient by Drug drug product manufacturer is attached.
Product manufacturer is required
studies including specificity, accuracy specificity, accuracy and repeatability (method
and repeatability (method precision) precision) performed by the drug product manufacturer
performed by the Drug Product of drug substance(s) is attached
manufacturer of drug substance(s) shall
be submitted
5%. Clarification is required..

• The calibration curve is established • As per the USP General monograph “Validation of
with acceptable value for r2 by Compendial Procedure”
preparing the dilutions from 80%
to 120%. Since complete method “The range of the procedure is validated by verifying
for preparation of these dilutions is that the analytical procedure provides acceptable
not provided in the dossier, precision, accuracy, and linearity when applied to
therefore, you are required to samples containing analyte at the extremes of the range
submit the complete method for the as well as within the range.”
said testing.
• Moreover, the dilutions for testing We performed the accuracy-test in extreme ranges of 50
of accuracy parameter have been to 150 % based on the above guidelines. The recovery
prepared from 50% to 150% while results in the 50-150% and 80-120 % ranges are well
the calibration curve was within the limits, indicating that the method is more
constructed by taking the dilutions accurate and reliable in both ranges. We have, however,
of 80% to 120% into account, conducted accuracy tests ranging from 80% to 120 %.
please justify whether accuracy The recovery limits of 97-103% in accordance with the
parameter can be established by reference as attached
taking the dilutions outside the “FOOD AND DRUG ADMINISTRATION OFFICE
calibration curve or otherwise, OF REGULATORY AFFAIRS ORA LABORATORY
refer the relevant guideline as MANUAL VOLUME II GUIDELINE
well..
from 97% to 103%, please refer the
guideline as well.
Firm submitted fee of Rs: 7500/- Deposit slip # 5705685858 Dated: 09-03-2022 for change of dissolution
specifications
168. Name, address of Applicant / Marketing "M/s Hilton Pharma (Pvt.) Ltd. Plot No. 13-14, Sector-15,
Authorization Holder Korangi, Industrial Area, Karachi.”
Name, address of Manufacturing site. "M/s Hilton Pharma (Pvt.) Ltd. Plot No. 13-14, Sector 15,
Korangi, Industrial Area, Karachi.”

☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No19287 Dated: 09-07-2021
Details of fee submitted PKR 20,000/- (Slip No. 2027062 Dated: 12/04/2021)
Racehil Capsules 100mg
name
Strength / concentration of drug of Active Each Capsule Contains:
Pharmaceutical ingredient (API) per unit Racecadotril ………………… 100mg
Pharmaceutical form of applied drug Capsules
Pharmacotherapeutic Group of (API) Antidiarrheal
Reference to Finished product specifications Innovator
Proposed Pack size 10’s, 20’s, 30’s
Proposed unit price As per DPC
The status in reference regulatory
Hidrasec® Capsules 100mg by France Approved.
authorities
For generic drugs (me-too status) “Hidrasec® Capsules 100mg” by M/s Abbott Laboratories Reg#
087518
GMP status of the Finished product Section for Capsule (General) was granted after renewal of Drug
manufacturer Manufacturing Licence inspection vide letter No.
F. 2-14/85-Lic (Vol-V) Dated: 30/06/2020
Name and address of API manufacturer. Racecadotril:
M/s SVK Laboratories Private Limited
D-16, Phase-I, IDA-Jeedimetla Hyderabad-500055 Telangana
State-India.
Module III (Drug Substance) Firm has submitted detailed drug substance data on CTD format
manufacturing process and controls, impurities, specifications
and analytical procedures, batch analysis and justification of

Racecadotril:
Batches #: (RCL/00415, RCL/00515, RCL/00615)
manufacturing process and process control, control of
procedures, validation of analytical procedures, batch analysis,
justification of specifications, reference standard or materials,
dissolution profile Hidrasec® Capsules 100mg manufactured by Sophatrex 21 Rue
du pressoir , France for Abbott Laboratories
The firm has submitted the comparative dissolution with
Hidrasec® Capsules 100mg manufactured by Sophatrex 21 Rue
du pressoir , France for Abbott Laboratories. and dissolution
profile in Acid media (pH 1.2-4.5) & Phosphate Buffer (pH 6.8).
Analytical method validation/verification of Method validation studies have submitted including, Specificity,
product linearity, range, accuracy, Precision Repeatability, Intermediate
precision, Robustness, System Suitability.
Manufacturer of API Racecadotril:
M/s SVK Laboratories Private Limited
D-16, Phase-I, IDA-Jeedimetla Hyderabad-500055 Telangana State-India.
API Lot No. Racecadotril:
Lot No.: RCL/0050919
Description of Pack
(Container closure Alu-Alu blister packed in printed carton along with leaflet.
system)
Batch No. RAC-417004-2 RAC-417004-3 RAC-417004-4
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of their product
applications with stability study data of the “HILVEL 400mg + 100mg (Sofosbuvir +Velpatasvir)”, which
firm (if any) was conducted on 14th December, 2017 and was presented in
277th meeting of Registration Board held on 27-29th December,
2017.
Following two observations were reported in the report:
i. The HPLC software is 21 CFR compliant.
ii. Audit trail on the testing reports of Hilvel Tablets
400mg+100mg is available.

Adequate monitoring and control are available for stability
chamber. Chamber are controlled and monitored through
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No (61422/TS/2021) issued by Drugs
API manufacturer issued by concerned control administration Telangana (DCA) valid until 24.06.2022.
3. Documents for the procurement of API with Copy commercial invoice (Invoice# EXP/2019-20/010 Dated:
approval from DRAP (in case of import). 05-12-2019 with received quantity i.e. 2 kg) of Racecadotril
Batch No# RCL/0050919 with attestation of DRAP Karachi
dated: 16-12-2019
testing
S.No Section Shortcomings Communicated Replies
1. 2.3.R.1.2 For applications of locally manufactured Blank master production document
drug product(s), provide blank master / batch manufacturing record is attached.
production document
/ batch manufacturing record to be used
during the commercial manufacturing of the
applied product
2. 3.2.S.4.1 Copies of the Drug substance specifications Copies of the Drug substance specifications of the
of the Drug substance /Active Drug substance /Active Pharmaceutical Ingredient
Pharmaceutical Ingredient by Drug Product by Drug Product manufacturer are attached
3. 3.2.S.4.2 Detailed analytical procedures for the Detailed analytical procedures for the testing of
testing of drug substance by Drug Product drug substance by Drug Product manufacturer are
manufacturer shall be provided. attached.
4. 3.2.S.4.3 Analytical Method Verification studies Analytical Method Verification studies has been
including specificity, accuracy and performed by the Drug Product manufacturer for
repeatability (method precision) performed drug substance and data enclosed.
by the Drug Product manufacturer for drug
5. 3.2.P.2.2.1 Pharmaceutical equivalence of the applied Innovator and test product have been analyzed
drug shall be established with the innovator simultaneously and found satisfactory and
/ reference / comparator product and results comparable results enclosed.
of all the quality tests (mentioned in any
official pharmacopoeia or section 3.2.P.5.1
of this application) of the developed
formulation and the innovator / reference /
comparator product shall be submitted and
discussed
6. 3.2.P.4.5 Excipients of Human or Animal Origin TSE & BSE certificate are attached.
shall be addressed for the use of
“Magnesium stearate” in the applied
formulation.

7. 3.2.P.5.2 You have applied Paddle speed = 100 rpm with reference to USP general chapter <1092>
in dissolution parameters. You are advised (The Dissolution Procedure; Development and
to justify the speed of paddle apparatus with Validation). , justification of paddle apparatus
reference to USP general chapter <1092> speed is following
(The Dissolution Procedure; Development “During dissolution method development on
and Validation). Racehil Capsules 100mg, we have observed that
the capsule content did not dispersed freely
throughout the vessel in a uniform fashion and we
were getting aberrant results at lower rpm.”
8. 3.2.P.8 • Documents for the procurement of API • Attested invoice submitted.
with approval from DRAP. • Data of stability batches will be supported
• Data of stability batches will be supported by attested respective documents like
by attested respective documents like chromatograms, Raw data sheets, COA,
chromatograms, Raw data sheets, COA, summary data sheets etc, submitted.
Decision: Approved with Innovator’s specifications.
169. Name, address of Applicant / Marketing M/s Pharmatec Pakistan Private Limited
Authorization Holder D-86/A, S.I.T.E, Mangopir Road, Karachi
Name, address of Manufacturing site. M/s Pharmatec Pakistan Private Limited
D-86/A, S.I.T.E, Mangopir Road, Karachi
☐ Importer
Status of application ☒New Drug Product (NDP)
☐ Export sale
Reltus DM Liquid (Sugar free)
name
Pharmaceutical ingredient (API) per unit Dextromethoprhan HBr……. 7.5mg
Pharmaceutical form of applied drug Clear bright pink with a characteristic odour and taste (Cherry
Grenadine Flavor)
Oral liquid
Pharmacotherapeutic Group of (API) Cough suppressant (ATC R05DA09)
Proposed Pack size 120ml amber Glass Bottle

The status in reference regulatory Robitussin Dry Cough Medicine by GlaxoSmithKline Consumer
authorities Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.
UK MHRA Approved
For generic drugs (me-too status) Not Available
GMP status of the Finished product cGMP certificate on the basis of evaluation conducted on 12-02-
manufacturer 2019 and valid for 2 years.
Name and address of API manufacturer. Wockhardt Limited Plot No. 138, GIDC Industrial Estate
Ankleshwar-393 002 Gujrat, India
Module III (Drug Substance) Specification based on Official monograph of dextromethorphan
HBr USP is this section. The firm as submitted detail of
controls, tests for impurity Levemethrophan, N-N Dimethyl
Alanine & Limit of Phenolic compound , specifications,
closure system and stability studies of drug substance
closure system and stability studies of drug product alongwith
chromatograms
dissolution profile brand leader that is Robitussin Dry Cough Oral Solution by
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
Brentford, TW8 9GS, U.K. UK MHRA Approved by
performing Patalibility test, quality tests (appearance,
Identification, Assay, pH, specific gravity, Viscosity, related
substance, Microbial Limits of dosage form).
Analytical method validation/verification of Method verification studies have submitted including system
product suitability, specificity, intermediate precision, Detection Limit,
Quantitation Limit, Linearity, Range, Accuracy, Precision.
Manufacturer of API M/s Wockhardt Limited Plot No. 138, GIDC Industrial Estate Ankleshwar-393 002 Gujrat,
India
API Lot No. ETS11515
Description of Pack
(Container closure 120ml Amber Glass Bottle
system)

Frequency Accelerated: 0, 3 & 6 (Months)
Real Time: 0, 3, 6 & 9 (Months)
Batch No. 19PD133DEXT02 (B) 19PD141DMPT03 19PD143DMPT04
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No19041310 issued by Food and Drug
API manufacturer issued by concerned control administration Gandhinagar, Gujrat Stat, India valid till
regulatory authority of country of origin. 17/04/2022.
3. Documents for the procurement of API with Firm has submitted copy of invoice (invoice# 100019308)
approval from DRAP (in case of import). Dated: 23-08-2018 cleared by DRAP Karachi office dated 31-
08-2018 specifying import 200Kg Dextromethorphan
Hydrobromide (Batch# ETS11515-).
testing
1. 1.3.5 (c) GMP inspection report/ GMP certificate of Submitted cGMP certificate on the basis of
the manufacturing unit issued within the evaluation conducted on 12-02-2019 and valid for
last three years shall be submitted. 2 years.
2. 2.3.S.2.1 Name, address of API manufacturer This was a typographical error, corrected in
(a) Shangai china mentioned . while in section attached QOS
1.6.5 Wockhardt Limited mentioned.
Clarification is required in this regard.
3. 2.3.P.2.4 Dapazin tablet mentioned. Clarification is This was a typographical error, corrected in
required in this regard. attached QOS
4. 2.3.P.3.2 Batch size mentioned is 500000 bottles There was a typographical error.
while in 3.2.P.2 3000 liter mentioned For Liquid dosage form, we use both batch size
3000 Liter and 6000 Liter.
Whereas for this product, our intended batch size
is 6000 liter or (50,000 bottle of 120ml)
Corrected in attached QOS

5. 2.3.P.8.1 Batch size mentioned is 2500 bottles while Al three trial batch size are of 5 Liter. Corrected
batch size mentioned in 2.3.P.5.4 is 5liter. in attached QOS
6. 2.3.R.1.1 Provide copy of Batch Manufacturing Trial batches record are attached
Record (BMR) for all the batches of drug
provided in Module 3 section 3.2.P.8.3
7. 2.3.R.1.2 For applications of locally manufactured Draft blank master production document (6000
drug product(s), provide blank master Liter) is attached
production document/ batch manufacturing
record to be used during the commercial
manufacturing of the applied product
8. 2.3.R.2 Provide analytical method validation / Analytical method verification result is provided in
verification results in the table provided in this section.
CTD guidelines in relevant section. Provided in attached QOS
9. 3.2.S.4.1 Copies of the Drug substance specifications We have already provided the same in initial
and analytical procedures used for routine dossier how provided again for your quick
testing of the Drug substance/Active reference
Pharmaceutical Ingredient by Drug Product
10. 3.2.S.4.3 Analytical Method Verification studies Since test for assay, chromatographic condition,
performed by the Drug Product preparation of mobile phase, preparation of
manufacturer of drug substance(s) shall be standard solution are same in the USP monograph
submitted. both i.e. Dextromethorphan HBr (Drug substance)
and Dextromethorphan Hbr Oral Solution
(Finished Drug Product), hence verification of
assay method for API is already cover in finished
product.
Same has been included in scope of protocol for
analytical method verification for
Dextromethorphan Oral Solution.
Verification protocol and reports are attached
documents are attached
11. 3.2.S.7. Real and accelerated Stability studies are of As in 3.2.S.7.3 of API Drug Master file 03
different batches. Justify. batches of both accelerated 40°C ±2, RH 75±5%
and real time 25°C ± 2, RH 60% ±5% is
performed on following batch No.
1. EMS 13050
2. EMS 13090
3. EMS 13104
Whereas API manufacturer has additionally
performed only real time studies in Zone IV-B
i.e. 30°C ± 75% ±5% on following different
batches.
1. EMS 10043
2. EMS 10080
3. EMS 10283
These batches are manufactured on later date and
perform a stability studies on routine that is why
they are batches are different whereas its
accelerated studies were not required to be
performed by API manufacturer, hence not
provided.

12. 3.2.P.1 (b) Provide Reference to excipients quality Revised 3.2.P.1 with addition of excipient
standards (e.g. compendial monographs or specification is enclosed
manufacturer’s specifications)
13. 3.2.P.2.1.1 Compatibility studies of the Drug As innovator used sodium cyclamate in their
Substance(s) with excipients shall be formulation whose usage is banned as per DRAP
provided as the qualitative composition of Circular No. F.286-DRB/2018 (PE&R) dated
the formulation is not similar to innovator / 28th May 2019.
reference product. Sucralose is not included Alternatively we have used sucralose, as
in reference product. sweetener which is not a novel ingredients
moreover during analytical method validation
studies placebo batch was taken and no
interference was observed
During 18 months of stability studies no
interference and no significant change is observed
hence it is presumed that it is compatible with other
ingredient in formulation.
14. 3.2. • As per relevant guidelines & • Pharmaceutical equivalency has already been
P.2.2.1 structure of Form 5F, performed in the pharmaceutical
Pharmaceutical equivalence shall developmental report but upon your request,
be established with the innovator / we have provided you in a separate protocol.
reference / comparator product at In that protocol you can find the same in its
the time of formulation scope heading.
development, while according to • Regarding the Clarification of innovator.
your submitted data, During Development, we have downloaded
Pharmaceutical equivalence have innovator SMPC from emc website when
been performed after commencing marketing authorization was named after
stability studies.i.e 08-03-2020 Pfizer but during filing of CTD dossier Form -
Justification shall be submitted. 5F application, product marketing
• Manufacturer of Innovator product authorization has been revised to GSK by emc
mentioned is Pfizer Consumer as product is transfer from Pfizer to Gsk.
Healthcare (UK) mentioned. While Both old (2019) and new (2021) SMPC is attached
in 1.5.9 Glaxosmithkline is for you reference.
mentioned. Clarification is Same has been confirmed from EMC and GSK,
required. email proof is attached
15. 3.2.P.3.1 Batch size in process validation 6000liter For Liquid dosage form, we use both batch size
while in batch formula 3000 liter. 3000 Liter and 6000 Liter but for this product our
Clarification is required. intended batch size is 6000 Liter or 50,000 Bottle
of 120ml.
Accordingly, batch formula of 6000 Liter is

attached.
16. 3.2.P.3.4 Granules and core tablet mentioned in this There was typographical error. Corrected in
section. attached document
17. 3.2.P.5.3 • As per relevant guidelines & structure Refer to USP chapter <1226> verification of
of Form 5F Analytical test method compendial procedures, where it says Specificity
verification has to be performed at the and system suitability is two key parameter for
time of formulation development, while verification for both substance and product.
according to your submitted data,
Analytical test method verification of In Light of above, system suitability and
Levomethorphan have been performed specificity have been performed in Dec-2019
on 12-11-2020 and Dextromethorphan before commencing stability data as directed in
have been performed on 09-11-2020 above USP chapter. Suitability and specificity
while stability studies started on 12- chromatogram is enclosed hence accuracy has not
2019 and 01-2020. Justification shall be performed but upon your recommendation we
submitted in this regard. have performed accuracy As accuracy along with

• Accuracy was not performed. Justify other necessary parameter whose protocol and
report is attached
18. 3.2.P.8 • Documents for the procurement of • API import license is enclosed
API with approval from DRAP (in • Compliance certificate of HPLC is
case of import). enclosed.
• Compliance Record of HPLC • Both accelerated and real time stability
software 21CFR & audit trail study chamber data is enclosed.
• Record of Digital data logger for
temperature and humidity
monitoring of stability chambers
2nd letter
1. 3.2.S.4.3 Analytical Method Analytical Method Verification studies performed by the Drug
Verification studies performed Product manufacturer of drug substance(s) is submitted.
by the Drug Product
manufacturer of drug
substance(s) shall be
submitted.
2. 3.2.P.8 • Justify that the proposed • The selected batch size of stability batches was 5000ml,
batch size yielded enough that yielded 40 bottles of 120ml, those are sufficient for
number of Units to test for complete course of stability studies at both storage
complete the long term conditions i.e Accelerated and long term.
stability studies (till No of Bottles Required for Stability
claimed shelf life) and
accelerated stability studies Initial 3M 6M 9M 12M 18M 24M
till 6 month as per testing
submitted Stability studies A L A L
protocol. C T C T
• Documents for the 4 3 3 3 4 3 3 3 4
procurement of API with
approval from DRAP
submitted license is of 01-
Total No of 30
09-2020 and moreover,
Bottles
commercial invoice is not
• Commercial invoice submitted
submitted.
170. Name, address of Applicant / Marketing Hansel Pharmaceuticals (Pvt.) Ltd. Plot No.2, Pharma City, 30
Authorization Holder km, Multan Road-Lahore.
Name, address of Manufacturing site. Hansel Pharmaceuticals (Pvt.) Ltd. Plot No.2, Pharma City, 30
km, Multan Road-Lahore.
☐ Importer

☐ Export sale
Lynex 500mcg Tablet
name
Pharmaceutical ingredient (API) per unit Lynestrenol BP…………….. 500mcg
Pharmaceutical form of applied drug White round tablet
Pharmacotherapeutic Group of (API) Contraceptive / Birth Control
Reference to Finished product specifications Hansel Specifications
The status in reference regulatory authorities Exlutena 500mcg Tablet
Marketing Authorization Holder: Merck Sharp & Dohme BV
Approval Authority / Country: Sweden
For generic drugs (me-too status) Brand Name: Minipyl 500mcg Tablet
Active Pharmaceuticals Ingredients (API): Lynestrenol BP
API unit dose weight: 500mcg
Reg. No. 081463
GMP status of the Finished product Renewal of GMP certificate issued on dated 10/10/2019
manufacturer Tablet (Hormone) section approved.
Name and address of API manufacturer. ASG BIOCHEM PVT. LTD. West Bengal
general properties, solubility’s, physical form, manufacturers,
Module III (Drug Substance) Official monograph of Lynestrenol is present in BP. The firm as
submitted detail of nomenclature, structure, general properties,
solubility’s, physical form, manufacturers, description of
manufacturing process and controls, tests for impurity D, G &
related substances (impurity A & unspecified), specifications,
Batches: (LX-0001, LX-0002, LX-0003)

dissolution profile brand leader that is Minipyl 500mcg tablet by Zafa
Pharmaceuticals by performing quality tests (Identification,
Assay, Dissolution, and Uniformity of dosage form).
CDP has been performed against the same brand that is Minipyl
500mcg tablet by Zafa Pharmaceuticals in Acid media (pH 1.0-
1.2) & Phosphate Buffer (pH 6.8). The values for f1 and f2 are
in the acceptable range.
Manufacturer of API ASG BIOCHEM PVT. LTD.
API Lot No. LNZ01A024
Description of Pack
Alu-PVC blister packed in unit carton (1×28’s)
Batch No. LX-0001 LX-0001 LX-0001
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of DML certificate DL-1571-M &DL-802-MB issued by
API manufacturer issued by concerned Government of west Bengal Directorate of Drug control Health
regulatory authority of country of origin. & family welfare Department valid till 24-10-2024.
3. Documents for the procurement of API with Copy commercial invoice (Invoice# EXP-LNZ-02-1918 )
approval from DRAP (in case of import). Dated: 18-12-2018 with received quantity i.e. 20 gm) of
Lynestrenol Batch No# LNZ01A024 with attestation of DRAP
Lahore dated:06-01-2019.
chromatograms,
etc.

1. 1.3.5. Provide Evidence that Tablet Hormone Section approval letter and detail of already
section is steroidal or non steroidal section registered products to justify that tablet Hormone
section is steroidal.
2. 1.6.5 Valid Good Manufacturing Practice DML certificate of API manufacturer issued by
(GMP) certificate of the Drug Substance concerned regulatory authority of country of origin.
manufacturer issued by relevant
regulatory authority of country of origin
3. 2.3.R.1.1 • In batch manufacturing Potency of • In batch manufacturing potency of API use is
API is adjusted on dried basis of (99.98% on as is basis by potentiometric
assay. Clarification is required. titration method. Whereas on ODB Assay of
• In stability batch production Overage API is 100.42% after adjusting LOD i.e 0.44%
is used. Clarification is required. (Limit B.P Max 0.5%). Difference in Assay on
both as is basis and ODB is less than 1% (i.e
0.44%), so impact on results of stability batches
is almost negligible Certificate of API by Drug
product manufacturer is attached.
• In stability batch production 2% Overage is
used to compensate manufacturing losses due
to small batch sizes. We will closely monitor
4. 2.3.R.1.2 For applications of locally manufactured Blank master production document
drug product(s), provide blank master / batch manufacturing record to be used during the
production document commercial manufacturing of the applied product is
/ batch manufacturing record to be used attached.
during the commercial manufacturing of
the applied product
5. 2.3.R.2 Provide analytical method validation / Submitted
verification results in the table given in the
guidelines.
6. 3.2.S.4.1 Copies of the Drug substance Copies of the Drug substance specifications of the
specifications of the Drug substance Drug substance /Active Pharmaceutical Ingredient
/Active Pharmaceutical Ingredient by by Drug Product manufacturer is attached.
Drug Product manufacturer is required.
7. 3.2.S.4.2 Detailed analytical procedures for the Detailed analytical procedures for the testing of drug
testing of drug substance by Drug Product substance by Drug Product manufacturer is
manufacturer shall be provided. attached.
8. 3.2.S.4.3 Provide by which method assay is Assay verification of Active pharmaceutical
performed as Verification studies are done ingredient is done by Potent23iometric titration.
by HPLC.
9. 3.2.P.3.4 Tests and acceptance criteria shall be Critical steps identified in the manufacturing
provided (with justification, including process, to ensure that the process is controlled is
experimental data) performed at the attached.
critical steps identified in 3.2.P.3.3 of the
manufacturing process, to ensure that the
process is controlled.
10.3.2.P.3.5 Sampling plan is not described in process Submitted
validation protocol
11.3.2.P.5.2 Content uniformity not included however Drug product (Lynex 500mcg Tablet) is non-
part of specification. Clarify. Pharmacopeia and weight variation was with in
tolerance limit due to small batch size of stability
product. So we will make assure to perform content
uniformity in commercial batches.
12.3.2.P.5.3 Concentration of Standard preparation is 0.1mg/ml concentration of standard preparations is a
0.1mg/ml While in Precision and typographical mistake. It is also 0.05mg/ml as use in

Accuracy 100% concentration is 0.05% precision and Accuracy. Analytical method
concentrations. Clarification is required. validation attached.
13.3.2.P.5.4 You have not performed uniformity of Drug product (Lynex 500mcg Tablet) is non-
dosage unit by content uniformity, as Pharmacopeia and weight variation was with in
recommended by USP General Chapter tolerance limit due to small batch size of stability
<905>. Justification shall be submitted in product. So we will make assure to perform content
this regard. uniformity in commercial batches.
Decision: Approved with innovator’s specification.
• Manufacturer shall submit Pharmaceutical Equivalence and Comparative dissolution profile studies
with Innovator product /reference product, before issuance of registration letter.
171. Name, address of Applicant / Marketing The Searle Company Limited
Authorization Holder F-319, S.I.T.E., Karachi, Pakistan.
Name, address of Manufacturing site. The Searle Company Limited
F-319, S.I.T.E., Karachi, Pakistan.
☐ Importer
☐ Export sale
PKR 25,000/-: dated 22/06/2021
Torib 120mg Tablets
name
Strength / concentration of drug of Active Each Film coated tablet contains:
Pharmaceutical ingredient (API) per unit Extoricoxib……………...120mg
Pharmaceutical form of applied drug Pale green color, biconvex, almond shaped, film coated tablets,
engraved SEARLE on one side and plain from other side.
Pharmacotherapeutic Group of (API) Selective Cyclooxygenase-2 (COX-2) Inhibitor
Reference to Finished product specifications In-House
The status in reference regulatory authorities Approved by MHRA and marketed in UK, with the name of
ARCOXIA Tablets
Name and address of API manufacturer. Etoricoxib:
Manufacturer: Kekule pharma limited.

Reg Office Address: A-4, Madhura Nagar, S.R. Nagar,
Hyderabad-500 038, Telangana, INDIA
Factory: MIA, Khazipally, Jinnaram Mandal, Sangareddy – 502
319, T.S. India
Module III (Drug Substance) Etoricoxib has In-House Specifications. The firm as submitted
detail of nomenclature, structure, general properties, solubilities,
process and controls, tests for impurity D, G & related
substances (impurity A & unspecified), specifications, analytical
Etoricoxib
Batches: [ACE-3 (I) 160034, ACE-3 (I) 160035, ACE-3 (I)
160036]
dissolution profile brand leader that is Arcoxia 120mg Tablet, MHRA approved by
performing quality tests (Identification, Assay, Dissolution,
CDP has been performed against the same brand that is Arcoxia
120mg Tablet, MHRA in Acid media (pH 1.2) & Phosphate
Buffer (PH 4.5) And (pH 6.8). The values for f1 and f2 are in the
acceptable range.

Manufacturer of API Etoricoxib: Manufacturer: Kekule pharma limited.
Reg Office Address: A-4, Madhura Nagar, S.R. Nagar, Hyderabad-500 038, Telangana,
INDIA
Factory: MIA, Khazipally, Jinnaram Mandal, Sangareddy – 502 319, T.S. India
API Lot No. ACE 10116
Description of Pack
Alu-Alu blister packed in unit carton

Frequency Accelerated: 0, 2, 4, 6 (Months) Real Time: 0,3, 6, (Months)
Batch No. 18PD-240 18PD-240 18PD-240
Manufacturing Date 10-2018 Oct 2018 Oct 2018
Date of Initiation 11- 2018 Oct 2020 Oct 2020
No. of Batches 03
applications with stability study data of the “Tapendol Tablets 50mg, 75mg & 100mg” which was presented
firm (if any) in 289th meeting of Registration Board wherein the Board
Date of inspection: 11th March, 2019.
According to inspection report, following points were confirmed.
•The firm has 21CFR compliant HPLC software.

•The firm has audit trail reports available.
•Adequate monitoring and control are available for stability
chamber
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No (L. is.No.1772/E1/2019) issued by
API manufacturer issued by concerned Drugs control administration Telangana (DCA) valid until
regulatory authority of country of origin. 18.09.2022.
3. Documents for the procurement of API with Copy commercial invoice (Invoice# KPL/EXP/089/2016-17
approval from DRAP (in case of import). Dated: 11-11-2016 with received quantity i.e. 2.5 kg) of
Etoricoxib Batch No# ACE 10116 with attestation of DRAP
Karachi dated:24-11-2016.
S.No Section Shortcomings Communicated
1. 2.3.R.1.2 For applications of locally manufactured Attached
drug product(s), provide blank master
production document
/ batch manufacturing record to be used
the applied product
2. 3.2.P.2.2.1 You have applied Paddle speed = 100 rpm • This is happened due to some
in dissolution parameters Pharmaceutical typographical error
equivalence You are advised to justify the • Revised dissolution parameters in
speed of paddle apparatus with reference Pharmaceutical equivalence submitted
to USP general chapter <1092> (The with change of paddle speed 75rpm
Dissolution Procedure; Development and without any justification.
Validation).

3. 3.2.P.4.5 Excipients of Human or Animal Origin Magnesium stearate used in applied formulation is
shall be addressed for the use of not Human and Animal origin. Certificate of
“Magnesium stearate” in the applied absence of TSE & BSC submitted.
formulation.
4. 3.2.P.5.2 Justify dissolution acceptance criteria This in reference to query dissolution acceptance
NLT 75% in 60 min with dissolution criteria NLT 75% in 60 mins with dissolution
medium Sodium Acetate buffer pH 4.5 medium sodium acetate buffer ph 4.5 while
while dissolution specifications of dissolution specification of innovator is NLT Q in
innovator is NLT Q in 15 min with 15 mins with dissolution medium of 0.1N HCl.
dissolution medium 0.1N HCl Due to un-availability of monograph for
Etoricoxib and there is no reference is available
publicly. We, The Searle Company Ltd selected the
time point i.e 60 mins & NLT 75%Q by following
the guidance from the USP general chapter <1092>
having title “The Dissolution Procedure
Development & Validation”: which states that, “
for immediate release dosage form which contains
API has low solubility, the duration of the
dissolution procedure is typically 30 to 60mins”
and Etoricoxib belongs to class II under BCS due
to its low aqueous solubility.
Furthermore, we have revised the dissolution
method as per innovator specification i.e duration
15 mins, apparatus II, 75RPM and 0.1N HCl
dissolution medium after query response of
Etoricoxib Tablets 30 & 90mg and product update
as per new proposed dissolution method.
5. 3.2.P.8 Reference of previous approval of Attached.

the firm (if any)
• Firm shall submit fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as per
• Registration Board directed the firm to submit dissolution testing data with specifications of “NLT Q
within 15 minutes” at initial and one-month time point at both accelerated and real time stability
conditions for 2 batches, before issuance of registration letter.
application.
b. Deferred cases of Form 5-F

172. Name, address of Applicant / Marketing M/s. SAMI Pharmaceuticals (Pvt.) Ltd. F-95, Off Hub River
Authorization Holder Road, S.I.T.E. Karachi.
Name, address of Manufacturing site. M/s Sami Pharmaceuticals (Pvt) Ltd. F-95, Off Hub River Road,
S.I.T.E. Karachi.
☐ Importer

☐ Export sale
The proposed proprietary name / brand name TEDIZ 200mg Tablets
Pharmaceutical ingredient (API) per unit Tedizolid Phosphate MS ……….200mg
Innovator’s Specs.
Pharmaceutical form of applied drug Yellow color, capsular shaped, film coated tablet, with SAMI
engraved on one side and plain on the other side
Pharmacotherapeutic Group of (API) Antibacterial for systemic use, other antibacterial
Proposed Pack size 6’s, 10’s, 12’s & 20’s
The status in reference regulatory authorities SIVEXTRO 200mg film-coated tablets Mfr. By M/s Merck
Sharp & Dohme B.V
GMP status of the Finished product GMP Certificate issued date 11-08-2020 on the basis of
manufacturer inspection conducted on 28-08-2019
Name and address of API manufacturer. Chongqing Kangle Pharmaceutical Co., Ltd.
Address: No. 4 Huazhong Road, Chongqing (Changshou)
Chemical Industries Park, Chongqing, China 401221
of drug substance. Firm has submitted data of drug product
development, manufacture, manufacturing process and process
control, process validation protocols, control of excipients,
nomenclature, structure, general properties, solubility, physical
of drug substances.
Stability studies Firm has submitted 6 months accelerated and 24 months real
time stability data of 3 batches of API as per Zone IVA

Pharmaceutical equivalence and comparative Firm has not performed Pharmaceutical equivalence and
dissolution profile comparative dissolution profile .
product accuracy, precision, robustness, specificity.
Manufacturer of API Chongqing Kangle Pharmaceutical Co., Ltd.
Address: No. 4 Huazhong Road, Chongqing (Changshou) Chemical Industries Park,
Chongqing, China 401221
API Lot No. ASC003-OR-191201
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0, 1,2,3,4, 6 (Months)
No. of Batches 03
with stability study data of the firm (if any) “EMPOLI (Empagliflozin) 10mg & 25mg Tablets” which was
presented in 290th meeting of Registration Board wherein the
Board decided to approve registration of this product
Date of inspection: 13th June, 2019.
confirmed.

chamber
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. CQ20190054 issued by China food
manufacturer issued by concerned regulatory and Drugs Administration valid till 25/11/2024
3. Documents for the procurement of API with Firm has submitted copy of invoice specifying import of 1000gm
approval from DRAP (in case of import). of Tedizolid Phospahte (Batch # ASC003-OR-191201). (invoice
# ASC-SAMI19121101) attested by AD (I&E), Karachi dated
20-01-2020

attested respective documents like Firm has submitted complete record of testing of all batches
chromatograms, along with chromatograms, raw data sheets, COA and summary
Raw data sheets, COA, summary data sheets data sheets.
etc.
5. Compliance Record of HPLC software 21CFR Firm has submitted audit trail record of product testing of HPLC
& audit trail reports on product testing for all test intervals.
and humidity monitoring of stability chambers and humidity monitoring of real time and accelerated stability
S.N Section Shortcomings Communicated Reply
o
1. 1.5.15 – Commitments are not signed Signed commitments attached
1.5.20
2. 3.2.S.4 In COA’s residual solvents test limits The limit of Acetone is same in both COA’s of API
of Acetone is greater of Drug product provided by DP manufacturer and DS manufacturer
manufacturer than Drug substance (NMT 0.5%).
manufacturer. Clarification is
required.
3. 3.2.P.2.2.1 Pharmaceutical equivalence is not Pharmaceutical Equivalence against the innovator
performed product cannot be performed due to its unavailability
in Pakistan. Although, we have considered and
ensured the following parameters which gives the
confidence that in-vitro parameter of our product is
comparable with the innovator;
1) Formulation of our product is qualitatively similar
to that of innovator.
2) Dissolution method adopted as per FDA review of
innovator product and also set the tighter acceptance
criteria of NLT 80% (Q) in 20 minutes.
Previous Decision: Deferred for Performance of Pharmaceutical Equivalence and CDP by Drug product manufacturer.
(M-313)
Firm Response:
In this regard we have to humbly state as under:
• As per DRAP advice, we obtained a NOC from DRAP Karachi for procuring Sivextro (Tedizolid Phosphate)
200mg Tablet for conducting Comparative studies.
• We contacted several online Pharmacies as per list attached with full evidence but unfortunately none responded
favourable.
• Having failed to obtain the Originator’s sample we developed the product as per Innovator formulation and
specifications from the FDA chemistry review and other authorities published data of Innovator.
In view of the above, it is humbly requested that the condition of CDP against Innovator’s product may kindly be waived
off and consider our application for a favourable decision in the next upcoming meeting of the Registration board.
Decision: Registration Board decided to defer the case for submission of Pharmaceutical Equivalence and CDP
studies against Innovator /reference product.

b. Deferred cases
173. Name and address of manufacturer / M/s GT Pharma Pvt Ltd.
Applicant 23km, Raiwind Road, Lahore
Brand Name +Dosage Form + Strength GT-CIP 125mg Suspension
Ciprofloxacin (as taste mask granules 35%)…125mg
Diary No. Date of R& I & fee Dy.No 5306 dated 14-02-2018 Rs. 20,000/- Dated 14-02-2018

Type of Form Form 5
Finished product Specifications Manufacturer specifications
Approval status of product in Cipro 250mg/5ml of USFDA approved
Reference Regulatory Authorities
Me-too status (with strength and Novidate 125mg/5ml Dry Suspension by M/s Sami
dosage form) Pharmaceuticals
GMP status cGMP certificate on the basis of Evaluation conducted on 13-10-
2021
Previous remarks of the Evaluator. • GMP certificate of source of granules not provided
• Stability study of 3 batches of granules not provided
• Certificate of analysis of granules not provided.
• Clarify it is ciprofloxacin HCl granules or only ciprofloxacin
Previous decision(s) Deferred for following reasons:
Deferred for source of granules, along with stability studies data,
GMP certificate of supplier and differential fee in case of import of
granules. (M-295)
Evaluation by PEC • Source of granules: Vision Pharmaceuticals
• GMP certificate of source of granules provided
• Stability study of 3 batches of granules provided
• Certificate of analysis of granules provided.
• It is ciprofloxacin base granules 35% used.
Decision: Approved with USP specifications. Diluent shall be as per innovator’s composition.
174. Name and address of manufacturer / M/s Aries Pharmaceuticals.
Applicant 1-W, Industrial Estate, Hayatabad, Peshawar, k.p.k
Brand Name +Dosage Form + Strength Levon Tablet 0.75mg
Levonorgestrel…0.75mg
Diary No. Date of R& I & fee Dy.No 5884 dated 11-02-2019 Rs.20,000/- Dated 11-02-2019
Pharmacological Group Hormonal contraceptives for systemic use
Finished product Specifications BP
Approval status of product in WHO recommended formulation
Me-too status (with strength and Morning Pill Tablet by M/s OBS
dosage form)
GMP status Last GMP inspection conducted on 20-07-2019 and report
concludes that as per findings of the inspection recorded on cGMP
audit proforma and keeping in view the overall cGMP compliance
status of the firm in terms of plant, premises, manufacturing, quality
control, environmental facilities provided, documentation, qualified
staff employed, validation and calibration record evaluation, the
panel unanimously recommended the grant of cGMP certificate to
the firm.
Previous remarks of the Evaluator. The firm change formulation from film coated tablet to uncoated
tablet with submission of fee of Rs. 5000/- (deposit slip # 1984264).
Tablet Hormone section available but not clear Steroidal Hormonal
Tablet Section or non Steroidal Hormonal Tablet Section

Deferred for confirmation of required manufacturing facility /
section from Licensing Division. (M-295)
Evaluation by PEC Firm submitted renewal of Drug manufacturing License In which
Tablet (steroidal Hormone) mentioned.
Decision: Approved.
175. Name and address of manufacturer / M/s Venus Pharma, 23 Km, Multan Road, Lahore
Applicant
Brand Name +Dosage Form + Strength Tramacet
Tramadol Hydrochloride ………….. 37.5mg
Paracetamol ………….. 325mg
Diary No. Date of R& I & fee Dy. No. 1394 R&I Rs. 20,000/- Dated 05-03-2015
Pharmacological Group Analgesic
Finished product Specifications Manufacturers specifications
Pack size & Demanded Price Price: 250/- 10’s
Approval status of product in Not found
Me-too status (with strength and Not found
dosage form)
GMP status
Deferred for confirmation of formulation in reference drug
agencies. (M-249)
Evaluation by PEC:
Now firm change formulation from Capsule to tablet with submission of fee of RS: 20000/- Dated:29-04-2021
Deposit slip #2060244
Brand Name +Dosage Form + Strength Tramacet Tablet 37.5mg+325mg
Composition Each film coated contains:
Diary No. Date of R& I & fee Dy. No. 12674 Dated:29-04-2021
Type of Form Form-5
Approval status of product in Tramacet tablet of (MHRA approved)
Me-too status (with strength and Radol-P tablet of M/s Regal Pharmaceuticals
dosage form)
GMP status Certificate of current Good manufacturing practices on the basis of
evaluation conducted on 05-09-2019
Each film coated contains:
Applicant
Brand Name +Dosage Form + Strength Hefrid - 50
Itopride Hydrochloride ………….. 50mg
Pharmacological Group Gastroprokinetic

Approval status of product in Not found
dosage form)
GMP status
agencies. (M-249)
Evaluation by PEC:
Brand Name +Dosage Form + Strength Hefrid Tablet 50mg
Itopride as Hydrochloride ………….. 50mg
Type of Form Form-5
Approval status of product in Ganaton of M/s Abbott Laboratories (PMDA) Japan
Reference Regulatory Authorities Approved
Me-too status (with strength and Itop 50mg Tablet by M/s Nexus.
dosage form)
Decision: Approved with innovator’s specification as per following label claim:
Itopride as Hydrochloride ………….. 50mg
Applicant
Brand Name +Dosage Form + Strength Colax
Thiocolchicoside …………. 4mg
Pharmacological Group Skeletal Muscle Relaxant
Approval status of product in Authorized by national procedures in several EU Member States
Reference Regulatory Authorities (Czech Republic, France, Greece, Hungary, Italy, Malta, Portugal
and Spain)
Me-too status (with strength and Thiocol M/s Ray Pharma
dosage form)
GMP status
agencies. (M-249)
Evaluation by PEC:
Brand Name +Dosage Form + Strength Colax Tablet 4mg

Composition Each Tablet contains:
Type of Form Form-5
Approval status of product in THIOCOLCHICOSIDE EG 4 mg, scored tablet. ANSM
Reference Regulatory Authorities France approved.
Me-too status (with strength and Myolax Tablets 4mg by M/s Reko Pharma Reg. No. 74170
dosage form)
Each Tablet contains:
178. Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd.
Applicant Plot No. 206 & 207. Industrial Triangle, Kahuta
Road, Islamabad
Brand Name +Dosage Form + Strength Lemoxol Forte Tablet
Artemether…80mg
Lumefantrine…480mg
Diary No. Date of R& I & fee Dy.No. 12695 dated 06-03-2019 Rs.20,000/- Dated 05-03-2019
Pharmacological Group Anti-malarial
Type of Form Form-5
Finished product Specifications International Pharmacopoeia
Pack size & Demanded Price 4’s, 6’s : As per SRO
Approval status of product in WHO prequalified
Me-too status (with strength and Artem Ds Plus Tablet by M/s Hilton
GMP status GMP certificate issued on the basis of inspection dated: 12-08-2020
Deferred for consideration on its turn. (M-296)
Remarks of the Evaluator.
Decision: Approved.
Road, Islamabad
Brand Name +Dosage Form + Strength Rota-12 1000mcg Injection
Composition Each ml Ampoule Contains:
Cyanocobalamin…1000mcg
Pharmacological Group Vitamin b12
Type of Form Form 5
Pack size & Demanded Price 1ml x 100’s: As per SRO
Approval status of product in Cytamen Injection 1000mcg Of (MHRA
Reference Regulatory Authorities Approved)
Me-too status (with strength and Cyfort Injection M/s Swiss Pharma
dosage form)

Decision: Approved.
Road, Islamabad
Brand Name +Dosage Form + Strength Feripro 500mg Tablet
Deferiprone…500mg
Pharmacological Group Iron Chelating Agent
Type of Form Form 5
Finished product Specifications Manufacturer specification
Approval status of product in FERRIPROX Of (USFDA Approved)
Me-too status (with strength and Proxifer 500mg Tablets of M/s Nabiqasim
dosage form) Industries ( Reg # 045032)
Road, Islamabad
Brand Name +Dosage Form + Strength Benmox 100mg/5ml Liquid Suspension
Mebendazole…100mg
Pharmacological Group Anthelmintics
Type of Form Form 5
Pack size & Demanded Price 30ml:: As per SRO
Approval status of product in Vermox 100 mg/5 ml oral suspension of MHRA approved
Me-too status (with strength and Mebizin Suspension of M/s Shrooq Pharmaceuticals
dosage form)
Decision: Approved.
Road, Islamabad
Brand Name +Dosage Form + Strength V-Gil 100mg Tablet
Composition Each Uncoated Tablet Contains:
Modafinil…100mg

Pharmacological Group Psychostimulants, agents used for adhd and
nootropics (Centrally acting sympathomimetics)
Type of Form Form 5
Approval status of product in Modafinil 100 mg tablets of MHRA approved
Me-too status (with strength and Monalert 100mg Tablet of M/s Hilton Pharma Reg # 047170)
dosage form)
Decision: Approved.
Road, Islamabad
Brand Name +Dosage Form + Strength V-Gil 200mg Tablet
Modafinil…200mg
Pharmacological Group Psychostimulants, agents used for adhd and
nootropics (Centrally acting sympathomimetics)
Type of Form Form 5
Approval status of product in Modafinil 200 mg tablets of MHRA approved
Me-too status (with strength and Monalert 200mg Tablet of M/s Hilton Pharma (Reg # 047171)
dosage form)
Decision: Approved.
Road, Islamabad
Brand Name +Dosage Form + Strength Vmax 250mg Tablet
Penicillamine……250mg
Pharmacological Group Anti-rehumatic
Type of Form Form 5
Finished product Specifications JP
Approval status of product in Penicillamine 250 mg film-coated tablets of MHRA approved
Me-too status (with strength and Penicillamine 250mg Tablet of M/s Medisure
dosage form) Lab Reg no # 083907

Decision: Approved.
Road, Islamabad
Brand Name +Dosage Form + Strength V-Fox Tablet
Venlafaxine as Hcl…37.5mg
Pharmacological Group Anti-depressant
Type of Form Form 5
Pack size & Demanded Price 10’s,: As per SRO
Approval status of product in EFFEXOR of (USFDA approved)
Me-too status (with strength and Venlor-37.5 Tablets of M/s Genome
Decision: Approved.
Road, Islamabad
Brand Name +Dosage Form + Strength Ropim 1mg Tablet
Ropinirole as HCl…1mg
Pharmacological Group Anti-Parkinson/ Dopamine agonist
Type of Form Form 5
Pack size & Demanded Price 10’s, 21’s; As per SRO
Approval status of product in REQUIP of USFDA approved
Me-too status (with strength and Ronirol 1mg Tablets of M/s Hilton Pharma
dosage form)
Decision: Approved.
Road, Islamabad
Brand Name +Dosage Form + Strength Klovir 800mg Tablet
Acyclovir ……800mg
Pharmacological Group Antiviral
Type of Form Form 5

Pack size & Demanded Price 10’s, 20’s, 25’s ; As per SRO
Approval status of product in Aciclovir 800 mg Tablets of MHRA approved
Me-too status (with strength and Virocyc Tablets of M/s Global Pharmaceuticals
dosage form)
Decision: Approved.
188. Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd. Plot No. 206 & 207. Industrial Triangle,
Applicant Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Bosnim 62.5mg Tablet
Bosentan Monohydrate Eq. to Bosentan ……62.5mg
Pharmacological Group Endothelin Receptor Antagonist
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, ; As per SRO
Approval status of product in Tracleer of USFDA approved
Me-too status Bozpah 62.5mg Tablet of M/s Nabiqasim
Brand Name +Dosage Form + Strength Donil 5mg Tablet
Donepezil HCl…5mg
Pharmacological Group Anticholinesterases
Type of Form Form-5
Approval status of product in Donepezil Hydrochloride 5 mg film-coated tablets of MHRA
Me-too status Remembrin Tablets by PharmEvo (Reg. No# 045401)
Decision: Approved with change of brand name
Brand Name +Dosage Form + Strength Donil 10mg Tablet

Donepezil Hcl…10mg
Pharmacological Group Anticholinesterases
Type of Form Form-5
Approval status of product in Donepezil Hydrochloride 10 mg film-coated tablets of MHRA
Me-too status Remembrin Tablets by PharmEvo (Reg. No# 045402)
Decision: Approved with change of brand name
Brand Name +Dosage Form + Strength Arbex 150mg Tablet
Irbesartan…….150mg
Pharmacological Group Angiotensin-II receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 28’s ; As per SRO
Approval status of product in Aprovel 150 mg film-coated tablets of (MHRA approved)
Me-too status Irbest Tablets 150mg of M/s. Highnoon Laboratories,
Decision: Approved.
Brand Name +Dosage Form + Strength Arbex 300mg Tablet
Irbesartan…….300mg
Pharmacological Group Angiotensin-II receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 28’s; As per SRO
Approval status of product in Aprovel 300 mg film-coated tablets of (MHRA
Reference Regulatory Authorities approved)
Me-too status Irbest Tablets 300mg of M/s. Highnoon Laboratories,
Decision: Approved.

Brand Name +Dosage Form + Strength Arbex D 300/12.5 mg Tablet
Composition Each Film Caoted Tablet Contains:
Irbesartan…300mg
Hydrochlorothiazide…12.5mg
Pharmacological Group Angiotensin receptor blockers/diuretics
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 28’s : As per SRO
Approval status of product in AVALIDE of ( USFDA approved)
Me-too status (with strength and Irbest Plus Tablets of M/s Highnoon Laboratories
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Ornex 3g Sachet
Composition Each Sachet Contains:
L-Ornithine-L-Aspartate…3gm
Pharmacological Group Hepatoprotectant
Type of Form Form 5
Approval status of product in Hepa-Merz Sachet containing ornithine aspartate
Reference Regulatory Authorities (granules for solution). AGES approved
Me-too status Couthy 3gm Sachet of M/s Martin Dow
Previous remarks of the Evaluator. Reference product contains granules while applied
product contain powder. Now firm change form 5 and formulation
with granules.
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in composition
(correction/change of formulation from powder to granules), as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Strength Fenak 500mg Tablet
Mefenamic Acid…500mg
Type of Form Form 5
Pack size & Demanded Price 100’s, 200’s: As per SRO
Approval status of product in Ponstan Forte Tablets 500mg of MHRA approved

Me-too status (with strength and Genston 500mg Tablets of M/s Genome
Previous remarks of the Evaluator. • The firm change formulation from uncoated to film coated
with submission of fee of RS: 5000/- Deposit slip no #
2017949, Dated: 03-08-2020
Decision: Approved with BP specification.
Brand Name +Dosage Form + Strength Rivarox 15mg Tablet
Rivaroxaban…15mg
Pharmacological Group Anticoagulant
Type of Form Form 5
Finished product Specifications Manufacturer,s specification
Pack size & Demanded Price 14’s, : As per SRO
Approval status of product in Xarelto 15mg tablet Of ( USFDA Approved)
Me-too status Xarelto 15mg Tablet Of M/S Bayer
Road, Islamabad
Brand Name +Dosage Form + Strength Rovi 5mg Tablet
Rosuvastatin as Calcium Salt…5mg
Pharmacological Group HMG CoA reductase inhibitor/Antihyprlipidemic
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s: As per SRO
Approval status of product in CRESTOR tablet of (USFDA approved)
Me-too status (with strength and RosuBar 5mg Tablet by M/s Barrett Hodgson
dosage form)
Decision: Approved with USP specification.

Brand Name +Dosage Form + Strength Silrex 1% Cream
Composition Each Gram Contains:
Silver Sulphadiazine…10mg
Pharmacological Group Antibiotic for topical use
Type of Form Form 5
Pack size & Demanded Price 10gm, 15gm, 20gm, 25gm, 30gm,50gm, 250gm,
500gm,: As per SRO
Approval status of product in Silvadene Cream of (USFDA approved)
Me-too status Quench cream of M/s Ferozesons
Decision: Approved.
195. Name and address of manufacturer / M/s Medimarker's Labortaries Pvt Ltd
Applicant A-104, S.I.T.E Area, Hyderabad
Brand Name +Dosage Form + Strength Megenta Drops 0.3%
Gentamycin as sulphate…0.3% w/v
Diary No. Date of R& I & fee Dy.No. 12247 dated 06-03-2019 Rs.20,000/- Dated
05-03-2019
Pharmacological Group Aminoglycoside Antibiotic
Type of Form Form-5
Pack size & Demanded Price 5ml, 7.5ml & 10ml; /As per SRO
Approval status of product in Genoptic of USFDA approved
Me-too status (with strength and Ocugent 0.3% 5ml & 10ml Drops of M/s Farmigea
GMP status Last GMP inspection of conducted on 16-10-2018
and the report concludes that the panel unanimously
recommend the grant of renewal DML
Previous remarks of the Evaluator. Eye and Ear drop section available
Brand Name +Dosage Form + Strength Volden-M 50mg/200mcg Tablet
Composition Each Delayed Release Tablet Contains:
Diclofenac Sodium…50mg
Misoprostol…200mcg
05-03-2019

Pharmacological Group NSAID along with mucoprotective
Type of Form Form-5
Pack size & Demanded Price 20’s / As per SRO
Approval status of product in Arthrotec of USFDA Approved
Me-too status (with strength and Dipros 50 Tablet by Helix (Reg. No#076456)
dosage form)
Previous remarks of the Evaluator. • The formulation contains misoprostol 1% HPMC
dispersion and product is approved in
USFDA as delayed release tablet that consists of a gastro
resistant core containing 50mg of diclofenac sodium
surrounded by an outer mantle containing 200mcg
misoprostol along with box warning.
• Firm revise formulation from plain tablet to bilayer
delayed release tablet in line with reference product With
submission of fee of Rs: 5000/- Deposit slip no # 2017947,
dated: 03-08-2020
• For Evidence of bilayer machine firm submitted invoice
from Shanghai Tianhe pharmaceuticals china
Each bi-layered Tablet Contains:
Diclofenac Sodium (as enteric coated core) ….…50mg
Misoprostol (outer mantle) ….…200mcg
(correction/change of formulation from Plain tablet to bilayer delayed release tablet), as per
• Registration letter will be issued after submission IQ, OQ and PQ of bi-layered tablet machine.
Brand Name +Dosage Form + Strength Volden-M 75mg/200mcg Tablet
Composition Each Delayed Release Tablet Contains:
Diclofenac Sodium…75mg
Misoprostol…200mcg
05-03-2019
Pharmacological Group NSAID along with mucoprotective
Type of Form Form-5
Pack size & Demanded Price 20’s / As per SRO
Approval status of product in Arthrotec of USFDA Approved
Me-too status Dipros 75 Tablet by Helix (Reg. No#076456)
Previous remarks of the Evaluator. • The formulation contains misoprostol 1% HPMC
dispersion and product is approved in
USFDA as delayed release tablet that consists of a gastro
resistant core containing 50mg of diclofenac sodium
surrounded by an outer mantle containing 200mcg
misoprostol along with box warning.

• Firm revise formulation from plain tablet to bilayer
delayed release tablet in line with reference product With
submission of fee of Rs: 5000/- Deposit slip no # 2017948,
dated: 03-08-2020
• For Evidence of bilayer machine firm submitted invoice
from Shanghai Tianhe pharmaceuticals china
Decision: Approved.
Each bi-layered Tablet Contains:
Diclofenac Sodium (as enteric coated core) ….…75mg
Misoprostol (outer mantle) ….…200mcg
(correction/change of formulation from Plain tablet to bilayer delayed release tablet), as per
• Registration letter will be issued after submission IQ, OQ and PQ of bi-layered tablet machine.
Brand Name +Dosage Form + Strength Zincom 20mg Tablet
Composition Each Dispersible Tablet Contains:
Zinc Sulphate Monohydrate Eq. to Elemental
Zinc…20mg
Pharmacological Group Antidiarrheal
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s : As per SRO
Approval status of product in WHO prequalified Zincfant Tablet 20 mg manufactured by
Reference Regulatory Authorities Laboratoires Pharmaceutique s Rodael -France
Me-too status Zinxus Tablet of M/s Ferozsons
Decision: Approved.
Case no. 03 Registration applications of newly granted DML or New section (Human)
a. New DML
Enzon Pharma Labs Pvt Ltd, 5 km off Raiwind Manga Road, Lahore
CLB in its 273 meeting held on 15th January 2020 has considered and approved the grant of DML by way of
Formulation. Now firm has applied for following products
199. Name, address of Applicant / Marketing Enzon Pharma Labs Pvt Ltd
Authorization Holder 5 km off Raiwind Manga Road, Lahore
Name, address of Manufacturing site. Enzon Pharma Labs Pvt Ltd
5 km off Raiwind Manga Road, Lahore
☐ Importer

☐ Export sale
Ensol- DS ½ IV Infusion 500mL
name
Strength / concentration of drug of Active Each 100mL contains:
Pharmaceutical ingredient (API) per unit Glucose Anhydrous……….5gm%w/v
Sodium Chloride…….................0.45%w/v
Pharmaceutical form of applied drug Intravenous Injection
Pharmacotherapeutic Group of (API) Other IV Solution Additives
Glucose ATC CODE: V06DC01
Sodium Chloride ATC CODE: A12CA01
Proposed Pack size 500mL
The status in reference regulatory authorities BAXTER 0.45% SODIUM CHLORIDE and 5% GLUCOSE
AHB6028 1000mL injection BP of TGA approved
For generic drugs (me-too status) Sterifluid- DS ½ (Intravenous Infusion BP) of Frontier Dextrose
Ltd. Plot No. 18/3, Phase- 1 Hatter Industrial Estate Haripur
Pakistan (Reg # 342120)
GMP status of the Finished product New DML Approved. Last inspection conducted on 15 & 16-10-
manufacturer 2020 and report concludes that overall evaluation of inspection
report rating is Good
Sodium Chloride:
Nanchang Baiyun Pharmaceutical Co., Ltd
Name and address of API manufacturer. Address: Yangzizhou Forest Farm, Qingshanhu District,
Nanchang city, Jiangxi province, China
Glucose Anhydrous:
Weifang Shengtai Medicine Co., Ltd. The East of Changda Road,
Changle county, Weifang Shandong, China.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO QOS-PD template.
Module III (Drug Substance) Firm has submitted relevant information against the Module III,
including Process validation protocol, Finished product analytical
method validation report & stability studies data of drug substance
Stability studies Sodium Chloride:
Stability study conditions:
Batches: (2871, 2872 and 2873)
Glucose Anhydrous:

Batches: (W20150514, W20150515 and W20150516)
analytical procedure, its verification studies, batch analysis and
Pharmaceutical equivalence and Sterifluid -DS 1/2 Infusion of Frontier Dextrose Ltd Reg # 049285
comparative dissolution profile
Analytical method validation/verification of Method verification studies has been submitted including
product accuracy, precision, specificity and robustness.
Manufacturer of API Sodium Chloride:
Address: Yangzizhou Forest Farm, Qingshanhu District, Nanchang city, Jiangxi
province, China
Glucose Anhydrous:
Weifang Shengtai Medicine Co., Ltd. The East of Changda Road, Changle
county, Weifang Shandong, China.
API Lot No. Sodium Chloride: 20200204
Dextrose anhydrous: 20200427-2
Description of Pack
500mL LDPE bottle w/ Eurocap
Batch No. A B C
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Sodium Chloride:
API manufacturer issued by concerned Copy of DML Certificate (Certificate No# Gan 20110113) for
regulatory authority of country of origin. Nanchang Baiyun Pharmaceutical Co., Ltd
Address: Yangzizhou Forest Farm, Qingshanhu District, Nanchang
city, Jiangxi province, China issued by China Food and Drug
Administration valid upto 03-12-2025 is submitted
Glucose Anhydrous:
Copy of GMP Certificate (Certificate No. # SD20180787) for
Changle county, Weifang Shandong, China issued by China food
& Drug Administration valid up to 14-10-2023 is submitted.

3. Documents for the procurement of API with Glucose Anhydrous:
approval from DRAP (in case of import). Firm has submitted copy invoice (invoice# WFST312 dated: 28-
04-2020 from Weifang Shengtai Medicine Co., Ltd. The East of
Changda Road, Changle county, Weifang Shandong, China cleared
by DRAP Lahore office dated 01-06-2020.
Sodium Chloride:
Firm has submitted copy invoice (invoice# HZA20CS88024)
dated: 17-04-2020 from Hangzhou Zhongbao Imp & Exp.
Corp.Ltd., China, cleared by DRAP Lahore office dated 08-06-
2020
5. Compliance Record of HPLC software NA
testing
accelerated)
Remarks Of Evaluator: In TGA Australia BAXTER 0.45% SODIUM CHLORIDE and 5% GLUCOSE AHB6028
1000mL injection BP of TGA approved in which Glucose anhydrous used pack size of 1000ml available however in
MHRA UK Sodium Chloride 0.45 % w/v and Glucose 5.0 % w/v Solution for Infusion BP available in 500ml but
Glucose as monohydrate used.
Decision: Approved with Euro Cap container closure system.
200. Name, address of Applicant / Marketing Enzon Pharma Labs Pvt Ltd
Authorization Holder 5 km off Raiwind Manga Road, Lahore
Name, address of Manufacturing site. Enzon Pharma Labs Pvt Ltd
5 km off Raiwind Manga Road, Lahore
☐ Importer
☐ Export sale
Ensol- Paed’s IV Infusion 500mL
name
Strength / concentration of drug of Active Each 100mL contains:
Pharmaceutical ingredient (API) per unit Glucose Anhydrous……….4.3%w/v
Sodium Chloride…….................0.18%w/v

Pharmaceutical form of applied drug Intravenous Injection
Pharmacotherapeutic Group of (API) Other IV Solution Additives
Glucose ATC CODE: V06DC01
Sodium Chloride ATC CODE: A12CA01
The status in reference regulatory authorities BAXTER 0.18% SODIUM CHLORIDE and 4% GLUCOSE
500mL injection of TGA Australia approved
For generic drugs (me-too status) Sterifluid- Paed’s (Intravenous Infusion BP) of Frontier Dextrose
Ltd.
Plot No. 18/3, Phase- 1 Hatter Industrial Estate Haripur Pakistan
(Reg # 049286)
GMP status of the Finished product New DML Approved. Last inspection conducted on 15 & 16-10-
manufacturer 2020 and report concludes that overall evaluation of inspection
report rating is Good
Sodium Chloride:
Name and address of API manufacturer. Address: Yangzizhou Forest Farm, Qingshanhu District,
Glucose Anhydrous:
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO QOS-PD template.
Module III (Drug Substance) Firm has submitted relevant information against the Module III,
including Process validation protocol, Finished product analytical
method validation report & stability studies data of drug substance
Stability studies Sodium Chloride:
Batches: (2871, 2872 and 2873)
Glucose Anhydrous:
Batches: (W20150514, W20150515 and W20150516)
analytical procedure, its verification studies, batch analysis and
Pharmaceutical equivalence and Sterifluid -Paed’s Infusion of Frontier Dextrose Ltd Reg # 049286
comparative dissolution profile

Analytical method validation/verification of Method verification studies has been submitted including
product accuracy, precision, specificity and robustness.
Manufacturer of API Sodium Chloride:
Address: Yangzizhou Forest Farm, Qingshanhu District,
Glucose Anhydrous:
API Lot No. Sodium Chloride: 20200204
Glucose Anhydrous: 20200427-2
Description of Pack
500mL LDPE bottle w/ Eurocap
Batch No. A B C
Manufacturing Date 30-07- 30-07-2020 30-07-2020
2020
Date of Initiation 31-07-
31-07-2020 31-07-2020
2020
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Sodium Chloride:
API manufacturer issued by concerned Copy of DML Certificate (Certificate No# Gan 20110113) for
regulatory authority of country of origin.Nanchang Baiyun Pharmaceutical Co., Ltd
Address: Yangzizhou Forest Farm, Qingshanhu District, Nanchang
city, Jiangxi province, China issued by China Food and Drug
Administration valid up to 03-12-2025 is submitted
Glucose Anhydrous:
Copy of GMP Certificate (Certificate No. # SD20180787) for
Changle county, Weifang Shandong, China issued by China food
& Drug Administration valid up to 14-10-2023 is submitted.
3. Documents for the procurement of API with Glucose Anhydrous:
approval from DRAP (in case of import). Firm has submitted copy invoice (invoice# WFST312 dated: 28-
04-2020 from Weifang Shengtai Medicine Co., Ltd. The East of
Changda Road, Changle county, Weifang Shandong, China cleared
by DRAP Lahore office dated 01-06-2020.
Sodium Chloride:
Firm has submitted copy invoice (invoice# HZA20CS88024)
dated: 17-04-2020 from Hangzhou Zhongbao Imp & Exp.

Corp.Ltd., China, cleared by DRAP Lahore office dated 08-06-
2020

chromatograms,
etc.
testing
accelerated)
Remarks Of Evaluator:
1. 1.5.9 Provide Evidence of reference The reference is of Baxter Healthcare Ltd, that manufactures
in Regulatory Authority 4.3% Sodium Chloride 0.18% and Glucose 4% Solution for Infusion
Glucose anhydrous used. BP.
The product applied by Enzon Pharmaceuticals is Sodium
Chloride 0.18% and Glucose 4.3% Solution for Infusion BP.
The same combination was discussed in 297th meeting of DRAP
that took place in between 12-15th Jan 2021. In the minutes of
297th meeting, DRAP approved the Pacidexal-DPS Infusion
500ml of Pacific Pharmaceuticals Ltd that had applied for the
same product in the similar combination of Sodium Chloride
0.18% and Glucose 4.3% Solution for Infusion, with the same
RRA reference (1.5.9). The minutes of 297th meeting of
Pacidexal-DPS Infusion 500ml is attached for reference of the
applied product.
Decision: Approved with Euro Cap container closure system as per following label claim:
"Each 100ml Contains:
Sodium Chloride ……... 0.18gm
Dextrose (as monohydrate) ……. 4gm”
• Firm shall submit fee of Rs. 30,000 for each product for standardization of label claim, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
b. New/Additional section(s)
Quaper (Pvt) Ltd. 26-A, Small Industrial Estate, Lahore Road Sargodha.
Quaper (Pvt) Ltd Sargodha.has been granted approval of additional section by Licensing division DRAP dated
29-
09-2020. specifies following sections:
• Tablet (General) (Revised)
• Capsule (General) section (New)
• R&D Laboratory (New)
• Sachet (General) (New)

Another letter from Secretary Central Licensing Board dated 19-03-2021 states that CLB in its 279th meeting
has
considered and approved correction in the name / title of section from Tablet (general) section revised to Tablet
(General) section new.
Now the firm has submitted following applications as per the details mentioned in the table below:
No of molecules No of products
01 02
201. Name, address of Applicant / Marketing M/s Quaper Pvt.Ltd 26-A, small Insustrial Estate, Lahore
Authorization Holder Road, Sarghodha
Name, address of Manufacturing site. M/s Quaper Pvt.Ltd 26-A, small Insustrial Estate, Lahore
Road, Sarghodha
☐ Importer
Status of application ☐New Drug Product (NDP)
☐ Export sale
Omax Plus 20mg/1680mg Sachet for Oral Suspension
name
Pharmaceutical ingredient (API) per unit Omeprazole……. 20mg
Sodium Bicarbonate……1168mg
Pharmaceutical form of applied drug Immediate Release Powder for Oral Suspension in Sachet
Pharmacotherapeutic Group of (API) Proton pump Inhibitor
Reference to Finished product specifications As per Innovator
Proposed Pack size As per SRO
The status in reference regulatory authorities Zegerid 20 mg Sachet by Santarus INC. USFDA
Approved
For generic drugs (me-too status) Mep-Insta Sachet 20mg/1680mg of M/s Bio-Mark
Pharmaceuticals
GMP status of the Finished product Additional section of dated: 29th September, 2020
manufacturer
Name and address of API manufacturer. Omeprazole: M/s Everest Organics limited.
Regd. Office & factory: Aroor Village, Sadasivpet
Mandal, Sangareddy
Dist. Telangana
Sodium Bicarbonate: M/s TATA Chemicals Europe
Ltd., Mond House, Winnington Lane, Northwich
Cheshire, CW84DT, United
Kingdom
Summarized information related to nomenclature,

Module III (Drug Substance) Omeprazole and Sodium bicarbonate both exist in USP
pharmacopeia0. The firm has submitted detail of
manufacturing process and controls, tests for impurity D,
G & related substances (impurity A & unspecified),
drug substance
Omeprazole:
Real time: 2°C to 8°C / for 36 months
Sodium Bicarbonate: Real time: 30°C ± 2°C / 75% ±
5%RH for 60 months
description of manufacturing process and controls, ,
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established
dissolution profile against the brand leader that is Zegerid 20 mg Sachet by
Santarus INC. by performing quality tests (Identification,
Zegerid 20 mg Sachet by Santarus INC. in Acid media
0.1N HCl (pH 1.2), Buffer (pH 4.5) & Buffer (pH 6.8).
The values for f2 are in the acceptable range.
Analytical method validation/verification of Method validation studies have submitted including,
product accuracy, precision, specificity.
Manufacturer of API Omeprazole: M/s Everest Organics limited.
Regd. Office & factory: Aroor Village, Sadasivpet Mandal, Sangareddy
Dist. Telangana
Sodium Bicarbonate: M/s TATA Chemicals Europe Ltd., Mond House,
Winnington Lane, Northwich Cheshire, CW84DT, United
Kingdom.
API Lot No. Omeprazole Batch No. OME/E-347/18
Sodium Bicarbonate Batch No.0000058111
Description of Pack
Aluminium foil sachet packed in unit carton

Batch No. T1/21 T2/21 T3/21
No. of Batches 03
firm (if any)
2. `` Approval of API/ DML/GMP certificate of Omeprazole: Copy of GMP certificate (Certificate
API manufacturer issued by concerned No.L.Dis. No.1221/E1/2019) for M/s Everest Organics
regulatory authority of country of origin. Ltd. Aroor Village, Sadasivpet Mandal, Medak District –
502291 Telangana India issued by Drug Control
Adminstration Government of Telgana issued on 10-09-
2019 and, valid for three years.
Sodium Bicarbonate:Copy of Drug manufacturing
license (License no. UK API 10762 Insp GMP
10762/1649-0005) for M/s TATA Chemicals Europe
Limited Issued by Medicines and Healthcare Products
Regulatory Agency United Kingdom is submitted, valid
upto 20-09-2022
3. Documents for the procurement of API with Omeprazole: Firm submitted GD from M/s Everest
approval from DRAP (in case of import). Organics Limited to M/s Quaper Pvt.Ltd of dated 20-06-
2020 specifying 2kg of Omeprazole Powder USP
Sodium Bicarbonate: Firm has submitted copy of
Invoice 21-0030 Dated:14-12-2020 from Toss enterprises
1st Floor,Sattar Villa A, 32-1-C-1/6, Block 6, P.E.C.H.S.,
Osman Issabhai Memon Road, (Near Hill Park), Karachi.
Firm also submitted GD from TATA chemicals Europe
Limited to Toss chemicals.
5. Compliance Record of HPLC software HPLC system are not CFR Compliant
1. 2.3.A.1 Provide evidence of atomic absorption Atomic absorption spectrophotometer is not
spectrophotometer required for the testing of either
Omeprazole or Sodium bicarbonate.

2. 2.3.R.1.1 Provide copy of Batch Manufacturing Copies of Batch manufacturing Record
Record (BMR) for all the batches of drug (BMR) for all three stability batches are
product for which attached.
stability studies data is provided in Module
3 section 3.2.P.8.3
3. 2.3.R.1.2 Provide blank master production document Copy of Blank Batch Manufacturing
/ batch manufacturing record to be used Record is attached.
the applied product
4. 3.2.S.4.2 Detailed analytical procedures for the Detailed analytical procedure for drug
testing of drug substance shall be provided substance for both omeprazole and sodium
of both Omeprazole and Sodium bicarbonate are attached.
bicarbonate
5. 3.2.S.4.3 • Analytical Method Verification • Method verification Studies for
studies including specificity, both Omeprazole and Sodium
accuracy and repeatability (method bicarbonate are attached.
precision) performed by the Drug • This is typographical error .
Product manufacturer for drug Corrected data is attached.
including protocol and method in
detail for both Omeprazole and
Sodium bicarbonate
• In Sodium chloride verification
studies in Accuracy weight of
Sodium chloride mentioned.
6. 3.2.S.5 COA of primary / secondary reference COA of reference standard including source
standard including source and lot number and lot number for Omeprazole is attached.
shall be provided for omeprazole
7. 3.2.P.2.1.1 • In pharmaceutical Equivalence Mep- This is typographical error. Corrected data
Insta Sachet from contract is attached.
manufacturer mentioned. while applied
product with different brand name .
• In comparative dissolution graph Mep-
Insta mentioned while applied product
with different brand name
8. 3.2.P.5.1 Justify the submitted specification of Updated finished product specifications are
dissolution test as NLT 75% under the attached, while our finished product results
“finished product specification” , while as also fall within the limit
per “Guidance for Industry, Dissolution
testing of Immediate Release Solid Oral
Dosage Forms” issued by USFDA, a
single-point dissolution test specification
of NLT 85% (Q=80%) in 60 minutes or
less is sufficient as a routine quality control
test for batch-to-batch uniformity
9. 3.2.P.5.3 • Submit Analytical method validation • Analytical method validation for both
protocol and method in detail for both Omeprazole and sodium bicarbonate are
Omeprazole and Sodium bicarbonate. attached.
• Specificity not performed for • Specificity data for Omeprazole is
Omeprazole. Clarification is required attached.
• In Sodium chloride verification studies • This is typographical error. Corrected
in Accuracy weight of Sodium data is attached.

chloride mentioned. Justification is
required.
10. 3.2.P.8 • Documents for the procurement of • Commercial Invoice submitted.

API with approval from DRAP (in • GD submitted.
case of import). • Chromatograms for Omeprazole
• Assay chromatograms for assay are attached.
omeprazole are not provided. • Record for 6 month of accelerated
• Record of Digital data logger for and real time stability chambers are
temperature and humidity attached.
complete for 6 months.
• Manufacturer shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product
174. Name, address of Applicant / Marketing M/s Quaper Pvt.Ltd 26-A, small Insustrial Estate, Lahore
Authorization Holder Road, Sarghodha
Name, address of Manufacturing site. M/s Quaper Pvt.Ltd 26-A, small Insustrial Estate, Lahore
Road, Sarghodha
☐ Importer
☐ Export sale
Omax Plus 40mg/1680mg Sachet for Oral Suspension
name
Pharmaceutical ingredient (API) per unit Omeprazole……. 40mg
Sodium Bicarbonate……1680mg
Pharmaceutical form of applied drug Immediate Release Powder for Oral Suspension in Sachet
Pharmacotherapeutic Group of (API) Proton pump Inhibitor
Reference to Finished product specifications As per Innovator
The status in reference regulatory authorities Zegerid 40 mg Sachet by Santarus INC. USFDA
Approved

For generic drugs (me-too status) Mep-Insta Sachet 40mg/1680mg of M/s Bio-Mark
Pharmaceuticals
GMP status of the Finished product Additional section of dated: 29th September, 2020
manufacturer
Name and address of API manufacturer. Omeprazole: M/s Everest Organics limited.
Regd. Office & factory: Aroor Village, Sadasivpet
Mandal, Sangareddy
Dist. Telangana
Sodium Bicarbonate: M/s TATA Chemicals Europe
Ltd., Mond House, Winnington Lane, Northwich
Cheshire, CW84DT, United
Kingdom
Module III (Drug Substance) Omeprazole and Sodium bicarbonate both exist in USP
pharmacopeia0. The firm has submitted detail of
manufacturing process and controls, tests for impurity D,
G & related substances (impurity A & unspecified),
drug substance
Omeprazole:
Real time: 2°C to 8°C / for 36 months
Sodium Bicarbonate: Real time: 30°C ± 2°C / 75% ±
5%RH for 60 months
description of manufacturing process and controls, ,
dissolution profile against the brand leader that is Zegerid 40 mg Sachet by
Santarus INC. by performing quality tests (Identification,
Zegerid 40 mg Sachet by Santarus INC. in Acid media
0.1N HCl (pH 1.2), Buffer (pH 4.5) & Buffer (pH 6.8).

product accuracy, precision, specificity.
Manufacturer of API Omeprazole: M/s Everest Organics limited.
Regd. Office & factory: Aroor Village, Sadasivpet Mandal, Sangareddy
Dist. Telangana
Sodium Bicarbonate: M/s TATA Chemicals Europe Ltd., Mond House,
Winnington Lane, Northwich Cheshire, CW84DT, United
Kingdom.
API Lot No. Omeprazole Batch No. OME/E-347/18
Sodium Bicarbonate Batch No.0000058111
Description of Pack
Aluminium foil sachet packed in unit carton
Batch No. T1/21 T2/21 T3/21
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Omeprazole: Copy of GMP certificate (Certificate
API manufacturer issued by concerned No.L.Dis. No.1221/E1/2019) for M/s Everest Organics
regulatory authority of country of origin.Ltd. Aroor Village, Sadasivpet Mandal, Medak District –
502291 Telangana India issued by Drug Control
Adminstration Government of Telgana issued on 10-09-
2019 and, valid for three years.
Sodium Bicarbonate:Copy of Drug manufacturing
license (License no. UK API 10762 Insp GMP
10762/1649-0005) for M/s TATA Chemicals Europe
Limited Issued by Medicines and Healthcare Products
Regulatory Agency United Kingdom is submitted, valid
upto 20-09-2022
3. Documents for the procurement of API with Omeprazole: Firm submitted GD from M/s Everest
approval from DRAP (in case of import). Organics Limited to M/s Quaper Pvt.Ltd of dated 20-06-
2020 specifying 2kg of Omeprazole Powder USP
Sodium Bicarbonate: Firm has submitted copy of
Invoice 21-0030 Dated:14-12-2020 from Toss enterprises
1st Floor,Sattar Villa A, 32-1-C-1/6, Block 6, P.E.C.H.S.,
Osman Issabhai Memon Road, (Near Hill Park), Karachi.
Firm also submitted GD from TATA chemicals Europe
Limited to Toss chemicals.

chromatograms,
etc.
5. Compliance Record of HPLC software HPLC system are not CFR Compliant
1. 2.3.A.1 Provide evidence of atomic absorption Atomic absorption spectrophotometer is not
spectrophotometer. required for the testing of either Omeprazole
or Sodium bicarbonate.
2. 2.3.R.1.1 Provide copy of Batch Manufacturing Copies of Batch manufacturing Record
Record (BMR) for all the batches of drug (BMR) for all three stability batches are
product for which attached.
stability studies data is provided in Module
3 section 3.2.P.8.3
3. 2.3.R.1.2 Provide blank master production document Copy of Blank Batch Manufacturing Record
/ batch manufacturing record to be used is attached.
during the commercial manufacturing of the
applied product
4. 3.2.S.4.2 Detailed analytical procedures for the Detailed analytical procedure for drug
testing of drug substance shall be provided substance for both omeprazole and sodium
of both Omeprazole and Sodium bicarbonate are attached.
bicarbonate
5. 3.2.S.4.3 • Analytical Method Verification • Method verification Studies for both
studies including specificity, Omeprazole and Sodium
accuracy and repeatability (method bicarbonate are attached.
precision) performed by the Drug • This is typographical error .
Product manufacturer for drug Corrected data is attached.
including protocol and method in
detail for both Omeprazole and
Sodium bicarbonate
• In Sodium chloride verification
studies in Accuracy weight of
Sodium chloride mentioned.
6. 3.2.S.5 COA of primary / secondary reference COA of reference standard including source
standard including source and lot number and lot number for Omeprazole is attached.
shall be provided for omeprazole
7. 3.2.P.2.1.1 • In pharmaceutical Equivalence Mep- This is typographical error. Corrected data
Insta Sachet from contract is attached.
manufacturer mentioned. while applied
product with different brand name .
• In comparative dissolution graph Mep-
Insta mentioned while applied product
with different brand name Clarification
is required in this regard.

8. 3.2.P.5.1 Justify the submitted specification of Updated finished product specifications are
dissolution test as NLT 75% under the attached, while our finished product results
“finished product specification” , while as also fall within the limit
per “Guidance for Industry, Dissolution
testing of Immediate Release Solid Oral
Dosage Forms” issued by USFDA, a single-
point dissolution test specification of NLT
85% (Q=80%) in 60 minutes or less is
sufficient as a routine quality control test for
batch-to-batch uniformity
9. 3.2.P.5.3 • Submit Analytical method validation • Analytical method validation for both
protocol and method in detail for both Omeprazole and sodium bicarbonate are
Omeprazole and Sodium bicarbonate. attached.
• Specificity not performed for • Specificity data for Omeprazole is
Omeprazole. Clarification is required. attached.
• Method verification is submitted • This is typographical error. Corrected
however, product is non pharmacopeia. data is attached.
Clarification is required
• In Sodium chloride verification studies
in Accuracy weight of Sodium chloride
mentioned. Justification is required.
10. 3.2.P.8 • Documents for the procurement of • Commercial Invoice submitted.
API with approval from DRAP (in • GD submitted
case of import). • Chromatograms for Omeprazole
• In omeprazole chromatograms for assay are attached.
Assay, of 3rd & 6th months product • Record for 6 month of accelerated
name Desan Plus 40mg mentioned. and real time stability chambers are
Clarification is required. attached.
complete for 6 months.
• Manufacturer shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product
On the recommendations of panel of experts, the CLB in its 278th meeting held on 10th & 11th
December, 2020 has considered and approved the following (03) additional section of M/s City
Pharmaceutical Laboratories, Plot No. 12-A, 1-5, Sector 5, NewSurvey No. 276, Korangi
Industrial Area, Karachi Under Drug Manufacturing License Number 000723 (Formulation)
S.No. Name of Section
1. Sterile Dry Powder Injection (Penicillin)
2. Capsule (Penicillin)
3. Dry Powder for Suspension (Penicillin)
175. Name, address of Applicant / Marketing M/S City Pharmaceuticals Laboratories

Authorization Holder Plot # 12-A, I-5 Sector 5, New Survey No. 276, Korangi
Industrial Area Karachi Pakistan
Name, address of Manufacturing site. M/S City Pharmaceuticals Laboratories

Plot # 12-A, I-5 Sector 5, New Survey No. 276, Korangi
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 32568- dated 13-12-2021
Details of fee submitted PKR 30000/-: dated 02/10/2021
Amoxi 500mg IV Injection
name
Pharmaceutical ingredient (API) per unit Amoxicillin Sodium sterile powder for solution for
injection eq. to Amoxicillin ………. 500mg
Pharmaceutical form of applied drug Powder for Reconstitution for Intravenous injection
Pharmacotherapeutic Group of (API) Penicillin antibiotic
BP
specifications
The status in reference regulatory Amoxicillin 500mg Powder for Solution for Injection or Inf
authorities by M/s Ibigen Srl, Via Fossignano 2 04011 – Aprilia MHRA
Approved.
For generic drugs (me-too status) AMOXIL INJECTION 500 by M/s GSK Reg. No. 004512
GMP status of the Finished product GMP certificate issued on basis of inspection conducted
manufacturer on 18-11-2020.
Evidence of approval of manufacturing Firm has submitted copy of section approval letter dated
facility 22-12-2020, wherein approval for “Sterile dry powder for
injection (Penicillin)”, Capsule (Penicillin), Dry powder for
suspension (Penicillin).”
Name and address of API manufacturer. CONCEPT PHARMACEUTICALS LIMITED.
A-28/3, MIDC Indl. Area, Chikalthana, Aurangabad- 431
006 India.
submitted.
Module III (Drug Substance) Official monograph of Amoxicillin Sodium is present in BP.

controls, tests for impurity & related substances,
drug substance
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established against
comparative dissolution profile the brand leader that is Amoxil 500mg IV injection by GSK
pH).
CDP has not been performed because it is not applicable in
this case.
Analytical method validation/verification Method verification studies have submitted including
of product linearity, range, accuracy, precision, specificty.
Manufacturer of API CONCEPT PHARMACEUTICALS LIMITED.
A-28/3, MIDC Indl. Area, Chikalthana, Aurangabad- 431 006 India.
API Lot No. C21YO50013
Description of Pack
10 ml glass vial with rubber stopper and aluminium seal. (1’s)
Batch No. T-001 T-002 T-003
Batch Size 750 vials 750 vials 750 vials
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. 6098230 issued by FDA
API manufacturer issued by concerned Maharashtra state India valid till 14-02-2022.

3. Documents for the procurement of API Copy commercial invoice (Invoice# EX/20077,) Dated: 04-
with approval from DRAP (in case of 12-2020 with received quantity i.e. 1.2Kg gm) of
import). Amoxicillin Sodium Batch No# C21YO50013 with
attestation of DRAP Karachi dated:18-12-2020.
4. Data of stability batches will be supported Submitted
chromatograms,
Raw data sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC software We have maintained manual logs of all tests.
testing
accelerated)
1. 2.3.R.1.1 Submit complete calculations for Drug Calculation submitted.
substance’s quantity dispensed for Evaluation: Salt factor of sodium is 1.060 so
manufacturing according to this quantity dispensed should be
560mg while firm used 1.063 so dispensed
quantity is 562mg
2. 2.3.R.1.2 For applications of locally Blank master production document
manufactured drug product(s), provide / batch manufacturing record to be used during
blank master production document the commercial manufacturing of the applied
/ batch manufacturing record to be product
used during the commercial
manufacturing of the applied product
3. 3.2.S.4.1 Copies of the Drug substance Copies of the Drug substance specifications Drug
specifications Drug Product Product manufacturer are attached.
4. 3.2.S.4.2 Detailed analytical procedures for the Detailed analytical procedures for the testing of
testing of drug substance used for drug substance used for routine testing of the
routine testing of the Drug substance Drug substance /Active Pharmaceutical
/Active Pharmaceutical Ingredient by Ingredient by Drug product manufacture.
Drug product manufacture.
5. 3.2.S.4.3 Analytical Method Verification studies Analytical method verification studies submitted
including specificity, accuracy and but in Accuracy data of Robustness submitted.
repeatability (method precision)
manufacturer for drug substance(s)
shall be submitted.
6. 3.2.S.4.4 Submitted COA of Drug substance Complete COA of Drug substance manufacturer
manufacturer incomplete are submitted.
7. 3.2.P.1 • Amoxicillin Sodium Lyophilized • It was typographical error made by drug
sterile powder mentioned while product manufacturer. The material is not
3.2.S.2 does not mentioned step of lyophilized.
Lyophilization. • According to calculation the filling weight is
• Quantity of Amoxicillin sodium is about 562mg per vial including factor for
not according to label claim. sodium and water content.
8. 3.2.P.2.2.1 Developed formulation Exit 2gm and It was a typographical mistake the correct data is
reference product Inocef 2gm now attached

9. 3.2.P.5.1 A copy of the drug product A copy of the drug product specification(s)
specification(s) including tests, including tests, acceptance criteria and reference
acceptance criteria and reference to to analytical procedure are attached.
analytical procedure shall be provided.
10.3.2.P.5.2 Detailed analytical procedures used for Detailed analytical procedures used for testing
testing the drug product shall be the drug product are attached.
provided.
11.3.2.P.8 • In stability summary sheets 6th • The year was written as 2020 by typing
month mentioned 24-09-2020 error. The corrected stability data sheets
while on other months mentioned are attached.
2021. Clarification is required. • The supporting chromatograms are
• Data of stability batches will be attached.
supported by attested respective • Compatibility studies of finished product
documents like Raw data sheets, with diluent not submitted.
COA,
• Submit Compatibility studies of
finished product with diluent.
Decision: Approved with BP specification.
• Manufacturer will perform process validation of first three commercial batches as per the
• Firm shall submit following before issuance of registration letter:
➢ Performance of accuracy parameter in the analytical method verification studies of drug
substance.
➢ Compatibility studies of finished product with diluent.
Case no. 04 Registration applications for local manufacturing of (veterinary) drugs

a. New Cases
176. Name and address of manufacturer / MYLAB Pvt. Ltd, Khankah Shariff Bahawalpur.
Applicant
Brand Name +Dosage Form + Strength I-Vit-C Oral Solution
Vitamin C…..…20gm
Diary No. Date of R& I & fee Dy.No 40630 dated 06-12-2018 Rs.20,000/- Dated 04-12-
2018
Pharmacological Group Vitamin
Type of Form Form 5
Finished product Specification Manufacturer‘s specifications
Pack size & Demanded Price 250ml, 500ml, 1liter, 5 liter:Decontrolled
I-VIT-C ORAL SOLUTION of M/s M/S.
Me-too status
INTERNATIONAL PHARMA LABS.(Reg# 074776)
concluded that the firm was found to be operating at a
satisfactory level of GMP compliance.
IV
Applicant
Brand Name +Dosage Form + Strength Combigent Injection

Tylosin Tartrate…5g
Gentamicin as Sulphate…10g
Colistin Sulphate…20 IU
2018
Type of Form Form 5
Pack size & Demanded Price 100ml: Decontrolled
Me-too status Not found
Remarks of the Evaluator IV
Firm provided Me-too status with change of formulation with submission of fee of Rs:30000/-
Deposit slip # 181515906528 Dated:04-01-2022.
Tylosin Tartrate…5g
Gentamicin as Sulphate…10g
Colistin Sulphate…20 MIU
Me-too status COMBIGENT INJECTION of M/s M/S. SELMORE
PHARMACEUTICALS (Reg # '088086)
Applicant
Brand Name +Dosage Form + Strength Solvasol Forte Injection
Composition Each ml Contains:
DL-Acetymethionine…200mg
Cyanocobalamine…20mg
L-Carnitine…50mg
a-TocopherolAcitate…33mg
2018
Pharmacological Group Vitamin and aminoacid
Type of Form Form 5
Pack size & Demanded Price 250ml Decontrolled
Me-too status
Deposit slip # 94560941596, Dated:04-01-2022.
DL-Acetymethionine…200mg
Cyanocobalamine…0.2mg
L-Carnitine Hydrochloride 61.3mg
(Equivalent To Carnitine….…50mg
Alpha-Tocopherol Acetate 33.0mg (Equivalent
To Alpha.…30mg

Me-too status METABOLASE FORTE INJECTABLE SOLUTION.of M/S.
FATRO S.P.A. PHARMACEUTICAL (Reg # '043109)
Applicant
Brand Name +Dosage Form + Strength Strepro Injection
Procaine Penicillin G …200mg
Streptomycin Sulphate…60mg
2018
Pharmacological Group Penicillin antibiotic
Type of Form Form 5
Deposit slip # 188315590, Dated:04-01-2022
Procaine Penicillin G …200mg
Streptomycin Sulphate…160mg
Me-too status Neo Strep-Pen Injection Of M/S Nawan Laboratories Reg#
053997
Applicant
Brand Name +Dosage Form + Strength Javamox Injection
Cloxacillin as Sodium…50mg
2018
Pharmacological Group Penicilline antibiotic
Type of Form Form 5
Pack size & Demanded Price 50ml:Decontrolled
Firm provided Me-too status with change of formulation and revised dossier with submission of
fee of Rs:30000/- Deposit slip # 6557874230, Dated:04-01-2022
Cloxacillin as Sodium…50mg
Amoxicillin (As Trihydrate)…….100MG

Me-too status I-Moclox Injection Of M/S. International Pharma
LABS.Reg# 074762
Applicant
Brand Name +Dosage Form + Strength M-Strep LA Injection
Procaine Penicillin G…100,000 IU
Benzathine Penicillin G…150,000 IU
Dihydrostreptomycin Sulphate Eq. to
Dihydrostreptomycin…200mg
2018
Pharmacological Group Penicillin antibiotic
Type of Form Form 5
Deposit slip #088432640, Dated:04-01-2022
Procaine Penicillin G…150,000 IU
Benzathine Penicillin G…100,000 IU
Dihydrostreptomycin Sulphate Eq. to
Dihydrostreptomycin…200mg
Me-too status Bps-La Injection Of M/S. M/S. Selmore Pharmaceuticals
.Reg# 080951
Applicant
Brand Name +Dosage Form + Strength Solvasol Super Injection
L-Carnitine Hcl…500mg
Thioctic Acid…20mg
Pyridoxin Hcl…15mg
DL-Acetylmethionine…2mg
L-Arginine…240mg
L-Ornithine…153.2mg
L-Citrullin…120mg
L-lysine…62.5mg
Glycine...150mg
Taurine...150mg
Aspartic Acid...150mg
Glutamic Acid...150mg

Fructose...5gm
Sorbitol...8gm
2018
Pharmacological Group Multivitamins & Amino Acid
Type of Form Form 5
Pack size & Demanded Price 250ml : Decontrolled
Firm provided Me-too status with picture and change of formulation according to metoo
with submission of fee of Rs:30000/- Deposit slip # 69036568, Dated:04-01-2022
L-Carnitine Hcl 613.3mg Eq to L-Carnitine …500mg
L-Arginine…240mg
L-Ornithine HCl 153.2mg Eq to L-Ornithine …120mg
L-Citrullin…120mg
L-lysine HCl 62.5mg Eq to L-lysine …50mg
Glycine...150mg
Taurine...150mg
Fructose...5gm
Sorbitol...8gm
Me-too status Metabolase Injectable Solution Of M/S. Prix
Pharmaceutical .Reg# '019904
Each 100ml Contains:
L-Carnitine Hcl 613.3mg Eq to L-Carnitine …500mg
L-Arginine…240mg
L-Ornithine HCl 153.2mg Eq to L-Ornithine …120mg
L-Citrullin…120mg
L-lysine HCl 62.5mg Eq to L-lysine …50mg
Glycine...150mg
Taurine...150mg
Applicant
Brand Name +Dosage Form + Strength Dicalfon-D Injection

Calcium Borogluconate…20.83gm
Magnesium Hypophosphate…5.33gm
Magnesium Chloride…2gm
Calcium D-Saccharate…1gm
Boric Acid…4.33gm
Dextrose…20gm
Vit B1…100mg
Vit B12…9.3mg
Nicotinamide…200mg
Pharmacological Group Vitamins and minerals
Type of Form Form 5
Pack size & Demanded Price 300ml Decontrolled
Firm provided Me-too status with picture and change of formulation according to metoo
Calcium gluconate…20.83gm
Magnesium Hypophosphate…5.33gm
Magnesium Chloride…2gm
Calcium D-Saccharate…1gm
Boric Acid…4.33gm
Dextrose…20gm
Vit B1…100mg
Vit B6….70mg
Vit B12…3000mcg
Nicotinamide…200mg
Me-too status MILFONE-D INJ Of M/S. STAR LHR .Reg# '007629
Applicant
Brand Name +Dosage Form + Strength Ag-Mox Injection
Amoxicillin as Trihydrate…200mg
Gentamicin Sulphate…25mg
2018
Type of Form Form 5
Pack size & Demanded Price 50ml :Decontrolled
IV
Firm provided Me-too status with change of Fill volume according to metoo

Me-too status Amoxygent Injection Of M/S. Selmore
Pharmaceuticals.Reg# '080953
b. Deferred Cases
185. Name and address of manufacturer / M/s ISIS Pharmaceuticals & Chemical Works.
Applicant 25/1-3, Sector 12-C, North Karachi Industrial Area,
Karachi
Brand Name +Dosage Form + Strength Iskeda Oral Powder
Composition Each KG contains:
Vit A…33MIU
Vit D…3.3MIU
Vit E 50%...2500mg
Vit K 25%...2000mg
Pharmacological Group Vitamin supplements
Type of Form Form 5
Finished product Specifications Manufacturer‘s specifications
Pack size & Demanded Price 100 gm, 500gm, 1000gm ; Decontrolled
Me-too status (with strength and ELKEDA POWDER Of M/S ELKO ORGANIZATION
dosage form) Reg.# 026537
GMP status Last GMP inspection conducted on 12-02-2020 and report
concludes that their overall current compliance level is rated as
Good.
Previous remarks of the Evaluator. Master formulation is submitted.
Firm has Dry powder Suspension Veterinary General
section while applied product is oral powder and no
suspending agent was added.
Deferred for clarification of the composition of Vitamin E 50% &
Vitamin K 25% in applied formulation. (M-293)
Evaluation by PEC
Firm replied that there was a typing error in the application, the amended formulation is attached with
submission of fee of Rs: 30000/- Deposit slip # 5252274139 dated: 10-01-2022
Also said that our area fall in Dry Powder Section which can be verified by differtent inspection reports as well
as layout plan approved on 19-06-2008.
Composition Each KG contains:
Vit A…33MIU
Vit D…3.3MIU
Vit E...2500mg
Vit K...2000mg
• Firm shall submit fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as
186. Name and address of manufacturer / M/s Intervac Pvt. Limited.
Applicant 18-Km, Lahore Sheikhupura Road, Sheikhupura,
Pakistan
Brand Name +Dosage Form + Strength Colifas 60-Injection
Colistin Sulphate…60 MIU
Diary No. Date of R& I & fee Dy.No. 4219 dated 30-01-2019 Rs.20,000/- Dated 30-01-

2019
Pharmacological Group Antibacterial
Type of Form Form 5
Pack size & Demanded Price 50ml ; Decontrolled
dosage form)
GMP status Last GMP inspection conducted on 28-05-2019, and the report
concludes that the panel recommend the grant of renewal of DML.
Previous remarks of the Evaluator. • COLIRAN-60 INJECTION of M/S ZAKFAS
PHARMACEUTICAL Reg #057073 Provided metoo is
available in 10ml and 30ml
Deferred for evidence of applied formulation/drug in same filled
volume already approved by DRAP (generic / me-too status) along
with registration number, brand name and name of firm. (M-295)
Evaluation by PEC COLISTAN FORTE INJECTION of M/s LEADS PHARMA
Reg# 043514
• Firm shall submit fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as
Case no. 05 Registration applications of import cases

a. New Cases (Human)
187. Name, address of Applicant / Importer M/s AJM Pharma (Pvt) Ltd.
1st Floor, Shafi Court, Civil Lines Merewether Road, ,
Karachi.
Address of the godown:
Address1:
Ground floor, Plot no. 44 Sector 27, Korangi Industrial Area,
Karachi
Address2:
Shed No. F-9, PI.No.S1, Survey No.230 Sector – 02, Road 4000,
Korangi Industrial area, Karachi.
Details of Drug Sale License of importer Address: 1st Floor Shafi Court Civil Lines, Merewether Road,
Karachi
Name and address of marketing M/s Jiangsu Hengrui Medicine Co. Ltd. 38 Huanghe Road,
authorization holder (abroad) economic and technological
development zone, Lianyungang, Jiangsu 222047, P.R.China
Name, address of manufacturer(s) M/s Jiangsu Hengrui Medicine Co. Ltd. 38 Huanghe Road,
economic and technological development zone, Lianyungang,
Jiangsu 222047, P.R.China.
Name of exporting country CHINA

Detail of certificates attached (CoPP, Free CoPP: Firm has submitted Original Valid CoPP
sale certificate, GMP certificate) (Certificate#MTMU-9M53) issued by United States Food And
Drug Administration for Carmustine 100mg For Injection. The
CoPP confirms free sale status of the product in the exporting
periodic inspection once in a year.
The certificate is valid till 08.09.2023.
Copy of GMP certificate No : JS20180922 Valid till 18-10-2023
is submitted issued by China food and drug Adminstration
Details of letter of authorization / sole Firm has submitted a copy of letter of authorization M/s Jiangsu
agency agreement Hengrui Medicine Co. Ltd. 38 Huanghe Road, economic and
technological development zone, Lianyungang, Jiangsu 222047,
P.R. China. According to the letter, the firm authorizes M/s AJM
Pharma (Pvt) Ltd. with registered address at 1st floor, Shafi
Court, Merewether Road, Civil Lines, Karachi -75520, Pakistan
to apply for registration of applied product manufactured by M/s
Jiangsu Hengrui Medicine Co. Ltd. for importation and
distribution in the territory of Pakistan.
The letter was issued on 04-07-2019 and it is valid for five years
from date of issue.
☒ Importer
☐ Export sale
For imported products, specify one the ☒ Finished Pharmaceutical product import
these ☐ Buk import and local repackaging
Dy. No. and date of submission Dy.No. 15879 dated 27-08-2019
The proposed proprietary name / brand Carmus 100mg/Vial For Injection
name
Pharmaceutical ingredient (API) per unit Carmustine for Injection USP…..100 mg
Pharmaceutical form of applied drug Sterile lyophilized pale-yellow granule or congealed mass for
intravenous infusion after reconstitution
Pharmacotherapeutic Group of (API) Alkylating antineoplastic agent
Reference to Finished product USP
specifications
Proposed Pack size 1 Vial with 1 Vial of Sterile Diluent 3 mL of Dehydrated Alcohol
Injection
Proposed unit price As per PRC
The status in reference regulatory BiCNU (carmustine for
authorities injection) under NDA 017422 held by Emcure Pharmaceuticals
Ltd. Was approved by FDA

process validation protocols, control of excipients, control of drug
Name, address of drug substance Jiangsu Hengrui Medicine Co., Ltd.
manufacturer 22 Jinqiao Road, Dapu Industrial Park
Lianyungang, Jiangsu 222002, China
Contact: Lin Li, Ph.D.
form, manufacturers, Characterization, specifications, analytical
(Conditions & duration of Stability accelerated and real time conditions. The real time stability data
studies) were conducted at 5±3oC for 36 months and accelerated stability
data were conducted at 25°C ± 2°C, RH: 60% ± 5% for 2 months
description of manufacturing process and process control, process
validation report, control of excipients, control of drug product,
stability.
Pharmaceutical Equivalence and Pharmaceutical equivalence is established against Carmustine for
Comparative Dissolution Profile injection Batch No# CDAA608 BiCNU (Carmustine for
injection) under NDA 017422 held by Emcure Pharmaceuticals
Ltd. Was approved by FDA.
Analytical method validation/verification The firm has submitted validation results of assay method, related
of product substances, of Carmus Injection 100mg.
Container closure system of the drug Glass Vial: 30 mL vial made of neutral borosilicate glass tubing,
product Type I clear, amber and siliconized glass.
Stopper: 20 mm rubber stopper for lyophilization,
V9154/FM257
Aluminum Flip-off Seal: 20 mm*7.2 mm, blue flip-off seals
without logo

Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches with
life and storage conditions upright and inverted orientation:
170803AB 4254 Vials 24-08-2017
170830AB 4557 Vials 21-09-2017
170909AB 4522 Vials 21-09-2017
The firm has performed Real time stability study at 2oC – 8 oC
for 18 months and accelerated stability study at 25 oC±2
oC/60%±5%RH for 06 months.
In-use stability study at 2oC – 8 oC for 24hours
Evaluation by PEC:
1. 1.3.3. Importer shall provide Certificate of Not submitted.
Pharmaceutical Product (CoPP) / Free Sale
certificate issued by relevant regulatory
authority in the country of origin and name of
exporting country.
2. 1.4.1. Generic Drug Product (GDP mentioned while Firm submitted fee of Rs: 50000/- deposit slip
fee of Rs: 50000/- submitted. No:72513093 , Dated:12-11-2021
3. 3.2.S.7 Submit Stability Studies data of Drug In Drug substance accelerated stability studies
Substance. terminated after 2months due to the result of
2-chloroethanol was out of specification for
two of three batches,
4. 3.2.P.2 Pharmaceutical equivalence of the applied Details of RLD including brand name,
P.2.2.1 drug shall be established with the innovator / manufacturer etc. not submitted
reference / comparator product and results of
all the quality tests (mentioned in any official
pharmacopoeia or section 3.2.P.5.1 of this
application) of the developed formulation and
the innovator / reference / comparator product
shall be submitted and discussed
nd th
2 letter 26 November, 2021
1. 1.3.3. Importer shall provide Certificate of COPP from United states submitted
Pharmaceutical Product (CoPP) /
Free Sale certificate issued by
relevant regulatory authority in the
country of origin and name of
exporting country.
2. 3.2.S.7 In Drug substance if accelerated According to IC Q1A 2.1.7.2. Drug substances
stability studies terminated after intended for storage in a refrigerator:
2months due to the result of 2- “If significant change occurs between 3 and 6 months’
chloroethanol was out of testing at the accelerated storage condition, the
specification for two of three batches, proposed re-test period should be based on the real
then how finished product was time data available at the long term storage condition.
manufactured. If significant change occurs within the first 3 months’
testing at the accelerated storage condition, a

discussion should be provided to address the effect of
short term excursions outside the label storage
condition, e.g., during shipping or handling. This
discussion can be supported, if appropriate, by further
testing on a single batch of the drug substance for a
period shorter than 3 months but with more frequent
testing than usual
It is considered unnecessary to continue to test a drug
substance through 6 months when a significant change
has occurred within the first 3 months.”
More over the short term Excursion stability data for
drug substance could address the effect of short term
excursion outside the label storage condition (between
2oC –and 8 oC) during the finished product was
manufactured.
The short term excursion stability study was
conducted at 25°C ± 2°C/60% RH ± 5% RH for three
batches of drug substance, and the testing results
obtained up to 30 days for drug substance meet the
acceptance criteria in the specification and show no
significant changes during the storage, which could
support short term excursion during shipping or
handling
3. 3.2.P.2 Submit details of RLD including BiCNU (carmustine for
P.2.2.1 brand name, manufacturer etc. injection) under NDA 017422 held by Emcure
Pharmaceuticals Ltd. Was approved by FDA

• Justification regarding submitted COPP, since country of origin of applied product is China, whereas
submitted COPP has been issued by the United States Food And Drug Administration.
• Scientific rationale for formulating drug product with a drug substance having accelerated stability studies
of only two months.
c. Deferred cases
i. Human
188. Name, address of Applicant / Importer M/s AJM Pharma (Pvt) Ltd
1st Floor, Shafi Court, Merewether Road, Civil Lines,
Karachi- Pakistan
Address: AJM Pharma (Pvt) Ltd
1st Floor, Shafi Court, Merewether Road, Civil Lines,
Karachi- Pakistan
Name and address of marketing authorization M/s Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
holder (abroad) No. 5 Dongjin Road Economical and Technical
Development Zone, Lianyungang, Jiangsu Province, China.
Name, address of manufacturer(s) M/s Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
No. 5 Dongjin Road Economical and Technical
Development Zone, Lianyungang, Jiangsu Province, China.
Exporting country China
Detail of certificates attached (CoPP, Free sale certificate, GMP certificate)

• Original legalized CoPP issued by Guangdong province Food and Drug Administration, China issued on
11/12/2020. The applied product is present in the market of exporting country for free sale. The facilities
and operations conform to WHO-GMP.
Certificate No: JS20200404
Issuing authority: Jiangsu Drug Administration
Date of issue: 11/12/2020
Validity:05-09-2021
MAH and Manufacturer: M/s Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
No. 5 Dongjin Road Economical and Technical Development Zone, Lianyungang, Jiangsu Province, China..
• Copy of GMP certificate No : JS20180777 Valid till 22-02-2023 is submitted issued by China food and
drug administration
Details of letter of authorization / sole agency agreement
Original/notarized Sole Agency Agreement is submitted whereby M/s AJM Pharma (Pvt) Ltd
is the sole and exclusive exporting subjected products of representative of M/s Jiangsu Hansoh
Pharmaceutical Group Co., Ltd,. for the applied product. PEMOSH 100mg/Vial
☒ Importer
☐ Export sale
☐Buk import and local repackaging for export purpose
only
Dy. No. and date of submission Dy. No 4843 Dated 12/02/2021
Details of fee submitted Rs. 100,000/- Dated 11/01/2021
The proposed proprietary name / brand name Pemosh 100mg/Vial for Injection
Pharmaceutical ingredient (API) per unit Pemetrexed disodium hemipentahydrate Eq to
Pemetrexed………..…100mg
Pharmaceutical form of applied drug Lyophilized Powder for Injection
Pharmacotherapeutic Group of (API) Folate analog metabolic inhibitor
Proposed Pack size 10ml glass vial
The status in reference regulatory authorities Almita 100mg /Vial of,USFDA approved.
For generic drugs (me-too status) Almita 100mg /Vial of Eli Lilly ,
Module-II (Quality Overall Summary) Submitted.
Name, address of drug substance manufacturer M/s Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Addrress: Kaiitai Road, Dapu Industrial Park,
Economical and Technical Development Zone,
Lianyungang, Jiangsu Province, China.
Module-III Drug Substance: Submitted

Stability Studies of Drug Substance: (Conditions • 36 months real time stability data at -20°C ± 5°Cof
& duration of Stability studies) 03 batches.
• 06 month accelerated stability data 5°C ± 3°C of 03
batches.
Module-III Drug Product: Submitted.
Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence is established against
Dissolution Profile Alimta 100mg/ml by M/s Eli Lilly.
Analytical method validation/verification of The firm has submitted all the relevant data including
product analytical method verification studies.
Container closure system of the drug product • 10ml TypeI clear Glass vial, Sealed with20- D2
Lyophilization bromobutyl rubber stopper for injection
and secured with aluminium flip –off seal
Stability study data of drug product, shelf life and • 36 months real time stability data at 30°C ± 2°C / 75%
storage conditions ± 5%RH of 03 batches (151101, 51102, 51103)
• 06 month accelerated stability data 40°C ± 2°C / 75% ±
5%RH of 03 batches (20140601, 20140602, 20140603)
• In -use 25mg/ml at 2-8°C (20140601, 20140602,
20140603)
• In -use 1mg/ml at (20140601, 20140602, 20140603)
Evaluation by PEC-IV
1. 3.2.S.4.4 Provide results of analysis of Submitted.
relevant batch(es) of Drug
Substance performed by Drug
Product manufacturer used during
product development and stability
studies, along with Certificate of
Analysis (CoA) of the same batch
2. 3.2.S.7 Reference product manufacturer Based on the patent, the pemetrexed
conducted Drug Substance stability Disodium Heptahydrate is more
studies at 25 °C / 60% RH Long term stable than the Pemetrexed Disodium
and 40 °C / 75% RH Accelerated Hemipentahydrtae. In this patent,
stability studies while Drug stability study was performed at 25°C
substance manufacturer is conducting ± 2°C RH 60% ± 5% in 6 months
stability at -20°C ± 5°C Long term with Pemetrexed Disodium
and 5°C ± 3°C Accelerated stability Heptahydrate and Pemetrexed
studies. Clarification is required in Disodium Hemipentahydrate, and the
this regard. results shows that the degradation of
the related substances for Pemetrexed
Disodium Hemipentahydrate is more
obvious than the pemetrexed
Disodium heptahydrate.
We Acknowledge that controlled
room temperature is specified on the
storage condition for Pemetrexed
Disodium Heptahydrate in both USP
and EP monograph. But considering
the special attributes of the
Hemipentahydrate, Hansoh prefer to
use storage condition of -20°C ± 5°C
for our Pemetrexed Disodium
Hemipentahydrate.
Results from accelerated stability
study conducted under 5± 3°C and

long-term stability study under -20°C
± 5°C support the proposed shelf life
under the current storage condition
and packages configuration. The
quality index of our drug substance
Pemetrexed Dsodium
Hemipentahydrate can be well
maintained at storage condition of
-20°C ± 5°C
Previous Decision (M-312): Deferred for clarification whether applied product contains same Active Pharmaceuticals
Ingredient as that of Reference product or otherwise.
Firm submitted reply:
“Drug product Pemetrexed for injection 100mg/Vial and the RLD (Almita, 100mg/vial) owned by Eli Lilly and
company is supplied as single-use vial as sterile, lyophilized powder and administered as parenteral solutions after
reconstitution, contain the same active ingredient and the same formulation”
Evaluation: FDA product contain Pemetrexed disodium heptahydrate while applied formulation contains Pemetrexed
disodium hemipentahydrate.
Evaluation by PEC : FDA product Almita contains Pemetrexed disodium Heptahydrate however firm applied
Pemetrexed disodium hemipentahydrate. EMA approved product Pemetrexed Krka contains same active ingredient
that is Pemetrexed disodium hemipentahydrate.
Previous Decision: Since the product approved by EMA contains same hydrate form of drug substance as that in the
applied product. Therefore, the Board decided to defer the case for submission of Pharmaceutical Equivalence against
the product containing same hydrate form of drug substance.(M-313)
Firm Reply: Attached herewith a Declaration with reference to our product PEMOSH 100mg (Pemetrexed) for the
drug substance used in RLD (Alimta 100mg/vial) owned by Eli Lilly and in our proposed product PEMOSH
100mg/vial
In which it is concluded that the hydrate crystalline form will not affect the quality of final product , active ingredient
and formulation in proposed generic drug product Pemetrexed for injection is consistent with that in RLD Almita
(Pemetrexed for injection) . The composition of the proposed drug product is qualitatively/quantitatively same to the
reference product.
Decleration
“when Pemetrexed disodium hemipentahydrate and Pemetrexed disodium heptahydrate dissolve in water, the unit
cells under crystalline state will completely dissolve in the water. The unit cells will be destroyed and pemetrexed
disodium will be electrolyzed to pemetrexed acid radical and sodium in water , crystal water previously in unite celss
will integrate together with the water molecule in water solution to perform as free water. Therefore water molecule
in different crystalline form of pemetrexed disodium will present in water solution. That’s to say Pemetrexed
Disodium hemipentahydarate and Pemetrexed disodium heptahydrate will both perform as pemetrexed acid radical,
sodium and free water when they dissolve in water solution, and exert their therapeutic effect in the form of
pemetrexed.”
The pharmaceutical Equivalence of PEMoSH 100mg (Pemetrexed disodium hemipentahydrate) is available

against Reference listed Drug (RLD) Almita 100mg (Pemetrexed disodium heptahydrate) which is USFDA approved
product by Lilly USA, LLC, so when it is equivalent to USFDA approved Almita (heptahydrate) then there is no need
to arrange Pharmaceutical Equivalence with same hydrate i.e hemipentahydrate such as Krka (EMA approved).
Decision: Registration Board noted the fact that the EMA public assessment report of drug product
“Pemetrexed Krka” having drug substance “pemetrexed disodium hemipentahydrate”, declares that it has the
same active substance in comparable amounts to the centrally approved reference medicinal product Alimta
having drug substance “pemetrexed disodium heptahydrate”, hence Board decided to approve the applied
product with USP specifications as per Policy for inspection of Manufacturer abroad and verification of local
storage facility.
Case no. 06 Registration applications of drugs for which stability study data is submitted
a. New cases
189. Name and address of manufacturer / M/s Neutro pharma (Pvt) Ltd., 9.5Km, Seikhupura Road,
Applicant Lahore

Brand Name +Dosage Form + Strength NEUCURE 5g/10ml Infusion
Composition Each 10 ml contains:
L-ornithine L-aspartate………5g
Diary No. Date of R& I & fee Diary No:5272, 08/06/2017, Rs: 20,000/-
Pharmacological Group Amino acid
Type of Form Form 5
Pack size & Demanded Price 1‘s x 10ml /As Per SRO
Approval status of product in Not submitted by the firm
Reference Regulator Authorities
Me-too status Hepa-merz 5gm/10ml Infusion Concentrate by M/s Brookes
pharma (Reg#008633)
GMP status 03-05-17; Inspection of Additional Sections. Panel recommends
grant of additional sections.
Remarks of the Evaluator. Approval status of product in Reference Regulatory Authorities
not confirmed.
● Primary packaging material not confirmed from Reference
● Applied pack size not confirmed from Reference Regulatory
Authorities.
Previous Decision 274th Deferred for evidence of approval of applied formulation in
Reference Regulatory Authorities.
Evaluation by PEC The firm has submitted the followitng reply.
In the light of above decision kindly note that following product
is health and OTC product that is not under drug category that‘s
why product is not available in DRA website. Furthermore,
please find the attached herewith the evidence of International
/Local availability ● Hepa-merz 5gm/10ml by Merz Pharma
GmbH & Co. KGaA (Germany)
Decision of 276th meeting: Deferred for further deliberation
Remarks of Evaluator: Firm has approved S.V.P section (Blow fill & sealing in LDPE)
Previous Decision M-281: Registration Board was apprised that applied formulation is available in glass
ampoules, both in Reference Regulatory Authorities and as generics approved by DRAP, whereas, firm has
applied for formulation in polyethylene ampoules. Registration Board deliberated that difference in
packaging material is not considered as New Drug. So, Form 5D is not required and such applications shall
be treated as Me-too/Generic, while stability studies data, as decided by Registration Board in its 278th
meeting, shall be submitted to establish shelf life with applied packaging material. Hence Registration Board
deferred the case for submission of stability studies data, as decided in its 278th meeting
The reference of approval for said formulation now has been verified from ―Austrian Agency for Health
and Food Safety (AGES)‖ in the same strength and dosage form, which is a reference regulatory authority
as adopted by Registration Board. The details of product registration are as follows:
● Brand Name: Hepa-Merz 5 g / 10 ml infusion solution concentrate
● Approval Number: Z.Nr.: 14964
● Pharmaceutical form: Concentrate for solution for infusion
● Composition: 1 ampoule of 10 ml contains 5 gm of Ornithine aspartate in
aqueous solution
● Owner of the Approval: Merz Pharma Austria GmbH, 17, 1110 Vienna
Drug NEUCURE 5g/10ml Infusion

Name of Manufacturer M/s Neutro pharma (Pvt) Ltd., 9.5Km, Seikhupura Road, Lahore
Manufacturer of API M/s Evonik Rexim S.A.S 33 rue de Verdun, HAM, 80400, France
API Lot No. 6791190407
Description of Pack
Glass ampoule
Stability Storage Condition Real time : 30°C ± 2° C / 75% ± 5% RH
Frequency Accelerated:0,1,2,3,4,6 ( month)
Real Time: 0,3,6, (month)
Batch No. ORN-INJ-5-001-19 ORN-INJ-5-002-19 ORN-INJ-5-003-19
Batch Size 5 liter 5 liter 5 liter
No. of Batches 03
Date of Submission 28-08-2020 (21776)
Sr. No. Documents To Be Provided Status
1. Reference of previous approval of
applications with stability study data of • Not submitted
the firm
2. Certificate of Analysis of API from both Copy of COA of L-Ornithine L-Aspartate
API Manufacturer and Finished Product (Batch#6791190407)) from M/S Evonik Rexim S.A.S
manufacturer. france,is submitted
Copy of COA of L-Ornithine L-Aspartate
(Batch#6791190407)) from M/S Neutro Pharma,is submitted
3. Method used for analysis of API from
both API Manufacturer and Finished
Yes
Product
manufacturer
4. Stability study data of API from API The firm has submitted copy of accelerated, 06 Months (40°C
manufacturer ± 2°C & 75±5%RH) & long term, 48 Months (30°C ± 2°C &
65±5%RH) stability study reports of 03 batches
5. Approval of API/ DML/GMP certificate Copy of GMP Certificate No # 21MPP026HVFR01 for M/s
of API manufacturer issued by concerned :EVONIK REXIM., 33 rue de Verdun, HAM, 80400, France
regulatory authority of country of origin. issued by National Agency for safety of medicine and Health
products France, is submitted. Based on inspection conducted
on 23-04-2021 valid for 3 years
6. Documents for the procurement of API Commercial Invoice No: 8893303432 Dated: 05-11-2019
with approval from DRAP (in case of from M/S Evonik Singapore specialty Chemicals Pte Ltd 3
import). International Business park Nordic European Centre,
Singapore, is submitted for L-Ornithine- L- Aspartate
Attested by DRAP Lahore dated:13-09-2019
7. Protocols followed for conduction of
Yes
stability study
8. Method used for analysis of FPP Yes

9. Drug-excipients compatibility studies
Yes
(where applicable)
10. Complete batch manufacturing record of The firm has submitted copy of Trial batch
three stability batches. manufacturing record.
Details are as under:
NEUCURE 5g/10ml Infusion
Batch No. Bach Mfg. Started
size
ORN-INJ- 5 Liter 17-10-2019
5-001-19
5-002-19
5-003-19
11. Record of comparative dissolution data
Not applicable
(where applicable)
12. Data of 03 batches will be supported by
Yes
21CFR & audit trail reports on product Not submitted
testing.
Not submitted
accelerated)
S.No Shortcomings communicate Reply

1. Certificate of analysis from M/S Evonik Certificate of analysis, invoice and GMP certificate from M/S
Rexim S.A.S France but invoice and Evonik Rexim S.A.S France Submitted.
GMP certificate from Evonik Germany.
Clarify.
2. Certificate of Analysis of API from Certificate of Analysis of API from Finished Product
Finished Product manufacturer. manufacturer is attached.
3. Valid Approval of API/ DML/GMP Valid Approval GMP certificate is attached.
certificate of API manufacturer issued by
concerned regulatory authority of country
of origin as submitted GMP certificate is
invalid.
4. Method used for analysis of API from Method used for analysis of API from both API Manufacturer
both API Manufacturer and Finished and Finished Product Manufacturer is attached.
Product Manufacturer
5. Stability study data of API from API Stability study data of API from API manufacturer is attached.
manufacturer.
6. Documents for the procurement of API Documents for the procurement of API with approval from
with approval from DRAP as submitted DRAP are submitted.
invoice is not attested from DRAP
7. Complete batch manufacturing record of Complete batch manufacturing record of three stability
three stability batches. batches submitted.

8. Batch size mentioned is 2000ml and fill Actual batch size is 5 liters while mistakenly on stability
volume of ampoule is 10ml, while summary sheets 2000ml was mentioned. Kindly ignore the
sample size in stability sheets mentioned typographical mistake.
is 210 Ampoules Clarify.
Firm submitted fee of Rs: 7500, deposit slip# 95821235844, dated:24-02-2022
• Firm shall submit differential fee of Rs. 22,500 for correction/pre-approval change in Container closure
(correction/change of polyethylene ampoules to glass ampoule), as per notification No.F.7-11/2012-
•

b. Exemption from onsite verification of stability data
Deferred case:
190. Name and address of manufacturer / M/s Tabros Pharma Pvt Ltd. L-20/B,Sector-22, Federal B
Applicant Industrial Area, Karachi
Brand Name +Dosage Form + Strength Melinta 10mg Tablet
Vonoprazan Fumarate eq to Vonoprazan..........…10mg
Diary No. Date of R& I & fee Dy.No 1144 dated 18-04-2020 Rs.50,000 /- Dated
18-04-2016
Pharmacological Group Potassium-Competitive Acid Blocker(
Type of Form Form 5D
Pack size & Demanded Price 14‘s: As per SRO
Approval status of product in Takecab 10mg Tablets (PMDA Japan Approved)
Me-too status
GMP status Last inspection conducted on 07/02/18 and concludes that On
the basis of current inspection it was observed that the firm
rectified all observations noted during last GMP Inspection.
Remarks of the EvaluatorIV
Drug Melinta 10mg Tablet
Name of Manufacturer M/s Tabros Pharma Pvt Ltd. L-20/B,Sector-22, Federal B Industrial Area, Karachi
Manufacturer of API M/S Beijing THTD Pharmeceuticals Technology Co., Ltd, China
API Lot No. 20170115
Description of Pack Alu-Alu foil
Accelerated:6 months
Frequency Accelerated: 0,,3,6 ( month)
Real Time: 0,3,6,9,12,18 (month)
Batch No. TR001-1/MEL TR002-1/MEL TR003-1/MEL
No. of Batches 03
No.
applications with stability study data of the Vibrenta-VPT 400mg/100mg tablets which was conducted on
firm

19th February , 2018 and was presented in 279th meeting of
Registration Board held on 28-02nd March , 2018.
• The firm has 21 CFR compliant HPLC software
• The firm possesses stability chambers with digital
data loggers.
2. Certificate of Analysis of API from both API Copy of COA of Vonoprazone fumarate (Batch# 20170115)
Manufacturer and Finished Product from M/S Beijing THTD Pharmeceuticals Technology Co.,
manufacturer. Ltd, China is submitted.
Copy of COA (Batch# 20170115) from M/S Tabros Pharma
(Pvt) Ltd is submitted
3. Method used for analysis of API from both Yes
API Manufacturer and Finished Product
manufacturer
4. Stability study data of API from API The firm has submitted copy of accelerated, 06 Months
manufacturer (40°C ± 2°C & 75±5%RH) & long term, 12 Months (30°C
± 2°C & 65±5%RH) stability study reports of 03 batches
5. Approval of API/ DML/GMP certificate of Copy of GMP Certificate No # AH20170423 for M/s Hefei
API manufacturer issued by concerned Lifeon Pharmaceutical Co., Ltd China issued by China Food
regulatory authority of country of origin. and Drug Administration, is submitted. It is valid till 12-04-
2021.
6. Documents for the procurement of API with Copy of form-6 form 7 Copy of Commercial Invoice No:
approval from DRAP (in case of import). 20170108-TPL-A Dated: 08-01-2017 from Beijing THTD
Pharmaceuticals Technology Co., Ltd , is submitted attested
by ADC(Karachi) dated ; 13-02-2018 for Vonoprazan
fumarate quantity 130gms
On form 3 manufacturer address mentioned is No.3288
Yikang Avenue. Tengzhou City. Shandong province
However the name of manufacturer is not mentioned.
study
9. Drug-excipients compatibility studies (where Same excipients used as used by innovator.
applicable)
10. Complete batch manufacturing record of three The firm has submitted copy of Trial batch
stability batches. manufacturing record.
Melinta 10mg Tablet
Batch No. Bach size Mfg. Started
TR001- 1000 tablets 04-12-2018
1/MEL
TR002- 1000 tablets 05-12-2018
1/MEL
TR003- 1000 tablets 11-12-2018
1/MEL
11. Record of comparative dissolution data Firm has submitted Comparative dissolution study of
(where applicable) their product with Innovator’s Brand “Takecab”.
The details are as follows:
Feature Reference product Product of
Tabros

Brand Takecab tablet Melinta 10mg
name 10mgof Takeda Tablet
pharmaceuticals
Batch No. HH1271 TR001-1/MEL
● Comparative dissolution studies have been
performed in following mediums:
1. pH 1.2 HCl buffer
2. pH 4.5 Acetate buffer
3. pH 6.8 Phosphate buffer
12. Data of 03 batches will be supported by Yes
13. Compliance Record of HPLC software Yes
21CFR & audit trail reports on product testing.
14. Record of Digital data logger for temperature Yes
REMARKS OF EVALUATORIV
First letter No. F.1-1/2019/PEC-DRAP (AD PEC-IV) Dated: 10-12-2020 communicated and reply by firm as
follows:
S. No. Deficiencies / Short-comings Justification
1. COA of API is of supplier instead of This is to clarify that our supplier Beijing THTD
manufacturer. Clarify. Pharmaceutical Co., Ltd is also a Pharmaceutical
manufacturer and involved in R & D of new drugs together
2. API accelerated & real time stability studies with production and selling of raw materials. For reference
are of supplier instead of manufacturer. please see
Clarify. (http://en.thtdpharm.com/A/?C-1-44.Html).
3. Form 6, form 7 and form 3 for import of API • Initially we selected Beijing THTD Pharma for
is by supplier instead of manufacturer. Clarify. Vonoprazan Fumarate and received all documents
including COA, method of analysis, stability studies
reports with the name of Beijing THTD
Pharmaceutical Co., Ltd. with assurance of the
availability of DMF & GMP. Therefore we
purchased API from Beijing THTD Pharmaceutical
Co.
• Later on DMF & GMP was provided by Beijing

THTD Pharma with the name of Hefei Lifeon
Pharmaceutical Co., Ltd.
• We inquired about change of manufacturer.

Beijing THTD provided us undertaking in which it is
mentioned that:
“Hefei Lifeon Pharmaceutical Co., limited is the
manufacturer for commercial scale manufacturing of
Vonoprazan Fumarate”.
4. You have applied paddle speed = 100RPM in The product Vonoprazan Fumarate tablet is not a compendial
dissolution parameters. Please justify the product. Its dissolution method is also not available in any

speed of paddle with reference to USP general pharmacopoeia as well as in any reference literature so there
chapter <1092> (the dissolution procedure; was no limitation of any specific fixed rpm so we used 100
Development and validation) rpm during development and stability studies to achieve good
dissolution i.e. > 85% at later time point.
As product is fast dissolving in all three pH mediums (pH
1.2, 4.5 and 6.8 see CDP results) so the only reason of 100
rpm was just to increase method robustness and to get
uniform and precise results. Moreover product related
changes e.g. change of formulation or changes of
manufacturing procedure are not expected during
development and stability studies.
• USP general chapter <1092> also allows 100 rpm for
Paddle apparatus with sufficient justification.
• USP also recommends 100 RPM with Apparatus 2
in some of monographs of tablets.
• Further we would like to inform you that now we
have performed dissolution profile study of our
product at 75 rpm in three pH medium (pH1.2, 4.5
and 6.8) and test results in all three mediums meeting
acceptance criteria. (Documents are enclosed as
Annexure I).
• Moreover we would like to inform that 75 rpm can
be used for routine quality control testing for release
of commercial scale batches where product related
changes are expected during manufacturing.
5. Calculations of assay are not as per analytical • As per analytical method the solution is prepared in
method. Clarify only one dilution whereas practically we prepared same
concentration of solution in two steps. Therefore the
final concentration of standard solution is same in
analytical method as well as in calculations.
This practice is in line with USP pharmacopeia, as in
USP monographs usually only final concentration of
standard solution is provided.
Furthermore we are enclosing the revised method which
shows the same method as applied during analysis and
calculations. (See Annexure II)
6. Details of content uniformity at initial testing • We have performed content uniformity at initial stage.
not submitted. (Copy is enclosed as Annexure III).
7. Submit complete Audit trail with date and • Copy of Audit trail is enclosed (See Annexure IV).
time.
• Second letter No. F.1-1/2019/PEC-DRAP (AD PEC-IV) dated: 06-01-2020 communicated as follows:
Shortcoming communicated Reply of firm
• All initially submitted documents including certificate We want to clarify that M/S Beijing THTD
of analysis of API, stability study data, commercial Pharmaceutical technology Co. Ltd. is a supplier for
invoice, form 6 ( License to import drugs for Clinical Vonoprazan Fumarate (Please refer submitted
trial Examination, Test or analysis), form 3 and form 7 undertaking from supplier) and also a DMF holder of
were from Beijing THTD Pharmaceutical Technology Vonoprazan Fumarate (see enclosed DMF reference on
Co Ltd, while GMP certificate and API testing method page# 04). Beijing THTD has also applied for US DMF.

is of Hefei Lifeon Pharmaceutical Co Ltd. In reply you (Reference https://www.pharmacompass.com/us-drug-
have mentioned that you have purchase API from master-files-dmfs/beijing-thtd-pharmaceutical-tech.
Beijing THTD Pharmaceutical Technology Co Ltd and DMF 32831 submission date 26-06-2018). Beijing THTD
also provided an undertaking from Beijing THTD in share technology for contract manufacturing with other
which it is mentioned that Hefei Lifeon Pharmaceutical manufacturers.
Co Ltd China is the manufacturer for commercial scale
We inquired M/S Beijing THTD Pharmaceutical
batches of vonoprazan fumarate . Clarification is
technology Co. Ltd. regarding query of original
required that who is the actual manufacturer of API used
manufacturer of API lot which we purchased for stability
for manufacturing of stabilities batches Keeping in view
studies, they clarified with undertaking that previously
form 6 issued by DRAP.
they had contract with M/S Shandong Yikang
• Provide relevant documents as mentioned above from Pharmaceutical Co. Ltd. for Vonoprazan Fumarate and
actual manufacturer of API used for manufacturing of they supplied API from this source (copy of undertaking
stabilities batches and GMP certificate enclosed). Address of API
manufacturer M/S Shandong Yikang is already mentioned
in submitted form 3 to DRAP which can be verified with
provided GMP certificate of M/S Shandong Yikang.
In China suppliers usually provide their name on CoA,
form 6 and form 7 therefore, name of M/S Beijing THTD
mentioned on previous submitted documents. Now they
have clarified that Beijing THTD has authorized Hefei
Lifeon Pharma for commercial scale manufacturing and
will provide all documents (CoA, MOA, Stability data,
MSDS and DMF) in the name of manufacturing site Hefei
Lifeon.
Previous Decision: Deferred for further deliberations.(M-297)

Reply by firm: This is in reference to our application of Melinta Tablets 10 and 20 mg (Vonoprazan Fumarate tablets)
deferred in 297th meeting of registration board for further deliberation.
Our case was deferred as API supplier cancelled contract manufacturing agreement with manufacturer who supplied
API for stability studies of our product and contracted a different API manufacturer for future supplies.
M/S Beijing THTD Pharmaceutical Technology Co. Ltd. is our supplier. Previously they had contract with M/S
Shandong Yikang Pharmaceutical Co. Ltd and they supplied API from that source which we used in stability studies
but later they authorized M/S Hefei Lifeon Pharma for commercial scale manufacturing of Vonoprazan Fumarate and
provided all documents (CoA, MOA, Stability data, MSDS and DMF) in the name of this new manufacturing site
(M/S Hefei Lifeon Pharma).
Now we would like to inform you that we have arranged API from the new source (M/s. Hefei Lifeon Pharma) for
repeat stability studies of our product Melinta tablets 10 and 20 mg (Vonoprazan Fumarate tablets).
All documents related to purchase of API from M/S Hefei Lifeon Pharma like copy of DRAP receiving NOC, Form3,
Form6, Form7, GMP, COAs are enclosed with the application for ready reference.
As we have already submitted 06 months accelerated stability data along with 18 months data of real time stability
study with previous manufacturer, we would request competent authority to allow us to submit 03 months stability
data of our product with new source of API for registration.
We shall provide a written undertaking to continue 06 months accelerated stability studies and real time stability
studies till shelf life and also submit stability data to competent authority if required.
We further request to pend our application till submission of fresh stability data of 03 months.
I hope your kind honour will consider our application and give us favour in this regard.
Previous Decision: Registration Board acceded firm’s request and deferred for submission of stability data as per
requirement decided in 293rd meeting.(M-307)

Evaluation by PEC: Now firm submitted data from new Source the details of which are as follows.
Manufacturer of API M/S Hefei Lifeon Pharmaceutical Co., Ltd China
Frequency Accelerated: 0,3,6 ( month)
Real Time: 0,3,6 (month)
No. of Batches 03
No.
applications with stability study data of the Baxib 5mg & 2.5mg Tablet which was conducted on 5th
firm January 2021 and was presented in 297th meeting of
Registration Board held on 12-15 January 2021.
● The firm has 21 CFR compliant HPLC software
● The firm has audit trail reports available.
● The firm possesses stability chambers with digital
data loggers.
2. Certificate of Analysis of API from both API Copy of COA of Vonoprazan fumarate (Batch# 20201201)
Manufacturer and Finished Product from M/S Hefei Lifeon Pharmaceutical Co., Ltd China is
manufacturer. submitted. Copy of COA (Batch# 20201201) from M/S
Tabros Pharma (Pvt) Ltd also submitted.
manufacturer
API manufacturer issued by concerned Lifeon Pharmaceutical Co., Ltd Tangkou Road and
regulatory authority of country of origin. Qingluan Road, Hefei Economic and Technological
Development Zone; No. 446, Wenqu Road, High-tech Zone,
Hefei City. China issued by China Food and Drug
Administration, is submitted. It is valid till 20-12-2022.
approval from DRAP (in case of import). TM20210305-11945E Dated: 05-03-2021 from Chifeng
Eyeris Company Ltd , is submitted attested by
ADC(Karachi) dated ; 22-03-2021 for Vonoprazan fumarate
quantity 250gms
study

applicable)
Melinta 10mg Tablet

TR004-1/MEL 1500 tablets 10-04-2021
TR005-1/MEL 1500 tablets 12-04-2021
TR006-1/MEL 1500 tablets 14-04-2021
Feature Reference Product of Tabros
product

name 10mg of Takeda Tablet
pharmaceuticals
Batch No. 502940 TR006-1/MEL

1. 0.1N HCl
2. Acetate buffer pH 4.5
3. Phosphate buffer pH 6.8
S. Deficiencies / Short-comings Justification
No.
1. Calculations of Assay is not in line with Revised calculations of Assay of finished product analytical
standard and sample preparations in Analytical testing method are in line with standard and sample
testing method. Clarification is required. preparation.
2. Submit calculations for Content uniformity as Calculation of content uniformity is enclosed as
recommended by USP General Chapter <905> recommended by USP General Chapter <905>
Decision:
• Registration Board decided to approve registration of Melinta 10mg Tablet with Innovator’s
specifications by M/s Tabros Pharma Pvt Ltd. Manufacturer will place first three production batches
of products on long term stability studies throughout proposed shelf life and on accelerated studies
for six months.
• Firm shall submit the fee of Rs. 30,000 for change of source of Drug substance and subsequent product
development data, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.

191. Name and address of manufacturer / M/s Tabros Pharma Pvt Ltd. L-20/B,Sector-22, Federal B
Brand Name +Dosage Form + Strength Melinta 20mg Tablet
Vonoprazan Fumarate eq to Vonoprazan..........…20mg
Diary No. Date of R& I & fee Dy.No 1150 dated 18-04-2020 Rs.50,000 /- Dated
18-04-2016
Pharmacological Group Potassium-Competitive Acid Blocker(
Type of Form Form 5D
Pack size & Demanded Price 14‘s: As per SRO
Approval status of product in Takecab 20mg Tablets (PMDA Japan Approved)
Me-too status
GMP status Last inspection conducted on 07/02/18 and concludes that On
the basis of current inspection it was observed that the firm
rectified all observations noted during last GMP Inspection.
Remarks of the EvaluatorIV
Manufacturer of API M/S Beijing THTD Pharmeceuticals Technology Co., Ltd, China
Address: The intersection of Tangkou Road and Qingluan Road, Hefei Economic and
Technological Development Zone; No. 446, Wenqu Road, High-tech Zone, Hefei City.
Frequency Accelerated: 0,,3,6 ( month)
Real Time: 0,3,6,9,12,18 (month)
No. of Batches 03
applications with stability study data of the Vibrenta-VPT 400mg/100mg tablets which was conducted on
firm 19th February , 2018 and was presented in 279th meeting of
Registration Board held on 28-02nd March , 2018.

data loggers.
2. Certificate of Analysis of API from both API Copy of COA of Vonoprazone fumarate (Batch# 20170115)
Manufacturer and Finished Product from M/S Beijing THTD Pharmeceuticals Technology Co.,
manufacturer. Ltd, China is submitted.
manufacturer
API manufacturer issued by concerned Lifeon Pharmaceutical Co., Ltd China issued by China Food
regulatory authority of country of origin. and Drug Administration, is submitted. It is valid till 12-04-
2021.
approval from DRAP (in case of import). 20170108-TPL-A Dated: 08-01-2017 from Beijing THTD
Pharmaceuticals Technology Co., Ltd , is submitted attested
by ADC(Karachi) dated ; 13-02-2018 for Vonoprazan
fumarate quantity 130gms
On form 3 manufacturer address mentioned is No.3288
Yikang Avenue. Tengzhou City. Shandong province
However the name of manufacturer is not mentioned.
study
applicable)
Melinta 0mg Tablet
TR001- 1000 tablets 15-12-2018
2/MEL
TR002- 1000 tablets 20-12-2018
2/MEL
TR003- 1000 tablets 28-12-2018
2/MEL
Feature Reference Product of Tabros
product

Brand Takecab tablet Melinta 20mg Tablet
name 20mgof Takeda
pharmaceuticals
Batch No. HH1254 TR001-2/MEL

follows:
S. # Deficiencies / Short-comings Justification
1.COA of API is of supplier instead of This is to clarify that our supplier Beijing THTD
manufacturer and involved in R & D of new drugs together
2.API accelerated & real time stability studies with production and selling of raw materials. For reference
are of supplier instead of manufacturer. please see
Clarify. (http://en.thtdpharm.com/A/?C-1-44.Html).
• Initially we selected Beijing THTD Pharma for
3.Form 6, form 7 and form 3 for import of API Vonoprazan Fumarate and received all documents
is by supplier instead of manufacturer. Clarify. including COA, method of analysis, stability studies
reports with the name of Beijing THTD
purchased API from Beijing THTD Pharmaceutical
Co.
mentioned that:
4.You have applied paddle speed = 100RPM in The product Vonoprazan Fumarate tablet is not a compendial
dissolution parameters. Please justify the product. Its dissolution method is also not available in any
speed of paddle with reference to USP general pharmacopoeia as well as in any reference literature so there
chapter <1092> (the dissolution procedure; was no limitation of any specific fixed rpm so we used 100
Development and validation) rpm during development and stability studies to achieve good
dissolution i.e. > 85% at later time point.

• USP general chapter <1092> also allows 100 rpm for
Paddle apparatus with sufficient justification.
and 6.8) and test results in all three mediums meeting
acceptance criteria. (Documents are enclosed as
Annexure I).
be used for routine quality control testing for release
of commercial scale batches where product related
changes are expected during manufacturing.
5.Calculations of assay are not as per analytical • As per analytical method the solution is prepared in
method. Clarify only one dilution whereas practically we prepared same
concentration of solution in two steps. Therefore the
final concentration of standard solution is same in
Furthermore we are enclosing the revised method which
shows the same method as applied during analysis and
calculations. (See Annexure II)
6.Details of content uniformity at initial testing • We have performed content uniformity at initial stage.
7.Submit complete Audit trail with date and • Copy of Audit trail is enclosed (See Annexure IV).
time.
Beijing THTD Pharmaceutical Technology Co Ltd and DMF 32831 submission date 26-06-2018). Beijing THTD
also provided an undertaking from Beijing THTD in share technology for contract manufacturing with other
which it is mentioned that Hefei Lifeon Pharmaceutical manufacturers.
Co Ltd China is the manufacturer for commercial scale We inquired M/S Beijing THTD Pharmaceutical
batches of vonoprazan fumarate . Clarification is technology Co. Ltd. regarding query of original

required that who is the actual manufacturer of API used manufacturer of API lot which we purchased for stability
for manufacturing of stabilities batches Keeping in view studies, they clarified with undertaking that previously
form 6 issued by DRAP. they had contract with M/S Shandong Yikang
• Provide relevant documents as mentioned above from Pharmaceutical Co. Ltd. for Vonoprazan Fumarate and
actual manufacturer of API used for manufacturing of they supplied API from this source (copy of undertaking
stabilities batches and GMP certificate enclosed). Address of API
manufacturer M/S Shandong Yikang is already mentioned
in submitted form 3 to DRAP which can be verified with
provided GMP certificate of M/S Shandong Yikang.
form 6 and form 7 therefore, name of M/S Beijing THTD
mentioned on previous submitted documents. Now they
have clarified that Beijing THTD has authorized Hefei
Lifeon Pharma for commercial scale manufacturing and
will provide all documents (CoA, MOA, Stability data,
MSDS and DMF) in the name of manufacturing site Hefei
Lifeon.
follows:
1. COA of API is of supplier instead of This is to clarify that our supplier Beijing THTD
2. API accelerated & real time stability studies manufacturer and involved in R & D of new drugs together
are of supplier instead of manufacturer. with production and selling of raw materials. For reference
Clarify. please see
(http://en.thtdpharm.com/A/?C-1-44.Html).
3. Form 6, form 7 and form 3 for import of API • Initially we selected Beijing THTD Pharma for
is by supplier instead of manufacturer. Clarify. Vonoprazan Fumarate and received all documents
including COA, method of analysis, stability
studies reports with the name of Beijing THTD
purchased API from Beijing THTD
Pharmaceutical Co.
mentioned that:
4. You have applied paddle speed = 100RPM in The product Vonoprazan Fumarate tablet is not a
dissolution parameters. Please justify the compendial product. Its dissolution method is also not
speed of paddle with reference to USP general available in any pharmacopoeia as well as in any reference
chapter <1092> (the dissolution procedure; literature so there was no limitation of any specific fixed
Development and validation) rpm so we used 100 rpm during development and stability
studies to achieve good dissolution i.e. > 85% at later time
point.

• USP general chapter <1092> also allows 100 rpm
for Paddle apparatus with sufficient justification.
and 6.8) and test results in all three mediums
meeting acceptance criteria. (Documents are
enclosed as Annexure I).
be used for routine quality control testing for
release of commercial scale batches where product
related changes are expected during
manufacturing.
5. Calculations of assay are not as per analytical • As per analytical method the solution is prepared in
method. Clarify only one dilution whereas practically we prepared
same concentration of solution in two steps. Therefore
the final concentration of standard solution is same in
Furthermore we are enclosing the revised method
which shows the same method as applied during
analysis and calculations. (See Annexure II)
6. Details of content uniformity at initial testing • We have performed content uniformity at initial stage.
7. Submit complete Audit trail with date and • Copy of Audit trail is enclosed (See Annexure IV).
time.
Beijing THTD Pharmaceutical Technology Co Ltd and DMF 32831 submission date 26-06-2018). Beijing
also provided an undertaking from Beijing THTD in THTD share technology for contract manufacturing
which it is mentioned that Hefei Lifeon Pharmaceutical with other manufacturers.
Co Ltd China is the manufacturer for commercial scale
batches of vonoprazan fumarate . Clarification is We inquired M/S Beijing THTD Pharmaceutical
required that who is the actual manufacturer of API used technology Co. Ltd. regarding query of original
for manufacturing of stabilities batches Keeping in view manufacturer of API lot which we purchased for
form 6 issued by DRAP. stability studies, they clarified with undertaking that

• Provide relevant documents as mentioned above from previously they had contract with M/S Shandong
actual manufacturer of API used for manufacturing of Yikang Pharmaceutical Co. Ltd. for Vonoprazan
stabilities batches Fumarate and they supplied API from this source (copy
of undertaking and GMP certificate enclosed). Address
of API manufacturer M/S Shandong Yikang is already
mentioned in submitted form 3 to DRAP which can be
verified with provided GMP certificate of M/S
Shandong Yikang.

form 6 and form 7 therefore, name of M/S Beijing
THTD mentioned on previous submitted documents.
Now they have clarified that Beijing THTD has
authorized Hefei Lifeon Pharma for commercial scale
manufacturing and will provide all documents (CoA,
MOA, Stability data, MSDS and DMF) in the name of
manufacturing site Hefei Lifeon.
Previous Decision: Deferred for further deliberations.(M-297)

Reply by firm: This is in reference to our application of Melinta Tablets 10 and 20 mg (Vonoprazan Fumarate tablets)
deferred in 297th meeting of registration board for further deliberation.
Our case was deferred as API supplier cancelled contract manufacturing agreement with manufacturer who supplied
API for stability studies of our product and contracted a different API manufacturer for future supplies.
M/S Beijing THTD Pharmaceutical Technology Co. Ltd. is our supplier. Previously they had contract with M/S
Shandong Yikang Pharmaceutical Co. Ltd and they supplied API from that source which we used in stability studies
but later they authorized M/S Hefei Lifeon Pharma for commercial scale manufacturing of Vonoprazan Fumarate and
provided all documents (CoA, MOA, Stability data, MSDS and DMF) in the name of this new manufacturing site
(M/S Hefei Lifeon Pharma).
Now we would like to inform you that we have arranged API from the new source (M/s. Hefei Lifeon Pharma) for
repeat stability studies of our product Melinta tablets 10 and 20 mg (Vonoprazan Fumarate tablets).
All documents related to purchase of API from M/S Hefei Lifeon Pharma like copy of DRAP receiving NOC, Form3,
Form6, Form7, GMP, COAs are enclosed with the application for ready reference.
As we have already submitted 06 months accelerated stability data along with 18 months data of real time stability
study with previous manufacturer, we would request competent authority to allow us to submit 03 months stability
data of our product with new source of API for registration.
We shall provide a written undertaking to continue 06 months accelerated stability studies and real time stability
studies till shelf life and also submit stability data to competent authority if required.
We further request to pend our application till submission of fresh stability data of 03 months.
I hope your kind honour will consider our application and give us favor in this regard.
Previous Decision: Registration Board acceded firm’s request and deferred for submission of stability data as per
requirement decided in 293rd meeting.(M-307)
Evaluation by PEC: Now firm submitted data from new Source the details of which are as follows.
Manufacturer of API M/S Hefei Lifeon Pharmaceutical Co., Ltd China

Frequency Accelerated: 0,3,6 ( month)
No. of Batches 03
No.
applications with stability study data of the Baxib 5mg & 2.5mg Tablet which was conducted on 5th
firm January 2021 and was presented in 297th meeting of
Registration Board held on 12-15 January 2021.
● The firm has 21 CFR compliant HPLC software
● The firm has audit trail reports available.
● The firm possesses stability chambers with digital
data loggers.
2. Certificate of Analysis of API from both API Copy of COA of Vonoprazan fumarate (Batch# 20201201)
Manufacturer and Finished Product from M/S Hefei Lifeon Pharmaceutical Co., Ltd China is
Manufacturer. submitted.
(Pvt) Ltd also submitted.
manufacturer
API manufacturer issued by concerned Lifeon Pharmaceutical Co., Ltd Tangkou Road and
regulatory authority of country of origin. Qingluan Road, Hefei Economic and Technological
Development Zone; No. 446, Wenqu Road, High-tech Zone,
Hefei City. China issued by China Food and Drug
Administration, is submitted. It is valid till 20-12-2022.
approval from DRAP (in case of import). TM20210305-11945E Dated: 05-03-2021 from Chifeng
Eyeris Company Ltd , is submitted attested by
ADC(Karachi) dated ; 22-03-2021 for Vonoprazan fumarate
quantity 250gms
study
applicable)
10. Complete batch manufacturing record of three
stability batches. The firm has submitted copy of Trial batch
manufacturing record.

Melinta 20mg Tablet

TR004-2/MEL 1500 tablets 26-04-2021
TR005-2/MEL 1500 tablets 28-04-2021
TR006-2/MEL 1500 tablets 04-05-2021
11. Record of comparative dissolution data
(where applicable) Firm has submitted Comparative dissolution study of
their product with Innovator’s Brand “Takecab”.
Feature Reference Product of
product Tabros

name 20mg of Takeda Tablet
pharmaceuticals
Batch No. 489507 TR006-2/MEL

1. 0.1N HCl
2. Acetate buffer pH 4.5
3. Phosphate buffer pH 6.8
15. Calculations of Assay is not in line with Revised calculations of Assay of finished product analytical
standard and sample preparations in testing method are in line with standard and sample
Analytical testing method. Clarification is preparation.
required.
16. Submit calculations for Content uniformity as Calculation of content uniformity is enclosed as
recommended by USP General Chapter recommended by USP General Chapter <905>
<905>
Decision:
• Registration Board decided to approve registration of Melinta 20mg Tablet with Innovator’s
specifications by M/s Tabros Pharma Pvt Ltd. Manufacturer will place first three production batches
of products on long term stability studies throughout proposed shelf life and on accelerated studies for
six months.
• Firm shall submit the fee of Rs. 30,000 for change of source of Drug substance and subsequent product
development data, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
192. Name and address of manufacturer M/s Sante Pvt Ltd. 245/2-Z, Block 6, PECHS, Karachi 75400"
/ Applicant

Brand Name +Dosage Form + Xepat-OD 0.7% Opthalmic Solution
Strength
Olopatadine as Hydrochloride eq to Olopatadine……..7mg"
Duplicate
Pharmacological Group Decongestants And Antiallergics
Type of Form Form 5
Pack size & Demanded Price As per PRC
Approval status of product in PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7%For
Reference Regulator Authorities topical ophthalmic administration. USFDA Approved.
Me-too status Could not be confirmed in applied strength.
GMP status 02-07-2019 Conclusion:
Based on the current practices and keeping in view the
attitude of the management towards better compliance of
GMP their overall compliance level for the said dosage
form is rated as Good
Remarks of the Evaluator Firm has ophthalmic section. • Firm has submitted that stability is
under process
Previous Decision Registration Board deferred the case for submission of stability study
data as per the guidelines provided in 278th meeting of Registration
Board.(M-292)
PATADAY ONCE DAILY RELIEF of USFDA approved
Drug Xepat-OD 0.7% Opthalmic Solution
Name of Manufacturer M/s Sante Pvt Ltd. 245/2-Z, Block 6, PECHS, Karachi 75400"
Manufacturer of API M/S Crystal Pharma, S.A.U., a subsidiary of AMRI Parque technologico de Boecillo,
Parcela 105. 47151 Boecillo, Valladolid spain
API Lot No. V0673/0 18030
Description of Pack 2.5 ml LDPE bottle
Stability Storage Real time : 30°C ± 2° C / 35% ± 5% RH
Condition Accelerated: 40°C ± 2°C / 25% ± 5% RH
Frequency Accelerated:0,3,6 ( month)
Real Time: 0,3,6, (month)
Batch No. 05T 06T 07T
No. of Batches 03

No.
with stability study data of the firm product “Zithrosan 1% eye drops” which was presented
Date of inspection: 14th March, 2019.
confirmed.

stability chamber
2. Certificate of Analysis of API from both API Copy of COA of Olopatadine HCl (Batch#V0673/0
Manufacturer and Finished Product 18030) from M/S Crystal Pharma, S.A.U., a subsidiary of
manufacturer. AMRI Parque technologico de Boecillo, Parcela 105.
47151 Boecillo, Valladolid spain is submitted.
Copy of COA (Batch# V0673/0 18030) from M/S Sante

3. Method used for analysis of API from both API Yes
Manufacturer and Finished Product
manufacturer
manufacturer (40°C ± 2°C & 75±5%RH) & long term, 60 Months
(25°C ± 2°C & 60±5%RH) stability study reports of 03
batches
5. Approval of API/ DML/GMP certificate of API Copy of GMP Certificate No # ES/057/20 for M/s
manufacturer issued by concerned regulatory Crystal Pharma, S.A.U., Planta API no esteroides site
authority of country of origin. address Parque technologico de Boecillo, Parcela 105.
47151 Boecillo, Valladolid Spain issued by Agencia
Espanola de Medicamentos y productos Sanitarious, is
submitted. Based on inspection conducted on 13-03-
2020 valid for 3 years
6. Documents for the procurement of API with Copy of Commercial Invoice No: 20190001 Dated: 10-
approval from DRAP (in case of import). 01-2019 from M/S Crystal Pharma, S.A.U., a subsidiary
of AMRI is submitted attested by AD(Karachi) dated ;
15-01-2019 for Oloptadine HCl quantity 2KG
study
applicable)

Xepat-OD Ophthalmic solution
05T 2 Liter 19-06-2019
06T 2 Liter 19-06-2019
07T 2 Liter 19-06-2019
11. Record of comparative dissolution data (where Not applicable

applicable)
respective documents like chromatograms, Raw
data sheets, COA, summary data sheets etc.
13. Compliance Record of HPLC software 21CFR & Yes
S.No Shortcoming Reply

1. Valid Approval of API/ DML/GMP certificate of API Valid GMP certificate submitted
manufacturer issued by concerned regulatory authority of country
of origin
2. Method used for analysis of API from both API Manufacturer and Submitted
Finished Product Manufacturer
3. Stability study data of API from API manufacturer at zone IV-A Only Protocols of stability study
submitted
4. Stability studies initiation date not mentioned Submitted
5. Data of 03 batches will be supported by attested respective Not submitted
documents like chromatograms, Raw data sheets, COA
6. Complete batch manufacturing record of three stability batches Submitted
2nd letter
No.F.1-1/2019/PEC-DRAP (D PEC-IV).
Dated: March,09, 2021
S.No Shortcoming Reply
1. Summary sheets for Real time and Long term, 60 Months (25°C ± 2°C & 60±5%RH) stability study
accelerated Stability study data for 03 reports of 03 batches submitted
batches of API from API manufacturer.
2. Stability studies protocols of API are not Not submitted
according to zone IV-A/B. Submit
stability studies of API according to zone
IV-A/B otherwise submit degradation
studies of finished product for 6th months

in the light of 297th DRB meeting
decision.
3. COA’s of all time points for real time and Submitted
accelerated stability studies of 3 batches of
finished product.
4. Raw data sheets for Assay calculations of Submitted
all time point of finished products.
Third Letter Dated: 29-06-2021
1. Stability studies of API are not according Manufacturer “Crystal Pharma” had performed stability studies
to zone IV-A/B. Submit degradation at following conditions,
studies of finished product for 6th months Zone II For Long term 25°C ± 2°C and 60% ± 5%RH
as per USP monograph in the light of For 40°C ± 2°C and 75% ± 5%RH
297th DRB meeting decision. Accelerated
To comply with other climatic zones, manufacturer had also
performed degradation studies, details attached, and found
following conclusions,
Conclusions
1. Olopatadine HCl is stable after 24h in solution.
2. Olopatadine HCl is stable at 105°C after 24h.
3. Olopatadine HCl is stable at 150°C.
4. The product is stable at daylight radiation after 24 h. The
appearance of the product was not changed after the exposure
5. After the treatment with Hydrochloride acid, 1N, Olopatadine
HCl is found to be stable.
6. After the treatment with Sodium hydroxide, Olopatadine HCl
is found to be stable.
7. Oxidizing conditions: After oxidizing conditions Olopatadine
HCl suffers a slight degradation (2%).
8. Combined conditions:
- Acid condition at 60°: Olopatadine shows a little degradation
(0.5%)
- Alkaline conditions at 60°C: Olopatadine shows a very slightly
degradation.
- Oxidizing conditions at 60°C: The product degrades around
20%.
9. After each degradation test, the peak of Olopatadine HCl was
shown to represent a pure substance since the purity angle was
below the purity threshold in each case. This demonstrates that
the product peak is homogeneous and does not mask any other
impurities.
As conclusion the HPLC method adopted by manufacturer is as
per USP and same will be used for FPP analysis and suitable to
determine the impurities originated after the forced degradation
conditions; and during stability conditions conducted at Zone II
or Zone-IVA/IVB or any, the method is stability indicating.
Decision:
• Registration Board decided to approve registration of Xepat-OD 0.7% Opthalmic Solution with USP
specifications by M/s Sante Pvt Ltd.
• Manufacturer will place first three commercial batches of product on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
• Moreover, Manufacturer will conduct degradation studies on commercial Batches.

193. Name and address of manufacturer / M/s AGP Limited B-23, S.I.T.E., Karachi
Applicant
Brand Name +Dosage Form + Strength Rigix-D Tablet
Composition Each bilayer Sustain release tablet contains:
Cetirizine HCl (USP) …5mg
Pseudoephedrine HCl (USP) …120mg
Diary No. Date of R& I & fee Diary No:2197, 08-12-2016, Rs: 50,000/- 08-12-2016
Pharmacological Group Histamine antagonist & Adrenergic antagonist
Type of Form Form 5-D
Finished product Specifications BP
Pack size & Demanded Price 10‘s, 30’s : As per SRO
Approval status of product in ZYRTEC-D 12 HOUR of USFDA approved
Me-too status
GMP status cGMP certificate on the basis of evaluation conducted on03-06-
2021
Remarks of the Evaluator. • Firm is requesting for change of brand name from Rigix-D to
Rigix Plus Via A letter by company dated 11-01-2021.
Details of Pseudoephedrine permission M/s AGP Limited B-23, S.I.T.E Karachi firm has requested for
grant of permission to purchase
Pseudoephedrine HCl for Trial Batches/Stability Studies of their
following product. The firm has informed that they have acquired
the permission to purchase 900gm of Pseudoephedrine from M/s
alpha Chemicals (Pvt.) limited on dated 12th February, 2018. As
this product is a bilayer tablet having a combination of
Pseudoephedrine HCl in sustained release from (Layer 1) and
Cetirizine HCl in immediate release form (Layer 2), they are in
need of more Pseudoephedrine HCl to produce the large trial
batches for stability studies. This will also confirm the
reproducibility of trial batches.
Decision of Registration Board: Registration Board decided to
recommend allocation of controlled drug substance i.e
Pseudoephedrine Hydrochloride for trial/stability batches of
Rigix-D Tablet & also acceded to the request for purchase of
above mentioned Reference Standards from USP. However,
previously acquired material consumption record shall be verified
by Area FID.
The Board further advised the firm to maintain records of used
substances and waste materials having above API and shall be
destroyed after approval of Controlled Drug Division, DRAP (M-
290)
Drug Rigix-D Tablet
Name of Manufacturer M/s AGP Limited B-23, S.I.T.E., Karachi
Manufacturer of API Cetirizine HCl : M/s Praveen Laboratories Limited Block No.206 Moje- Jolwa, Taluka-
Palsana, Dist-Surat, Gujrat India
Pseudoephedrine HCl : M/s alpha Chemicals (Pvt.) limited pakistan
API Lot No. Cetirizine HCl :MK40119138
Pseudoephedrine HCl :20PEH-0404

Description of Pack ALU/PVC/PVDC
Intermediate: 25°C ± 2° C / 60% ± 5% RH
Frequency Accelerated:0,3,6 ( month)
Real Time: 0,6 (month)
Intermediate: 0,3,6
No. of Batches 03
No.
1. Reference of previous approval of Firm has referred to onsite inspection report of their product Glyzia-XR
applications with stability study data tablets which was conducted on 26th September, 2018 and was presented
of the firm in 285th meeting of Registration Board held on 03-04th October , 2018.
• The firm possesses stability chambers with digital data loggers.
2. Certificate of Analysis of API from Cetirizine HCl : Copy of COA of Cetirizine HCl (Batch# MK40119138)
both API Manufacturer and Finished from M/s Praveen Laboratories Limited Block No.206 Moje- Jolwa,
Product manufacturer. Taluka-Palsana, Dist-Surat, Gujrat India
is submitted.
Copy of COA (Batch# MK40119138) from M/s AGP (Private) Limited
is submitted.
Pseudoephedrine HCl : Copy of COA of Fluticasone propionate
(Batch# 20PEH-0404.) from M/s alpha Chemicals (Pvt.) limited is
submitted.
Copy of COA (Batch# 20PEH-0404) from M/s AGP (Private) Limited
is submitted.
3. Method used for analysis of API Yes
from both API Manufacturer and
Finished Product manufacturer
4. Stability study data of API from API Cetirizine HCl : The firm has submitted copy of accelerated, 06 Months
manufacturer (40°C ± 2°C & 75±5%RH) & long term, 60 Months (30°C ± 2°C &
75±5%RH) stability study reports of 03 batches
Pseudoephedrine HCl : The firm has submitted copy of accelerated, 06

Months (40°C ± 2°C & 75±5%RH) & long term, 60 Months (30°C ± 2°C
& 75±5%RH) stability study reports of 03 batches
5. Approval of API/ DML/GMP Cetirizine HCl (USP): Copy of GMP certificate S-GMP/21092927
certificate of API manufacturer for M/s Praveen Laboratories Limited Block No.206 Moje- Jolwa,
Taluka-Palsana, Dist-Surat, Gujrat India issued by Food and Drug

issued by concerned regulatory Adminstration Gujrat state india, issued on 20-09-2021 and, valid
authority of country of origin. upto 19-09-2023
Pseudoephedrine HCl : Submitted DML No3000373 of basic
manufacturing also receipt of renewal of drug manufacturing License
of dated: 15-10-2020
They also submitted letter No# 996/2021-DRAP (DDG) dated: 18-
January, 2021 by Additional director Drug Regulatory Authority of
Pakistan Lahore that “The License has not been suspended or cancelled
as per record of this office.
6. Documents for the procurement of Cetirizine HCl :Copy of form 3, 5, 7 and Commercial Invoice No:
API with approval from DRAP (in Ex/060 Dated: 27-12-2019 from M/s Praveen Laboratories Limited
case of import). India attested by AD DRAP (Karachi) dated ; 01-01-2020 for Cetirizine
HCl batch No# MK40119138
Pseudoephedrine HCl : Copy of Commercial Invoice No:
ACL/20PEH/010 Dated: 09-05-2020 from M/s alpha Chemicals (Pvt.)
limited for Pseudoephedrine HCl batch No# 20PEH-0404 mentioning
3.65Kg
7. Protocols followed for conduction of Yes
stability study
9. Drug-excipients compatibility Same excipients used as used by innovator.
studies (where applicable)
10. Complete batch manufacturing The firm has submitted copy of Trial batch
record of three stability batches. manufacturing record.
Rigix-D Tablet
TR-610 8000 Tablets 24-06-2020
TR-611 8000 Tablets 24-06-2020
TR-612 8000 Tablets 24-06-2020
11. Record of comparative dissolution Firm has submitted Comparative dissolution study of
data (where applicable) their product with Innovator’s Brand “Rigix-D”.
Feature Reference product Product of AGP

Brand name Cirrus Tablet Rigix-D Tablet
Batch No. 268988 TR-611
● Comparative dissolution studies have been performed in

following mediums:
12. Data of 03 batches will be supported Yes
by attested respective documents
like chromatograms, Raw data
sheets, COA, summary data sheets
etc.
13. Compliance Record of HPLC Yes
software 21CFR & audit trail reports
on product testing.

14. Record of Digital data logger for Yes
S.NO Shortcomings communicated Reply

1. Submit Evidence of bilayer tablet machine. We have already purchased the compression machine for
the single/bilayer tablets. An undertaking is enclosed with
related documents
2. Method used for analysis of API’s from Method used for analysis of API’s from Finished Product
Finished Product manufacturer. manufacturer is attached.
3. Submit Real time Stability study data of Real time Stability study data of cetirizine HCl According
cetirizine HCl According to zone IV-A/B from to zone IV-A from API manufacturer is enclosed.
API manufacturer.
4. Submit Accelerated Stability study data of Accelerated Stability study data of Pseudoephedrine HCl
Pseudoephedrine HCl from API manufacturer. from API manufacturer is enclosed.
5. Submit valid Approval of API/ DML/GMP Valid approval of GMP certificate of cetirizine HCl
certificate of cetirizine HCl manufacturer issued manufacturer is enclosed.
by concerned regulatory authority of country of
origin.
6. Approval of API/ DML/GMP certificate of Valid approval of DML certificate of pseudoephedrine HCl
Pseudoephedrine HCl issued by concerned is enclosed
7. Stability condition for Real time stability 25°C We would like to clarify that this product is not available in
± 2° C / 60% ± 5% RH . Clarification is required. Pakistan and Innovator’s storage condition is store at 20°C
to 25°Cn. The product I also complying the USP
Specifications and as per USP, the recommended storage
condition is “Store below 25°C”
Therefore, we have conducted the stability studies on the
following conditions:
30°C ± 2° C / 65% ± 5% RH
40°C ± 2° C / 75% ± 5% RH
25°C ± 2° C / 60% ± 5% RH
As per stability results till 12 months, this product is stable
at both temperature conditions i.e 25°C ± 2° C / 60% ± 5%
RH and 30°C ± 2° C / 60% ± 5% RH and it is also stable at
40°C ± 2° C / 75% ± 5% RH
Evaluation : (Firm submitted conducted on 0,3, 6th
month 25°C ± 2° C / 60% ± 5% RH and 0, 6th month 30°C
± 2° C / 65% ± 5% RH and data submitted. In reply
summary sheets of stability at 30°C ± 2° C / 65% ± 5%
RH for 0, 6, 9 & 12th months are included.)
8. Compliance Record of HPLC software 21CFR The audit trail is printed on each chromatogram submitted
& audit trail reports on product testing. in the dossier regarding stability studies.
Decision: Deferred for justification of not performing long/real term stability studies testing at 3rd month time
point.
Agenda of Evaluator PEC-VII

New sections:
Case No. 01: M/s Sayyed Pharmaceutical (Pvt) Ltd,67/2, Phase 3, Industrial estate, hattar, Haripur.

M/s M/s Sayyed Pharmaceutical (Pvt) Ltd,67/2, Phase 3, Industrial estate, hattar, Haripur has been granted additional
section Tablet section (Psychotropic) section) dated 07-04-2020 by Licensing division DRAP. Now the firm has
submitted following applications as per the details mentioned in the table below:
Tablet section (Psychotropic): 01 Molecules / 02 Products
194. Name, address of Applicant / Marketing M/s Sayyed Pharmaceutical (Pvt) Ltd,67/2,Phase 3,Industrial
Authorization Holder estate, hattar, Haripur.
Name, address of Manufacturing site. M/s Sayyed Pharmaceutical (Pvt) Ltd,67/2,Phase 3,Industrial
estate, hattar, Haripur.
☐ Importer

☐ Export sale
Closyd 0.5mg tablet
name
Pharmaceutical ingredient (API) per unit Clonazepam…….0.5mg
Pharmaceutical form of applied drug White, Round shaped, bisect oral tablet
Pharmacotherapeutic Group of (API) Benzodiazepine
Klonopin 0.5mg tablet by M/s Roche, USFDA Approved.
authorities
For generic drugs (me-too status) Rivotril 0.5 mg Tablet by M/s Martin Dow
GMP status of the Finished product New Section approved on 09/04/2020
manufacturer Tablet (Psychotropic)
Name and address of API manufacturer. M/s Cambrex Profarmaco Milano S.R.L Via Curiel,34-20067
Paullo-Milano, Italy.
Module III (Drug Substance) Official monograph of Clonazepam is present in USP. The firm
as submitted detail of nomenclature, structure, general

impurity A & related substances (2-Amino-5-
Chlorobenzophenone), specifications, analytical procedures
Batches: (340118),(341936), (338199)
analytical procedure (including dissolution testing at acidic
and buffer medium) and its verification studies, batch analysis
comparative dissolution profile Comparator product that is Rivotril 0.5mg tablet by Martin
Dow by performing quality tests (Identification, Assay,
CDP has been performed against the same brand that is Rivotril
0.5mg tablet by Roche in Acid media (pH 1.2), (pH 4.5), &
Phosphate Buffer (pH 6.8). The values for f1 and f2 are in the
acceptable range.
Manufacturer of API M/s Cambrex Profarmaco Milano S.R.L Via Curiel,34-20067 Paullo-
Milano,Italy.
API Lot No. 605526
Description of Pack
Alu-PVC blister packed in unit carton (5×10’s)
Batch No. Trial-01 Trial-02
Batch Size 5000 tab 5000 tab
Manufacturing Date 07-2021 07-2021
Date of Initiation 31-07-2021 31-07-2021
No. of Batches 02
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. II-API/44/H/2019 issued by
API manufacturer issued by concerned Italian Medicine Agency.

3. Documents for the procurement of API with Copy of letter No. F.5-1/2021-CD (M-73)dated 22/02/2021
approval from DRAP (in case of import). for the purpose of test/analysis and stability studies is granted.
Invoice No.1000000757 dated 28/04/2021
testing
Remarks OF Evaluator VII:
S No Section #. Deficiencies Replies
1. 1.6.5 For drug substance GMP certificate number IT-API/20/H/2022 issued by
manufacture Valid GMP AIFA-Italian medicine agency
issued by the relevant
regulatory authority of
country of origin is needed
2. 3.2.P.3.5 Process validation and/or Process validation and/or evaluation, for applications of
evaluation, For applications locally manufactured drug products, a brief description
of locally manufactured drug of process validation including the proposed protocol
products, a brief description data is submitted
of process validation
including the proposed
protocol shall be described.
3. 3.2.P.5.6 Justification of specifications Firm has followed USP monograph for the said product.
A discussion should be Specifications, analytical procedures and acceptance
provided on the omission or criteria are as per USP (data submitted).
inclusion of certain tests, For the reason that tablets must be able to withstand the
evolution of tests, analytical rigors of handling and transportation experienced in the
procedures and acceptance manufacturing plant, in drug distribution system, and in
criteria the field at the hands of the end users
(Patients/consumers), Manufacturing processes such as
packaging and printing can involve considerable stresses,
which the tablets must be able to withstand. Some other
physical tests are performed to assess the strength of the
compact as well as response to contact with water and
other liquids. Theses tests include
1: Disintegration ( USP 701) 2 : Tablet Friability ( USP
1216)
and Tablet breaking force (Hardness) ( USP 1217)
4. 3.2.P.4.5 Reference of previous Tablet Alprazolam 0.25 mg, Tablet Alprazolam 0.5 mg
approval of applications with and Tablet Alprazolam 1 mg approved in DRB M-313
stability study data of the firm (No inspection)
(if any)
5. 3.2.P.5 In assay the injection volume 100 μl injection loop is fixed from the manufacturer with
prescribed in USP is 50 ul but our HPLC.
firm used 100 ul. justification In the assay as per USP final concentration of standard
is needed and sample is 0.1 mg/ml
OR 0.1 µg/µl ( Note 1 mg = 1000µg , and 1 ml = 1000µl),
in USP in the assay the injection volume prescribed is 50
µl, so final concentration to be injected with 50 µl
injection volume would be 0.1 x 50 = 5 µg

The Firm in the assay prepared the standard and sample
concentration 2 times less to the concentration specified
in USP i.e 0.05 mg/ml OR 0.05 µg/µl, so the final
concentration injected into the chromatograph in the
assay with 100 µl volume injection is 0.05 x 100=5 µg.
So in the assay the same concentration of standard and
sample injected which was required as per USP.
Also By Using 100 µl, RSD of standard in system
suitability is less than 2%, which is within the limit. (Data
submitted)
Also follow Lambert-Beer law
6. Letter of approval for import Firm provides the Letter # 5-1/2021-CD(M73) of
of narcotic/psychotropic approval for import of narcotic/psychotropic substance
substance for manufacturing (Clonazepam) for manufacturing of trial batches and
of trial batches and conduction of stability studies
conduction of stability studies
Decision: Approved.
application.
195. Name, address of Applicant / Marketing M/s Sayyed Pharmaceutical (Pvt) Ltd,67/2,Phase 3,
Authorization Holder Industrial estate,hattar,Haripur.
Name, address of Manufacturing site. M/s Sayyed Pharmaceutical (Pvt) Ltd,67/2,Phase 3,
Industrial estate,hattar,Haripur.
☐ Importer

☐ Export sale
Details of fee submitted PKR 30,000/-: (#290706655061) dated 06/12/2021
The proposed proprietary name / brand name Closyd 2mg tablet
Pharmaceutical ingredient (API) per unit Clonazepam…….2mg
Pharmacotherapeutic Group of (API) Benzodiazepine
The status in reference regulatory authorities Klonopin 2mg tablet by M/s Roche, USFDA
Approved.
For generic drugs (me-too status) Rivotril 2 mg Tablet by M/s Martin Dow

GMP status of the Finished product manufacturer New Section approved on 09/04/2020
Tablet (Psychotropic)
Name and address of API manufacturer. M/s Cambrex Profarmaco Milano S.R.L Via
Curiel,34-20067 Paullo-Milano, Italy.
nomenclature, structure, general properties,
solubilities, physical form, manufacturers, description
Module III (Drug Substance) Official monograph of Clonazepam is present in USP.
The firm as submitted detail of nomenclature,
structure, general properties, solubilities, physical
form, manufacturers, description of manufacturing
process and controls, tests for impurity A & related
substances (2-Amino-5-Chlorobenzophenone),
Batches: (340118),(341936), (338199)
impurities, specifications, analytical procedure
(including dissolution testing at acidic and buffer
medium) and its verification studies, batch analysis
product.
dissolution profile against the Comparator product that is Rivotril 2mg
tablet by Martin Dow by performing quality tests
(Identification, Assay, Dissolution, Uniformity of
dosage form).
CDP has been performed against the same brand that
is Rivotril 0.5mg tablet by Martin Dow in Acid media
(pH 1.2), (pH 4.5), & Phosphate Buffer (pH 6.8). The
Analytical method validation/verification of product Method verification studies have submitted including
linearity, range, accuracy, precision, specificty.
Manufacturer of API M/s Cambrex Profarmaco Milano S.R.L Via Curiel,34-20067 Paullo-Milano,
Italy.
API Lot No. 605526
Description of Pack Alu-PVC blister packed in unit carton (3×10’s)

Batch No. Trial-01 Trial-02
Batch Size 5000 tab 5000 tab
Manufacturing Date 08-2021 08-2021
Date of Initiation 09-08-2021 09-08-2021
No. of Batches 02
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. II-API/44/H/2019 issued
manufacturer issued by concerned regulatory by Italian Medicine Agency.
3. Documents for the procurement of API with approval • Copy of letter No. F.5-1/2021-CD (M-73)dated
from DRAP (in case of import). 22/02/2021 for the purpose of test/analysis and
stability studies is granted.
• Invoice No.1000000757 dated 28/04/2021
5. Compliance Record of HPLC software 21CFR & Submitted
and accelerated)
S No Section #. Deficiencies Replies
1. 1.6.5 For drug substance GMP certificate number IT-API/20/H/2022 issued by
manufacture Valid GMP AIFA-Italian medicine agency
issued by the relevant
regulatory authority of
country of origin is needed
2. 3.2.P.3.5 Process validation and/or Process validation and/or evaluation, For applications of
evaluation, For applications locally manufactured drug products, a brief description of
of locally manufactured drug process validation including the proposed protocol data is
products, a brief description submitted
of process validation
including the proposed
protocol shall be described.
3. 3.2.P.5.6 Justification of specifications Firm has followed USP monograph for the said product.
A discussion should be Specifications, analytical procedures and acceptance criteria
provided on the omission or are as per USP (data submitted).
inclusion of certain tests, For the reason that tablets must be able to withstand the
evolution of tests, analytical rigors of handling and transportation experienced in the
procedures and acceptance manufacturing plant, in drug distribution system, and in the
criteria field at the hands of the end users (Patients/consumers),

Manufacturing processes such as packaging and printing
can involve considerable stresses, which the tablets must be
able to withstand. Some other physical tests are performed
to assess the strength of the compact as well as response to
contact with water and other liquids. Theses tests include
1: Disintegration ( USP 701) 2 : Tablet Friability ( USP
1216)
and Tablet breaking force (Hardness) ( USP 1217)
4. 3.2.P.4.5 Reference of previous Tablet Alprazolam 0.25 mg, Tablet Alprazolam 0.5 mg and
approval of applications with Tablet Alprazolam 1 mg approved in DRB M-313 (No
stability study data of the inspection)
firm (if any)
5. 3.2.P.5 In assay the injection volume 100 μl injection loop is fixed from the manufacturer with
prescribed in USP is 50 µl our HPLC.
but firm used 100 ul. In the assay as per USP final concentration of standard and
justification is needed sample is 0.1 mg/ml
OR 0.1 µg/µl ( Note 1 mg = 1000µg , and 1 ml = 1000µl),
in USP in the assay the injection volume prescribed is 50
µl, so final concentration to be injected with 50 µl injection
volume would be 0.1 x 50 = 5 µg
The Firm in the assay prepared the standard and sample
concentration 2 times less to the concentration specified in
USP i.e 0.05 mg/ml OR 0.05 µg/µl, so the final
concentration injected into the chromatograph in the assay
with 100 µl volume injection is 0.05 x 100=5 µg.
So in the assay the same concentration of standard and
sample injected which was required as per USP.
Also By Using 100 µl, RSD of standard in system suitability
is less than 2%, which is within the limit. (Data submitted)
Also follow Lambert-Beer law
6. Letter of approval for import Firm provides the Letter # 5-1/2021-CD(M73) of approval
of narcotic/psychotropic for import of narcotic/psychotropic substance (Clonazepam)
substance for manufacturing for manufacturing of trial batches and conduction of
of trial batches and stability studies
conduction of stability
studies
Decision: Approved.
application.

Item No. I: Agenda of Evaluator PEC-VII
Case no. 01 Registration applications for local manufacturing of (Human) drug
a. Deferred cases
196. Name and address of manufacturer / M/S Sigma Pharma International (Pvt) Ltd. Plot # E-50 North
Applicant Western Industrial Zone,Bin Qasim, Karachi.
Brand Name +Dosage Form + Strength Ecvir 0.5 mg tablet
Entecavir as monohydrate……..…0.5mg
Diary No. Date of R& I & fee Dy.No.22939, 13-6-18, Rs. 20,000/-
Form Form-5
Approval status of product in Reference Baraclude tablets by Bristol Myers (MHRA Approved)
Me-too status Livose-C tablets by Wilson
GMP status GMP inspection conducted on 15th September 2017 with
conclusive remarks that firm is operating at satisfactory level of
GMP compliance.
Remarks of Evaluator VII
Decision 285:
Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm on priority.
Remarks of Evaluator VII:

Firm provided the GMP certificate #147/2020-DRAP(K) base on evaluation dated 12 November 2020.
Decision of 316th meeting: Approved
Following cases of were received from PR-I/EFD vide letter No. F. 1-6/2019-PR.I (EFD) dated 17th August, 2020.
According to the contents of the letter the firm has claimed 3 molecule to be considered on priority against export
worth USD 102,656.27/- which is duly verified from submitted documents (Form E GD and shipment invoices) as
per the decision of Registration Board.
197. Name and address of manufacturer / M/s. Libra (Private) Ltd., 77, Peshawar industrial estate,
Applicant Hayatabad Peshawar
Brand Name +Dosage Form + Strength Spasnil Tablets
Composition Each sugar coated tablet contains:
Hydrated Phloroglucinol…………..80mg
Trimethyl phloroglucinol………….80mg
Diary No. Date of R& I & fee Diary No. Date of R& I & fee Dy.No. 196, 20-3-2015,
Rs.20,000/-
Pharmacological Group Antispasmodic
Form Form-5
Finished product Specifications Innovators
Pack size & Demanded Price 3x10‘s pack ; Rs.400 for 30‘s
Approval status of product in Reference Spasfon sugar coated 80mg/80mg (ANSM) France Approved
Me-too status Despasm Tablet by Irza Pharmaceuticals (Reg#085210)
GMP status Last GMP Inspection of Libra Pharma
GMP certificate dated 14-12-2020 was provided
Remarks of Evaluator VII Evidence of approval of applied formulation in reference

regulatory authorities/agencies which were
declared/approved by the Registration Board in its 249th

meeting.
• Latest GMP inspection report (which should have been
conducted within the period of last one year).
• Evidence of pharmacopoeial reference of finished
product specification. In case, the product is non
pharmacopoeial, submit product specification in the light
of decision taken in 267th meeting of Registration Board.
• Approval of section/manufacturing facility by the
Central Licensing Board. However, you may submit panel
inspection report for renewal of DML verifying the
section/manufacturing facility
Decision 273 Deferred due to paucity of time
S. Query Response
No
1. Evidence of approval of Present in ANSM as sugar
applied formulation in coated not as film coated
reference regulatory tablet as applied by the
authorities/agencies firm
2. Latest GMP inspection GMP certificate dated 14-
report (which should have 12-2020 was provided
been conducted within the
period of last one year).
3. Approval of Tablet genal section
section/manufacturing available
facility by the Central
Licensing Board. However,
you may submit panel
inspection report for
renewal of DML verifying
the section/manufacturing
facility.
4. Justification of overage in Revised formulation is
master formulation. submitted
5. Methylene chloride and Revised formulation is
Sodium cyclamate are submitted
discontinued/banned
excipients. For this reason,
you have
to revise the formulation
and re-submit the same.
Previous decision 312 Deferred for the following
Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved by
the Registration Board in its 275th meeting.
For the confirmation of manufacturing facility, as GMP shows the
suspension of production in Cream/ointment, injection general and
capsule section

Remarks of evaluator VII
S. Query Response
No
1. Evidence of approval The Firm revised its
of applied formulation formulation as sugar
in reference coated tablet which is in
regulatory line with innovators
authorities/agencies product. Without
which were submission of fee
declared/approved by
the Registration Board
in its 275th meeting.
2. For the confirmation Inspection dated 12-08-

of manufacturing 2020 the production is
facility, as GMP resumed in capsule
shows the suspension (General/antibiotic)
of production in Cream ointment, dry
Cream/ointment, powder injection (Ceph)
injection general and
capsule section
Decision: Approved with innovator’s specification. Firm shall submit fee of Rs. 30,000 for correction/pre-
approval change in composition (correction/change of formulation from film-coated tablet to sugar
coated tablet), as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
198. Name and address of manufacturer / M/s. Libra (Private) Ltd., 77, Peshawar industrial estate, Hayatabad
Applicant Peshawar
Brand Name +Dosage Form + Strength Mecofin Tablets
Diary No. Date of R& I & fee Dy.No. 174, 20-3-2015, Rs.20,000/-
Composition Each sugar-coated tablet contains:
Mecobalamin……………..500mcg
Pharmacological Group Coenzyme –type Vitamin B12
Type of Form Form-5
Finished Product Specification JP
Pack size & Demanded Price 2x10’s Rs.100 per 20’s
Approval status of product in Reference Approved by PMDA of Japan
Me-too status Elgin 500 mcg tablet of M/s Novartis Pharma (Pvt)
GMP status Last GMP Inspection of Libra Pharma
GMP certificate dated 14-12-2020 was provided
Remarks of Evaluator VII • Latest GMP inspection report (which should have been
conducted within the period of last one year).
• Evidence of pharmacopoeial reference of finished product
specification. In case, the product is non
pharmacopoeial, submit product specification in the light
of decision taken in 267th meeting of Registration Board.
• Approval of section/manufacturing facility by the
Central Licensing Board. However, you may submit panel
inspection report for renewal of DML verifying the
section/manufacturing facility
Decision 273 Deferred due to paucity of time

S. Query Response
No
1. Evidence of approval of Present in PMDA as
applied formulation in sugar coated in line
reference regulatory with applied product
authorities/agencies
2. Latest GMP inspection GMP certificate dated

report (which should have 14-12-2020 was
been conducted within the provided
period of last one year).
3. Approval of Tablet genal section
section/manufacturing available
facility by the Central
Licensing Board. However,
you may submit panel
inspection report for
renewal of DML verifying
the section/manufacturing
facility.
4. Justification of overage in Revised formulation
master formulation. is submitted
5. Methylene chloride and Revised formulation
Sodium cyclamate are is submitted
discontinued/banned
excipients. For this reason,
you have
to revise the formulation
and re-submit the same.
Previous decision 312 Deferred to review and present requirement of JP monograph

regarding storage and testing of drug substance and container
closure system of drug product.
Remarks of evaluator
S. Query Response
No
1. Deferred to review Stored in Light resistant
and present amber color PVC
requirement of JP Testing method is
monograph regarding provided which
storage and testing of mentioned that procedure
drug substance and is conducted without
container closure exposure to light
system of drug Tight container (PVC
product. bister)
Decision: Approved
199. Name and address of manufacturer / M/s Invictus Pharmaceuticals. Plot No. 21,26, Street No.NS-2,
Applicant National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Invoflox 500mg Tablet
Levofloxacin as hemihydrate ….…500mg
Diary No. Date of R& I & fee Form-5 Dy.No 9306 dated 01-03-2019 Rs.20,000/- Dated 28-02-
2019 (#0825812)

Form Form-5
Approval status of product in Reference Levofloxacin (250mg & 500mg) Film-coated Tablets by M/s
Regulatory Authorities Accord Healthcare Limited, MHRA Approved
Me-too status Cubac Tablets 250mg by M/s Schazoo Labs, Reg. No. 47943
GMP status 13-11-2018, The panel recommended the grant
DML.
VII
Remarks of Evaluator In RRA it is approved as film coated tablet
Decision 296: Deferred for clarification of applied formulation since reference product is film coated whereas
firm has applied for tablet.
Remarks VII
The firm provides with the revised master formulation and form 5 for
Each Tablet Contains:
Levofloxacin as hemihydrate …500mg
to
Levofloxacin as hemihydrate …500mg
Fee for the revision is not submitted
Decision: Approved with innovator’s specification. Firm shall submit fee of Rs. 30,000 for
correction/pre-approval change in composition (correction/change of formulation from uncoated tablet
to film coated tablet), as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
200. Name and address of manufacturer / M/s Invictus Pharmaceuticals. Plot No. 21,26, Street No. NS-2,
Applicant National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Urosol 10mg Tablets
Solifenacin as Succinate…10mg
Diary No. Date of R& I & fee Form-5 Dy.No 9315 dated 01-03-2019 Rs.20,000/- Dated 28-02-
2019 (#0825828)
Pharmacological Group Muscarinic antagonist
Form Form-5
Finished product Specifications Manufacturing specification
Pack size & Demanded Price 1x10’s
2x10’s As per SRO
Approval status of product in Reference Vesicare® (5mg& 10mg) film-coated tablet by M/s Astellas
Regulatory Authorities Pharma Ltd, MHRA Approved.
Me-too status Solifen Tablet 10mg by M/s Getz Pharma, Reg. No. 61203
GMP status 13-11-2018, The panel recommended the grant
DML.
Remarks of Evaluator VII In RRA Film coated tablet on communication the firm change its
form 5 and master formulation without fee.

Decision: Deferred for evidence of approval of applied formulation as “uncoated tablets” in reference
regulatory authorities/agencies which were adopted by the Registration Board in its 275th meeting or else the
formulation may be revised in accordance with reference product along with submission of requisite fee.
Remarks VII:
The firm provides with the revised master formulation and form 5 for
to
Fee for the revision is not submitted
correction/pre-approval change in composition (correction/change of formulation from un-coated tablet
to film coated tablet), as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
201. Name and address of manufacturer/ M/s Fynk Pharmaceuticals, 19km G.T. Road Kalashah Kaku,
Applicant Lahore, Pakistan.
Brand Name + Dosage Form + Strength Fyprox CR Tablet 25mg
Composition Each enteric film coated tablet contains:
Paroxetine as hydrochloride……….…25mg
Diary No. Date of R & I & fee Dy. No 7539 dated 22-02-2019 Rs.20,000/- Dated 21-02-2019.
Pharmacological Group Antidepressant
Type of Form Form-5
Finished product Specification USP Specification.
Pack size & Demanded Price 10’s, 30’s: As per SRO
Approval status of product in Reference Approved in USFDA
Me-too status Deroxat CR tablet 25mg by Global Pharma
GMP status GMP inspection conducted on 21-11-17 concluded that firm is
operating at satisfactory level of GMP compliance.
Remarks of the Evaluator Submit composition/label claim of applied formulation in line
with product approved in reference agencies i.e. each enteric,
filmcoated, controlled-release tablet contains paroxetine
hydrochloride equivalent to paroxetine as follows: 12.5 mg–
yellow, 25 mg–pink, 37.5 mg–blue. One layer of the tablet
consists of a degradable barrier layer and the other contains the
active material in a hydrophilic matrix.
Decision of 296th meeting of Registration Deferred for submission of composition/label claim and
Board. : manufacturing method for applied formulation in line with
reference product i.e. each enteric, film-coated, controlled-
release tablet contains paroxetine hydrochloride equivalent to
paroxetine 25 mg. One layer of the tablet consists of a
degradable barrier layer and the other contains the active
Submission by the firm. The firm submitted that their applied formulation in form-5 is
in line with reference product i.e. Each Enteric Film coated,
Controlled-Release Tablet Contains; Paroxetine as
Hydrochloride ……… 25mg.
However, in minutes the word-controlled release is completely
missing.
Remarks of the Evaluator-PEC-XIII • The applied formulation on form-5 is as under:
Each enteric film coated tablet contains:
Paroxetine as Hydrochloride ……………25mg
• Label claim needs revision along with applicable fee.
• GMP certificate issued on 08-08-2019 on the basis of

Previous Decision (297-DRB) Deferred for submission of manufacturing outline as per
reference formulation
Evaluation by PEC The firm did not mention seal coating and enteric coating
Previous Decision (307-DRB) Deferred for submission of manufacturing outline as per the
reference product
Evaluation by PEC VII Revised label claim and master formulation as per reference i.e.
Each enteric film coated control release tablet contains:
Paroxetine as Hydrochloride……….…25mg
Decision: Approved. Firm shall submit fee of Rs.7,500 for correction/pre-approval change in the method
of manufacture, as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021
202. Name and address of manufacturer / M/s Cure Laboratories.Plot # 11,12,NS-2 RCCI, Industrial
Applicant Estate, Rawat, Islamabad
By
M/s Nicholas Pharmaceuticals. Plot # 34, St. # SS-02, National
Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Renom 1g Injection
Meropenem as trihydrate blended with anhydrous sodium
carbonate……..1gm
Diary No. Date of R& I & fee Form-5 Dy.No 13079 dated 06-03-2019 Rs.50,000/- Dated 06-
03-2019 (#0849676)
Pharmacological Group Carbapenem
Form Form-5
Approval status of product in Reference MERREM IV (as the trihydrate blended with anhydrous sodium
Regulatory Authorities carbonate for re-constitution) of sterile meropenem powder.
(USFDA)
Me-too status Mopen 1gm Injection of M/s Hilton Pharma
GMP status M/S Necholas:
GMP certificate dated 7-04-2021 (Valid till 06-04-2023)
M/S Cure Laboratories:
Dated 05-03-2019, Issuance of DML in 269th Meeting of CLB.
Remarks of Evaluator VII Total sections: 3
Total products on toll: No
Previous decision (296) Deferred for consideration on its turn
Decision: Approved
203. Name and address of manufacturer / M/s Cure Laboratories.
Applicant Plot # 11,12,NS-2 RCCI, Industrial Estate, Rawat, Islamabad
By
M/s Nicholas Pharmaceuticals. Plot # 34, St. # SS-02, National
Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Renom 500mg Injection
Meropenem as trihydrate…500mg
03-2019 (#0807635)
Form Form-5

Approval status of product in Reference MERREM IV (as the trihydrate blended with anhydrous sodium
Regulatory Authorities carbonate for re-constitution) of sterile meropenem powder.
(USFDA)
Me-too status Mopen 500mg Injection of M/s Hilton Pharma
GMP status Same As Above


Decision: Approved
204. Name and address of manufacturer / M/s Cure Laboratories.
Applicant Plot # 11,12,NS-2 RCCI, Industrial Estate, Rawat, Islamabad
By
M/s Vision Pharmaceuticals.
Plot # 22,23, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Esocure 40mg Injection
Esomeprazole as Sodium…40mg
03-2019 (#0807480)
Form Form-5
Finished product Specifications Manufacturing specifications
Approval status of product in Reference Nexium IV 40mg/vial injection by M/s ASTRAZENECA
Regulatory Authorities PHARMS (USFDA approved)
Me-too status Esold 40mg/vial Injection of M/s Weather Folds
Pharmaceutical, Reg No. 74824
GMP status M/S Vision:
GMP Certificate issued on 08.05.2018.
VII
Remarks of Evaluator The applicant has submitted that they are not having any
manufacturing on contract basis from any firm. Currently the
firm have 3 Sections.
205. Name and address of manufacturer / M/s Cure Laboratories. Plot # 11,12,NS-2 RCCI, Industrial
By
M/s Vision Pharmaceuticals Plot # 22,23, Industrial Triangle,
Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength P-Role 40mg Injection
Omeprazole as Sodium………40mg
03-2019 (#0807479)
Form Form-5

Approval status of product in Reference Omeprazole 40mg Powder for Solution for Infusion by M/s
Regulatory Authorities Sandoz Limited, MHRA Approved.
Me-too status RISEK 40MG INJECTION. Reg. No. 45617
VII
Remarks of Evaluator The applicant has submitted that they are not having any
manufacturing on contract basis from any firm. Currently the
firm have .. sections.
206. Name and address of manufacturer / M/s Cure Laboratories. Plot # 11,12,NS-2 RCCI, Industrial
By
M/s Vision Pharmaceuticals. Plot # 22,23, Industrial Triangle,
Brand Name +Dosage Form + Strength Quantum 5mg Injection
Composition Each ampoule contains:
Cholecalciferol …5mg
03-2019 (#0807483)
Pharmacological Group Vitamin D3 analogue
Form Form-5
Pack size & Demanded Price 1 ml As per SRO
Approval status of product in Reference Vitamin D3 Good 200,000 IU / 1 ml IM solution for injection of
Regulatory Authorities ( ANSM France approved)
Me-too status D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
GMP inspection dated 11-2-2019 concluding good GMP
compliance
Remarks of Evaluator VII Each Ampoule (1ml) Contains:
Cholecalciferol (Vitamin D3)…200,000 IU Eq. to 5mg/ml
VII
Remarks of Evaluator Total sections: 3
Decision: Deferred according to the decision of 313th meeting of Registration Board, for capacity
assessment of manufacturing and testing facility of M/s Vision Pharmaceuticals Pvt. Ltd. For “Dry
Powder Injection vial section (General)” & “Dry Powder Injection section (Steroid )”, notified vide letter
No. F.15-1/2022-PEC dated 08-03-2022.
207. Name and address of manufacturer / M/s Cure Laboratories Plot # 11,12,NS-2 RCCI, Industrial
By
M/s Vision Pharmaceuticals. Plot # 22,23, Industrial Triangle,
Brand Name +Dosage Form + Strength Mecomet 500mcg Injection
Composition Each 1ml ampoule contains:
Mecobalamin……..500mcg
03-2019 (#0807481)

Form Form-5
Finished product Specifications Manufacturing specicifcations
Pack size & Demanded Price 1 ml ampoule type 1
As per SRO
Approval status of product in Reference Comezengen injection 500 μg of M/s Tatsumi Chemical
Regulatory Authorities (PMDA Japan Approved)
Me-too status Flench injection of M/s Tabros Pharma
(Reg. # 029050)
Decision: Approved wih innovator’s specification. Firm shall submit fee of Rs.7,500 for correction/pre-
approval change in the finished drug product specifications, as per notification No.F.7-11/2021-
208. Name and address of manufacturer / M/s. Winthrox Laboratories Plot # K-219-A, SITE, Super
Applicant Highway Phase II, Karachi
Brand Name +Dosage Form + Strength Womic-D Tablet 830mg+400IU
Diary No. Date of R& I & fee Diary No: 521 , 17/11/2016 , Rs. 20,000/-
Composition Each Tablet contains:
Ossein MineralComplex……..830mg
Vitamin D………………..400 I.U
Pharmacological Group Mineral + Vitamin
Type of Form Form-5
Finished Product Specification Mfg.
Pack size & Demanded Price As per SRO / Pack size as per SRO
Approval status of product in Reference Wellese Calcium and Vitamin D3 Tablet by Botanical
Regulatory Authorities. Laboratories, USA.
Me-too status Bonmin Tablet by M/s. S J & G Fazal Elahi, Karachi.
GMP status 19-11-2020 Routine GMP Inspection “overall GMP compliance
level is rated as good.”
Remarks of Evaluator Evidence of international availability provided by firm could not
be confirmed in reference regulatory authority.
Previous Decision (M275) Registration Board in its 275th meeting decided as under:
Deferred for submission of following:
Evidence of approval in reference regulatory authorities.
Evidence of availability of atomic absorption
spectrophotometer
Remarks of Evaluator XIII Firm provide the evidence of Me-Too product Bonmin Tablet
Registered in the name of M/s. S J & G Fazal Elahi Pvt Ltd,
Karachi. (Reg. No. 070532)
Evidence of availability of atomic absorption
spectrophotometer is required.
Previous Decision (M295) Deferred for confirmation of availability of Atomic absorption
spectrophotometer
Remarks of Evaluator VII Firm provide the evidence of availability of atomic absorption
spectrophotometer. In manufacturing license inspection report
of winthrox Lab dated 1-01-2015 atomic absorption is verified
by Federal inspector of drug in the list of equipment’s.
Previous Decision (M312) Deferred for submission of complete composition of Ossein
mineral complex and confirmation of availability of atomic
absorption spectrophotometer for analysis of minerals.

Remarks of Evaluator VII Firm provide the evidence of availability of atomic absorption
spectrophotometer. In manufacturing license inspection report
of winthrox Lab dated 1-01-2015 atomic absorption is verified
by Federal inspector of drug in the list of equipment’s.
Composition is
Each Film coated tablet contains:
Ossein Mineral Complex 830mg corresponds to:
Calcium….177.6mg
Phosphorous….82.2mg
Residual Mineral Salts…24.9mg
Collagen…224mg
Other Proteins…66.4mg
Trace elements F, Mg, Fe, Zn, Cu, Ni corresponding to approx.
440mg hydroxyapatite
Firm has provided the evidence of the same product Womic-D
in different dosage form i.e. Womic-D oral liquid suspension
registration # 080534 registered by DRAP so request for the
grant of registration as brand extension
Decision: Approved wih innovator’s specification and as per following label claim:
Ossein Mineral Complex 830mg corresponds to:
Calcium….177.6mg
Phosphorous….82.2mg
Residual Mineral Salts…24.9mg
Collagen…224mg
Other Proteins…66.4mg
Trace elements F, Mg, Fe, Zn, Cu, Ni corresponding to approx.
440mg hydroxyapatite
Firm shall submit fee of Rs.7,500 for correction/pre-approval change in the finished drug product
Case no. 02 Registration applications for Form 5D drug

a. New Cases
Priority Registration applications of Export Facilitation
Assistant Director PR-I/EFD vide letter NO.1-6/2019-PR-I (EFD) dated 18-06-2021 has informed that Reg. Board
in its 263rd meeting held on 29-30th November 2016 decided to grant registration on priority basis to the
pharmaceutical firms/manufacturers who have shown appreciable performance in export of pharmaceuticals. The
Board further decided to consider one molecule for each 50,000 USD worth of export of medicines (to a maximum
of 15 such molecules) during a fiscal year. In compliance to the aforementioned decision of the Board, the following
firms have achieved the benchmark of USD 656,218.90/- during FY 2020-21. Following applications submitted by
the firms for priority consideration/ evaluation in lieu of export facilitation are submitted before the Board for its
consideration please:
Name and address of manufacturer / M/s. Nabiqasim Industries (Pvt). Ltd., 17/24,
209. Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Redupres-S 49/51 mg Tablet
Sacubitril……..48.6 mg
Valsartan…..…51.4 mg
(as sacubitril valsartan sodium salt complex).
Diary No. Date of R& I & fee Dy. No 24324 dated 13-12-2017 Rs.50,000/- Dated 13-12-2017
Pharmacological Group Angiotensin II receptor blocker
Type of Form Form 5

Pack size & Demanded Price 10’s, 14‟s As per SRO
Approval status of product in Entresto™ (sacubitril/valsartan) Tablets, 97/103, 49/51, and
Reference Regulator Authorities 24/26 mg (USFDA)
Me-too status NA
GMP status 03.08.2017, The firm is operating at an acceptable level of
compliance of GMP requirements at the time of inspection.
Remarks of the Evaluator Assay is by HPLC method
Drug Redupres-S 49/51 mg Tablet
Name of Manufacturer M/s. Nabiqasim Industries (Pvt). Ltd., 17/24, Korangi Industrial Area, Karachi
Manufacturer of API Sacubitril/valsartan: M/s Zhuhai Rundu Pharmaceutical Co.,
Ltd, China
Address: No 6,North airport Road Sanzao Town, Jinwan District
Zhuhai, Guangdong province China
API Lot No. sacubitril/valsartan: 57318060103
Description of Pack
As per SRO
Stability Storage Condition Real time: 30°C ± 2° C / 75% ± 5% RH
Accelerated: 40 °C ± 2 °C/75% ± 5%
Frequency Accelerated: 0,1,2,3,4, 6 (month)
Batch No. 375DS01 375DS02 375DS03
Batch Size 1500 1500 1500
No. of Batches 03
Date of Submission 2/June/2021 (15245)
Sr. Documents to Be Provided Status
No.
1. Reference of previous approval of applications with A panel inspection of Sofosbuvir 400 mg tablet
stability study data of the firm conducted on 26th October 2020 and approved in 297
meeting. Audit trail on the testing reports cannot be
made as audit trail was not activated.
2. Certificate of Analysis of API from both API For Sacubitral/Valsartin:
Manufacturer and Finished Product The firm has submitted COA from both API Zhuhai
manufacturer. Rundu Pharmaceutical Co. Ltd China No.6, North
Airport Road, Sanzao Town, Jinwan District,
Guangdong, China and FPP manufacturer
3. Method used for analysis of API from both API
Manufacturer and Finished Product Yes
Manufacturer
4. Stability study data of API from API manufacturer Provided (for zone IV-B)

5. Approval of API/ DML/GMP certificate of API Sacubitril/Valsartan:
manufacturer issued by concerned regulatory The firm has provided copy of Certificate
authority of country of origin. of GMP compliance issued to M/s Zhuhai food and
Drug administration, valid Up to 21-12-2021.
Not provided by Guangdong Province.
6. Documents for the procurement of API with approval Sacubitril/Valsartan:
from DRAP (in case of import). Copy of commercial invoice has been
submitted issued by ADC, Karachi DRAP.
Import quantity: 3.3 kg
Impurities: Provided
Address of Exporter (Head office): M/s
Zhuhai Rundu Pharmaceutical Co. Ltd
China No.6, North Airport Road,Sanzao
Town, Jinwan District, Guangdong, China
7. Protocols followed for conduction of stability study Yes
8. Method used for analysis of FPP Yes (same as API manufacturer)
9. Drug-excipients compatibility studies (where NA
applicable) (Formulation of applied drug product is qualitatively
similar to that of innovator Brand)
10. Complete batch manufacturing record of three The firm has submitted photocopy of Batch
stability batches. Manufacturing Orders of following 03 Batches:
375DS01 1500 10-2020

10-2020
375DS02 1500
375DS03 1500 10-2020
11. Record of comparative dissolution data (where Firm has submitted Comparative dissolution study of
applicable) their product with Innovator’s Brand “Uperio 100 mg
Tablets” The details are as follows:
Reference Test Product
product
Produ Uperio Product Sacubitri
ct 100 mg name l/Valsart
name Tablets an tablet
Batch TEJ85 Batch # 375DS01
#
Mfg 05-2019 Mfg 10-2020
date date
Comparative dissolution studies have been
12. Data of 03 batches will be supported by attested
respective documents like chromatograms, Raw data Yes
Submitted

humidity monitoring of stability chambers (real time Submitted
and accelerated)
REMARKS OF EVALUATOR VII
Sr. Observations/Documents Required Status of Document/Justifications
No.
The firm didn’t provide detailed dissolution
method, 2ndly It shall justify the dissolution
specification NLT 80% (Q) after 45 minutes, since
the USFDA review document of the innovator The revise Finished Product Specification as per
1. product specify dissolution specifications i.e. NLT the reference product is submitted without
(Q) after 25 minutes. Revise the dissolution submission of any fee
specifications to NLT (Q) after 25 minutes as per
the reference product as per the decision of 293rd
meeting of Registration Board.
Submitted GMP Certificate of supplier of API has
The valid GMP Certificate of API Manufacturer
been issued by M/s. Zhuhai Food and Drug
M/s. Zhuhai Rundu Pharmaceutical Co. Ltd.,
2. Administration, instead of Provincial Drug
(Vali till 15-09-2026) issued by the China Food
Regulatory Authority. Clarification is required for
and Drug Administration is provided
this regard.
Firm has not submitted documents for procurement The documents for procurement of reference and
3.
of reference and impurity standards. impurity standards is provided
The valid DML # 000105 (by way of
Valid DML of FPP should be provided as provided
4. formulation) renewed w.e.f. 12-07-2019 and
one is expired.
valid upto 11-07-2024 is attached
In Reference of previous approval of application We in this regard would like to state that our latest
with stability study data firm provides the panel GMP Inspection report carried out by the DRAP
inspection of Sofosbuvir 400 mg tablet conducted Panel for our new drug “Novasept 7.1% Gel” on
on 26th October 2020 and approved in 297 meeting 27th October 2020 (Report enclosed herewith)
but the Audit trail of the testing reports cannot be confirms the availability of audit trials on the
made as audit trail was not activated. So, on that testing report. Copy of Inspection Report of
base exemption could be granted. Novasept Gel is product
Comparative Dissolution Profile. We are also enclosing Firm has submitted

Comparative dissolution study of their product
with Innovator’s Brand “Uperio 100 mg
product
Prod Uperio Produ Sacubit
uct 100 mg ct ril/Vals
nam Tablets name artan
e tablet
Batc TEJ85 Batch 375DS
h# # 01
Mfg 05- Mfg 10-
date 2019 date 2020
Comparative dissolution studies have been done
in 3 mediums
Decision: Deferred for consideration on turn as product development data was submitted on 02-06-2021.

Sacubitril……..24.3mg
(as sacubitril valsartan sodium salt complex).
Diary No. Date of R& I & fee Dy. No 24322 dated 13-12-2017 Rs.50,000/- (#0709180) Dated
13-12-2017
Type of Form Form 5

Me-too status NA
Remarks of the Evaluator • Assay is by HPLC method

• Certificate for NMDA provided
Manufacturer of API Sacubitril/Valsartan: M/s Zhuhai Rundu Pharmaceutical Co.,
Ltd, China
Address: No 6, North airport Road Sanzao Town, Jinwan District
API Lot No. Sacubitril/Valsartan: 57318060103
Description of Pack
As per SRO
Accelerated: 40 °C ± 2 °C/75% ± 5%
Batch No. 374DS01 374DS02 374DS03
Batch Size 1500 1500 1500
No. of Batches 03
Date of Submission 28/5/2021 (14567)
No.

meeting.
2. Certificate of Analysis of API from both API For Sacubitral/Valsartan:
Manufacturer
authority of country of origin. (Certificate# …) of GMP compliance issued to M/s
Zhuhai food and Drug administration, valid Up to 21-
12-2021.
stability batches. The firm has submitted photocopy of Batch
Manufacturing Orders of following 03 Batches:
374DS01 1500 10-2020

10-2020
374DS02 1500
374DS03 1500 10-2020
11. Record of comparative dissolution data (where No

applicable) Firm has submitted Comparative dissolution study of
their product with Innovator’s Brand “Uperio 100 mg
product

#
Mfg 05-2019 Mfg 10-2020
date date
Comparative dissolution studies for other strengths
not performed. It has been performed with competitor
product Uperio 100 mg by Novartis for higher
strength i.e. Sita/Met XR 100/1000 mg as
formulation is dose proportional)
Provided
humidity monitoring of stability chambers (real time Provided
and accelerated)
No.
The firm didn’t provide detailed dissolution method,
2ndly It shall justify the dissolution specification NLT
80% (Q) after 45 minutes, since the USFDA review
The revise Finished Product Specification as
document of the innovator product specify dissolution
1. per the reference product is submitted without
specifications i.e. NLT (Q) after 25 minutes. Revise the
submission of any fee
dissolution specifications to NLT (Q) after 25 minutes
rd
as per the reference product as per the decision of 293
The valid GMP Certificate of API
Submitted GMP Certificate of supplier of API has been
Manufacturer M/s. Zhuhai Rundu
issued by M/s. Zhuhai Food and Drug Administration,
2. Pharmaceutical Co. Ltd., (Vali till 15-09-2026)
instead of Provincial Drug Regulatory Authority.
issued by the China Food and Drug
Clarification is required for this regard.
Administration is provided
Firm has not submitted documents for procurement of The documents for procurement of reference
3.
reference and impurity standards. and impurity standards is provided
Valid DML of FPP should be provided as provided one
is expired.
In Reference of previous approval of application with We in this regard would like to state that our
stability study data firm provides the panel inspection latest GMP Inspection report carried out by the
of Sofosbuvir 400 mg tablet conducted on 26th October DRAP Panel for our new drug “Novasept 7.1%
2020 and approved in 297 meeting but the Audit trail Gel” on 27th October 2020 (Report enclosed
of the testing reports cannot be made as audit trail was herewith) confirms the availability of audit
not activated. So, on that base exemption could be trials on the testing report. Copy of Inspection
granted. Report of Novasept Gel is product

Comparative Dissolution Profile.
We are also enclosing Firm has submitted
Comparative dissolution study of their product
with Innovator’s Brand “Sacvin 50 mg tablet”
product
Prod Sacvin Produ Sacubit
nam tablet name artan
e tablet
Batc IA0Z9 Batch 375DS
h# # 01
Mfg 1-2021 Mfg 10-
date date 2020
done in 3 mediums
Sacubitril……..97.2 mg
(as sacubitril valsartan sodium salt complex)
Diary No. Date of R& I & fee Dy. No 24322 dated 13-12-2017 Rs.50,000/- (#0709182) Dated
13-12-2017
Type of Form Form 5
Me-too status NA
Remarks of the Evaluator • Assay is by HPLC method

• The firm didn’t provide detailed dissolution method, 2ndly it
shall justify the dissolution specification NLT 80%(Q) after
45 minutes, since the USFDA review document of the
innovator product specify dissolution specifications i.e NLT
(Q) after 25 minutes. Revise the dissolution specifications to
NLT (Q after 25 minutes as per the reference product and as
per the decision of 293rd meeting of Registration Board.
• GMP certificate by API manufacturer Not provided by
Guangdong Province. But the city

• Reference and working standard missing
• Certificate for NMDA provided

Manufacturer of API Sacubitril/Valsartan: M/s Zhuhai Rundu Pharmaceutical Co., Ltd,
China
Address: No 6, North airport Road Sanzao Town, Jinwan District
Description of Pack
As per SRO
Accelerated: 40 °C ± 2 °C/75% ± 5%
Batch No. 376DS01 376DS02 376DS03
Batch Size 1500 1500 1500
No. of Batches 03
Date of Submission 11 June 2021 (11251)
No.
meeting.
2. Certificate of Analysis of API from both API For Sacubitral/Valsartan:
Manufacturer
authority of country of origin. (Certificate# …) of GMP compliance issued to M/s
Zhuhai food and Drug administration, valid Up to 21-
12-2021.

stability batches. The firm has submitted photocopy of Batch
Manufacturing Orders of following 03 Batches:
376DS01 1500 10-2020

10-2020
376DS02 1500
376DS03 1500 10-2020
applicable) their product with Innovator’s Brand “Uperio 100 mg
product
#
Mfg 05-2019 Mfg 10-2020
date date
Comparative dissolution studies for other strengths
not performed. It has been performed with competitor
product Uperio 100 mg by Novartis for higher
strength i.e. Sita/Met XR 100/1000 mg as
formulation is dose proportional)
Provided

humidity monitoring of stability chambers (real time Provided
and accelerated)
No.
The firm didn’t provide detailed dissolution method,
2ndly It shall justify the dissolution specification
NLT 80% (Q) after 45 minutes, since the USFDA
review document of the innovator product specify The revise Finished Product Specification as
1. dissolution specifications i.e. NLT (Q) after 25 per the reference product is submitted without
minutes. Revise the dissolution specifications to submission of any fee
NLT (Q) after 25 minutes as per the reference
product as per the decision of 293rd meeting of
Registration Board.
Submitted GMP Certificate of supplier of API has The valid GMP Certificate of API
been issued by M/s. Zhuhai Food and Drug Manufacturer M/s. Zhuhai Rundu
2. Administration, instead of Provincial Drug Pharmaceutical Co. Ltd., (Vali till 15-09-2026)
Regulatory Authority. Clarification is required for issued by the China Food and Drug
this regard. Administration is provided
Firm has not submitted documents for procurement The documents for procurement of reference
3.
of reference and impurity standards. and impurity standards is provided
Valid DML of FPP should be provided as provided
one is expired.
In Reference of previous approval of application We in this regard would like to state that our
with stability study data firm provides the panel latest GMP Inspection report carried out by the
inspection of Sofosbuvir 400 mg tablet conducted on DRAP Panel for our new drug “Novasept 7.1%
26th October 2020 and approved in 297 meeting but Gel” on 27th October 2020 (Report enclosed
the Audit trail of the testing reports cannot be made herewith) confirms the availability of audit
as audit trail was not activated. So, on that base trials on the testing report. Copy of Inspection
exemption could be granted. Report of Novasept Gel is product
Comparative Dissolution Profile.

We are also enclosing Firm has submitted
Comparative dissolution study of their
product with Innovator’s Brand “Uperio 200
mg Tablets” The details are as follows:
product
Prod Uperio Produ Sacubit
nam Tablets name artan
e tablet
Batc TEJ85 Batch 375DS
h# # 01
Mfg 2021 Mfg 10-
date date 2020
done in 3 mediums
212. Name and address of manufacturer / M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial
Applicant Zone, Port Qasim, Karachi.

Brand Name +Dosage Form + Strength Erlin-S 15/100 mg Tablet
Composition "Each Film Coated Tablet Contains:

Ertugliflozin L-Pyroglutamic Acid 19.43 mg eq. to
Ertugliflozin……15mg
Sitagliptin Phosphate Monohydrate 128.5 mg eq. to
Sitagliptin…….100mg"
Diary No. Date of R& I & fee Diary No. Date of R& I & fee Dy.No 10089 dated 04-03-2019
Rs.50,000/- Dated 21-2-2019 (0794087)
Pharmacological Group Anti-Diabetic (A10BK04), (A10BD24)
Finished product Specification Innovator specifications
Pack size & Demanded Price As per SOP
Approval status of product in Reference STEGLUJAN™ (ertugliflozin and sitagliptin)
Me-too status NA
GMP status 07-02-2019 issuance of GMP certificate.
Drug Erlin-S 15/100 mg Tablet
Name of Manufacturer M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial Zone, Port Qasim,
Karachi.
Manufacturer of API Ertugliflozin as L-Pyroglutamic acid: Shanghai Pharma group
Changzhou kony Pharmaceuticals co., Ltd Daixi street Luoyang town Wujin district
Changzhou, Jiangsu China is submitted
Sitagliptin Phosphate Monohydrate: Zhejiang yonta pharmaceutical co LTD No 1
4th Donghai avenue Zhejiang provincial chemical and medical raw material base
Linhai zone Linhai city Zhejiang province China
API Lot No. Ertugliflozin L-Pyroglutamic Acid: ETG20190101
Sitagliptin Phosphate Monohydrate: 1827-0001-19049
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0,1,2,3,4,6 months
Real Time: 0,3,6 months
Batch No. 19PD-2978-05-T 19PD-2979-06-T 19PD-2980-07-T
Batch Size 2500 2500 2500
No. of Batches 03
Date of Submission 22-12-2020 (Dy. No.34038)

No.
Inspection of Empagmin XR 5/1000 mg Tablet
with stability study data of the firm
conducted on 6 January 2020 and approved in 293
meeting. Case is Approved
2. Certificate of Analysis of API from both API Ertugliflozin: Copy of COA (Batch # ETG2019010) from
Manufacturer and Finished Product M/s Shanghai Pharma Group Changzhou Kony
manufacturer. Pharmaceutical Co., Ltd. Jiangsu China is submitted.
Sitagliptin: M/s Zhejiang Yongtai Pharmaceutical Co.,
Ltd. No.1, 4th Donghai Road, Zhejiang Provincial
Chemical and Medical Raw Material Base Linhai Zone,
Linhai City, Zhejiang Province, 317016, China
Manufacturer and Finished Product Provided
Manufacturer
4. Stability study data of API from API Ertugliflozin: Provided (The firm has submitted
manufacturer accelerated & real time stability studies for 3 batches
(ETG20161201, ETG20161202, ETG20170101) at Real
time: 30°C ± 2°C / 65% ± 5%RH and Accelerated: 40°C ±
2°C / 75% ± 5%RH)
Sitagliptin: Provided (The firm has submitted accelerated
& real time stability studies for 3 batches (1827-0001-
18001, 1827-0001-18002, 1827-0001-18003) at Real time:
30°C ± 2°C / 65% ± 5%RH and Accelerated: 40°C ± 2°C /
75% ± 5%RH)
5. Approval of API/ DML/GMP certificate of API Ertugliflozin: Copy of GMP certificate (certificate
manufacturer issued by concerned regulatory No.JS20180935) issued to Shanghai pharma group
authority of country of origin. Changzhou by CFDA. It is valid until 26/11/2023
Sitagliptin: cGMP certificate # ZJ20170014 issued by
china food and drug administration to the manufacturer
(Zheijiang Youngtai pharmaceuticals co. ltd) and its valid
till 3rd May 2022.
6. Documents for the procurement of API with Ertugliflozin The firm has submitted copy of invoice for
approval from DRAP (in case of import). the purchase (1.2Kg) attested by Assistant Director DRAP,
dated 7-1-2020
Sitagliptin:
The firm has submitted copy of invoice for the purchase
(500 Kg) attested by Assistant Director DRAP, but
commercial invoice was attested provided by Hangzhou
biobounce technology co Ltd.
7. Protocols followed for conduction of stability
Yes
study
9. Drug-excipients compatibility studies (where Drug-excipients compatibility studies were not performed
applicable) as the firm has used the same excipients as of innovator.

10. Complete batch manufacturing record of three The firm has submitted copy of Trial batch manufacturing
stability batches. record. Details are as under:
Batch no. Batch Size Mfg.
Started
19PD-2978- 2500 9-2019
05-T
19PD-2979- 2500 9-2019
06-T
19PD-2980- 2500 9-2019
07-T
applicable) their product with Innovator’s Brand Steglujan”.
Product PharmEvo
Brand Name Steglujan Erlin-S
Tablet Tablet
15mg/100m 15/100mg
g
Batch No. T027271 19PD-2978-
05-T
Comparative dissolution studies have been performed in
following mediums:
respective documents like chromatograms, Raw The firm has submitted photocopy of Batch Manufacturing
data sheets, COA, summary data sheets etc. Record of three stability batches such as.
Ertugliflozin/Sitagliptin
Batch No. Date of Batch Size
Mfg.
19PD- 30-10- 2500 Tablets
2978-05-T 2019
19PD- 30-10- 2500 Tablets
2979-06-T 2019
19PD- 30-10- 2500 Tablets
2980-07-T 2019

Provided
humidity monitoring of stability chambers (real Provided

S Deficiency Response
No
1. Need GMP issued by the province as the current cGMP certificate # ZJ20170014 issued by china
GMP certificate of Copy of GMP certificate food and drug administration to the manufacturer
(certificate No.201807039) issued by Zheijang (Zheijiang Youngtai phamaceuticals co ltd) and
medical Centre for economic development. its valid till 3rd May 2022
2. The GMP, quality control department analysis The Shanghai Pharma Group Changzhou Kony
report and COA is from Shanghai Pharma Group Pharmaceutical Co., Ltd. Jiangsu China is the
Changzhou Kony Pharmaceutical Co., Ltd. Jiangsu manufacturer which might be confirmed by the
China. And on many documents including submitted GMP whereas shanghai pansopharm
commercial invoice name is mentioned as Shanghai technology co Ltd is an exporter of
Pansopharma technology Co., Ltd. Jiangsu China. ertigluphlozin. Declaration letter is provided.
Provide the relationship.
3. Commercial invoice of sitagliptin wasn’t attested Commercial invoice of sitagliptin was attested
and provided by Hangzhou biobounce technology and provided by Hangzhou biobounce
Co LTD not zheijang youngtai pharma. technology Co LTD which is the exporter of
Clarification is needed sitagliptin. zheijang youngtai pharma co Ltd is
the manufacturer of sitagliptin
4. Stability study data of API from API manufacturers Provided
of both active are needed.
5. Reference of previous approval of applications with Provided
stability study data of the firm is needed
6. Certificate of analysis of API from both drug Certificate of analysis of API from both drug
substance and drug product manufacturer substance and drug product manufacturer were
provided
7. Record of comparative dissolution data is needed Provided
8. Compliance Record of HPLC software 21CFR & Provided
audit trail reports on product testing is needed
9. Record of Digital data logger for temperature and Provided
time and accelerated) is needed
Decision: Approved with innovator’s specification

Manufacturer will place first three production batches on long term stability studies throughout proposed
application.
Manufacturer will perform process validation of first three batches as per the commitment submitted in the
213. Name and address of manufacturer / M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial
Applicant Zone, Port Qasim, Karachi.
Brand Name +Dosage Form + Strength Erlin-M 7.5/500 mg Tablet

Ertugliflozin (as L-pyroglutamic acid) …….. 7.5 mg
Metformin hydrochloride……..500 mg
Diary No. Date of R& I & fee Diary No. Date of R& I & fee Dy.No 10089 dated 04-03-2019
Rs.50,000/- Dated 21-2-2019 (0794087)
Pharmacological Group Anti-Diabetic (A10BK04), (A10BD24)

Finished product Specification Innovator specifications
Pack size & Demanded Price As per SOP
Approval status of product in Reference SEGLUROMET (ertugliflozin and Metformin)
Regulatory Authorities USFDA Approved
Me-too status NA
GMP status 07-02-2019 issuance of GMP certificate.
Drug Erlin-S 7.5/100 mg Tablet
Name of Manufacturer M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial Zone, Port Qasim,
Karachi.
Manufacturer of API Ertugliflozin:
M/s Shangai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.,
Daixi Street, Louyang Town, Wujin District, Changzhou, Jiangsu 213105, China.
Metformin HCl:
Smruthi Organics Limited, A-27, MIDC Chincholi, Tal-Mohol, Solapur 413255
Maharashtra State, India.
API Lot No. Ertugliflozin L-Pyroglutamic Acid: LPGA: ETG20190101
Metformin: MET-559/19
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0,1,2,3,4,6 months
Real Time: 0,3,6 months
Batch No. 19PD-3041-02-T 19PD-3042-03-T 19PD-3043-04-T
Batch Size 2500 Tablet 2500 Tablet 2500 Tablet
No. of Batches 03
Date of Submission 22-12-2020 (Dy. No.34038)

No.
with stability study data of the firm product Erli Plus XR Tablet 5/1000mg, 10/1000mg,
12.5/1000mg & 25/1000mg (Empagliflozin + Metformin
HCl XR) which was conducted on 05th December, 2019
and were presented in 293rd meeting of Registration Board
held on 6th -8th Jan, 2020.
• Firm has 21 CFR compliant HPLC software.
• Firm has audit trail reports available.

• Firm possesses stability chambers with digital
data loggers.
2. Certificate of Analysis of API from both API Ertugliflozin- LPGA: Copy of COA of Ertugliflozin L-
Manufacturer and Finished Product pyroglutamic acid eq to Ertugliflozin (L-Pyroglutamic
manufacturer. acid) (Batch# ETG20190101)) from M/s Shangai Pharma
Group Changzhou Kony Pharmaceutical Co., Ltd.,
Daixi Street, Louyang Town, Wujin District, Changzhou,
Jiangsu 213105, China is submitted. Copy of COA from
M/s PharmEvo (private) Limited is submitted.
Metformin HCl:
Copy of COA (Batch# MET-559/19) from Smruthi
Organics Limited A-27, MIDC Chincholi, Tal-Mohol,
Solapur 413255 Maharashtra State, India is submitted.
Copy of COA (Batch# 1835) from M/s PharmEvo
(private) Limited is submitted.
Manufacturer and Finished Product Provided
Manufacturer
4. Stability study data of API from API The firm has submitted accelerated & real time stability
manufacturer studies for 3 batches at Real time: 30°C ± 2°C / 65% ± 5%
RH and Accelerated: 40°C ± 2°C / 75% ± 5%RH)
5. Approval of API/ DML/GMP certificate of API Ertugliflozin- LPGA: Copy of Drug manufacturing
manufacturer issued by concerned regulatory license (License no. JS20180935) for M/s Shangai Pharma
authority of country of origin. Group Changzhou Kony Pharmaceutical Co., Ltd., China
issued by China Food and Drug Administration of the
People’s Republic of China is submitted, valid up to 26-
11-2023.
Metformin: of Drug manufacturing license (License no.
NEW-WHO-GMP/CERT/PD/86368/2019/11/30111) for
Smruthi Organics Limited
A-27, MIDC Chincholi, Tal-Mohol, Solapur 413255
Maharashtra State, India is submitted, valid up to 13-Nov-
2022
6. Documents for the procurement of API with Ertugliflozin The firm has submitted copy of invoice for
approval from DRAP (in case of import). the purchase (1.2 kg) attested by Assistant Director DRAP,
dated 7-1-2020
Metformin: Firm has submitted copy of commercial
invoice specifying import of 3000 Kg metformin dated 27-
11-2018. The invoice is signed by AD (I&E) DRAP
Lahore.
7. Protocols followed for conduction of stability
study
Yes
9. Drug-excipients compatibility studies (where Drug-excipients compatibility studies were not performed
applicable) as the firm has used the same excipients as of innovator.

stability batches. manufacturing record. Details are as under:
Batch no. Batch Size Mfg. Started
19PD-3041-02-T 2500 11-2019
19PD-3042-03-T 2500 11-2019
19PD-3043-04-T 2500 11-2019
applicable) their product with Innovator’s Brand “Segluromet” The
details are as follows:
Product PharmEvo
Brand Segluromet Erlin-M
Name Tablet Tablet
2.5mg/1000 7.5/500mg
mg
Batch No. T042906 19PD-3041-
02-T
Comparative dissolution studies have been performed in
following mediums:
Firm submit letter and clarify that our products
Ertugliflozin L-pyroglutamic acid eq to Ertugliflozin +
Metformin HCl Tablets 2.5mg + 500mg, 2.5mg + 1000mg,
7.5mg + 500mg & 7.5mg + 1000mg are dose proportional
in accordance with EMA Guidelines on the Investigation
of Bioequivalence (extract attached) which states that:
- The pharmaceutical products are manufactured by the
same manufacturing process.
- The Qualitative composition of the different strengths is
the same.
- The composition of strengths are Quantitatively
proportional i.e., amount of all the excipients in the
tablet range is similar to each other with respect to tablet
weight except filler for which the active substance is
adjusted.
In view of the above, we have benchmarked Segluromet
Tablet 2.5mg + 1000mg as reference product for all the
strengths.
12. Data of 03 batches will be supported by attested The firm has submitted photocopy of Batch Manufacturing
respective documents like chromatograms, Raw Record of three stability batches such as.
data sheets, COA, summary data sheets etc. Ertugliflozin/Metformin
Batch No. Date of Batch Size
Mfg.
19PD- 30-10-2019 2500 Tablets
2978-05-T
19PD- 30-10-2019 2500 Tablets
2979-06-T
19PD- 30-10-2019 2500 Tablets
2980-07-T
Yes

humidity monitoring of stability chambers (real Yes
S. No. Deficiency Response
1. Need GMP issued by the province as the current cGMP certificate # ZJ20170014 issued by china
GMP certificate of Copy of GMP certificate food and drug administration to the
(certificate No.201807039) issued by Zheijang manufacturer (Zheijiang Youngtai
medical Centre for economic development. phamaceuticals co ltd) and its valid till 3rd May
2022
2. The GMP, quality control department analysis The Shanghai Pharma Group Changzhou Kony
report is from Shanghai Pharma Group Changzhou Pharmaceutical Co., Ltd. Jiangsu China is the
Kony Pharmaceutical Co., Ltd. Jiangsu China. And manufacturer which might be confirmed by the
on man documents including commercial invoice submitted GMP whereas shanghai pansopharm
name is mentioned as Shanghai Pansopharma technology co Ltd is an exporter of
technology Co., Ltd. Jiangsu China. Provide the ertigluphlozin. Declaration letter is provided.
relationship.
3. Stability study data of API from API manufacturers Provided
of both active are needed.
4. Reference of previous approval of applications with Provided
stability study data of the firm is needed.
5. Certificate of analysis of API from both drug Certificate of analysis of API from both drug
substance and drug product manufacturer substance and drug product manufacturer were
provided.
6. Record of comparative dissolution data is needed. Not Provided

audit trail reports on product testing is needed
and accelerated) is needed.
Decision: Approved with subject to the submission of CDP for same strength before issuance of letter.
application.
Case no. 02 Registration applications for Form 5F drug

b. New Cases
214. Name, address of Applicant / Marketing M/s Valor Pharmaceuticals. 124/A Industrial Triangle,
Authorization Holder Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Valor Pharmaceuticals. 124/A Industrial Triangle,
Kahuta Road Islamabad
☐ Importer


☐ Export sale
Dy. No. and date of submission Dy. No. 23210 dated 30-aug-2021
Details of fee submitted PKR 20,000/- + 10,000
dated 11/12/2020
The proposed proprietary name / brand name Valofam 250mg Tablet
Pharmaceutical ingredient (API) per unit Famciclovir ………250mg
Pharmacotherapeutic Group of (API) Antivirals for systemic use. Nucleosides and
nucleotides excluding reverse transcriptase inhibitors
Proposed Pack size 1×10’s, 21’s,30’s
The status in reference regulatory authorities Famvir by M/s Novartis, USFDA Approved.
For generic drugs (me-too status) Famvir (Reg.018994) of M/s. Novartis, Pakistan.
GMP status of the Finished product manufacturer GMP granted on 10/09/2020
Tablet section approved.
Name and address of API manufacturer. M/s Shanghai Pharma Group Changzhou Kony
Pharmaceutical Co., Ltd. Daixi Street, Luoyang Town,
Wujin District, Changzhou, Jiangsu, China
Module III (Drug Substance) Official monograph of Famciclovir is not present. The
firm as submitted detail of nomenclature, structure,
controls, tests for impurity D, G & related substances
(impurity A & unspecified), specifications, analytical
procedures and its verification, batch analysis and
justification of specification, reference standard,
substance
Stability studies of drug substance Stability study conditions:
Batches: (FCV20150304), (FCV20150304),
(FCV20150304)
medium) and its verification studies, batch analysis and

product.
dissolution profile against the brand leader that is Viracure 250mg tablet by
ATCO Laboratory by performing quality tests
dosage form).
Viracure 250mg Tablets by ATCO Laboratory in Acid
media (pH 1.0-1.2) & Phosphate Buffer (pH 6.8). The
Remarks:
Manufacturer of API M/s Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. Daixi
Street, Luoyang Town, Wujin District, Changzhou, Jiangsu, China
Description of Pack
Batch No. T-007 T-007 T-007
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. JS20180935 issued by
manufacturer issued by concerned regulatory CFDA valid till 26/11/2023.
3. Documents for the procurement of API with • Copy of documents dated 16/07/2020 is submitted
approval from DRAP (in case of import). wherein the permission to import different APIs
including Paroxetine HCl for the purpose of
• AWB No.157-HKG-2717-3381 dated 16/07/2020
attested respective documents like chromatograms,

S. No. Section #. Deficiencies Replies
1. 1.6.5 Valid Drug Manufacturing License issued Drug Manufacturing License # 000496 Valid
by the relevant regulatory authority of till 3-2022 issued by the DRAP to valor
country of origin is needed pharma is provided
2. 3.2.P In Pharmaceutical equivalence submit As Famvir of Novartis was not available
date of analysis, the comparison of the immediately at time of comparative
developed formulation was made by equivalence studies so therefore Viracure of
using local product viracure of Atco when Atco was used. In both the samples and
innovators product by Novartis is reference products showed more than 85%
available in Pakistan. dissolution are with in first 15 minutes so
results are satisfactory
3. 3.2.P.4.5 Regarding query that Excipients of The firm provided the certificate showing
Human or Animal Origin shall be that the magnesium stearate is of plant origin.
addressed for the use of “Magnesium
stearate” in the applied formulation
For excipients of human or animal origin,
a certificate shall be provided, confirming
that the excipient(s) are free from BSE
and TSE. the firm provided the certificate
from “Peter geven” that this magnesium
stearate is from plant source
4. Composition is different from reference In innovators formulation sodium lauryl
product of USFDA sulphate is not included
5. 2.3.P.4 Control of excipients is missing Provided
6. 3.2.P.3.4 Tests and acceptance criteria should be Provided
provided (with justification, including
experimental data) performed at the
critical steps identified in 3.2.P.3.3 of the
manufacturing process, to ensure that the
process is controlled
7. 3.2.P.5.4 In the specifications of coated tablets for It was a typographical error which is
batch T-008 is mentioned as USP but the corrected to innovators specification
tablet is not available in monograph
8. 3.2.P.6 COA of primary / secondary reference Provided
standard including source and lot number
shall be provided
9. 3.2.P.8 Compliance Record of HPLC software Compliance Record of HPLC software
21CFR & audit trail reports on product 21CFR & audit trail reports on product
testing testing is provided
10. 3.2.P.8 Record of Digital data logger for Record of Digital data logger for temperature
temperature and humidity monitoring of and humidity monitoring of stability
stability chambers (real time and chambers is provided
accelerated)

Decision: Deferred for the following:
• Submision of Comparitive dissolution profile (CDP) in three Physiological mediums of pH 1.2, pH 4.5 &
pH 6.8.
• Clarification of difference in composition from the refrence product and submission of Drug-excipient
compatibility studies, since the reference product dosen’t contain sodium lauryl sulphate.
215. Name, address of Applicant / Marketing M/s CCL Pharmaceuticals (Pvt.) Ltd,
Authorization Holder 62-Industrial Estate, Kot Lakhpat, Lahore-54770, Pakistan.
Name, address of Manufacturing site. M/s CCL Pharmaceuticals (Pvt.) Ltd,
62-lndustrial Estate, Kot Lakhpat, Lahore-54770, Pakistan.
☐ Importer
☐ Export sale
Empa-Lina 10/5 tablet
name
Strength / concentration of drug of Each film coated tablet contains:
Active Pharmaceutical ingredient (API) Empagliflozin....................10mg
per unit Linagliptin........................... 5mg
Pharmaceutical form of applied drug Purple colored, oval biconvex shaped film coated tablet.
Pharmacotherapeutic Group of (API)
Drugs used in diabetes, combinations of oral blood glucose
lowering drugs

Innovator
specifications
Proposed Pack size 5's. l0's, 14's, 20's, 28's, 30's, 50's and 100's
The status in reference regulatory Glyxambi l0/5 Tablet by Boehringer lngelheim, USA.
authorities
manufacturer Tablet, Capsule (Antibiotic Non-antibiotics, Cephalosporin),
Syrup (Non-Antibiotics), Dry powder suspension (Non-
Antibiotics, Antibiotics), Dry Powder Injectable (Cephalosporin)
sections approved.
Name and address of API manufacturer. Empagliflozin: M/s Fuxin Long Rui Pharmaceutical Co. Ltd,
Fluoride Industrial Park, Fuxin City, Liaoning Province, China.
Linagliptin: M/s Fuxin Long Rui Pharmaceutical Co. Ltd,
Summarized information related to structure, general properties,

Manufacturers, description of manufacturing process and controls,
Characterization, Impurities, Specifications, Analytical
procedures, Validation of analytical procedure, batch analysis and
submitted.
Module III (Drug Substance) Empagliflozin and Linagliptin have manufacturer specifications.
The firm as submitted detail of General information, General
properties, Manufacturers, description of manufacturing process
and process controls, Characterization, Impurities, Control of drug
substance, Reference standard or materials container closure
Stability studies Empagliflozin:
Batch No Accelerat Long Term
ed
20160606 6 Months 24 Months
Linagliptin:
Real time: 30°C ± 2°C / 65% ± 5%RH for 24 Months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 Months
Batch No Accelerated Long Term
L-20170429-D01-L9-01 6 Months 24 Months
Module-III (Drug Product): The firm has submitted detail of Drug Products including
Description and composition of drug product, Pharmaceutical
Development, Manufacturing process development,
Microbiological attribution, Manufacturer, Master formulations,
Description of Manufacturing Process and Process Controls,
Control of Critical Steps and Intermediates, Process Validation
and/ or Evaluation, Control of Excipients with specification and
Analytical methods, Control of Drug Products including Finished
product specifications and test methods, validation of Analytical
methods, Batch analysis , Characterization of impurities, reference
standard or impurities, Container closure and stabilities studies.
comparative dissolution profile brand leader that is Glyxambi tablet by Boehringer Ingelheim by
performing quality tests (Identification, Assay, Dissolution. CDP
has been performed against the same brand that is Glyxambi tablet
by Boehringer Ingelheim in Medium Buffer pH 6.8, 4.5, 1.2).
Analytical method validation/verification Method verification studies have submitted including Introduction,
of product Verification of assay method, Specificity, Accuracy, Precision,
Linearity concentration and peak range.
Manufacturer of API Empagliflozin: M/s Fuxin Long Rui Pharmaceutical Co. Ltd,

API Lot No. Empagliflozin:
E-20190920-D02-E06-01
Linaglptin:
L-20180705-D01-L09-02
Description of Pack Alu-Alu in bleach board with leaflet
Batch No. ELA-T2-20 ELA-T3-20 ELA-T4-20
No. of Batches 03
applications with stability study data of Brivaracetam tablet 10, 25, 50, 75 and 100 mg Tablets which was
the firm (if any) conducted on 14-10-2020 According to the report following points
were confirmed.
• The firm possesses stability chambers with digital data
loggers
2. Approval of API/ DML/GMP certificate Empagliflozin: Firm had provided valid GMP
of API manufacturer issued by concerned Certificate of M/s Fuxin Long Rui Pharmaceutical
regulatory authority of country of origin. Co., Ltd, China issued by Fuxin Food and Drug
Administration, China valid till 23-08-2023.
Linagliptin: Firm had provided valid GMP
Certificate of M/s Fuxin Long Rui Pharmaceutical
Co., Ltd, China issued by Fuxin Food and Drug
Administration, China valid till 23-08-2023.
3. Documents for the procurement of API Empagliflozin: The firm has imported
with approval from DRAP (in case of Empagliflozin raw material 20 kg (1 drum) from Beijing Sino
import). Hanson import & Export Go., Ltd on 18-12-2019.
Linagliptin: The firm has purchased Linagliptin 1.200 kg from
Beijing Sino Hanson import & Export Go., Ltd on 26.04.2019
through DRAP, Lahore.

chromatograms,
sheets etc.
5. Compliance Record of HPLC software HPLC used in the stability studies of current Product and
21CFR & audit trail reports on product 21 CFR Compliant.
testing

6. Record of Digital data logger for Firm has submitted record of Digital data logger for
temperature and humidity monitoring of temperature and humidity monitoring of stability
stability chambers (real time and chambers.
accelerated)
Decision: Approved.
216. Name, address of Applicant / Marketing M/s CCL Pharmaceuticals (Pvt.) Ltd,
Authorization Holder 62-Industrial Estate, Kot Lakhpat, Lahore-54770, Pakistan.
Name, address of Manufacturing site. M/s CCL Pharmaceuticals (Pvt.) Ltd,
62-lndustrial Estate, Kot Lakhpat, Lahore-54770, Pakistan.
☐ Importer
☐ Export sale
Empa-Lina 25/5 tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin....................25mg
per unit Linagliptin........................... 5mg
Pharmaceutical form of applied drug
Orange coloured, oval biconvex shaped film coated tablet.
Pharmacotherapeutic Group of (API) Drugs used in diabetes, combinations of oral blood glucose
lowering drugs

Innovator
specifications
Proposed Pack size 5's. l0's, 14's, 20's, 28's, 30's, 50's and 100's
The status in reference regulatory Glyxambi 25/5 Tablet by Boehringer lngelheim, USA.
authorities

manufacturer

Tablet, Capsule (Antibiotic Non-antibiotics, Cephalosporin),
Syrup (Non-Antibiotics) , Dry powder suspension (Non-
Antibiotics, Antibiotics), Dry Powder Injectable (Cephalosporin)
sections approved.
Name and address of API manufacturer. Empagliflozin: M/s Fuxin Long Rui Pharmaceutical Co. Ltd,
Summarized information related to structure, general properties,
Manufacturers, description of manufacturing process and controls,
Characterization, Impurities, Specifications, Analytical
procedures, Validation of analytical procedure, batch analysis and
submitted.
Module III (Drug Substance) Empagliflozin and Linagliptin have manufacturer specifications.
The firm as submitted detail of General information, General
properties, Manufacturers, description of manufacturing process
and process controls, Characterization, Impurities, Control of drug
substance, Reference standard or materials container closure
Batch No Accelerated Long Term
Linagliptin:
Real time: 30°C ± 2°C / 65% ± 5%RH for 24 Months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 Months
Batch No Accelerate Long Term
d
L-20170429-D01- 6 Months 24 Months
L9-01
L9-02
L9-02
Module-III (Drug Product): The firm has submitted detail of Drug Products including
Description and composition of drug product, Pharmaceutical
Development, Manufacturing process development,
Microbiological attribution, Manufacturer, Master formulations,
Description of Manufacturing Process and Process Controls,
Control of Critical Steps and Intermediates, Process Validation
and/ or Evaluation, Control of Excipients with specification and
Analytical methods, Control of Drug Products including Finished
product specifications and test methods, validation of Analytical
methods, Batch analysis , Characterization of impurities, reference
standard or impurities, Container closure and stabilities studies.

comparative dissolution profile brand leader that is Glyxambi tablet by Boehringer Ingelheim by
performing quality tests (Identification, Assay, Dissolution has
been performed against the same brand that is Glyxambi tablet by
Boehringer Ingelheim in Medium Buffer pH 6.8, 4.5, 1.2) .
Analytical method validation/verification Method verification studies have submitted including Introduction,
of product Verification of assay method, Specificity, Accuracy, Precision,
Linearity concentration and peak range.

Manufacturer of API Empagliflozin: M/s Fuxin Long Rui Pharmaceutical Co. Ltd,
API Lot No. Empagliflozin:
E-20190920-D02-E06-01
Linaglptin:
L-20180705-D01-L09-02
Description of Pack Alu-Alu in bleach board with leaflet
Batch No. ELB-T2-20 ELB-T3-20 ELB-T4-20
No. of Batches 03
applications with stability study data of Brivaracetam tablet 10, 25, 50, 75 and 100 mg Tablets which was
the firm (if any) conducted on 14-10-2020 According to the report following points
were confirmed.
• The firm possesses stability chambers with digital data
loggers
2. Approval of API/ DML/GMP certificate Empagliflozin: Firm had provided valid GMP Certificate of M/s
of API manufacturer issued by concerned Fuxin Long Rui Pharmaceutical Co., Ltd, China issued by Fuxin
regulatory authority of country of origin. Food and Drug Administration, China valid till 23-08-2023.
Linagliptin: Firm had provided valid GMP Certificate of M/s
Fuxin Long Rui Pharmaceutical Co., Ltd, China issued by Fuxin
Food and Drug Administration, China valid till 23-08-2023.

3. Documents for the procurement of API Empagliflozin: The firm has imported
with approval from DRAP (in case of Empagliflozin raw material 20 kg (1 drum) from Beijing Sino
import). Hanson lmport & Export Go., Ltd on 18-12-2019.
Linagliptin: The firm has purchased Linagliptin 1.200 kg from
Beijing Sino Hanson lmport & Export Go., Ltd on 26.04.2019
through DRAP, Lahore.

chromatograms,
sheets etc.
5. Compliance Record of HPLC software HPLC used in the stability studies of current Product and 21 CFR
21CFR & audit trail reports on product Compliant.
testing
6. Record of Digital data logger for Firm has submitted record of Digital data logger for temperature
temperature and humidity monitoring of and humidity monitoring of stability
accelerated)
Decision: Approved.
217. Name,
` address of Applicant / Marketing Hansel Pharmaceuticals Private Limited 30 km Multan Road,
Authorization Holder Lahore-Pakistan.
Name, address of Manufacturing site. Hansel Pharmaceuticals Private Limited 30 km Multan Road,
Lahore-Pakistan.
☐ Importer
- ☒ Generic Drug Product (GDP)

☐ Export sale
Dy. No. and date of submission Form-5F Dy.No 8359 dated 15-03-2021 Rs.20,000/- dated 28-
08-2020
Details of fee submitted PKR 20,000/ dated 28-08-2020
Norethate-Ject Injection 200mg
name
Strength / concentration of drug of Active Each 1mL ampoule contains:
Pharmaceutical ingredient (API) per unit Norethisterone Enanthate……..200mg
Pharmaceutical form of applied drug 1mL IM oily Injection
Pharmacotherapeutic Group of (API) Sex hormones and modulators of the genital systemhormonal
contraceptives for systemic use (Contraceptive)

Hansel Specifications
specifications
The status in reference regulatory Noristerat 200mg Solution for IM Injection
authorities Marketing Authorization Holder: Bayer plc 400 South Oak
Way Reading
Approval authority / Country: UK / MHRA
For generic drugs (me-too status) NOVA-JECT 200 mg Inj. by M/s Medipharm (Pvt.) Ltd.
Lahore, Reg. No. 019823
manufacturer Hormone Liquid Injectable section approved.
Name and address of API manufacturer. Name: Zhejiang Xianju Junye Pharmaceutical Co., Ltd.
Address: 1 Junye Road, Xianju, Taizhou, Zhejiang, China
/ No.1 Lingxiu Road, Modern Industrial Centralization Zone,
Xianju, Taizhou,
Zhejiang, China.
Module-II (Quality Overall Summary) Hansel Pharmaceuticals Pvt. Ltd. has submitted QOS as per
WHO QOS-PD template. Summarized information related to
nomenclature, structure, general properties, solubility’s,
submitted.
Module III (Drug Substance) The Hansel Pharmaceuticals Pvt. Ltd as submitted detail of
nomenclature, structure, general properties, solubility’s,
process and controls, tests for impurity D, G & related
substances (impurity A & unspecified), specifications,
(Norethisterone Enanthate).
Batches: (NET-001, NET-002, NET-003)
Module-III (Drug Product): The Hansel Pharmaceuticals Pvt. Ltd. has submitted detail of
controls, impurities, specifications, analytical procedure
(including dissolution testing at acidic and buffer medium) and
its verification studies, batch analysis and justification of
stability studies of drug product.
comparative dissolution profile brand leader that is Nova-Ject by Bayer Pharma by performing
quality tests (Identification, Assay, pH, Particulate matter,
Sterility). Dissolution Profile in Not applicable in Norethate-
Ject Injection

Remarks:
The excipients are Castor oil for injection, Benzyl benzoate
Special test includes fee heptonic acid determination
Manufacturer of API Zhejiang Xianju Junye Pharmaceutical Co., Ltd. , 1 Junye Road, Xianju, Taizhou,
Zhejiang, China
API Lot No. 3076200701M
Description of Pack 1 amber color ampoule of 1mL packed in unit carton along with disposable syringe,
(Container closure system) alcohol swab and a leaflet.
Batch No. NET-001 NET-002 NET-003
No. of Batches 03
1. Reference of previous approval of It is submission of firm first dossier on CTD format, thus no
applications with stability study data of the inspection conducted regarding stability studies of the applied
firm (if any) product. Firm has submitted the
Audit trail reports and Temperature, Humidity record of Data
logger of stability chamber for both Accelerated and Real
time studies.
2. Approval of API/ DML/GMP certificate of The GMP certificate # ZJ20190169 issued to Zhejiang Xianju
API manufacturer issued by concerned Junye Pharmaceutical Co valid till 29-11-2024 issued by
regulatory authority of country of origin. National medical product administration
3. Documents for the procurement of API with Norethisterone Enanthate 2.0 kg material was imported
approval from DRAP (in case of import). against commercial invoice Number JY20198 for firm
already registered product for export Name “Norez Inj.”
(Reg# 008179-EX), from Zhejiang Xianju Junye
Pharmaceuticals Co. Ltd. China
Thus Use material from available stock for the purpose of
test/analysis and stability studies for the applied product.
21CFR & audit trail reports on product Submitted
testing

S No Section #. Deficiencies Reply
1. 1.6.5 Valid Good Manufacturing Practice (GMP) The GMP certificate # ZJ20190169
certificate of the Drug Substance issued to Zhejiang Xianju Junye
manufacturer issued by relevant regulatory Pharmaceutical Co valid till 29-11-
authority of country) for API’s. Valid date 2024 issued by National medical
on GMP certificate is not visible product administration
2. 3.2.S.4.4 Provide results of analysis of relevant The COA and batch analysis of batch
batch(es) of Drug Substance performed by # 3076190701M of dug substance is
Drug Product manufacturer used during provided
along with Certificate of Analysis (COA).
3. 3.2.P.6 COA of primary / secondary reference COA of primary / secondary
standard including source and lot number reference standard provided
shall be provided
4. 3.2.P.8 Stability: Provides commercial invoice Norez injection is there registered
along with the quantity mentioned on it. The product. It is a combination of two
firm stated that “Norethisterone Enanthate products Norethisterone Enanthate
2.0 kg material was imported against Estradiol Valerate
commercial invoice Number JY20198 for Thus, Use material from available
firm already registered product for export stock for the purpose of test/analysis
Name “ Norez Inj.” (Reg# 008179-EX) , and stability studies for the applied
from Zhejiang Xianju Junye product.
Pharmaceuticals Co. Ltd. China”
Thus Use material from available stock for
the purpose of test/analysis and stability
studies for the applied product. But no
previous registration of Norethisterone
Enanthate product is here on the name of
Hensel pharma
Justify?
5. 3.2.S.4.1 “Free haptonic acid, and limit of ethynyl These tests are performed by drug
group” are performed. With reference to substance manufacturer which are
above cited extract, justification shall be mentioned in specifications
submitted for the exemption of these test by
both drug substance and drug product
manufacturer
6. Provide the evidence of appropriate section
for this product The firm has injectable (Hormones)
section granted in 227th meeting of
CLB
approval change in the finished drug product specifications, as per notification No.F.7-11/2021-B&A/DRAP
dated 13-07-2021.
218. Name, address of Applicant / Marketing M/s Martin Dow Limited, Plot no. 37, Sector 19, Korangi
Authorization Holder Industrial Area, Karachi
Name, address of Manufacturing site. M/s Martin Dow Limited, Plot no. 37, Sector 19, Korangi
Industrial Area, Karachi

☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 170… dated 18-6-2021
PKR 25,000/-: dated 03-06-2021
The proposed proprietary name / brand name Empator-L Tablet 10mg + 5mg
Pharmaceutical ingredient (API) per unit Empagliflozin…………….10mg
Linagliptin……..…………..5mg
Pharmacotherapeutic Group of (API) Drugs used in diabetics (Combination of oral blood
glucose lowering drugs)
Reference to Finished product specifications Manufacturer specifications
The status in reference regulatory authorities GLYXAMBI 10mg/5mg TABLET by Boehringer
Ingelheim, USFDA, UK & Health Canada Approved.
GMP status of the Finished product GMP certificate issued on 11-6-2020
manufacturer
Name and address of API manufacturer. Empagliflozin: RUYUAN HEC Pharm Co., Ltd. Xiaba
Development Zone, Ruyuan County, Shaoguan City,
Guangdong Province, P.R. China.
Linagliptin: Fuxin Long Rui Pharmaceutical
Co.,Ltd. Fluoride Industrial Park, Fumeng
County (Yi Ma Tu), Fuxin City, Liaoning Province -
123000, China
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO
QOS PD template.
closure system and stability studies of in APIMFs of both
drug substances
Empagliflozin:

Batches: (EGLZ-20160501, EGLZ-20160502, EGLZ-
20160503)
Linagliptin:
Batches: (L-20170429-D01-L9-01, L-20170429-D01-L9-
02, L-20170429-D01-L9-03)
Module-III (Drug Product): The firm has submitted detail of manufacturer, description
of manufacturing process and controls, impurities, speci
fications, analytical procedure (including dissolution
testing at acidic and buffer medium) and its validation
dissolution profile the Innovator product that is Glyxambi tablet 10mg+5mg
by Boehringer Ingelheim, USA by performing quality tests
(Identification, Disintegration, Assay, Dissolution,
Glyxambi tablet 10mg+5mg by Boehringer Ingelheim,
USA in Acid media (pH 1.2), Acetate buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and f2 are in
the acceptable range.
Analytical method validation/verification of Method Validation studies have submitted including
Manufacturer of API Empagliflozin: RUYUAN HEC Pharm Co., Ltd. Xiaba Development Zone,
Ruyuan County, Shaoguan City, Guangdong Province, P.R. China.
Linagliptin: Fuxin Long Rui Pharmaceutical Co., Ltd. Fluoride Industrial Park,
Fumeng County (Yi Ma Tu), Fuxin City, Liaoning Province -123000, China
API Lot No. Empagliflozin: 202004002
Linagliptin: L20200219D
Description of Pack
Batch No. NPD-T-1209-L NPD-T-1278-L NPD-T-1279-L
No. of Batches 03

with stability study data of the firm (if any) product Empator 10mg Tablets which was conducted on
6th August 2019 and was presented in 291st meeting of
Registration Board held on 02nd – 4th September 2019.
data loggers.
2. Approval of API/ DML/GMP certificate of API Empagliflozin: Copy of GMP Certificate for RUYUAN
manufacturer issued by concerned regulatory HEC Pharm Co., Ltd. (Certificate: 2018024) issued by
authority of country of origin. Shaoguan Food and
Drug Administration & valid upto 04-12-2021 is
submitted. Copy of Declaration letter from RUYUAN
HEC Pharm Co., Ltd. for assuring that CFDA authority is
not issuing GMP certificates now, is also submitted.
Linagliptin: Copy of GMP certificate for Fuxin Long Rui
Pharmaceutical Co., Ltd issued by Liaoning Fuxin
Management committee for Fluoride Industrial
Development zone. & Valid up to 23-Aug-2023 is
submitted
3. Documents for the procurement of API with Empagliflozin: Firm has submitted copy of invoice
approval from DRAP (in case of import). (invoice# WIS200034) Dated: 16-04-2020 from WIS
Pharmatech Co., Ltd, cleared by DRAP Karachi office
dated 04-5-2020 specifying import 10Kg Empagliflozin
(Batch# EGLZRD202004002).
Linagliptin: Firm has submitted copy of invoice
(invoice# HN200413-F) Dated: 13-04-2020 from Fuxin
Long Rui Pharmaceutical Co., Ltd, cleared by DRAP
Karachi office dated 08-05-2020 specifying import of
0.75Kg Linagliptin (Batch# L20200219-D01-L09-01).
5. Compliance Record of HPLC software 21CFR Submitted
S Section #. Deficiencies Reply
No
1. 1.6.5 Approval of API/ DML/GMP The GMP certificate # 20160622 valid
certificate of Empagliflozin till 2026 is provided along with drug
manufacturer issued by concerned manufacturer licence of RUYUAN
regulatory authority of country of HEC Pharm Co., Ltd
origin. Inspection report is not
conclusive
2. 3.2.P In USFDA dissolution method The dissolution time point for
database the last recommended sampling was set for Empagliflozin
sampling time is 45minutes but firm and Linagliptin tablets dissolution
according to NDA, “Glyxambi”

last time point is 30 minutes Clinical Pharmacology and
justification is needed Biopharmaceutics review(s) FDA
206073Orig1s000ClinPharmR. (page
50-51 of
206073Orig1s000ClinPharmR.)
3. 3.2.P.4.5 Regarding query that Excipients of Magnesium stearate” is from plant
Human or Animal Origin shall be source as declared by manufacturer
addressed for the use of “Magnesium “Peter Greven” therefore it is not
stearate” in the applied formulation applicable for BSE and TSE
For excipients of human or animal
origin, a certificate shall be provided,
confirming that the excipient(s) are
free from BSE and TSE.
4. 3.2.P.8 The test for uniformity of dosage form Uniformity of Dosage Units is a
is include in the specifications of the critical quality attribute (CQA) for
innovator’s product while the stability controlling consistency in dosing
studies are conducted without requires that the variation in the drug
performing the test for uniformity of substance content of each dosage unit
dosage form, please clarify. be accurately controlled throughout the
manufactured batch and it is typically
demonstrated by one of two
procedures: content uniformity or
weight variation. It is conducted at the
time of release and should be the part
of release specification and both
Empator-L (10 mg + 5 mg & 25 mg +
5mg) batches tested at release (data
included in 3.2.P.5.4 - batch analysis).
Referring to ICH Q1F / WHO

Technical Report Series, No. 1010,
2018 – Annex 10 Appendix 1
(Examples of testing parameters), As
required in general, appearance, assay,
degradation products taken throughout
the time points and microbial limit test
(non-sterile oral dosage forms) at least
at the beginning and at the end of the
shelf life while disintegration and
dissolution additionally and has the
part of stability specification
throughout the shelf lifetime points.
For reference product specification

referred document Glyxambi-EPAR-
public-assessment-report.
dated 13-07-2021.

219. Name, address of Applicant / Marketing M/s Martin Dow Limited, Plot no. 37, Sector 19, Korangi
Authorization Holder Industrial Area, Karachi
Name, address of Manufacturing site. M/s Martin Dow Limited, Plot no. 37, Sector 19, Korangi
Industrial Area, Karachi
☐ Importer
☐ Export sale
PKR 25,000/-: dated 03-06-2021
The proposed proprietary name / brand name Empator-L Tablet 25mg + 5mg
Pharmaceutical ingredient (API) per unit Empagliflozin…………….25mg
Linagliptin……..…………..5mg
Pharmacotherapeutic Group of (API) Drugs used in diabetics (Combination of oral blood
glucose lowering drugs)
Reference to Finished product specifications Manufacturer specifications
Proposed Pack size 7’s, 14’s& 28’s
The status in reference regulatory authorities GLYXAMBI 25mg/5mg TABLET by Boehringer
Ingelheim, USFDA, UK & Health Canada Approved.
GMP status of the Finished product GMP certificate issued 11-6-2020
manufacturer
Name and address of API manufacturer. Empagliflozin: RUYUAN HEC Pharm Co., Ltd. Xiaba
Development Zone, Ruyuan County, Shaoguan City,
Guangdong Province, P.R. China.
Linagliptin: Fuxin Long Rui Pharmaceutical
Co.,Ltd. Fluoride Industrial Park, Fumeng
County (Yi Ma Tu), Fuxin City, Liaoning Province -
123000, China
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO
QOS PD template.
closure system and stability studies of in APIMFs of both
drug substances

Batches: (NPD-T-1210-L, NPD-T-1297-L, NPD-T-1298-
L)
Module-III (Drug Product): The firm has submitted detail of manufacturer, description
testing at acidic and buffer medium) and its validation
dissolution profile the Innovator product that is Glyxambi tablet 25mg+5mg
by Boehringer Ingelheim, USA by performing quality tests
(Identification, Disintegration, Assay, Dissolution,
Glyxambi tablet 25mg+5mg by Boehringer Ingelheim,
USA in Acid media (pH 1.2), Acetate buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and f2 are in
the acceptable range.
Analytical method validation/verification of Method Validation studies have submitted including
Manufacturer of API Empagliflozin: RUYUAN HEC Pharm Co., Ltd. Xiaba Development Zone,
Ruyuan County, Shaoguan City, Guangdong Province, P.R. China.
Linagliptin: Fuxin Long Rui Pharmaceutical Co., Ltd. Fluoride Industrial Park,
Fumeng County (Yi Ma Tu), Fuxin City, Liaoning Province -123000, China
API Lot No. Empagliflozin: 202004002
Linagliptin: L20200219D
Description of Pack
Batch No. NPD-T-1210-L NPD-T-1297-L NPD-T-1298-L
No. of Batches 03

with stability study data of the firm (if any) product Empator 10mg Tablets which was conducted on
6th August 2019 and was presented in 291st meeting of
Registration Board held on 02nd – 4th September 2019.
data loggers.
2. Approval of API/ DML/GMP certificate of API Empagliflozin: Copy of GMP Certificate for RUYUAN
manufacturer issued by concerned regulatory HEC Pharm Co., Ltd. (Certificate: 2018024) issued by
authority of country of origin. Shaoguan Food and
Drug Administration & valid upto 04-12-2021 is
submitted. Copy of Declaration letter from RUYUAN
HEC Pharm Co., Ltd. for assuring that CFDA authority is
not issuing GMP certificates now, is also submitted.
Linagliptin: Copy of GMP certificate for Fuxin Long Rui
Pharmaceutical Co., Ltd issued by Liaoning Fuxin
Management committee for Fluoride Industrial
Development zone. & Valid up to 23-Aug-2023 is
submitted
3. Documents for the procurement of API with Empagliflozin: Firm has submitted copy of invoice
approval from DRAP (in case of import). (invoice# WIS200034) Dated: 16-04-2020 from WIS
Pharmatech Co., Ltd, cleared by DRAP Karachi office
dated 04-5-2020 specifying import 10Kg Empagliflozin
(Batch# EGLZRD202004002).
Linagliptin: Firm has submitted copy of invoice
(invoice# HN200413-F) Dated: 13-04-2020 from Fuxin
Long Rui Pharmaceutical Co., Ltd, cleared by DRAP
Karachi office dated 08-05-2020 specifying import of
0.75Kg Linagliptin (Batch# L20200219-D01-L09-01).
Remarks of evaluator VII:

No
1. 1.6.5 Approval of API/ DML/GMP The GMP certificate # 20160622 valid
certificate of Empagliflozin till 2026 is provided along with drug
manufacturer issued by concerned manufacturer licence of RUYUAN HEC
regulatory authority of country of Pharm Co., Ltd
origin. Inspection report is not
conclusive
2. 3.2.P In USFDA dissolution method The dissolution time point for sampling
database the last recommended was set for Empagliflozin and
sampling time is 45minutes but firm Linagliptin tablets dissolution according

last time point is 30 minutes to NDA, “Glyxambi” Clinical
justification is needed Pharmacology and Biopharmaceutics
review(s) FDA
206073Orig1s000ClinPharmR. (page
50-51 of
206073Orig1s000ClinPharmR.)
3. 3.2.P.4.5 Regarding query that Excipients of Magnesium stearate” is from plant
Human or Animal Origin shall be source as declared by manufacturer
addressed for the use of “Magnesium “Peter Greven” therefore it is not
stearate” in the applied formulation applicable for BSE and TSE
For excipients of human or animal
origin, a certificate shall be provided,
confirming that the excipient(s) are
free from BSE and TSE.
4. 3.2.P.8 The test for uniformity of dosage form Uniformity of Dosage Units is a critical
is include in the specifications of the quality attribute (CQA) for controlling
innovator’s product while the stability consistency in dosing requires that the
studies are conducted without variation in the drug substance content
performing the test for uniformity of of each dosage unit be accurately
dosage form, please clarify. controlled throughout the manufactured
batch and it is typically demonstrated by
one of two procedures: content
uniformity or weight variation. It is
conducted at the time of release and
should be the part of release
specification and both Empator-L (10
mg + 5 mg & 25 mg + 5mg) batches
tested at release (data included in
3.2.P.5.4 - batch analysis).
Referring to ICH Q1F / WHO Technical

Report Series, No. 1010, 2018 – Annex
10 Appendix 1 (Examples of testing
parameters), As required in general,
appearance, assay, degradation products
taken throughout the time points and
microbial limit test (non-sterile oral
dosage forms) at least at the beginning
and at the end of the shelf life while
disintegration and dissolution
additionally and has the part of stability
specification throughout the shelf
lifetime points.
For reference product specification
referred document Glyxambi-EPAR-
public-assessment-report.
dated 13-07-2021.

220. Name, address of Applicant / Marketing M/S City Pharmaceuticals Laboratories
Authorization Holder Plot # 12-A, I-5 Sector 5, New Survey No. 276, Korangi
Name, address of Manufacturing site. M/S City Pharmaceuticals Laboratories
Plot # 12-A, I-5 Sector 5, New Survey No. 276, Korangi

☐ Importer
☐ Export sale
Details of fee submitted PKR 30000/-: dated 06/10/2021
The proposed proprietary name / brand name Amoxi 125mg/5ml Suspension
Strength / concentration of drug of Active Each reconstituted 5ml contains:
Pharmaceutical ingredient (API) per unit Amoxicillin Trihydrate eq. to Amoxicillin ……….
125mg
Pharmaceutical form of applied drug Powder for Reconstitution for Oral use (Suspension)
Proposed Pack size 60 ml 1’s
The status in reference regulatory authorities Amoxicillin 125mg/5ml Powder for reconstitution for
oral use by M/s SANDOZ, USFDA Approved.
For generic drugs (me-too status) ABAC 125mg/5ml (60ml) Suspension by M/s
Rakaposhi, Reg. No. 034689
GMP status of the Finished product manufacturer license granted on 15/06/2016
GMP inspection is pending.
Name and address of API manufacturer. Pharmagen Limited.
Kot Nabi Bukshwala, 34 Km Ferozepur Road, Lahore.
batch analysis and justification of specification,
reference standard, container closure system and
stability studies of drug substance and drug product is
submitted.
Module III (Drug Substance) Official monograph of Amoxicillin Trihydrate is present

and controls, tests for impurity & related substances,
reference standard, container closure system and
product.
dissolution profile against the brand leader that is Amoxil 125mg/5ml
suspension by GSK Pakistan by performing quality tests
(Identification, Assay, pH).
CDP has not been performed because it is not applicable
in this case.
Manufacturer of API Pharmagen Limited.
API Lot No. 00078/522/2021
Description of Pack
Glass bottle with PP cap (1’s)
Batch No. T-001 T-002 T-003
No. of Batches 03

2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 06/2019-DRAP
manufacturer issued by concerned regulatory (AD/607409-530) issued by DRAP valid till 08-01-
3. Documents for the procurement of API with Invoice # 321, Dated 03-02-2021 is submitted.

5. Compliance Record of HPLC software 21CFR & We have maintained manual logs of all tests.
1. 1.6.5 Valid Latest GMP inspection The inspection report for the renewal of DML dated
report which should have been 17 Aug 2021 is submitted
conducted within the period of 3
year for drug product
manufacturer
2. 3.2.S.4.1 Justify why the tests for heavy The drug substance is release as per USP
metals are not performed during specification and the manufacturer state that USP
the stability studies by drug does not state heavy metals as compulsion therefore
substance manufacturer the heavy metal test was not performed during the
stability studies
3. 3.2.P In pharmaceutical equivalence Submitted
submit date of analysis,
chromatographs and batch number
of competitors product.
4. 2.3.P.4 Control of excipients is missing Submitted
5. 3.2.P.3.4 Tests and acceptance criteria Tests and acceptance criteria is provided
should be provided (with
justification, including
experimental data) performed at
the critical steps identified in
3.2.P.3.3 of the manufacturing
process, to ensure that the process
is controlled
6. 3.2.P.8 Evidence of availability of “TOC Evidence of availability of “TOC analyser” &
analyser” & “Liquid Particle “Liquid Particle Counter” in the form of
Counter” shall be submitted. undertaking and QC equipment list is provided
7. 2.3.P.2.5 Discussion of microbiological The USP stated the microbial limit 103 cfu/g
attributes of the Drug Product (e.g. aerobic microbial count that has been achieved by
preservative effectiveness studies adding preservative. We have developed pe
to be performed as per formulation trails to achieve the maximum results
recommendations of and at the current ratio the preservative show best
pharmacopoeia) not provided. results and efficacy
8. 3.2.P.8 Justify the effective date on The stability of the product start from 25-02-2021
stability data sheets for 6 month is the 3d month testing was performed in July 2021
(05-2021) and the 6th month stability test was

26-08-2020 but the stability starts performed on 26-08-2021 because we stated
at 25-02-2021 stability testing from 25-0202021 the effective date
is mentioned as 25-02-2021.
Decision: Approved.
• Manufacturer shall submit microbial attributes of the drug product (e.g preservative effectiveness
studies) before issuance of letter.
221. Name, address of Applicant / Marketing M/s City pharmaceuticals laboratories
Authorization Holder Plot # 12-a, i-5 sector 5, new survey no. 276, korangi
industrial area Karachi Pakistan
Name, address of Manufacturing site. M/s city pharmaceuticals laboratories
Plot # 12-a, i-5 sector 5, new survey no. 276, korangi
industrial area Karachi Pakistan
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. -29432 dated 28/10/2021
Details of fee submitted PKR 30000/-: (3206007404)
dated 06/10/2021
The proposed proprietary name / brand name Amoxi 250 mg/5ml Suspension
Strength / concentration of drug of Active Each reconstituted 5ml contains:
Pharmaceutical ingredient (API) per unit Amoxicillin Trihydrate eq. to Amoxicillin ……….
250mg
Pharmaceutical form of applied drug Powder for Reconstitution for Oral use (Suspension)
The status in reference regulatory authorities Amoxicillin 250mg/5ml Powder for reconstitution for
oral use by M/s SANDOZ, USFDA Approved.
For generic drugs (me-too status) Amoxil 250mg/5ml (60ml) Suspension by M/s GSK,
Reg. No. 006814
GMP status of the Finished product manufacturer license granted on 15/06/2016
GMP inspection is pending.

Name and address of API manufacturer. Pharmagen Limited.
Kot Nabi Bukshwala, 34 Km Ferozepur Road,
Lahore.
Module III (Drug Substance) Official monograph of Amoxicillin Trihydrate is
present in USP. The firm as submitted detail of
of manufacturing process and controls, tests for
impurity & related substances, specifications,
analytical procedures and its verification, batch
of drug substance
medium) and its verification studies, batch analysis
product.
dissolution profile against the brand leader that is Amoxil 250mg/5ml
suspension by GSK Pakistan by performing quality
tests (Identification, Assay, pH).
CDP has not been performed because it is not
applicable in this case.
Analytical method validation/verification of product Method verification studies have submitted including
linearity, range, accuracy, precision, specificity.
Manufacturer of API Pharmagen Limited.
API Lot No. 00078/522/2021
Description of Pack
Glass bottle with PP cap (1’s)

Batch No. T-001 T-002 T-003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 06/2019-DRAP
manufacturer issued by concerned regulatory (AD/607409-530) issued by DRAP valid till 08-01-
3. Documents for the procurement of API with approval Invoice # 321, Dated 03-02-2021 is submitted.

5. Compliance Record of HPLC software 21CFR & We have maintained manual logs of all tests.
and accelerated)
1. 1.6.5 Valid Latest GMP inspection report The inspection report for the renewal of DML
which should have been conducted dated 17 Aug 2021 is submitted
within the period of 3 year for drug
product manufacturer
2. 3.2.S.4.1 Justify why the tests for heavy metals The drug substance is release as per USP
are not performed during the stability specification and the manufacturer state that
studies by drug substance USP does not state heavy metals as compulsion
manufacturer therefore the heavy metal test was not performed
during the stability studies
3. 3.2.P In pharmaceutical equivalence Submitted
submit date of analysis,
chromatographs and batch number of
competitors product.
4. 2.3.P.4 Control of excipients is missing Submitted
5. 3.2.P.3.4 Tests and acceptance criteria should Tests and acceptance criteria is provided
be provided (with justification,
including experimental data)
performed at the critical steps
identified in 3.2.P.3.3 of the
manufacturing process, to ensure that
the process is controlled

6. 3.2.P.8 Evidence of availability of “TOC Evidence of availability of “TOC analyser” &
analyser” & “Liquid Particle “Liquid Particle Counter” in the form of
Counter” shall be submitted. undertaking and QC equipment list is provided
7. 2.3.P.2.5 Discussion of microbiological The USP stated the microbial limit 103 cfu/g
attributes of the Drug Product (e.g. aerobic microbial count that has been achieved
preservative effectiveness studies to by adding preservative. We have developed pe
be performed as per formulation trails to achieve the maximum
recommendations of pharmacopoeia) results and at the current ratio the preservative
not provided. show best results and efficacy
8. 3.2.P.8 Justify the effective date on stability It was typographical error. The stability of the
data sheets for 6 month is 26-08-2020 product start from 25-02-2021 the 3d month
but the stability starts at 25-02-2021 testing was performed in July 2021 (05-2021)
and the 6th month stability test was performed on
26-08-2021 because we stated stability testing
from 25-0202021 the effective date is
mentioned as 25-02-2021.
Decision: Approved.
• Manufacturer shall submit microbial attributes of the drug product (e.g preservative effectiveness
studies) before issuance of letter.
application.
222. Name, address of Applicant / Marketing M/s Nawan Laboratories Ltd. 136, sector 15, KIA,
Authorization Holder Korangi Karachi from M/s Bio-Labs (Pvt) Ltd
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No 145 Industrial
Triangle, Kahuta road, Islamabad.
☐ Importer
☐ Export sale
Details of fee submitted PKR 50,000/- (#2009144) dated 17-02-2021
The proposed proprietary name / brand name Nevitix Injection 500mcg
Strength / concentration of drug of Active Each ml contains:
Pharmaceutical ingredient (API) per unit Mecobalamin ……500mcg
Pharmaceutical form of applied drug Almost red colour solution filled in amber glass ampoule.
Pharmacotherapeutic Group of (API) Antianemia
Reference to Finished product specifications Innovator’s
The status in reference regulatory authorities Methycobal Injection PMDA approved

For generic drugs (me-too status) Amcobal Injection 500mcg/ml by Amson Vaccine &
Pharma 069899
GMP status of the Finished product GMP certificate issued based upon inspection conduct
manufacturer 23-4-2019, valid upto 22-4-2022.
Name and address of API manufacturer. M/s. Vital Laboratories (Pvt) Ltd.
Plant II, Plot No. 1710, GIDC Estate, Phase III, Vapi –
396 195 Gujrat India
template.
Firm has summarized information related to
physical form, manufacturers,
Characterization, specifications, analytical procedures
system and stability studies of drug substance. The firm
has summarized information of drug product including its
process validation protocols, control of excipients,
control of drug product, specifications, analytical
procedures, validation/verification of analytical
reference standard or materials, container closure system
and stability.
Module III (Drug Substance) Firm has submitted detailed data for both drug
substance data related to nomenclature, structure,
manufacturers, description of
drug substance. (assay by HPLC with PDA detector, limit
98to 101%), residual solvent by GC
40 O ± 2 O C /75% ± 5% RH for 6 months. The real time
stability data is conducted at 30OC ± 2 O C / 65% ± 5%
RH for 48 months (batch no. 7805016001, 7805016002
& 7805016003).
impurities, specifications, analytical procedure and its
Pharmaceutical equivalence and comparative Firm has performed pharmaceutical equivalence against
dissolution profile the product Methycobal 500 mg injection by Hilton
Pharma

Manufacturer of API
Vital Laboratories (Pvt) Ltd.
Plant II, Plot No. 1710, GIDC Estate, Phase III, Vapi – 396 195 Gujrat India
API Lot No. MCB2010061

Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. A-431 A-443 A-456
Batch Size 37,000 Ampoules 10,000 Ampoules 10,800 ampoules
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API
GMP certificate # 20031928 of M/s. Vital Laboratories
(Pvt) Ltd. Plant II, Plot No. 1710, GIDC Estate, Phase
authority of country of origin. III, Vapi – 396 195 Gujrat India
valid upto 16-03-2023
3. Documents for the procurement of API with Firm has submitted attested copy of invoice (invoice #
approval from DRAP (in case of import). HHM/2021/00256) attested by AD DRAP
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches along
attested respective documents like with chromatograms, raw data sheets, COA and
chromatograms, Raw data sheets, COA, summary data sheets.
5. Compliance Record of HPLC software 21CFR & N/A
6. Record of Digital data logger for temperature and Firm has submitted record of data logger for temperature
humidity monitoring of stability chambers (real and humidity monitoring of real time and accelerated
time and accelerated) stability chambers.
Sr. No. Section #. Deficiencies Reply
1. 3.2.P.2 How much overage is added in the 30% overage is added

formulation? Justify the percentage of
overage added in the formulation
2. 3.2.P.8 Justify the selection of limit of assay test For the case of Vitamin preparations
as “90 – 150 %” while the official limit normally and most of the cases followed
of vitamin preparations is 120%. Compendial limits are 90-130%. In our
nivitex inj 500mcg we have added 30% of
overage in the batch formula. Unit contains
30% of overage of API,

So considering the addition of 30% of
overage, assay limits are set as 90-150%.
We have now revised the specs and make it
more stringent after complete stability data
and market feedback, so the revised limits
are now set as 90-130%.
3. 3.2.P.8 Justify how UV method was adopted for M/s Bio-labs have the registration of our
the testing of drug product, since the product Mine injection as per manufacture
testing method of drug substance specification and UV-VIS
manufacturer for assay of mecobalamin Spectrophotometer method is DRAP
was based on HPLC approved method. Since stability data is
proved at old batches of 2018 so the applied
method is UV-VIS Spectrophotometer
which has been updated now. Validation of
the applied testing method has been
provided in terms of all the parameters as per
validation guidelines.
4. 3.2.P.8 Justify the effective date on stability Effective data on stability data sheet is 01-
data sheet is 01-01-2020 but the stability 01-2020 because old data has been provided
starts at 29-08-2018 on the new formats. Formats for
interpretations of stability results are new
and revised with old stability data for
presentation.
5. 3.2.P.8 Justify the results of assay as all the Results of assay showed normal decrease in
batches just showed minor decrease in assay results, which is well within the trend
assay results less than which is usually as of vitamins preparation. In the stability
observed in vitamin preparations. data provided, assay results decreases
Scientific justification / clarification is gradually e.g. in batch number A-431 assay
required in this regard. results decreases from 12.62% to 109.93%
(stability sheet for real time analysis
provided), in batch number A-433 assay
results decreased from 121.21% to 107.23%
and in batch number A-456 results
decreased from 121.2% to 106.83%.
• Justification for applying UV spectrophotometric method for the Assay test of drug product, since the
testing method of drug substance manufacturer for assay of mecobalamin was based on HPLC
• Justification for the declining trend of Assay results.
• Justification of the percentage of overage added in the formulation.
223. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals (Pvt.) Ltd Lahore
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals (Pvt.) Ltd., 28km
Ferozepur Road Lahore

☐ Importer
Status of application ☒New Drug Product (NDP)

☐ Export sale

Details of fee submitted PKR 50,000/-: dated 18/5/2020 (#2004310)
The proposed proprietary name / brand name Invid -3 Injection 300,000IU
Pharmaceutical ingredient (API) per unit Cholecalciferol…………..…300,000IU
Pharmaceutical form of applied drug Clear colorless oily liquid free from foreign particles
Pharmacotherapeutic Group of (API) Fat soluble vitamin, Vitamin-D Analogue
(IM injection)
Reference to Finished product specifications Manufacturer Specs
Proposed Pack size 1’s (1ml)
5’s (1ml)
100’s
The status in reference regulatory authorities XARENEL 300,000 IU / ml solution for injection Italy
Approved
GMP status of the Finished product License granted on 08/04/2006 and renewed on 08/04/2021
manufacturer General liquid section approved and GMP certificate on
06/08/2021
Name and address of API manufacturer. Sichuan Province Yuxin Pharmaceutical Co., Ltd.
Weicheng Jinhe East Road, Shifang City, Sichuan
submitted.
Batches: (B-3-01-130601 , B-3-01-130602 ,
B-3-01-130603)

dissolution profile the innovator that is Dibase by Abiogen Pharmaceuticals
by performing quality tests (Identification, Assay,
Dissolution,).
CDP has not been applicable
Remarks:
The excipient use is XARENEL 300,000 IU / ml solution for injection: refined olive oil for injectable use.
The overage added is 25%
The membrane filtration is done
Particulate matter is counted by particulate counter
Manufacturer of API Sichuan Province Yuxin Pharmaceutical Co., Ltd.
Weicheng Jinhe East Road, Shifang City, Sichuan
API Lot No. B-1-51-M190105
Description of Pack USP Type-1 Glass ampoule blistered in Alu - PVC and further packed in unit carton
(Container closure system) (1’s ,5’s (1ml)
Batch No. TP-140-T2 TP-140-T3 TP-140-T4
Batch Size 5000 Ampoule 5000 Ampoule 5000 Ampoule
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted copy of Last inspection Report
with stability study data of the firm (if any) conducted on 24/01/2018.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. SC20160032 issued by
manufacturer issued by concerned regulatory CFDA valid till 17/11/2021.
3. Documents for the procurement of API with • Copy of AD Attested invoice No F 1919090 vide
approval from DRAP (in case of import). No.5354/2019/DRAP-AD-CD(I&E) dated 16/04/2019
is submitted wherein the permission to import Vitamin
D3 API is granted.

chromatograms,

S. Sections Observations/ Short-comings Remarks
No
1. 1.3.4 Valid Drug Manufacturing License Copy of valid DML is attached.
(DML) of manufacturer/Applicant
shall be submitted as submitted
DML was not valid.
2. 2.3.R.1.1 Provide copy of Batch Copies of Executed/Trial batches &
manufacturing record (BMR) Commercial batch BMR were attracted in
for all the batches of the drug 3.2.R.
product for which stability However, Copies of BMR of all the batches of
study data is provide in the drug product for which stability study data
module 3 section 3.2.P.8.3. are provided in 2.3.R.1.1.
3. 3.2.P.8 Stability: on commercial Invoice the As per COA,40MIU is the potency of vitamin
quantity mentioned was Vit D3 D3 i.e 40,000,000 IU/gm , as per label claim of
40MIU but the prepare strength is the applied strength the quantity of vitamin d3
300,000IU with this potency is calculated which is
equivalent to vitamin d3 300,000IU (7.5 mg).
COA and calculation is attached.
4. 3.2.P.1 The composition contains BHA and Compatibility of crodamol oil and BHA were
Crodamol oil but in the reference performed against Vitamin d3 Active, no
product Xarenel 300,000IU/ml interference was observed during the
solution for injection. The excipient compatibility Analysis
use is refined olive oil for injectable
use.
5. 3.2.P.1 Description and composition of the Overage was reflecting in the amount of API
drug product Details of Overage /unit, however composition with overage
not provide in the formulation details is attached.
6. 3.2.S.7.3 Justification of the stability of the Revised Stability Data of new batches
drug substance at 25˚C±2˚C/ attached.
60%RH±5%RH.
In case where the real time stability
data of the drug substance is
conducted at
25˚C±2˚C/60%RH±5%RH,
The firm shall submit the record of
data logger for the storage
condition throughout the
transportation.
7. 3.2.S.4.1 Specification assay limit is According to USP 42 NF 37 Acceptance
mentioned as 97-103% but in USP criteria limit for Cholecalciferol material is 97-
the limit is from 90-120%. 103%.Copy of USP monograph is attached
for reference.
8. 3.2.P.1 In composition no Overage is Overage was reflecting in the amount of API
mentioned in this section. /unit, however composition with overage
details is Attached.
9. 2.3.P.3.2 In 2.3.P.3.2 batch formula it is Vitamins generally have tendency to degrade.
mentioned that after 6 month of As vitamin D3 is photolytic, thermally unstable
accelerated and real time stability and have oxidative nature but at the same time
studies product is stable so overage it is a fat-soluble vitamin and more stable with
will be omitted during commercial Crodamol Oil, because of this property product
validation batches but in the assay, show no significant change in assay as defined
there is a steady decrease in assay in guideline.

limit. Justification is needed about
this statement.
10. 3.2.A and Appendices and regional Appendices and regional information as per
3.2R information is missing. approved checklist of 296th DRB is attached.
11. 3.2.P.8 Justify the result of Assay as all the Vitamins generally have tendency to degrade.
batches just showed minor decrease As vitamin D3 is photolytic, thermally unstable
in assay results less than which is and have oxidative nature but at the same time
usually observed in vitamin it is a fat-soluble vitamin and more stable with
preparations. Scientific Crodamol Oil, because of this property product
Justification/clarification is show no significant change in assay as defined
required in this regard. in guideline.
12. 3.2.P.2.1.1 As As per relevant guidelines & Owing to the prevailed condition of covid
structure of Form 5F, Comparative throughout the world We had performed PE
assay Pharmaceutical equivalence after formulation development due to
has to be performed at the time unavailability of the Innovator pack. So, as per
formulation development, while the need of hour or to overcome this challenge
according to your submitted data, it we deviated from the chronological flow.
has been performed after However, we confirm that this deviation will
commencing stability studies. not be repeated.
Justification shall be submitted.
Decision: Deferred for justification of not performing stability studies of applied formulation as per BP
monograph of “Choleclaiferol injection”.
224. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals (Pvt.) Ltd Lahore
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals (Pvt.) Ltd ., 28km Ferozepur
Road Lahore
☐ Importer
☐ Export sale
Details of fee submitted PKR 50,000/-: (2047490) dated 04/01/2021
Fervial 200mg/10ml Injection
name
Pharmaceutical ingredient (API) per unit Iron Sucrose …………200mg
Pharmaceutical form of applied drug Amber glass vial labelled USP type-1 filled with dark brown
liquid of iron Sucrose clear free from foreign particles
Pharmacotherapeutic Group of (API) Hematinic
USP
specifications

Venofer Injection 200mg/10ml, approved in FDA USA.
authorities
GMP status of the Finished product License granted on 08/04/2006 and renewed on 08/04/2021
manufacturer General liquid section approved and GMP certificate on
06/08/2021
Name and address of API manufacturer. Guangdong Techpool Bio-Pharma Co.Ltd
Address: 89, Gaopo Lu, Gaotang Hi-tech Industry Park,
Tianhe District,
Guangzhou,China.
Module III (Drug Substance) Official monograph of Iron Sucrose is present in USP. The
firm as submitted detail of nomenclature, structure, general
Batches: (1703002 ,1703005,1703007
comparative dissolution profile innovator that is Venofer Injection (#TP-157-T2) by
Novamed Pharmaceuticals by performing quality tests
(Identification, Assay, Dissolution,).
CDP has not been Applicable.
Remarks:
The method of sterility is aseptic filling along with filtration

Manufacturer of API Guangdong Techpool Bio-Pharma Co.Ltd

Address: 89, Gaopo Lu, Gaotang Hi-tech Industry Park, Tianhe
District, Guangzhou,China.
API Lot No. 1909005
Description of Pack Amber glass vial labelled USP type-1 filled with dark brown liquid of iron
(Container closure system) Sucrose clear free from foreign particles (1’s (10ml)
Batch No. TP/157/T2 TP/157/T3 TP/157/T4
Batch Size 500 vial 500 vial 500 vial
No. of Batches 03
1. Reference of previous approval of The firm has submitted copy of Last inspection Report
applications with stability study data of the conducted on 24/01/2018.
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. GD20170774 issued by CFDA
API manufacturer issued by concerned valid till 21/12/2022.
3. Documents for the procurement of API with Copy of AD Attested invoice No WEIBIN-036 vide
approval from DRAP (in case of import). No.12584/2019/DRAP-AD-CD(I&E) dated 30/09/2019 is
submitted. Wherein the permission to import Iron Sucrose
API is granted.

chromatograms,
etc.
5. Compliance Record of HPLC software Not Applicable (Analysis performed on AAS)
testing
accelerated)
S# Section Query Reply
1. 1.3.4 Valid Drug Manufacturing License Copy of valid DML is provided

shall be submitted as submitted DML
was not valid.

2. 3.2.P.1 The composition of Drug Venofer containing the generic Iron
Substance (API) is iron sucrose sucrose as per the innovator pack
but in the reference product imported for the Pharmaceutical
active material is ferric Equivalence.
oxyhydroxide. Provide the MHRA approved product venofer
evidence of approval of applied states generic as iron as iron sucrose
formulation in reference (iron(III)-hydroxide sucrose complex).
regulatory authorities/agencies https://mhraproducts4853.blob.core.win
which were declared/approved dows.net/docs/156fb15dee4b1cce34e9f
by the Registration Board in its caeefc83a96bfd30ecd
275th meeting. Public Assessment Report of Sucrofer
20 mg iron/ml, Solution for injection
/infusion mention generic as Iron as iron
sucrose
https://mhraproducts4853.blob.core.win
dows.net/docs/1da34b3b4056c2865220
bda62866f2395324fc8e
Moreover, in current revision of USP
product is still mention as Iron Sucrose
Injection (Monograph provided )
3. 3.2.a and Appendices and regional Appendices and regional information as
3.2R information are missing. per approved checklist of 296th DRB is
attached.
4. 3.2.P.8 Documents for the procurement of Copy of DRAP attested invoice is
API with approval from DRAP. attached.
5. 1.3.4 Valid Drug Manufacturing License Copy of valid DML is attached.
shall be submitted as submitted DML
was not valid.
“Each 10ml contains:
Iron sucrose (iron(III)-hydroxide sucrose complex) eq. to elemental Iron …….. 200mg”
• Firm shall submit fee of Rs. 30,000 for each product for standardization of label claim, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
225. Name, address of Applicant / Marketing M/s Sami Pharmaceuticals (Pvt) Ltd. F-95, Off Hub River
Authorization Holder Road, S.I.T.E. Karachi
Name, address of Manufacturing site. M/s Sami Pharmaceuticals (Pvt) Ltd. F-95, Off Hub River
Road, S.I.T.E. Karachi
☐ Importer

☐ Export sale

Dy. No. and date of submission Dy. No.18268 dated 29/06/2021
Balance fee PKR 20,000 dated 30/05/2021
10,000 PKR dated 7-06-2021
Proposed proprietary name / brand name PROVAS CF Day 500mg/5mg Tablets
Pharmaceutical ingredient (API) per unit Paracetamol BP ……..500mg
Phenylephrine HCl BP….5mg
Innovator’s specs
Pharmaceutical form of applied drug White to off-white coloured, capsular shaped tablet having
score line in one side and other side is plain
Pharmacotherapeutic Group of (API) Paracetamol: NSAID
Phenylephrine HCl: Sympathomimetic drug
Innovator’s specifications
specifications
Proposed Pack size 10’s, 20’s, 30’s, 50’s & 100’s
The status in reference regulatory PANADOL COLD & FLU PLUS DECONGESTANT
authorities capsule-shaped tablet TGA approved
For generic drugs (me-too status) Panadol CF Day Caplet by M/s GSK Pakistan
Reg. No. 094797
GMP status of the Finished product GMP certificate issued dated: 11-08-2020
manufacturer
Name and address of API manufacturer. Paracetamol
Name: HEBEI JIHENG (Group) Pharmaceutical Co. Ltd.,
Shenzhou Plant
(shortened as Jiheng Shenzhou)
Address: Southeast Xijingming Village, Donganzhuang
Township, Shenzhou County Hengshui City, Hebei
Province, 053800 CHINA
Phenylephrine HCl
Name: Shenzhen Oriental Pharmaceutical Co. Ltd.
Address: 43 Dakeng Road Tongle Village, Longgang
District Shenzhen, China
drug substance and drug product is submitted.
procedures and its verification studies, batch analysis and
closure system and stability studies of both drug substances.

Paracetamol
Batches Nos.
Accelerated (31106030, 31106031 & 31106032)
Real time (31404023, 31404024 & 31404025)
Phenylephrine HCl
Batches Nos.
Accelerated (PEH-160404, PEH-160405 &
PEH-160406)
Real time (PEH-170923, PEH-170924 & PEH-170925)
“The batch of long term stability is not consistent with
accelerated batch it is because the zone IV test started from
2017 which is also the first time 3 batches and no need to do
accelerated test again”
testing at acidic and buffer medium) and its validation, batch
Pharmaceutical equivalence and Firm has also submitted of Pharmaceutical equivalence and
comparative dissolution profile comparative dissolution profile of their product with the
innovator product i.e. PANADOL CF Day Caplet of by M/s.
GSK has performed and the results are within acceptable limit
of F2 value.
Analytical method validation/verification Method validation studies have submitted including linearity,
Manufacturer of API Paracetamol
Name: HEBEI JIHENG (Group) Pharmaceutical Co. Ltd. China
Phenylephrine HCl
Name: Shenzhen Oriental Pharmaceutical Co. Ltd. China
API Lot No. Paracetamol
31709016
Phenylephrine HCl
PEH-200303
Description of Pack
Alu-Pvc Blister

No. of Batches 03
applications with stability study data of the “EMPOLI (Empagliflozin) 10mg & 25mg Tablets” which was
firm (if any) presented in 290th meeting of Registration Board wherein the
Board decided to approve registration of this product
Date of inspection: 13th June, 2019.
confirmed.
stability chamber
2. Approval of API/ DML/GMP certificate of Paracetamol
API manufacturer issued by concerned Copy of GMP certificate (HE20180054) issued to M/s
regulatory authority of country of origin. HEBEI JIHENG (Group) Pharmaceutical Co. Ltd. China
issued by China Food & Drug Control Administration, valid
till 08-07-2023 is submitted
Phenylephrine HCl
Copy of GMP certificate (GD190014) issued to M/s.
Shenzhen Oriental Pharmaceutical Co. Ltd. China issued by
China Food & Drug Control Administration, valid till 11-09-
2022 is submitted
3. Documents for the procurement of API Firm has submitted copy of following invoices specifying:
import). Paracetamol
5000kgs of Paracetamol (Batch # 31709016). (invoice #
1708ZP03) attested by AD (I&E), Karachi dated 1-11-2017 is
submitted
Phenylephrine HCl
1kg of Phenylephrine HCl (Batch # PEH-200303) (invoice #
SZ-2003021) attested by AD (I&E), Karachi dated 15-04-
2020 is submitted
Firm has submitted complete record of testing of all batches
along with chromatograms, raw data sheets, COA and
summary data sheets.
Firm has submitted audit trail record of product testing of
HPLC for all test intervals.
testing
Firm has submitted record of digital data logger for
temperature and humidity monitoring of real time and
accelerated stability chambers.
accelerated)
No
1. 1.6.5 Approval of API/ DML/GMP HEBEI JIHENG (Group) Pharmaceutical Co. Ltd.,
certificate of API manufacturer Shenzhou Plant china, is the usfda approved plant
issued by concerned regulatory GMP certificate is attaced issued by China food and
authority of country of origin. drug administration valid till 8/7/2023

2. 3.2.P • Justification is required The development of specifications and test results
for dissolution parameters is based on our batch analysis as well as general
including chapter of USP and BP the test includes
i. Dissolution apparatus Appearance, average weight, disintegration time,
ii. RPM Assay, content uniformity organic impurities,
iii. Dissolution parameters microbial limits etc.
iv. Sampling time
• Justification is required
for assay of paracetamol, and
phenylephrine
3. 3.2.P.8 The test for uniformity of dosage The uniformity of dosage form is the part of our
form is not performed specially in release specification s and is performed at 0-month
case of phenylephrine, please analysis. certificate of analysis of stability batches
clarify. are provided
Decision: Approved with Innovator’s specifications

c. Deferred Cases:
226. Name, address of Applicant / Marketing M/s Indus Pharma (Pvt.) Ltd Plot No. 26-27 & 63/67,
Authorization Holder Sector 27, Korangi Industrial Area, Karachi-74900.
Name, address of Manufacturing site. M/s Indus Pharma (Pvt.) Ltd Plot No. 26-27 & 63/67,
Sector 27, Korangi Industrial Area, Karachi
☐ Importer
☐ Export sale
Details of fee submitted PKR 20,000/- dated 19/10/2020 (#1932559)
The proposed proprietary name / brand name Lecetam Oral Solution
Pharmaceutical ingredient (API) per unit Levetiracetam……………100mg
Pharmaceutical form of applied drug A clear, colourless or almost colourless, apple

flavoured solution filled in amber glass bottle.
Pharmacotherapeutic Group of (API) Antiepileptics
Proposed Pack size 10ml, 15ml, 30ml, 60ml, 120ml

The status in reference regulatory authorities Levetiracetam Oral Solution, USP
by ACI Healthcare USA, Inc., USFDA Approved.
For generic drugs (me-too status) Lerace Oral Solution by Hilton Pharma (pvt) Ltd.,
Reg. No. 061224
GMP status of the Finished product GMP inspection dated 28-11-2019 concludes as under:
manufacturer “After reviewing their QA System, QC & Manufacturing,
relevant documents, utilities and personal capacity the
current GMP are rated as GOOD.”
Name and address of API manufacturer. Zhejiang Huahai Pharmaceutical Co. Ltd.
Chuannan, Duqiao, Linhai, Zhejiang, 317016, China
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO QOS PD
template
drug substance. (assay by HPLC with PDA detector, limit
98to 101%), residual solvent by GC
Stability studies Levetiracetam (Batches: C5146-09-016, C5146-09-017,
C5146-09-018)
Real time: 30°C ± 2°C / 65% ± 5%RH
Module-III (Drug Product): Firm has submitted relevant information against the
Module III, including, “Process validation protocol,
Finished (product analytical method validation report
& stability studies data
dissolution profile the brand leader Lumark Oral Solution by Searle
Pakistan Limited by performing quality tests.

Manufacturer of API Zhejiang Huahai Pharmaceutical Co. Ltd.
API Lot No. D5294-18-127
Description of Pack Printed unit carton containing 1 Amber glass bottle of 60ml with
(Container closure system) aluminium PP Cap Pack also contains leaflet.

Batch No. TR-1/LVT
TR-2/LVT 60ml TR-3/LVT 60ml
60ml
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to their previous inspection report of
with stability study data of the firm (if any) “Canazin tablets (Canagliflozin)”, which was presented in
289th meeting of Registration Board. Registration Board
approved the application of Canazin tablets and wherein
HPLC system was declared as 21 CFR compliant.
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of EU-GMP certificate
API manufacturer issued by concerned (Certificate# IT/E/API/10/2019 REV.1) in the name of M/s
regulatory authority of country of origin. Zhejiang Huahai Pharmaceutical Co., Ltd China, valid up
to 14/03/2022 issued by Italian Medicine Agency
3. Documents for the procurement of API with Firm has submitted copy of invoice (Invoice# HH2020169)
approval from DRAP (in case of import). specifying the quantity of 124Kg of Levetiracetam HCl
from M/s Zhejiang Huahai Pharmaceutical Co., Ltd China

chromatograms,
etc.
Submitted
S. No Section Observations/Deficiencies/Short- Remarks of the firm
# comings
01 3.2.S.4.4 The submitted COA from drug The API and Finished product both were tested as
substance manufacturer mentions the per the pharmacopeia monograph of USP, for
reference for specs as USP but drug which the COA of API (tested by manufacturer)
product manufacturer is claiming BP USP specification is provided
specification. Clarification is needed
02 3.2.P.1 Composition is different from Formulation of Lecetam oral solution is as per the
reference product of USFDA formulation of USFDA approved products of
following
ACI Healthcare USA, Inc., Marlex
Pharmaceuticals Inc and Roxane Laboratories, Inc.
Comparison table is provided
03 2.3.P.2.5 Discussion of microbiological The preservative effectiveness study of Lecetam
attributes of the Drug Product (e.g., Oral Solution is performed and the results are
preservative effectiveness studies to found satisfactory till 14th day (Results Attached).
be performed as per recommendation The study will be completed on 23-11-21 and the
of pharmacopoeia) not provided. results till 28th day will be shared accordingly
The firm follow the USP 43 for Finished product
testing and followed the same specification and

covered all quality attributes and specification as
mentioned in USP.
04 2.3.P.4 Control of excipients is missing We have used Pharmacopeia standard excipients
for which monographs and Analytical Procedures
are attached, however for inhouse excipient,
analytical procedure is attached along with the
COA of all excipients used in formulation.
Decision of 213: Deferred for the submission of microbiological attributes of the Drug Product i.e. complete 28-day
preservative effectiveness study.
Remarks:
The full microbiological attributes of the Drug Product i.e. complete 28-day preservative effectiveness study is
submitted
Decision of 316th meeting: Approved.
• Manufacturer will place first three commercial batches on long term stability studies throughout proposed
application.
227. Name and address of manufacturer / Applicant M/s Wilshire Laboratories Pvt Ltd. 124/1, Quaid-e-Azam
Industrial Estate, Kot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Regus 97/103 mg Tablet
Sacubitril…..97mg
Valsartan…..103mg
Diary No. Date of R& I & fee Dy. No. 113, 1/1/2018, Rs: 50,000/- 20/12/2019
(#0619510),
Pharmacological Group Angiotensin Receptor Neprilysin Inhibitor
Type of Form Form 5
Pack size & Demanded Price 10, 20, 30, 60’s
As per SRO
Approval status of product in Entresto Tablet of Novartis pharms (USFDA Approved)
Me-too status NA
GMP status Last GMP inspection conducted on 08-08-2019, and the
report concludes that the firm was operating at an
acceptable compliance of cGMP. The firm was further
advised to submit CAPA report with respect to the current
inspection proceedings.
Drug Regus 97/103 mg Tablet
Name of Manufacturer M/s Wilshire Laboratories Pvt Ltd. 124/1, Quaid-e-Azam Industrial Estate,
Kot Lakhpat, Lahore
Manufacturer of API M/s Zhuhai Rundu Pharmaceutical Co., Ltd, No 6-airport north road, Sanzao
town, Jinwan district Zhuhai Guangdong, China,

Description of Pack
As per SRO
Accelerated: 40 °C ± 2 °C/75% ± 5%
Real Time: 0,3,6, 9,12, 18, 24 (month)
Batch Size 1.5 kg (83 pack) 1.5 kg 1.5 kg
No. of Batches 03
No.
1. Reference of previous approval of applications with Inspection dated 20-07-2019 for verification of
stability study data of the firm authenticity of stability data submitted for
registration of velbuvir 400 mg/100 mg tablet
2. Certificate of Analysis of API from both API Sacubitril/Valsartan: Copy of COA (Batch#
Manufacturer and Finished Product 57317080101 from Zhuhai Rundu Pharmaceutical
manufacturer. Co., Ltd China is submitted.
Manufacturer
4. Stability study data of API from API manufacturer Yes (for zone IV-B)
5. Approval of API/ DML/GMP certificate of API Copy of certificate of cGMP: Valid Dated: 21-12-2021
manufacturer issued by concerned regulatory authority from office of the Zhuhai Food and drug
of country of origin. administration (City not a provincial)
6. Documents for the procurement of API with approval Commercial invoice/ air way bill for
from DRAP (in case of import). Sacubitril/Valsartan from M/s Zhuhai Rundu
Pharmaceutical Co., Ltd, Guangdong, China, has
been submitted NOT attested by AD, DRAP I&E
Lahore.
10. Complete batch manufacturing record of three stability The firm has submitted photocopy of Batch
batches. Manufacturing Orders of following 03 Batches:
T001 1.5 kg 01-2019
T002 1.5 kg 01-2019
T003 1.5 kg 01-2019

11. Record of comparative dissolution data (where Comparative dissolution studies have been performed
applicable) with competitor product Enteresto (Novartis) batch #
EW2457 in
following mediums:
a. pH 6.8 buffer
b. pH 4.5 buffer
c Water
d. pH 0.1 N HCl buffer
F2 factor value has calculated which is within
acceptance range for 0.1 HCL in other medium the
dissolution is more than 85% within 15 min so no F2
calculation needed.
Yes
humidity monitoring of stability chambers (real time Yes
and accelerated)
No
1. Firm has to submit valid copy of cGMP for M/s Firm has submitted the valid GMP of
Zhuhai Rundu Pharmaceuti`1cal Co., Ltd, Zuhai rundu pharma issued by Guangdong
Guangdong, China, issued by Guangdong Food food and drug administration China
and Drug Administration not city. (#YUE20160246) valid till 2024
2. On air way bill no batch number or AD attestation The commercial invoice for the batch
is there. Provide some evidence (like Form 7 etc.) number 57318060102 attested by AD
that same batch was used in the stability study for DRAP Lahore is provided along with form
which import documents had been submitted 3 and 7.
3. The applicant has not performed impurity testing The API manufacturer Zhuhai Rundu has
for NDMA or NDEA. The COA provided by the conducted impurity testing for NMDA and
API manufacturer do not confirm impurity testing NDEA as per results the NDMA has been
for NDMA or NDEA as well. found under the limit i.e. NMT 0.3ppm and
NDEA was not detected. Declaration,
Detailed method and results provided
4. Justify the formula used to calculate the assay and Formula used to calculate assay Abd
dissolution. Formula for assay it does not have dissolution is the ratio between absorption
potency of standard LC and wt. of tablet etc. of sample to absorption of standard taking
potency equivent to 100%. Whereas the
tablet taken is as per prescribes in the
testing method
5. Reference standard is as cocrystals complex The Reference standard used by
sacubitril/ valsartan or both are separate, provide manufacturer for identification test by
COA of reference standard. Need detail of comparing the IR spectra of API is a
reference standard used for the performance of cocrystal complex sacubitril/ valsartan
identification tests by comparing the IR spectra of COA with batch # 160405 was provided
the API shall be submitted.
6. The API manufacturer and Finished product The manufacture evaluates the said product
manufacturer have not performed powder X-ray for structure elucidation from instrument
diffraction analysis to differentiate the co-crystals analysis and research center of sunyatsen
from coprecipitate etc. university china. They also done evaluation
for crystal form but x ray diffraction was

not done. The firm also claims that some
other renowned pharma is also purchasing
API from the same source)
Decision 313:
The Board deferred the case for submission of characterization studies of drug substance performed
to differentiate co-crystal from coprecipitate by drug substance manufacturer.
Remarks of evaluator:
The firm provides the characterization studies and test reports including NMR, UV spectra and XRPD studies of
sacubitril / valsartan from drug substance manufacturer that confirm that crystal form and crystal status
• Firm shall submit fee of Rs.7,500 for correction/pre-approval change in the finished drug product
application.
228. Name and address of manufacturer / M/s Wilshire Laboratories Pvt Ltd. 124/1, Quaid-e-
Applicant Azam Industrial Estate, Kot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Regus 24/26 mg Tablet
Sacubitril…..24 mg
Valsartan…..26 mg
Diary No. Date of R& I & fee Dy. No. 111, 1/1/2018, Rs: 50,000/- 20/12/2019
(#0619524),
Pharmacological Group Angiotensin Receptor Neprilysin Inhibitor
Type of Form Form 5
Pack size & Demanded Price 10, 20, 30, 60’s
As per SRO
Approval status of product in Entresto Tablet of Novartis pharms (USFDA Approved)
Me-too status NA
GMP status Last GMP inspection conducted on 08-08-2019, and the
report concludes that the firm was operating at an
acceptable compliance of cGMP. The firm was further
advised to submit CAPA report with respect to the current
inspection proceedings.
Drug Regus 24/26 mg Tablet
Name of Manufacturer M/s Wilshire Laboratories Pvt Ltd. 124/1, Quaid-e-Azam Industrial Estate,
Kot Lakhpat, Lahore

Manufacturer of API M/s Zhuhai Rundu Pharmaceutical Co., Ltd, No 6-airport north road, Sanzao
town, Jinwan district Zhuhai Guangdong, China,
Description of Pack
As per SRO
Accelerated: 40 °C ± 2 °C/75% ± 5%
Real Time: 0,3,6, 9,12, 18, 24 (month)
Batch Size 0.375 (83 pack) 0.375 (83 pack) 0.375 (83 pack)
No. of Batches 03
No.
1. Reference of previous approval of applications with Inspection dated 20-07-2019 for verification of
stability study data of the firm authenticity of stability data submitted for
registration of velbuvir 400 mg/100 mg tablet
2. Certificate of Analysis of API from both API Sacubitril/Valsartan: Copy of COA (Batch#
Manufacturer and Finished Product 57317080101 from Zhuhai Rundu Pharmaceutical
manufacturer. Co., Ltd China is submitted.
Manufacturer
4. Stability study data of API from API manufacturer Yes (for zone IV-B)
5. Approval of API/ DML/GMP certificate of API Copy of certificate of cGMP: Valid Dated: 21-12-2021
manufacturer issued by concerned regulatory authority from office of the Zhuhai Food and drug
of country of origin. administration (City not a provincial)
6. Documents for the procurement of API with approval Commercial invoice/ air way bill for
from DRAP (in case of import). Sacubitril/Valsartan from M/s Zhuhai Rundu
Pharmaceutical Co., Ltd, Guangdong, China, has
been submitted NOT attested by AD, DRAP I&E
Lahore.
10. Complete batch manufacturing record of three stability The firm has submitted photocopy of Batch
batches. Manufacturing Orders of following 03 Batches:
T001 1.5 kg 01-2019

T002 1.5 kg 01-2019
T003 1.5 kg 01-2019
11. Record of comparative dissolution data (where Comparative dissolution studies have been performed
applicable) with competitor product Enteresto (Novartis) batch #
EW2457 in following mediums:
a. pH 6.8 buffer
b. pH 4.5 buffer
c Water
d. pH 0.1 N HCl buffer
F2 factor value has calculated which is within
acceptance range for 0.1 HCL in other medium the
dissolution is more than 85% within 15 min so no F2
calculation needed.
Yes
humidity monitoring of stability chambers (real time Yes
and accelerated)
No
1. Firm has to submit valid copy of cGMP for M/s Firm has submitted the valid GMP of
Zhuhai Rundu Pharmaceuti`1cal Co., Ltd, Zuhai rundu pharma issued by
Guangdong, China, issued by Guangdong Food and Guangdong food and drug administration
Drug Administration not city. China (#YUE20160246) valid till 2024
2. On air way bill no batch number or AD attestation is The commercial invoice for the batch
there. Provide some evidence (like Form 7 etc.) that number 57318060102 attested by AD
same batch was used in the stability study for which DRAP Lahore is provided along with
import documents had been submitted form 3 and 7.
3. The applicant has not performed impurity testing for The API manufacturer Zhuhai Rundu has
NDMA or NDEA. The COA provided by the API conducted impurity teting for NMDA and
manufacturer do not confirm impurity testing for NDEA as per results the NDMA has been
NDMA or NDEA as well. found under the limit i.e. NMT 0.3ppm
and NDEA was not detected. Declaration,
Detailed method and results provided
4. Justify the formula used to calculate the assay and Formula used to calculate assay Abd
dissolution. Formula for assay it does not have dissolution is the ratio between absorption
potency of standard LC and wt. of tablet etc. of sample to absorption of standard taking
potency equivent to 100%. Whereas the
tablet taken is as per prescribes in the
testing method
5. Reference standard is as cocrystals complex sacubitril/ The Reference standard used by
valsartan or both are separate, provide COA of manufacturer for identification test by
reference standard. Need detail of reference standard comparing the IR spectra of API is a
used for the performance of identification tests by cocrystal complex sacubitril/ valsartan
comparing the IR spectra of the API shall be COA with batch # 160405 was provided
submitted.
6. The API manufacturer and Finished product The manufacture evaluate the said product
manufacturer have not performed powder X-ray for structure elucidation from instrument
diffraction analysis to differentiate the co-crystals analysis and research center of sunyatsen
from coprecipitate etc. university china . They also done

evaluation for crystal form but x ray
diffraction was not done. The firm also
claims that some other renowned pharma
are also purchasing API from the same
source)
and accelerated)
Decision 313:
The Board deferred the case for submission of characterization studies of drug substance performed
to differentiate co-crystal from coprecipitate by drug substance manufacturer.
Remarks of evaluator:
The firm provides the characterization studies and test reports including NMR, UV spectra and XRPD studies of
sacubitril / valsartan from drug substance manufacturer that confirm that crystal form and crystal status
• Firm shall submit fee of Rs.7,500 for correction/pre-approval change in the finished drug product
application.
Agenda of Evaluator PEC-XI

Case No. 1: New cases for registration of Human Drugs on Form 5F (Import)
229. Name, address of Applicant / Importer M/s Biocare Pharmaceutica. Address: 807 Shadman-1,
Lahore
Address: 807 Shadman-1, District Lahore.
Address of Godown: First floor B-C, Street No. 3, Near LGS
School, Shah Jamal District Lahore.
Validity: 17-04-2022.
Status: License to sell drugs as distributor
Renewal: N/A. Valid Drug sales License is attached with
CTD dossier Module 1.
Name and address of marketing authorization Hainan Hualon Pharmaceutical Co., Ltd
holder (abroad) Address: - Pharmacy Valley Three Cross Road No.8,
Haikou National Hi-Tech Industrial Development Zone,
Hainan Province, China.
Name, address of manufacturer(s) Hainan Hualon Pharmaceutical Co., Ltd
Address: - Pharmacy Valley Three Cross Road No.8, Haikou
National Hi- Tech Industrial Development Zone, Hainan
Province, China.

Detail of certificates attached (CoPP, Free CoPP: Firm has submitted embassy attested copy of CoPP
sale certificate, GMP certificate) certificate (No.Hainan20200100) dated 25-11-2020 issued
by Hainan Medical Product Administration to M/s Hainan
Hualon Pharmaceutical Co., Ltd No. 8, Three Cross Road,
Medicine Valley, National Hi-Tech Industrial Development
Zone, Haikou, Hainan Province China for Aztreonam for
injection 1g. The CoPP confirms free sale status of the
product in exporting country as well as GMP status of the
manufacturing site through periodic inspection every year.
Pakistan. Furthermore, the CoPP is valid till 25-11-2022.
Firm has submitted embassy attested copy of GMP
certificate No. HI20180041 issued by Hainan Provincial
Medical Product Administration to M/s Hainan Hualon
Pharmaceutical Co., Ltd No. 8, Three Cross Road, Medicine
Valley, National Hi-Tech Industrial Development Zone,
Haikou, Hainan Province valid till 18/11/2023.
Details of letter of authorization / sole agency Firm has submitted copy of distribution and agency
agreement agreement contract signed by both parties Biocare
Pharmaceutica & Hainan Hualon Pharmaceutical Co., Ltd.
Agreement mention manufacturer Hualon Pharmaceutical
appoints M/s Biocare Pharmaceutica to register/market/sell
their product Aztreonam 1 gm in Pakistan and is valid for 5
years from the first day of month when distributor receives
registration certificate.
☒ Importer
☐ Export sale
The proposed proprietary name / brand name AZTAM, AZOM, AZENOT
Strength / concentration of drug of Active Each vial contains mixture of Aztreonam and Arginine
Pharmaceutical ingredient (API) per unit equivalent to Aztreonam 1.0g
Pharmaceutical form of applied drug Sterile powder for injection
white or off-white powder or loose cake in 10ml tubular vial,
sealed with rubber stopper and aluminium-plastic
combination cap.
Pharmacotherapeutic Group of (API) Anti-infectives for systemic use-Monobactams
ATC code: J01DF01
Reference to Finished product specifications USP 39 &CP (Chinese Pharmacopeia)

Proposed unit price Rs 800/- single dose vial
The status in reference regulatory authorities Azactam (Aztreonam for injection) 1 gm by M/s Bristol
Myers Squibb Co., (USFDA Approved).
For generic drugs (me-too status) Azactam (Aztreonam) 1 gm Injection of Squibb (Karachi)
(Reg # 009002)
Name, address of drug substance manufacturer Fuan Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co., Ltd;
Address: No.1, Huanan Yi Road, Changshou, Chongqing,
China
(Conditions & duration of Stability studies) at accelerated as well as real time conditions. The accelerated
study is complete for 3 batches at 40±2°C/75±5%RH (Batch
No. Az(Ar)150101V，Az(Ar)150102V，Az(Ar)150103V).
The real time stability data is conducted at
30±2°C/65±5%RH (Batch No. Az(Ar)150101V，
Az(Ar)150102V，Az(Ar)190101). The stability study data
of two batches is performed till 36 months while stability of
one batch (No# Az(Ar)190101) is performed upto 18th
months
process validation, control of drug product, specifications,
Pharmaceutical Equivalence and Comparative Firm has submitted Comparative Specifications of Test
Dissolution Profile performed with Reference Product Azactam (Aztreonam) 1
gm of Bristol Myers Squibb.
Analytical method validation/verification of Firm has submitted analytical method validation/verification
product studies for the applied product.
Container closure system of the drug product Low Borosilicate tubular vial, sealed with Halogenated butyl
rubber stopper, covered by aluminium-plastic combination
cap for antibiotic bottle

Stability study data of drug product, shelf life • Firm has submitted stability study data of 3 batches of
and storage conditions Aztreonam for Injection 1.0g vial. The firm has submitted
accelerated stability study data at 40°C ± 2°C / 75% ± 5%
RH for 6 months and real time stability study data at 30
°C ±2 °C / 65 % ± 5%RH for 24 months.
•
Batch No. Mfg. Date Initiation date
20181201 Dec.12, 2018 Dec.12, 2018
20190101 Jan.4, 2019 Jan.4, 2019
20190102 Jan.4, 2019 Jan.4, 2019
Evaluation by PEC XI:
Section Observations Response
1.3 Provided form 5F is from the New Form 5F duly signed/stamped by Drug Sale
manufacturer / Marketing authorization License holder Biocare Pharmaceutica is
holder side while it should be from the submitted
applicant holding the Drug sale license.
1.3.4 Provide valid legalized GMP certifcate Title as per Online Link:
from the manufacturer as the name and Hainan Huanglong Pharmaceutical Co., Ltd.
adress of manufacturer in the submitted Address: No. 8, Sanheng Road, Yaogu, National
GMP is different from the one verified High-tech Industrial Development Zone, Haikou,
from China CFDA website Hainan Province
Title as per submitted GMP:
Hainan Hualon Pharmaceutical Co., Ltd
Address: No. 8, Three Cross Road, Medicine
Valley, National Hi-Tech Industrial Development
Zone, Haikou, Hainan Province
The firm submitted that they have two
manufacturing site;
1. Pharmacy Valley Three Cross Road No.8,
Haikou National Hi- Tech Industrial
Development Zone, Hainan Province
2. Guilinyang Economic Development Area,
Haikou Hainan (for tablets).
Aztreonam for injection is in 1st manufacturing
address.
1.5.6 In Form 5F you have mentioned both Manufacturer/In-house quality specifications
USP 39 &CP (Chinese Pharmacopeia) referenced USP39 and Chinese Pharmacopoeia
reference for the product under section parameters/limits
1.5.6. specify a particular specification Referencing USP and Chinese Pharmacopoeia,
for applied product. we established our enterprise quality
specifications. Our enterprise quality
specifications are stringent in which limits or
parameters comply with both USP and Chinese
Pharmacopoeia reference standard. For the
critical items, our enterprise specifications are
equivalent to, or even stricter than USP. For
example, pH, sterile, water, related substances are
equivalent to USP., while bacterial endotoxins
and assay are stricter than USP. Below reference
is given for DRAP reference.

Submit valid and original product Valid notarized product specific Soles agency
specific sole agency agreement/ letter of agreement duly signed/stamped by both Biocare
authorization for applied product Pharmaceutica & manufacturer Hainan Hualon
Pharmaceutical Co., Ltd is submitted.

1.5.15- Commitments must be submitted by Commitments is submitted by applicant
1.5.19 applicant (marketing authorization (marketing authorization Holder)
Holder) instead of manufacturer
3.2.S.4.2.2 Chromatographic conditions e.g. mobile We have separately tested the same batch of
phase is not same as mentioned in USP aztreonam under chromatographic conditions of
monograph of aztreonam for injection, Chinese pharmacopoeia and USP.
clarify? The study shows that, under the chromatographic
conditions of Chinese pharmacopoeia, the peak
shape of each compound is better than that of
USP, and the number of impurities detected and
the resolution of each compound are better than
those under the USP test methods. Therefore, our
mobile phase adopts the chromatographic
conditions of Chinese pharmacopoeia.
3.2.S.7.3 Long term stability data of drug The dossier was submitted in the year 2020 and
substance batch No. Az(Ar)190101 is the batch No. Az(Ar)190101 was manufactured in
performed upto 18th months only in the year 2019, so we could only submitted 18th
months data then and did not submit complete 36th
months stability data.
Now we submit 24th months stability data No.
Az(Ar)190101 and complete 36th months stability
data of Az(Ar)150103V.
3.2.S.7.3 Stability study data of one different batch At that time, the batch number of three batches of
of drug substance is performed at real long term stability data which were provided to us
time and accelerated conditions by the API manufacturer were Az(Ar)150101V，
Az(Ar)150102V，Az(Ar)190101). We directly
quoted these three batches of long-term stability
data without careful consideration.
To reply this point, we asked the API
manufacturer to provide us the complete data of
Az(Ar)150103V. The long-term stability data of
same batch is submitted
3.2.P.1 Quantity of arginine is not mentioned in We use mixture of aztreonam and arginine
composition? (premixed by API manufacturer). The quantity of
aztreonam: arginine is 1:0.78, which is same as
the originator (Bristol-Myer Squibb Company
USA).
So, in one vial there are 1.0g aztreonam and 0.78g
arginine
3.2.P.1 Provide information including type of The firm submitted that their product Aztreonam
diluent, its composition, quantity or Sterile powder for injection will be supplied to
volume, specifications (as applicable) Biocare Pharmaceutica in a pack that only contain
and regulatory status in Pakistan (as Aztreonam Vial without any diluent. We are not
applicable) for the diluent which is to be providing any diluent. Our pack only contains
provided along with the applied drug. Aztreonam Vial.
3.2.P.5.2 Chromatographic conditions e.g. mobile We have separately tested the same batch of
phase is not same as mentioned in USP aztreonam under chromatographic conditions of
monograph of aztreonam for injection, Chinese pharmacopoeia and USP.
clarify? The study shows that, under the chromatographic
conditions of Chinese pharmacopoeia, the peak
shape of each compound is better than that of
USP, and the number of impurities detected and
the resolution of each compound are better than
those under the USP test methods. Therefore, our
mobile phase adopts the chromatographic
conditions of Chinese pharmacopoeia.

Note that the chromatographic conditions of the
injection and its API is the same because the
injection is produced by simply filling the API
into the bottle without adding any other
excipients.
Decision: Deferred for clarification as the name and address mentioned on submitted GMP is different from
the name and address verified from online weblink of the “NMPA” of China.
230. Name, address of Applicant / Importer M/s. Novartis Pharma (Pakistan) Limited, 15 West Wharf,
Karachi, Pakistan
Address: Novartis Pharma (Pakistan) Ltd, 15 West Wharf,
Dockyard Road Karachi, Pakistan.
Address of Go-down: - C-21 site Karchi
Status: Drug License By way of wholesale
Renewal: Not Applicable
Name and address of marketing authorization M/s Novartis Pharma Schweiz AG, 6343 Risch, Switzerland.
holder (abroad)
Name, address of manufacturer(s) M/s Novartis Pharma Stein AG, Schaffhauserstrasse, 4332
Stein, Switzerland.
Name of exporting country Switzerland
Detail of certificates attached (CoPP, Free- CoPP: Firm has submitted original, legalized CoPP
sale certificate, GMP certificate) certificate (No. 20005866) dated 23-12-2020 issued by
Swissmedic, Swiss Agency for therapeutic Products for
Atectura Breezhaler inhalation powder, hard capsule 150/80
microgram. The CoPP confirms free sale status of the
manufacturing site through periodic inspection.
Pakistan.
The firm has also submitted legalized copy of GMP
certificate No. GMP-CH-1000722 dated 19.12.2019
Details of letter of authorization / sole agency Firm has submitted original & legalized letter of
agreement Authorization/ Sole Agency Agreement dated November 26,
2020 from Novartis Pharma AG Regulatory Affairs Global
Drug Development Lichtstrasse 35, 4056 Basel Switzerland.
The firm M/s Novartis Pharma AG located at Lichtstrass 35,
CH-4056 Basel Switzerland confirms that Novartis Pharma
Schweiz AG with registered office located at 6343 Risch,
Switzerland is marketing authorization holder in
Switzerland. The letter states that M/s Novartis Pharma Stein
AG, Schaffhauserstrasse, 4332 Stein, Switzerland is the
global manufacturer of M/s Novartis Pharma AG Basel
Switzerland for the product Atectura Breezhaler
150/80mcg inhalation powder hard capsule, Atectura
Breezhaler 150/160mcg inhalation powder hard capsule,
Atectura Breezhaler 150/320mcg inhalation powder hard
capsule. This letter specifies M/s Novartis Pharma
(Pakistan) Ltd., 15 West Wharf, Karachi. as Sole Agent in
Pakistan.
☒ Importer

☐ Export sale
The proposed proprietary name / brand name Atectura Breezhaler inhalation powder, hard capsule
150/80mcg
Pharmaceutical ingredient (API) per unit Indacaterol (as acetate) …………150 mcg
Mometasone furoate……………. 80 mcg
Each delivered dose (the dose that leaves the mouthpiece of

the inhaler) contains 125 mcg of Indacaterol (as acetate) and
62.5 mcg of Mometasone furoate
Pharmaceutical form of applied drug Inhalation powder Hard capsule
Pharmacotherapeutic Group of (API) Adrenergics in combination with corticosteroids or other
drugs, excl. anticholinergics
ATC code: R03AK14
Reference to Finished product specifications Innovator’s Specs
Proposed Pack size 30 X 1 Capsules + 1 Breezhaler (Concept1 inhalation device)
The Concept1 inhaler consists of a protective cap, a
mouthpiece and an inhaler body which contains the capsule
receiving and piercing system. All plastic components with
the exception of the push buttons are made of ABS
(Acrylonitrile Butadiene Styrene). The push buttons are
made of MABS (Methyl Methacrylate Acrylonitrile
Butadiene Styrene). Piercing needles and the springs are
made of stainless steel.
The Concept1 device is manufactured by Plastiape S.p.A.,
23875 Osnago (LC), Italy by injection molding using
automatic cycle injection machines and an automated
assembly line.
Proposed unit price Proposed MRP per pack shall be furnished later
The status in reference regulatory authorities Atectura has been approved in many stringent regulatory
authorities such as Belgium, Denmark, EMA, Austria, and
Germany.
For generic drugs (me-too status) Not Applicable
Module-II (Quality Overall Summary) As Firm is innovator of product hence submitted QOS as per
ICH guidelines. Firm has provided the summarized
information related to nomenclature, structure, general

Name, address of drug substance manufacturer Indacaterol acetate:
Novartis Pharma Schweizerhalle AG, Rothausstrasse, 4133
Pratteln, Switzerland
Mometasone furoate:
MSD International GmbH (Singapore Branch), 50 Tuas
West Drive, Singapore 638408, Singapore.
Stability Studies of Drug Substance Firm has submitted stability study data of mometasone
(Conditions & duration of Stability studies) furoate under the 30°C / 65% RH for long term and 40°C /
75% RH for accelerated condition. The stability study for
long term data up to 36 months is provided.
The Firm has submitted stability data of indacaterol acetate
under 30°C / 75% RH for long term and 40°C / 75% RH for
accelerated condition. The stability study data for long term
data up to 24 months is provided.
Pharmaceutical Equivalence and Comparative Firm has submitted complete data of formulation
Dissolution Profile development process. As it is an innovator product, complete
clinical studies are also performed.
Container closure system of the drug product Inhalation powder, hard capsules are primary packaged into
PA/AL/PVC (ALU/ALU) blister packs.
Stability study data of drug product, shelf life Firm has submitted stability study data for 18 months long-
and storage conditions term stability conditions of 30°C/75% RH. Stability was also
monitored at accelerated storage condition at 40 °C/75% RH
for 6 months.
3.2.S.7.3 Stability study data of mometasone Mometasone furoate is an established drug
furoate drug substance submitted is of substance which is manufactured by MSD
different batches at real time and International GmBH (Singapore) and supplied to
accelerated conditions. Clarify? Novartis for use in production of QMF149 150/80
µg, 150/160 µg, 150/320 µg Inhalation powder,
hard capsules. The same quality of Mometasone
furoate supplied to Novartis, is also used in MSD’s

medicinal product marketed globally such as
Asmanex Twisthaler. Therefore, as the
Mometasone furoate is an established drug
substance and of established quality, the stability
data submitted in the marketing application dossier
was a compilation of most recent available stability
data (long term and accelerated) at the time of the
application and reflected different batches.
3.2.S.2.1 Since multiple manufacturing sites are The firm submitted the role of each manufacturer
involved in the production and testing and mentioned the site address involved in the
of the drug substance Indacaterol manufacturing and quality control testing of
acetate and the role of every Indacaterol drug substance.
manufacturer is not clear from the
information provided in the submitted
dossier. Therefore, the role of each
manufacturer along with the complete
address of the site is required.
3.2.P.3.1 Which site will issue Batch release The manufacturing of the product and some quality
certificate as manufacturing, quality control tests are performed at M/s Novartis Pharma
control tests and packaging (Novartis Stein AG, Schaffhauserstrasse, 4332 Stein,
Pharma Spain) for the applied product Switzerland.
are performed at different sites and Some quality control tests are performed at Solvias
from which site the product will be AG Romerpark 2, 4303 Kaiseraugst, Switzerland
imported to Pakistan and at Pharmanaltica S.A, Via Balestra, 6600
Locarno, Switzerland.
Primary and Secondary packaging are performed at
Siegfried Barbera S.L. Ronda de Santa Maria, 158,
Barbera del Valles, 08210 Barcelona Spain.
Siegfried Barbera S.L. was previously known as
Novartis Farmaceutica, SA and operates at the
same address.
Siegfried Barbera S.L. Ronda de Santa Maria,
158, Barbera del Valles, 08210 Barcelona Spain
issue batch release certificate while product will

be imported from M/s Novartis Pharma Stein AG,
Schaffhauserstrasse, 4332 Stein, Switzerland
3.2.P.8 Provide details i.e., batch no., The firm provided details batch no., manufacturing
manufacturing site, of relevant batches site, of relevant batches of indacaterol drug
of indacaterol drug substance, which substance, which was used in the formulation of
was used in the formulation of drug drug product stability batches.
product stability batches. However, the provided details show that the drug
substance was manufactured in Novartis
Ringaskiddy limited, Ringaskiddy, Ireland while
the firm have applied that the drug substance
manufacturer is Novartis Pharma Schweizerhalle
AG, Rothausstrasse, 4133 Pratteln, Switzerland.
The firm submitted that manufacturer written in
batch analysis against batch C0004 explains the
intermediate state of the mentioned batch while
final site is Novartis Pharma Schweizerhalle AG
Rothausstrasse 4133 Pratteln, Switzerland as
mentioned in 32S2.
The firm further submitted that the drug substance
indacaterol acetate was manufactured in Novartis
Ringaskiddy Ltd, Ireland producing un-micronised
API, which is then subsequently processed
(micronisation and post micronisation treatment) at
Novartis Pharma Schweizerhalle AG, Switzerland.
3.2.P.8.3 Long term stability study of drug Firm has submitted stability study data of three
product is performed at 30°C/75% RH batches at long term conditions 30 °C ±2 °C / 75 %
for 18th month while the claimed shelf ± 5%RH for 24 months
life is 30 months in zone I & II
conditions. Therefore, you are required
to submit the long term stability study
data till claimed shelf life as per zone
IV-A.
Decision: Approved with Innovator’s specifications as per Policy for inspection of Manufacturer abroad
and verification of local storage facility. The Board further advised the P.E&R division to include following
information on the registration letter of Dry Powder Inhaler Capsules:
i. Label claim for the “Target Delivered Dose”.
ii. Description of the delivery device (inhaler) intended to be marketed along with the applied formulation.
Karachi, Pakistan
holder (abroad)
Stein, Switzerland.

Atectura Breezhaler inhalation powder, hard capsule
150/160 microgram. The CoPP confirms free sale status of
the product in exporting country as well as GMP status of the
Pakistan.
Details of letter of authorization / sole agency Firm has submitted copy of Authorization/ Sole Agency
agreement Agreement dated November 26, 2020 from Novartis Pharma
AG Regulatory Affairs Global Drug Development
Lichtstrasse 35, 4056 Basel Switzerland. The firm M/s
Novartis Pharma AG located at Lichtstrass 35, CH-4056
Basel Switzerland confirms that Novartis Pharma Schweiz
AG with registered office located at 6343 Risch, Switzerland
is marketing authorization holder in Switzerland. The letter
states that M/s Novartis Pharma Stein AG,
Schaffhauserstrasse, 4332 Stein, Switzerland is the global
manufacturer of M/s Novartis Pharma AG Basel Switzerland
for the product Atectura Breezhaler 150/80mcg inhalation
powder hard capsule, Atectura Breezhaler 150/160mcg
inhalation powder hard capsule, Atectura Breezhaler
150/320mcg inhalation powder hard capsule. This letter
specifies M/s Novartis Pharma (Pakistan) Ltd., 15 West
Wharf, Karachi. as Sole Agent in Pakistan.
☒ Importer
☐ Export sale
150/160mcg

127.5 mcg of Mometasone furoate
ATC code: R03AK14

mouthpiece and an inhaler body which contains the
capsule receiving and piercing system. All plastic
components with the exception of the push buttons are
made of ABS (Acrylonitrile Butadiene Styrene). The
push buttons are made of MABS (Methyl Methacrylate
Acrylonitrile Butadiene Styrene). Piercing needles and
the springs are made of stainless steel.
The Concept1 device is manufactured by Plastiape
S.p.A., 23875 Osnago (LC), Italy by injection molding
using automatic cycle injection machines and an
automated assembly line.
Germany.
Mometasone furoate:

for 6 months.
3.2.S.7.3 Stability study data of mometasone Mometasone furoate is an established drug
furoate drug substance submitted is of substance which is manufactured by MSD
different batches at real time and International GmBH (Singapore) and supplied to
accelerated conditions. Clarify? Novartis for use in production of QMF149 150/80
µg, 150/160 µg, 150/320 µg Inhalation powder,
hard capsules. The same quality of Mometasone
furoate supplied to Novartis, is also used in MSD’s
medicinal product marketed globally such as
Asmanex Twisthaler. Therefore, as the
Mometasone furoate is an established drug
substance and of established quality, the stability
data submitted in the marketing application dossier
was a compilation of most recent available
stability data (long term and accelerated) at the
time of the application and reflected different
batches.
3.2.S.2.1 Since multiple manufacturing sites are The firm submitted the role of each manufacturer
involved in the production and testing of and mentioned the site address involved in the
the drug substance Indacaterol acetate and manufacturing and quality control testing of
the role of every manufacturer is not clear Indacaterol drug substance.
from the information provided in the
submitted dossier. Therefore, the role of
each manufacturer along with the
complete address of the site is required.

3.2.P.3.1 Which site will issue Batch release The manufacturing of the product and some
certificate as manufacturing, quality quality control tests are performed at M/s Novartis
control tests and packaging (Novartis Pharma Stein AG, Schaffhauserstrasse, 4332
Pharma Spain) for the applied product are Stein, Switzerland.
performed at different sites and from Some quality control tests are performed at Solvias
which site the product will be imported to AG Romerpark 2, 4303 Kaiseraugst, Switzerland
Pakistan and at Pharmanaltica S.A, Via Balestra, 6600
Locarno, Switzerland.
Primary and Secondary packaging are performed
at Siegfried Barbera S.L. Ronda de Santa Maria,
158, Barbera del Valles, 08210 Barcelona Spain.
Siegfried Barbera S.L. was previously known as
Novartis Farmaceutica, SA and operates at the
same address.
Siegfried Barbera S.L. Ronda de Santa Maria,
158, Barbera del Valles, 08210 Barcelona Spain
issue batch release certificate while product will
be imported from M/s Novartis Pharma Stein AG,
Schaffhauserstrasse, 4332 Stein, Switzerland
3.2.P.8 Provide details i.e., batch no., The firm provided details batch no., manufacturing
manufacturing site, of relevant batches of site, of relevant batches of indacaterol drug
indacaterol drug substance, which was substance, which was used in the formulation of
used in the formulation of drug product drug product stability batches.
stability batches. However, the provided details show that the drug
substance was manufactured in Novartis
Ringaskiddy limited, Ringaskiddy, Ireland while
the firm have applied that the drug substance
manufacturer is Novartis Pharma Schweizerhalle
AG, Rothausstrasse, 4133 Pratteln, Switzerland.
The firm submitted that manufacturer written in
batch analysis against batch C0004 explains the
intermediate state of the mentioned batch while
final site is Novartis Pharma Schweizerhalle AG

Rothausstrasse 4133 Pratteln, Switzerland as
mentioned in 32S2.
Ringaskiddy Ltd, Ireland producing un-
micronised API, which is then subsequently
processed (micronisation and post micronisation
treatment) at Novartis Pharma Schweizerhalle AG,
Switzerland.
3.2.P.8.3 Long term stability study of drug product Firm has submitted stability study data of three
is performed at 30°C/75% RH for 18th batches at long term conditions 30 °C ±2 °C / 75
month while the claimed shelf life is 30 % ± 5%RH for 24 months
months in zone I & II conditions.
Therefore, you are required to submit the
long term stability study data till claimed
shelf life as per zone IV-A.
Karachi, Pakistan
holder (abroad)
Stein, Switzerland.
Atectura Breezhaler inhalation powder, hard capsule
150/320 microgram. The CoPP confirms free sale status of
the product in exporting country as well as GMP status of the
Pakistan.
Details of letter of authorization / sole agency Firm has submitted copy of Authorization/ Sole Agency
agreement Agreement dated November 26, 2020 from Novartis Pharma
AG Regulatory Affairs Global Drug Development
Lichtstrasse 35, 4056 Basel Switzerland. The firm M/s
Novartis Pharma AG located at Lichtstrass 35, CH-4056
Basel Switzerland confirms that Novartis Pharma Schweiz

AG with registered office located at 6343 Risch, Switzerland
is marketing authorization holder in Switzerland. The letter
states that M/s Novartis Pharma Stein AG,
Schaffhauserstrasse, 4332 Stein, Switzerland is the global
manufacturer of M/s Novartis Pharma AG Basel Switzerland
for the product Atectura Breezhaler 150/80mcg inhalation
powder hard capsule, Atectura Breezhaler 150/160mcg
inhalation powder hard capsule, Atectura Breezhaler
150/320mcg inhalation powder hard capsule. This letter
specifies M/s Novartis Pharma (Pakistan) Ltd., 15 West
Wharf, Karachi. as Sole Agent in Pakistan.
☒ Importer
☐ Export sale
150/320mcg

260 mcg of Mometasone furoate
ATC code: R03AK14
mouthpiece and an inhaler body which contains the
capsule receiving and piercing system. All plastic
components with the exception of the push buttons are
made of ABS (Acrylonitrile Butadiene Styrene). The
push buttons are made of MABS (Methyl Methacrylate
Acrylonitrile Butadiene Styrene). Piercing needles and
the springs are made of stainless steel.
The Concept1 device is manufactured by Plastiape
S.p.A., 23875 Osnago (LC), Italy by injection molding

using automatic cycle injection machines and an
automated assembly line.
Germany.
Mometasone furoate:

for 6 months.
3.2.S.7.3 Stability study data of mometasone furoate Mometasone furoate is an established drug substance
drug substance submitted is of different which is manufactured by MSD International GmBH
batches at real time and accelerated (Singapore) and supplied to Novartis for use in production
conditions. Clarify? of QMF149 150/80 µg, 150/160 µg, 150/320 µg
Inhalation powder, hard capsules. The same quality of
Mometasone furoate supplied to Novartis, is also used in
MSD’s medicinal product marketed globally such as
Asmanex Twisthaler. Therefore, as the Mometasone
furoate is an established drug substance and of established
quality, the stability data submitted in the marketing
application dossier was a compilation of most recent
available stability data (long term and accelerated) at the
time of the application and reflected different batches.
3.2.S.2.1 Since multiple manufacturing sites are The firm submitted the role of each manufacturer and
involved in the production and testing of mentioned the site address involved in the manufacturing
the drug substance Indacaterol acetate and and quality control testing of Indacaterol drug substance.
the role of every manufacturer is not clear
from the information provided in the
submitted dossier. Therefore, the role of
each manufacturer along with the complete
address of the site is required.
3.2.P.3.1 Which site will issue Batch release The manufacturing of the product and some quality
certificate as manufacturing, quality control tests are performed at M/s Novartis Pharma Stein
control tests and packaging (Novartis AG, Schaffhauserstrasse, 4332 Stein, Switzerland.
Pharma Spain) for the applied product are

performed at different sites and from Some quality control tests are performed at Solvias AG
which site the product will be imported to Romerpark 2, 4303 Kaiseraugst, Switzerland and at
Pakistan Pharmanaltica S.A, Via Balestra, 6600 Locarno,
Switzerland.
Primary and Secondary packaging are performed at
Barbera del Valles, 08210 Barcelona Spain. Siegfried
Barbera S.L. was previously known as Novartis
Farmaceutica, SA and operates at the same address.
Barbera del Valles, 08210 Barcelona Spain issue batch
release certificate while product will be imported from
M/s Novartis Pharma Stein AG, Schaffhauserstrasse,
4332 Stein, Switzerland
3.2.P.8 Provide details i.e., batch no., The firm provided details batch no., manufacturing site,
manufacturing site, of relevant batches of of relevant batches of indacaterol drug substance, which
indacaterol drug substance, which was was used in the formulation of drug product stability
used in the formulation of drug product batches.
stability batches. However, the provided details show that the drug
substance was manufactured in Novartis Ringaskiddy
limited, Ringaskiddy, Ireland while the firm have applied
that the drug substance manufacturer is Novartis Pharma
Schweizerhalle AG, Rothausstrasse, 4133 Pratteln,
Switzerland.
The firm submitted that manufacturer written in batch
analysis against batch C0004 explains the intermediate
state of the mentioned batch while final site is Novartis
Pharma Schweizerhalle AG Rothausstrasse 4133 Pratteln,
Switzerland as mentioned in 32S2.
Ringaskiddy Ltd, Ireland producing un-micronised API,
which is then subsequently processed (micronisation and
post micronisation treatment) at Novartis Pharma
Schweizerhalle AG, Switzerland.
3.2.P.8.3 Long term stability study of drug product Firm has submitted stability study data of three batches at
is performed at 30°C/75% RH for 18th long term conditions 30 °C ±2 °C / 75 % ± 5%RH for 24
month while the claimed shelf life is 30 months
months in zone I & II conditions.
Therefore, you are required to submit the
long term stability study data till claimed
shelf life as per zone IV-A.

Case No. 2: New cases for registration of Human Drugs on Form 5F (Local)
233. Name, address of Applicant / Marketing M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
Authorization Holder Road, Islamabad
Name, address of Manufacturing site. M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
Road, Islamabad
☐ Importer
☐ Export sale
Dy. No. and date of submission Form-5F Dy. No 16112 dated 10-06-2021
Proposed proprietary name/brand name Gludap 5mg Tablet
Pharmaceutical ingredient (API) per unit Dapagliflozin as Propanediol Monohydrate…5mg
Reference to Finished product In house
specifications
The status in reference regulatory FARXIGA (5mg, 10mg) film coated tablets USFDA Approved
authorities
For generic drugs (me-too status) Xiga 5mg Tablets by M/s CCL Pharmaceuticals (Reg#090504)
GMP status of the Finished product GMP certificate issued to firm on 21st May 2019, based on
manufacturer inspection conducted on 23-04-2019 & valid upto 22-4-20222
Name and address of API manufacturer. Jiangsu yongan Pharmaceutical Co. Ltd., No. 18, 237 provincial
road economic development zone, huaian Jiangsu China.
of drug substance.
The firm has submitted summarized information of drug product
control, control of excipients, control of drug product,

properties, solubilities, physical form, manufacturers, tests for
of drug substance.
accelerated stability study is conducted at 40 O ± 2 OC /75% ± 5%
RH for 6 months. The real time stability study is conducted at
30OC ± 2 O C / 65% ± 5% RH for 36 months.
(Batch No. 130401, 130402 & 130501)
manufacturing process and controls, process validation
specifications, analytical procedures and its verification studies,
batch analysis, justification of specifications, reference standard
or materials, container closure system and stability studies of
drug product.
Pharmaceutical equivalence and Pharmaceutical Equivalence has been performed against
comparative dissolution profile innovator product Forxiga 5mg tablet.
CDP has been performed against innovator product Forxiga 5mg
tablet in Acid media (pH 1.2), acetate buffer pH 4.5 & Phosphate
Buffer (pH 6.8). The values for f2 are in the acceptable range.
Analytical method validation/verification Method validation studies is submitted including linearity,
Manufacturer of API Jiangsu yongan Pharmaceutical Co. Ltd., No. 18, 237 provincial road economic
development zone, huaian Jiangsu China.
API Lot No. DGF-201902001
Description of Pack Alu/Alu Blister Packing
(Container closure
system)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. DPT-001 DPT-002 DPT-003
No. of Batches 03
1. Reference of previous approval of The firm submitted copy of minutes of 296th meeting of
applications with stability study data of the registration board dated 8th, 9th & 10th September, 2020 in which
firm (if any) their product Empaglif 10mg and 25mg applied on form 5F has
been approved based on the inspection conducted by the panel
for authenticity of stability data

2. Approval of API/ DML/GMP certificate of The firm submitted copy of GMP certificate of Jiangsu Yongan
API manufacturer issued by concerned Pharmaceutical Co., Ltd China valid up to 03-03-2021
3. Documents for the procurement of API Firm has submitted clearance certificate and form 6 attested by
with approval from DRAP (in case of Assistant Director (I&E) DRAP Islamabad dated 01-04-2019 for
import). the import of 200gm Dapagliflozin Propanediol Monohydrate
and 5mg impurity A and 5mg Impurity B. However, the firm has
not submitted invoice for import of said materials.
4. Data of stability batches will be supported Firm has submitted record of testing of all batches along with
by attested respective documents like chromatograms, raw data sheets, COA and summary data sheets.
5. Compliance Record of HPLC software Firm has submitted audit trail reports on product testing
testing
6. Record of Digital data logger for Firm has submitted record of data logger for temperature and
temperature and humidity monitoring of humidity monitoring of real time and accelerated stability
accelerated)
Remarks of Evaluator XI:
1.3.4 Submit Valid copy of Drug Manufacturing The firm have submitted valid Drug Manufacturing
License License
1.6.5 Submit valid GMP certificate of the Drug The firm submitted valid GMP certificate
Substance manufacturer issued by relevant
3.2.S.4.1 Copies of the Drug substance specifications Firm have submitted Copies of the Drug substance
. - and analytical procedures used for routine specifications and analytical procedures used for
3.2.S.4.2 testing of the Drug substance /Active routine testing of the Drug substance /Active
Pharmaceutical Ingredient by Drug Product Pharmaceutical Ingredient by Drug Product
manufacturer is required. manufacturer.
However, the chromatographic test conditions were
different as compared with drug substance
manufacturer.
For example, the chromatographic conditions used
by the drug substance manufacturer are:
Related substances:
Mobile phase; Water R (0.01M NaH2PO4);
Acetonitrile R (50;50v/v)
DetectIion; 225nm
Injection; 20ul
Flow rate; 1ml/min
Drug product manufacturer;
Related substances:
Mobile phase; Methanol:Water (70;30 v/v)
Detectio; 223nm
Injection; 20ul
Flow rate; 1.5ml/min
Temperature; 40ºC
Drug substance manufacturer:

Assay:
Acetonitrile R (50;5 v/v)

Detection; 225nm
Injection; 20ul
Flow rate; 1ml/min
Temperature: 25ºC

Assay:
Detection; 223nm
Injection; 20ul
Temperature; 40ºC
3.2.S.4.3 • Analytical Method Verification studies The firm have submitted Analytical Method
including specificity, accuracy and validation studies performed by the Drug Product
repeatability (method precision) manufacturer for drug substance(s)
manufacturer for drug substance(s) shall
be submitted.
3.2.S.4.4 • In batch analysis of drug substance • The firm submitted that during analysis
performed by drug product manufacturer, Dapagliflozin was identified. However due to
in test for identification you have typo-graphical error Empagliflozin was written
submitted that it is positive for instead of dapagliflozin in COA. The rectified
empagliflozin while the applied product is COA with supportive documents is submitted.
dapagliflozin, clarify? • No justification provided for incomplete analysis
• Justification shall be provided for any
incomplete analyses of the drug substance
/ API by Drug Product manufacturer
(propanediol, residue on ignition, heavy
metals, related substances, residual
solvents, particle size)
3.2.P.1 • You have used lactose monohydrate in The firm submitted that we designed formulation
your formulation while innovator product qualitatively similar to innovator (Forxiga tablet).
has used lactose anhydrous. Justify that the We actually used lactose anhydrous and was
applied product is equivalent to innovator mistakenly written as lactose monohydrate. The firm
product. have submitted revised BMR.
3.2.P.4 • In control of excipients you have given The firm submitted that it was mistakenly written,
specifications for croscarmellose while specifications for lactose anhydrous is submitted
you have not used croscarmellose in
formulation, clarify? Moreover, you have
used lactose monohydrate while you have
not provided specifications of lactose
monohydrate?
3.2.P.8.1 • Stability data of drug product at initial • Stability data of drug product at initial time point
time point is not submitted is submitted
• You have mentioned in house • The firm submitted that they have designed their
specifications in module I section 1.5.6 product on innovator’s specifications and updated
while innovators specifications in stability the specifications at section 1.5.6. as innovator’s
summary sheets, clarify? specifications without submission of applicable
fee. The firm also submitted revised form 5F
• Submit invoice for the imported raw • The firm have not submitted invoice for the
materials. imported raw material
• Submit Compliance Record of HPLC • The firm submitted A General Compliance
software 21CFR certificate of HPLC software 21CFR
• The firm have submitted calculation for
determining the quantity of dispensed drug

• Provide complete calculation for substance on theoretical basis. The water content
determining the quantity of dispensed drug was not kept in mind while making calculation for
substance keeping in view water content dispensing drug substance
• Justification for incomplete analyses of the drug substance / API by Drug Product manufacturer
• Justification for using different chromatographic conditions for analysis of related substances and
assay test by the drug product manufacturer than those applied by drug substance manufacturer.
• Clarification for not considering the water content while making calculation for dispensing of drug
substance
• Submission of the fee of Rs. 7,500 for correction/pre-approval change in product specifications, as
234. Name, address of Applicant / Marketing M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
Authorization Holder Road, Islamabad
Road, Islamabad
☐ Importer
☐ Export sale
The proposed proprietary name / brand Gludap 10mg Tablet
name
Pharmaceutical ingredient (API) per unit Dapagliflozin as Propanediol Monohydrate…10mg
specifications
The status in reference regulatory FARXIGA (5mg, 10mg) film coated tablets USFDA Approved
authorities
For generic drugs (me-too status) Dapa 10mg Tablet by M/s Hilton Pharma (Reg#089368)
GMP status of the Finished product GMP certificate issued to firm on 21st May 2019, based on
manufacturer inspection conducted on 23-04-2019 and valid upto 22-04-20222
Name and address of API manufacturer. Jiangsu yongan Pharmaceutical Co. Ltd., No. 18, 237 provincial
road economic development zone, huaian Jiangsu China.

of drug substance.
The firm has submitted summarized information of drug product
control, control of excipients, control of drug product,
properties, solubilities, physical form, manufacturers, tests for
of drug substance.
accelerated stability study is conducted at 40 O ± 2 OC /75% ± 5%
RH for 6 months. The real time stability study is conducted at
30OC ± 2 O C / 65% ± 5% RH for 36 months.
(Batch No. 130401, 130402 & 130501)
manufacturing process and controls, process validation
specifications, analytical procedures and its verification studies,
batch analysis, justification of specifications, reference standard
or materials, container closure system and stability studies of
drug product.
Pharmaceutical equivalence and Pharmaceutical Equivalence has been performed against
comparative dissolution profile innovator product Forxiga 10mg tablet.
CDP has been performed against innovator product Forxiga
10mg tablet in Acid media (pH 1.2), acetate buffer pH 4.5 &
Phosphate Buffer (pH 6.8). The values for f2 are in the
acceptable range.
Analytical method validation/verification Method validation studies is submitted including linearity,
Manufacturer of API Jiangsu yongan Pharmaceutical Co. Ltd., No. 18, 237 provincial road economic
development zone, huaian Jiangsu China.
API Lot No. DGF-201902001
Description of Pack Alu/Alu Blister Packing
(Container closure
system)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. DPT-004 DPT-005 DPT-006

No. of Batches 03
applications with stability study data of the registration board dated 8th, 9th & 10th September, 2020 in which
firm (if any) their product Empaglif 10mg and 25mg applied on form 5F has
been approved based on the inspection conducted by the panel
for authenticity of stability data
2. Approval of API/ DML/GMP certificate of The firm submitted copy of GMP certificate of Jiangsu Yongan
API manufacturer issued by concerned Pharmaceutical Co., Ltd China valid up to 03-03-2021
3. Documents for the procurement of API Firm has submitted clearance certificate and form 6 attested by
with approval from DRAP (in case of Assistant Director (I&E) DRAP Islamabad dated 01-04-2019 for
import). the import of 200gm Dapagliflozin Propanediol Monohydrate
and 5mg impurity A and 5mg Impurity B. However, the firm has
not submitted invoice for import of said materials.
by attested respective documents like chromatograms, raw data sheets, COA and summary data sheets.
5. Compliance Record of HPLC software Firm has submitted audit trail reports on product testing
testing
accelerated)
1.3.4 Submit Valid copy of Drug Manufacturing The firm have submitted valid Drug Manufacturing
License License
1.6.5 Submit valid GMP certificate of the Drug The firm submitted valid GMP certificate
Substance manufacturer issued by relevant
3.2.S.4.1. Copies of the Drug substance specifications Firm have submitted Copies of the Drug substance
-3.2.S.4.2 and analytical procedures used for routine specifications and analytical procedures used for
testing of the Drug substance /Active routine testing of the Drug substance /Active
Pharmaceutical Ingredient by Drug Product Pharmaceutical Ingredient by Drug Product
manufacturer is required. manufacturer.
However, the chromatographic test conditions were
different as compared with drug substance
manufacturer.
For example, the chromatographic conditions used by
the drug substance manufacturer are:
Related substances:
Detector 225nm
Injection; 20ul
Flow rate; 1ml/min

Related substances:
Detector 223nm
Injection; 20ul
Temperature; 40ºC
Drug substance manufacturer:
Assay:
Detector 225nm
Injection; 20ul
Flow rate; 1ml/min
Temperature: 25ºC
Assay:
Detector 223nm
Injection; 20ul
Temperature; 40ºC
3.2.S.4.3 Analytical Method Verification studies The firm have submitted Analytical Method validation
including specificity, accuracy and studies performed by the Drug Product manufacturer
repeatability (method precision) performed for drug substance(s)
by the Drug Product manufacturer for drug
3.2.S.4.4 • In batch analysis of drug substance • The firm submitted that during analysis
performed by drug product manufacturer, Dapagliflozin was identified. However due to typo-
in test for identification you have graphical error Empagliflozin was written instead of
submitted that it is positive for dapagliflozin in COA. The rectified COA with
empagliflozin while the applied product is supportive documents is submitted.
dapagliflozin, clarify? • No justification provided for incomplete analysis
• Justification shall be provided for any
incomplete analyses of the drug
substance/API by Drug Product
manufacturer (propanediol, residue on
ignition, heavy metals, related substances,
residual solvents, particle size)
3.2.P.1 • You have used lactose monohydrate in The firm submitted that we designed formulation
your formulation while innovator qualitatively similar to innovator (Forxiga tablet). We
product has used lactose anhydrous. actually used lactose anhydrous and was mistakenly
Justify that the applied product is written as lactose monohydrate. The firm have
equivalent to innovator product. submitted revised BMR.
3.2.P.2.2. The batch number of innovator product The batch No. of innovator product Forxiga 10mg
1 Forxiga 10mg tablet mentioned in tablet taken in Pharmaceutical equivalence report is
Pharmaceutical equivalence report is NX101. Submitted chromatogram too is written with
132642 while the batch number mentioned batch No. NX101. It was a typo error in report.
in comparative dissolution report is NX101. Corrected repot is submitted.
Clarify that which batch number product
was used in both the studies
3.2.P.4 • In control of excipients you have given It was mistakenly written, specifications for lactose
specifications for croscarmellose while anhydrous is submitted
you have not used croscarmellose in
formulation, clarify? Moreover, you
have used lactose monohydrate while

you have not provided specifications of
lactose monohydrate?
3.2.P.5.2 • The Mobile phase composition in assay Method for analysis of drug product is submitted along
test is not mentioned in analytical with chromatographic conditions / mobile phase
procedure? composition in assay analysis
3.2.P.8.1 • Stability data of drug product at initial • Stability data of drug product at initial time point is
time point is not submitted submitted
• Stability summary sheet for accelerated • Stability summary sheet for accelerated and real time
and real time stability data at 6th month stability data at 6th month time point is submitted
time point is not submitted • The firm submitted that they have designed their
• You have mentioned in house product on innovator’s specifications and updated
specifications in module I section 1.5.6 the specifications at section 1.5.6. as innovator’s
while innovators specifications in specifications without submission of applicable fee.
stability summary sheets, clarify? The firm also submitted revised form 5F
• Submit invoice for the imported raw • The firm have not submitted invoice for the imported
materials. raw material
• Submit Compliance Record of HPLC • The firm submitted A General Compliance
software 21CFR certificate of HPLC software 21CFR
• Provide complete calculation for • The firm have submitted calculation for determining
determining the quantity of dispensed the quantity of dispensed drug substance on
drug substance keeping in view water theoretical basis. The water content was not kept in
content consideration while making calculation for
dispensing drug substance
• Justification for using different chromatographic conditions for analysis of related substances and
assay test by the drug product manufacturer than drug substance manufacturer.
• Justification for incomplete analyses of the drug substance / API by Drug Product manufacturer
• Clarification for not considering the water content while making calculation for dispensing of drug
substance
• Submission of the fee of Rs. 7,500 for correction/pre-approval change in product specifications, as
235. Name, address of Applicant / M/s Axis Pharmaceuticals., 3-B Value Additional City, 1.5 Km
Marketing Authorization Holder Khurrianwala – Sahianwala Road, Faisalabad – Pakistan
Name, address of Manufacturing M/s Axis Pharmaceuticals., 3-B Value Additional City, 1.5 Km
site. Khurrianwala – Sahianwala Road, Faisalabad – Pakistan
☐ Importer
Dy. No. and date of submission Dy. No. 17395, dated; 22.06.2021
(deposit slip # 400702636272)
The proposed proprietary name / Lansix Capsule 30mg
brand name
Strength / concentration of drug of Each capsule contains:
Active Pharmaceutical ingredient Lansoprazole enteric coated pellets eq.
(API) per unit Lansoprazole……………………………..30mg

Pharmaceutical form of applied drug Hard capsule
Pharmacotherapeutic Group of Proton Pump Inhibitor
(API)
Reference to Finished product USP specification
specifications
Proposed Pack size 14’s, 10’s
The status in reference regulatory PREVACID (15mg, 30mg) delayed-release capsules, USFDA
authorities approved
For generic drugs (me-too status) Laprazole Capsule 30mg by M/s Novamed Pharmaceuticals
(Reg#043641)
GMP status of the Finished product GMP certificate issued to the firm on 06-07-2020 based on
manufacturer inspection conducted on 09-06-2020.
Name and address of API Vision Pharmaceuticals (Pvt.) Ltd., Plot# 22 – 23, Industrial triangle,
manufacturer Kahuta Road, Islamabad. Pakistan
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template. Firm has
Summary) summarized information related to nomenclature, structure, general
properties, solubilities, physical form, manufacturers, impurities,
specifications, analytical procedures and its validation, batch analysis
and justification of specification, reference standard, container closure
system and stability studies of drug substance and drug product.
form, manufacturers, impurities, specifications, analytical procedures
and its validation, batch analysis and justification of specification,
drug substance.
Stability studies Firm has submitted stability study data of 3 batches of drug substance
at both accelerated as well as real time conditions. The accelerated
stability data is conducted at 40 º ± 2 º C /75% ± 5% RH for 6 months.
The real time stability data is conducted at 30 ºC ± 2 º C / 65% ± 5%
RH for 36 months. (Batch No. LPS0129, LPS0134 & LPS0141)
protocols, control of drug product, specifications, analytical
procedures, validation / verification of analytical procedures, batch
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical equivalence for their
comparative dissolution profile product against Laprazole 30mg capsule by M/s NovaMed
Pharmaceuticals and comparative dissolution profile against
Laprazole 30mg capsule by M/s NovaMed Pharmaceuticals
Analytical method Firm has submitted report of validation/verification of analytical
validation/verification of product method for the drug product.
Manufacturer of API Vision Pharmaceuticals (Pvt.) Ltd., Plot# 22 – 23, Industrial triangle, Kahuta Road,
Islamabad. Pakistan
API Lot No. B#: LPS0333 (QC #: R-440/20)

Description of Pack Alu – Alu Blister
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. T-001 T-002 T-003
Batch Size 1250 Caps. 1250 Caps. 1250 Caps.
Manufacturing Date 11 – 2020 11 – 2020 11 – 2020
No. of Batches 03
1. Reference of previous approval of Not submitted
applications with stability study data
of the firm (if any)
2. Approval of API/ DML/GMP The firm has submitted copy of GMP Certificate of Vision
certificate of API manufacturer Pharmaceuticals issued based on inspection conducted on 11-02-2019.
issued by concerned regulatory The certificate is valid till 10-02-2022
3. Documents for the procurement of The firm has submitted copy of invoice No. 701250 dated 13-10-2020
API with approval from DRAP (in for procurement of 5.0Kg of Lansoprazole EC Pellets 8.5% from M/s
case of import). Vision Pharmaceuticals.
4. Data of stability batches will be Firm has submitted copy of complete record of testing of all batches
supported by attested respective along with chromatograms, raw data sheets, COA and summary data
documents like chromatograms, Raw sheets.
data sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC Not submitted
software 21CFR & audit trail reports
on product testing
6. Record of Digital data logger for Not submitted
accelerated)
3.2.S.3. Justification shall be submitted for • Lansoprazole Enteric Coated Pellets as a drug substance is
1 applying IR spectrum for not available in USP monograph and Lansoprazole Delayed
characterization of the delayed Release Capsules are available, therefore the material was
release pellets of Lansoprazole since treated as such and drug substance manufacturer also
it does not contain API in pure form. claimed USP specifications, therefore only IR spectrum was
provided.
• However, drug substance manufacturer performed HPLC,
UV & IR technique for characterization and provided as part
of DMF. Copy for evidence are submitted.
3.2.S.4. • Copies of the Drug substance • Copies of CoA & SOP from Drug substance & Drug
1. - specifications and analytical Product manufacturer are submitted.
3.2.S.4. procedures used for routine testing
2 of the Drug substance /Active

Pharmaceutical Ingredient by both • Lansoprazole Enteric Coated Pellets as a drug substance is
Drug substance & Drug Product not available in USP monograph and Lansoprazole Delayed
manufacturer is required.” Release Capsules are available therefore “MS”
• Drug substance manufacturer have specifications is mentioned for Pellets.
claimed USP specifications while • The said specifications by drug substance manufacturer
you have claimed M.S were taken from DMF, which was a typographic mistake
specifications, clarification is and correct specifications are as per COA & SOP which are
required submitted herewith.
• The limits for dissolution in • Moreover, drug substance manufacturer used USP
phosphate buffer (pH 6.8) claimed specifications of Lansoprazole Delayed Release Capsule
by drug substance manufacturer is which states a sampling time point of 60 minutes for both
NLT 80% for 30 min after acid acid stage & buffer stage. The firm submitted revised
resistance while NLT 80% in buffer documents
release (pH 6.8) after 1h by drug
product manufacturer.
3.2.S.4. • COA of the drug substance • Analytical method provided by the drug substance
4 manufacturer has stated assay by manufacturer contains both HPLC & UV method, therefore
HPLC method while drug product we adopted UV method to compensate analytical testing
manufacturer has stated UV method load on HPLC.
for assay test. Justification is • However, testing as per HPLC method has been performed
required and data is provided herewith.
3.2.P.1 • You have not performed FAQs about form-5F by DRAP states that “Pharmaceutical
pharmaceutical equivalence against equivalence and comparative dissolution profile (where
the innovator brand justify? applicable) of the applied drug shall be established preferably
with the innovator / reference product, however comparator
product may be used.” Therefore, comparator product was
used which was readily available.
3.2.P.5. • The injection volume used by drug The HPLC system used for analysis has a single fixed volume
2 product manufacturer in assay test loop of 20µL. Moreover, USP <621> states that injection
is 20µl while the official volume can be adjusted as far as it is consistent with
monograph in USP have mentioned acceptable precision (evidence submitted herewith) and
10µl injection volume in assay test. analytical method verification has been performed and
Justification is required submitted.
3.2.P.8. • Test of content uniformity has not • Content Uniformity is applicable to those form which
1 been performed at the time of batch contains less than 25mg and less than 25% of drug substance
release, justify? in drug product. As the drug product label claim is 30mg per
• Compliance record of HPLC capsule, therefore content uniformity was not performed and
software 21CFR & audit trail weight variation test is applied and submitted. However, the
reports on product testing is USP monograph specifies content uniformity test for the
required. applied product
• Record of digital data logger of • The firm have submitted audit trail reports on product
temperature & relative humidity testing.
monitoring of stability chamber • The have submitted record of digital data logger of
(accelerated & long-term) is temperature & relative humidity monitoring of stability
required. chamber for long-term conditions only
Decision: Approved.
• Manufacturer shall submit performance of content uniformity test as per USP monograph, for all
three stability batches, before issuance of registration letter.

236. Name, address of Applicant / Marketing M/s Atco Laboratories Ltd, B-18, S.I.T.E, Karachi.
Name, address of Manufacturing site. M/s Atco Laboratories Ltd, B-18, S.I.T.E, Karachi.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name DAPAGLIFLOZIN 5mg Tablets.
Pharmaceutical ingredient (API) per unit Dapagliflozin…………5mg
(as Dapagliflozin Propanediol Monohydrate MS)
Pharmaceutical form of applied drug Green color, round shaped film coated biconvex
tablets plain from both sides.
Pharmacotherapeutic Group of (API) Sodium-Glucose Co-Transporter 2 (SGLT2)
Inhibitors.
Reference to Finished product specifications In house Specifications.
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s, 30’s, 56’s, & 60’s.
The status in reference regulatory authorities FARXIGA (5mg, 10mg) film coated tablets USFDA
Approved
For generic drugs (me-too status) Dapa 5mg Tablet by M/s Hilton Pharma
(Reg#089367)
GMP status of the Finished product manufacturer GMP certificate issued on 24-12-2020 based on
inspection conducted on 06-11-2020
Name and address of API manufacturer. M/s Jiangsu Yongan Pharmaceutical Co. Ltd., No.18,
237 Provincial road, Economic Development Zone,
Huaian, Jiangsu, China.,
Module III (Drug Substance) The firm has submitted detail of nomenclature,
process and controls, tests for impurity & related
substances, specifications, analytical procedures and

conditions. The accelerated stability study is
conducted at 40 O ± 2 OC /75% ± 5% RH for 6 months.
The real time stability study is conducted at 30OC ± 2
O
C / 65% ± 5% RH for 36 months.
(Batch No. 130401, 130402 & 130501)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been performed
dissolution profile against innovator product Forxiga 5mg tablet.
CDP has been performed against innovator product
Forxiga 5mg tablet in Acid media (pH 1.2), acetate
buffer pH 4.5 & Phosphate Buffer (pH 6.8). The values
Analytical method validation/verification of product The firm have submitted method validation studies
including linearity, range, accuracy, precision,
specificity.
Manufacturer of API M/s Jiangsu Yongan Pharmaceutical Co. Ltd., No.18, 237 Provincial road,
Economic Development Zone, Huaian, Jiangsu, China.,
API Lot No. 7100-201912001
Description of Pack Alu-Alu blister packed in printed carton
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. AP120B AP121B AP122B
No. of Batches 03
1. Reference of previous approval of applications with The firm submitted copy of minutes of 277th meeting
stability study data of the firm (if any) of registration board dated 27-29 December, 2017 in
which their product Rofl 500mcg tablet has been
approved based on the inspection conducted on 10-10-
2017 by the panel for authenticity of stability data

2. Approval of API/ DML/GMP certificate of API The firm submitted copy of GMP certificate of Jiangsu
manufacturer issued by concerned regulatory Yongan Pharmaceutical Co., Ltd China.
3. Documents for the procurement of API with The firm has submitted copy of invoice
approval from DRAP (in case of import). No#ZY20022603G/W dated 26-02-2020 for 1 kg
Dapagliflozin Propanediol Monohydrate batch No.
7100-201912001 attested by AD DRAP (Khi)
4. Data of stability batches will be supported by attested Firm has submitted record of testing of all batches
respective documents like chromatograms, Raw data along with chromatograms, raw data sheets, COA and
5. Compliance Record of HPLC software 21CFR & Firm has submitted Compliance Record of HPLC
audit trail reports on product testing software 21CFR & audit trail reports on product testing
XI
Remarks of Evaluator :
1.3.4 Submit Valid copy of Drug Manufacturing The firm submitted that their application for renewal
License as submitted DML expired on 10- of drug manufacturing license is under consideration
04-2021 at Central Licensing Board of DRAP and renewed
DML is not yet issued. The firm submitted DRAP
acknowledgement receipt of application for renewal of
DML, dated 17th March, 2021
1.6.5 Submit valid GMP certificate of the Drug The firm submitted copy the valid GMP certificate of
Substance manufacturer issued by relevant M/s Jiangsu Yongan Pharmaceutical Co., Ltd China.,
regulatory authority of country of origin. No.18, 237 Provincial road, Economic Development
Zone, Huaian, Jiangsu, valid upto 14th January 2024.
Drug Manufacturing License (DML #Su20160324) of
M/s Jiangsu Yongan Pharmaceutical Co. Ltd., China
issued by Jiangsu Drugs Administration, China. The
2.3 Submit module II as per WHO QOS-PD The firm have submitted Module II as per WHO-PD
template without referring to any annexure template without referring to any annexure of Module
of Module III. III as Section 2.3.
3.2.S.4.3 • Analytical Method Verification studies Copy of Analytical method verification studies
including specificity, accuracy and including specificity, accuracy and repeatability
repeatability (method precision) (method precision) performed by drug product
performed by the Drug Product manufacturer for drug substance is submitted
be submitted.
3.2.S.4.4 • justification shall be provided for any The firm have submitted that from 2020, USP has
incomplete analyses of the drug substance excluded Heavy metals test from its specifications. We
/ API by Drug Product manufacturer have applied same in our in-house testing procedures.
(propanediol, residue on ignition, heavy Updated Analytical report of drug substance / API by
metals, related substances, residual drug product manufacturer is submitted including test
solvents, particle size) for propanediol, residue on ignition, related substances
3.2.S.7.2 • In Post-approval Stability Protocol and The firm have submitted Post-approval Stability
Stability Commitment you have Protocol and Stability Commitment at 30°C ±
mentioned long term testing conditions 2°C/65% ± 5%RH Section.
25OC ± 2 O C / 65% ± 5% while submitted
stability data at 30OC ± 2 O C / 65% ± 5%
RH justify.

3.2.S.7.3 • You have submitted the stability data at The firm submitted that we have initially submitted the
long term testing conditions of 25OC ± 2 O stability protocol and report with typographic error
C / 65% ± 5% and 30OC ± 2 O C / 65% ± i.e.25°C ± 2°C/60% ± 5% rather than 30°C ± 2°C/65%
5% RH which contains the same results of ± 5% against observation of pre- screening, we have
different tests at both the conditions, submitted the same stability data after just typographic
justify? correction of long term condition i.e. 30°C ± 2°C/65%
± 5% so you are informed that earlier submitted data
was also produced on 30°C ± 2°C/65% ± 5% and no
studies were conducted by drug substance
manufacturer at 25°C ± 2°C/60% ± 5%.
3.2.P.2 • Submit Pharmaceutical Development as • The firm have submitted Pharmaceutical
per relevant sections and subsections of Development as per relevant sections and
form 5F subsections of form 5F.
• A minimum of three time-points should • As per WHO Guideline “enclosed Section 3.2.P.2”:
be included for CDP, the time-points for Multisource (generic) pharmaceutical products:
both reference (comparator) and test guidelines on registration requirements to establish
product being the same as per WHO interchangeability”, If both the test and reference
guidelines while you have performed at (comparator) products show more than 85%
only two time points i.e. 10 min and 15 dissolution in 15 minutes the profiles are considered
min, justification is required similar (no calculations required). Our test and
reference sample both showed more than 85%
release in dissolution within 15 minutes. That’s why
we have submitted data till 15 minutes. Referred
document is submitted. However, the firm have
performed CDP at only two time points.
3.2.P.5.2 • The value of Q in the dissolution limits The firm have submitted that in testing procedure
declared in the analytical procedure is Value of Q is mentioned which is 75% but limit of
different from that proposed in the dissolution is prescribed (Q+5) which should
specifications & stability sheets. ultimately 75% + 5 is equal to 80%. Specification and
stability sheets mentioned dissolution limit rather than
Q value which is 80%.
3.2.P.5.3 • Analytical method validation report Analytical method validation for Related substances
concludes that “the applied method is test is covered under Analytical method validation for
validated for both Assay & Related Assay by adding parameter of Force Degradation
substances test”, whereas the performance studies. Analytical method validation protocol and
has been done for the Assay method only. report with results of Force Degradation studies is
submitted.
3.2.P.8.1 • Stability Summary sheets of batch no. • The firm have submitted copy of stability summary
Ap120B real time conditions is not sheets of all batches at real time and accelerated
submitted conditions.
• Readings of 3rd month time point of Batch • The firm have submitted revised stability summary
no. AP121B of Real time conditions is sheets and raw data sheets and submit correct
written in accelerated conditions in readings accordingly
stability summary sheet as evident from
COA and vice versa.
Decision: Approved with innovators specifications. Registration letter will be issued after submission of
CDP studies for the applied product.
• Firm shall submit CDP studies against the innovator/reference product with minimum three
sampling time points, as recommended by the relevant guidelines of CDP, before issuance of
• Firm shall submit fee of Rs. 7,500 for correction/pre-approval change in product specifications, as

237. Name, address of Applicant / Marketing M/s Atco Laboratories Ltd, B-18, S.I.T.E, Karachi.
Name, address of Manufacturing site. M/s Atco Laboratories Ltd, B-18, S.I.T.E, Karachi.
☐ Importer
☐ Export sale
Details of fee submitted PKR 20,000/- dated 09/02/2021 or 10/06/2021
The proposed proprietary name / brand name DAPAGLIFLOZIN 10mg Tablets.
Pharmaceutical ingredient (API) per unit Dapagliflozin…………10mg
(as Dapagliflozin Propanediol Monohydrate MS)
Pharmaceutical form of applied drug Green color, round shaped film coated biconvex
tablets plain from both sides.
Pharmacotherapeutic Group of (API) Sodium-Glucose Co-Transporter 2 (SGLT2)
Inhibitors.
Reference to Finished product specifications In house Specifications.
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s, 30’s, 56’s, & 60’s.
The status in reference regulatory authorities FARXIGA (5mg, 10mg) film coated tablets USFDA
Approved
For generic drugs (me-too status) Dapa 10mg Tablet by M/s Hilton Pharma
(Reg#089368)
GMP status of the Finished product manufacturer GMP certificate issued on 24-12-2020 based on
Name and address of API manufacturer. M/s Jiangsu Yongan Pharmaceutical Co. Ltd., No.18,
237 Provincial road, Economic Development Zone,
Huaian, Jiangsu, China.,
Module III (Drug Substance) The firm has submitted detail of nomenclature,

process and controls, tests for impurity & related
substances, specifications, analytical procedures and
conditions. The accelerated stability study is
conducted at 40 O ± 2 OC /75% ± 5% RH for 6 months.
The real time stability study is conducted at 30OC ± 2
O
C / 65% ± 5% RH for 36 months.
(Batch No. 130401, 130402 & 130501)
Pharmaceutical equivalence and comparative CDP has been performed against innovator product
dissolution profile Forxiga 10mg tablet in Acid media (pH 1.2), acetate
buffer pH 4.5 & Phosphate Buffer (pH 6.8). The values
Analytical method validation/verification of product The firm have submitted method validation studies
including linearity, range, accuracy, precision,
specificity.
Manufacturer of API M/s Jiangsu Yongan Pharmaceutical Co. Ltd., No.18, 237 Provincial road,
Economic Development Zone, Huaian, Jiangsu, China.,
API Lot No. 7100-201912001
Description of Pack Alu-Alu blister packed in printed carton
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. AP117B AP118B AP119B
No. of Batches 03
1. Reference of previous approval of applications with The firm submitted copy of minutes of 277th meeting
stability study data of the firm (if any) of registration board dated 27-29 December, 2017 in
which their product Rofl 500mcg tablet has been
approved based on the inspection conducted on 10-10-
2017 by the panel for authenticity of stability data

2. Approval of API/ DML/GMP certificate of API The firm submitted copy of GMP certificate of Jiangsu
manufacturer issued by concerned regulatory Yongan Pharmaceutical Co., Ltd China.
3. Documents for the procurement of API with The firm has submitted copy of invoice
approval from DRAP (in case of import). No#ZY20022603G/W dated 26-02-2020 for 1 kg
Dapagliflozin Propanediol Monohydrate batch No.
7100-201912001 attested by AD DRAP (Khi)
respective documents like chromatograms, Raw data along with chromatograms, raw data sheets, COA and
5. Compliance Record of HPLC software 21CFR & Firm has submitted Compliance Record of HPLC
audit trail reports on product testing software 21CFR & audit trail reports on product testing
XI
Remarks of Evaluator :
The firm have submitted Fee for
registration Rs. 20000/- challan date 09-
02-2021 while endorsed on 10-06-2021.
1.3.4 Submit Valid copy of Drug The firm submitted that their application for renewal of
Manufacturing License as submitted drug manufacturing license is under consideration at
DML expired on 10-04-2021 Central Licensing Board of DRAP and renewed DML is
not yet issued. The firm submitted DRAP
acknowledgement receipt of application for renewal of
DML, dated 17th March, 2021
1.6.5 Submit valid GMP certificate of the The firm submitted copy the valid GMP certificate of M/s
Drug Substance manufacturer issued by Jiangsu Yongan Pharmaceutical Co., Ltd China., No.18,
relevant regulatory authority of country 237 Provincial road, Economic Development Zone,
of origin. Huaian, Jiangsu, valid upto 14th January 2024.
Drug Manufacturing License (DML #Su20160324) of M/s
Jiangsu Yongan Pharmaceutical Co. Ltd., China issued by
Jiangsu Drugs Administration, China. The certificate is
2.3 Submit module II as per WHO QOS-PD The firm have submitted Module II as per WHO-PD
template without referring to any template without referring to any annexure of Module III as
annexure of Module III. Section 2.3.
3.2.S.4. • Analytical Method Verification Copy of Analytical method verification studies including
3 studies including specificity, accuracy specificity, accuracy and repeatability (method precision)
and repeatability (method precision) performed by drug product manufacturer for drug
performed by the Drug Product substance is submitted
manufacturer for drug substance(s)
shall be submitted.
3.2.S.4. • justification shall be provided for any The firm have submitted that from 2020, USP has excluded
4 incomplete analyses of the drug Heavy metals test from its specifications. We have applied
substance / API by Drug Product same in our in-house testing procedures. Updated
manufacturer (propanediol, residue on Analytical report of drug substance / API by drug product
ignition, heavy metals, related manufacturer is submitted including test for propanediol,
substances, residual solvents, particle residue on ignition, related substances
size)
3.2.S.7. • You have submitted the stability data The firm submitted that we have initially submitted the
3 at long term testing conditions of 25OC stability protocol and report with typographic error i.e.25°C
± 2 O C / 60% ± 5% and 30OC ± 2 O C ± 2°C/60% ± 5% rather than 30°C ± 2°C/65% ± 5% against
observation of pre- screening, we have submitted the same

/ 65% ± 5% RH which contains the stability data after just typographic correction of long term
same results of different tests at both condition i.e. 30°C ± 2°C/65% ± 5% so you are informed
the conditions, justify? that earlier submitted data was also produced on 30°C ±
2°C/65% ± 5% and no studies were conducted by drug
substance manufacturer at 25°C ± 2°C/60% ± 5%.
3.2.P.2 • Submit Pharmaceutical Development • The firm have submitted Pharmaceutical Development as
as per relevant sections and per relevant sections and subsections of form 5F.
subsections of form 5F • As per WHO Guideline “enclosed Section 3.2.P.2”:
• A minimum of three time-points Multisource (generic) pharmaceutical products:
should be included for CDP, the time- guidelines on registration requirements to establish
points for both reference (comparator) interchangeability”, If both the test and reference
and test product being the same as per (comparator) products show more than 85% dissolution
WHO guidelines while you have in 15 minutes the profiles are considered similar (no
performed at only two time points i.e. calculations required). Our test and reference sample both
10 min and 15 min, justification is showed more than 85% release in dissolution within 15
required minutes. That’s why we have submitted data till 15
• You have not performed minutes. Referred document is submitted. However, the
Pharmaceutical equivalence of the firm have performed CDP at only two time points.
applied drug with the innovator / • The firm have submitted Pharmaceutical equivalence of
reference / comparator product, the applied drug with the innovator product Forxiga 10mg
justify? tablet
3.2.P.5. • The value of Q in the dissolution The firm have submitted that in testing procedure Value of
2 limits declared in the analytical Q is mentioned which is 75% but limit of dissolution is
procedure is different from that prescribed (Q+5) which should ultimately 75% + 5 is equal
proposed in the specifications & to 80%. Specification and stability sheets mentioned
stability sheets. dissolution limit rather than Q value which is 80%.
3.2.P.5. • Analytical method validation report Analytical method validation for Related substances test is
3 concludes that “the applied method is covered under Analytical method validation for Assay by
validated for both Assay & Related adding parameter of Force Degradation studies. Analytical
substances test”, whereas the method validation protocol and report with results of Force
performance has been done for the Degradation studies is submitted.
Assay method only.
Decision: Approved with innovators specifications. Registration letter will be issued after submission of
CDP studies for the applied product.
• Firm shall submit CDP studies against the innovator/reference product with minimum three
sampling time points, as recommended by the relevant guidelines of CDP, before issuance of
• Firm shall submit fee of Rs. 7,500 for correction/pre-approval change in product specifications, as
238. Name, address of Applicant / Marketing M/s Ferozsons Laboratories Limited, PO Ferozsons Amangarh
Authorization Holder Nowshera Khyber Pakhtunkhwa - Pakistan.
Name, address of Manufacturing site. M/s Ferozsons Laboratories Limited, PO Ferozsons Amangarh
Nowshera Khyber Pakhtunkhwa - Pakistan.
☐ Importer

☐ Export sale
PKR 10,000/-: dated 03/06/2021
The proposed proprietary name / brand CIVADINE 5MG TABLETS
name
Pharmaceutical ingredient (API) per unit Ivabradine hydrochloride eq. to Ivabradine…...5mg
Pharmaceutical form of applied drug Film coated tablets
Pharmacotherapeutic Group of (API) Cardiovascular Drug
Reference to Finished product Innovator’s specifications
specifications
Proposed Pack size 10’s, 14’s, 20’s, 28’s and 30’s
The status in reference regulatory Corlanor 5mg, 7.5mg film coated tablet USFDA Approved.
authorities
For generic drugs (me-too status) Sivab 5mg Tablets by M/s Getz Pharma (Reg#076442)
manufacturer inspection conducted on 25-01-2019. Tablet (General) section
approved vide letter No. F.3-14/2004-Lic, dated: 08-04-2015
Name and address of API manufacturer. M/s Fuxin Long Rui Pharmaceutical Co, Ltd - Fluoride
Industrial Park, Fumeng County (Yi Ma Tu), Fuxin City,
Liaoning Province – 123000 – China
and drug product.
Module III (Drug Substance) The firm submitted detail of nomenclature, structure, general
The accelerated stability data is conducted at 40 º ± 2 º C /75%
± 5% RH for 6 months. The real time stability data is conducted
at 30 ºC ± 2 º C / 65% ± 5% RH for 36 months.
Batches: (160416, 160506, 160722)
analytical procedure and validation/verification studies, batch

Pharmaceutical equivalence and Firm has submitted pharmaceutical equivalence against report
comparative dissolution profile Coralan 5mg tablet by Les Laboratoires Servier Industrie,905
route de saran 45520 Giddy France.
The firm have submitted comparative dissolution profile of
Civadine 5mg Tablets and Coralan 5mg Tablet by M/s Les
Laboratories Servier Industrie 905 route de Saran, 42250 Gidy
France in all three Buffer media pH 1.2, Acetate Buffer pH 4.5
and Phosphate Buffer pH 6.8
Analytical method validation/verification of The firm have submitted method validation/verification studies
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical Co, Ltd - Fluoride Industrial Park, Fumeng
County (Yi Ma Tu), Fuxin City, Liaoning Province – 123000 – China
API Lot No. YF-20170214-D01-YF08-05
Description of Pack Alu-PVDC blister packed in cardboard box. (1x10’s)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. IBTab-001 IBTab-002 IBTab-003
No. of Batches 03
applications with stability study data of the Registration Board in which their product Empagen tablet
firm (if any) 10mg & 25mg were approved based on inspection conducted
for PSI by the panel on 25th October 2019.
2. Approval of API/ DML/GMP certificate of The firm has submitted GMP certificate of M/s Fuxin Long Rui
API manufacturer issued by concerned Pharmaceutical Co, Ltd - Fluoride Industrial Park, Fuxin City,
regulatory authority of country of origin. Liaoning Province – 123000 – China.
Firm has submitted copy of Drug Manufacturing
License (DML # Liao20150233) of Fuxin Long Rui
Pharmaceutical Co. Ltd., China issued by Food & Drug
Administration, Liaoning Province China. The certificate is
3. Documents for the procurement of API with The firm submitted copy of Form-6, No.00393/2018-DRAP (P)
approval from DRAP (in case of import). / 1612 dated 26/04/2018, attested by AD DRAP Peshawar.
The firm submitted copy of Commercial invoice and packing

list for Ivabradine HCl. However, the invoice is not attested by
AD DRAP Peshawar.

by attested respective documents like chromatograms, raw data sheets, COA and summary data
5. Compliance Record of HPLC software The firm submitted A General Compliance certificate of HPLC
21CFR & audit trail reports on product software 21CFR and audit trial reports on product testing
testing
stability chambers (real time & accelerated) chambers.
3.2.P.2.2.1 • Pharmaceutical equivalence of the • Firm has submitted Pharmaceutical equivalence of the
applied drug with the innovator / applied drug with the reference product Coralan 5mg
reference / comparator product is not tablet
submitted • The firm submitted that Reference product used in
• Details of marketing authorization CDP studies is Coralan 5mg tablets Reg#078161
holder of the reference product used in Marketed by: Servier Research and Pharmaceuticals
the CDP studies shall be submitted Pakistan
Manufactured by: Les Laboratories Servier Industrie,
France
3.2.P.4.3 Chromatograms submitted in analytical • Readable analytical validation report is submitted
validation report is not readable
3.2.P.8.1 • You have mentioned innovators • The firm have submitted revised certificate of analysis
specifications in module I section and stability summary sheets of all the three trial
1.5.6 while in house specifications in batches manufactured for stability testing mentioning
batch analysis section 3.2.P.5.4 and “innovator’s specifications” without submission of
stability summary sheets, clarify? applicable fee.
• The name of supplier mentioned on • The firm submitted that Beijing Sino Hason Import &
form 6 is M/s Beijing Huikang Export Co. Ltd. Is responsible for exporting the
Boyuan Chemical Tech Co, Ltd-China products of manufacturer / group company and
Manufacturing site M/s Fuxin Long declaration for the same from the manufacturer is
Rui Pharmaceutical Co., Ltd-China submitted. However, the name of supplier mentioned
while the name of supplier mentioned on form-6 and invoice is different.
on invoice is Beijing Sino hason • The firm submitted that invoice was not attested
Import & Export Co. Ltd. Justification because the drug substance was imported against
is required form-6. Form-6 was signed by AD-DRAP and
Furthermore, invoice is not attested by intimation regarding receiving of the drug substance
AD DRAP, clarify? was also submitted to the concerned. Copy of both
form 6 and DRAP acknowledgement is submitted.
Decision: Registration Board noted the fact that the name of drug substance manufacturer was same on
the submitted COA and GMP certificate and decided to approve the application with innovators
specifications.
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in product specifications,
239. Name, address of Applicant / Marketing M/s Ferozsons Laboratories Limited,
Authorization Holder PO Ferozsons Amangarh Nowshera Khyber Pakhtunkhwa -
Pakistan.
Name, address of Manufacturing site. M/S Ferozsons Laboratories Limited,

PO Ferozsons Amangarh Nowshera Khyber Pakhtunkhwa -
Pakistan.
☐ Importer
☐ Export sale
PKR 10,000/-: dated 03/06/2021
The proposed proprietary name / brand CIVADINE 7.5MG TABLET
name
Pharmaceutical ingredient (API) per unit Ivabradine hydrochloride eq. to Ivabradine …….7.5mg
Pharmacotherapeutic Group of (API) Cardiovascular Drug
Reference to Finished product Innovator’s specifications
specifications
Proposed Pack size 10’s, 14’s, 20’s, 28’s and 30’s
The status in reference regulatory Corlanor 5mg, 7.5mg film coated tablet USFDA Approved.
authorities
For generic drugs (me-too status) Sivab 7.5mg Tablets by M/s Getz Pharma (Reg#076443)
manufacturer inspection conducted on 25-01-2019. Tablet (General) section
approved vide letter No. F.3-14/2004-Lic, dated: 08-04-2015
Name and address f API manufacturer. M/s Fuxin Long Rui Pharmaceutical Co, Ltd - Fluoride
Industrial Park, Fumeng County (Yi Ma Tu), Fuxin City,
Liaoning Province – 123000 – China
and drug product.
Module III (Drug Substance) The firm submitted detail of nomenclature, structure, general

The accelerated stability data is conducted at 40 º ± 2 º C /75%
± 5% RH for 6 months. The real time stability data is conducted
at 30 ºC ± 2 º C / 65% ± 5% RH for 36 months.
Batches: (160416, 160506, 160722)
analytical procedure and validation/verification studies, batch
Pharmaceutical equivalence and Firm has submitted pharmaceutical equivalence against report
comparative dissolution profile Coralan 7.5mg tablet by Les Laboratoires Servier Industrie,905
route de saran 45520 Giddy France.
The firm have submitted comparative dissolution profile of
Civadine 7.5mg Tablets and Coralan 7.5mg Tablet by M/s Les
Laboratories Servier Industrie 905 route de Saran, 42250 Gidy
France in all three Buffer media pH 1.2, Acetate Buffer pH 4.5
and Phosphate Buffer pH 6.8
Analytical method validation/verification of The firm have submitted method validation/verification studies
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical Co, Ltd - Fluoride Industrial Park, Fumeng
County (Yi Ma Tu), Fuxin City, Liaoning Province – 123000 – China
API Lot No. YF-20170214-D01-YF08-05
Description of Pack Alu-PVDC blister packed in cardboard box. (1x10’s)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. IBTab-004 IBTab-005 IBTab-006
No. of Batches 03
applications with stability study data of the Registration Board in which their product Empagen tablet
firm (if any) 10mg & 25mg were approved based on inspection conducted
for PSI by the panel on 25th October 2019.
2. Approval of API/ DML/GMP certificate of The firm has submitted GMP certificate of M/s Fuxin Long Rui
API manufacturer issued by concerned Pharmaceutical Co, Ltd - Fluoride Industrial Park, Fuxin City,
regulatory authority of country of origin. Liaoning Province – 123000 – China.
License (DML # Liao20150233) of Fuxin Long Rui
Pharmaceutical Co. Ltd., China issued by Food & Drug

Administration, Liaoning Province China. The certificate is
3. Documents for the procurement of API with The firm submitted copy of Form-6, No.00393/2018-DRAP (P)
approval from DRAP (in case of import). / 1612 dated 26/04/2018, attested by AD DRAP Peshawar.
The firm submitted copy of Commercial invoice and packing

list for Ivabradine HCl. However, the invoice is not attested by
AD DRAP Peshawar.
by attested respective documents like chromatograms, raw data sheets, COA and summary data
5. Compliance Record of HPLC software The firm submitted A General Compliance certificate of HPLC
21CFR & audit trail reports on product software 21CFR and audit trial reports on product testing
testing
stability chambers (real time & accelerated) chambers.
3.2.P.2.2.1 • Pharmaceutical equivalence of the • Firm has submitted Pharmaceutical equivalence of
applied drug with the innovator / the applied drug with the reference product
reference / comparator product is not Coralan 7.5mg tablet
submitted • The firm submitted that Reference product used in
• Details of marketing authorization holder CDP studies is Coralan 7.5mg tablets Reg#078162
of the reference product used in the CDP Marketed by: Servier Research and Pharmaceuticals
studies shall be submitted Pakistan
Manufactured by: Les Laboratories Servier
Industrie, France
3.3.P.3.2 • Batch formula of civadin 5mg tablet is The firm have submitted Batch formula of Civadine
submitted 7.5mg tablet
3.2.P.4.3 Chromatograms submitted in analytical Readable analytical validation report is submitted
validation report is not readable
3.2.P.8.1 • You have mentioned innovators • The firm have submitted revised certificate of
specifications in module I section 1.5.6 analysis and stability summary sheets of all the
while in house specifications in batch three trial batches manufactured for stability
analysis section 3.2.P.5.4 and stability testing mentioning “innovator’s specifications”
summary sheets, clarify? Furthermor, in without submission of applicable fee.
stability summary sheet of batch No. • The firm have corrected date in stability summary
IBtab-004 USP specifications is sheet of Batch No. IBTab-005 as 27-Aug-2020
mentioned, clarify? • The firm submitted that Beijing Sino Hason Import
• The date of initiation of stability study & Export Co. Ltd. Is responsible for exporting the
mentioned in stability summary sheet of products of manufacturer / group company and
Batch No. IBTab-005 is 28-jul-2020 declaration for the same from the manufacturer is
while date of manufacturing is aug-2020, submitted. However, the name of supplier
clarify mentioned on form-6 and invoice is different.
• The name of supplier mentioned on form • The firm submitted that invoice was not attested
6 is M/s Beijing Huikang Boyuan because the drug substance was imported against
Chemical Tech Co, Ltd-China form-6. Form-6 was signed by AD-DRAP and
Manufacturing site M/s Fuxin Long Rui intimation regarding receiving of the drug
Pharmaceutical Co., Ltd-China while the substance was also submitted to the concerned.
name of supplier mentioned on invoice is

Beijing Sino hason Import & Export Co. Copy of both form 6 and DRAP acknowledgement
Ltd. Justification is required is submitted.
Furthermore, invoice is not attested by AD
DRAP, clarify?
Decision: Registration Board noted the fact that the name of drug substance manufacturer was same on
the submitted COA and GMP certificate and decided to approve the application with innovators
specifications.
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in product specifications,
240. Name, address of Applicant / Marketing M/s Pacific Pharmaceuticals Ltd., 30 Km Multan Road,
Authorization Holder Lahore
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd., 30 Km Multan Road,
Lahore
☐ Importer
☐ Export sale
The proposed proprietary name / brand Gluset 10mg Tablets
name
Pharmaceutical ingredient (API) per unit Empagliflozin …. 10 mg
Pharmaceutical form of applied drug Oral solid dosage form
ATC code: A10BK03
Reference to Finished product In-House
specifications
The status in reference regulatory JARDIANCE (10mg, 25mg) film coated tablets USFDA
authorities Approved
For generic drugs (me-too status) Diampa Tablet 25 mg by M/s Getz Pharma (Reg#093073)
GMP status of the Finished product The firm have submitted GMP certificate issued on 25-04-
manufacturer 209 based on inspection conducted 07-03-2019.
Name and address of API manufacturer. Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride Industrial
Park, Fumeng County (Yi Ma Tu), Fuxin City, Liaoning
Province - 123000, China

studies of drug substance and drug product.
Module-III (Drug Substance): Firm has submitted detailed data for drug substance data
substance.
Stability Studies of Drug Substance Long-term stability studies were performed at a storage
temperature of 30°C±2°C/65%±5% RH for 24 months.
Accelerated stability studies were performed at a temperature
of 40±2°C/75%±5% RH for 6 months.
(Batch No. 20160606, 20161017, 20161219)
Pharmaceutical Equivalence and The firm has submitted Pharmaceutical Equivalence Studies
Comparative Dissolution Profile of the applied product against the reference product of
“Diampa 10 mg Tablet” by M/s Getz pharma.
CDP has been performed against the same brand that
“Diampa 10 mg Tablet” by Getz pharma in HCl buffer
Acetate Buffer pH 4.5 and Phosphate buffer pH 6.8.
Analytical method validation / verification Firm has submitted verification/ validation studies of the drug
of product product.
Manufacturer of APIs Fuxin Long Rui Pharmaceutical Co., Ltd
Fluoride Industrial Park, Fumeng County (Yi Ma Tu), Fuxin City, Liaoning
API Lot No. L-E-20200409-D01-E06-01
Description of Pack Alu-PVC blisters sealed with Aluminium foil
Real time: 30oC ± 2oC / 65% HR ±5%
Stability Storage Condition
Accelerated: 40oC ± 2oC / 75% HR ±5%
Real time: 6 months
Time Period
Accelerated: 0, 3, 6 (Months)
Frequency
Real Time: 0, 3, 6, 9, 12, 24, (Months)
Batch No. SEG00109P SEG00209P SEG00309P
Manufacturing Date 09/2020 09/2020 09/2020

No. of Batches 03
1. Reference of previous approval of applications Refer to previous onsite inspection report of their product
with stability study data of the firm (if any) Esmelin tablet 15mg dated 10-08-2020 on the basis of
which Registration Board in its 313th meeting decided to
approve the registration of Esmelin 15mg tablet.
The report shows that:
• The HPLC software is 21 CFR compliant and Log of
data was available in the HPLCs. The data was also
checked through hard copies of chromatograms.
• Adequate monitoring and control were available for
stability chamber. The firm was advised to improve the
alarm system.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate in the name of M/s Fuxin Long
manufacturer issued by concerned regulatory Rui Pharmaceutical Co., Ltd, Fluoride Industrial Park,
authority of country of origin. Fumeng County (Yi Ma Tu), Fuxin City, Liaoning
Province - 123000, China issued on dated: 24/08/2020,
valid till 23/08/2023 by Liaoning Fuxin Management
Committee – China is submitted.
3. Documents for the procurement of API with The firm has submitted copy of commercial invoice
approval from DRAP (in case of import). attested by AD I&E DRAP, Lahore.
Invoice Date of
Quantity
No. Batch No. approval
Imported
by DRAP
SY2006 L-E-20200409- 0.35 kg 26-06-
1201-F D01-E06-01 2020
The invoice is issued from M/s Shenyang Vast Pharm-
Tech Co., Ltd China and it does not contain the name of
manufacturer.
4. Data of stability batches will be supported by The firm has submitted supporting document including
5. Compliance Record of HPLC software 21CFR Not submitted
6. Record of Digital data logger for temperature & Not submitted
humidity monitoring of stability chambers
1.3.4- 1.3.5 • Submit copy of valid drug • The firm have submitted copy of DML issued on
manufacturing license 22-07-2015 and renewal of DML applied on 13-
• Provide evidence of required 07-2020.
manufacturing facility • The firm have submitted panel inspection report
dated 13-04-2017 for renewal on DML showing
presence of Tablets (General, Antibiotic, Anti-TB,
Psychotropic) section
1.4.1 • You have applied for a new drug product • The firm submitted that it is a typographical
while the applied product is generic drug mistake and we applied for generic drug product
product, clarify? and submitted corrected form 5F
1.5.15-1.5.20 • Commitments submitted without • The firm have submitted signed commitments as
signature per module-I

3.2.S.4.3 • Analytical Method Verification studies • Analytical Method Verification studies including
including specificity, accuracy and specificity, accuracy and repeatability (method
repeatability (method precision) precision) performed by the Drug Product
performed by the Drug Product manufacturer for drug substance(s) is submitted
be submitted.
3.2.S.5 • The firm have submitted COA of • The firm submitted that this reference standard was
Reference Standards or Materials which use in the analysis of stability batches of drug
was expired on 18.04.2018. Justification substance. So, it was not expired at that time. COA
is required for using expired working of drug substance is submitted. However, the firm
standard did not submit COA of the reference standard that
was used in analysis of drug substance.
3.2.P.1 • You have used Povidone K-30 instead of • The firm have submitted compatibility study
hydroxypropyl cellulose used by report. The firm have performed compatibility
innovator product and not performed study through binary mixture approach and
compatibility study, clarify? assessed through HPLC. The samples were stored
• Pharmaceutical equivalence of the at 25ºC/60% and 40ºC/75% in both open and
applied drug with the innovator product closed container for 1month. However,
is not performed, justify? compatibility report of only 40ºC/75% RH open
container is submitted and compatibility report
40ºC/75% closed container and 25ºC/60% in both
open and closed container is not submitted
• The firm submitted that innovator product was not
available so they use reference product for
pharmaceutical equivalence studies.
3.2.P.2.2.1 • Justify the CDP studies at 50 rpm, since • The firm submitted that in FDA dissolution
the innovator product review documents guidance 2018, CDP studies is at 50 rpm, but we
specifies 75 rpm for dissolution studies. also perform at 75 rpm and submitted revised CDP
report.
3.2.P.5.1 • Justify the acceptance criteria of • The firm submitted that it is a typographical
dissolution test i.e. NLT 70% (Q) in mistake, the acceptance criteria of dissolution test
30min since FDA review documents is NLT 80% in 30 min as per FDA dissolution
specifies that dissolution criteria shall be guidance 2018. And our batches results are more
NLT Q in 15 min and BP/USP/Ph. Int that 100%. However, FDA review documents
specifies that Q should not be less than specifies that dissolution criteria shall be NLT Q in
75%. 15 min
• Justification is required as the
registration board in its 293rd meeting • We are assuring that we do not variate from
decided that For rapidly dissolving as innovator / reference product with reference to
well as immediate release drug products, dissolution specifications
wherein the stability batches will be
manufactured after 01-06-2020, • The firm submitted that we also performed these
variation from innovator /reference tests and also updated the specifications. However,
product with reference to dissolution test for degradation products are not performed.
specification will not be acceptable. Updated SOP and COA of the product is submitted
• Test for identification, degradation
products, content uniformity and • The firm submitted that in FDA dissolution
microbial quality not included in guidance 2018, CDP studies is at 50 rpm, but we
specifications although included by also perform at 75 rpm and submitted revised CDP
innovator’s product, justify? report.
• Justify the dissolution studies at 50 rpm,
since the innovator product review
documents specifies 75 rpm for
dissolution studies.
3.2.P.5.3 • In validation of analytical procedure • The firm submitted that it is a typographical
Methanol 45; buffer 55 is mentioned as mistake, no methanol is used, ACN is used as per

the mobile phase while in analytical analytical procedure and submitted revised
procedure ACN 45; buffer 55 is validation of analytical procedure report.
mentioned as mobile phase, Clarify?
3.2.P.6 Justify the use of Reference Standards or • The firm stated that we use Reference Standards or
Materials from M/s Clearsynth Labs Ltd Materials from Fuxin Long Rui Pharmaceutical
India since drug substance manufacturer is Co., Ltd for testing. The use of M/s Clearsynth
Fuxin Long Rui Pharmaceutical Co., Ltd Labs reference standard is only for comparison
china. purpose. However, the firm did not submit COA of
Reference Standards or Materials from Fuxin Long
Rui Pharmaceutical Co., Ltd
3.2.P.8 • Submit documents for procurement of • The firm submitted that only distributor name is
API, since the submitted invoice does not mentioned in invoice but Batch no. and expiry date
specify the details of manufacturer of product is mentioned.
• Valid GMP certificate / DML of the • The firm submitted copy of DML certificate No.
Drug Substance manufacturer issued by Liao20150233, dated: 21/12/2017 valid till
relevant regulatory authority of country 20/12/2022, issued by Food & Drug
of origin is required. Administration of Liaoning Province- China.
• Submit chromatograms, raw data sheets • The firm have submitted chromatograms, raw data
& COAs of the conducted stability study sheets of the conducted stability study. The COAs
with proper separator so that the data can are still not submitted. Chromatograms of assay at
be evaluated initial time point is still not submitted. Submitted
• Submit Compliance Record of HPLC chromatogram not readable. Raw data sheet of
software 21CFR & audit trail reports on accelerated stability study at 3rd month time point
product testing. is not submitted
• Submit Record of Digital data logger for • The lambda given in chromatogram is 225/224nm
temperature & humidity monitoring of while lambda mentioned in analytical procedure is
stability chambers (real time and 210nm.
accelerated) • The firm have submitted declaration of software
quality form Agilent for HPLC software 21CFR.
However, the firm have not submitted Compliance
Record of HPLC software 21CFR & audit trail
• The firm have submitted Record of Digital data
logger for temperature & humidity monitoring of
stability chambers at real time conditions. Record
of Digital data logger for temperature & humidity
monitoring of stability chambers at accelerated
conditions is not submitted
• Submission of COA of the reference/working standard that was used in analysis of drug substance.
• Justification of the acceptance criteria of dissolution test i.e. NLT 70% (Q) in 30min since FDA review
documents specifies that dissolution criteria shall be NLT Q in 15 min
• Submission of COA of Reference/Working Standards from Fuxin Long Rui Pharmaceutical Co., Ltd.
• Submission of COAs and readable copies of Chromatograms of assay at initial time point.
• Submission of Raw data sheet of accelerated stability study at 3rd month time point
• Clarification regarding variation in the lambda wavelength specified in analytical procedure from
that mentioned on chromatograms.
• Submission of Compliance Record of HPLC software 21CFR & audit trail reports on product testing
for complete stability studies
• Submission of Record of Digital data logger for temperature & humidity monitoring of stability
chambers at accelerated conditions
• Submission fee of Rs. 7,500 for correction/pre-approval change in product specifications, as per
241. Name, address of Applicant / Marketing M/s Pacific Pharmaceuticals Ltd., 30 Km Multan Road, Lahore

Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd., 30 Km Multan Road,
Lahore
☐ Importer
☐ Export sale
The proposed proprietary name / brand Gluset 25 mg Tablets
name
Pharmaceutical ingredient (API) per unit Empagliflozin …. 25 mg
Pharmaceutical form of applied drug Oral solid dosage form
ATC code: A10BK03
Reference to Finished product In-House
specifications
The status in reference regulatory JARDIANCE (10mg, 25mg) film coated tablets USFDA
authorities Approved
For generic drugs (me-too status) Diampa Tablet 25 mg by M/s Getz Pharma (Reg#093074)
GMP status of the Finished product The firm have submitted GMP certificate issued on 25-04-209
manufacturer based on inspection conducted 07-03-2019.
Name and address of API manufacturer. Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride Industrial
Park, Fumeng County (Yi Ma Tu), Fuxin City, Liaoning
studies of drug substance and drug product.
Module-III (Drug Substance): Firm has submitted detailed data for drug substance data
Stability Studies of Drug Substance Long-term stability studies were performed at a storage
(Conditions duration of Stability studies) temperature of 30°C±2°C/65%±5% RH for 24 months.

Accelerated stability studies were performed at a temperature
of 40±2°C/75%±5% RH for 6 months.
(Batch No. 20160606, 20161017, 20161219)
Pharmaceutical Equivalence and The firm has submitted Pharmaceutical Equivalence Studies of
Comparative Dissolution Profile the applied product against the reference product of “Diampa
25 mg Tablet” by M/s Getz pharma.
“Diampa 25 mg Tablet” by Getz pharma in HCl buffer, Acetate
Buffer pH 4.5 and Phosphate buffer pH 6.8.
Analytical method validation/verification Firm has submitted verification/ validation studies of the drug
of product product.
Fuxin Long Rui Pharmaceutical Co., Ltd
Manufacturer of APIs
Fluoride Industrial Park, Fumeng
County (Yi Ma Tu), Fuxin City, Liaoning Province - 123000, China
API Lot No. L-E-20200409-D01-E06-01
Description of Pack Alu-PVC 110 mm blisters sealed with Aluminium foil
Stability Storage Condition Real time: 30oC ± 2oC / 65% HR ±5%
Accelerated: 40oC ± 2oC / 75% HR ±5%
Real Time: 0, 3, 6, 9, 12, 24, (Months)
Batch No. SEP00109P SEP00209P SEP00309P
No. of
03
Batches
1. Reference of previous Refer to previous onsite inspection report of their product Esmelin tablet
approval of applications with 15mg dated 10-08-2020 on the basis of which Registration Board in its
stability study data of the firm 313th meeting decided to approve the registration of Esmelin 15mg tablet.
(if any) The report shows that:
• The HPLC software is 21 CFR compliant and Log of data was available
in the HPLCs. The data was also checked through hard copies of
chromatograms.
• Adequate monitoring and control were available for stability chamber.
The firm was advised to improve the alarm system.

2. Approval of API/ DML/GMP Copy of GMP certificate in the name of M/s Fuxin Long Rui
certificate of API Pharmaceutical Co., Ltd, Fluoride Industrial Park, Fumeng County (Yi Ma
manufacturer issued by Tu), Fuxin City, Liaoning Province - 123000, China issued on dated:
concerned regulatory authority 24/08/2020, valid till 23/08/2023 by Liaoning Fuxin Management
of country of origin. Committee – China is submitted.
3. Documents for the The firm has submitted copy of commercial invoice attested by AD I&E
procurement of API with DRAP, Lahore.
approval from DRAP (in case Invoice No. Date of
of import). Quantity approva
Batch No. Importe l
d by
DRAP
SY2006120 L-E-20200409- 0.35 kg 26-06-
1-F D01-E06-01 2020
The invoice is issued from M/s Shenyang Vast Pharm-Tech Co., Ltd
China and it does not contain the name of manufacturer.
4. Data of stability batches will The firm has submitted supporting document including summary data
be supported by attested sheets etc.
respective documents like
chromatograms, Raw data
sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC Not submitted
software 21CFR & audit trail
6. Record of Digital data logger Not submitted
for temperature & humidity
monitoring of stability
chambers
1.3.4- • Submit copy of valid drug • The firm have submitted copy of DML issued on
1.3.5 manufacturing license 22-07-2015 and renewal of DML applied on 13-07-
• Provide evidence of required 2020.
manufacturing facility • The firm have submitted panel inspection report
dated 13-04-2017 for renewal of DML showing
presence of Tablets (General, Antibiotic, Anti-TB,
Psychotropic) section
1.4.1 • You have applied for a new drug • The firm submitted that it is a typographical
product while the applied product is mistake and we applied for generic drug product
generic drug product, clarify? and submitted corrected form 5F
1.5.6 • The firm have claimed In house • No reply submitted
specifications and the product is not
available in any pharmacopeia
1.5.15- • Commitments submitted without • The firm have submitted signed commitments as
1.5.20 signature per module-I
3.2.S.4.3 • Analytical Method Verification • Analytical Method Verification studies including
accuracy and repeatability (method precision) performed by the Drug Product
precision) performed by the Drug manufacturer for drug substance(s) is submitted
Product manufacturer for drug
3.2.S.5 • The firm have submitted COA of • The firm submitted that this reference standard was
Reference Standards or Materials use in the analysis of stability batches of drug
which was expired on 18.04.2018. substance. So, it was not expired at that time. COA

Justification is required for using of drug substance is submitted. However, the firm
expired working standard did not submit COA of the reference standard that
was used in analysis of drug substance.
3.2.P.1 • You have used Povidone K-30 • The firm have submitted compatibility study
instead of hydroxypropyl cellulose report. The firm have performed compatibility
used by innovator product and not study through binary mixture approach and
performed compatibility study, assessed through HPLC. The samples were stored
clarify? at 25ºC/60% and 40ºC/75% in both open and closed
• Pharmaceutical equivalence of the container for 1month. However, compatibility
applied drug with the innovator report of only 40ºC/75% RH open container is
product is not performed, justify? submitted and compatibility report 40ºC/75%
closed container and 25ºC/60% in both open and
closed container is not submitted
• The firm submitted that innovator product was not
available so they use reference product for
pharmaceutical equivalence studies.
3.2.P.2.2.1 • Justify the CDP studies at 50 rpm, • The firm submitted that in FDA dissolution
since the innovator product review guidance 2018, CDP studies is at 50 rpm, but we
documents specifies 75 rpm for also perform at 75 rpm and submitted revised CDP
dissolution studies. report.
3.2.P.5.1- • Justify the acceptance criteria of • The firm submitted that it is a typographical
3.2.P.5.2 dissolution test i.e. NLT 70% (Q) in mistake, the acceptance criteria of dissolution test
30min since FDA review documents is NLT 80% in 30 min as per FDA dissolution
specifies that dissolution criteria guidance 2018. And our batches results are more
shall be NLT Q in 15 min and that 100%. However, FDA review documents
BP/USP/Ph. Int specifies that Q specifies that dissolution criteria shall be NLT Q
should not be less than 75%. in 15 min
• Justification is required as the
registration board in its 293rd • We are assuring that we do not variate from
meeting decided that For rapidly innovator / reference product with reference to
dissolving as well as immediate dissolution specifications. Our product dissolution
release drug products, wherein the results are within limits of innovator specifications.
stability batches will be
manufactured after 01-06-2020, • The firm submitted that we updated the
variation from innovator /reference specifications as per innovator’s specifications.
product with reference to However, test for degradation products are not
dissolution specification will not be performed. Updated SOP and COA of the product
acceptable. is submitted
• Test for identification, degradation
products, content uniformity and • The firm submitted that in FDA dissolution
microbial quality not included in guidance 2018, CDP studies is at 50 rpm, but we
specifications although included by also perform at 75 rpm and submitted revised CDP
innovator’s product, justify? report.
• Justify the dissolution studies at 50
rpm, since the innovator product
review documents specifies 75 rpm
for dissolution studies.
3.2.P.5.3 • In validation of analytical procedure • The firm submitted that it is a typographical
Methanol 45; buffer 55 is mentioned mistake, no methanol is used, ACN is used as per
as the mobile phase while in analytical procedure and submitted revised
analytical procedure ACN 45; buffer validation of analytical procedure report.
55 is mentioned as mobile phase,
Clarify?
3.2.P.6 Justify the use of Reference Standards • The firm stated that we use Reference Standards or
or Materials from M/s Clearsynth Materials from Fuxin Long Rui Pharmaceutical
Labs Ltd India since drug substance Co., Ltd for testing. The use of M/s Clearsynth Labs

manufacturer is Fuxin Long Rui reference standard is only for comparison purpose.
Pharmaceutical Co., Ltd china. However, the firm did not submit COA of
Reference Standards or Materials from Fuxin
Long Rui Pharmaceutical Co., Ltd
3.2.P.8 • Submit documents for procurement • The firm submitted that only distributor name is
of API, since the submitted invoice mentioned in invoice but Batch no. and expiry
does not specify the details of date of product is mentioned.
manufacturer • The firm submitted copy of DML certificate No.
• Valid GMP certificate / DML of the Liao20150233, dated: 21/12/2017 valid till
Drug Substance manufacturer 20/12/2022, issued by Food & Drug Administration
issued by relevant regulatory of Liaoning Province- China.
authority of country of origin is • The firm have submitted chromatograms, raw data
required. sheets of the conducted stability study. The COAs
• Submit chromatograms, raw data are still not submitted. Chromatograms of assay at
sheets & COAs of the conducted initial time point is still not submitted. Submitted
stability study with proper separator chromatogram not readable. Raw data sheet of
so that the data can be evaluated accelerated stability study at 3rd month time point
• Submit Compliance Record of is not submitted
HPLC software 21CFR & audit trail • The lambda given in chromatogram is 225/224nm
reports on product testing. while lambda mentioned in analytical procedure
• Submit Record of Digital data is 210nm.
logger for temperature & humidity • The firm have submitted declaration of software
monitoring of stability chambers quality form Agilent for HPLC software 21CFR.
(real time and accelerated) However, the firm have not submitted Compliance
• The quantity of imported drug Record of HPLC software 21CFR & audit trail
substance as per submitted invoice reports on product testing.
is 0.35kg and three batches of 25mg • The firm have submitted Record of Digital data
gluset tablets and 10mg gluset logger for temperature & humidity monitoring of
tablets each of 5000 tablets were stability chambers at real time conditions. Record
manufactured from it. Justification of Digital data logger for temperature & humidity
is required as how the imported drug monitoring of stability chambers at accelerated
substance was sufficient enough to conditions is not submitted
manufacture three batches of each • The firm submitted that we import more material to
strength. fulfil the required batch quantity.
• The total quantity required for • The firm has submitted another copy of
manufacturing of three batches of commercial invoice attested by AD I&E DRAP,
both strength is 0.525kg while Lahore.
imported drug substance is 0.35kg Invoice Batch No. Quantity Date of
No. Importe approva
d l
by
DRAP
SY20071 L-E- 0.75 kg 27-07-
4-F 20200409 2020
-D01-
E06-01
The invoice is issued from M/s Shenyang Vast
Pharm-Tech Co., Ltd China and it does not contain
the name of manufacturer
• Submission of COA of the reference/working standard that was used in analysis of drug substance.
• Justification of the acceptance criteria of dissolution test i.e. NLT 70% (Q) in 30min since FDA review
documents specifies that dissolution criteria shall be NLT Q in 15 min
• Submission of COA of Reference/Working Standards from Fuxin Long Rui Pharmaceutical Co., Ltd
• Submission of COAs and readable copies of Chromatograms of assay at initial time point.
• Submission of Raw data sheet of accelerated stability study at 3rd month time point

• Clarification regarding variation in the lambda wavelength specified in analytical procedure from
that mentioned on chromatograms.
• Submission of Compliance Record of HPLC software 21CFR & audit trail reports on product testing
for complete stability studies
• Submission of Record of Digital data logger for temperature & humidity monitoring of stability
chambers at accelerated conditions
• Submission fee of Rs. 7,500 for correction/pre-approval change in product specifications, as per
Case No. 3: Registration applications for local manufacturing of Human drugs (Form 5)
New cases
242. Name and address of manufacture / M/s Hudson Pharma Private Limited. Site-Plot No. D-93, North
Applicant Western Industrial Zone, Port Qasim Authority, Pakistan
Brand Name + Dosage Form and Flutisal 500mcg/50mcg Rotacaps
Strength
Composition Each Rotacaps Contains:
Fluticasone Propionate…….…500mcg
Salmeterol as Xinafoate…………50mcg
Dairy No. date of R &I fee Form-5 Dy.No 10352 dated 05-03-2019 Rs.20,000/- dated 05-
03-2019
Pharmacological Group Adrenergics in combination with corticosteroids or other drugs,
excl. anticholinergics
Type of form Form 5
Pack size and Demand Price 15’s, 30’s; As per SRO
Approval status of product in Reference ADVAIR DISKUS (100/50mcg, 250/50mcg, 500/50mcg)
Regulatory Authorities inhalation powder USFDA approved
Me-too-status Salmicort DPI Capsule 500mcg/50mcg by M/s Macter
International (Reg#095139)
GMP Status The firm was inspected on 03-04-2019 and conclusion of
inspection was:
Overall cGMP is found at acceptable level and the management
is committed for continual improvement and has assured further
cGMP compliance.
Remark of the Evaluator XI • The firm submitted letter No. F. 2-12/2010-Lic (Vol-I) dated
13th February 2020 issued by secretary CLB showing Capsule
(DPI Steroidal) section
• The firm refer to routine GMP inspection report dated
08.06.2021 in which area FID/AD has stated that blending,
encapsulation and blistering is carried out in separate area.
The firm has also submitted IQ, OQ, PQ for mixing facility of
the double cone blender used to ensure the required particle
size of the formulation blend
13.12.2019 in which area FID/AD has stated that QC is well
equipped with all necessary equipment including cascade
impactor. The firm also submitted picture of “Uniformity of
Delivered Dose” and “Aerodynamic Particle Size Distribution”
equipment available with the firm.
• The firm submitted that they will use ROBUST-H03 DPI
device manufactured by Rizwan Associates Karachi with the
applied product.
• The firm have submitted label claim for Target Delivery Dose
as under:
Each Rotacaps Contains:
Fluticasone Propionate…………500mcg

Salmeterol as Xinafoate………...50mcg
Corresponding with a delivered dose:
Corresponding to delivered dose:

Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in label claim, as per
Brand Name + Dosage Form and Flutisal 100mcg/50mcg Rotacaps
Strength
Composition Each Rotacaps Contains:
Salmeterol as Xinafoate………...…50mcg
03-2019
Pharmacological Group Adrenergics in combination with corticosteroids or other drugs,
excl. anticholinergics
Type of form Form 5
Approval status of product in Reference ADVAIR DISKUS (100/50mcg, 250/50mcg, 500/50mcg)
Regulatory Authorities inhalation powder USFDA approved
Me-too-status Salmicort DPI Capsule 100mcg/50mcg by M/s Macter
International (Reg#095137)
inspection was:
cGMP compliance.
Remark of the Evaluator XI • The firm submitted letter No. F. 2-12/2010-Lic (Vol-I) dated
13th February 2020 issued by secretary CLB showing Capsule
(DPI Steroidal) section
08.06.2021 in which area FID/AD has stated that blending,
encapsulation and blistering is carried out in separate area. The
firm has also submitted IQ, OQ, PQ for mixing facility of the
double cone blender used to ensure the required particle size of
the formulation blend
13.12.2019 in which area FID/AD has stated that QC is well
equipped with all necessary equipment including cascade
impactor. The firm also submitted picture of “Uniformity of
Delivered Dose” and “Aerodynamic Particle Size Distribution”
equipment available with the firm.
• The firm submitted that they will use ROBUST-H03 DPI
device manufactured by Rizwan Associates Karachi with the
applied product.

• The firm have submitted label claim for Target Delivery Dose
as under:
Corresponding with a delivered dose:
Corresponding to a delivered dose:

Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in label claim, as per
Brand Name + Dosage Form and Carbofer 100mg Injection
Strength
Ferric Carboxymaltose………100mg
03-2019
Pharmacological Group Trivalent iron, parenteral preparations
Type of form Form 5
Finished product specifications Manufacturer’s specifications
Pack size and Demand Price 2ml; As per SRO
Approval status of product in Reference FERINJECT 50mg /ml, solution for injection / infusion (2ml,
Regulatory Authorities 10ml, 20ml) ANSM France approved
Me-too-status Ferinject Injectable 500mg/10ml by M/s RG Pharmaceutical
(Reg#072548)
inspection was:
cGMP compliance.
Remark of the Evaluator XI • The firm submitted revised label claim but not as per reference
product. The reference product contains Iron as ferric
carboxymaltose while the firm has applied otherwise. The
revised label claim is as under:
Each 2ml Ampoule Contains:
Ferric Carboxymaltose………100mg
• The firm did not provide evidence of me-too in the applied
volume. However, the firm provided evidence of iromalt
injection 100mg/2ml by Wilshire Laboratories approved in
295th meeting but letter issuance was linked with patent issue
of applied formulation.
• The firm mentioned the use of LDPE plastic ampoule as
primary packaging material of applied formulation. However,
the reference product is packed in type I glass vial with
bromobutyl rubber stopper and aluminium cap
• The firm did not submit undertaking at the of form 5

• The firm submitted letter No. F. 2-12/2010-Lic dated 30th
August issued by secretary CLB showing plastic ampoules
(BFS Technology) section
• Revision of label claim as per reference formulation along with submission of applicable fee.
• Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.
• Submission of undertaking at the end of Form 5
• Evidence of approval of applied formulation, with LDPE plastic ampoule as primary
packaging material, in reference regulatory authorities/agencies which were
declared/approved by the Registration Board or else submit stability studies as per checklist
approved in 293rd meeting of Registration Board along with compatibility studies for the
container closure system as recommended by general Pharmacopoeial monographs.
245. Name and address of manufacture / M/s Jenner Pharmaceuticals Pvt Ltd.
Applicant 26-km, Lahore Sharaqpur Road, Sheikhupura
Brand Name + Dosage Form and Jenserk 8mg tablets
Strength
Betahistine dihydrochloride………….8mg
Dairy No. date of R &I fee Form-5 Dy.No 40287 dated 05-12-2018 Rs.20,000/- Dated 05-
12-2018
Pharmacological Group Antivertigo preparations
Type of form Form 5
Finished product specifications BP
Pack size and Demand Price 30’s; As per SRO
Approval status of product in Reference Betahistine Dihydrochloride 8mg Tablets MHRA Approved
Me-too-status Betalab 8mg Tablet by M/s Biolabs (Pvt) Ltd (Reg# 093258)
inspection was:
Keeping in view the findings of inspection, and commitment of
the management for future improvement, the members of the
panel are of the opinion to recommend the grant of renewal of
Drug manufacturing License (000823) by way of formulation to
M/s Jenner Pharma. 26 Km Lahore Shariqpur Road, District
Sheikhupura.
Remark of the Evaluator XI •
Decision: Approved.
246. Name and address of manufacture / M/s Baxter Pharmaceuticals.
Applicant A-1/A, Scheem No.33,Phase-1,S.I.T.E,Super Highway,
Karachi
Brand Name + Dosage Form and Nacdium 50mg Tablet
Strength
Composition Each Enteric Coated Tablet Contains:
Diclofenac Sodium…………….50mg
09-2018
Pharmacological Group NSAIDS
Type of form Form-5
Pack size and Demand Price 10’s, 20’s, 30’s, 50’s, 100’s: As per SRO
Approval status of product in Reference VOLTAREN (25mg, 50mg, 75mg) Delayed Release/ enteric-
Regulatory Authorities coated tablets USFDA Approved

Discontinued **Federal Register determination that product
was not discontinued or withdrawn for safety or efficacy
reasons**
Me-too-status Techfen 50mg Tablet by M/s Curatech Pharma (Reg#101667)
inspection was:
Based on the observations and keeping in view the attitude of the
management of the firm towards better compliance and
continuous improvement, their current compliance level is rated
as satisfactory
Remark of the Evaluator XI • The firm have submitted revised master formulation and
mentioned enteric coating polymer (Eudragit L100) used in
the applied formulation
Decision: Approved. Firm shall submit fee of Rs.7, 500 for correction/pre-approval change in the
master formulation (correction/pre-approval change in the excipients), as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Karachi
Brand Name + Dosage Form and Max-Calm 7.5mg Tablet
Strength
Meloxicam……….7.5mg
02-2019
Pharmacological Group Non-steroidal anti-inflammatory drugs (NSAIDs)
Type of form Form-5
Pack size and Demand Price As per SRO
Approval status of product in Reference MOBIC (7.5mg, 15mg) uncoated Tablets USFDA
Regulatory Authorities Approved
Me-too-status Melflam 7.5mg Tablets by M/s Aries Pharmaceuticals
(Reg#84265)
inspection was:
as satisfactory
Decision: Approved.
248. Name and address of manufacture / M/s Baxter Pharmaceuticals.A-1/A, Scheem No.33,Phase-
Applicant 1,S.I.T.E,Super Highway, Karachi
Brand Name + Dosage Form and Max-Calm 15mg Tablet
Strength
Meloxicam………….15mg
02-2019
Type of form Form-5

Me-too-status Melflam 15mg Tablets by M/s Aries Pharmaceuticals
(Reg#84266)
inspection was:
as satisfactory
Decision: Approved.
Brand Name + Dosage Form and Celix 100mg Capsule
Strength
Celecoxib…………100mg
02-2019
Pharmacological Group Non-steroidal anti-inflammatory and antirheumatic drugs,
NSAIDs, Coxibs, ATC code: M01AH01.
Type of form Form 5
Approval status of product in Reference Celebrex 100mg capsule (MHRA Approved)
Me-too-status Invoxib 100mg Capsule by M/s Innvotek Pharmaceuticals
(Reg#099960)
inspection was:
as satisfactory
Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in product specifications, as
250. Name and address of manufacture / M/s Baxter Pharmaceuticals. A-1/A, Scheem No.33,Phase-
Brand Name + Dosage Form and Eproxin 250mg Tablet
Strength
Naproxen………..…250mg
02-2019
Type of form Form 5
Approval status of product in Reference Naproxen Tablets 250mg MHRA Approved
Me-too-status Rokflex 250mg Tablets by M/s Rock Pharmaceutical
Laboratories (Reg# 077306)
inspection was:

as satisfactory
removed coating composition and revise manufacturing
outline and removed coating procedure
Decision: Approved.
Firm shall submit fee of Rs.7,500 for correction/pre-approval change in the method of manufacture
and master formulation (removal of coating ingredients and coating procedure), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Eproxin 500mg Tablet
Strength
Naproxen………….…500mg
02-2019
Type of form Form 5
Approval status of product in Reference Naproxen Tablets 500mg MHRA Approved
Me-too-status Rokflex 500mg Tablets by M/s Rock Pharmaceutical
inspection was:
as satisfactory
Decision: Approved.
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Endozol 5mg Tablet
Strength
Carbimazole…………..5mg
02-2019
Pharmacological Group Antithyroid Preparations
Type of form Form 5
Approval status of product in Reference Carbimazole 5mg Tablets MHRA Approved
Me-too-status Bymazol Tablet 5mg by M/s Maxitech Pharma (Reg# 100417)

inspection was:
as satisfactory
Decision: Approved.
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Atenox Tablet 100mg
Strength
Atenolol………..…100mg
02-2019
Pharmacological Group Beta blocking agents, selective
Type of form Form 5
Approval status of product in Reference TENORMIN (25mg, 50mg, 100mg) USFDA Approved
Me-too-status Atefix-100 Tablets by M/s Hicon Pharmaceuticals (Reg#
095162)
inspection was:
as satisfactory
Decision: Approved.
Karachi
Brand Name + Dosage Form and Pirox 20mg Capsule
Strength
Piroxicam…………..20mg
02-2019
Pharmacological Group Oxicams
Type of form Form 5
Approval status of product in Reference Piroxicam Capsules 20mg MHRA Approved
Me-too-status Delzene 20mg Capsule by M/s Genetics Pharmaceuticals (Reg#
098486)
inspection was:

as satisfactory
Decision: Approved.
255. Name and address of manufacture / M/s PDH Laboratories Pvt Ltd.
Applicant 9.5 km, Sheikhupura Road, Lahore, Pakistan
Brand Name + Dosage Form and Cyanocobalamin Injection 1000mcg/ml
Strength
Cyanocobalamin………1000mcg
03-2019
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues)
Type of form Form 5
Approval status of product in Reference Cytamen Injection 1000mcg (1ml) MHRA approved
Me-too-status Cyanocobalamin Injection by M/s Amaan Pharma,
(Reg#094555)
GMP Status The firm was inspected on 03-01-2022 and 04-01-2022 and
conclusion of inspection was:
In view of the above inspection proceedings and facilities
verified, building, material management, production, in-process
controls, quality control testing, machinery/equipment, air
handling, water treatment system, personnel and documentation
e.t.c. the panel recommends the renewal of Drug Manufacturing
License (by way of formulation), Regularization of layout plan
and grant of additional section to M/s. PDH Laboratories (Pvt.)
Ltd., 9.5km Sheikhupura Road, Lahore
Decision: Approved.
256. Name and address of manufacture / M/s PDH Pharmaceuticals Pvt Ltd.
Applicant 19 km, Ferozepur Road, Lahore, Pakistan
Brand Name + Dosage Form and Lignocaine 2% w/v Injection
Strength
Composition Each 10 ml ampoule Contains:
Lignocaine HCl……………..200mg
Dairy No. date of R &I fee Form-5 Dy.No 11546 dated 05-03-2019 Rs.20,000 dated 05-
03-2019
Pharmacological Group Local anesthetics
Type of form Form 5
Approval status of product in Reference Lidocaine Hydrochloride Injection BP 2% w/v. MHRA
Regulatory Authorities approved (2ml, 5ml,10ml, 20ml ampoules)
Me-too-status Avecaine Injection 2%w/v by M/s Avensis Pharmaceuticals
(Reg#097107)
In view of the above inspection proceedings and facilities
verified, building, material management, production, in-process
controls, quality control testing, machinery/equipment, air
handling, water treatment system, personnel and documentation

e.t.c. the panel recommends the renewal of Drug Manufacturing
License (by way of formulation), Regularization of layout plan
and grant of additional section to M/s. PDH Laboratories (Pvt.)
Ltd., 9.5km Sheikhupura Road, Lahore
Decision: Approved.
257. Name and address of manufacture / M/s Neutro Pharma (Pvt) Ltd.
Applicant Sheikhupura Road,Lahore
Brand Name + Dosage Form and Tebrin Tablets 2.5mg
Strength
Terbutaline Sulphate……..…2.5mg
03-2019
Pharmacological Group Selective beta-2-adrenoreceptor agonists
Type of form Form 5
Pack size and Demand Price 10x10’s; As per SRO
Approval status of product in Reference BRETHINE (2.5mg, 5mg) USFDA approved
Regulatory Authorities Label not available
Me-too-status Respair 2.5mg Tablet by M/s Zanctok Pharmaceutical
(Reg#073635)
GMP Status Certificate of GMP issued to Neutro Pharma on 11.07.2019
based on inspection conducted on 28.02.2019
Remark of the Evaluator XI
• BOXED WARNING: TOCOLYSIS
Oral terbutaline sulfate has not been approved and should not be
used for acute or maintenance tocolysis. In particular, terbutaline
sulfate should not be used for maintenance tocolysis in the
outpatient or home setting. Serious adverse reactions, including
death, have been reported after administration of terbutaline
sulfate to pregnant women. In the mother, these adverse
reactions include increased heart rate, transient hyperglycemia,
hypokalemia, cardiac arrhythmias, pulmonary edema and
myocardial ischemia. Increased fetal heart rate and neonatal
hypoglycemia may occur as a result of maternal administration
Decision: Approved. Registration letter will be issued after submission of GMP audit report from
QA&LT Division, valid within last three years.
Applicant Sheikhupura Road, Lahore
Brand Name + Dosage Form and Alenate 70mg Tablet
Strength
Alendronate (as Sodium)………..…70mg
03-2019
Pharmacological Group Bisphosphonate, for the treatment of bone diseases
Type of form Form 5
Approval status of product in Reference FOSAMAX 70mg uncoated tablets USFDA Approved
Me-too-status Alidium 70mg Tablets by M/s Panacea Pharmaceuticals
(Reg#081428)

Remark of the Evaluator XI • The firm have mentioned the hydrated form of alendronate in
label claim and adjusted its weight in master formulation
considering the salt and hydrated form without submission of
applicable fee. The revised label claim is as under:
Alendronic acid (as Sodium trihydrate)………..…70mg
Alendronic acid (as Sodium trihydrate)………..…70mg
Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in composition
(correction/change of hydrated form of the drug substance), as per notification No.F.7-11/2012-
Registration letter will be issued after submission of GMP audit report from QA&LT Division, valid
Applicant Sheikhupura Road, Lahore
Brand Name + Dosage Form and Zidon 80mg Capsule
Strength
Ziprasidone HCl……….…80mg
03-2019
Pharmacological Group Antipsychotics, Indole Derivatives
Type of form Form 5
Approval status of product in Reference ZIPROX ziprasidone (as hydrochloride) 80mg capsule (TGA
Regulatory Authorities Approved)
Me-too-status Zipronia 80mg capsule by M/s Ipram International
(Reg#082361)
• The firm have revised the label claim considering the salt
factor and mentioned the hydrated form of ziprasidone in
label claim as per reference formulation along with
submission of Rs. 7500/- on deposit slip No#7394183012.
The revised label claim is as under:
Each Capsule Contains:
Ziprasidone HCl monohydrate eq. to Ziprasidone ….…80mg
Firm shall submit the differential fee of Rs. 22,500 for correction/pre-approval change in composition
(correction/change of equivalency factor for salt and hydrated form of the drug substance), as per
Brand Name + Dosage Form and Zidon 40mg Capsule
Strength
Ziprasidone HCl…….…40mg
03-2019
Pharmacological Group Antipsychotics, Indole derivatives

Type of form Form 5
Approval status of product in Reference ZIPROX ziprasidone (as hydrochloride) 40mg capsule TGA
Me-too-status Zipronia 40mg capsule by M/s Ipram International
(Reg#082363)
Remark of the Evaluator XI • The firm have revised the label claim considering the salt
factor and mentioned the hydrated form of ziprasidone in
label claim as per reference formulation along with
submission of Rs. 7500/- on deposit slip No#80940483525.
Ziprasidone HCl monohydrate eq. to Ziprasidone….…40mg
(correction/change of equivalency factor for salt and hydrated form of the drug substance), as per
Brand Name + Dosage Form and Sulfox Plus Tablet 50/500/25mg
Strength
Artesunate……………..50mg
Sulfadoxine……………500mg
Pyrimethamine………..25mg
03-2019
Pharmacological Group Artemisinin and derivatives, combinations
Type of form Form 5
Finished product specifications Sulfadoxine+Pyrimethamine (USP), Artesunate (IP)
Approval status of product in Reference Artesunate 50mg Tablets + Sulfadoxine/Pyrimethamine
Regulatory Authorities 500mg/25mg, Tablets
WHO prequalified Drug
Manufacturer: Guilin Pharmaceutical Co. Ltd. China.
Me-too-status Noart-SP 50 Tablet by M/s Noa Hemis Pharmaceuticals
(Reg#083755)
• The reference formulation is a combokit containing
Sulfadoxine+Pyremethamine 500mg/25mg Tablets and
artesunate 50mg tablet. The firm have not revised the label
claim as per reference formulation along with submission of
applicable fee.
• You have mentioned Sulfox Plus Tablet 50/50/25mg on cover
letter and form while strength of API in label claim is
50/500/25mg, clarify?
• The firm have not revised master formulation and
manufacturing outline as per the reference product

• Undertaking at the end of form 5 is not submitted
• The applied pack size is also not as per reference product,
clarify?
• The firm have not provided evidence of availability of co-
blister machine.
• Revision of the label claim as per innovator drug product along with submission of applicable
fee.
• Revision of master formulation and manufacturing outline as per the innovator drug product
product
• Submission of undertaking at the end of form 5
• Submission of evidence of availability of co-blister machine
• Clarification as firm have mentioned Sulfox Plus Tablet 50/50/25mg on cover letter and form
5while strength of API in label claim is 50/500/25mg.
262. Name and address of manufacture / M/s Demont Research Laboratories. 20km, Lahore-Sharikpur
Applicant Road, Sheikhupura, Pakistan
Brand Name + Dosage Form and Emeb 10mg Tablet (ezetimibe)
Strength
Metoprolol tartrate……….…100mg
12-2018
Pharmacological Group Lipid Lowering Agents
Type of form Form 5
Approval status of product in Reference Zetia 10mg Tablet USFDA Approved
Me-too-status Simnex 10mg Tablet by Nexus Pharma, (Reg# 086646)
GMP Status The firm was inspected on 23-02-2018 & 26-02-2018 and
recommendations of inspection was:
Based on the physical inspection of the unit, the technical
personal met and documents evaluated, the panel concluded that
the firm M/s Demont Research Lab Sheikhupura has maintained
a satisfactory level of GMP compliance as per Schedule B-II of
the Drugs Lic, Advt, Reg Rules 1976.
• Clarification was taken from the firm regarding the applied
composition since applied product as per Form 5 and fee
challan is ezetimibe tablet while the applied label claim as per
enclosure of form 5 is of metoprolol tartrate tablet. The firm
submitted that they have applied two local registration at the
time of submission namely Emeb (Ezetimibe) 10mg tablet and
carsel (Metoprolol tartrate) 100mg tablet but during compiling
and assembling these files wrong form 5 were put in respective
application. The firm further humbly requested to kindly
accept the correct label claim and form 5 and proceed for
further process and give leniency as it is a personal
mishandling mistake and not some conscious technical error.
The firm submitted revised form 5 of applied product. The
corrected label claim as per revised form 5 is as under:
Each tablet Contains:
Ezetimibe…….…10mg
Each tablet Contains:
Ezetimibe…….…10mg

Firm shall submit fee of Rs. 30,000 for correction/pre-approval change in composition
(correction/change of applied drug in form 5), as per notification No.F.7-11/2012-B&A/DRAP dated
13-07-2021.
263. Name and address of manufacture / M/s Paramount Pharmaceuticals.
Applicant Plot No. 36, Industrial Triangle, Kahuta Road, Islamabad
Contract Manufactured By: M/s Bio Labs Pvt Ltd.
Plot # 145, Industrial Triangle, Kahuta Road, Islamabad
Brand Name + Dosage Form and Colistacin 1 M IU Injection
Strength
Colistimethate Sodium eq. to Colistimethate Lyophilized
Powder…….1MIU
03-2019
Pharmacological Group other antibacterials (polymyxins)
Type of form Form 5
Approval status of product in Reference Colistimethate Sodium 1 Million I.U. Powder for Solution for
Regulatory Authorities Injection MHRA Approved
Me-too-status Colicraft Injection by Biolabs (Pvt) Ltd. (Reg# 082407)
GMP Status The firm M/s Paramount Pharmaceuticals was inspected on 08-
02-2019 and conclusion of inspection was:
During review of approval of above-mentioned
sections/manufacturing facilities, it was assessed that following
two sections needs regularization from Licensing Division:
1- Cream/Ointment
2- Tablet (General)
The firm has applied for the regularization of same in Licensing
Division.
Keeping in view the observations noticed during inspection as
narrated above, the panel is of the opinion that the firm may be
allowed to start manufacturing in the light of GMP guidelines.
The panel further recommended granting the GMP certificate for
export purpose.
Certificate of GMP Issued to M/s Bio Labs Pvt on 25-05-2019.

• The firm have submitted differential fee Rs. 55000/- on deposit
slip No# 873385180685 for contract manufacturing.
• Form 5 is submitted by the applicant i.e. M/s Paramount
Pharmaceuticals duly signed by the applicant
• The firm submitted list of 08 approved sections of applicant.
i.e. M/s Paramount Pharmaceuticals
• The firm submitted list of 11 products registered/approved on
contract manufacturing in name of applicant. i.e. M/s
Paramount Pharmaceuticals
• The firm submitted list of 14 products applied for contract
manufacturing by the applicant.
• The firm submitted copy of contract manufacturing agreement
between M/s Paramount Pharmaceuticals and M/s Bio Labs
Pvt Ltd
• The firm have not revised the label claim as per reference
formulation without considering the salt factor. The submitted
label claim is as under:

Each Vial Contains:
Colistimethate Sodium eq. to Colistimethate …….1MIU
Lyophilized Powder
• Confirmation of method of manufacturing of applied formulation whether by lyophilization or
otherwise.
• Further deliberation for revision of label claim as per reference formulation and
pharmcopoeial specifications.
Brand Name + Dosage Form and Paracin 1g Injection
Strength
Vancomycin HCl eq. to Vancomycin……………1g
(lyophilized powder)
03-2019
Pharmacological Group Glycopeptide antibacterials
Type of form Form 5

Approval status of product in Reference Vancomycin 1g Powder for Solution for Infusion MHRA
Regulatory Authorities approved
Me-too-status Vancozon 1000mg Injection by M/s Horizon Healthcare
(Reg#099988)
During review of approval of above mentioned
1- Cream/Ointment
2- Tablet (General)
Division.
export purpose.

Remark of the Evaluator XI • The firm have submitted differential fee Rs. 55000/- on deposit

Pvt Ltd
Decision: Deferred for confirmation of method of manufacturing of applied formulation as well as of
innovator, whether by lyophilization or oth.
Brand Name + Dosage Form and Paracin 500mg Injection
Strength
Vancomycin HCl eq. to Vancomycin ……….…500mg
(lyophilized powder)
03-2019
Pharmacological Group Glycopeptide antibacterials
Type of form Form 5
Approval status of product in Reference Vancomycin 500mg Powder for Solution for Infusion MHRA
Me-too-status Vancozon 500mg Injection by M/s Horizon Healthcare
(Reg#099987)
During review of approval of above mentioned
1- Cream/Ointment
2- Tablet (General)
Division.
export purpose.

Remark of the Evaluator XI • The firm have submitted differential fee Rs. 55000/- on deposit
Pvt Ltd
Decision: Deferred for confirmation of method of manufacturing of applied formulation as well as of
innovator, whether by lyophilization or otherwise.

266. Name and address of manufacture / M/s MTI Medical Pvt Ltd.
Applicant 586-587, Sundar Industrial Estate, Lahore, Pakistan
Brand Name + Dosage Form and Valopin-A 5mg/160mg Tablet
Strength
Amlodipine………5mg
Valsartan…………160mg
03-2019
Pharmacological Group Calcium channel blockers and Angiotensin II receptor blockers
(ARBs)
Type of form Form 5
Approval status of product in Reference Exforge (5/160mg, 10/160mg, 5/320mg, and 10/320mg) film
Me-too-status Amlodine Tablet 5/160 by M/s Jupiter Pharma (Reg#081932)
GMP Status GMP certificate issued on 25.11.2020 based on inspection
conducted on 23.11.2020
Remark of the Evaluator XI • The firm have revised the formulation from uncoated to film
coated tablet and mentioned the salt form of amlodipine and
adjusted its weight in master formulation considering the salt
form along with submission of Rs. 7500/- on deposit slip
No#3757864310. The revised label claim is as under:
Amlodipine as besylate………5mg
Amlodipine as besylate………5mg
(correction/change of salt form of the drug substance) and correction/change of formulation from un-
coated tablet to film coated tablet, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Cimbex Injection 10mg/5ml vial
Strength
Composition Each 5ml Vial Contains:
Cisatracurium as Besylate………..10mg
03-2019
Pharmacological Group Muscle Relaxants, Peripherally Acting Agents
Type of form Form 5
Approval status of product in Reference NIMBEX (2 mg/mL (5ml)) injection USFDA approved
Me-too-status Cis-Curon Injection 5ML(2mg/ml) by M/s Brookes Pharma
(Reg#088248)
Remark of the Evaluator XI • Revise the 1st page of form 5 as per prescribed format
• Undertaking at the end of form 5 is missing

• Submit stability studies data of three batches as per the
guidelines approved in 293rd meeting of Registration Board
• Revision of the 1st page of form 5 as per prescribed format
• Submission of stability studies data of three batches as per the guidelines approved in 293 rd
meeting of Registration Board
Brand Name + Dosage Form and Relaxo 20mg Tablet
Strength
Escitalopram as Oxalate………..20mg
03-2019
Type of form Form 5
Approval status of product in Reference Lexapro (5mg, 10mg, 20mg) film-coated tablets USFDA
Me-too-status Avulus 20mg Tablet by M/s Seatle (Pvt) Ltd (Reg#098268)
coated tablet along with submission of Rs. 7500/- on deposit
slip No#96755468. The revised label claim is as under:
Brand Name + Dosage Form and Relaxo 10mg Tablet
Strength
Escitalopram as Oxalate……….10mg
03-2019
Type of form Form 5
Approval status of product in Reference Lexapro (5mg, 10mg, 20mg) film-coated tablets USFDA
Me-too-status Avulus 10mg Tablet by M/s Seatle (Pvt) Ltd (Reg#098267)

Brand Name + Dosage Form and Monto 10mg Tablet
Strength
Montelukast as Sodium…10mg
03-2019
Pharmacological Group Leukotriene receptor antagonists
Type of form Form 5
Approval status of product in Reference Singulair 10mg film coated Tablet USFDA Approved
Me-too-status Nohist film coated Tablet 10mg by M/s Bio-Mark
Pharmaceuticals (Reg#085713)
Brand Name + Dosage Form and Monto 5mg Tablet
Strength
03-2019
Pharmacological Group Leukotriene receptor antagonists
Type of form Form 5
Approval status of product in Reference Singulair (4mg, 5 mg) Chewable Tablet USFDA Approved
Me-too-status Nohist Chewable Tablet 5mg by M/s Bio-Mark
Remark of the Evaluator XI • The firm have revised the formulation from uncoated to
chewable tablet along with submission of Rs. 7500/- on
deposit slip No#577621523794. The revised label claim is as
under:
Each Chewable Tablet Contains:
Montelukast as Sodium……5mg
Each Chewable Tablet Contains:
Montelukast as Sodium……5mg

Firm shall submit differential fee of Rs. 22,500 for correction/pre-approval change in composition
(correction/change of formulation from uncoated tablet to chewable tablet), as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Paragesic Tablet 325mg/37.5mg
Strength
Paracetamol……….325mg
Tramadol HCl……..37.5mg
03-2019
Pharmacological Group Opioids in combination with non-opioid analgesics
Type of form Form 5
Approval status of product in Reference Tramadol hydrochloride/Paracetamol 37.5mg/325mg Film-
Regulatory Authorities coated Tablets MHRA Approved
Me-too-status Distalgesic Tablets by M/s Atco Lab (Reg#073865)
• The firm have revised the formulation from uncoated to film
Brand Name + Dosage Form and Pioglet 30mg Tablet
Strength
Pioglitazone as HCl….…30mg
03-2019
Pharmacological Group Thiazolidinediones
Type of form Form 5
Approval status of product in Reference ACTOS (15mg, 30mg, 45mg) tablets USFDA approved
Me-too-status Glzone 30mg Tablet by M/s Innvotek Pharmaceuticals,
(Reg#099251)
Remark of the Evaluator XI • The firm have removed coating composition from master
formulation, however the firm did not submit revised
manufacturing outline. Furthermore, firm have not adjusted
the weight of pioglitazone in master formulation without
considering the salt factor
Decision: Deferred for adjustment of the weight of pioglitazone in master formulation without
considering the salt factor and revision of manufacturing outline as per innovator product.

Furthermore firm shall submit fee of Rs. 7,500 for correction/pre-approval change in Form-5
(correction/pre-approval change in master formulation & manufacturing method), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Rosuva 10mg Tablet
Strength
Rosuvastatin as Calcium …10mg
03-2019
Pharmacological Group HMG CoA reductase inhibitors
Type of form Form-5
Approval status of product in Reference CRESTOR (5, 10, 20, 40mg) film coated tablets USFDA
Me-too-status R-Vastin-10 Tablet by M/s Rasco Pharma, (Reg#080208)
Decision: Approved with USP specifications and following label claim:
Brand Name + Dosage Form and Sitmap 50mg Tablet
Strength
Sitagliptin Phosphate Monohydrate…50mg
03-2019
Pharmacological Group Antidiabetic
Type of form Form 5
Approval status of product in Reference Januvia (25mg, 50mg, 100mg) film-coated tablets USFDA
Regulatory Authorities Approved.
Me-too-status Sitarem Tablets 50mg by M/s Remington Pharmaceutical
(Reg#099830)
coated tablet and revised the label claim considering the salt
factor along with submission of Rs. 7500/- on deposit slip
Sitagliptin as Phosphate Monohydrate…50mg
Sitagliptin as Phosphate Monohydrate…50mg

(correction/change of equivalency factor of the drug substance salt form) and change of formulation
from un-coated tablet to film coated tablet, as per notification No.F.7-11/2012-B&A/DRAP dated 13-
07-2021.
Brand Name + Dosage Form and Sitmap 100mg Tablet
Strength
Sitagliptin Phospate Monohydrate….…100mg
03-2019
Type of form Form 5
Approval status of product in Reference Januvia (25mg, 50mg, 100mg) film-coated tablets USFDA
Me-too-status Sitarem Tablets 100mg by M/s Remington Pharmaceutical
(Reg#099829)
• The firm have revised the formulation from uncoated to film
coated tablet and revised the label claim considering the salt
Sitagliptin as Phosphate Monohydrate…..100mg
Sitagliptin as Phosphate Monohydrate…….100mg
(correction/change of equivalency factor of the drug substance salt form) and change of formulation
from un-coated tablet to film coated tablet, as per notification No.F.7-11/2012-B&A/DRAP dated 13-
07-2021.
Brand Name + Dosage Form and Sitmap M 50/100mg Tablet
Strength
Sitagliptin…….…….50mg
Metformin HCl……..1000mg
03-2019
Type of form Form 5
Approval status of product in Reference Janumet film coated tablet (50mg/500mg, 50mg/1000mg)
Regulatory Authorities USFDA Approved.
Me-too-status Silomet M 50/1000mg Tablet by M/s High-Q Pharmaceuticals
(Reg#76400)
coated tablet and mentioned the salt and hydrated form of

sitagliptin in label claim along with submission of Rs. 7500/-
on deposit slip No#588505512. The revised label claim is as
under:
Metformin HCl…………………………….1000mg
Metformin HCl…………………………….1000mg
(correction/change of salt form of the drug substance) and change of formulation from un-coated tablet
to film coated tablet, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Valopin 160mg Tablet
Strength
Valsartan………….160mg
03-2019
Pharmacological Group Angiotensin II receptor blockers (ARBs), plain
Type of form Form 5
Approval status of product in Reference Valsartan 160mg film-coated Tablets MHRA Approved
Me-too-status Valbar Tablet 160mg by M/s Barrett Hodgson Pakistan
(Reg#086703)
279. Name and address of manufacture / M/s Perfect Pharma Pvt Ltd. 5-Km, Manga Road, Raiwind,
Applicant Lahore, Pakistan
Contract Manufactured by: M/s Semos Pharmaceuticals Pvt
Ltd. Plot No. 11, Sector 12-A, North Karachi, Krachi-75850,
Pakistan"
Brand Name + Dosage Form and Draxil Capsule 500mg
Strength
Cefadroxil as Monohydrate….…500mg
03-2019
Pharmacological Group Cephalosporins
Type of form Form 5
Finished product specifications Manufacturer’ s Specifications
Approval status of product in Reference Cefadroxil 500mg Capsules MHRA approved

Me-too-status Caredrox Capsule 500mg by M/s Bryon Pharmaceuticals
(Reg#090694)
GMP Status The firm M/s Semos Pharmaceuticals was inspected on 04-07-
2018 and conclusion of inspection was:
Based on above observations their current GMP compliance
level is rated as GOOD.
The firm M/s Perfect Pharma was inspected on 22/09/2021 &
08/10/2021 and conclusion of inspection was:
Overall, the firm showed satisfactory improvements as per
cGMP requirements.
• Form 5 is submitted by the applicant i.e. M/s Perfect Pharma
Pvt Ltd
i.e. M/s Perfect Pharma Pvt Ltd
• The firm submitted that they never applied before any product
for registration on contract manufacturing
• The firm did not submit list of products applied for contract
manufacturing.
• The firm submitted contract manufacturing agreement
between M/s Perfect Pharma and M/s Semos Pharmaceuticals
• The firm have revised specifications from manufacturer’s
specifications to USP specifications along with submission of
Rs. 7500/- on deposit slip No#8460441523.
Decision: Approved with USP specifications. Registration letter will be issued after submission of GMP
audit report of M/s Semos Pharmaceuticals Pvt Ltd. from QA&LT Division, valid within last three
years.
Pakistan"
Brand Name + Dosage Form and Draxil 125mg/5ml Suspension
Strength
Cefadroxil as Monohydrate………125mg
03-2019
Type of form Form 5
Finished product specifications Manufacturer’ s Specifications
Me-too-status Ozix Dry Powder Suspension 125mg/5ml by M/s Maxitech
Pharma (Reg#097182)
cGMP requirements.
Remark of the Evaluator XI • The firm did not provide evidence of approval of applied
formulation in reference regulatory authorities / agencies

which were adopted by the Registration Board in its 275th
meeting
Pvt Ltd
manufacturing.
specifications to USP specifications without submission of
applicable fee.
• Submission of fee of Rs. 7,500 for correction/pre-approval change in product specifications, as
Pakistan"
Brand Name + Dosage Form and Draxil 250mg/5ml suspension
Strength
Cefadroxil as Monohydrate……..…250mg
03-2019
Type of form Form 5
Approval status of product in Reference Cefadroxil Mylan 250mg/5ml powder for oral suspension
Regulatory Authorities ANSM approved
Pharma (Reg#097183)
cGMP requirements.
Pvt Ltd
manufacturing.

Decision: Approved with USP specifications. Registration letter will be issued after submission of
GMP audit report of M/s Semos Pharmaceuticals Pvt Ltd. from QA&LT Division, valid within last
three years.
Pakistan"
Brand Name + Dosage Form and Pimor 1000mg Injection IV/IM
Strength
Cefepime as HCl with L-Arginine eq. to
Cefepime…………...1000mg
03-2019
Pharmacological Group Fourth-generation cephalosporins
Type of form Form 5
Approval status of product in Reference MAXIPIME (500mg, 1g, 2g) for injection USFDA approved
Me-too-status Pimazon Injection 1g by M/s Horizon Healthcare
(Reg#098041)
cGMP requirements.
Pvt Ltd
manufacturing.
• The firm have revised specifications from innovator’s
three years.

Pakistan"
Brand Name + Dosage Form and Pimor 500mg Injection IV/IM
Strength
Cefepime as HCl with L-Arginine eq. to
Cefepime…………………………500mg
03-2019
Pharmacological Group Fourth-generation cephalosporins
Type of form Form 5
Approval status of product in Reference MAXIPIME (500mg, 1g, 2g) for injection USFDA approved
Me-too-status Pimazon Injection 500mg by M/s Horizon Healthcare
(Reg#098042)
cGMP requirements.
Remark of the Evaluator XI • Form 5 is submitted by the applicant i.e. M/s Perfect Pharma
Pvt Ltd
manufacturing.
• The firm have revised specifications from innovator’s
three years.
Pakistan"
Brand Name + Dosage Form and Cefrax Capsule 400mg
Strength
Cefixime as Trihydrate…….400mg
03-2019
Pharmacological Group Cephalosporin
Type of form Form 5
Finished product specifications JP

Approval status of product in Reference SUPRAX capsules 400mg, (USFDA approved)
Regulatory Authorities Discontinued **Federal Register determination that product
reasons**
Me-too-status Xalfocin 400mg Capsule by Martin Dow Karachi (Reg#80646)
cGMP requirements.
Pvt Ltd
manufacturing.
• The firm have revised the specifications from Manufacturer’s
specifications to JP specifications without submission of
applicable fee.
Decision: Approved with manufacturer specifications as per decision of 313th Meeting of Registration
Board communicated vide letter No. F.14-1/2022-PEC dated 14th March 2022. Registration letter will
be issued after submission of GMP audit report of M/s Semos Pharmaceuticals Pvt Ltd. from QA&LT
Division, valid within last three years.
Pakistan"
Brand Name + Dosage Form and Cefrax DS Suspension 200mg/5ml
Strength
Composition Each 5ml reconstituted Suspension Contains:
Cefixime (as Trihydrate)……….…200mg
03-2019
Type of form Form 5
Approval status of product in Reference SUPRAX 200mg/5ml powder for oral suspension USFDA
Me-too-status Regcef 200mg/5ml Dry Suspension Regal Pharmaceutical
(Reg#098276)

cGMP requirements.
Pvt Ltd
manufacturing.
• The firm have revised the specifications from Manufacturer’s
three years.
Pakistan"
Brand Name + Dosage Form and Cpsm 1gm IV/IM Injection
Strength
Cefoperazone as Sodium………….500mg
Sulbactam as Sodium……………...500mg
03-2019
Type of form Form 5
Approval status of product in Reference Sulperazon Injection 1g by Pfizer Co. Ltd PMDA Approved
Me-too-status Aricef Plus Injection 1g IV/IM by M/s Aries Pharmaceuticals
(Reg#097285)
cGMP requirements.
Pvt Ltd
manufacturing.

• The firm have revised the specifications from USP
specifications to JP specifications along with submission of Rs.
7500/- on deposit slip No#851924374.
Decision: Approved with JP specifications. Registration letter will be issued after submission of GMP
years.
Pakistan"
Brand Name + Dosage Form and Cpsm 2gm IV/IM Injection
Strength
Cefoperazone as Sodium………..…1000mg
Sulbactam as Sodium……………...1000mg
03-2019
Type of form Form 5
Approval status of product in Reference Approved in 03 European countries, i.e., Czech Republic,
Regulatory Authorities Poland and Slovakia
Me-too-status Aricef Plus Injection 2g IV/IM by M/s Aries Pharmaceuticals
(Reg# 097286)
cGMP requirements.
Pvt Ltd
manufacturing.
• The firm have revised the specifications from USP
specifications to JP specifications along with submission of Rs.
7500/- on deposit slip No#509207674.
Decision: Approved with JP specifications. Registration letter will be issued after submission of GMP
years.

Pakistan"
Brand Name + Dosage Form and Proxim 1000mg Dry Powder Injection IV/IM
Strength
Cefotaxime Sodium eq to Cefotaxime……1000mg
03-2019
Pharmacological Group Cephalosporine
Type of form Form-5
Approval status of product in Reference Cefotaxime 1g powder for solution for injection. MHRA
Me-too-status Amzax Injection 1g by M/s Amrose Pharmaceuticals,
(Reg#100465)
cGMP requirements.
Pvt Ltd
• Manufacturing outline of the applied product is not submitted
manufacturing.
• The firm have revised the specifications from manufacturer’s
• Firm shall submit manufacturing outline of the applied product before issuance of registration
letter.
• Registration letter will be issued after submission of GMP audit report of M/s Semos
Pharmaceuticals Pvt Ltd. from QA&LT Division, valid within last three years.
Pakistan"
Strength
Cefotaxime Sodium eq to Cefotaxime……..250mg
03-2019

Type of form Form-5
Approval status of product in Reference Cefotaxima Normon 250mg Powder and Solvent for Solution for
Regulatory Authorities Injectable IV EFG, CIMA spain approved
Me-too-status Amzax Injection 250mg by M/s Amrose Pharmaceuticals,
(Reg#100463)
cGMP requirements.
Pvt Ltd
manufacturing.
three years.
Pakistan"
Strength
Cefotaxine Sodium eq to Cefotaxime……..500mg
03-2019
Type of form Form-5
Approval status of product in Reference Cefotaxime 500mg powder for solution for injection. MHRA
Me-too-status Amzax Injection 500mg by M/s Amrose Pharmaceuticals,
(Reg#100464)

cGMP requirements.
Pvt Ltd
manufacturing.
three years.
Pakistan"
Brand Name + Dosage Form and Cefrax Suspension 100mg/5ml
Strength
Composition Each 5ml Reconstituted Suspension Contains:
Cefixime as trihydrate….…100mg
03-2019
Type of form Form-5
Approval status of product in Reference SUPRAX 100mg/5ml powder for oral suspension USFDA
reasons**
Me-too-status Regcef 100mg/5ml Dry suspension Regal Pharmaceutical
(Reg#098275)
cGMP requirements.
Pvt Ltd

manufacturing.
three years.
Pakistan"
Brand Name + Dosage Form and Podoxime Suspension 40mg/5ml
Strength
Cefpodoxime Proxetil eq to Cefpodoxime….…40mg
03-2019
Type of form Form 5
Approval status of product in Reference Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
Regulatory Authorities MHRA approved
Me-too-status Cepodox Dry Powder Suspension 40mg/5ml by M/s Maxitech
Pharma (Reg# 096375)
cGMP requirements.
Pvt Ltd
manufacturing.
three years.

Pakistan"
Brand Name + Dosage Form and Podoxim Suspension 80mg/5ml
Strength
Cefpodoxime Proxetil eq to Cefpodoxime……..80mg
03-2019
Type of form Form 5
Me-too-status
cGMP requirements.
Pvt Ltd
manufacturing.
specifications to USP specifications without submission of
applicable fee.
• The firm provided evidence of RRA. VANTIN Oral
Suspension 100mg/5ml USFDA Approved.
reasons**
• The firm provided evidence of me-too. Cedoxin 100mg/5ml
Dry Suspension by M/s Regal Pharmaceuticals (Reg#098284)
• The firm revised the strength of formulation along with
submission of Rs. 7500/- on deposit slip No#3289603937. The
Each 5ml Contains:
Cefpodoxime as Proxetil ……..100mg
Decision: Approved as per following label claim with USP specifications:
Each 5ml Contains:
Cefpodoxime as Proxetil ……..100mg
(correction/change of strength of the applied formulation), as per notification No.F.7-11/2012-

Registration letter will be issued after submission of GMP audit report of M/s Semos Pharmaceuticals
Pvt Ltd. from QA&LT Division, valid within last three years.
Pakistan"
Brand Name + Dosage Form and Cexon 500mg IV Injection
Strength
Ceftriaxone Sodium eq to Ceftriaxone………….500mg
03-2019
Type of form Form 5
Approval status of product in Reference Ceftriaxone 500mg powder for solution for injection MHRA
Me-too-status Cesh Injection 500mg IV by Sigma Pharma (Reg#101218)
cGMP requirements.
Pvt Ltd
manufacturing.
• The firm have revised the specifications from innovator’s
three years.
Pakistan"
Brand Name + Dosage Form and Cexon 2gm Dry powder Injection IV
Strength
Ceftriaxone Sodium eq to Ceftriaxone………..…2gm
03-2019

Type of form Form 5
Approval status of product in Reference Ceftriaxone 2g powder for solution for injection or infusion
Regulatory Authorities MHRA Approved
Me-too-status Soloxone Dry Powder Injection 2g (IV) by Pharmasol (Pvt) Ltd
(Reg#090474)
cGMP requirements.
Pvt Ltd
manufacturing.
three years.
Pakistan"
Brand Name + Dosage Form and Cexon 250mg IM Injection
Strength
Ceftriaxone Sodium eq to Ceftriaxone……..…250mg
03-2019
Type of form Form 5
Approval status of product in Reference Ceftriaxone 250mg powder for solution for injection MHRA
Me-too-status Cesh Injection 250mg IM by Sigma Pharma (Reg#101220)

cGMP requirements.
Pvt Ltd
manufacturing.
three years.
Pakistan"
Brand Name + Dosage Form and Cexon 1000mg IV Injection
Strength
Ceftriaxone Sodium eq to Ceftriaxone……………1000mg
03-2019
Type of form Form 5
Approval status of product in Reference Ceftriaxone 1g powder for solution for injection or Infusion
Regulatory Authorities MHRA Approved
Me-too-status Cesh Injection 1g IV by Sigma Pharma (Reg#101219)
cGMP requirements.

Pvt Ltd
manufacturing.
Rs. 7500/- on deposit slip No#4609287791
three years.
Pakistan"
Brand Name + Dosage Form and Cefra Capsule 250mg
Strength
Cephradine…………..250mg
03-2019
Type of form Form-5
Approval status of product in Reference Cefradine 250mg Capsules MHRA Approved
Me-too-status Verakef 250mg Capsule by M/s Cure Laboratories
(Reg#097825)
cGMP requirements.
Pvt Ltd
manufacturing.

three years.
Pakistan"
Brand Name + Dosage Form and Cefra Capsule 500mg
Strength
Cephradine…………..500mg
03-2019
Type of form Form-5
Approval status of product in Reference Cefradine 500mg Capsules MHRA Approved
Me-too-status Verakef 500mg Capsule by M/s Cure Laboratories
(Reg#097826)
cGMP requirements.
Remark of the Evaluator XI • The firm have submitted revised form 5 and enclosure of form
5 and mentioned the correct strength of Cefra Capsule 500mg
instead of Cefra Capsule 250mg as per cover letter, fee challan
and master formulation
Pvt Ltd
manufacturing.
(correction/change of strength of formulation in form 5), as per notification No.F.7-11/2012-

Pakistan"
Brand Name + Dosage Form and Cefra 125mg/5ml Suspension
Strength
Cephradine as Monohydrate………..…125mg
03-2019
Type of form Form-5
Me-too-status Cefra Dry Suspension 125mg by M/s Max Pharmaceuticals,
(Reg#075406)
cGMP requirements.
formulation in reference regulatory authorities/agencies which
Pvt Ltd
manufacturing.
Pakistan"
Brand Name + Dosage Form and Cefra 250mg/5ml suspension
Strength
Cephradine as monohydrate……………250mg
03-2019

Type of form Form-5
Approval status of product in Reference Nicef Syrup 250mg/5ml MHRA Approved
Me-too-status Solexin DS Dry Suspension 250mg /5ml by M/s Pharmasol
(Pvt) Ltd (Reg#090463)
cGMP requirements.
Remark of the Evaluator XI • The reference formulation is syrup the applied product is dry
suspension
• The firm have revised the label claim and removed
monohydrate from label claim as per reference formulation.
Each 5ml Contains:
Cephradine ……………250mg
Pvt Ltd
manufacturing.
Decision: Approved with USP specifications and following label claim:
Each 5ml Contains:
Cephradine ……………250mg
Firm shall submit the diffential fee of Rs. 22,500 for correction/pre-approval change in composition
(correction/change of hydrated form of the drug substance), as per notification No.F.7-11/2012-
302. Name and address of manufacture / M/s Hamaz Pharmaceuticals (Pvt.) Ltd.
Applicant 13-km, Bosan Road, Lutfabad, Multan
Brand Name + Dosage Form and Acysteine Sachet 200mg
Strength
Acetylcysteine………...200mg
03-2019
Pharmacological Group Mucolytics
Type of form Form 5
Finished product specifications Manufacturer’s Specifications

Approval status of product in Reference Acetylcysteine 200 mg Powder for Oral Solution MHRA
Me-too-status Mucyst Sachet 200mg by M/s Faas Pharmaceuticals
(Reg#096349)
GMP Status GMP certificate issued to Hamaz pharmaceuticals on dated 25-
05-2021 based on inspection conducted on 13-04-2021
Remark of the Evaluator XI • The firm have mentioned different names on cover letter, form
5 and fee challan. Acysteine Sachet 200mg (on cover letter
and form 5), acetyl cysteine/acey (fee challan)
• The firm submitted that brand name Acysteine sachet 200mg
proposed in form-5 is for the formulation of acetyl cysteine
200mg.
• They further undertake that if their claim is found
contradictory at later stage, they will pay fee against above
mentioned brand.
• Dosage form and strength is not mentioned on fee challan
• The firm submitted letter No. F. 6-1/2013-Lic (M-232) dated
29th August 2013 issued by Secretary CLB showing presence
of Sachet Section (Non Antibiotic)
Decision: Approved with innovator’s specifications. Firm shall submit fee of Rs. 7,500 for
correction/pre-approval change in product specifications, as per notification No.F.7-11/2012-
Brand Name + Dosage Form and CDL Forte Suspension 250mg
Strength
Composition Each 5ml After Reconstitution Contains:
Cefadroxil as monohydrate…………..…250mg
02-2019
Type of form Form 5
Approval status of product in Reference Cefadroxil Mylan 250mg/5ml powder for oral suspension
Regulatory Authorities ANSM approved
Pharma (Reg#097183)
5 and fee challan. CDL Forte Suspension 250mg (on cover
letter and form 5), CDL dry Suspension 250mg/5ml (fee
challan)
• The firm submitted that brand name CDL Forte Suspension
250mg proposed in form-5 is for the formulation of
cephadroxil 250mg.
mentioned brand.
• The firm submitted letter No. F. 1-37/93-Lic (Vol.I) (M-215)
dated 29th January 2009 issued by Deputy drugs controller
(L&A) showing presence of Dry powder (Cephalosporin)
Decision: Approved with change of brand name.

Brand Name + Dosage Form and CDL Capsule 500mg
Strength
Cefadroxil (as monohydrate)………….500mg
03-2019
Type of form Form 5
Approval status of product in Reference Cefadroxil 500mg Capsules MHRA approved
Me-too-status Caredrox Capsule 500mg by M/s Bryon Pharmaceuticals
(Reg#090694)
Remark of the Evaluator XI • The firm submitted letter No. F. 1-37/93-Lic (Vol.I) (M-215)
(L&A) showing presence of Capsule (Cephalosporin)
Brand Name + Dosage Form and CDL Suspension 125mg/5ml
Strength
Composition Each 5ml After Reconstitution Contains:
Cefadroxil (as monohydrate)…………125mg
03-2019
Type of form Form 5
Approval status of product in Reference DURICEF 125mg/5ml for suspension; USFDA Approved
Regulatory Authorities Discontinued **Federal Register determination that
product was not discontinued or withdrawn for safety or
efficacy reasons**
Pharma (Reg#097182)
Remark of the Evaluator XI • The firm submitted letter No. F. 1-37/93-Lic (Vol.I) (M-215)
Brand Name + Dosage Form and Otirox Injection 1.5g
Strength
Cefuroxime Sodium eq. to Cefuroxime………….1.5gm

03-2019
Type of form Form 5
Approval status of product in Reference Zinacef for Injection or Infusion (250mg, 750mg, 1.5g) MHRA
Me-too-status Ceroxime Dry Powder Injection 1.5gm by M/s Pharmasol (Pvt)
Ltd (Reg#090479)
Remark of the Evaluator XI • The firm submitted form 5 and mentioned correct strength of
otirox injection 1.5g, as per label claim and fee challan instead
of Otirox Injection 1.5mg on cover letter.
• The firm did not submit master formulation of the applied
product
• The firm have mentioned the use of type II glass container as
the primary packaging material of applied formulation
• The firm submitted letter No. F. 1-37/93-Lic dated 03rd August
2015 issued by secretary CLB showing presence of Dry
powder injectable (Cephalosporin)
• Submission of master formulation of the applied product
• Clarifiction regarding type of the primary packaging material for applied formulation.
Brand Name + Dosage Form and Otirox Injection 750mg
Strength
Cefuroxime Sodium eq to Cefuroxime……..…750mg
03-2019
Type of form Form 5
Approval status of product in Reference Zinacef for Injection or Infusion (250mg, 750mg, 1.5g) MHRA
Me-too-status Ceroxime Dry Powder Injection 750mg by M/s Pharmasol
(Pvt) Ltd (Reg#090478)
Remark of the Evaluator XI • The firm did not submit master formulation of the applied
product
• The firm have mentioned the use of type II glass container as
the primary packaging material of applied formulation
• The firm submitted letter No. F. 1-37/93-Lic dated 03rd August
2015 issued by secretary CLB showing presence of Dry
powder injectable (Cephalosporin)
• Submission of master formulation of the applied product
• The use of type of the primary packaging material of applied formulation

Brand Name + Dosage Form and Ibilex Suspension 125mg
Strength
Composition Each 5ml Suspension Contains:
Cephalexin………….…125mg
03-2019
Type of form Form 5
Approval status of product in Reference Cefalexin 125 mg/5ml Powder for Oral Suspension MHRA
Me-too-status Furex 125mg/5ml Dry Suspension by M/s Cure Laboratories
(Reg# 098366)
Remark of the Evaluator XI • The firm have not mentioned the hydrated form of Cephalexin
in label claim, and adjust its weight in master formulation
considering the hydrated form
• The firm have not submitted undertaking at the end of form 5
• Revision of label claim and master formulation as per innovator product along with submission
of applicable fee.
• Submision of undertaking at the end of form 5
Brand Name + Dosage Form and Ibilex Capsule 500mg
Strength
Cephalexin…………500mg
03-2019
Type of form Form 5
Approval status of product in Reference Keflex Capsules 500mg MHRA approved
Me-too-status Furex 500mg capsule by M/s Cure Laboratories (Reg#098365)
Remark of the Evaluator XI • The firm have not mentioned the hydrated form of Cephalexin
in label claim, and adjust its weight in master formulation
considering the hydrated form
(L&A) showing presence of Capsule (Cephalosporin)

Decision: Deferred for Revision of label claim and master formulation as per innovator product along
with submission of applicable fee.
Brand Name + Dosage Form and Closon Cream 0.05% w/w
Strength
Composition Each Gm Contains:
Clobetasone Butyrate…..….0.5mg (0.05% w/w)
03-2019
Pharmacological Group Corticosteroids
Type of form Form 5
Finished product specifications BP Specifications
Pack size and Demand Price 5gm, 10gm; As per SRO
Approval status of product in Reference Eumovate 0.05% w/w Cream MHRA Approved
Me-too-status
Remark of the Evaluator XI • The firm have provided evidence of me-too Cabsole cream by
M/s Derma Techno (Reg# 071265). However, the provided
me-too is not as per applied product.
• The firm have mentioned different names on cover letter, form
5 and fee challan. closon cream (cover letter), closon cream
0.05% (form 5), cloba/clobetasone (butyrate)/colson (fee
challan)
• The firm submitted that brand name closon cream 0.05%
proposed in form-5 is for the formulation of clobetasone
0.05%.
mentioned brand.
• Dosage form is not mentioned on fee challan
• The firm have not submitted complete manufacturing outline
of the applied formulation
• The firm submitted letter No. F. 1-37/93-Lic dated 03.08.2015
issued by Secretary Central Licensing Board confirming the
presence of Cream/Ointment/Gel (General) Section
• Submission of complete manufacturing outline of the applied formulation
Brand Name + Dosage Form and Trima V Cream 2% w/w
Strength
Clotrimazole……..… 20mg (2%)
03-2019
Pharmacological Group Imidazole derivatives
Type of form Form 5
Pack size and Demand Price 10gm, 20gm, 35gm; As per SRO

Approval status of product in Reference Soul Pattinson Antifungal Clotrimazole Women's Treatment
Regulatory Authorities 2% w/w vaginal cream tube TGA approved
Me-too-status Coapt 2% Vaginal Cream by M/s Saffron Pharmaceuticals
(Reg#103285)
5 and fee challan. Trima V Cream (cover letter and form 5),
clotrimazole 20mg/lavizole (on fee challan)
• The firm submitted that brand name Trima V Cream 2%
proposed in form-5 is for the formulation of clotrimazole
20mg.
mentioned brand.
Decision: Approved.
Brand Name + Dosage Form and Trima B Cream (1%/0.5%)
Strength
Clotrimazole……………………………….10mg (1%)
Betamethasone (As Dipropionate)…………0.5mg (0.05%)
03-2019
Pharmacological Group Antifungal with corticosteroids
Type of form Form 5
Approval status of product in Reference LOTRISONE (clotrimazole and betamethasone dipropionate)
Regulatory Authorities cream, for topical use (1%/0.05%) USFDA Approved
Me-too-status Conic-B Cream by M/s Rotex Pharma (Reg#100796)
5 and fee challan. Trima B Cream (1%/0.5%) (on cover
letter), Trima V Cream (on form 5),
clotrimazole+betamethasone as dipropionate/fungin (on fee
challan).
• The firm submitted that brand name Trima B Cream 2%
proposed in form-5 is for the formulation of
clotrimazole+betamethasone.
mentioned brand.
Decision: Approved.
Brand Name + Dosage Form and Lorine Syrup 2.5mg / 5ml
Strength

Composition Each tablet Contains:
Desloratadine..………2.5mg
03-2019
Pharmacological Group Antihistamine
Type of form Form 5
Pack size and Demand Price 60ml, 120ml; As per SRO
Approval status of product in Reference Desloratadine 0.5mg/ml Oral Solution MHRA approved
Me-too-status Lorades 2.5 mg/5ml Syrup by winlet Pharmaceuticals
(Reg#098321)
5 and fee challan. Clarinex Syrup 2.5mg / 5ml (cover letter),
lorin syrup 2.5mg/5ml (form 5) desloratadine syp/Clarinex
(fee challan)
• The firm submitted that brand name lorin syrup 2.5mg/5ml
proposed in form-5 is for the formulation of desloratadine
2.5mg/5ml.
mentioned brand.
• The firm submitted that regarding banned excipient Sodium
cyclamate in formulation we hereby confirmed that
alternative option will be used
• The firm have revised the label claim as per reference
formulation without submission of applicable fee. The
Each 5ml Contains:
Decision: Approved with innovator’s specifications and following label claim:
Each 5ml Contains:
Firm shall submit fee of Rs. 30,000 for correction/pre-approval change in product specifications and
correction/pre-approval change in label claim in Form 5 (i.e., change in dosage form) as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Doperi Tablet 10mg
Strength
Domperidone as Maleate ………… 5mg
03-2019
Pharmacological Group Propulsives
Type of form Form 5
Approval status of product in Reference DOMPERIDONE APOTEX domperidone (as maleate) 10mg
Regulatory Authorities tablets TGA Approved
Me-too-status Domlis 10mg Tablet by M/s Lisko Pakistan (Reg#094897)

Remark of the Evaluator XI • The firm have revised the label claim in form 5 as per the
submitted documents without submission of applicable fee.

5 and fee challan. Adegut tablet 5mg (on cover letter), doperi
10mg tablet (on form 5), adegut/domperidone (on fee challan)
• The firm submitted that brand name doperi 10mg tablet
proposed in form-5 is for the formulation of domperidone
10mg.
mentioned brand.
(correction/change of strength of applied formulation), as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
Brand Name + Dosage Form and Ersteine Sachet 225mg
Strength
Erdosteine ……………225mg
03-2019
Pharmacological Group Mucolytics
Type of form Form 5
Me-too-status Erdozet Sachet 225 mg by M/s Wenovo Pharmaceuticals
(Reg# 078072)
meeting
5 and fee challan. Erdo Sachet 225mg (on cover letter),
Erdosteine/Erdo (on fee challan) Ersteine Sachet 225mg (on
form 5).
• The firm submitted that brand name Ersteine Sachet 225mg
proposed in form-5 is for the formulation of Erdosteine
225mg.

mentioned brand.
• Dosage form and strength is not mentioned on fee challan.
Brand Name + Dosage Form and Fotamol Sachet 3gm
Strength
Composition Each sachet Contains:
Fosfomycin As Trometamol ……..3gm
03-2019
Pharmacological Group Other antibacterial
Type of form Form 5
Pack size and Demand Price 1’s, 5’s, 10’s; As per SRO
Approval status of product in Reference Berny 3g granules for oral solution MHRA approved
Me-too-status Monufos 3g Oral Sachet by M/s Rotex Pharma (Reg#097453)
5 and fee challan. Fosfomycin As Trometamol Sachet(on
cover letter), Fotamol Sachet 3gm(on form 5), Fosfomycin
As Trometamol /Fosimax (on fee challan)
• The firm submitted that brand name Fotamol Sachet 3gm
proposed in form-5 is for the formulation of Fosfomycin 3mg.
mentioned brand.
Brand Name + Dosage Form and Fusim Cream 2% w/w
Strength
Fusidic Acid……….….20mg
03-2019
Pharmacological Group Other antibiotics for topical use
Type of form Form 5
Approval status of product in Reference Fucidin (fusidic acid) 20mg/g cream MHRA Approved

Me-too-status Fusinax-A Cream 2%w/w by M/s Winbrain Research
5 and fee challan. Fusim Cream 2% (on cover letter and form
5), Fusidic Acid /Fusitrim (on fee challan)
• The firm submitted that brand name Fusim Cream 2%
proposed in form-5 is for the formulation of fusidic acid.
mentioned brand.
Decision: Approved.
Brand Name + Dosage Form and Fusim B Cream
Strength
Fusidic Acid ……………………20mg
Betamethasone As Valerate ……..1mg
03-2019
Pharmacological Group Corticosteroids combinations with antibiotic
Type of form Form 5
Approval status of product in Reference Xemacort 20 mg/g + 1 mg/g cream MHRA Approved
Me-too-status Tribetafusid 15gm Cream by M/s Trigon Pharmaceuticals
(Reg#100597)
5 and fee challan. Fusim B Cream (on cover letter and form
5), Fusidic Acid-
Betamethasone As Valerate /Fusib (on fee challan)
• The firm submitted that brand name Fusim B Cream proposed
in form-5 is for the formulation of fusidic
acid+betamethasone.
mentioned brand.

Brand Name + Dosage Form and Iburin Forte Suspension 200mg
Strength
Ibuprofen………..…200mg
03-2019
Pharmacological Group NSAIDs
Type of form Form 5
Approval status of product in Reference Ibuprofen 200mg/5ml Oral Suspension MHRA Approved
Me-too-status Mfin Suspension 200mg/5ml M/s Bio-Mark Pharmaceuticals
(Reg#85691)
Remark of the Evaluator XI • The firm did not submit manufacturing outline mentioning
filling and packing processes.
Decision: Approved.
• Firm shall submit complete manufacturing outline of applied product before issuance of
• Firm shall submit fee of Rs.7,500 for correction/pre-approval change in the method of
manufacture, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Ben 10 Plus Syrup
Strength
Iron III Hydroxide Polymaltose Complex eq to Elemental
Iron……………………50mg
Folic Acid…………….0.35mg
03-2019
Pharmacological Group Iron in combination with folic acid
Type of form Form 5
Me-too-status Maltowin-F Oral Syrup Winthrox Laboratories (Reg#098599)
meeting
• The firm did not give clarification regarding use of Sodium
cyclamate in formulation which is a banned excipient as per
286th Registration Board decision.
• The firm did not submit manufacturing outline mentioning

• Evidence of approval of applied formulation in reference regulatory authorities / agencies
which were adopted by the Registration Board in its 275th meeting
• Clarification regarding use of Sodium cyclamate in formulation which is a banned excipient
as per 286th Registration Board decision.
• Submission of manufacturing outline mentioning filling and packing processes.
• Submission fee of Rs.7,500 for correction/pre-approval change in the method of manufacture,
Brand Name + Dosage Form and Alertal Tablet 10mg
Strength
Loratadine…………….…10mg
03-2019
Pharmacological Group Other antihistamines for systemic use
Type of form Form 5
Approval status of product in Reference Loratadine 10mg Tablets MHRA Approved
Me-too-status Histeg 10mg Tablets by M/s EG Pharmaceuticals
(Reg#095826)
Blistering and packing processes.
Decision: Approved.
Brand Name + Dosage Form and Alertal Syrup 5mg/5ml
Strength
Loratadine………..5mg
03-2019
Pharmacological Group Other antihistamines for systemic use
Type of form Form 5
Approval status of product in Reference Loratadine 5mg/5ml Syrup MHRA approved
Me-too-status Alavert Syrup 5mg/5ml by M/s Hiranis Pharmaceuticals
(Reg#098894)

Decision: Approved.
Brand Name + Dosage Form and Ornitate Sachet 3Gm
Strength
L-Ornithine L-Aspartate……….…3gm
03-2019
Pharmacological Group Hepatoprotective, Lipotropic
Type of form Form 5
Approval status of product in Reference Hepa-Merz 3gm Sachet containing ornithine aspartate (granules
Regulatory Authorities for solution). AGES (Austria) approved
Me-too-status Lolar Sachet by M/s Hiranis Pharmaceuticals (Reg#076499)
5 and fee challan. Ornithine Amino acid sachet (on cover
letter), Ornitate sachet (form 5), L-Ornithine L-Aspartate
/Enojone(on fee challan)
• The firm submitted that brand name Ornitate sachet 3gm
proposed in form-5 is for the formulation of L-Ornithine L-
Aspartate.
mentioned brand.
• The firm did not give clarification regarding use of Sodium
cyclamate in formulation which is a banned excipient as per
286th Registration Board decision.
• Firm shall submit revised master formulation of applied product excluding Sodium cyclamate,
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in product
specifications and master formulation (change of excipients), as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Micona Cream 2%
Strength
Miconazole Nitrate………… 20mg (2% w/w)
03-2019
Pharmacological Group Imidazole derivatives

Type of form Form 5
Approval status of product in Reference Daktarin 2% w/w Cream MHRA approved
Me-too-status Bicrole Cream 2% by M/s Searle IV Solutions (Reg#078895)
5 and fee challan. Micona cream 2% (on cover letter and form
5), Miconazole /Micozol (on fee challan)
• The firm submitted that brand name Micona cream 2%
proposed in form-5 is for the formulation of Miconazole.
mentioned brand.
Decision: Approved.
Brand Name + Dosage Form and Micohyd Cream 2% / 1%
Strength
Miconazole Nitrate……..…. 20 mg (2%w/w)
Hydrocortisone…………..…. 10mg (1%w/w)
03-2019
Pharmacological Group Antifungal, Corticosteroid
Type of form Form 5
Approval status of product in Reference Daktacort 2% / 1% w/w cream MHRA Approved
Me-too-status Conicort-H Cream by M/s Brookes Pharma (Reg# 096303)
5 and fee challan. Micohyd Cream (on cover letter and form
5), Miconazole Nitrate+Hydrocortisone /Hydomic (on fee
challan),
• The firm submitted that brand name Micohyd Cream 2% / 1%
proposed in form-5 is for the formulation of Miconazole
Nitrate+Hydrocortisone.
mentioned brand.

Decision: Approved.
Brand Name + Dosage Form and UCRAL Suspension 1g/5ml
Strength
Sucralfate……….…. 1gm
03-2019
Pharmacological Group Other drugs for peptic ulcer and gastro-oesophageal reflux
disease (GORD)
Type of form Form 5
Pack size and Demand Price 60ml, 120ml; As per SRO
Approval status of product in Reference Antepsin 1g/5ml Oral Suspension. MHRA approved
Me-too-status Gastromed Oral Suspension 1gm/5ml by M/s Aries
Pharmaceuticals (Reg# 82601)
5 and fee challan. ulsenil 1gm/5ml (on cover letter), ucral
suspension (form 5), Sucralfate syp /ulsenil (on fee challan).
• The firm submitted that brand name ucral suspension 1gm/5ml
proposed in form-5 is for the formulation of Sucralfate syp.
mentioned brand.
• The firm submitted that regarding banned excipient of Sodium
cyclamate we hereby undertake that we will not use banned
excipient while production
Firm shall submit fee of Rs. 7,500 for correction/pre-approval change in product specifications, as per
Brand Name + Dosage Form and Demuco Syrup
Strength
Terbutaline Sulfate…………1.5mg
Guaifenesin……………..… 66.5mg
03-2019
Pharmacological Group Selective beta-2-adrenoreceptor agonists / Expectorants
Type of form Form 5
Me-too-status Respair Expectorant Syrup by M/s Kaizen Pharma
Reg#083196)

meeting
5 and fee challan. Demuco Syrup (cover letter and form 5)
Terbutaline Sulfate +
Guaifenesin / Lumin (fee challan)
• The firm submitted that brand name Demuco Syrup proposed
in form-5 is for the formulation of Terbutaline
Sulfate+Guaifenesin .
mentioned brand.
• The firm did not submit manufacturing outline mentioning
• Submission of complete manufacturing outline mentioning filling and packing processes.
Brand Name + Dosage Form and Glipmet Tablet 50/1000
Strength
Composition Each film Coated Tablet Contains:
Vildagliptin…………………………50mg
Metformin Hydrochloride…………. 1000mg
03-2019
Pharmacological Group Blood glucose lowering drugs, excl. Insulins
Type of form Form-5
Pack size and Demand Price 3x10’s, 14’s; As per SRO
Approval status of product in Reference GALVUMET (50mg vildagliptin and 1,000mg metformin
Regulatory Authorities hydrochloride) film coated tablets TGA Australia Approved
Me-too-status Vildiptin-Met 50mg/1000mg Tablet by Aspin Pharma (Reg#
098919)
Remark of the Evaluator XI • Firm have mentioned different names on cover letter, form 5
and fee challan. Videm tablet (cover letter), Glipmet tablet
50/1000 (form 5), (Vildagliptin+Metformin /Videm (fee
challan)
• The firm submitted that brand name Glipmet tablet 50 / 1000
proposed in form-5 is for the formulation of
Vildagliptin+Metformin.
mentioned brand.
329. Name and address of manufacture / M/s MTI Medical Pvt Ltd. 586-587, Sundar Industrial Estate,

Contract Manufactured By: M/s Medisave Pharmaceuticals.
Plot 578-579, Sundar Industrial Estate, Lahore, Pakistan
Brand Name + Dosage Form and Mozex 400mg/250ml Infusion
Strength
Moxifloxacin HCl……….1.6mg
03-2019
Pharmacological Group Fluoroquinolones
Type of form Form 5
Approval status of product in Reference Moxifloxacin 400mg/250mL Solution for infusion MHRA
Me-too-status M-Floxsel Infusion 400mg/250ml by M/s Pharmasol (Pvt) Ltd
(Reg#100857)
GMP Status GMP certificate issued to M/s MTI Medical (Pvt.) Ltd dated 25-
GMP certificate issued to M/s Medisave Pharmaceuticals dated
01-10-2021 based on inspection conducted on 18-09-2021
Remark of the Evaluator XI • The firm have revised the label claim considering the salt
Each 250ml vial Contains:
Moxifloxacin as HCl……….400mg
• The firm have adjusted the weight of moxifloxacin in master
formulation considering the salt factor
• The firm have submitted 07 approved sections of M/s MTI
Medical Pvt Ltd
• The firm submitted list of 04 products already
registered/approved on contract manufacturing in the name of
applicant
• The firm submitted that no product is applied for contract
manufacturing in name of M/s MTI Medical Pvt Ltd
• The firm submitted the use of type II USP glass vial as primary
packaging material of applied formulation
between M/s MTI Medical Pvt Ltd and M/s Medisave
Pharmaceuticals
Each 250ml vial contains:
Moxifloxacin as HCl……….400mg
(correction/change of salt factor of the drug substance) and product specifications, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
330. Name and address of manufacture / M/s Fedro Pharmaceuticals Laboratories Private Limited.
Applicant 149-Industrial Estate, Hayatabad, Peshawar
Brand Name + Dosage Form and Amlosart 5/80mg Tablets
Strength
Amlodipine as Besylate…………………….5mg
Valsartan……………………………………80mg
03-2019
Pharmacological Group Calcium channel blockers and Angiotensin II receptor blockers
(ARBs)

Type of form Form-5
Pack size and Demand Price 10’s, 14’s, 28’s, 30’s; As per SRO
Approval status of product in Reference Amlodipine/Valsartan 5mg/80mg film-coated tablets MHRA
The firm was inspected by the panel in detail on prescribed
evaluation form and the panel unanimously recommends the
grant of renewal of DML and grant of additional section (Dry
Suspension section-General).
Decision: Approved.
331. Name and address of manufacture / M/s City Pharmaceutical Laboratories. Plot No. 12A, Sector 5,
Applicant I-5 New Serveyno-276, Korangi Industrial Area, Karachi-
Pakistan
Brand Name + Dosage Form and Asrovit 20mg Tablet
Strength
Composition Atorvastatin Calcium…………20mg/tab
03-2019
Type of form Form 5
Approval status of product in Reference Lipitor 20mg film-coated tablets MHRA Approved
Me-too-status Atorviz 20mg tablets by Tabros Pharma (Reg#098541)
GMP Status The firm M/s City Pharmaceutical Laboratories Karachi was
inspected for grant of renewal of DML and regularization of
layout plan on 29-12-2021 and conclusion of inspection was:
Based on the stated facts and observations, production facilities,
QA system, QC Lab, Stores, Utilities and people met during the
inspection, the panel unanimously recommends the grant of
renewal of DML No. 000723 and regularization of layout plan.
Remark of the Evaluator XI • The firm have mentioned the label claim and mentioned the
hydrated form of atorvastatin calcium and revised the
formulation from uncoated to film coated as per reference
formulation without submission of applicable fee. However,
the firm have not adjusted the weight of API in master
formulation considering the salt and hydrated form. The
Atorvastatin as calcium trihydrate….…20mg
Registration Board futher decided that registration letter will be issued after submission of:
• Revised master formulation adjusting the weight of API considering the salt factor
• Undertaking the end of Form 5
(correction/change of salt factor of the drug substance) and change of formulation from un-

coated tablet to film coated tablet as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
332. Name and address of manufacture / M/s City Pharmaceutical Laboratories.
Applicant Plot No. 12A, Sector 5, I-5 New Serveyno-276, Korangi
Industrial Area, Karachi-Pakistan
Brand Name + Dosage Form and Asrovit 10mg Tablet
Strength
Composition Atorvastatin Calcium………10mg/tab
03-2019
Type of form Form 5
Approval status of product in Reference Lipitor 10mg film-coated tablets MHRA Approved
Me-too-status Atorviz 10mg tablets by Tabros Pharma (Reg#098542)
Remark of the Evaluator XI • The firm have mentioned the label claim and mentioned the
hydrated form of atorvastatin calcium and revised the
formulation without submission of applicable fee. However,
the firm have not adjusted the weight of API in master
formulation considering the salt and hydrated form. The
Atorvastatin as calcium trihydrate....…10mg
Registration Board futher decided that registration letter will be issued after submission of:
• Revised master formulation adjusting the weight of API considering the salt factor
• Undertaking at the end of form 5
• Firm shall submit fee of Rs. 30,000 for correction/pre-approval change in composition
(correction/change of salt factor of the drug substance) and change of formulation from un-
coated tablet to film coated tablet as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
Pakistan
Brand Name + Dosage Form and Claronil 500mg Tablet
Strength
Composition Clarithromycin……….…500mg/tab
03-2019
Pharmacological Group Macrolides
Type of form Form-5

Approval status of product in Reference Clarithromycin 500mg Film-coated Tablets. MHRA approved
Me-too-status Clarital 500mg Tablet. By M/s Arsons Pharmaceuticals
(Reg#085500)
Remark of the Evaluator XI • The firm have mentioned the label claim and revised the
formulation without submission of applicable fee. The revised
label claim is as under:
Clarithromycin……….…500mg
Clarithromycin……….…500mg
Registration Board futher decided that registration letter will be issued after submission of
Undertaking at the end of form 5.
(correction/change of formulation from un-coated tablet to film coated tablet), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Pakistan
Brand Name + Dosage Form and Ibistan DS 300/25mg Tablet
Strength
Irbesartan……………….300mg
Hydrochlorothiazide…….25mg
03-2019
Pharmacological Group Angiotensin II receptor blockers (ARBs)/diuretics
Type of form Form 5
Approval status of product in Reference AVALIDE (25mg:300mg) film coated tablets USFDA
reasons**
Me-too-status Irbest Plus Tablets 300mg/25mg by M/s Highnoon
Laboratories (Reg#79680)

coated tablets as per reference formulation without submission
of applicable fee. The revised label claim is as under:
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Pakistan
Brand Name + Dosage Form and Ibistan 150/12.5mg Tablet
Strength
Hydrochlorothiazide…....12.5mg
03-2019
Pharmacological Group Angiotensin II receptor blockers (ARBs)/diuretics
Type of form Form 5
Approval status of product in Reference AVALIDE (12.5mg:150mg) film coated tablets USFDA
Me-too-status Co- Irbisaff 150mg/12.5mg Tablet by M/s Saffron
Undertaking at the end of form 5

No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Pakistan
Brand Name + Dosage Form and Ibistan plus 300/12.5mg Tablet
Strength
Irbesartan………………….300mg
Hydrochlorothiazide……….12.5mg
Dairy No. date of R &I fee Form-5 Dy.No 10792 dated 05-03-2019 Rs.20,000/- 04-03-
2019
Pharmacological Group Angiotensin II receptor blockers (ARBs)/ diuretics
Type of form Form 5
Approval status of product in Reference AVALIDE (12.5mg:300mg) film coated tablets USFDA
Me-too-status Co- Irbisaff 300mg/12.5mg Tablet by M/s Saffron
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Pakistan
Brand Name + Dosage Form and Levister 500mg Tablet
Strength
Levetiracetam……………500mg
2019
Pharmacological Group Antiepileptics
Type of form Form 5

Approval status of product in Reference KEPPRA (250mg, 500mg, 750mg, 1000mg) film coated tablets
Me-too-status Episaf Tablet 500mg by Saffron Pharmaceuticals (Reg#81384)
Remark of the Evaluator XI • The firm have not revised the label claim from uncoated to film
coated tablets and nor submitted fee for revision of
formulation.
• Revision of the label claim from uncoated to film coated tablets along with submission of applicable
fee.
Pakistan
Brand Name + Dosage Form and Levister 250mg Tablet
Strength
Levetiracetam………….250mg
2019
Type of form Form 5
Approval status of product in Reference KEPPRA (250mg, 500mg, 750mg, 1000mg) film coated tablets
Me-too-status Episaf Tablet 250mg by Saffron Pharmaceuticals (Reg#81383)
Remark of the Evaluator XI • The firm have not revised the label claim from uncoated to film
coated tablets and nor submitted fee for revision of
formulation.
• Revision of the label claim from uncoated to film coated tablets along with submission of applicable
fee.
Pakistan

Brand Name + Dosage Form and Peridoline DS Tablet 8/10mg
Strength
Perindopril………………………8mg
Amlodipine (as Besylate)...……..10mg
2019
Pharmacological Group ACE inhibitors and calcium channel blockers
Type of form Form-5
Approval status of product in Reference Perindopril/Amlodipine 8mg/10mg tablets MHRA Approved
Me-too-status Rilerb Tablet 8mg/10mg by M/s Martin Dow Ltd (Reg#081054)
Remark of the Evaluator XI • The firm have mentioned the salt form of Perindopril in label
claim and revised the formulation from uncoated to film coated
as per reference formulation without submission of applicable
fee. The firm have adjusted the weight of API in master
formulation considering the salt form. The revised label claim
is as under:
Perindopril Erbumine………….……..8mg
Amlodipine (as Besylate)……...……..10mg
(correction/change of salt form of the drug substance), and correction/change of formulation from un-
coated tablet to film coated tablet as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
340. Name and address of manufacture / M/s City Pharmaceutical Laboratories Plot No. 12A, Sector 5, I-
Applicant 5 New Serveyno-276, Korangi Industrial Area, Karachi-Pakistan
Brand Name + Dosage Form and Peridoline plus Tablet 4/10mg
Strength
Perindopril…………………..…4mg
Amlodipine (as Besylate)..…….10mg
2019
Type of form Form-5

Me-too-status Rilerb 4mg/10mg Tablet by M/s Martin Dow Ltd
(Reg#082998)
Remark of the Evaluator XI • The firm have mentioned the salt form of Perindopril in label
is as under:
Pakistan
Brand Name + Dosage Form and Peridoline Tablet 4/5mg
Strength
Perindopril…………………….4mg
Amlodipine (as Besylate)..……5mg
03-2019
Type of form Form-5
Me-too-status Rilerb Tablet 4mg/5mg by M/s Martin Dow Marker Ltd
(Reg#096123)
• The firm have mentioned the salt form of Perindopril in label

is as under:
Case No. 4: Cases of M/s Obsons Pharmaceuticals 209-S, Quaid-e-Azam Industrial Estate, Kot lakhpat,
Lahore,
The Central Licensing Board in its 280th meeting held on 26th & 27th April 2021 has cancelled the Drug
Manufacturing License No. 000416 by way of (formulation) of M/s Obsons Pharmaceuticals, 209-S, Quaid-e-
Azam Industrial Estate, Kot lakhpat, Lahore, conveyed vide letter No. F.1-5/84-Lic (Vol-IV) dated 25th May 2021
by Secretary Central Licensing Board. Later on, the Appellate Board in its meeting No. 156th held on 9th June,
2021 decided as: The Board after hearing the arguments and pursuing record of case, decided to give final
opportunity of two years period to the firm for submission of new lay out plan for approval of the Central
Licensing Board. The decision of cancellation of Drug Manufacturing License by the Central Licensing Board
is set aside.
Furthermore, the firm has been granted GMP certificate dated 07-03-2022 based on inspection conducted on
22-02-2022
342. Name and address of manufacture / M/s Obsons Pharmaceuticals. 209-S, Quaid e Azam Industrial
Applicant Estate, Kotlakhpat, Lahore, Pakistan
Brand Name + Dosage Form and Obfenac Tablet 100mg
Strength
Aceclofenac…………100mg
03-2019
Pharmacological Group Antiinflammatory And Antirheumatic Products, Non-Steroids
Type of form Form 5
Approval status of product in Reference Aceclofenac 100mg Film-coated Tablets MHRA Approved
Me-too-status Ace-100 Tablets by M/s Aries Pharmaceutical (Reg#084268)
GMP Status GMP certificate issued on dated 07-03-2022 based on inspection
conducted on 22-02-2022
Remark of the Evaluator XI • The firm have claimed for BP specifications while the official
monograph is not available in any pharmacopeia
• The firm have corrected the label claim in enclosure of form 5
as per the master formulation without submission of applicable
fee. The revised label claim is as under:

(correction/change of formulation from un-coated tablet to film coated tablet), and product
Brand Name + Dosage Form and Ossomax D Tablet
Strength
Alendronate Sodium eq to Alendronic Acid ……70mg
Cholecalciferol…………2800IU
03-2019
Pharmacological Group Bisphosphonates, combinations,
Type of form Form 5
Approval status of product in Reference FOSAVANCE 70 mg/2,800 IU (70mcg) tablets MHRA
Me-too-status Caldron Tablet 70mg/70mcg by M/s Pharmasol (Pvt) Ltd
(Reg#091431)
Remark of the Evaluator XI • The firm have revised the label claim from film coated tablets
to uncoated tablets and mentioned the hydrated form of
alendronate and adjusted its weight in master formulation
along with submission of Rs. 7500/- on deposit slip No.
76989165161. The revised label claim is as under:
Alendronate Sodium Trihydrate eq to Alendronic Acid
…………….…70mg
Alendronate Sodium Trihydrate eq to Alendronic Acid …………….…70mg
(correction/change of hydrated form of the drug substance), correction/change of formulation from
film coated tablet to un-coated tablet and product specifications as per notification No.F.7-11/2012-
Registration Board further decided to limit validity of registration for two years in line with the
decision of the Appellate Board.
Brand Name + Dosage Form and Desdine Tablet 5mg
Strength
Desloratadine…….…5mg
03-2019
Type of form Form 5
Approval status of product in Reference Clarinex 5mg film coated tablet USFDA Approved.

Me-too-status Desatil Tablets 5mg by M/s Aries Pharmaceuticals
(Reg#084270)
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Desdine syrup 0.5mg/ml
Strength
Composition Each ml Of Syrup Contains:
Desloratadine………….0.5mg
03-2019
Type of form Form 5
Approval status of product in Reference Desloratadine 0.5mg/ml Oral Solution MHRA approved
Me-too-status Lorades 2.5mg/5ml Syrup by winlet Pharmaceuticals
(Reg#098321)
Brand Name + Dosage Form and Obstine Tablet 10mg
Strength
Ebastine…………..10mg
03-2019
Type of form Form 5
Approval status of product in Reference EBASTINE ARROW 10mg film-coated tablets ANSM

Me-too-status Acmin 10mg Tablets by M/s Medpharm Research
(Reg#100559)
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Obaryl Tablet 3mg
Strength
Glimepiride……….…3mg
03-2019
Pharmacological Group Sulfonylureas
Type of form Form 5
Approval status of product in Reference Glimepiride 3mg Tablets MHRA Approved
Me-too-status Zoryl 3mg tablet by M/s Innvotek Pharmaceuticals (Reg#099263)
Remark of the Evaluator XI • The firm submitted revised manufacturing outline and removed
coating procedure.
Decision: Approved.
Firm shall submit fee of Rs.7,500 for correction/pre-approval change in the method of manufacture,
Strength
Glimepiride……………4mg
03-2019
Type of form Form 5
Approval status of product in Reference AMARYL (1mg, 2mg, 4mg) tablets USFDA Approved

Me-too-status Zoryl 4mg tablet by M/s Innvotek Pharmaceuticals
(Reg#099264)
coating procedure.
Decision: Approved.
Strength
Glimepiride……….…2mg
03-2019
Type of form Form 5
(Reg#099262)
coating procedure.
Decision: Approved.
Strength
Glimepiride……..…1mg
03-2019
Type of form Form 5
(Reg#099261)

coating procedure.
Decision: Approved.
Brand Name + Dosage Form and Leep 2.5mg Tablet
Strength
Letrozole ……………….2.5mg
03-2019
Pharmacological Group Aromatase inhibitor
Type of form Form 5
Approval status of product in Reference FEMARA 2.5mg film coated tablet USFDA Approved
Me-too-status Letzole 2.5mg Tablet by M/s Opal Labs (Reg#075805)
Decision: Approved. Registration Board further decided to limit validity of registration for two years
in line with the decision of the Appellate Board.
Brand Name + Dosage Form and Lizlid Suspension 100mg/5ml
Strength
Composition Each ml Of Suspension Contains:
Linezolid…………..…100mg
03-2019
Pharmacological Group Oxazolidinone Antibiotic
Type of form Form 5
Approval status of product in Reference ZYVOX (100mg/5ml) for oral suspension USFDA Approved
Me-too-status Nezo 100mg/5ml Dry Suspension by M/s Rotex Pharma
(Reg#097440)
• The firm have revised the label claim and corrected the strength
as per reference formulation. The firm has also revised the
formulation from liquid suspension to dry powder for
suspension along with submission of Rs. 7500/- on deposit slip
No#57546744393. The firm has also submitted revised master
formulation. The revised label claim is as under:
Each 5ml Of Suspension Contains:
Each 5ml of Suspension Contains:

(correction/change of strength and formulation from liquid suspension to dry powder for suspension),
and product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Lizlid Tablet 600mg
Strength
Linezolid……….…600mg
03-2019
Pharmacological Group Oxazolidinone Antibacterial
Type of form Form 5
Approval status of product in Reference ZYVOX 600mg film coated Tablets USFDA Approved.
Me-too-status Novozid 600mg Tablet by M/s Wenovo Pharmaceuticals
(Reg#098240)
Brand Name + Dosage Form and Obprox tablet 550mg
Strength
Naproxen Sodium…………..…550mg
03-2019
Pharmacological Group NSAIDS
Type of form Form 5
Approval status of product in Reference APRANAX 550mg film-coated tablets. ANSM approved
Me-too-status Napromor 550mg Tablets by M/s Moringa Pharmaceuticals
(Reg#100765)
Remark of the Evaluator XI • The firm have corrected the label claim in enclosure of form 5

No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Oston Tablet 8mg
Strength
Ondansetron HCl as Dihydrate………8mg
03-2019
Pharmacological Group Antiemetics and Antinauseants
Type of form Form 5
Approval status of product in Reference Ondansetron 8mg film coated Tablets MHRA approved
Me-too-status Onran Tablet 8mg by M/s Aspin Pharma (Reg#097196)
Ondansetron HCl Dihydrate eq. to Ondansetron………8mg
(correction/change of equivalency factorfor the hydrated form of drug substance), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Oston Tablet 4mg
Strength
Ondansetron HCl as Dihydrate…..…4mg
03-2019
Type of form Form 5
Approval status of product in Reference Ondansetron 4mg film coated Tablets MHRA approved
Me-too-status Onran Tablet 4mg by M/s Aspin Pharma (Reg#097195)

No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Oston Syrup 4mg/5ml
Strength
Composition Each 5ml of Syrup Contains:
Ondansetron HCl as Dihydrate……….4mg
03-2019
Type of form Form 5
Approval status of product in Reference Ondansetron 4mg/5ml Syrup MHRA approved
Me-too-status Dysit 4mg/5ml Syrup by M/s Wimits Pharmaceuticals
(Reg#096447)
Each 5ml of Syrup Contains:
Each 5ml of Syrup Contains:
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Roxitin CR 12.5mg Tablet
Strength
Composition Each Controlled Release Tablet Contains:
Paroxetine as HCl……………12.5mg
03-2019
Type of form Form 5
Regulatory Authorities (USFDA Approved)
Approved with box-warning.

Warning: Suicidal Thoughts and Behaviors
Me-too-status Panox CR Tablet 12.5mg by M/s Regal Pharmaceuticals
(Reg#081953)
Remark of the Evaluator XI • The firm have revised the formulation as per reference
formulation along with submission of Rs. 7500/- on deposit
Each enteric, film coated, Controlled Release Tablet Contains:
• The firm have submitted revised master formulation
Each enteric, film coated, Controlled Release Tablet Contains:
Brand Name + Dosage Form and Obtolin Syrup 2mg/5ml (120ml)
Strength
Salbutamol as Sulphate………..2mg
03-2019
Type of form Form 5
Approval status of product in Reference Salbutamol 2mg/5ml Oral Solution MHRA approved
Me-too-status Ventosal 2mg/5ml Syrup by M/s Wimits Pharmaceuticals
(Reg#099739)
•
Decision: Approved. Registration Board further decided to limit validity of registration for two years
in line with the decision of the Appellate Board.
Brand Name + Dosage Form and Gliptomet tablet 50/1000mg
Strength
Sitagliptin as Phosphate……….50mg
Metformin HCl….……………1000mg
2019
Type of form Form 5
Me-too-status Sildomet M 50/1000mg Tablet by M/s High-Q Pharmaceuticals
(Reg#76400)

as per the master formulation. The firm have mentioned the
hydrated form of sitagliptin and adjust its weight in master
formulation considering the salt and hydrated form without
submission of applicable fee. The revised label claim is as
under:
Sitagliptin Phosphate monohydrate eq. to Sitagliptin ….50mg
(correction/change of equivalency factorfor the hydrated form of drug substance), correction/change
of formulation from un-coated tablet to film coated tablet and product specifications as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Gliptomet tablet 50/500mg
Strength
Sitagliptin as Phospate……….50mg
Metformin HCl……………….500mg
2019
Type of form Form 5
Me-too-status Silomet M 50/500mg Tablet by M/s High-Q Pharmaceuticals
(Reg#76399)
as per the master formulation. The firm have mentioned the
hydrated form of sitagliptin and adjust its weight in master
formulation considering the salt and hydrated form without
submission of applicable fee. The revised label claim is as
under:
(correction/change of equivalency factorfor the hydrated form of drug substance), correction/change

of formulation from un-coated tablet to film coated tablet and product specifications as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Obtaline Syrup 0.3mg/ml (60ml)
Strength
Composition Each ml of Syrup Contains:
Terbutaline Sulphate….…0.3mg
03-2019
Type of form Form 5
Approval status of product in Reference Bricanyl 0.3 mg/ml Syrup MHRA approved
Me-too-status Butali Liquid Syrup by M/s Fynk Pharmaceuticals
(Reg#079712)
•
Case No. 5: Deferred cases:

a. Deferred cases of Human Drugs on form 5F
363. Name, address of Applicant / Marketing Invictus Pharmaceuticals NS2, Rawalpindi, Rawat Industrial
Authorization Holder Estate, Islamabad, Rawalpindi, Islamabad Capital Territory
Name, address of Manufacturing site. Invictus Pharmaceuticals
NS2, Rawalpindi, Rawat Industrial Estate, Islamabad, Rawalpindi,
Islamabad Capital Territory
Status of the applicant ☒Manufacturer
☐ Importer
☐Is involved in none of the above (contract giver)
☐ Export sale
proposed proprietary name / brand name Cef –Vic Dry Suspension 100mg /5ml
Pharmaceutical ingredient (API) per unit Cefixime as Trihydrate….100mg

Pharmaceutical form of applied drug Almost light pink color powder having Strawberry powder for
Reconstitution
Powder for suspension
Pharmacotherapeutic Group of (API) Cephalosporine

specification
status in reference regulatory authorities Cefixime for oral suspension 100mg/5ml by M/s BELCHER
USFDA approved
For generic drugs (me-too status) Cefexol Suspension 100mg/5ml by M/s Nabiqasim Industries (Pvt)
Ltd (Reg#025641)
GMP status of the Finished product New section
manufacturer
Name and address of API manufacturer. Pharmagen Limited
Tel: +92 (042) 5935261-68
Fax: +92 (042) 5935269
E-mail: [email protected]
Web: www.pharmagen.com.pk
manufacturers, Characterization, specifications, analytical
stability studies of drug substance. The firm has summarized
information of drug product including its description, composition,
pharmaceutical development, manufacture, manufacturing process
and process control, process validation protocols, control of
procedures, validation/verification of analytical procedures, batch
related to nomenclature, structure, general properties, solubilities,
accelerated stability data is conducted at 40 º ± 2 º C /75% ± 5%
RH for 6 months. The real time stability data is conducted at 30 ºC
± 2 º C / 65% ± 5% RH for 36 months. (Batch No. 00244/135/2010,
00243/136/2010 & 00244/137/2010)
procedure and its verification studies, batch analysis and

Pharmaceutical equivalence and Firm has performed pharmaceutical equivalence against the
comparative dissolution profile product Cefspan DS 100mg/5ml by M/s Barret Hodgson (Pvt) Ltd
Analytical method validation / The firm have submitted method verification studies for applied
verification of product product
Manufacturer of API Pharmagen Limited
Tel: +92 (042) 5935261-68
Fax: +92 (042) 5935269
API Lot No. 00243/078/2020
Description of Pack Powder Filled in Amber colored 30ml glass bottle USP Type III with 25 mm PP
(Container closure system) Alu caps with conical cups.
Real Time: 0, 3, 6, 9, 12 & 24 (Months)
Batch No. TDS-001 TDS-002 TDS-003
Batch Size 1000 packs 1000 packs 1000 packs
No. of Batches 03
1. Reference of previous approval of applications with stability NA
2. Approval of API/ DML/GMP certificate of API manufacturer GMP certificate of M/s Pharmagen Limited,
issued by concerned regulatory authority of country of origin. valid Up to 8-1-2022.
3. Documents for the procurement of API with approval from Not Applicable
4. Data of stability batches will be supported by attested Firm has submitted record of testing of all
respective documents like chromatograms, Raw data sheets, batches along with chromatograms, raw data
COA, summary data sheets etc. sheets, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR & audit trail N/A

6. Record of Digital data logger for temperature and humidity Firm has submitted record of data logger for
monitoring of stability chambers (real time and accelerated) temperature and humidity monitoring of real
time and accelerated stability chambers.
XI
Evaluation by PEC :
1.3.1.-1.3.2 The address mentioned in submitted The address of applicant in section 1.3.1 & 1.3.2 is
application is different from the address updated as per follows:
mentioned on DML, clarify?

“M/s Invictus Pharmaceuticals, Plot No. 21 & 26,
Street No. NS-2, RCCI, Industrial Estate, Rawat”.
Relevant page of module 1 Form 5F is submitted.
1.5.6 In Form 5F you have mentioned We have mentioned USP specifications in section
innovator’s specifications for the 1.5.6 and have also provided the same USP
product under section 1.5.6. while the specifications for the drug product is all relevant
monograph of applied product is sections of module 2 and module 3.
available in USP, clarify?
3.2.S.4.1. As per the drug substance specifications • The drug substance have been procured from
of the drug substance manufacturer i.e. Pharmagen Limited which have been granted
M/s Pharmagen Limited, the firm approval for manufacturing of cefixime by
submitted that material complies BP, Licensing Division DRAP and the same source have
USP and in-house specifications, been approved by Registration Board in the cases of
justification is required as how the drug local manufacturing of cefixime for various firms on
substance follow all the specifications CTD after review of its complete data.
• There are certain differences in the specifications of
cefixime as defined in USP and BP, the drug
substance manufacturer has identified all the
changes and have tested its product against the BP
as well as USP specifications.
• The drug substance manufacturer has also
performed validation / verification studies of the
analytical method for assay, related substances and
residual solvents for both BP as well as USP
analytical procedures. As per the results of the
verification studies both methods have been verified
and the material complies the individual acceptance
criteria for each test as specified in the monograph.
• As per our vendor qualification system we have
selected Pharmagen Limited based on its regulatory
approval by DRAP, availability of DMF and
stability study data as per zone IV-A. As per our
approved SOPs after document review, we ordered
small quantity of the drug substance for testing
purpose and performed testing as per the USP
specifications and finally selected the vendor when
all tests as per USP specifications were complied.
Our specifications and analytical method for in
house testing of the drug substance is also based on
USP method.
• It is worth mentioning that, Assay limits and type of
tests are different between two monographs of USP
& BP, hence compliance to both monographs has to
be justified.
• Relevant documents of drug substance validation
report and API specifications and analytical method
of drug product manufacturer is submitted
3.2.S.4.1. - Copies of Drug substance specification Drug substance specification and analytical procedure
3.2.S.4.2 and analytical procedures used for of Invictus Pharmaceuticals is provided
routine testing of Drug substance
/Active Pharmaceutical Ingredient by
Drug Product manufacturer is required.
3.2.S.4.3 Analytical Method Verification studies Analytical method verification studies (including
including specificity, accuracy and specificity, accuracy, repeatability) performed by
repeatability (method precision) drug product manufacturer is provided

manufacturer of drug substance(s) shall
be submitted.
3.2.P.1 • The composition of applied product is • The qualitative composition of our product is
not as per innovator’s product, clarify based upon the USFDA approved reference
• Quantity of cefixime per unit dose product i.e. Cefixime suspension by Belcher
shall be justified with equivalency Pharmaceuticals, LLC. Furthermore, all the
factor for cefixime trihydrate. excipients used in our formulation are commonly
used excipients and no incompatibility among any
excipient has been reported in handbook of
pharmaceutical excipients. All excipients are also
recommended for use in similar formulations in the
FDA excipients database as well. We have also
performed pharmaceutical equivalence studies
with the innovator product and also completed
the accelerated stability studies and real time
stability studies till 6 months, and the results within
acceptable limit also support that the formulation
is compatible and stable. However, the composition
of applied product is different from the innovator
product as mentioned below
Applied product Suprax 100mg/5ml DS
Cefixime trihydrate Cefixime trihydrate
(micronized)
CMC Sodium Xanthan gum
Sodium benzoate Sodium benzoate
Sugar Fine Sucralose
Colloidal silicon dioxide Colloidal silicon
dioxide
Strawberry flavor Strawberry flavor
Sucrose
• Quantity of cefixime per unit dose and per batch
have been explained and justified based upon the
salt factor calculation and assay results. The
justification is submitted.
• Firm has used the theoretical factor for adjustment
of water content while dispensing, instead of the
actual results of “water content test” reported in
the drug substance analysis.
3.2.P.2.1.1 Compatibility studies of the Drug Compatibility studies of the drug substance with
Substance(s) with excipients shall be excipients is not required to be performed since the
provided as the qualitative composition qualitative composition of our product is based upon
of the formulation is not similar to the USFDA approved reference product i.e. Cefixime
innovator / reference product. suspension by Belcher Pharmaceuticals, LLC.
Furthermore, all the excipients used in our
formulation are commonly used excipients and no
incompatibility among any excipient has been
reported in handbook of pharmaceutical excipients.
All excipients are also recommended for use in
similar formulations in the FDA excipients database
as well. We have also performed pharmaceutical
equivalence studies with the innovator product and
also completed the accelerated stability studies and
real time stability studies till 6 months, and the results
within acceptable limit also support that the
formulation is compatible and stable. However,
Compatibility studies of the Drug Substance(s) with

excipients shall be provided as the qualitative
composition of the formulation is not similar to
innovator / reference product.
3.2.P.3.3 In Description of manufacturing We have used the same composition of the
process and process controls, you have formulation for the product development and stability
submitted manufacturing outline studies and have provided the same formulation in all
mentioning different composition of sections of our CTD application. However, any
formulation than applied formulation difference in the formulation in section 3.2.P.3.3 may
be considered as a typographical mistake. However
we assure that we have used only one composition
throughout the studies which have already been
provided in section 3.2.P.1.
3.2.P.4.1 The specifications for all the excipients We have provided specifications and procedures for
used in formulation of applied product all excipients in section 3.2.P.4.1 and 3.2.P.4.2 as per
is not provided the CTD guidance document approved by
Registration Board. However, we are again
submitting the same for your consideration. All
excipients used in our formulation are well studied
and all excipients except strawberry flavor are
pharmacopoeial. The specifications and analytical
procedures are submitted.
Specifications for CMC Sodium, is not submitted
3.2.P.5.1 Justification for finished product • The drug substance have been procured from
specifications of USP is required as the Pharmagen Limited which have been granted
drug substance manufacturer have approval for manufacturing of cefixime by
claimed BP specifications as per section Licensing Division DRAP and the same source have
3.2.S.4.4 Batch Analyses? been approved by Registration Board in the cases of
local manufacturing of cefixime for various firms on
CTD after review of its complete data.
• There are certain differences in the specifications
of cefixime as defined in USP and BP, the drug
substance manufacturer has identified all the
changes and have tested its product against the BP
as well as USP specifications.
• The drug substance manufacturer has also
performed validation / verification studies of the
analytical method for assay, related substances and
residual solvents for both BP as well as USP
analytical procedures. As per the results of the
verification studies both methods have been
verified and the material complies the individual
acceptance criteria for each test as specified in the
monograph.
• As per our vendor qualification system we have
selected Pharmagen Limited based on its
regulatory approval by DRAP, availability of DMF
and stability study data as per zone IV-A. As per
our approved SOPs after document review, we
ordered small quantity of the drug substance for
testing purpose and performed testing as per the
USP specifications and finally selected the vendor
when all tests as per USP specifications were
complied. Our specifications and analytical
method for in house testing of the drug substance
is also based on USP method.

We have developed the drug product as per USP
specifications after thorough analysis of the drug
substance as per USP specifications.
3.2.P.5.2 Provide signed copy of analytical We are submitting the analytical procedure of the drug
methods used for applied product product as per the CTD guidance document approved
by Registration Board.
3.2.P.5.3 Submitted method verification report Protocols and report for method verification studies
does not describe the sample are again submitted for your review and consideration.
preparation/standard preparation for We would also like to inform that the sample and
various performance parameters. standard preparation method are defined in the
analytical procedure of drug product in section
3.2.P.5.2. The verification protocols and report are
submitted.
The sample preparation procedure for different
concentrations in the parameter of accuracy shall be
submitted.
3.2.P.8 • Submit Raw data sheets and COA • The details of sample preparation and standard
containing detail of sample preparation is the same throughout the stability
preparation, standard preparation for studies as mentioned in section 3.2.P.5.2. We have
various performance parameters. used the USP method for sample and standard
• Preservative content and efficacy test preparation throughout the stability studies.
not performed during stability study, However Raw data sheets are submitted.
clarify? • Preservative content and effectiveness is not the part
• In use stability study of reconstitution of stability specifications nor recommended in USP
suspension shall be submitted monograph or ICH Q1 guidelines, therefore this test
• The applied pack size is 30ml while was not performed.
the pack size mentioned in two Furthermore, the acceptable results of all the tests
batches of stability study is 60ml and like physical appearance, taste, flavor, moisture, pH
one batch is 30ml, clarify and assay depicts the effectiveness of preservative
content in the formulation.
• However, tests for antimicrobial preservative
content and efficacy of preservative as
recommended by ICH Q1 (R2) guidelines and USP
chapter <51> should be performed for finished
product
• We are submitting the in-use stability study
results. The submitted pack size in the in-use
stability study is also 60ml
• There is a typographic mistake, the applied
product is 30mL suspension.
• Raw data sheets, including actual details of
sample solution preparation & standard
preparation, weight of standard, potency of
standard & calculation formula applied, shall be
submitted.
Decision of 313th meeting of Registration Board:
Deferred for following:
• Justification for use of CMC sodium as an excipient, since innovator’s formulation does not include it.
• The specifications for CMC sodium used in formulation of applied product is not provided
• The sample preparation procedure for different concentrations in the parameter of accuracy shall be submitted.
• Clarification since the submitted COA of relevant batch of drug substance used for development studies is according
to B.P while the specifications submitted for drug substance are USP.
• Tests for antimicrobial preservative content and efficacy of preservative as recommended by ICH Q1 (R2) guidelines
and USP chapter <51> should be performed for finished product

• Raw data sheets, including actual details of sample solution preparation & standard preparation, weight of standard,
potency of standard & calculation formula applied, shall be submitted.
Response by the firm:
Reason for deferment Response by the firm
• Justification for use of CMC sodium as an • The firm have submitted that they have performed accelerated
excipient, since innovator’s formulation stability studies of their product for 6 months and
does not include it. pharmaceutical equivalence with brand leader and results are
• The specifications for CMC sodium used satisfactory and well within the limits. The firm also referred
in formulation of applied product is not to literature of cexime dry suspension of GSK and submitted
provided that they have used same CMC sodium instead Xanthan gum
as suspending agent.
• The sample preparation procedure for • Firm have submitted sample preparation procedure for
different concentrations in the parameter different concentrations in the parameter of accuracy
of accuracy shall be submitted.
• Clarification since the submitted COA of • Firm have submitted COA of same batch from drug substance
relevant batch of drug substance used for manufacturer which is according to USP.
development studies is according to B.P
while the specifications submitted for drug
substance are USP.
• Tests for antimicrobial preservative • Firm have submitted test results for antimicrobial preservative
content and efficacy of preservative as content and efficacy of preservative performed for finished
recommended by ICH Q1 (R2) guidelines product
and USP chapter <51> should be
performed for finished product
• Raw data sheets, including actual details • Firm have submitted Raw data sheets, including actual details
of sample solution preparation & standard of sample solution preparation & standard preparation, weight
preparation, weight of standard, potency of of standard & calculation formula applied.
standard & calculation formula applied,
shall be submitted.
• Firm shall submit fee of Rs. 7,500 for correction/pre-approval change in product specifications, as per
364. Name, address of Applicant / Marketing Invictus Pharmaceuticals, NS2, Rawalpindi, Rawat Industrial
Authorization Holder Estate, Islamabad, Rawalpindi, Islamabad Capital Territory
Name, address of Manufacturing site. Invictus Pharmaceuticals, NS2, Rawalpindi, Rawat Industrial
Estate, Islamabad, Rawalpindi, Islamabad Capital Territory
Status of the applicant ☒Manufacturer
☐ Importer
☐Is involved in none of the above (contract giver)
☐ Export sale
proposed proprietary name / brand name Cef –Vic Dry Suspension 200mg /5ml

Pharmaceutical ingredient (API) per unit Cefixime as Trihydrate….200mg
Pharmaceutical form of applied drug Almost light pink color powder having Strawberry powder for
Reconstitution
Powder for suspension
Pharmacotherapeutic Group of (API) Cephalosporine
specifications
The status in reference regulatory Cefixime for oral suspension 200mg/5ml by M/s BELCHER
authorities USFDA approved
For generic drugs (me-too status) Megnett DS Oral Suspension 200mg/5ml by M/s SJ & G Fazul
Ellahie (Pvt) Ltd (Reg#024000)
GMP status of the Finished product New section
manufacturer
Name and address of API manufacturer. Pharmagen Limited
Tel: +92 (042) 5935261-68
Fax: +92 (042) 5935269
manufacturers, Characterization, specifications, analytical
stability studies of drug substance. The firm has summarized
information of drug product including its description, composition,
pharmaceutical development, manufacture, manufacturing process
and process control, process validation protocols, control of
procedures, validation/verification of analytical procedures, batch
accelerated stability data is conducted at 40 º ± 2 º C /75% ± 5%
RH for 6 months. The real time stability data is conducted at 30 ºC
± 2 º C / 65% ± 5% RH for 36 months. (Batch No. 00244/135/2010,
00243/136/2010 & 00244/137/2010)

procedure and its verification studies, batch analysis and
Pharmaceutical equivalence and Firm has performed pharmaceutical equivalence against the
comparative dissolution profile product Cefspan DS 200mg/5ml by M/s Barret Hodgson Pakistan
(Pvt) Ltd
Analytical method validation / The firm have submitted method verification studies for applied
verification of product product
Manufacturer of API Pharmagen Limited
Tel: +92 (042) 5935261-68
Fax: +92 (042) 5935269
API Lot No. 00243/078/2020
Description of Pack Powder Filled in Amber colored 30ml glass bottle USP Type III with 25 mm PP
(Container closure system) Alu caps with conical cups.
Real Time: 0, 3, 6, 9, 12 & 24 (Months)
Batch No. TDS-001 TDS-002 TDS-003
Batch Size 1000 packs 1000 packs 1000 packs
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API GMP certificate of M/s Pharmagen Limited, valid
manufacturer issued by concerned regulatory authority of Up to 8-1-2022.
country of origin.
3. Documents for the procurement of API with approval Not Applicable
respective documents like chromatograms, Raw data along with chromatograms, raw data sheets, COA
sheets, COA, summary data sheets etc. and summary data sheets.
5. Compliance Record of HPLC software 21CFR & audit N/A
humidity monitoring of stability chambers (real time and temperature and humidity monitoring of real time
accelerated) and accelerated stability chambers.

1.3.1.- The address mentioned in submitted The address of applicant in section 1.3.1 & 1.3.2 is updated
1.3.2 application is different from the as per follows:
address mentioned on DML, clarify? “M/s Invictus Pharmaceuticals, Plot No. 21 & 26, Street No.
NS-2, RCCI, Industrial Estate, Rawat”.
Relevant page of module 1 Form 5F is submitted.
1.5.6 In Form 5F you have mentioned We have mentioned USP specifications in section 1.5.6 and
innovator’s specifications for the have also provided the same USP specifications for the drug
product under section 1.5.6. while product is all relevant sections of module 2 and module 3.
the monograph of applied product is
available in USP, clarify?
3.2.S.4. As per the drug substance • The drug substance have been procured from Pharmagen
1. specifications of the drug substance Limited which have been granted approval for manufacturing
manufacturer i.e. M/s Pharmagen of cefixime by Licensing Division DRAP and the same source
Limited, the firm submitted that have been approved by Registration Board in the cases of
material complies BP, USP and in- local manufacturing of cefixime for various firms on CTD
house specifications, justification is after review of its complete data.
required as how the drug substance • There are certain differences in the specifications of
follow all the specifications cefixime as defined in USP and BP, the drug substance
manufacturer has identified all the changes and have tested its
product against the BP as well as USP specifications.
• The drug substance manufacturer has also performed
validation / verification studies of the analytical method for
assay, related substances and residual solvents for both BP as
well as USP analytical procedures. As per the results of the
verification studies both methods have been verified and the
material complies the individual acceptance criteria for each
test as specified in the monograph.
• As per our vendor qualification system we have selected
Pharmagen Limited based on its regulatory approval by
DRAP, availability of DMF and stability study data as per
zone IV-A. As per our approved SOPs after document review,
we ordered small quantity of the drug substance for testing
purpose and performed testing as per the USP specifications
and finally selected the vendor when all tests as per USP
specifications were complied. Our specifications and
analytical method for in house testing of the drug substance
• It is worth mentioning that, Assay limits and type of tests
are different between two monographs of USP & BP, hence
compliance to both monographs has to be justified.
• Relevant documents of drug substance validation report and
API specifications and analytical method of drug product
manufacturer is submitted.
3.2.S.4. Copies of the Drug substance Drug substance specification and analytical procedure of
1. - specifications and analytical Invictus Pharmaceuticals is submitted.
3.2.S.4. procedures used for routine testing of
2 the Drug substance /Active
Pharmaceutical Ingredient by Drug
3.2.S.4. Analytical Method Verification Analytical method verification studies (including specificity,
3 studies including specificity, accuracy, repeatability) performed by drug product
accuracy and repeatability (method manufacturer is submitted.
precision) performed by the Drug
Product manufacturer drug

3.2.P.1 • The composition of applied • The qualitative composition of our product is based
product is not as per innovator’s upon the USFDA approved reference product i.e.
product, clarify Cefixime suspension by Belcher Pharmaceuticals, LLC.
• Quantity of cefixime per unit dose Furthermore, all the excipients used in our formulation
shall be justified with equivalency are commonly used excipients and no incompatibility
factor for cefixime trihydrate. among any excipient has been reported in handbook of
pharmaceutical excipients. All excipients are also
recommended for use in similar formulations in the FDA
excipients database as well. We have also performed
pharmaceutical equivalence studies with the innovator
product and also completed the accelerated stability studies
and real time stability studies till 6 months, and the results
within acceptable limit also support that the formulation
is compatible and stable. However, the composition of applied
product is different from the innovator product as mentioned
below
Applied product Suprax 100mg/5ml DS
Cefixime trihydrate Cefixime trihydrate
(micronized)
CMC Sodium Xanthan gum
Sodium benzoate Sodium benzoate
Sugar Fine Sucralose
Colloidal silicon Colloidal silicon
dioxide dioxide
Strawberry flavor Strawberry flavor
Sucrose
• Quantity of cefixime per unit dose and per batch have been
explained and justified based upon the salt factor calculation
and assay results. The justification is submitted.
• Firm has used the theoretical factor for adjustment of water
content while dispensing, instead of the actual results of
“water content test” reported in the drug substance analysis.
3.2.P.2. Compatibility studies of the Drug Compatibility studies of the drug substance with excipients is
1.1 Substance(s) with excipients shall be not required to be performed since the qualitative
provided as the qualitative composition of our product is based upon the USFDA
composition of the formulation is not approved reference product i.e. Cefixime suspension by
similar to innovator / reference Belcher Pharmaceuticals, LLC. Furthermore, all the
product. excipients used in our formulation are commonly used
excipients and no incompatibility among any excipient has
been reported in handbook of pharmaceutical excipients. All
excipients are also recommended for use in similar
formulations in the FDA excipients database as well. We have
also performed pharmaceutical equivalence studies with the
innovator product and also completed the accelerated stability
studies and real time stability studies till 6 months, and the
results within acceptable limit also support that the
formulation is compatible and stable.
However, Compatibility studies of the Drug Substance(s) with
excipients shall be provided as the qualitative composition of
the formulation is not similar to innovator / reference
product.
3.2.P.2. The results of pH (5.08) mentioned There was a typographical mistake in the results of pH during
6 in compatibility study is out of the compatibility studies. We have rechecked the results and
specifications, clarify? (Limit 2.5- found the typographical mistake. We are submitting the actual
4.5) results of compatibility studies
The submitted results were within the limits (pH-2.82)

3.2.P.3. In Description of manufacturing We have used the same composition of the formulation for
3 process and process controls, you the product development and stability studies and have
have submitted manufacturing provided the same formulation in all sections of our CTD
outline mentioning different application. However, any difference in the formulation in
composition of formulation than section 3.2.P.3.3 may be considered as a typographical
applied formulation mistake. However we assure that we have used only one
composition throughout the studies which have already been
provided in section 3.2.P.1.
3.2.P.4. The specifications for all the We have provided specifications and procedures for all
1 excipients used in formulation of excipients in section 3.2.P.4.1 and 3.2.P.4.2 as per the CTD
applied product is not provided guidance document approved by Registration Board.
However, we are again submitting the same for your
consideration. All excipients used in our formulation are well
studied and all excipients except strawberry flavor are
pharmacopoeial. The specifications and analytical procedures
are submitted.
Specifications for CMC Sodium, is not submitted
3.2.P.5. Justification for finished product • The drug substance have been procured from Pharmagen
1 specifications of USP is required as Limited which have been granted approval for manufacturing
the drug substance manufacturer of cefixime by Licensing Division DRAP and the same source
have claimed BP specifications as have been approved by Registration Board in the cases of
per section 3.2.S.4.4 Batch local manufacturing of cefixime for various firms on CTD
Analyses? after review of its complete data.
• There are certain differences in the specifications of
cefixime as defined in USP and BP, the drug substance
manufacturer has identified all the changes and have tested its
product against the BP as well as USP specifications.
• The drug substance manufacturer has also performed
validation / verification studies of the analytical method for
assay, related substances and residual solvents for both BP as
well as USP analytical procedures. As per the results of the
verification studies both methods have been verified and the
material complies the individual acceptance criteria for each
test as specified in the monograph.
• As per our vendor qualification system we have selected
Pharmagen Limited based on its regulatory approval by
DRAP, availability of DMF and stability study data as per
zone IV-A. As per our approved SOPs after document review,
we ordered small quantity of the drug substance for testing
purpose and performed testing as per the USP specifications
and finally selected the vendor when all tests as per USP
specifications were complied. Our specifications and
analytical method for in house testing of the drug substance
We have developed the drug product as per USP

specifications after thorough analysis of the drug substance as
per USP specifications.
3.2.P.5. Provide signed copy of analytical We are submitting the analytical procedure of the drug
2 methods used for applied product product as per the CTD guidance document approved by
Registration Board.
3.2.P.5. Submitted method verification report Protocols and report for method verification studies are again
3 does not describe the sample submitted for your review and consideration. We would also
preparation/standard preparation for like to inform that the sample and standard preparation
various performance parameters. method are defined in the analytical procedure of drug

product in section 3.2.P.5.2. The verification protocols and
report is submitted.
The sample preparation procedure for different
concentrations in the parameter of accuracy shall be
submitted.
3.2.P.5. In section 3.2.P.1, under description No reply submitted
4 you have mentioned “almost light
pink colour powder having
strawberry powder for
reconstitution” while in batch
analysis and stability study you have
mentioned “off white to light yellow
colour powder having strawberry
powder for reconstitution”, clarify?
3.2.P.8 • Submit Raw data sheets and COA • The details of sample preparation and standard preparation
containing detail of sample is the same throughout the stability studies as mentioned in
preparation, standard preparation for section 3.2.P.5.2. We have used the USP method for sample
various performance parameters. and standard preparation throughout the stability studies.
• Preservative content and efficacy However Raw data sheets are submitted.
test not performed during stability • Preservative content and effectiveness is not the part of
study, clarify? stability specifications nor recommended in USP monograph
• In use stability study of or ICH Q1 guidelines, therefore this test was not performed.
reconstitution suspension shall be Furthermore, the acceptable results of all the tests like
submitted physical appearance, taste, flavor, moisture, pH and assay
• The applied pack size is 30ml while depicts the effectiveness of preservative content in the
the pack size mentioned in stability formulation.
study summary & in two batches of • However, tests for antimicrobial preservative content and
stability study is 60ml and one batch efficacy of preservative as recommended by ICH Q1 (R2)
is 30ml, clarify guidelines and USP chapter <51> should be performed for
• The date of initiation mentioned in finished product
stability study is 12.05.2020 while • No reply submitted for in use stability study
the date of manufacturing mentioned • No reply submitted for different pack size
in BMR is 13.05.2021. Clarify how • No reply submitted for date of initiation of stability study
stability study started before the and date of manufacturing
manufacturing of batch. • Raw data sheets, including actual details of sample solution
preparation & standard preparation, weight of standard,
potency of standard & calculation formula applied, shall be
submitted.
th
Decision of 313 meeting of Registration Board:
Deferred for following:
• Justification for use of CMC sodium as an excipient, since innovator’s formulation does not include it.
• The specifications for CMC sodium used in formulation of applied product is not provided
• The sample preparation procedure for different concentrations in the parameter of accuracy shall be submitted.
• Clarification since the submitted COA of relevant batch of drug substance used for development studies is according
to B.P while the specifications submitted for drug substance are USP.
• Tests for antimicrobial preservative content and efficacy of preservative as recommended by ICH Q1 (R2) guidelines
and USP chapter <51> should be performed for finished product
• In use stability study of reconstitution suspension is not submitted
• Raw data sheets, including actual details of sample solution preparation & standard preparation, weight of standard,
potency of standard & calculation formula applied, shall be submitted.
Response by the firm:
Reason for deferment Response by the firm
• Justification for use of CMC sodium as an • The firm have submitted that they have performed accelerated
excipient, since innovator’s formulation stability studies of their product for 6 months and
does not include it. pharmaceutical equivalence with brand leader and results are

• The specifications for CMC sodium used satisfactory and well within the limits. The firm also referred
in formulation of applied product is not to literature of cexime dry suspension of GSK and submitted
provided that they have used same CMC sodium instead Xanthan gum
as suspending agent.
• The sample preparation procedure for • Firm have submitted sample preparation procedure for
different concentrations in the parameter different concentrations in the parameter of accuracy
of accuracy shall be submitted.
• Clarification since the submitted COA of • Firm have submitted COA of same batch from drug substance
relevant batch of drug substance used for manufacturer which is according to USP.
development studies is according to B.P
while the specifications submitted for drug
substance are USP.
• Tests for antimicrobial preservative • Firm have submitted test results for antimicrobial preservative
content and efficacy of preservative as content and efficacy of preservative performed for finished
recommended by ICH Q1 (R2) guidelines product
and USP chapter <51> should be
performed for finished product
• In use stability study of reconstitution • Firm have submitted in use stability study of reconstitution
suspension is not submitted suspension
• Raw data sheets, including actual details • Firm have submitted Raw data sheets, including actual details
of sample solution preparation & standard of sample solution preparation & standard preparation, weight
preparation, weight of standard, potency of of standard & calculation formula applied.
standard & calculation formula applied,
shall be submitted.
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in product specifications, as
b. Deferred cases of Human Drugs on form 5

365. Name and address of manufacture / M/s Medera Pharmaceuticals Pvt Ltd. Plot #2, Street #4, National
Applicant Industrial Zone, Rawat, Islamabad
Brand Name + Dosage Form and Climed H Cream
Strength
Composition Each Gram of Cream Contains:
Clotrimazole………….…1% w/w
Hydrocortisone …………1% w/w
Dairy No. date of R &I fee Form-5 Dy.No 11046 dated 05-03-2019 Rs.20,000/- dated 04-03-
2019
Pharmacological Group Azole Antifungal, Corticosteroid
Type of form Form 5
Pack size and Demand Price 10gm; As per SRO
Approval status of product in Canesten HC Cream clotrimazole / hydrocortisone (MHRA
Reference Regulatory Authorities Approved)
Me-too-status Unicort-H Cream by M/s Iqra Pharmaceuticals (Reg#097762)
GMP Status The firm was inspected on 06-11-2018 and conclusion of inspection
was:
Keeping in view the above facts, overall GMP Compliance is found
Good as today.

Previous Remark of Evaluator XI • The firm have mentioned the salt form of hydrocortisone in label
claim without submission of applicable fee. However, the firm
have applied the label claim without considering the salt factor.
Each Gram of Cream Contains:
Clotrimazole……………………1% w/w
Hydrocortisone acetate…………1% w/w
• The firm have submitted letter No. F. 1-16/2005-Lic dated 15th

June, 2011 issued by Secretary Central Licensing Board confirming
the presence of Cream/Ointment (Steroidal) section
Previous Decision (307-DRB) • Deferred for correction of label claim considering the salt factor in
case of hydrocortisone as per reference product along with
Evaluation by PEC • The firm submitted revised form 5. However, the firm did not
correct the label claim as per reference product.
Previous Decision (312-DRB) • Deferred for correction of label claim considering the salt factor in
case of hydrocortisone as per reference product along with
Evaluation by PEC • The firm have revised the label claim and mentioned the salt form
of hydrocortisone considering the salt factor as per reference
formulation without submission of applicable fee. The revised label
claim is as under:
Hydrocortisone as acetate…………1% w/w
Hydrocortisone as acetate…………1% w/w
(correction/change of salt form of the drug substance), as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
• Registration letter will be issued after submission of GMP audit report from QA&LT
Division, valid within last three years.
366. Name and address of manufacture / M/s Welmed Pharmaceuticals Industries (Pvt) Ltd.
Applicant Plot # 108, R:2, Industrial Estate Gadoon, Swabi
Brand Name + Dosage Form and Mebwel SR 200mg Capsule
Strength
Mebeverine HCl (SR pellets 50% w/w)………..…200mg
(Source of pellets: Vision Pharma)
2019
Pharmacological Group Anticholinergic
Type of form Form 5
Approval status of product in Colofac MR Modified release capsule (MHRA Approved)
Me-too-status Mebro-MR 200mg Capsule by M/s Regal Pharmaceuticals (Reg#
083115)
GMP Status The firm M/s Welmed Pharmaceutical Industries was inspected on
17-09-2020 and conclusion of inspection was:
Based on the area inspected, the people met and documentation
reviewed and considering the findings of inspection, M/s Welmed

Pharmaceutical Industries (Pvt.) Ltd. Gadoon-Swabi is considered to
be operating at fair level of compliance with GMP guidelines as per
Drug Act, 1976 and rules framed thereunder.
Previous Remark of the Evaluator XI • The firm submitted GMP certificate of Vision Pharma valid upto
10th February 2022, COA and did not stability studies data of pellets
of three batches as per zone IV-A.
Previous Decision (307-DRB) • Deferred for submission of stability study data of pellets as per the
guidelines approved in 293rd meeting of Registration Board.
Evaluation by PEC • The firm have submitted stability study data of three batches as per
zone IV-A from Vision Pharmaceuticals

367. Name and address of manufacture / M/s Fynk Pharmaceuticals.
Applicant 19km G.T. Road Kalashah Kaku, Lahore, Pakistan
Brand Name + Dosage Form and Fyprox CR Tablet 12.5mg
Strength
Composition Each enteric film coated tablet contains:
Paroxetine as HCl…………………….…12.5mg
Dairy No. date of R &I fee Form-5 Dy.No 7538 dated 21-02-2019 Rs.20,000/- Dated 21-02-
2019
Type of form Form 5
Approval status of product in Paxil CR extended-release Tablet (12.5mg, 25mg, 37.5mg)
Reference Regulatory Authorities (USFDA Approved)
Approved with boxwarning.
Warning: Suicidal Thoughts and Behaviors
Me-too-status Panox CR Tablet 12.5mg by M/s Regal Pharmaceuticals
(Reg#081953)
GMP Status The firm was inspected on 14.06.2019 & 16.07.2019 and
Keeping in view the above improvements made by the firm, the
members of the panel are of the opinion to recommend the grant of
Renewal of drug Manufacturing License 000494 formulation of
M/s Fynk Pharmaceuticals (pvt.) Ltd, 19km G.T. Road Kalashah
Kaku, Tehsil Ferozwala, District Sheikhupura for the following
section by way of formulation only:-
1- Liquid Syrup/suspension section
2- Liquid injectable section general
3- Narcotic/Psychotropic Liquid injectable section
4- Cephalosporine Dry Powder injectable section
5- Cephalosporine Dry Powder suspesion section
6- Cephalosporine capsule section
7- General Cream/ointment section
8- Steroidal Cream/ointment section
9- General Tablet section
10- General Capsule section
11- General Dry Powder oral suspension
12- General Sachet section
13- General Dry Powder injectable section
Previous Remark of Evaluator XI • The firm revised the label claim as per reference formulation
along with submission of Rs. 20000/- on deposit slip
No#2045169 dated 31.12.2020. The revised label claim is as
under:
Each enteric, film coated controlled release tablet contains:
Paroxetine as HCl………..…12.5mg
• The firm did not submit manufacturing outline as per
Previous Decision (297-DRB) • Deferred for submission of manufacturing outline as per
Evaluation by PEC • The firm did not mention seal coating and enteric coating
separately in manufacturing outlines.
Previous Decision (307-DRB) • Deferred for submission of manufacturing outline as per the
reference product.
Evaluation by PEC • The firm have submitted manufacturing outline as per the
reference product.
Decision: Approved.

368. Name and address of manufacture / M/s Efroze Chemical Industries Pvt Ltd.
Applicant 146/23, Korangi Industrial Area, Karachi
Brand Name + Dosage Form and Dufanor 10mg Tablet
Strength
Dydrogesterone………….…10mg
Dairy No. date of R &I fee Form-5 Dy.No 11400 dated 05-03-2019 Rs.20,000/- 05-03-2019
Pharmacological Group Progestogens
Type of form Form 5
Approval status of product in Duphaston 10mg film-coated tablets by M/s Mylan IRE
Reference Regulatory Authorities Healthcare Limited (Ireland Approved)
Me-too-status Dydrstone 10mg Tablet by M/s Pharmasol (Pvt) Ltd (Reg#096477)
GMP Status GMP certificate issued to Efroze Chemical Industries (Pvt.) Ltd on
dated 03-05-2020 based on inspection conducted on 17-03-2021
Previous Remark of Evaluator XI
• Dydrogesterone is available as Cis and Trans isomer. The firm
did not clarify about the type of isomer that will be used in
formulation. (Trans Isomeric Form active)
• The firm did not provide evidence of required manufacturing
facility / section approval letter for the applied formulation
Previous Decision (307-DRB) Deferred for following:
• Clarification about the type of isomer of Dydrogesterone that will
be used in formulation
• Evidence of required manufacturing facility / section from
Licensing Division
Evaluation by PEC • The firm submitted that they will be using Trans-Isomer of
dydrogesterone in their formulation and provided COA of API
and GMP certificate of supplier M/s Yangzhou Aurisco
Pharmaceutical Co., Ltd China.
• The firm submitted letter No. F. 2-11/2000-Lic (Vol-V) dated
22nd November 2021 issued by Secretary Central Licensing Board
showing the presence of Tablet section (Hormone)
Decision: Deferred for review oof submitted COA of Dydrogesterone for compliance against the
Pharmacopoeial monograph
Brand Name + Dosage Form and Nitrocard 6.4mg tablet
Strength
Glyceryl Trinitrate……...6.4mg
(as Diluted Nitroglycerin)
2019
Pharmacological Group Vasodilators used in Cardiac Diseases
Type of form Form 5
Approval status of product in Sustac 6.4mg prolonged release tablet (as Diluted Nitroglycerin)
Reference Regulatory Authorities MHRA Approved
Me-too-status Niglys SR 6.4mg Tablets by M/s Unimark Pharmaceuticals
(Reg#087718)

Previous Remark of Evaluator XI • The firm did not revise the label claim as per reference product
and stated that their label claim is same as per reference product.
However, the firm stated that we have mentioned the dosage form
as “sustained release tablets” in our application in form 5.
• The firm give following justification for addition of 10% overage
in formulation
➢ Nitroglycerine is hygroscopic in nature with melting point
of 14ºC
➢ Nitroglycerine loses its potency due to its low volatility at
room temperature
➢ Sensitivity of glycerin due to its low hygroscopic nature
causes loss of potency during its shelf life
➢ The tendency of nitroglycerin to evaporate from tablets is
due to its high vapour pressure resulting in decreasing the
assay content
➢ The potency loss is compensated by adding overage to
maintain the efficacy of nitroglycerin
Previous Decision (307-DRB) • Deferred for revision of the label claim as per reference
formulation along with submission of applicable fee
Evaluation by PEC • The firm have revised the label claim as per reference formulation
Each Modified Release Tablet Contains:
(as Diluted Nitroglycerin USP 2%)
(correction/change of formulation from un-coated tablet to modified release tablet), and product
Brand Name + Dosage Form and Nitrocard 2.6mg tablet
Strength
Glyceryl Trinitrate…………2.6mg
(as Diluted Nitroglycerin)
Pharmacological Group Vasodilators used in Cardiac Diseases
Type of form Form 5
Approval status of product in Sustac 2.6mg prolonged release tablet (as Diluted Nitroglycerin)
Reference Regulatory Authorities MHRA Approved
Me-too-status Niglys SR 2.6mg Tablet by M/s Unimark Pharmaceuticals
(Reg#090197)
Previous Remark of Evaluator XI • The firm did not revise the label claim as per reference product
and stated that their label claim is same as per reference product.
However, the firm stated that we have mentioned the dosage form
as “sustained release tablets” in our application in form 5.
• The firm give following justification for addition of 10% overage
in formulation

➢ Nitroglycerine is hygroscopic in nature with
melting point of 14ºC
➢ Nitroglycerine loses its potency due to its low
volatility at room temperature
➢ Sensitivity of glycerin due to its low hygroscopic
nature causes loss of potency during its shelf life
➢ The tendency of nitroglycerin to evaporate from
tablets is due to its high vapour pressure resulting
in decreasing the assay content
➢ The potency loss is compensated by adding
overage to maintain the efficacy of nitroglycerin
Previous Decision (307-DRB) • Deferred for revision of the label claim as per reference
Evaluation by PEC • The firm have revised the label claim as per reference formulation
(correction/change of formulation from un-coated tablet to modified release tablet), and product
Brand Name+Dosage Form+Strength Recuro UD Eye Drops (solution)
Carboxymethylcellulose Sodium…..…5mg
Glycerin………………………………10mg
Polysorbate 80………………………...5mg
Pharmacological Group Lubricating and moisturizing comfort solution
Type of form Form 5
Pack size and Demand Price 0.4ml (30’s ampoules), 0.4ml (60’s ampoules); As per SRO
Approval status of product in
Me-too-status
GMP Status Firm was inspected on 03-04-2019 and conclusion of inspection
was:
Overall cGMP is found at acceptable level and the management is
committed for continual improvement and has assured further
cGMP compliance.
Previous Remark of Evaluator XI • The firm provided evidence of RRA. Refresh Optive Advanced
Lubricant Eye Drops OTC product by M/s Allergan Inc, (Daily
Med)
• The firm provided evidence of me-too. Recuro Drops 0.5% by
M/s Hudson Pharma (Reg#091123). However, the provided me-
too is not as per applied product (contain only carboxymethyl
cellulose 5mg).
Previous Decision (307-DRB) • Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration number,

Evaluation by PEC • The firm again provided evidence of same me-too. Recuro Drops
0.5% by M/s Hudson Pharma (Reg#091123). However, the
provided me-too is not as per applied product (contain only
carboxymethyl cellulose 5mg).
• The firm itself revised the formulation and revised the label claim
along with submission of Rs 30000/- on deposit
SlipNo.991599286662. The revised label claim is as under:
Each ml Contains:
Carboxymethylcellulose Sodium…..…5mg
Evidence of RRA: Celluvisc 0.5 %w/v eye drops solution (Ireland
approved)
Pack size: 30’s (0.4ml LDPE container), 60’s (0.4ml LDPE
container)
• The same molecule is already registered with the firm
• The firm submitted revised master formulation of already applied
product containing all three APIs.
Previous Decision (313-DRB) • Deferred for evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm OR
submission of stability study data as per the guidelines approved
in 293rd meeting of Registration Board.
Evaluation by PEC • The firm submitted that they have already registered RECURO
(Carboxymethylcellulose) Eye Drops 5mg in multi-dose
container of 15ml with the registration No. 091123.
• The firm further stated that they want the same composition in
unit dose container of 0.4mlx30’s, but mistakenly we had added
two of its excipients (glycerin & polysorbate) in composition of
registration application. For the same we have submitted the fee
of standardization of formulation as per international reference
and locally available product and requested to accept the
clarification.
Decision: Ddeferreed for clarification regarding maanufacturiong of applied product in the proposed
manufacturing facility “Plastic ampoules (BFS) section.
372. Name and address of manufacturer / M/s Ray Pharma Pvt. Ltd., S-58, S.I.T.E Karachi, Pakistan
Applicant
Brand Name + Dosage Form+Strength Rayvir 400mg Tablet
Acyclovir…….…400mg
Type of form Form 5
Approval status of product in Aciclovir 400mg tablets MHRA Approved
Me-too-status Zavisol Tablet 400mg by M/s Pharmasol (Pvt) Ltd (Reg#098428)
GMP Status The firm was inspected on 22/12/2020 and observation of
inspection was as under:
i. Some doors in tablet manufacturing area need proper
maintenance.
ii. Additional training is required for personal especially for
labour/operator level.
iii. The HVAC system needs continuous monitoring by
engineering and QA department jointly for effective
monitoring.

Previous Remark of Evaluator XI • Fee for the applied product is submitted on 05-03-2019 while
endorsed by assistant Director Revenue (B&A) on 06-03-2019.
• The firm submitted revised master formulation and
manufacturing outline and remove coating composition from
master formulation and coating procedure from manufacturing
outline respectively along with submission of Rs. 7500 on deposit
slip No. 6581172531.
Previous Decision (312-DRB) • Registration Board referred the case to QA & LT division for
updated GMP status of the firm.
Evaluation by PEC • The firm submitted GMP inspection report dated 03.12.2021 and
Based on the areas inspected, the people met and documents
reviewed & considering the findings of the inspection, M/s Ray
Pharma (Pvt) Ltd was considered operating at Good Level of
Compliance with cGMP guidelines as per Drug Act 1976 & rules
framed there under.
Decision: Approved.
373. Name and address of manufacturer / M/s Ray Pharma Pvt Ltd. S-58, S.I.T.E Karachi, Pakistan
Applicant
Brand Name + Dosage Form+Strength Dexofin 400mg Tablet
Dexibuprofen…………….400mg
Pharmacological Group NSAIDs
Type of form Form 5
Finished product specifications Innovator’s specifications
Approval status of product in Dexibuprofen 400 mg Film-coated Tablets MHRA approved
Me-too-status Diprofen Tablet 400mg tablets by M/s Neutro Pharma (R#084432)
maintenance.
monitoring.
•
Previous Decision (312-DRB) • Registration Board referred the case to QA & LT division for
updated GMP status of the firm.
Evaluation by PEC • The firm submitted GMP inspection report dated 03.12.2021 and
Based on the areas inspected, the people met and documents
reviewed & considering the findings of the inspection, M/s Ray
Pharma (Pvt) Ltd was considered operating at Good Level of
Compliance with cGMP guidelines as per Drug Act 1976 & rules
framed there under.
374. Name and address of manufacture / M/s Alina Combine Pharmaceuticals Pvt Ltd
Applicant A-127, S.I.T.E Super Highway, Karachi
Brand Name + Dosage Form and Rosulip 10mg Tablet
Strength

Rosuvastatin (as calcium)…………10mg
Type of form Form-5
Approval status of product in CRESTOR (5, 10, 20, 40 mg) film coated tablets USFDA
GMP Status
Previous Remark of Evaluator XI • The firm was inspected on 27.08.2018 and conclusion of
inspection was:
Veterinary sections were noted at satisfactory level of
compliance. GMP in rests of the sections could not be gauged
amid these static conditions. The firm was further advised to
submit this authority in writing once the production in other areas
is being resumed. All the areas were seen practically shut down
except veterinary non-sterile due to their no market demand
Previous Decision (307-DRB) • Deferred for updated status of GMP of the firm from QA &
LT division as inspection report submitted by firm does not
conclude GMP compliant status.
Evaluation by PEC • The firm was inspected on 30.06.2021 and conclusion of
inspection was:
Based on stated facts and keeping in view the attitude of the
management towards continuous improvements their current GMP
level is rated as satisfactory, the observations pointed out during
the inspection were discussed at length with the management of the
firm and it was assured that all the raised points would be addressed
well before the upcoming panel inspection for the grant of renewal
of their DML.
Decision: Deferred for updated status of GMP of the firm from QA & LT division as inspection report
submitted by firm does not conclude GMP compliant status.
Brand Name + Dosage Form and Rosulip 5mg Tablet
Strength
Rosuvastatin (as calcium)…………5mg
Type of form Form-5
Approval status of product in CRESTOR (5, 10, 20, 40 mg) film coated tablets USFDA
GMP Status
inspection was:

inspection was:
of their DML.
Brand Name + Dosage Form and Ureax 80mg Tablet
Strength
Febuxostat………………….80mg
Pharmacological Group Antigout preparation
Type of form Form-5
Approval status of product in ULORIC (40mg, 80mg) film coated tablets USFDA Approved
Me-too-status Febuxin 80mg tablet by AGP Ltd (Reg. 081105)
GMP Status
inspection was:
inspection was:
of their DML.

Brand Name + Dosage Form and Ureax 40mg Tablet
Strength
Febuxostat…………………..40mg
2019
Pharmacological Group Antigout preparation
Type of form Form 5
Approval status of product in ULORIC (40mg, 80mg) film coated tablets USFDA Approved
Me-too-status Febuxin 40mg tablet by AGP Ltd (Reg. 081104)
GMP Status
inspection was:
inspection was:
of their DML.
Brand Name + Dosage Form and Gabreg 150mg Capsules
Strength
Pregabalin………….150mg
2019
Type of form Form-5
Approval status of product in LYRICA (25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg,
Reference Regulatory Authorities 300mg) Capsules, USFDA Approved
Me-too-status Gabica 150mg Capsules by M/s Getz Pharma (Reg#48724)
GMP Status
inspection was:

inspection was:
of their DML.
Brand Name + Dosage Form and Alvit-D 5mg/ml Injection IM
Strength
Cholecalciferol (vitamin D3)…………5mg (200,000IU)
2019
Pharmacological Group Vitamin D analogue
Type of form Form 5
Approval status of product in Vitamin D3 Good 200,000 IU/1ml oral solution in ampoule
Reference Regulatory Authorities (ANSM France approved)
Vitamin D3 Good 200,000 IU/1ml IM solution for injection in
ampoule (ANSM France approved)
Me-too-status Mael-D Injection 5mg/ml by Pakistan Pharmaceutical Products
(Reg#097017)
GMP Status
Previous Remark of Evaluator XI • The firm submitted revised manufacturing outline and
removed ethanol from manufacturing outline.
• The firm submitted letter No. F. 2-6/91-Lic (Vol.III) (M-
212) dated 10th June 2008, issued by Secretary Licensing
Board confirming the presence of additional section Liquid
Injection (General antibiotic)
• The firm was inspected on 27.08.2018 and conclusion of
inspection was:

inspection was:
of their DML.
Brand Name + Dosage Form and Nermox 100mg Tablet
Strength
Mebendazole…………100mg
2019
Pharmacological Group Benzimidazole derivatives
Type of form Form 5
Approval status of product in Vermox 100mg tablets MHRA Approved
Me-too-status Blomeb Tablet 100mg by M/s Bloom Pharmaceuticals (Reg#
082919)
GMP Status
Previous Remark of Evaluator XI • The firm have applied for innovator’s specifications and the
product is available in USP
inspection was:
inspection was:
of their DML.
Brand Name + Dosage Form and Inezon Dry powder Suspension 100mg/5ml
Strength

Composition Each 5ml of suspension contains:
Linezolid………………100mg
2019
Pharmacological Group Oxazolidinone Antibiotic
Type of form Form 5
Approval status of product in ZYVOX (100mg/5ml) for oral suspension USFDA Approved
Me-too-status Nezo 100mg/5ml Dry Suspension by M/s Rotex Pharma (Reg#
097440)
GMP Status
Previous Remark of Evaluator XI • The firm have mentioned Inezon susp.tablet on fee challan
inspection was:
inspection was:
management towards continuous improvements their current
GMP level is rated as satisfactory, the observations pointed out
during the inspection were discussed at length with the
management of the firm and it was assured that all the raised
points would be addressed well before the upcoming panel
inspection for the grant of renewal of their DML.
382. Name and address of manufacturer / M/s Ray Pharma Pvt Ltd. S-58, S.I.T.E Karachi, Pakistan
Applicant
Brand Name + Dosage Form+Strength Osband 150mg tablet
Composition Each film coated tablet Contains:
Ibandronic Acid………150mg
2019
Pharmacological Group Bisphosphonate
Type of form Form 5
Approval status of product in Ibandronic acid 150mg film-coated tablets MHRA Approved
Me-too-status Franjic 150mg Tablet by M/s Martin Dow Ltd (Reg#81130)
maintenance.

monitoring.
• Fee for the applied product is submitted on 05-03-2019 while
endorsed by assistant Director Revenue (B&A) on 6-3-2019.
• The firm have revised specification from USP to In House
specification (as the official monograph is not available in any
pharmacopoeia) along with submission of Rs. 7500/- on deposit
slip No.325978803227.
• The firm has not revised the salt and hydrated form of Ibandronic
Acid in label claim.
• The firm have Submitted complete manufacturing outline
mentioning the coating and blistering process.
Previous Decision (312-DRB) • Deferred for correction of label claim as per reference
formulation
Evaluation by PEC • The firm have revised the label claim as per reference
formulation along with submission of Rs. 7500/- on deposit slip
No#325978803227. The firm have submitted copy of submitted
fee challan and is verified from DRAP website. The revised label
claim is as under:
Each film coated tablet Contains:
Ibandronic Acid (as ibandronate sodium monohydrate)…150mg
Decision: Approved as per following label claim with innovator’s specifications:
Each film coated tablet Contains:
Ibandronic Acid (as ibandronate sodium monohydrate)…150mg
dated 13-07-2021.
Brand Name + Dosage Form and Acyclowel 50mg/gm ointment
Strength
Acyclovir……….…5mg
2019
Type of form Form 5
Pack size and Demand Price 10gm; As per SRO
Approval status of product in ZOVIRAX 5% (50mg/gm) ointment, USFDA Approved
Me-too-status Hepex ointment 5% by M/s Evolution Pharmaceuticals
(Reg#091964)
Pharmaceutical Industries (Pvt.) Ltd. Gadoon-Swabi is considered
to be operating at fair level of compliance with GMP guidelines as
per Drug Act, 1976 and rules framed thereunder.
Previous Remark of Evaluator XI • The firm did not revise the 1st page of form 5 as per prescribed
format

• The firm did not submit manufacturing method of the applied
product
• The firm submitted letter No. F. 3-5/98-Lic dated 11th April
2017 issued by Secretary Central Licensing Board confirming
the presence of Cream/Ointment section
• Submission of manufacturing method of the applied product
Evaluation by PEC • The firm have revised 1st page of form 5 as per prescribed format
and submitted manufacturing method of the applied product
Decision: Approved.
Brand Name + Dosage Form and Betahis 16mg Tablet
Strength
Betahistine Dihydrochloride………….16mg
2019
Type of form Form 5
Approval status of product in Betahistine Dihydrochloride 16mg Tablets MHRA Approved
Previous Remark of Evaluator XI • The firm did not revise the 1st page of form 5 as per
prescribed format
• The firm did not revise manufacturing outline from coated
to uncoated tablets.
• Revision of manufacturing method of the applied product from
coated to uncoated tablets
Evaluation by PEC • The firm have revised 1st page of form 5 as per prescribed
format and revised manufacturing method of the applied
product from coated to uncoated tablets
Decision: Approved.
Brand Name + Dosage Form and Betahis 8mg Tablet
Strength
Betahistine Dihydrochloride……..…8mg

2019
Type of form Form 5
Approval status of product in Betahistine Dihydrochloride 8mg Tablets MHRA Approved
Previous Remark of Evaluator XI • The firm did not revise the 1st page of form 5 as per prescribed
format
• The firm submitted undertaking at the end of form 5 without
signature by the technical persons.
• The firm did not revise manufacturing outline from coated to
uncoated tablets.
• Submission of undertaking at the end of form 5 duly signed by
the technical persons
• Revision of manufacturing method of the applied product from
coated to uncoated tablets
Evaluation by PEC • The firm have revised 1st page of form 5 as per prescribed and
submitted undertaking at the end of form 5.
• The firm have submitted revised manufacturing method of the
applied product from coated to uncoated tablets
Decision: Approved.
386. Name and address of manufacture / Applicant M/s Invictus Pharmaceuticals. Plot No. 21,26, Street
No.NS-2, National Industrial Zone, Rawat, Rawalpindi
Brand Name+Dosage Form+Strength Ursan 500mg Capsule
Ursodeoxycholic Acid……………500mg
Dairy No. date of R &I fee Form-5 Dy.No 10101 dated 04-03-2019 Rs.20,000/-
04-03-2019
Pharmacological Group Bile acids and derivatives
Type of form Form 5
Pack size and Demand Price 1x6’s, 1x10’s; As per SRO
Me-too-status Vdoxyl 500mg Capsule by M/s EG Pharmaceuticals
(Reg#095838)
GMP Status The firm has been granted DML on the basis of
inspection 13.11.2018 & 17.12.2018.
• The firm provided evidence of approval of applied
formulation in RRA. “Ursochol 500mg capsule”,

approved by Swedish Medicine agency. However,
the product is Deregistered or temporarily recalled.
Previous Decision (307-DRB) • Deferred for evidence of approval of applied
formulation in reference regulatory
authorities/agencies which were adopted by the
Registration Board in its 275th meeting
Evaluation by PEC • The firm provided evidence of URSO FORTE
tablets, by USFDA, while the applied product is
capsule
Previous Decision (313-DRB) • Deferred for evidence of approval of applied
formulation in reference regulatory
authorities/agencies which were adopted by the
Registration Board in its 275th meeting
Evaluation by PEC • The firm provided evidence of product in RRA.
Ursochol 250mg & 500mg capsule DENMARK
approved
Decision: Approved.
387. Case Deleted because of duplication
388. Name and address of manufacture / M/s Kanel Pharma. Plot # 6, St # SS-3, National Industrial
Applicant Zone, Rawat, Rawalpindi.
Contract Manufactured By: M/s English Pharmaceuticals
Industries. Link Kattar Bund Road, Thokar Niaz Baig, Multan Road,
Lahore
Brand Name+Dosage Form+Strength Engferol Injection 5mg/ml Oral/IM
Cholecalciferol (vitamin D3)………….5mg (200,000IU)
2019
Type of form Form 5
Pack size and Demand Price 1mlx1’s; 1mlx5’s; As per SRO
Approval status of product in Vitamin D3 Good 200,000 IU/1ml oral solution in ampoule ( ANSM
Reference Regulatory Authorities France approved)
Vitamin D3 Good 200,000 IU/1ml IM solution for injection (
ANSM France approved)
Me-too-status D-Rick Injection by Caliph Pharmaceuticals (Pvt.) Ltd,
(Reg#82563)
GMP Status M/s Kanel Pharma was inspected on 06-03-2019 and
recommendations of inspection was:
Keeping in view the above stated observations during inspection,
areas visited, documents reviewed it is concluded that M/s Kanel
Pharma Rawat is operating in compliance to GMP guidelines as of
today. However the points of improvements have been discussed
and agreed by the representatives of the firm.
Certificate of GMP Issued to English Pharmaceuticals on 16-01-
2018.
Previous Remark of Evaluator XI • Form 5 has been submitted by the applicant duly signed by the
signatory
• The firm did not submit undertaking at the end of form 5
• A copy of contract manufacturing agreement between M/s Kanel
Pharma and M/s English Pharmaceuticals Industries is submitted
• The firm submitted list of 05 approved sections of applicant. i.e.
M/s Kanel Pharma

• The firm informed that they don’t have any product
registered/approved on contract manufacturing
• The firm submitted list of 09 applied products for contract
manufacturing
• The firm mentioned the use of type II glass container as primary
packaging material of applied formulation
• The firm informed that they are using asceptic technique for
filling so need no terminal sterilization process.
• The firm did not provide evidence of manufacturing facility i.e.
General Liquid Ampoule injection section
Previous Decision (296-DRB) • Deferred for submission of undertaking.
Evaluation by PEC • The firm submitted undertaking at the end of form 5 as per
prescribed format
• Consideration on its turn
• Clarification of the method of analysis of finished drug product for
quantification of Vitamin D in Assay test, whether UV
spectrophotometric method or HPLC method.
Evaluation by PEC • The firm submitted HPLC method for analysis of analysis of
finished drug product for quantification of Vitamin D in Assay
test
Registration letter will be issued after submission of GMP audit report of M/s Kanel Pharma and M/s
English Pharmaceuticals Industries. from QA&LT Division, valid within last three years.
389. Name and address of M/s Fedro Pharmaceuticals Laboratories Private Limited.
manufacture / Applicant 149-Industrial Estate, Hayatabad, Peshawar
Brand Name + Dosage Form Fexofed 60mg tablets
and Strength
Composition Fexofenadine HCl…….…60mg
Dairy No. date of R &I fee Form-5 Dy.No 11111 dated 05-03-2019 Rs.20,000/- dated 04-03-2019
Pharmacological Group Antihistamines
Type of form Form-5
Approval status of product in TELFAST fexofenadine hydrochloride 60mg film coated tablet, TGA
Reference Regulatory Approved
Authorities
Me-too-status Axofed 60mg Tablet by M/s Akson Pharmaceuticals, (Reg#101788)
GMP Status The firm was inspected on 09-12-2021 and 03-02-2022 and conclusion of
inspection was:
The firm was inspected by the panel in detail on prescribed evaluation form
and the panel unanimously recommends the grant of renewal of DML and
grant of additional section (Dry Suspension section-General).
Previous Remark of Evaluator • The firm have submitted 1st page of form 5.
XI
• The firm have mentioned the label claim in form 5. The submitted label
claim is as under:
Fexofenadine…….…60mg
However, the firm did not mention the salt form of fexofenadine in label
claim.
Previous Decision (307-DRB) • Deferred for mentioning the salt form of fexofenadine in label claim as
per reference formulation along with submission of applicable fee.

Evaluation by PEC • The firm have mentioned the correct salt form of fexofenadine in label
claim as per reference formulation without submission of applicable fee.
Fexofenadine HCl…….…60mg
Fexofenadine HCl…….…60mg
dated 13-07-2021.
390. Name and address of manufacture / M/s Fedro Pharmaceuticals Lab Pvt Limited.
Brand Name + Dosage Form and Strength Camro 7.5mg Tablet
Composition Meloxicam………….…7.5mg
Dairy No. date of R &I fee Form-5 Dy.No 30887 dated 13-09-2018 Rs.20,000/- Dated
13-09-2018
Type of form Form-5
Me-too-status Melflam 7.5mg Tablets by M/s Aries Pharmaceuticals
(Reg#84265)
• The firm did not submit 1st page of form 5
• The firm applied the following incorrect label claim
without submission of applicable fee.
Meloxicam………….…7.5mg
• The firm have applied for film coated tablet while the
reference formulation is uncoated. Revise the label
claim and master formulation as per reference
formulation along with submission of applicable fee.
• Submission of 1st page of form 5 as per prescribed format
• Revision of label claim and master formulation from film
coated to uncoated tablets as per reference formulation
along with submission of applicable fee
Evaluation by PEC • The firm have revised 1st page of form 5 as per
prescribed format
• The firm have revised the label claim and master
formulation from film coated to uncoated tablets as per
reference formulation along with submission of Rs.
30000/- on deposit slip No#129015162. The revised label
claim is as under:

391. Name and address of manufacture / M/s Fedro Pharmaceuticals Lab Pvt Limited.
Brand Name + Dosage Form and Strength Camro 15mg Tablet
Composition Meloxicam……………..15mg
Dairy No. date of R &I fee Form-5 Dy.No 30888 dated 13-09-2018 Rs.20,000/- Dated
13-09-2018
Type of form Form-5
Me-too-status Melflam 15mg Tablets by M/s Aries Pharmaceuticals
(Reg#84266)
• The firm did not submit 1st page of form 5
• The firm applied the following incorrect label claim
without submission of applicable fee.
Meloxicam………….…15mg
• The firm have applied for film coated tablet while the
reference formulation is uncoated. Revise the label
claim and master formulation as per reference
formulation along with submission of applicable fee.
• Submission of 1st page of form 5 as per prescribed format
• Revision of label claim and master formulation from
film coated to uncoated tablets as per reference
Evaluation by PEC • The firm have revised 1st page of form 5 as per
prescribed format
• The firm have revised the label claim and master
formulation from film coated to uncoated tablets as per
reference formulation along with submission of Rs.
30000/- on deposit slip No#83760135. The revised label
claim is as under:
392. Name and address of manufacture / M/s Fedro Pharmaceuticals Laboratories Private Limited.
Brand Name + Dosage Form and Strength Amlosart 5/160mg Tablets
Amlodipine as Besylate………………..……5mg
Valsartan…………………………………….160mg
Dairy No. date of R &I fee Form-5 Dy.No 11112 dated 05-03-2019 Rs.20,000/- dated
04-03-2019

Pharmacological Group Calcium channel blockers and Angiotensin II receptor
blockers (ARBs)
Type of form Form 5
Pack size and Demand Price 10’s, 14’s, 28’s, 30’s; As per SRO
Approval status of product in Reference Exforge (5/160mg, 10/160mg, 5/320mg, and 10/320mg) film
Previous Remark of Evaluator XI • The submitted fee challan and cover letter is for Amlosart
5/80mg Tablets while form 5 is for Amlosart 5/160mg
Tablets, clarify?
Previous Decision (307-DRB) • Deferred for clarification as firm have mentioned Amlosart
5/80mg Tablets on fee challan and cover letter while
Amlosart 5/160mg Tablets on form 5.
Evaluation by PEC • The firm submitted that they have also applied for Amlosart
5/80mg Tablets and submitted fee for that product as well
but mistakenly attach the cover letter and fee challan in this
dossier. The same application is presented in this agenda
and accordingly the cover letter and fee challan are
attached in respective dossier.
Decision: Approved.
c. Deferred cases of Priority Registration of Fludrocortisone tablets

The Drug Regulatory Authority of Pakistan in its 91st meeting held on 4th September 2020, exercising its power
under Rule 26 of Drugs (LRA) Rules amended vide SRO 713(I)/2018 dated 8th June, 2018, allowed to submit
registration applications on Form 5 / Form 5-A / Form 5-D instead of Form 5F, for Registration of Fludrocortisone
tablets in light of approvals granted by the reference regulatory authorities and with the following additional
conditions:
i. The applicants can submit their applications till 30-09-2020 and these applications will be considered out
of queue.
ii. Registration Board may consider grant of registration and submission of data of product development and
6 months accelerated and 6 months real time stability studies data before sale of product along with other
data as may be required.
393. Name and address of manufacture / M/s Pharma wise Labs Pvt Ltd.
Applicant 25-M. Q.A Industrial Estate, Kot Lakhpat Lahore, Pakistan
Brand Name+Dosage Form+Strength Floricort 0.1mg Tablet
Fludrocortisone Acetate…………….0.1mg
Dairy No. date of R &I fee Form-5D Dy.No 25498 dated 29-09-2020 Rs.50,000/- 29-09-
2020
Pharmacological Group Mineralocorticoid
Type of form Form 5D
Approval status of product in Fludrocortisone Acetate 0.1mg Tablets MHRA Approved
Me-too-status
GMP Status GMP certificate issued to M/s Pharma Wise Labs (Pvt.) Ltd on
13.12.2019 based on inspection conducted on 16.10.2019

Previous Remark of Evaluator XI • The firm submitted revised layout plan approved for
regularization of sections mentioned vide covering letter No.
F. 1-7/85-Lic (Vol-II) dated 18/12/2017 showing steroidal
tablet section.
• The firm submitted GMP certificate issued on 13.12.2019
based on inspection conducted on 16.10.2019 having tablet
steroidal section. However, the conclusion of inspection
report contains the following statement:
• The resumption of production activities in the following
sections:
a. Oral liquid section (syrup/suspension
b. Antiseptic section
c. Cream/Ointment section
d. General tablet section
• Resumption of production activities in the following sections
be allowed only after installation of 400 KVA transformer. The
installation / operations would be verified by area FID and
forwarded to DRAP, Islamabad for resumption.
a. Sachet section
b. Repacking section
c. Capsule section
d. General antibiotic tablet section
e. General antibiotic dry powder section
f. Steroid tablet section
• Panel did not recommend the resumption in penicillin area
Previous Decision (297-DRB) • Deferred for updated status of GMP of the firm as explanation
letter issued to the firm on 11th January 2021 from QA & LT
division.
Evaluation by PEC • The firm have submitted inspection report conducted by FID
dated 25-10-2021 and conclusion of inspection was:
In view of above inspection proceedings, it was observed that
the firm had rectified most of the deficiencies pointed out during
last GMP inspection, hence the firm display positive approach
towards compliance.
Decision: Deferred for confirmation of manufacturing facility i.e. Steroid tablet section from
Licensing Division
d. Deferred cases (Human-Covid):

Azithromycin lyophilized/ powder for solution for Infusion 500mg/vial:
Composition:
Each vial Contains:
Azithromycin dihydrate eq to Azithromycin…….500mg
Availability in RRAs:
ZITHROMAX (500mg) lyophilized powder for injection, for intravenous use USFDA Approved
Me-too status: Macrocap 500mg Dry Powder Injection by M/s Aries Pharmaceuticals (R.No.82589)
Specifications:
USP
Sr. Name of Brand Composition Diary no. / Date Pack Remarks/ GMP
No. applicant Name / fee / form Size / status
Price
394. M/s BF Azofer Each Vial Form-5 Dy.No 10ml;As Last GMP inspection
Biosciences 500mg/Vi Contains: 16818 dated 13- per SRO conducted on 22-08-
Limited. al Azithromycin (as 07-2020 2019 wherein the
5-Km, Sunder- Lyophiliz dihydrate)…500 Rs.20,000/- panel recommended
Raiwind Road, ed mg the renewal of DML

Raiwind, Powder Dated 13-07-
Lahore, for 2020
Pakistan Solution
for
Infusion
Previous Deferred for confirmation of manufacturing facility
Decision (296-
DRB)
Evaluation by The firm have submitted that they have applied for local manufacturing of Azofer
PEC (Azithromycin) Injection 500mg at BF Biosciences Limited under campaign
manufacturing approval of Honorable Drug Appellate Board for manufacturing of Non-
Biopharmaceuticals at same facility vide letter No. F.1-3/2018-AB (M-151) dated
04.02.2019. The firm further submitted that BF Biosciences Ltd is allowed for
manufacturing of following Non-Biopharmaceuticals products on campaign basis as
general section.
S.No. Reg. No. Name of Drug (s) & Composition
1 103375 Remidia (Remdesivir) Lyophilized powder for infusion
100mg
2 103376 Remidia (Remdesivir) Liquid solution for infusion 100mg
3 098036 Omega (Omeprazole) Lyophilized powder for infusion 40mg
4 098037 Esomega (Esomeprazole) Lyophilized powder for infusion
40mg
Decision: Registration Board did not acceded the request of firm and rejected the application in light
of the Appellate Boartd’s decision.
Chloroquine Phosphate 250mg Tablet:

Composition:
Each Film Coated Tablet contains:
Chloroquine phosphate……..250mg
International Availability:
Chloroquine phosphate (250mg & 500mg) film coated tablet by M/s Hima Pharma, USFDA Approved.
While the product approved in MHRA is uncoated.
Me too: RESOCHIN 250MG TAB by M/s Bayer Karachi, Reg. No. 000025
Specifications: USP Specification
Sr. Name of applicant Brand composition Diary no. / Date / Pack Size / Remarks/G
No. Name fee / form Price MP status
395. M/s Biorex Chlorrex Each Tablet contains: Dy. No.7619 As per Last
Pharmaceuticasl plot No. 250mg tablet Chloroquine dated 15/04/2020 SRO inspection
251-A, Industrial phosphate……250m Rs. 20,000/- report is older
Triangle Kahuta Road, g Form 5 than 3 years.
Islamabad.
Previous Decision (295- Registration Board referred the case to QA & LT Division to conduct GMP
DRB) inspection of Firm on priority.
Evaluation by PEC The firm have submitted GMP certificate issued on 28-01-2022 based on
Ascorbic acid chewable tablet 500mg:

Composition:
Each chewable tablet contains:
Ascorbic acid……..500mg
International availability:
Ascorbic acid chewable tablet (50mg, 100mg, 200mg, 500mg) by M/s Ennogen Pharma ltd, MHRA Approved
Me too status: Cecon 500mg tablet by M/s Abbott. Reg#006119
Specifications: USP

396. M/s Biorex Bio C Each Chewable Dy. No. 7618 As per Last
Pharmaceuticals Tablet Tablet Contains: dated 15/04/2020 SRO inspection
Plot No 251-A, 500mg Ascorbic Rs. 20,000/- 15- report is older
Industrial Triangle, Acid…….500mg 04-2020 Form 5 than 3 years.
Kahuta Road, Islamabad,
Pakistan
Previous Decision (295- Registration Board referred the case to QA & LT Division to conduct GMP
DRB) inspection of Firm on priority.
Azithromycin Tablet 500mg:

Composition:
Azithromycin as dihydrate…….500mg
Availability in RRAs: MHRA Approved
Me too status: "Azic 500mg Tablet by M/s Nabi Qasim (Reg # 055584)
Specifications: USP
397. M/s Biorex Zithrorex Each tablet Form-5 Dy.No 10’s Last
Pharmaceuticals 500mg contains: 13098 dated 06- inspection
Plot No 251-A, Tablet Azithromycin as 03-2019 report is older
Industrial Triangle, trihydrate…500mg Rs.20,000/- than 3 years
Kahuta Road, Islamabad, Dated 06-03-
Pakistan 2019
Previous Decision (295- Deferred for updated status of GMP from QA & LT.
DRB)
Decision: Approved as per following label claim with USP specifications.:
Azithromycin as trihydrate…500mg
(correction/change of formulation from un-coated tablet to film coated tablet), as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Azithromycin Tablet 250mg:

Composition:
Azithromycin as dihydrate…….250mg
Availability in RRAs: MHRA Approved
ME too status: " Azithrolide tablet of M/s Heal Pharma (Reg. # 084233)
Specifications: USP
398. M/s Biorex Zithrorex Each Film coated Form-5 Dy.No As per Last
Pharmaceuticals, 250mg tablet contains: 13097 dated 06- SRO inspection
Plot No 251-A, Tablet Azithromycin as 03-2019 1X10’s report is
Industrial Triangle, dihydrate…250 mg Rs.20,000/- per older than 3
Kahuta Road, Islamabad, Dated 06-03- pack Years.
Pakistan 2019
Previous Decision (295- Deferred for updated status of GMP from QA & LT.
DRB)
e. Deferred cases of Veterinary Drugs

399. Name and address of manufacturer / M/s Eterna Pharma (Pvt.) Ltd., Plot# (99,100,101,198) C, Sector
Applicant D1,Old Industrial Estate, Mirpur, AJ & K.
Brand Name +Dosage Form + Strength SUPER NOR 20 LIQUID
Enrofloxacin……………..…20%
Diary No. Date of R& I & fee Dy.No.138 dated 01-01-2021 Rs.20,000/- Dated 01-01-2021
Pharmacological Group Fluoroquinolone
Type of Form Form 5
Finished Product Specification Innovator’s Specs
Pack size & demanded price 50ml,100ml,150ml,250ml,500ml,1L.2.5L & 5 L / Decontrolled
Me-too status Bio-E Floxacin-20% Miscible Liquid by Bio-Labs Islamabad
(Reg#021290)
GMP status Keeping in view the above facts, detailed visit of the facility and
supporting documents provided by the firm, the panel unanimously
recommended M/s Eterna Pharma Plot No. 99,100,101 &198-
C,Sector D1,Old Industrial Estate, Mirpur,AJ & K for the grant of
drug manufacturing License for the following sections namely:
1. Oral Powder Section (Veterinary) General
2. Oral Liquid Section (Veterinary) General
3. Liquid Injection section (Veterinary) General
Previous Remark of Evaluator XI • In USP this product is available as “Enrofloxacin compounded,
veterinary oral suspension” while the firm have applied for oral
liquid and formulation shows it is oral solution. Clarification is
required
• You have mentioned Each 100 ml contains:
Enrofloxacin…………..…10% on form 5 while Each 100 ml
contains: Enrofloxacin………..…20% is mentioned in enclosure
of form 5 and master formulation. Submit correct strength in form
5
• Clarification of formulation as oral solution or oral suspension
and revision of formulation along with submission of applicable
fee.
• Submission of correct strength of formulation in form 5
Evaluation by PEC • The firm have mentioned correct strength in label claim and
master along with submission of Rs 5000/- on deposit slip No.
2108454 dated 05.03.2021. The revised label claim is as under:
Each 100 ml contains:
• The firm have submitted that European Pharmacopoeia
monograph number 2229 for Enrofloxacin (Enrofloxacin for
veterinary use) is the only monograph available for enrofloxacin
in European pharmacopeia. It describes the tests and
specifications that the raw material (enrofloxacin) must follow to
comply with Europoeian Pharmacopoeia standards. It does not
state that it is for suspension.
Previous Decision (307-DRB) • Deferred for clarification of formulation as oral solution or oral
suspension and revision of formulation along with submission of
applicable fee.
Evaluation by PEC • The firm submitted that they will manufacture it as suspension as
per USP and submitted revised master formulation containing
suspending agent without submission of applicable fee.
Decision: Approved as per following label claim with USP specifications and pack size of upto 1Ltr.:

(correction/change of formulation from solution to suspension), and product specifications, as per
Brand Name +Dosage Form + Strength SUPER BRO ORAL LIQUID
Bromhexine HCl…………….10%
Pharmacological Group Mucolytic agent
Type of Form Form 5
Pack size & demanded price 50ml,100ml,150ml,250ml,500ml,1L.2.5L&5L/Decontrolled
Me-too status
• Provide evidence of applied formulation already approved by
DRAP (generic/me-too status) alongwith registration number,
brand name and name of firm
Previous Decision (297-DRB) • Deferred for evidence of applied formulation already approved
by DRAP (generic/me-too status) alongwith registration number,
Evaluation by PEC • The firm provided me-too of the applied product
Bromosol Oral Liquid 10% by M/s Intervac (Reg#'080725)
However the applied strength in the provided me-too is not as per
as per applied product
Evaluation by PEC • The firm provided evidence of me-too Ebrom-Lytic 10% Oral
Liquid by M/s Vetec Laboratories (Reg#'099317)
Decision: Approved with innovator’s specifications and pack size of upto 1Ltr.
Brand Name +Dosage Form + Strength ETER-EN 10 LIQUID
Pharmacological Group Fluoroquinolone
Type of Form Form 5
Pack size & demanded price 50ml,100ml,150ml,250ml,500ml,1L.2.5L & 5 L / Decontrolled
Me-too status Enrolac 10 Liquid by Breeze Pharma (Reg#063549)

Previous Remark of Evaluator XI In USP this product is available as “Enrofloxacin compounded,
veterinary oral suspension” while the firm have applied for oral
liquid and formulation shows it is oral solution. Clarification is
required
Previous Decision (297-DRB) Deferred for clarification of formulation as oral solution or oral
applicable fee
Evaluation by PEC The firm have submitted fee Rs 5000/- on deposit slip No. 2108453
dated 05.03.2021. However, the firm did not any reply for this
product
Previous Decision (307-DRB) • Deferred for clarification of formulation as oral solution or oral
applicable fee
Evaluation by PEC • The firm submitted that they will manufacture it as suspension as
per USP and submitted revised master formulation containing
suspending agent without submission of applicable fee.
Decision: Approved with USP specifications and pack size of upto 1Ltr.
(correction/change of formulation from solution to suspension), and product specifications, as per
402. Name and address of manufacturer / M/s Krypton Pharma (Pvt) Ltd
Applicant Plot No. 052, M-3 Industrial city Sahianwala, Faisalabad
Brand Name +Dosage Form + Strength KPTIL ORAL 25% Oral Liquid
Composition Each ml contains :
Tilmicosin Phosphate (USP)……….…250mg
Diary No. Date of R& I & fee Form-5, Dy.No.1219 (08-01-2021) Rs.20,000/- 08-01-2021
Type of Form Form-5
Finished Product Specification In House specification
Pack size & demanded price 50ml, 100ml, 250ml, 450ml, 500ml, 1 liter, 2.5 liter, 5 liter, 10 liter,
15 liter, 20 liter, 25 liter in plastic Bottles/cane / Decontrolled
Approval status of product in Reference N.A
Me-too status Biotil Liquid by M/s Bio Labs (Reg#046568)
GMP status DML Inspection conducted on 12th October 2020 and Panel
recommended for grant of DML.
Previous Remark of Evaluator XI • You have applied the label claim without considering the salt
factor. Revise the label claim and master formulation as per me-
too product considering the salt factor along with submission of
applicable fee.
Previous Decision (307-DRB) • Deferred for revision of the label claim and master formulation
as per me-too product considering the salt factor along with
Evaluation by PEC • The firm have revised the label claim and master formulation as
per available me-too product considering the salt factor without
submission of applicable fee. The revised label claim is as under:
Each ml contains:
Tilmicosin (as Phosphate) (USP)……….…250mg
Decision: Approved as per following label claim with innovator’s specifications and pack size of upto
1Ltr.:
Each ml contains:
Tilmicosin (as Phosphate) (USP)……….…250mg

(correction/change of salt factor and adjustment of weight), and product specifications, as per
Brand Name +Dosage Form + Strength KPSOFRA SUSP Oral Liquid
Soframycin Sulphate (BP) ……100mg
Diary No. Date of R& I & fee Form-5, Dy.No.1199 (08-01-2021) Rs.20,000/- 08-01-2021
Type of Form Form-5
Pack size & demanded price 50ml, 100ml, 250ml, 450ml, 500ml, 1 liter, 2.5 liter, 5 liter in
plastic Bottles/cane / Decontrolled
Me-too status Sofracin Solution by M/s Bio Labs (Reg#026440)
Previous Remark of Evaluator XI You have applied KPSOFRA SUSP Oral Liquid which shows that
it is suspension and you have mentioned KPSOFRA Suspension on
the fee challan as well while the applied master formulation shows
that it is solution, clarify?
Previous Decision (307-DRB) • Deferred for clarification as the applied formulation is solution or
suspension and submission of master formulation accordingly
Evaluation by PEC • The firm submitted that the applied formulation is in solution
form and submitted revised master formulation and stated that
they have revised the name of product on master formulation and
fee challan as “KPSOFRA SUSP Oral Liquid”
Decision: Approved with innovator’s specifications and pack size of upto 1Ltr
404. Name and address of manufacturer / M/s Krypton Pharma (pvt) limited
Applicant Plot No. 52, M-3 Industrial city Sahianwala Faisalabad
Brand Name +Dosage Form + Strength DOXY TON CB Oral Liquid
Tylosin tartrate (E.P)……………100gm
Doxycycline as HCl (B.P.)…………200gm
Colistin Sulphate (B.P)…………...500MIU
Bromhexine HCl (E.P).…………..10gm
Diary No. Date of R& I & fee Form-5, Dy. No 1195 dated 08-01-2021 Rs 20,000/-
Dated 08-01-2021
Pharmacological Group Antibacterial & mucolytics
Type of Form Form-5
Finished Product Specification In house Specification
Me-too status Restidox Liquid by M/s Elegance Pharma(Reg#073918)
Previous Remark of Evaluator XI You have applied the label claim considering the salt factor in case
of doxycycline. Revise the label claim and master formulation as

per me-too product without considering the salt factor along with
as per me-too product without considering the salt factor in case
of doxycycline along with submission of applicable fee.
Evaluation by PEC • The firm have revised the label claim and master formulation as
per available me-too product without considering the salt factor
in case of doxycycline without submission of applicable fee. The
Each 1000ml contains:
Doxycycline HCl (B.P.)…………200gm
1Ltr.:
Each 1000ml contains:
Doxycycline HCl (B.P.)…………200gm
(correction/change of salt form of the drug substance) and product specifications, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Strength KP-TYDOX CB Oral Liquid
Tylosin Tartrate (E.P)………..……100gm
Doxycycline as HCl (B.P.)…………200gm
Colistin Sulphate (B.P)…………....450MIU
Bromhexine HCl (E.P)……………2.5mg
Diary No. Date of R& I & fee Form-5, Dy. No 1201 dated 08-01-2021 Rs 20,000
Dated 08-01-2021
Pharmacological Group Antibacterial & mucolytics
Type of Form Form-5
Me-too status Tylocab Oral Liquid by M/s Elegance Pharmaceuticals
(Reg#078277)
Previous Remark of Evaluator XI You have applied the label claim considering the salt factor in case
of doxycycline. Revise the label claim and master formulation as
per me-too product without considering the salt factor along with
as per me-too product without considering the salt factor in case
of doxycycline along with submission of applicable fee.
Evaluation by PEC • The firm have provided evidence of me-too Bio-Unibiotic Liquid
by M/s Bio-Labs (Pvt) Ltd., (Reg# '074006). The firm have
revised the label claim and submitted revised master formulation

as per available me-too without submission of applicable fee. The
Each ml contains:-
Tylosin Tartrate …….….100mg
Doxycycline HCI……....200mg
Colistin Sulphate…...450,000 IU
Bromhexine HCI……….2.5mg
1Ltr.:
Each ml contains:-
Tylosin Tartrate …….….100mg
Doxycycline HCI……....200mg
Colistin Sulphate…...450,000 IU
Bromhexine HCI……….2.5mg
(correction/change of salt form of the drug substance) and product specifications, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Applicant Plot No. 052, M-3 Industrial city Sahianwala, Faisalabad.
Brand Name +Dosage Form + Strength OXATON 2.265 Oral suspension
Oxfendazole (B.P.)……..2.265g
Dated 08-01-2021
Pharmacological Group benzimidazole anthelmintic
Type of Form Form-5
Finished Product Specification USP
Me-too status Zefinax Liquid (Drench) by M/s Bio Labs (Reg#025348)
Previous Remark of Evaluator XI The applied label claim is not as per available me-too product.
Provide evidence of applied formulation/drug already approved by
brand name and name of firm OR revise the label claim as per
available me-too product along with submission of applicable fee.
approved by DRAP (generic / me-too status) along with
Evaluation by PEC • The firm have provided evidence of me-too Wantox Drench by
M/s Breeze Pharma (Reg# '059141). The firm have revised the
label claim and submitted revised master formulation as per
available me-too without submission of applicable fee. The
Each ml contains:
Oxfendazole (B.P.)……..22.65mg (2.265% w/v)
Decision: Approved as per following label claim and pack size of upto 1Ltr.:
Each ml contains:
Oxfendazole (B.P.)……..22.65mg (2.265% w/v)
(correction/change of strength of the drug substance in formulation), as per notification No.F.7-11/2012-

Brand Name +Dosage Form + Strength KP FESCIOL Oral Liquid
Oxyclozanide (B.P.) …………...3.4gm
Sodium Selenite (B.P.)…………0.035gm
Cobalt Chloride (BP)………..…0.075gm
Dated 08-01-2021
Pharmacological Group Antinematodal & anthelminthic drugs
Type of Form Form-5
Pack size & demanded price 50ml, 100ml, 250ml, 450ml, 500ml, 1 liter, 2.5 liter, 5 liter, in
Me-too status Vety Fasciol Liquid by M/s Vety care pharmaceuticals
(Reg#021421)
Previous Remark of Evaluator XI The provided me-too is not as per applied product. The provided
me-too contains different API than the applied product. Provide
evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand
name and name of firm
registration number, brand name and name of firm
Evaluation by PEC • The firm provided evidence of me-too Clozabak Oral Suspension
by M/s Attabak Pharmaceutical Industries (Reg#034542).
Brand Name +Dosage Form + Strength KP-LEVOSUL PLUS Oral suspension
Oxyclozanide (B.P.)……………………3g
Levamisole HCl (B.P.)…………………1.5g
Cobalt sulphate heptahydrate (B.P.)……0.382g
Dated 08-01-2021
Pharmacological Group Antinematodal & anthelmintic drugs
Type of Form Form-5
Me-too status PARANIL PLUS Suspension by M/s Vety Care Pharmaceuticals
(Reg#028514)
Previous Remark of Evaluator XI You have applied for oral suspension while the master formulation
does not contain suspending agent, clarify?

Previous Decision (307-DRB) • Deferred for clarification as the applied formulation is oral
suspension while the master formulation does not contain
suspending agent
Evaluation by PEC • The firm have submitted revised master formulation containing
suspending agent
Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in product specifications and
master formulation (change in excipients), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
Brand Name +Dosage Form + Strength KRYPTOCIDE Oral Liquid
Oxyclozanide (B.P.)………….…3g
Levamisole HCl (B.P.)………….1.5g
Sodium Selenite (B.P.)………….0.035g
Cobalt Chloride (BP)…………….0.075g
Diary No. Date of R& I & fee Form-5, Dy.No.1193 dated 08-1-2021 Rs 20,000/- 08-1-2021
Pharmacological Group Antinematodal & Anthelminthic
Type of Form Form-5
Me-too status Vety-Vermicide Liquid by M/s Vety care (Reg#019937)
Previous Remark of Evaluator XI • The provided me-too is not as per applied product. The provided
me-too contains different API than the applied product. Provide
evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand
name and name of firm
• Submit correct master formulation as per applied label claim.
You have mentioned each 100ml in master formulation while
each 1000ml in the label claim.
• Submit correct master formulation as per applied label claim.
Evaluation by PEC • The firm have provided evidence of me-too Karzan Plus
Suspension by M/s Zakfas Pharmaceutical, (Reg#046525). The
firm have revised the label claim and submitted revised master
formulation as per available me-too. The revised label claim is as
under:
Each ml contains:
Oxyclozanide (B.P.)………….…30mg
Levamisole HCl (B.P.)………….15mg
Selenium (as Sodium Selenite) (B.P.)…….0.5mg
Cobalt (as sulphate) (BP)………….1.67mg
1Ltr.:
Each ml contains:
Oxyclozanide (B.P.)………….…30mg
Levamisole HCl (B.P.)………….15mg

Selenium (as Sodium Selenite) (B.P.)…….0.5mg
Cobalt (as sulphate) (BP)………….1.67mg
(correction/change of strength of the drug substance in formulation), and product specifications, as per
Brand Name +Dosage Form + Strength KP ENRO C Oral Liquid
Enrofloxacin E.P.………………100mg
Colistin Sulphate E.P. …………50mg
Diary No. Date of R& I & fee Form-5, Dy.No.1175 dated 08-01-2021 Rs 20,000/- 8-1-2021
Type of Form Form-5
Pack size & demanded price 50ml, 100ml, 250ml, 450ml, 500ml, 1 liter, 2.5 liter, 5 liter, in
Me-too status
• You have not mentioned the name of the firm on the fee challan
submitted for the applied product, clarify?
• Provide evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) along with registration
number, brand name and name of firm
• You have not mentioned the name of the firm on the fee challan
submitted for the applied product, clarify?
Evaluation by PEC • The firm have provided evidence of me-too Bioenrocolis Liquid
by M/s Elegance Pharmaceutical, (Reg#073916). The firm have
revised the label claim and submitted revised master formulation
as per available me-too. The revised label claim is as under:
Enrofloxacin E.P.………………10g
Colistin Sulphate E.P. …………52MIU
• The firm have submitted copy of fee challan and has mentioned
name of firm on fee challan.
1Ltr.:
Enrofloxacin E.P.………………10g
Colistin Sulphate E.P. …………52MIU
(correction/change of strength of the drug substance in formulation), and product specifications, as per
Brand Name +Dosage Form + Strength KP DOX-T Oral Liquid
Tylosin tartrate (E.P)………………..100mg
Doxycycline as HCl (B.P.)…………..200mg

Colistin Sulphate (B.P)………………0.5MIU
Bromhexine HCl (E.P)……………….5mg
Dated 08-01-2021
Type of Form Form-5
Me-too status
Previous Remark of Evaluator XI Provide evidence of applied formulation/drug already approved by
Evaluation by PEC • The firm have provided evidence of me-too Pulmo Shell Liquid
by M/s Inshal Pharmaceutical Industries, (Reg# '073937). The
firm have revised the label claim and submitted revised master
formulation as per available me-too. The revised label claim is as
under:
Each ml contains:
Doxycycline HCl (B.P.)…………..200mg
Colistin Sulphate (B.P)………………500000 IU
1Ltr.:
Each ml contains:
Doxycycline HCl (B.P.)…………..200mg
Colistin Sulphate (B.P)………………500000 IU
(correction/change of strength and salt form of the drug substance in formulation), and product
412. Name and address of manufacturer / M/s Krypton Pharma (pvt) limited Plot No. 52, M-3 Industrial city
Applicant Sahianwala Faisalabad Pakistan
Brand Name +Dosage Form + Strength KP-AGENT 60 Oral Powder
Amprolium HCl (USP) ….….. 600mg
Dated 08-01-2021
Pharmacological Group Anticoccidial
Type of Form Form-5
Pack size & demanded price 50g, 100g, 250g, 450g, 500 g, 1 Kg, 2.5 Kg, 5 Kg, 10kg, 15kg,
20kg, 25kg in plastic Jar/bag / Decontrolled
Me-too status Amporo-60 w/s powder by M/s Decent pharma (Reg#079825)

Previous Remark of Evaluator XI • The applied label claim is not as per available me-too product.
Provide evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm OR revise the label claim
as per available me-too product along with submission of
applicable fee.
Evaluation by PE • The firm have provided evidence of me-too Bio-Amprol 60
Powder by M/s Mallard Pharmaceutical (Reg#063773). The firm
have revised the label claim and submitted revised master
formulation as per available me-too without submission of
applicable fee. The revised label claim is as under:
Each gm contains:
Decision: Approved as per following label claim and pack size of upto 1Kg:
Each gm contains:
(correction/change of strength of the drug substance in formulation), as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Strength KP-AMANDIN Oral Powder
Amantadine HCl (USP) ……..10g
Dated 08-01-2021
Pharmacological Group Adamantane derivatives
Type of Form Form-5
Pack size & demanded price 50g, 100g, 250g, 450g, 500g, 1 Kg, 2.5 Kg, 5 Kg, 10kg, 15kg, 20kg,
25kg in plastic Jar/bag / Decontrolled
Me-too status Acedine Powder by M/s Leads Pharma (Reg#078356)
Previous Remark of Evaluator XI The applied label claim is not as per available me-too product.
Provide evidence of applied formulation/drug already approved by
brand name and name of firm OR revise the label claim as per
available me-too product along with submission of applicable fee.
Evaluation by PEC • The firm have provided evidence of me-too Antamits Water
Soluble Powder by M/s Wimits Pharmaceuticals, (Reg#078316).
The firm have revised the label claim and submitted revised
master formulation as per available me-too. The revised label
claim is as under:
Each gm contains:
Amantadine HCl (USP) ……..100mg

1Kg:
Each gm contains:
Amantadine HCl (USP) ……..100mg
Agenda of Evaluator PEC-XVII

Case No. 1: Registration applications for local manufacturing of (Human) drugs.
a; New cases:
413. Name and address of manufacturer/ M/s Valor pharmaceuticals, 124/A, Industrial Triangle, Kahuta
Applicant Road, Islamabad.
Brand Name + Dosage Form + Strength Valofix 550mg Tablet
Rifaxamin ……………550mg
Pharmacological Group Intestinal, anti-infective antibiotics
Finished product Specification Manufacturer Specifications
Pack size & Demanded Price As recommended by the PRC (M/o NHS, R&C)/Fedgovt.
Approval status of product in Reference TARGAXAN 550 mg film-coated tablets by M/s Norgine
Regulatory Authorities Pharmaceuticals Ltd UK, MHRA Approved
Me-too status Nimixa 550mg tablet by Getz Pharma, Reg. No. 070733.
GMP status Panel GMP inspection for issuance of GMP certificate conducted
on 23-07-2020 & 10-09-2020 by following panel:
1. Hafsa Karam Elahi, Addl. Director (QA & LT-I) DRAP,
Islamabad.
2. Ishtiaq Shafiq, Assistant Director (I & E), DRAP
Islamabad.
3. Babar Khan, Federal Inspector of Drugs-I, DRAP
Islamabad.
Conclusion: Based on the areas inspected, the people met and the
documents reviewed and considering the findings of the
inspection, Valor Pharma Pvt. Ltd. Plot No.124/A, Kahuta Road,
Industrial Triangle, Islamabad was considered to be operating at
an acceptable compliance level of GMP as of today as per the
Drugs Act, 1976 and Drap Act, 2012 and rules framed
thereunder.
Remarks of the Evaluator (PEC-XVII) • Firm revised finished drug product specifications from
manufacturer to innovators specifications and submitted fee Rs:
7500/- vide on-line deposit slip no. 1077431034.
• Tablet section (General) available as per DML renewal report
dated 20.04.2018. DML renewal issued w.e.f 29.03.2017, valid
till 28.03.2022.

414. Name and address of manufacturer/ M/s Valor pharmaceuticals, 124/A, Industrial Triangle, Kahuta
Brand Name + Dosage Form + Strength Valmet 50mg/850mg Tablet
Vildagliptin ……………50mg
Metformin HCl...............850mg
Pharmacological Group Antidiabetic drug

Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s. As recommended by the PRC (M/o
NHS, R&C)/Fedgovt.
Approval status of product in Reference Eucreas (MHRA)
Me-too status Galvus Met (50mg/850mg) tablet by Novartis Pharma, Reg. No.
066106.
GMP status As above
7500/- vide on-line deposit slip no. 190881449.
till 28.03.2022.
Decision: Approved with Innovator’s specifications with a shelf life of 18 months.
415. Name and address of manufacturer/ M/s Valor Pharmaceuticals, 124/A, Industrial Triangle, Kahuta
NHS, R&C)/Fedgovt.
Approval status of product in Reference Eucreas 50/1000mg film coated tablet, Novartis Pharma,
Regulatory Authorities Germany (MHRA)
066107.
GMP status As above
7500/- vide online deposit slip no. 470040930310.
till 28.03.2022.
NHS, R&C)/Fedgovt.
Approval status of product in Reference Eucreas 50/500mg film coated tablet, Novartis Pharma, Germany
Regulatory Authorities (MHRA)
078106.
GMP status As above

7500/- vide online deposit slip no. 2557554144.
till 28.03.2022.
Brand Name + Dosage Form + Strength V-Dipsar 5mg/20mg Tablet
Amlodipine as Besylate……………5mg
Olmesartan medoxomil…....................20mg
Pharmacological Group Antihypertensive drug
Pack size & Demanded Price 10’s,14’s,20’s,28’s,30’s. As recommended by the PRC (M/o
NHS, R&C)/Fedgovt
Approval status of product in Reference Sevikar 20mg/5mg film coated tablet, Daiichi-Sankyo UK ltd.
Regulatory Authorities UK (MHRA)
Me-too status Olmedip 5mg/20mg tablet by Shrooq Pharmaceuticals, Lahore.
Reg. No. 068083.
GMP status As above
Remarks of the Evaluator (PEC-XVII)
• Firm revised finished drug product specifications from
manufacturer to USP specifications and submitted fee Rs: 7500/-
vide online deposit slip no. 3029877372.
till 28.03.2022.
NHS, R&C)/Fedgovt
Approval status of product in Reference Azor 20mg/10mg film coated tablet, Daiichi-Sankyo UK ltd. UK
Regulatory Authorities (USFDA)
Reg. No. 068082.
GMP status As above
manufacturer to USP specifications and submitted differential
fee of Rs: 7500/- vide online deposit slip no. 517945721668
dated 06-01-2022.
till 28.03.2022.

NHS, R&C)/Fedgovt.
Reg. No. 068085
GMP status As above
fee of Rs: 7500/- vide online deposit slip no. 16875694923 dated
06-01-2022.
till 28.03.2022.
NHS, R&C)/Fedgovt.
Reg. No. 068084
GMP status As above
fee of Rs: 7500/- vide online deposit slip no. 71911271 dated 06-
01-2022.
till 28.03.2022.
Brand Name + Dosage Form + Strength Valofibren 67mg capsules
Composition Each hard gelatin capsules contains;

Fenofibrate…..67mg
Pharmacological Group Serum Lipid Reducing agents/Cholesterol and triglycerides
reducers/fibrates
Finished product Specification USP Specifications
Pack size & Demanded Price 10’s,14’s,20’s,30’s. As recommended by the PRC (M/o NHS,
R&C)/Fedgovt.
Approval status of product in Reference Fenofibrate 67mg capsules
Regulatory Authorities Actavis Barnstaple UK (MHRA approved)
Me-too status Fenoget 67mg micronized capsules of M/s Getz Pharmaceuticals,
Karachi.
Registration No.047197
GMP status As above
Remarks of the Evaluator (PEC-XVII) • Physical form of API in innovator product is micronized.
• Capsule section (General) available as per DML renewal report
till 28.03.2022.
Decision: Approved.
Brand Name + Dosage Form + Strength Valozole cream 1%
Composition Each gram contains;
Bifonazole…..10mg
Pharmacological Group Antifungals for dermatological use-Bifonazole
Finished product Specification Innovator Specifications
Pack size & Demanded Price 5gm, 10gm, 15gm & 30gm. As recommended by the PRC (M/o
NHS, R&C)/Fedgovt.
Approval status of product in Reference Canesten Bifonazole once daily 1% w/w Cream
Regulatory Authorities Bayer plc, UK (Marketing authorization holder)
Kern Pharma Barcelona, Spain (Manufacturer)
(MHRA approved)
Me-too status Mupiderm cream of Biogen Pharmaceuticals, Islamabad.
GMP status As above
manufacturer to innovators specifications and submitted
differential fee of Rs: 7500/- vide online deposit slip
no.76400255087 dated 06-01-2022.
• Cream/ointment/lotion section (General) available as per DML
renewal report dated 20.04.2018. DML renewal issued w.e.f
29.03.2017, valid till 28.03.2022.
Brand Name + Dosage Form + Strength Valomat eye drops 1% w/v
Composition Each ml contains;
Brinzolamide……10mg
(USP specifications)
Pharmacological Group Antiglaucoma preparations and miotics, carbonic anhydrase
inhibitors

Pack size & Demanded Price 5ml drops in plastic bottles (HDP). As recommended by the PRC
(M/o NHS, R&C)/Fedgovt.
Approval status of product in Reference Azopt 10ml/ml eye drops (suspension)
Regulatory Authorities Novartis Europharm ltd. UK (MHRA approved)
Me-too status Azopt (Ophthalic suspension) of M/s Novartis pharma, Karachi.
GMP status As above
• Eye drops section (General) available as per DML renewal report
till 28.03.2022.
Decision: Approved.
Brand Name + Dosage Form + Strength Vicort cream
Composition Each gm contains;
Diflucortolone valerate……1mg
Isoconazole nitrate…………10mg
Pharmacological Group Corticosteroids with anti-infective agents
Finished product Specification Innovators Specifications
Pack size & Demanded Price 5gm,10gm,15gm & 30gm. As recommended by the PRC (M/o
NHS, R&C)/Fedgovt.
Approval status of product in Reference Travocort 0.1 + 1% w/w Cream (AIFA Italy Approved)
Me-too status Travocort cream of M/s Bayer HealthCare, Karachi. Registration
No.005830
GMP status As above
manufacturer to innovators specifications and submitted
differential fee of Rs: 7500/- vide online deposit slip
no.08696685771 dated 06-01-2022.
• As per panel GMP inspection report conducted on 23.07.2020 &
10.09.2020, the firm has separate dispensing facilities for
steroids. The excerpt from the report is as follows;
“total three dispensing stations have been provided one in
general, one in steroid & one in Psychotropic. These dispensing
stations were operational with dispensing hood, weighing
balance and scoops.”
425. Name and address of manufacture / M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar Industrial
Applicant Estate, Lahore
Brand Name + Dosage Form and MEWO Tablet 10mg
Strength
Donepezil Hydrochloride …... 10mg
Dairy No. date of R &I fee Form-5 Dy. No. 10317 dated 05-03-2019 Rs.20,000 dated 04-03-
2019
Pharmacological Group Cholinesterase inhibitor
Type of form Form 5
Pack size and Demand Price 10’s & 20’s. As per SRO
Approval status of product in Reference ARICEPT 10mg Eisai Ltd UK. (MHRA approved)

Me-too-status ZILDON 10mg tablet of M/S Wilshire Pharmaceuticals,
Lahore. Reg. # 055315
GMP Status GMP certificate valid till 12-02-2022, issued on the basis of
Remarks of the Evaluator (PEC-XVII) • DML granted vide letter No. F.1-29/2011-Lic dated 12-06-2017
w.e.f 12.06.2017 for following sections:
Tablet I (General)
Tablet II (General)
Capsule (General)
Sachet (General)
Oral syrup (General)
Decision: Approved.
Brand Name + Dosage Form and TYZKA Tablet 600mg
Strength
Telbivudine …... 600mg
2019
Type of form Form 5
Pack size and Demand Price 28’s. As per SRO
Approval status of product in Sebivo 600mg film coated tablet by Mylan Pharma Gmbh
Reference Regulatory Authorities Switzerland (Swissmedic Switzerland approved)
Me-too-status Omana 600mg tablet, ICI Pakistan Ltd. Registration No.064497
Decision: Approved.
Brand Name + Dosage Form and GALNT 8mg Tablet
Strength
Composition Each Film-Coated Tablet Contains:
Galantamine as Galantamine Hydrobromide…8mg
Dairy No. date of R &I fee Form-5 Dy.No 10307 dated 05-03-2019 Rs.20,000 dated 04-03-
2019
Pharmacological Group Acetylcholinesterase inhibitor
Type of form Form 5
Approval status of product in Razadyne (Formerly Reminyl) 4mg, 8mg, 12mg
Reference Regulatory Authorities (US FDA Approved)
Me-too-status Reminyl 8mg (Jhonson & Jhonson, Pakistan)
Reg. # 039802
Decision: Approved.

Brand Name + Dosage Form and AVPRO-D 150mg/12.5mg Tablet
Strength
Irbesartan …. 150mg
Hydrochlorothiazide … 12.5mg
2019
Pharmacological Group Irbesartan: Angiotensin II receptor antagonists/Antihypertensive
Hydrochlorothiazide: Diuretic
Type of form Form 5
Pack size and Demand Price 10’s & 20’s, As per SRO
Approval status of product in Reference CoAprovel 150mg/12.5mg Sanofi Clir SNC France (MHRA
Me-too-status Co-Aprovel 150mg/12.5mg (Sanofi Pakistan) Reg # 043095
Decision: Approved.
Brand Name + Dosage Form and GLANT 12mg Tablet
Strength
Composition Each Film-Coated Tablet Contains:
Galantamine as Galantamine Hydrobromide…12mg
2019
Type of form Form 5
Pack size and Demand Price 14’s, 30’sAs per SRO
Approval status of product in Razadyne (Formerly Reminyl) 4mg, 8mg, 12mg
Reference Regulatory Authorities (US FDA Approved)
Me-too-status Reminyl 12mg (Jhonson & Jhonson, Pakistan)
Reg. # 039803
Decision: Approved.
Brand Name + Dosage Form and BTEPLK 500mg Tablet
Strength
Composition Each Pessary / Vaginal Tablet Contains:
Clotrimazole… 500mg
2019
Pharmacological Group Imidazole antifungal
Type of form Form 5
Pack size and Demand Price 1’s, As per SRO
Approval status of product in CANESTEN 500mg Bayer UK (MHRA Approved)
Me-too-status Canesten 500mg (M/S Bayer) Reg. # 007293

Decision: Approved.
Brand Name + Dosage Form and ALTRAZ Tablet 1mg
Strength
Anastrozole…. 1mg
2019
Pharmacological Group Aromatase inhibitor
Type of form Form 5
Approval status of product in Reference Arimidex 1mg tablet AstraZeneca UK (MHRA approved)
Me-too-status Astrazon 1mg tablet by Relizon Pharmaceuticals, Lahore
(Registration No. 093958)
Decision: Registration Board approved registration of applied product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of this drug.
Brand Name + Dosage Form and LECOPA 200/50/200mg Tablet
Strength
Composition Each film-coated tablet contains:
Levodopa … 200mg
Carbidopa … 50mg
Entacapone …. 200mg
2019
Pharmacological Group Levodopa: Dopamine agent
Carbidopa: Decarboxylase inhibitors
Entacapone: Catechol-O-methyltransferase (COMT) Inhibitor
Type of form Form 5
Pack size and Demand Price 30’s & 100’s, As per SRO
Approval status of product in STALEVO 200mg/50mg/200mg (Orion UK) Approved MHRA
Me-too-status Paridopa 200mg/50mg/200mg M/S Pharmevo Karachi
Registration No. 092720
Brand Name + Dosage Form and LECOPA 100/25/200mg
Strength

Composition Each Filmcoated Tablet Contains:
Levodopa … 100mg
Carbidopa … 25mg
Entacapone …. 200mg
2019
Pharmacological Group Levodopa: Dopamine agent
Carbidopa: Decarboxylase inhibitors
Entacapone: Catechol-O-methyltransferase (COMT) Inhibitor
Type of form Form 5
Finished product specifications Innovator
Approval status of product in STALEVO 100mg/25mg/200mg (UK) Approved MHRA
Me-too-status Paridopa 100mg/25mg/200mg M/S Pharmevo Karachi,
Brand Name + Dosage Form and FENFEX 180mg Tablet
Strength
Composition Each Film coated tablet contains:
Fexofenadine Hydrochloride …. 180mg
2019
Type of form Form 5
Approval status of product in Reference TELFAST 180mg tablet, Sanofi UK (MHRA approved)
Me-too-status Fendina-F 180mg tablet by M/s Highnoon laboratories, Lahore
(PEC-XVII)
Decision: Approved.
Brand Name + Dosage Form and DXBRO 300mg Tablet
Strength
Dexibuprofen…. 300mg
2019
Pharmacological Group NSAID (Non-steroidal anti-inflammatory drug)
Type of form Form 5
Approval status of product in Reference Dexibuprofen 300mg tablet (EMA, MHRA approved)

Me-too-status TERCICA 300mg tablet by Sami pharmaceuticals, Karachi
(Reg. # 058445)
Decision: Approved.
Brand Name + Dosage Form and Glant 4mg Syrup
Strength
Galantamine as hydrobromide…4mg
03-2019
Type of form Form 5
Pack size and Demand Price 60ml, As per SRO
Approval status of product in REMINYL Shire Pharmaceuticals UK (MHRA approved)
Reference RegulatoryAuthorities
Me-too-status Dementio 4mg oral solution by M/s Reko Pharmaceuticals,
Lahore (Registration No. 069433)
Remarks of the Evaluator (PEC-XVII) • DML granted vide letter No. F.1-29/2011-Lic dated 12-06-2017
w.e.f 12.06.2017 for following sections:
Tablet I (General)
Tablet II (General)
Capsule (General)
Sachet (General)
Oral syrup (General)
Decision: Approved.
Brand Name + Dosage Form and Suproxen 85mg/500mg Tablet
Strength
Sumatriptan Succinate 119mg Eq To Sumatriptan…..…85mg
Naproxen Sodium……..500mg
Dairy No. date of R &I fee Form-5 Dy. No. 10859 dated 05-03-2019 Rs.20,000/- dated 04-
03-2019
Pharmacological Group Sumatriptan Succinate: selective 5-hydroxytryptamine (5HT1)-
receptor agonist
Naproxen Sodium: Nonsteroidal anti-inflammatory drug
(NSAID).
Type of form Form 5
Pack size and Demand Price 2’s, 6’s, 10’s, As per SRO
Approval status of product in TREXIMET 85mg/500mg (Currax Pharmaceuticals USA) (US
Reference Regulatory Authorities FDA approved with Box warning).
Me-too-status IMTAXEN 85mg/500mg tablet Shaigan Pharmaceuticals,
Islamabad. (Reg. # 081678)

Decision: Approved with Innovator’s specifications and Boxed Warning for Risk of Serious
Cardiovascular and Gastrointestinal Events.
Brand Name + Dosage Form and Nocough 250mg/5mg/3.75mg
Strength
Paracetamol…250mg
Promethazine HCl…5mg
Dextromethorphan…3.75mg
03-2019
Pharmacological Group Paracetamol: NSAID
Promethazine HCl: Antihistamine
Dextromethorphan HBr: Antitussive
Type of form Form 5
Pack size and Demand Price 60ml, 120ml, As per SRO
Approval status of product in Night Nurse 1000mg,20mg,15mg Per 20ml GSK Consumer
Reference Regulatory Authorities Healthcare UK (MHRA approved)
Me-too-status Nightcare 250mg,5mg,3.75mg Per 5ml Highnoon laboratories,
Lahore (Reg. # 042798)
Remarks of the Evaluator (PEC-XVII) • MHRA approved product has composition per 20ml
Decision: Approved with Innovator’s specifications and change of brand name.
Brand Name + Dosage Form and Giflox 320mg Tablet
Strength
Composition Each Film Coated Tablet Contains Gemifloxacin as
Gemifloxacin Mesylate…….320mg
Dairy No. date of R &I fee Form-5 Dy. No. 10929 dated 05-03-2019 Rs.20,000/- dated 04-
03-2019
Pharmacological Group Quinolone Antibiotic
Type of form Form 5
Approval status of product in FACTIVE 320mg tablet (US-FDA approved)
Me-too-status Gemixa 320mg tablet b M/S Bosch Pharmaceuticals, Karachi.
(Reg. # 048499)
Brand Name + Dosage Form and Rispidon 5mg Syrup
Strength
Risperidone…5mg
03-2019
Pharmacological Group Atypical antipsychotic

Type of form Form 5
Pack size and Demand Price 30ml, 60ml and 120ml, As per SRO
Approval status of product in RISPERDAL 5mg/5ml Janssen-Cilag Ltd. UK
Reference Regulatory Authorities (MHRA approved)
Me-too-status Persch oral solution 1mg/ml by M/s Barett Hodgson Karachi

Decision: Approved.
441. Name and address of manufacture / M/s Bio-Labs (Pvt) ltd., Plot No.145, Industrial Triangle, Kahuta
Brand Name + Dosage Form and Cholitolrate tablets 1mg
Strength
Tolterodine tartrate….1mg
Dairy No. date of R &I fee Dy. No 12451 dated 06-03-2019 Rs.20,000/- dated 05-03-2019
Pharmacological Group Anti-cholinergic agent

Type of form Form 5
Finished product specifications BP specifications
Pack size and Demand Price 2×10’s as per DRAP’s pricing policy
Approval status of product in Reference Detrusitol 1 mg film coated tablets (MHRA approved)
Me-too-status Ezeecon 1mg tablet of Barett Hodgson, Pakistan, Karachi.
GMP Status GMP certificate issued to firm on 21st May, 2019, on the basis of
panel GMP inspection conducted on 23.04.2019 and valid upto
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Tablet section (General) approved vide Licensing Division letter
No.F.1-12/98-Lic (Vol-II) dated 24.03.2007.
Decision: Approved.
Brand Name + Dosage Form and Cholitolrate tablets 2mg
Strength
Tolterodine tartrate….2mg
Pharmacological Group Anti-cholinergic agent

Type of form Form 5
Pack size and Demand Price 2×10’s as per DRAP’s pricing policy
Approval status of product in Reference Detrusitol 1 mg film coated tablets (MHRA approved)
Me-too-status Ezeecon 2mg tablet of Barett Hodgson, Pakistan, Karachi.
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Tablet section (General) approved vide Licensing Division letter

Decision: Approved.
Brand Name + Dosage Form and Thiolaksent 4mg capsules
Strength
Thiocolchicoside……4mg
Pharmacological Group Muscle relaxant

Type of form Form 5
Finished product specifications Innovator specifications
Pack size and Demand Price 10’s as per DRAP’s pricing policy
Approval status of product in Reference MIOREL 4 mg, capsule (ANSM France) & MUSCORIL 4mg &
Regulatory Authorities 8mg capsules (AIFA Italy)
Me-too-status M-Lex 4mg capsule by Invictus pharmaceuticals, Rawat,
Rawalpindi. Registration No. 097808
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Capsule section (General) approved vide Licensing Division
letter No.F.1-12/98-Lic (Vol-II) dated 24.03.2007.
• Monograph for API Thiocolchicoside hydrate mentioned in B.P
Vol-II Page No. 1119
Brand Name + Dosage Form and NEW GABA CAPSULES 225mg
Strength
Pregabalin…...225mg
Type of form Form 5
Approval status of product in ReferenceLyrica 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg,
Regulatory Authorities and 300 mg, capsules, hard (Pfizer Limited, UK). (MHRA
approved)
Me-too-status Pregalin 225mg of M/s Barrett Hodgson Pakistan, Karachi.
22.04.2022.
• API monograph available in USP
Brand Name + Dosage Form and IRBEZIDE 300/12.5mg tablet
Strength
Irbesartan……….300mg
Hydrochlorothiazide……..12.5mg

Pharmacological Group Irbesartan: angiotensin receptor blockers (ARBs)
Hydrochlorothiazide: Diuretics
Type of form Form 5
Finished product specifications USP specifications
Approval status of product in Reference (MHRA approved)
Me-too-status Irbelex 300mg/12.5mg tablet of M/s Pharmasol (Pvt) ltd. Lahore.
22.04.2022.
(PEC-XVII)
Decision: Approved.
Brand Name + Dosage Form and Candelexet 16mg tablet
Strength
Candesartan cilexetil……...16mg
Pharmacological Group Angiotensin receptor blocker

Type of form Form 5
Approval status of product in Reference Amias 2mg, 4mg, 8mg, 16mg, 32mg, Takeda UK (MHRA
Me-too-status Cartex 16mg tables of M/s Schazoo laboratories, Lahore.
RegistrationNo.041886
22.04.2022.
Decision: Approved.
Brand Name + Dosage Form and Pepsinlate 1gm tablet
Strength
Sucralfate……...1gm
Pharmacological Group Anti-peptic ulcerants
Type of form Form 5
Approval status of product in Reference (US FDA approved)
Me-too-status Crusate 1gm tablet of M/s High-Q pharmaceuticals, Karachi.
22.04.2022.
(PEC-XVII)
Decision: Approved.

Brand Name + Dosage Form and Ceprozil suspension (DS) 125mg/5ml
Strength
Composition Each 5ml of constituted suspension contains:
Cefprozil (as monohydrate) …….125mg/5ml
Pharmacological Group Cephalosporin antibiotic
Type of form Form 5
Pack size and Demand Price 50ml, as per DRAP’s pricing policy
Approval status of product in Reference AUROBINDO PHARMA (US FDA approved)
Me-too-status Vegapor 125mg dry powder suspension of Vega
pharmaceuticals, Lahore. Registration No.078765
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Dry powder suspension (Cephalosporin) section approved vide
Licensing Division, letter No.F.6-3/2008-Lic dated 22.10.2008.
Section. The same section is also mentioned in GMP certificate
issue to the firm.
Decision: Approved.
Brand Name + Dosage Form and Ceprozil suspension (DS) 250mg/5ml
Strength
Cefprozil (as monohydrate) …….250mg/5ml
Pharmacological Group Cephalosporin antibiotic

Type of form Form 5
Pack size and Demand Price 50ml, as per DRAP’s pricing policy
Approval status of product in Reference AUROBINDO PHARMA (US FDA approved)
Me-too-status Ceftru 250mg/5ml dry powder suspension of Rotex
pharmaceuticals, Islamabad. Registration No.087294
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Dry powder suspension (Cephalosporin) section approved vide
Licensing Division, letter No.F.6-3/2008-Lic dated 22.10.2008.
Section. The same section is also mentioned in GMP certificate
issue to the firm.
Decision: Approved.
Brand Name + Dosage Form and Noxaflox 400mg tablet
Strength
Norfloxacin …….400mg
Pharmacological Group Antibacterial agent

Type of form Form 5
Pack size and Demand Price 14’s, as per DRAP’s pricing policy
Approval status of product in Reference (US FDA approved with boxed warning: serious adverse reactions
Regulatory Authorities including tendinitis, tendon rupture,
Peripheral neuropathy, central nervous system effects and
exacerbation of Myasthenia gravis)
Noroxin 400mg of Merck Sharp & Dohme. status is discontinued
with remarks **Federal Register determination that product was
not discontinued or withdrawn for safety or effectiveness
reasons**
Me-too-status Nortic 400mg tablet of M/s Reign pharmaceuticals, Karachi.
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • The firm has claimed USP specifications, while the product was
previously available in USP, is now unavailable in current
version USP 43 NF 38.
• Official monograph available in BP and Japanese
Pharamcopoeis.
• Revision of label claim is required as the reference product is
film coated.
Decision: Approved as per following label claim with BP specifications:
Each film-coated tablet contains:
Norfloxacin …….400mg
• Firm will submit the fee of Rs. 7,500 for pre-approval change in product specifications and
formulation from uncoated to film coated tablet.
Brand Name + Dosage Form and Glita-Met 15/850mg tablet
Strength
Pioglitazone HCl……15mg
Metformin HCl………850mg
Pharmacological Group Antihyperglycemic
Type of form Form 5
Approval status of product in Reference Competact 15mg/850mg film coated tablet (Takeda) (MHRA
Me-too-status Alromet 15mg/850mg tablet, Lexicon Pharmaceutical Karachi.
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Firm revised the label claim as:
Pioglitazone as HCl….15mg
Metformin HCl……850mg and submitted fee Rs: 30000/- vide
on-line deposit slip No. 4224053876.
• Tablet section (General) approved vide Licensing Division letter
Decision: Approved with following revised label claim:

Pioglitazone as HCl……..15mg
Metformin HCl…..……850mg
Brand Name + Dosage Form and Biovalavir 500mg tablet
Strength
Valaciclovir HCl…… 500mg
Pharmacological Group Antiviral agents
Type of form Form 5
Pack size and Demand Price 5’s & 10’s as per DRAP’s pricing policy
Me-too-status Valari 500mg tablet by Navegal pharmaceuticals, Hattar
22.04.2022.
• Firm revised the label claim as:
Each film-coated tablet contains
Valaciclovir (as valaciclovir hydrochloride monohydrate)
…...500mg and submitted fee Rs:30000/- vide on-line deposit
slip No. 0501703020
Valaciclovir (as Valaciclovir hydrochloride monohydrate) …………500mg
Brand Name + Dosage Form and Lorofen 60mg tablet
Strength
Loxoprofen Sodium (as dihydrate) …60mg
Type of form Form 5
Approval status of product in Reference Loxonin® Tablets 60mg (Uncoated tablets Daiichi Sankyo Co.,
Regulatory Authorities Ltd. Japan) (PMDA approved)
Me-too-status Naloxium tablet 60mg by S.J & G. Fazul Ellahie, Karachi.
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Firm revised innovator specifications as per Japanese
Pharmacopoeia and submitted requisite fee Rs: 7500/- vide on-
line deposit slip No. 09077695800
• Firm initially mentioned coating process in manufacturing
outlines, which were revised as per reference product which is
un-coated.
Decision: Approved with Japanese Pharmacopoeia.

Brand Name + Dosage Form and Clonazilab 2mg tablet
Strength
Clonazepam…...2mg
Pharmacological Group Benzodiazepine
Type of form Form 5
Me-too-status Lonese 2mg tablet by Heal Pharmaceuticals, Peshawar
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Firm has got approval for change of Tablet General Section into
Tablet Psychotropic Section vide Licensing Division, DRAP
Islamabad letter No.F.6-2/2009-Lic (M-217) dated 02-06-2009.
Decision: Approved.
Tablet Section (General)
Brand Name + Dosage Form and Ezopic 3mg tablet
Strength
Eszopiclone…...3mg
Pharmacological Group Hypnotics
Type of form Form 5
Approval status of product in Reference LUNESTA® (eszopiclone) 1mg, 2mg, 3mg tablets Sunovion
Regulatory Authorities Pharmaceuticals Inc. (US FDA approved)
Me-too-status Suzocil 3mg tablet by M/s Martin Dow Ltd (Reg#082986)
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Firm has revised pharmacological group in Form-5 from “Beta
blocking agent” to “Hypnotics”. Fee not submitted for the change
in pharmacological group.
Decision: Approved.
• Firm will submit the fee of Rs. 7,500 for pre-approval change in pharmacological group of applied
product.
Tablet Section (General)
Brand Name + Dosage Form and Bio-Famiral 250mg tablet
Strength
Famciclovir…….…250mg


Type of form Form 5
Me-too-status Flovir 250mg tablet by Maxitech pharma Pvt ltd. Karachi.
22.04.2022.
• Firm revised the finished drug product specifications as per
official monograph (USP), as drug product monograph is
available in USP42-NF37 1S – 8688 and onward. The requisite
fee Rs: 7500/- submitted vide on-line deposit slip
No.750511108367
Brand Name + Dosage Form and Bio-Famiral 500mg tablet
Strength
Famciclovir……500mg

Type of form Form 5
Me-too-status Trivir 500mg tablet by Trillium Pharmaceuticals, Faisalabad.
22.04.2022.
• Firm revised the finished drug product specifications as per
official monograph (USP), as drug product monograph is
available in USP42-NF37 1S – 8688 and onward. The requisite
fee Rs: 7500/- submitted vide on-line challan No.182050926884
Brand Name + Dosage Form and Minobac 100mg tablet
Strength
Minocycline HCl……100mg
Pharmacological Group antibiotic

Type of form Form 5

Me-too-status Minokane 100mg tablet by M/s Kanel Pharma, Islamabad.
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Firm revised label claim as per reference product as: Each tablet
contains:
Minocycline hydrochloride equivalent to 100mg Minocycline
and submitted fee Rs: 30000/- vide on-line deposit slip
No.8859176959
Each tablet contains:
Minocycline hydrochloride equivalent to Minocycline………100mg
Brand Name + Dosage Form and Biopamide 2.5mg tablet
Strength
Indapamide hemihydrate……...2.5mg
Pharmacological Group Thiazide-like diuretic

Type of form Form 5
Me-too-status Uromid 2.5mg tablet of M/s Maple pharmaceuticals, Karachi.
22.04.2022.
Remarks of the Evaluator (PEC-XVII) • Firm revised the label claim as:
Indapamide (as hemihydrate) ….2.5mg
and submitted fee Rs: 30,000/- vide challan No.7634873771
• The product is available as sugar coated (Manx Healthcare Ltd
UK, Strides Pharma UK), plain (Niche Generics Limited. UK)
and film coated tablets (Zentiva Pharma UK, Generics UK
Limited t/a Mylan) in MHRA.
Indapamide (as hemihydrate) …….. 2.5mg
460. Name and address of manufacture / M/s Barrett Hodgson Pakistan (Pvt) Ltd.
Applicant F/423, S.I.T.E, Karachi.
Brand Name + Dosage Form and Multibar tablet
Strength
Vitamin A USP….4000 IU
Beta Carotene USP…...1000 IU
Vitamin D BP…...400 IU
Vitamin E USP…30 IU
Vitamin C USP…...90 mg
Vitamin B1 USP….3 mg

Vitamin B2 BP….3.4 mg
Vitamin B6 USP…3 mg
Vitamin B12….9 mcg
Pantothenic Acid USP…10 mg
Folic Acid USP…...0.4 mg
Biotin USP….30 mcg
Niacin USP….20 mg
Iron BP…...27 mg
Calcium USP…...40 mg
Phosphorus BP…31 mg
Iodine USP….150 mcg
Magnesium USP….100 mg
Copper USP…2 mg
Zinc USP….15 mg
Manganese BP…...5 mg
Selenium USP…...10 mcg
Molybdenum BP….15 mcg
Chromium USP….15 mcg
Potassium USP….7.5 mg
Chloride USP…...7.5 mg
(Manufacturer specifications)
Challan No.0819826 dated: 27.02.2019
Pharmacological Group Multivitamin
Type of form Form 5
Finished product specifications Manufacturer specifications
Pack size and Demand Price Pack of 30’s, Rs: 630/-
Pack of 60’s, Rs: 1260/-
or as per DRAP’s pricing policy.
Approval status of product in Reference Could not be confirmed
Me-too-status Theragran Ultra tablet of GlaxoSmithKline Pakistan limited.
Registration No. 033732.
GMP Status GMP inspection conducted on 16th & 28th August 2018.
Conclusion: the firm has complied and addressed all the
observations as advised in the last inspection. Overall found
satisfactory and progressive towards good level of GMP
compliance.
Remarks of the Evaluator(PEC-XVII) • Specify the finished product specifications as in Form 5, the
manufacturer specifications mentioned while at Annexure VI &
Annexure IX of the dossier, the finished product specifications
are mentioned as USP specifications and submit requisite fee.
regulatory authorities/agencies which were declared/adopted by
the Registration Board in its 275th meeting as the evidence
provided in the application could not be confirmed.
• Application with same formulation has been decided in 312th
meeting held on 14-16th September 2021 as
“Deferred for review of formulation as per decision of 297th
meeting of Registration Board”.
Decision: Deferred for review of formulation as per decision of 291st meeting of Registration Board for
“Registration of Vitamin Formulations.”
461. Name and address of manufacture / M/s Adamjee Pharmaceuticals (Pvt.) Ltd. Plot No.39, Sector 15,
Applicant Korangi Industrial Area, Karachi.
Brand Name + Dosage Form and Adagab 100mg capsule
Strength

Gabapentin USP……100mg
Challan No.0807512 dated: 04.03.2019
Pharmacological Group antiepileptic
Type of form Form 5
Pack size and Demand Price As per price recommendation committee
Approval status of product in Reference Gabapentin 100mg, 300mg & 400mg capsules, hard (MHRA
Me-too-status Pentowan 100mg capsule of M/s Nawan laboratories, Karachi.
GMP Status • Panel inspection for renewal of DML of the firm conducted on 02-
06-2021, wherein inter-alia following remarks given:
“The panel found an adequate level of GMP compliance after
thorough review of their system. Based on the stated facts and
observations, production facilities, QA system, QC labs, stores,
utilities and people met during inspection, the panel unanimously
recommended” the grant of renewal of DML for different sections,
including Capsule (General/antibiotic) section.
Decision: Approved.
App0licant Korangi Industrial Area, Karachi.
Strength
Gabapentin ……300mg
Challan No.0807513 dated: 04.03.2019
Type of form Form 5
Pack size and Demand Price 1 × 10’s, As per price recommendation committee
Decision: Approved.
Strength
Gabapentin ……400mg

Challan No.0807514 dated: 04.03.2019
Type of form Form 5
Decision: Approved.
Brand Name + Dosage Form and Adamont 10mg tablet
Strength
Montelukast (as Sodium)……10mg
Challan No.0807516 dated: 04.03.2019
Pharmacological Group Leukotriene receptor antagonist
Type of form Form 5
Approval status of product in Reference Montelukast 10mg (as montelukast sodium) Film-coated tablets,
Regulatory Authorities MHRA approved.
Me-too-status Dowkast 10mg tablet of M/s Seatle (Pvt) Ltd. Lahore Registration
No. 103298
including Tablet (General) section.
Decision: Approved.
Brand Name + Dosage Form and Adamont 5 mg tablet
Strength
Montelukast (as Sodium) ……5 mg
Challan No.0807516 dated: 04.03.2019
Pharmacological Group Leukotriene receptor antagonist

Type of form Form 5
Approval status of product in Reference Singulair (4mg, 5 mg) Chewable Tablet
Regulatory Authorities (US FDA Approved)
Me-too-status Dowkast 5mg chewable tablet of M/s Seatle (Pvt) Ltd. Lahore
GMP Status Panel inspection for renewal of DML of the firm conducted on 02-
Remarks of the Evaluator (PEC-XVII) • Firm revised the label claim, master formulation and
manufacturing outline as per reference formulation which is
chewable tablet.
• Firm revised label as;
Montelukast (as sodium) ……5mg
and submitted fee Rs: 7500/- only vide on-line Slip No.
8132125851.
Montelukast (as sodium) …….5mg.
• Firm will submit the differential fee of Rs. 22,500 for correction/pre-approval change in
composition (correction/change of formulation from film-coated tablet to chewable tablet.)
466. Name and address of manufacture / M/s Adamjee Pharmaceuticals (Pvt.) Ltd.
App0licant Plot No.39, Sector 15, Korangi Industrial Area, Karachi.
Brand Name + Dosage Form and Durdgone DS tablet
Strength
Drotaverine HCl ...…80mg (Manufacturer specs)
Challan No.0807518 dated: 04.03.2019
Pharmacological Group Anti-spasmodic
Type of form Form 5
Approval status of product in Reference Applied formulation is present in different European Economic
Regulatory Authorities Area (EEA) states like Poland, Hungary, Lithuania & Latvia (both
as un-coated and coated tablets).
Me-too-status Dytra 80mg Tablet of M/s. Tabros Pharma, Karachi.
GMP Status Panel inspection for renewal of DML of the firm conducted on 02-
Remarks of the Evaluator (PEC-XVII) • Official monograph of the finished drug product not available.
Firm has submitted reply that specifications of reference product
that is “No-Spa tablet” is still on “Manufacturer specification”.

• Firm will submit the fee of Rs. 7,500 for pre-approval change in product specifications.
467. Name and address of manufacture / M/s Epharm Laboratories, A-40, Road No. 1, S.I.T.E. Super
Applicant Highway Industrial Area, North Karachi.
Brand Name + Dosage Form and Diaphage 500mg tablet
Strength
Metformin hydrochloride…...500mg
Challan No.0842155 dated: 01.03.2019
Pharmacological Group Blood glucose lowering agent (Biguanides)
Type of form Form 5
Pack size and Demand Price 50’s, 100’s, As per SRO
Approval status of product in Reference GLUCOPHAGE (US FDA Approved with following boxed
Regulatory Authorities warning:
WARNING: LACTIC ACIDOSIS
Postmarketing cases of metformin-associated lactic acidosis have
resulted in death, hypothermia, hypotension, and resistant
bradyarrhythmias. The onset of metformin associated lactic
acidosis is often subtle, accompanied only by nonspecific
symptoms such as
malaise, myalgias, respiratory distress, somnolence, and
abdominal pain. Metformin associated lactic acidosis was
characterized by elevated blood lactate levels (>5 mmol/Liter),
anion gap acidosis (without evidence of ketonuria or ketonemia),
an increased lactate/pyruvate ratio; and metformin plasma levels
generally >5 mcg/mL.
Risk factors for metformin-associated lactic acidosis include renal
impairment, concomitant use of certain drugs (e.g. carbonic
anhydrase inhibitors such as topiramate), age 65 years old or
greater, having a radiological study with contrast, surgery and
other procedures, hypoxic states (e.g., acute congestive heart
failure), excessive alcohol intake, and hepatic impairment.
Steps to reduce the risk of and manage metformin-associated lactic
acidosis in these high-risk groups are provided.
If metformin-associated lactic acidosis is suspected, immediately
discontinue GLUCOPHAGE or GLUCOPHAGE XR and institute
general supportive measures in a hospital setting. Prompt
hemodialysis is recommended.
Me-too-status Glumetza 500mg tablet of M/s Irza pharma (Pvt) Ltd.
Sheikhupura. Registration No. 074498
GMP Status Panel inspection for grant of renewal of DML dated 30-12-2021
attached wherein panel recommended granted of DML renewal to
the firm.
• Panel inspection for grant of renewal of DML dated 30-12-2021
provided as evidence for availability of Tablet (General) Section.
Decision: Approved.
Brand Name + Dosage Form and Diaphage 850mg tablet
Strength
Challan No.0842156 dated: 01.03.2019

Type of form Form 5
Approval status of product in Reference GLUCOPHAGE
Regulatory Authorities (US FDA Approved with following boxed warning:
Me-too-status Metmin 850mg tablet of M/s Maple pharmaceuticals, Karachi.
the firm.
Remarks of the Evaluator (PEC-XVII) • Panel inspection for grant of renewal of DML dated 30-12-2021
Decision: Approved.
Brand Name + Dosage Form and Diaphage-XR 750mg tablet
Strength
Composition Each extended release tablet contains:
Challan No.0842097 dated: 01.03.2019
Type of form Form 5
Approval status of product in Reference GLUCOPHAGE-XR 750mg tablet
Regulatory Authorities (US FDA Approved with boxed warning:
Me-too-status Zevia XR 750mg tablet of M/s AGP, Karachi. Registration No.
086788
the firm.
• Formulation submitted shows that the firm applied product is
film coated. The Glucophage XR tablet is uncoated. However, in
MHRA extended release products are both available as film-
coated and coated tablet.
Decision: Approved.
Brand Name + Dosage Form and Tetracin 250mg capsule
Strength
Oxytetracycline (as HCl) …...250mg
Challan No.0798549 dated: 01.03.2019
Pharmacological Group Tetracycline antibiotic
Type of form Form 5

Me-too-status Parkocyclin 250mg capsules of M/s Parkar Pharma, Kotri, Sindh.
the firm.
provided as evidence for availability of Capsule (General)
Section.
Decision: Approved.
Brand Name + Dosage Form and Pharmotidin 20mg tablet
Strength
Famotidine …...20mg
Challan No.0798547 dated: 01.03.2019
Pharmacological Group H2 antagonist
Type of form Form 5
Me-too-status Acicon 20mg tablet of M/s Barrett Hodgson, Karachi. Registration
No. 024254
the firm.
Decision: Approved.
Brand Name + Dosage Form and Flociprin 750mg tablet
Strength
Ciprofloxacin as HCl …...750mg
Challan No.0798548 dated: 01.03.2019
Pharmacological Group Anti-bacterial
Type of form Form 5
Approval status of product in Reference (US FDA approved) with boxed WARNING:
Regulatory Authorities serious adverse reactions including Tendinitis, tendon rupture,
peripheral Neuropathy, central nervous system effects and
exacerbation of myasthenia gravis
Me-too-status Olgram 750mg tablet of M/s Searle company, Karachi.
the firm.

Decision: Approved.
Brand Name + Dosage Form and L-Tan Plus 50/12.5mg tablet
Strength
Losartan potassium …...50mg
Hydrochlorothiazide……12.5mg
Challan No.0798535 dated: 01.03.2019
(Angiotensin II Receptor antagonist, Thiazide diuretic)
Type of form Form 5
Approval status of product in Reference Cozaar Comp 50 mg/12.5 mg film-coated tablets (MHRA
Me-too-status Lozarta HCT 50mg/12.5mg tablet of M/s Lisko Pakistan Pvt ltd.
Karachi Registration No. 094816
the firm.
Decision: Approved.
Brand Name + Dosage Form and PC-Trax 250mg Plus Injection (IM)
Strength
Ceftriaxone (as Sodium) …...250mg
Challan No.0842153 dated: 01.03.2019
Pharmacological Group Cephalosporin, antibiotic
Type of form Form 5
Me-too-status Getofin 250mg IM injection Getz Pharma, Karachi. Registration
No. 024628
the firm.
Remarks of the Evaluator (PEC-XVII) • The firm also has registration of Ceftriaxone Sodium injection
(PC-Trax 250mg injection, Registration No.047488) with route
of administration either IV or IM not specified. Firm claimed
both as IV and IM for their already registered drug product. For
current product, firm has specified IM route in Form-5.
provided as evidence for availability of Sterile Dry Powder
Injectable (Cephalosporin) Section.
Decision: Approved.
The firm will specify the route of administration of already registered drug product PC-Trax 250mg

injection (Reg. No.047488) before issuance of registration letter of applied product.
Brand Name + Dosage Form and PC-Trax 500mg Plus Injection (IM)
Strength
Ceftriaxone (as Sodium) …...500mg
Challan No.0842154 dated: 01.03.2019
Pharmacological Group Cephalosporin, antibiotic
Type of form Form 5
Me-too-status Getofin 500mg IM injection Getz Pharma, Karachi. Registration
No. 024627
the firm.
Remarks of the Evaluator (PEC-XVII) • The firm also has registration of Ceftriaxone Sodium injection
(PC-Trax 500mg injection, Registration No.048405) with route
of administration either IV or IM not specified. Firm claimed
both as IV and IM for their already registered drug product. For
current product, firm has specified IM route in Form-5.
provided as evidence for availability of Sterile Dry Powder
Injectable (Cephalosporin) Section.
Decision: Approved.
The firm will specify the route of administration of already registered drug product PC-Trax 500mg
injection (Reg. No.048405) before issuance of registration letter of applied product.
Brand Name + Dosage Form and Indopharm 25mg capsule
Strength
Indomethacin…...25mg
Challan No.0798536 dated: 01.03.2019
Type of form Form 5
Pack size and Demand Price 500’s, 1000’s, As per SRO
Me-too-status Andol 25mg capsules of M/s Soma laboratories, Lahore.
the firm.
provided as evidence for availability of Capsule General Section.
Decision: Approved.

Brand Name + Dosage Form and Eucaine suspension
Strength
Oxethazaine …...10 mg
Aluminium hydroxide……291 mg
Magnesium hydroxide……98 mg
Dairy No. date of R &I fee Dy. No. 12065 dated 06-03-2019 Rs.20,000/- dated 05-03-2019
Challan No. 0842151 dated: 01.03.2019
Pharmacological Group Antacids and anesthetic
Type of form Form 5
Pack size and Demand Price 120ml, As per SRO
Approval status of product in Reference Original formulation has been confirmed as Tepilta suspension in
Regulatory Authorities Germany (accessed on 10th March, 2022). Authorization granted on
04th May, 1962 to MEDA Pharma GmbH & Co.KG, Bad Homburg,
Germany. The last SmPC available is of February 2015.
Me-too-status Mucaine suspension of M/s ICI Pakistan ltd. Registration No.
000086
the firm.
Remarks of the Evaluator (PEC-XVII) • In 274th meeting of DRB, product with same formulation has
been approved of M/s Don Valley, Lahore with remarks
regarding availability in reference regulatory authorities as
“Original Formulation has been confirmed as Tepilta suspension
in Germany (accessed on 20th Sep 2017).
• Firm revised the drug product specifications as per innovators
specifications and submitted requisite fee Rs: 7500/- vide on-line
deposit slip No.3882786538.
provided as evidence for availability of Liquid Syrup General
Section.
Brand Name + Dosage Form and Iropharm-F Syrup
Strength
Iron (III) Hydroxide Polymaltose Complex eq. to Elemental
Iron………50mg
Folid Acid…………...0.35mg
Challan No. 0798550 dated: 01.03.2019
Pharmacological Group Anti-anemic drug
Type of form Form 5
Pack size and Demand Price 60ml, 120ml, As per SRO
Me-too-status B-Fer Syrup of M/s Bariell Pharmaceuticals, Lahore. Registration
No. 101564
the firm.
Remarks of the Evaluator (PEC-XVII) • Firm revised the drug product specifications as per innovators

product and submitted requisite fee Rs: 7500/- vide on-line
deposit slip No.782489443.
provided as evidence for availability of Liquid Syrup General
Section.
Decision: Registration Board approved the case with innovator’s specification, since iron preparations
are not considered as drug by various reference regulatory authorities.
Brand Name + Dosage Form and Astron infusion 400mg/250ml
Strength
Moxifloxacin (as hydrochloride) ……...400mg
Challan No. 0798534 dated: 01.03.2019
Pharmacological Group Anti-bacterial
Type of form Form 5
Pack size and Demand Price 1’s × glass vial, As per SRO
Approval status of product in Reference US FDA approved with following boxed warning:
Regulatory Authorities WARNING: Serious adverse reactions including Tendinitis, tendon
rupture, peripheral Neuropathy, central nervous system effects and
Exacerbation of myasthenia gravis
Me-too-status M-Floxsel infusion 400mg/250ml of M/s Pharmasol Pvt. Ltd.
Lahore Registration No. 100857
the firm.
Remarks of the Evaluator (PEC-XVII) • Firm revised the drug product specifications as per innovators
product and submitted requisite fee Rs: 7500/- vide on-line
deposit slip No.96783907834
provided as evidence for availability of Sterile Liquid Injection
(Ampoules/Vials) Section.
Brand Name + Dosage Form+Strength Lignopharm 1% IM Injection
Lidocaine Hydrochloride……...20mg (w/v)
Challan No. 0842152 dated: 01.03.2019
Pharmacological Group Anesthetic
Type of form Form 5
Pack size and Demand Price 2ml× 50ampoules, 2ml ×100 glass ampules, As per SRO
Approval status of product in Reference MHRA approved
Me-too-status Lidosol 1% injection of M/s Pharmasol Pvt. Ltd. Lahore
the firm.
Remarks of the Evaluator (PEC-XVII) • In MHRA, variety of route of administration are given depending
upon the intended purpose. Such as in ventricular arrhythmias

both IV bolus and IV infusion are mentioned. While the IM route
is also given in specific circumstances (in case ECG monitoring
is not available).
• For local anesthesia (local infiltration, spinal, epidural or caudal,
paracervical block for obstetric analgesia (including abortion).
• The preservative-free injection label given as
“For infiltration and Nerve block including caudal and epidural
use”
• The injection containing preservative, label is given as
“For infiltration and nerve block” Not for epidural and caudal use.
Contains preservative.
provided as evidence for availability of Sterile Liquid Injection
(Ampoules/Vials) Section.
Decision: Approved.
481. Name and address of manufacture / M/s Bloom Pharmaceuticals (Pvt.) Ltd. Plot No.30, Phase I & II,
Applicant Industrial Estate, Hattar (Tablet Section)
Brand Name + Dosage Form and Quetac 100mg tablet
Strength
Quetiapine (as fumarate) ……100mg
Challan No. 0817476 dated: 05.03.2019
Type of form Form 5
Pack size and Demand Price 10’s, 30’s, as per SRO
Approval status of product in Reference SEROQUEL (Astrazeneca) US FDA approved with boxed warning
Regulatory Authorities as:
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis; And Suicidal Thoughts and Behaviors
Me-too-status Quitalax 100mg tablet of M/s Gray’s pharmaceuticals, Islamabad.
GMP Status Panel inspection for renewal of DML conducted on 01-09-2021 and
recommended renewal of DML of the firm.
GMP certificate issued on 24-07-2019 based on inspection
Remarks of the Evaluator (PEC-XVII) • Firm revised label claim as:
Quetiapine (as fumarate) ………100mg and submitted the
requisite fee Rs: 7500/- vide on-line deposit slip No.6718043464.
manufacturer specifications to USP specifications.
Decision: Approved as per following revised label claim with USP specifications:
Quetiapine (as fumarate) ………100mg
Applicant Industrial Estate, Hattar (Tablet Section)
Brand Name + Dosage Form and Quetac 200mg tablet
Strength
Quetiapine (as fumarate) ……200mg
Challan No. 0817475 dated: 05.03.2019

Type of form Form 5
Approval status of product in Reference SEROQUEL (Astrazeneca) US FDA approved with boxed warning
Regulatory Authorities as:
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis; And Suicidal Thoughts and Behaviors
Me-too-status Q-Med 200mg tablet of M/s Medera pharmaceuticals, Islamabad.
• Firm revised label claim as:
Quetiapine (as fumarate) ………200mg and submitted the
requisite fee Rs: 7500/- vide on-line deposit slip No.9031868497
manufacturer specifications to USP specifications.
Decision: Approved as per following revised label claim with USP specifications:
Quetiapine (as fumarate) ………200mg
Applicant Industrial Estate, Hattar (Capsule Section)
Brand Name + Dosage Form and Fulanzo 3/25mg capsule
Strength
Olanzapine…………3mg
Fluoxetine HCl……25mg
Challan No. 0817473 dated: 05.03.2019
Pharmacological Group Antipsychotic, antidepressant
Type of form Form 5
Approval status of product in Reference SYMBYAX Capsules: 3 mg/25 mg, 6 mg/25 mg, 6 mg/50 mg, and
Regulatory Authorities 12 mg/50 mg (mg olanzapine/mg equivalent fluoxetine) of Eli
Lilly, US FDA approved with boxed warning as: Suicidal thoughts
and behaviors and increased mortality in elderly patients with
Dementia-related psychosis
Me-too-status Co-Depricap 3/25mg capsule of M/s Nabiqasim industries,
Karachi. Registration No. 076136
Remarks of the Evaluator (PEC-XVII) • Firm revised the label claim as;
Each capsule contains:
Fluoxetine (as Fluoxetine HCl) ……25mg
and submitted the requisite fee Rs: 7500/- vide on-line deposit slip
No. 1081575153
Decision: Approved as per following revised label claim:

Applicant Industrial Estate, Hattar (Capsule Section)
Brand Name + Dosage Form and Fulanzo 6/25mg capsule
Strength
Fluoxetine HCl……25mg
Challan No. 0817477 dated: 05.03.2019
Pharmacological Group Antipsychotic, antidepressant
Type of form Form 5
Approval status of product in Reference SYMBYAX Capsules: 3 mg/25 mg, 6 mg/25 mg, 6 mg/50 mg, and
Regulatory Authorities 12 mg/50 mg (mg olanzapine/mg equivalent fluoxetine) of Eli
Lilly, US FDA approved with boxed warning as: Suicidal thoughts
and behaviors and increased mortality in elderly patients with
Dementia-related psychosis
Me-too-status Co-Depricap 6/25mg capsule of M/s Nabiqasim industries,
Karachi. Registration No. 076135
Remarks of the Evaluator (PEC-XVII) • Firm revised the label claim as;
Fluoxetine (as Fluoxetine HCl) ……25mg and submitted the
requisite fee Rs: 7500/- vide on-line deposit slip No.
992900088143
Decision: Approved as per following revised label claim:
Case No. 2: Registration applications for local manufacturing of (Human) drugs (Differential Fee)
a) New cases
485. Name and address of manufacturer/ Vega pharmaceuticals (Pvt) Ltd. Pharma city, Plot No.4, 30-
Applicant Km, Multan Road, Lahore.
Brand Name + Dosage Form + Strength AZOCIN 500mg tablet
Azithromycin dihydrate equivalent to
Azithromycin………500mg
Diary No. Date of R & I & fee Dy. No.4183 dated 06/04/2011 Rs.8,000/- dated 06-04-2011
(Photocopy), Dy. No. 2406 dated 01-06-2016 Differential fee
Rs.12,000/- vide Challan No.0517707 (Photocopy) “duplicate
dossier, verified from R&I”
Pharmacological Group Anti-bacterial, Macrolide
Type of Form Form-5
Pack size & Demanded Price 1 × 6’s, M.R.P Rs: 300/- per pack
Me-too status Azomax 500mg tablet of M/s Novartis Pharma, Karachi.

GMP status Panel GMP inspection conducted on 09-01-2019 and 21-03-
2019 for grant of cGMP certificate with conclusion:
In light of the inspection conducted by the panel and based on
the people met, documents reviewed and findings during
inspection, M/s Vega pharmaceuticals (Pvt) Ltd., Pharma city
30-Km, Multan Road, Lahore was considered to be operating
at a fair level of cGMP compliance at the time of inspection.
Remarks of the Evaluator (PEC-XVII) • Firm provided complete analytical/testing methods for
finished drug product as per official monograph and
submitted requisite fee Rs: 7500/- vide on-line deposit slip
No.5122505054.
• Product with same brand name that is Azocin tablet 250mg
of Hansel pharmaceuticals, plot No.2, Pharmacity, 30km
Multan road, Lahore approved in 308th DRB meeting.
• Verification of initial and differential fee challans required.
Decision: Approved. Registration Board further decided to verify fee challans as per decision of 285th
486. Name and address of manufacturer/ Vega pharmaceuticals (Pvt) Ltd. Plot No.4, Pharma city 30-
Applicant Km, Multan Road, Lahore.
Brand Name + Dosage Form + Strength CLARITH 500mg tablet
Clarithromycin………500mg
Diary No. Date of R & I & fee Dy. No.4185 dated 06/04/2011, Rs.8,000/- dated 06-04-2011
(Photocopy), Dy. No.2405 dated 01-06-2016 Differential fee
Rs.12,000/- vide Challan No.0517709 (Photocopy) “duplicate
dossier, verified from R&I”
Pharmacological Group Anti-bacterial, Macrolide
Type of Form Form-5
Pack size & Demanded Price 1 × 10’s, M.R.P Rs: 600/- per pack
Me-too status C-Lar 500mg tablet of M/s Ciba Pharmaceuticals, District
Jamshoro, Karachi. Registration No.102909
GMP status Panel GMP inspection conducted on 09-01-2019 and 21-03-
2019 for grant of cGMP certificate with conclusion:
In light of the inspection conducted by the panel and based on
the people met, documents reviewed and findings during
inspection, M/s Vega pharmaceuticals (Pvt) Ltd., Pharma city
30-Km, Multan Road, Lahore was considered to be operating
at a fair level of cGMP compliance at the time of inspection.
Remarks of the Evaluator (PEC-XVII) • Firm provided complete analytical/testing methods for
finished drug product as per official monograph and submitted
requisite fee Rs: 7500/- vide on-line deposit slip
No.70381043908.
• Verification of R & I diary no., initial and differential fee
challans required.
Decision: Approved. Registration Board further decided to verify fee challans as per decision of 285th
487. Name and address of manufacturer/ Shrooq Pharmaceuticals (Pvt) Ltd. 21-Km, Ferozpur Road,
Applicant Lahore.
Brand Name + Dosage Form + Strength LINSIX 600mg tablet
Linezolid…….600mg

Diary No. Date of R & I & fee Form-5, Dy.# 443 dated 26-11-2012, Fee Rs:8,000/-, Date.26-
11-2012 (photocopy), Differential fee: Dy.# 419Rs.12,000
Dated 31-03-2015 (photocopy), Duplicate dossier verified
from R&I
Pharmacological Group Antibiotic (Oxazolidione)
Type of Form Form-5
Pack size & Demanded Price 12’s, As per SRO
Approval status of product in Reference ZYVOX® (linezolid) 600mg tablets (Pfizer) US FDA
Me-too status Linezolid 600mg tablet of M/s Saibins Pharmaceuticals,
Islamabad. Registration No. 098305
GMP status Panel inspection for renewal of DML conducted on 26-10-
2021 and 29-10-2021 and recommended renewal of DML of
the firm.
Remarks of the Evaluator (PEC-XVII) • Firm has claimed in-house specifications.
• API monograph available in USP.
• Verification of initial and differential fee challans required.
Decision: Approved. Registration Board further decided to verify, fee challan as per decision of 285th
488. Name and address of manufacturer/ Shrooq Pharmaceuticals (Pvt) Ltd. 21-Km, Ferozepur Road,
Applicant Lahore.
Brand Name + Dosage Form + Strength ZUCLO 25mg tablet
Zuclopenthixol (as Dihydrochloride) ……...25mg
Diary No. Date of R & I & fee Form-5, Fee Rs:8,000/-(photocopy), Date.14-09-2010,
Differential fee: Rs.12,000 Dated 31-03-2015 (photocopy),
Duplicate dossier
Pharmacological Group Anti-psychotic drug
Type of Form Form-5
Finished product Specification BP specifications
Pack size & Demanded Price 50’s, N. A
Me-too status Elana 25mg tablet of M/s Aries Pharmaceuticals, Peshawar.
2021 and 29-10-2021 and recommended renewal of DML.
cGMP certificate issued based on inspection conducted for
renewal of DML on 29-10-2021. Tablet Sections (General and
quinolone) are mentioned in DML inspection report as well in
GMP certificate.
• Firm provided analytical testing methods for the finished
drug product as per official monograph and submitted
requisite fee Rs: 7500/- vide on-line deposit slip
No.600875794114.
• Verification of R &I, initial and differential fee sips required
Decision: Deferred for verification of R & I diary No./date, fee challan as per decision of 285th meeting
of Registration Board.
489. Name and address of manufacturer/ Shrooq Pharmaceuticals (Pvt) Ltd. 21-Km, Ferozepur Road,
Applicant Lahore.
Brand Name + Dosage Form + Strength CLOVIR 250mg tablet
Famciclovir (USP) ……...250mg

Diary No. Date of R & I & fee Form-5, Fee Rs:8,000/-, Date.27-10-2010 (photocopy),
Differential fee: Rs.12,000 Dated 31-03-2015 (photocopy),
Duplicate dossier
Pharmacological Group Anti-viral drug
Type of Form Form-5
Pack size & Demanded Price 21’s, N. A
Me-too status Flovir 250mg tablet by Maxitech pharma Pvt ltd. Karachi.
2021 and 29-10-2021 and recommended renewal of DML.
cGMP certificate issued based on inspection conducted for
renewal of DML on 29-10-2021. Tablet Sections (General and
quinolone) are mentioned in DML inspection report as well in
GMP certificate.
Remarks of the Evaluator (PEC-XVII) • The firm has claimed manufacturer specifications
while drug product monograph is available in USP42-
NF37 1S – 8688 and onward.
• Verification of R &I, initial and differential fee sips
required.
Decision: Deferred for verification of R & I diary No./date, fee challan as per decision of 285th meeting
of Registration Board.
Case No. 03: Registration applications of import cases

a) New Cases (Human)
490. Name and address of Applicant M/s Biocare Pharmaceutica 807-Shadman 1, Lahore-
Pakistan
Detail of Drug Sale License Name: M/s Biocare Pharmaceutica
Go-down address: 8-C, Street No.3, Near LGS School, Shah
Jamal, District Lahore.
License No: 05-352-0063-032069D
Validity: 17-04-2022.
Status: Distributor license in Form No. 11
Name and address of manufacturer By M/s Reyoung Pharmaceutical Co. Ltd. No.1, Ruiyang
Road, Yiyuan County, Shandong Province, P.R. China.
Name and address of marketing By M/s Reyoung Pharmaceutical Co. Ltd. No.1, Ruiyang
authorization holder Road, Yiyuan County, Shandong Province, P.R. China.
Type of Form Form-5A
Diary No. & Date of R& I Dy. No. 12458 dated 05-03-2019
Fee including differential fee Rs.10,0000/- dated 06-03-2019 Challan No. 0318014 dated:
06.03.2019
Brand Name +Dosage Form + Strength VANCO 500mg For Injection
Vancomycin hydrochloride equivalent to
Vancomycin….500mg
Finished Product Specification USP specifications
Pharmacological Group Tricyclic glycopeptide antibiotic
Shelf life 36 months
Demanded Price PKR 744.00/- per vial
Pack size 1’s vial
International availability MHRA approved

Me-too status Vancozon 500mg injection of M/s Horizon Healthcare Pvt.
Ltd. Taxila. Registration No. 099987
Stability studies Firm has submitted real-time stability data sheets conducted
at 300C ± 2ºC and 65%RH ± 5%RH of three batches for 36
months and accelerated stability data sheets conducted at
400C ± 2 ºC and 75%RH ± 5%RH of three batches for six
months.
Mfg Date: 06-2012 Exp. Date: 05-2015
Detail of certificates attached Scan copy of legalized GMP certificate:
Certificate No: SD20180716
Certifying Authority: Shandong Food and Drug
Administration
Date of issuing: 13-06-2018
Scan copy of legalized DML.
No. 20160062
Expiry date: 31-12-2020
Original legalized CoPP (Embassy attested).
Certificate No: 2018052101
Certifying Authority: Yiyuan Food and Drug Administration
No.5 Junmin Road, Yiyuan county, Shandong, P.R. of China
Stamp and Date: 21-05-2018
Validity: Valid for two (02) years since the date of stamp.
Scan copy legalized Free sale Certificate.
Certificate No: 2018-0521
Certifying Authority: Yiyuan County Food & Drug
Administration of P.R. China.
Issuing Date: 21-05-2018
Validity: Valid for two years
Letter of Authorization
Distributorship & Agency agreement contract between
Reyoung Pharmaceutical Co., Ltd. No.1 Ruiyang Road, Yi
Yuan County, Shandong, PRC, 256100, China
(Supplier/Manufacturer) and Biocare Pharmaceutica, 807
Shadman-1 Lahore, Pakistan (Distributor).
Date of Agreement: 07-07-2018
Validity: Five (05) years
Remarks of the Evaluator (PEC-XVII) CoPP expired/ Free sale certificate expired
Decision: Deferred for clarification whether applied product and innovator is manufactured by
way of lyophilization or otherwise a with susubmission o valid legalized COPP/Free sale certificate.
491. Name and address of Applicant M/s Biocare Pharmaceutica 807-Shadman 1, Lahore-
Pakistan
Detail of Drug Sale License Name: M/s Biocare Pharmaceutica
Go-down address: 8-C, Street No.3, Near LGS School, Shah
Jamal, District Lahore.
License No: 05-352-0063-032069D
Validity: 17-04-2022.
Status: Distributor license in Form No. 11
Name and address of manufacturer By M/s Reyoung Pharmaceutical Co. Ltd. No.1, Ruiyang
Road, Yiyuan County, Shandong Province, P.R. China.
Name and address of marketing By M/s Reyoung Pharmaceutical Co. Ltd. No.1, Ruiyang
authorization holder Road, Yiyuan County, Shandong Province, P.R. China.
Type of Form Form-5A
Diary No. & Date of R& I Dy. No. 12459 dated 06-03-2019

Fee including differential fee Rs.100,000/- dated 06-03-2019 Challan No. 0318015 dated:
06.03.2019
Brand Name +Dosage Form + Strength VANCO 1gm For Injection
Vancomycin hydrochloride equivalent to
Vancomycin….1gm
Finished Product Specification USP specifications
Pharmacological Group Tricyclic glycopeptide antibiotic
Shelf life 36 months
Demanded Price PKR 1207.00/- per vial
Pack size 1’s vial
International availability MHRA approved
Me-too status Vancozon 500mg injection of M/s Horizon Healthcare Pvt.
Ltd. Taxila. Registration No. 099988
Stability studies Firm has submitted real-time stability data sheets conducted
at 300C ± 2ºC and 65%RH ± 5%RH of three batches for 36
months and accelerated stability data sheets conducted at
400C ± 2 ºC and 75%RH ± 5%RH of three batches for six
months.
Mfg. Date: 04/2008 Exp. Date: 03-2011
Detail of certificates attached Scan copy of legalized GMP certificate:
Certificate No: SD20180716
Certifying Authority: Shandong Food and Drug
Administration
Date of issuing: 13-06-2018
Scan copy of legalized DML.
No. 20160062
Expiry date: 31-12-2020
Original legalized CoPP (Embassy attested).
Certificate No: 2018052102
Certifying Authority: Yiyuan Food and Drug Administration
No.5 Junmin Road, Yiyuan county, Shandong, P.R. of China
Stamp and Date: 21-05-2018
Validity: Valid for two (02) years since the date of stamp.
Original legalized Free sale Certificate.
Certificate No: 2018-0521
Certifying Authority: Yiyuan County Food & Drug
Administration of P.R. China.
Issuing Date: 21-05-2018
Validity: Valid for two years
Letter of Authorization
Distributorship & Agency agreement contract between
Reyoung Pharmaceutical Co., Ltd. No.1 Ruiyang Road, Yi
Yuan County, Shandong, PRC, 256100, China
(Supplier/Manufacturer) and Biocare Pharmaceutica, 807
Shadman-1 Lahore, Pakistan (Distributor).
Date of Agreement: 07-07-2018
Validity: Five (05) years
Remarks of the Evaluator (PEC-XVII) CoPP expired
Free sale certificate expired
Decision: Deferred for clarification whether applied product and innovator is manufactured by
way of lyophilization or otherwise a with susubmission o valid legalized COPP/Free sale certificate.
Agenda of Evaluator PEC-I

Case No. I: Registration applications submitted of form 5F (New Section):

A: M/s Jaskan Pharmaceuticals (Pvt) Ltd., 50-Sundar Industrial Estate, Lahore was granted additional
section “DRY POWDER FOR INJECTION (CEPHALOSPORIN)” vide letter No.F.1-16/2006-Lic(Vol-I) dated
12th March, 2021.
Sr. No. No. of molecules No. of product
1 01 04
492. Name, address of Applicant / Marketing M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-Sundar
Authorization Holder Industrial Estate, Lahore.
Name, address of Manufacturing site. M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-Sundar
Industrial Estate, Lahore.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Jaxone Dry Powder for Solution for IM Injection 250mg
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium……250mg
Pharmaceutical form of applied drug Powder for solution for
The status in reference regulatory authorities Rocephin Inj 250mg, MHRA Approved.
For generic drugs (me-too status) Oxidil 250mg Injection by M/s Sami Pharma
GMP status of the Finished product Copy of GMP certificate No. 10/2021-DRAP(FID-797667-
manufacturer 1346) dated 18/02/2021 issued on the basis of inspection
conducted on 26/10/2020.
Name and address of API manufacturer. M/s Pharmagen Limited Kot Nabi Bukhshwla, 34 km
Ferozepur road, Lahore.
submitted.
process and controls, specifications, analytical procedures
and its complete validation studies, batch analysis and

justification of specification, details of reference standards,
substance.
Batches: (00241/007/2006, 00241/00/2006,
00241/009/2006)
specifications, analytical procedure and its validation
Ceftriaxone 250mg for IM injection should be dissolved in
1mL of 1% Lidocaine Hydrochloride Solution. The solution
should be administered by deep intramuscular injection
(MHRA).
Pharmaceutical equivalence and comparative Pharmaceutical equivalence is performed against Oxidil
dissolution profile Injection 250mg by M/s Sami Pharmaceuticals by
performing the quality tests. (B:013G).
Analytical method validation/verification of The firm has submitted analytical method verification
product studies including certain testing parameters such as
accuracy, precision and specificity for drug product and
substance performed by drug product manufacturer.
Manufacturer of API M/s Pharmagen Ltd., Kot Nabi Buksh wala, 34-km, Ferozepur road, Lahore.
API Lot No. 00421/002/2021
Description of Pack
Type I glass vial (15ml) with rubber stopper and grey flip off aluminium cap
Batch No. KE-01 KE-02 KE-03
No. of Batches 03
1. Reference of previous approval of applications with No response is submitted against this point.
2. Approval of API/ DML/GMP certificate of API Submitted.
manufacturer issued by concerned regulatory authority of
country of origin.
3. Documents for the procurement of API with approval The drug substance is locally procured.

respective documents like chromatograms, Raw data
5. Compliance Record of HPLC software 21CFR & audit Submitted.
6. Record of Digital data logger for temperature and The firm has submitted record of digital data
humidity monitoring of stability chambers (real time and logger.
accelerated)
Observations Response
Please submit complete method of analysis used Complete testing method for routine analysis of
for routine testing of drug substance by drug Ceftriaxone drug substance by the drug product
product manufacturer along with the verification manufacturer is submitted.
studies including specificity, accuracy and The analytical method verification studies including the
repeatability (method precision) performed by accuracy, precision and specificity parameters are
the Drug Product manufacturer. submitted.
The quantity to be dispensed as per submitted The firm has submitted complete calculations for the
dossier is 299.96mg/vial, please submit the quantity to be dispensed for ceftriaxone 250mg injection
detail with justification for dispensed quantity. which according to firm’s calculations is 299.96mg per vial
while 300.84g is correct quantity according to the assay of
drug substance (Difference=1.182mg)
Oxidil Injection by M/s Sami Pharma is used for “Rocephin 250mg injection is not available, we have used
pharmaceutical equivalence testing while the Oxidil 250mg Injection, (B:013G) by M/s Sami Pharma for
said studies are required to be performed against Pharmaceutical equivalence testing”.
innovator’s/reference product, please clarify.
The stability data is submitted till 3rd month time The firm has submitted stability data till 6th month time
point, please provide stability studies till 6th point.
month time point.
Copy of GMP/DML of drug substance GMP certificate No. 06/2019-DRAP(AD/607409-530)
manufacturer is required. dated 11/01/2019 issued on the basis of inspection
Decision: Approved.
• Registration Board directed that during production of commercial batches, for achieving the desired label
claim of “Ceftriaxone”, the amount of Ceftriaxone sodium dispensed must be calculated on the basis of
actual %age Potency of the drug substance on “as is basis” rather than the applying the theoretical factor
on the basis of molecular weight.
application.
☐ Importer
☐ Export sale

The proposed proprietary name / brand name Jaxone Dry Powder for Solution for IM Injection 500mg
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium……500mg
The status in reference regulatory authorities Ceftriaxone for injection 500mg, MHRA Approved.
For generic drugs (me-too status) Oxidil 500mg Injection by M/s Sami Pharma
submitted.
substance.
Batches: (00241/007/2006, 00241/00/2006,
00241/009/2006)
Ceftriaxone 500mg for IM injection should be dissolved in
2mL of 1% Lidocaine Hydrochloride Solution. The solution
should be administered by deep intramuscular injection
(MHRA).

dissolution profile Injection 500mg by M/s Sami Pharmaceuticals by
performing the quality tests. (B:018G).
Manufacturer of API M/s Pharmagen Ltd., Kot Nabi Buksh wala, 34-km, Ferozepur road,
Lahore.
API Lot No. 00421/002/2021
Description of Pack Type I glass vial (15ml) with rubber stopper and grey flip off
(Container closure system) aluminium cap
Batch No. KG-01 KG-02 KG-03
Batch Size 100 100 vials 100 vials
vials
Date of Initiation 25-03- 25-03-2021 25-03-2021
2021
No. of Batches 03
1. Reference of previous approval of applications No response is submitted against this point.
2. Approval of API/ DML/GMP certificate of API GMP certificate No. 06/2019-DRAP(AD/607409-530)
manufacturer issued by concerned regulatory dated 11/01/2019 issued on the basis of inspection
authority of country of origin. conducted on 08/01/2019.
3. Documents for the procurement of API with The drug substance is locally procured.

6. Record of Digital data logger for temperature and The firm has submitted record of digital data logger.
Please submit complete method of analysis used Complete testing method for routine analysis of Ceftriaxone
for routine testing of drug substance by drug drug substance by the drug product manufacturer is
product manufacturer along with the verification submitted.
studies including specificity, accuracy and

repeatability (method precision) performed by The analytical method verification studies including the
the Drug Product manufacturer. accuracy, precision and specificity parameters are submitted.
The quantity to be dispensed as per submitted The firm has submitted complete calculations for the quantity
dossier is 599.91mg/vial, please submit the to be dispensed for ceftriaxone 500mg injection which
detail with justification for dispensed quantity. according to firm’s calculations is 599.91mg per vial while
601.685mg is correct quantity according to the assay of drug
substance (Difference=1.775mg)
Oxidil Injection by M/s Sami Pharma is used for The firm has submitted Pharmaceutical equivalence testing
pharmaceutical equivalence testing while the against Rocephin 0.5g injection (B:0067) by performing the
said studies are required to be performed against quality tests.
The stability data is submitted till 3rd month time The firm has submitted stability data till 6th month time point.
point, please provide stability studies till 6th
month time point.
Copy of GMP/DML of drug substance GMP certificate No. 06/2019-DRAP(AD/607409-530) dated
manufacturer is required. 11/01/2019 issued on the basis of inspection conducted on
08/01/2019.
Decision: Approved.
application.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Jaxone Dry Powder for Solution for IV Injection 1g
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium……1g

The status in reference regulatory authorities Ceftriaxone for injection 1g, MHRA Approved.
For generic drugs (me-too status) Oxidil 1g Injection by M/s Sami Pharma
submitted.
substance.
Batches: (00241/007/2006, 00241/00/2006,
00241/009/2006)
Ceftriaxone 1g powder for IV injection/infusion should be
dissolved in 10ml of water for injection BP. The injection
should be administered over at least 2-4 minutes directly
into the vein or via the tubing of an intravenous infusion
(MHRA).
dissolution profile Injection 1g by M/s Sami Pharmaceuticals by performing
the quality tests. (B:017G).
Lahore.
API Lot No. 00421/002/2021

Batch No. KI-1 KI-2 KI-3
vials
2021
No. of Batches 03
2. Approval of API/ DML/GMP certificate of GMP certificate No. 06/2019-DRAP(AD/607409-530)
API manufacturer issued by concerned dated 11/01/2019 issued on the basis of inspection
regulatory authority of country of origin. conducted on 08/01/2019.

chromatograms,
etc.
5. Compliance Record of HPLC software 21CFR Submitted.
6. Record of Digital data logger for temperature The firm has submitted record of digital data logger.
Please submit complete method of analysis used Complete testing method for routine analysis of
for routine testing of drug substance by drug Ceftriaxone drug substance by the drug product
product manufacturer along with the verification manufacturer is submitted.
studies including specificity, accuracy and The analytical method verification studies including the
repeatability (method precision) performed by accuracy, precision and specificity parameters are
the Drug Product manufacturer. submitted.
The quantity to be dispensed as per submitted The firm has submitted complete calculations for the
dossier is 1.19g/vial, please submit the detail quantity to be dispensed for ceftriaxone 1g injection which
with justification for dispensed quantity. according to firm’s calculations is 1.19g per vial while
1.203g is correct quantity according to the assay of drug
substance (Difference=13mg)

Oxidil Injection by M/s Sami Pharma is used for The firm has submitted Pharmaceutical equivalence testing
pharmaceutical equivalence testing while the against Rocephin 1g injection (B:0774) by performing the
said studies are required to be performed against quality tests.
The stability data is submitted till 3rd month time The firm has submitted stability data till 6th month time
point, please provide stability studies till 6th point.
month time point.
Copy of GMP/DML of drug substance GMP certificate No. 06/2019-DRAP(AD/607409-530)
manufacturer is required. dated 11/01/2019 issued on the basis of inspection
Decision: Approved.
application.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Jaxone Dry Powder for Solution for IV Injection 2g
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium……2g
The status in reference regulatory authorities Ceftriaxone for injection 2g, MHRA Approved.
For generic drugs (me-too status) Oxidil 2g Injection by M/s Sami Pharma

submitted.
substance.
Batches: (00241/007/2006, 00241/00/2006,
00241/009/2006)
Ceftriaxone 2g powder for IV injection/infusion should be
dissolved in 20ml of water for injection BP. The injection
should be administered over at least 2-4 minutes directly
into the vein or via the tubing of an intravenous infusion
(MHRA).
dissolution profile Injection g by M/s Sami Pharmaceuticals by performing the
quality tests. (B:014G).
Lahore.
API Lot No. 00421/002/2021

Batch No. KH-1 KH-2 KH-3
vials
2021
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Submitted.
API manufacturer issued by concerned
5. Compliance Record of HPLC software 21CFR Submitted.
6. Record of Digital data logger for temperature The firm has submitted record of digital data logger.
Please submit complete method of analysis used for Complete testing method for routine analysis of
routine testing of drug substance by drug product Ceftriaxone drug substance by the drug product
manufacturer along with the verification studies manufacturer is submitted.
including specificity, accuracy and repeatability The analytical method verification studies including
(method precision) performed by the Drug Product the accuracy, precision and specificity parameters are
manufacturer. submitted.
The quantity to be dispensed as per submitted dossier The firm has submitted complete calculations for the
is 2.399g/vial, please submit the detail with quantity to be dispensed for ceftriaxone 2g injection
justification for dispensed quantity. which according to firm’s calculations is 2.399g per
vial while 2.407g is correct quantity according to the
assay of drug substance (Difference=7.739mg)
Oxidil Injection by M/s Sami Pharma is used for “Rocephin 2g injection is not available, we have used
pharmaceutical equivalence testing while the said Inocef 2g Injection, Batch No. C7695 (Mfg date:
studies are required to be performed against 04/2021) by Barret Hodgson for Pharmaceutical
innovator’s/reference product, please clarify. equivalence testing”.
The stability data is submitted till 3 month time The firm has submitted stability data till 6th month
rd
point, please provide stability studies till 6th month time point.
time point.
Copy of GMP/DML of drug substance manufacturer GMP certificate No. 06/2019-DRAP(AD/607409-
is required. 530) dated 11/01/2019 issued on the basis of
inspection conducted on 08/01/2019.
As per available literature of the reference product “The size of Jaxone 2g IV Injection vial is 25mL, due
(approved by MHRA), 2g ceftriaxone for injection to clerical mistake it was written 15mL vial”.
should be reconstituted for IV injection in 20ml of

water while the size of vial of the applied product is
15 mL, please clarify.
Decision: Approved.
application.
B: M/s Jaskan Pharmaceuticals (Pvt) Ltd., 50-Sundar Industrial Estate, Lahore was granted additional
section “DRY POWDER for SUSPENSION (CEPHALOSPORIN)” vide letter No.F.1-16/2006-Lic(Vol-I) dated
12th March, 2021.
1 01 04
496. Name, address of Applicant / Marketing M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-Sundar Industrial
Authorization Holder Estate, Lahore.
Name, address of Manufacturing site. M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-Sundar Industrial
Estate, Lahore.
☐ Importer
☐ Export sale
Cefixa DS dry suspension 200mg
name
Strength / concentration of drug of Active Each 5ml (reconstituted) contains:
Pharmaceutical ingredient (API) per unit Cefixime as trihydrate…….200mg
Pharmaceutical form of applied drug Powder for oral suspension
USP
specifications
The status in reference regulatory Cefixime for oral suspension (100mg/5ml & 200mg/5ml, after
authorities reconstitution) by M/s Aurobindo Pharma, USFDA Approved.
For generic drugs (me-too status) Caricef DS 200m/5ml by M/s Sami Pharma.

controls, specifications, analytical procedures and its complete
specification, details of reference standards, container closure
Batches: (00244/135/2010, 00243/136/2021, 00244/137/2021)
Pharmaceutical equivalence and Pharmaceuticals equivalence testing is performed against
comparative dissolution profile Caricef DS 200mg/5ml suspension by M/s Sami
Pharmaceuticals (Pvt.) Ltd., (B:012G).
Analytical method validation/verification
of product
Manufacturer of API
API Lot No. 00243/026/2021
Description of Pack
Type III glass bottle
Batch No. KM-01 KM-02 KM-03
Date of Initiation 17/03/2021 17/03/2021 17/03/2021
No. of Batches 03

1. Reference of previous approval of No response is submitted against this point.
firm (if any)
2. Approval of API/ DML/GMP certificate of GMP certificate No. 06/2019-DRAP(AD/607409-530) dated
API manufacturer issued by concerned 11/01/2019 issued on the basis of inspection conducted on
3. Documents for the procurement of API The drug substance is locally procured.
import).
testing
6. Record of Digital data logger for The firm has submitted record of digital data logger.
accelerated)
Remarks of Evaluator-I:
Observations Response by the firm
Submitted COA of drug substance from M/s Pharmagen The firm has submitted revised COA from M/s
states the remarks as “The product complies with the Pharmagen with the remarks “The product Complies
specifications of BP & USP”. Justification shall be with USP”.
submitted for this claim, since USP & BP monographs of B: 00243/026/2021
Cefixime trihydrtae define different limits for different tests,
please clarify.
Please submit complete method of analysis used for routine The firm has submitted analytical method used for
testing of drug substance by drug product manufacturer routine analysis for drug substance along with
along with the verification studies including specificity, method verification studies.
accuracy and repeatability (method precision) performed by
the Drug Product manufacturer.
As per COA from drug product manufacturer for drug The firm has stated that it was a typing mistake, it
substance (batch number 00243/026/2021) used for product was 9.11 actually.
development, the water content in 8.11% while the limits
defined by USP are 9-12%, clarify.
Since the excipients used for the development of the applied Excipients present in the product showed no any
product are different from the excipients present in reference incompatibility with cefixime and with any other
product, therefore, compatibility of excipients with the drug excipients present in the formulation. All excipients
substance is required. are compatible with each other and cefixime, No any
abnormality in product is noted during stability
study of 6 months.
Pharmaceuticals equivalence testing is performed against The firm has submitted Pharmaceutical equivalence
comparator’s product Caricef DS 200mg/5ml suspension testing against Cefspan DS 200mg/5mL (B:C8299)
(60ml) by M/s Sami Pharmaceuticals (Pvt.) Ltd., (B:012G) by M/s Barret Hodgson.
while the study is required against the reference/innovator’s
product, clarify.
The stability data is submitted till 3rd month time point, The firm has submitted stability studies till 6th
please provide stability studies till 6th month time point. month’s time point.
Please provide detailed calculations for quantity to be The firm has not considered the moisture content
dispensed per bottle considering the actual potency of while adjusting the potency.
Cefixime trihydrate.

1357.32mg per bottle while according to the
corresponding assay (98.93% ; anhydrous) value the
quantity should be 1334.52mg.
Documents confirming the procurement of Drug Substance The firm has submitted Invoice No. 2268 dated
are required. 24/02/2021 from M/s Pharmagen.
Detail of total volume of glass bottle for Cefixa DS dry Size of glass bottle is 60 mL while after
suspension (200mg and 100mg) is required with reconstitution the volume would be 30mL.
justification. Total number of doses according to submitted data
for the applied product is 6 while the innovator’s
product is available in 50mL, 75mL and 100mL
delivering 10, 15 and 20 doses respectively.
Decision: Approved.
claim of “Cefixime”, the amount of “Cefixime trihydrate” dispensed must be calculated on the basis of
• Firm shall submit “In-use stability studies” of the drug product with recommended diluent, before issuance
of registration letter.
application.
497. Name, address of Applicant / Marketing M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-Sundar Industrial
Authorization Holder Estate, Lahore.
Name, address of Manufacturing site. M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-Sundar Industrial
Estate, Lahore.
☐ Importer
☐ Export sale
Cefixa DS dry suspension 100mg
name
Strength / concentration of drug of Active Each 5ml (reconstituted) contains:
Pharmaceutical ingredient (API) per unit Cefixime as trihydrate…….100mg
Pharmaceutical form of applied drug Powder for oral suspension
USP
specifications
The status in reference regulatory Cefixime for oral suspension (100mg/5ml & 200mg/5ml, after
authorities reconstitution) by M/s Aurobindo Pharma, USFDA Approved.

For generic drugs (me-too status) Caricef DS 100m/5ml by M/s Sami Pharma.
controls, specifications, analytical procedures and its complete
specification, details of reference standards, container closure
Batches: (00244/135/2010, 00243/136/2021, 00244/137/2021)
Pharmaceutical equivalence and Pharmaceuticals equivalence testing is performed against
comparative dissolution profile Caricef 100mg/5ml suspension by M/s Sami Pharmaceuticals
(Pvt.) Ltd., (B:012G).
Analytical method validation/verification
of product
Manufacturer of API
API Lot No. 00243/026/2021
Description of Pack
Type III glass bottle
Batch No. KL-01 KL-02 KL-03

No. of Batches 03
1. Reference of previous approval of No response is submitted against this point.
firm (if any)
2. Approval of API/ DML/GMP certificate of GMP certificate No. 06/2019-DRAP(AD/607409-530) dated
API manufacturer issued by concerned 11/01/2019 issued on the basis of inspection conducted on
3. Documents for the procurement of API The drug substance is locally procured.
import).

testing
6. Record of Digital data logger for The firm has submitted record of digital data logger.
accelerated)
Remarks of Evaluator-I:
Submitted COA of drug substance from M/s Pharmagen states The firm has submitted revised COA from M/s
the remarks as “The product complies with the specifications Pharmagen with the remarks “The product
of BP & USP”. Justification shall be submitted for this claim, Complies with USP”.
since USP & BP monographs of Cefixime trihydrtae define B: 00243/026/2021
different limits for different tests, please clarify.
Please submit complete method of analysis used for routine The firm has submitted analytical method used
testing of drug substance by drug product manufacturer along for routine analysis for drug substance along
with the verification studies including specificity, accuracy with method verification studies.
and repeatability (method precision) performed by the Drug
As per COA from drug product manufacturer for drug The firm has stated that it was a typing mistake,
substance (batch number 00243/026/2021) used for product it was 9.11 actually.
development, the water content in 8.11% while the limits
defined by USP are 9-12%, clarify.
Since the excipients used for the development of the applied Excipients present in the product showed no any
product are different from the excipients present in reference incompatibility with cefixime and with any other
product, therefore, compatibility of excipients with the drug excipients present in the formulation. All
substance is required. excipients are compatible with each other and
cefixime, No any abnormality in product is
noted during stability study of 6 months.
Pharmaceuticals equivalence testing is performed against The firm has submitted Pharmaceutical
comparator’s product Caricef DS 200mg/5ml suspension equivalence testing against Cefspan DS
(60ml) by M/s Sami Pharmaceuticals (Pvt.) Ltd., (B:012G) 200mg/5mL (B:C8299) by M/s Barret Hodgson.
while the study is required against the reference/innovator’s
product, clarify.

The stability data is submitted till 3rd month time point, please
The firm has submitted stability studies till 6th
provide stability studies till 6th month time point. month’s time point.
Please provide detailed calculations for quantity to be The firm has not considered the moisture content
dispensed per bottle considering the actual potency of while adjusting the potency.
Cefixime trihydrate. 1357.32mg per bottle while according to the
corresponding assay (98.93% ; anhydrous) value
the quantity should be 1334.52mg.
Documents confirming the procurement of Drug Substance The firm has submitted Invoice No. 2268 dated
are required. 24/02/2021 from M/s Pharmagen.
Detail of total volume of glass bottle for Cefixa DS dry Size of glass bottle is 60 mL while after
suspension (200mg and 100mg) is required with justification. reconstitution the volume would be 30mL.
Total number of doses according to submitted
data for the applied product is 6 while the
innovator’s product is available in 50mL, 75mL
and 100mL delivering 10, 15 and 20 doses
respectively.
Decision: Approved.
claim of “Cefixime”, the amount of “Cefixime trihydrate” dispensed must be calculated on the basis of
• Firm shall submit “In-use stability studies” of the drug product with recommended diluent, before issuance
of registration letter.
application.
C: M/s Jaskan Pharmaceuticals (Pvt) Ltd., 50-Sundar Industrial Estate, Lahore was granted additional
section “Injectable vial (General)” vide letter No.F.1-16/2006-Lic(Vol-I) dated 12th March, 2021.
1 03 03
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Moxica 400mg Infusion
Pharmaceutical ingredient (API) per unit Moxifloxacin as HCl……400mg
Pharmaceutical form of applied drug Solution for Infusion

The status in reference regulatory authorities Avelox 400mg/250mL infusion MHRA Approved.
For generic drugs (me-too status) Mofest 400mg/250mL Infusion by M/s Sami
Pharmaceuticals Pvt. Ltd. Reg. No. 53227
GMP status of the Finished product Copy of GMP certificate No. 10/2021-DRAP(FID-
manufacturer 797667-1346) dated 18/02/2021 issued on the basis of
Name and address of API manufacturer. M/s Vital Laboratories Pvt. Ltd. Plant No. II, plot No.
1710 & A1/2208, GIDC estate, Phase III, Vapi-396195
Gujrat, India.
manufacturing process and controls, specifications,
analytical procedures and its complete validation studies,
batch analysis and justification of specification, details of
reference standards, container closure system and
Real time: 30°C ± 2°C / 65% ± 5%RH for 36 months for
3 batches (MOXPB112001, MOXPB112002,
MOXPB112003)
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months of
02 batches (MOXPB001, MOXPB001)
Pharmaceutical equivalence and comparative Pharmaceutical equivalence studies have been conducted
dissolution profile against Mofest Infusion 400mg/250mL Batch 041G By
M/s Sami Pharmaceuticals.
Analytical method validation/verification of Submitted.
product
Manufacturer of API M/s Vital Laboratories Pvt. Ltd. Plant No. II, plot No. 1710 & A1/2208, GIDC
estate, Phase III, Vapi-396195 Gujrat, India.

API Lot No. MOX2010023
Description of Pack
Type I glass vial with rubber stopper and flip off aluminium seal.
Batch No. KN-01 KN-02 KN-03
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of drug manufacturing license number License
manufacturer issued by concerned regulatory Retention/Vital/2019/63520 valid till 2024 is submitted.
3. Documents for the procurement of API with Invoice No. HHM/2021/00377 (Diary No.
approval from DRAP (in case of import). 1447/2021/DRAP) dated 26/01/2021 is submitted.
chromatograms,
Please provide analytical method used by drug product The firm has submitted method of analysis for
manufacturer for the routine analysis of drug substance. drug substance used for routine analysis as per
USP.
Submit analytical method verification studies including Analytical method verification studies for drug
specificity, accuracy and precision performed by drug substance including specificity, precision and
product manufacturer for drug substance. accuracy is submitted.
Since the excipients used in the applied formulation are Not submitted.
different from the excipients used in manufacturing of
reference product, therefore, provide compatibility
studies of excipients with the drug substance.
The stability summary sheets for drug substance are The firm could not clarify the difference of the
from M/s Vital Health Care Pvt. Ltd. (VAPI) Plot No. address of drug substance manufacturer
1416-18 & 1507, GIDC Phase III, Vapi 396195 Gujrat, mentioned in license, form 5F and stability
India while the address of manufacturer of drug summary sheets.
substance as mentioned on DML and Form 5F is
different, please clarify.

Clarification is required since pharmaceutical The firm has submitted pharmaceutical
equivalence is established against Mofest equivalence data against another product Avelox
400mg/250mL infusion by M/s Sami Pharmaceuticals Infusion 400mg/250mL (B: BXJE602) by M/s
while the studies should be carried out against the Bayer AG Pharmaceutical pvt ltd.
reference/innovator’s product.
Please provide detailed calculations for quantity to beThe firm has stated that without considering
dispensed per vial considering the actual potency of LOD factor, the assay results are well in limits.
Moxifloxacin HCl since “loss on drying” has not been The firm has further stated that in future they
considered. would consider this factor.
The stability data is submitted till 3rd month time point,
The firm has submitted the stability studies till
6th months’ time point.
please provide stability studies till 6th month time point.
Provide documents confirming import of the drug Invoice No. HHM/2021/00377 dated
substance used in the manufacturing of trial batches. 15/01/2021 (Diary No. 1447/2021/DRAP dated
26/01/2021) is submitted.
Decision: Deferred for clarification of variation in the address of drug substance manufacturer as mentioned in
Drug Manufacturing License, Form 5F and stability summary sheets of the drug substance.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Jazolin 600mg/300mL Infusion
Pharmaceutical ingredient (API) per unit Linezolid……600mg
Pharmaceutical form of applied drug Solution for IV infusion
Pharmacotherapeutic Group of (API) Antibiotic/Oxazolidinone
The status in reference regulatory authorities Zyvox 2mg/mL solution for infusion, MHRA Approved.
For generic drugs (me-too status) Nezkil 600mg Infusion by M/s S.J.&G Fazul Ellahie Pvt.
Ltd. Reg. No. 48804
GMP status of the Finished product Copy of GMP certificate No. 10/2021-DRAP(FID-
manufacturer 797667-1346) dated 18/02/2021 issued on the basis of
Name and address of API manufacturer. M/s Optrix Laboratories Private Limited, Survey No.
145/A & 147. Ramalingampally (V), Bommalaramaram

(M), Yadadri-Bhuvanagiri (Dist) 508126, Telangana,
India.
analytical procedures and its complete validation studies,
batch analysis and justification of specification, details of
reference standards, container closure system and
Batches: (OT-LID-S2-002/16, OT-LID-S2-003/16, OT-
LID-S2-004/16)
Pharmaceutical equivalence and comparative Pharmaceutical equivalence testing is conducted against
dissolution profile Nezkil 600mg Infusion by M/s S.J.&G Fazul Ellahie Pvt.
Ltd. by performing quality test.
Analytical method validation/verification of The firm has submitted the analytical method
product verification/validation for drug substance and drug
product including accuracy, precision and specificity for
UV method of analysis.
Manufacturer of API M/s Optrix Laboratories Private Limited Survey No. 145/A, 145/AA
& 47, Ramalingapally (V), Bommala Ramaparam (M), Yadadri
Bhuvanagiri (Dist.), 508126, India.
API Lot No. OT-LTD/07/20/036
Description of Pack
Type I Glass vial with rubber stopper and flip off aluminium seal.
Batch No. KQ-01 KQ-02 KQ-03

Batch Size 50 vial 50 vials 50 vials
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of drug manufacturing license number License
manufacturer issued by concerned regulatory Retention/Vital/2019/63520 valid till 2024 is submitted.
3. Documents for the procurement of API with Copy of attested invoice (vide diary No. 12780 dated
approval from DRAP (in case of import). 31/08/2021) No. 21220T135/EXP dated 27/08/2021 is
submitted.
chromatograms,
• Copy of attested invoice (vide diary No. 12780 dated 31/08/2021) No. 21220T135/EXP dated 27/08/2021 is
submitted while the stability batches were manufactured in April, 2021.
Clarification is used since the UV- “The drug product is not available in any
spectrophotometric method of analysis is used for pharmacopoeia so we have developed and validated
testing of drug substance as well as for drug product UV method for the finished product testing”.
while the method from drug substance is HPLC The firm has stated that the they had analyzed the drug
method. substance by using HPC method but no supporting data
is submitted.
Submit the analytical method verification studies The firm has submitted the analytical method
including specificity, accuracy and precision for drug verification/validation for drug substance and drug
substance performed by drug product manufacturer. product including accuracy, precision and specificity
Furthermore, provide the analytical method for drug for UV method of analysis.
substance used for routine testing.
Provide valid copy of GMP/DML of drug substance Copy of GMP certificate valid till 19/09/2022 for M/s
manufacturer. Optrix Laboratories private limited (license
No.L.Dis.No:68951/TS/2021.
Please provide detailed calculations for quantity to be “Since the LOD is 0.08%,
dispensed per vial considering the actual potency of Potency of drug substance is 99.53%,
Linezolid since “loss on drying” has not been Potency of the drug substance on as is basis is
considered nor the -percentage for LOD is mentioned 99.45%,
in COA of relevant batch used for development. So the quantity per batch is 0.060KG”.
While the quantity to be dispensed should be
603.32mg equivalent to 600 linezolid.
Difference=3.32mg
The stability data is submitted till 3 month time The firm has submitted the stability data till 6th months’
rd
point, please provide stability studies till 6th month time point.
time point.

Provide documents confirming import of the drug Copy of attested invoice (vide diary No. 12780 dated
substance used in the manufacturing of trial batches. 31/08/2021) No. 21220T135/EXP dated 27/08/2021 is
submitted.
• Scientific justification for applying UV spectrophotometric method for the Assay test in drug substance
analysis, whereas drug substance manufacture has applied HPLC method.
• Scientific justification for applying UV spectrophotometric method for the drug product Assay test
during stability studies, whereas drug substance manufacture has applied HPLC method for the drug
substance analysis.
• Clarification of the fact that copy of attested invoice (vide diary No. 12780 dated 31/08/2021) No.
21220T135/EXP dated 27/08/2021 is submitted while the stability batches were manufactured in April,
2021.
500. Name, address of Applicant / Marketing M/s Jaskan Pharmaceutical Private Limited
Authorization Holder Plot No 50 Sunder Industrial Estate Lahore
Name, address of Manufacturing site. M/s Jaskan Pharmaceutical Private Limited
Plot No 50 Sunder Industrial Estate Lahore
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Levokan Infusion 500mg/ 100ml
Strength / concentration of drug of Active Each 100 ml Vial contains:
Pharmaceutical ingredient (API) per unit Levofloxacin as hemihydrate..........500mg
Pharmaceutical form of applied drug Sterilized Liquid for Infusion
Pharmacotherapeutic Group of (API) Quinolone antibacterial/fluoroquinolones
The status in reference regulatory authorities MHRA Approved
For generic drugs (me-too status) Leflox Infusion 500mg/100ml Getz Pharma Pakistan
Registration No: 024664
GMP status of the Finished product cGMP No. FID-797667-1346 issued by DRAP valid till
manufacturer 25/10/2022.
New Section Approval granted on 12-03-2021
(Injectable General Ampoule & Injectable General vials)
section approved.
Name and address of API manufacturer. Zhejiang Starry Pharmaceutical Co., Ltd. (Starry) No.1
Starry Road of Xianju Modern Industrial Centralization
Zone, Xianju, Zhejiang, China 317300

Module III (Drug Substance) Official monograph of Levofloxacin is present in USP.
controls, tests for impurity & related substances (impurity
A & unspecified), specifications, analytical procedures
system and stability studies of drug substance
Batches: (C019-0912001, C019-1004001, C019-
1004003)
impurities, specifications, analytical procedure (including
dissolution testing at acidic and buffer medium) and its
verification studies, batch analysis and justification of
dissolution profile against the brand leader that is Leflox Infusion
500mg/100ml Getz Pharma Pakistan Registration No:
024664 by performing quality tests the results of all the
tests of both products falls within the specification and
are comparable. The firm has performed comparative
analysis with innovator’s product the studies
demonstrate comparable results with the innovator
product.
Analytical method validation/verification of Firm has submitted reports of verification studies of
product analytical method for the drug substance.
Firm has submitted reports of validation of analytical
method for the drug product.
Manufacturer of API Zhejiang Starry Pharmaceutical Co., Ltd. (Starry) No.1 Starry Road of Xianju
Modern Industrial Centralization Zone, Xianju, Zhejiang, China 317300
API Lot No. C008-2005306
Description of Pack
Sealed In Alu-Alu Poly bag in Plastic Drum
Frequency Accelerated: 0, 1, 2, 3, 6 (Months)
Real Time: 0, 3, 6, (Months)

Batch No. KL 01 KL 02 KL 03
No. of Batches 03
1 Reference of previous approval of applications Aqua-J Approved in DRB meeting 312th
2 Approval of API/ DML/GMP certificate of API Copy of DML certificate No. Z20040326 issued by The
manufacturer issued by concerned regulatory People’s Republic of China and GMP No ZJ20190108
3 Documents for the procurement of API with Firm has submitted copy of attested invoice No. EXI20-
approval from DRAP (in case of import). 509 specifying import of 500kg Levofloxacin
hemihydrate Dated 17-06-2020.
4 Data of stability batches supported by attested Submitted
respective documents like chromatograms, Raw
5 Compliance Record of HPLC software 21CFR & Ezchrome Software with HPLC is being used data
audit trail reports on product testing submitted
6 Record of Digital data logger for temperature and Submitted
Observation Response
Submit complete analytical method for routine analysis of Complete analytical method for analysis of drug
drug substance by drug product manufacturer. substance as per USP is submitted.
Analytical method verification/validation studies including Analytical method verification for analysis of
specificity, precision and accuracy performed by drug drug substance from drug product manufacturer
product manufacturer. including specificity, accuracy and precision is
submitted.
It is not clear from the COA of Levofloxacin Hemihydrate The firm has submitted revised COA mentioning
drug substance used for development of the applied product the assay value on anhydrous basis.
whether the assay value is calculated on As Is basis or it is
on anhydrous basis. Please clarify.
COA of reference standard used is required. COA of working standard is submitted.
Since the real time stability studies have not been conducted The firm has submitted real time stability data
according to the conditions of zone IV-A. Therefore, real according to zone IV-A for 04 batches till 18th
time stability studies according to zone IV-A is required or month time point.
otherwise submission of record of data logger for (Batches: C019-0912001, C015-1004001,
monitoring of temperature and humidity during C015-1004002, C015-10040003)
transportation and stability studies of finished product for 6
months along with the impurity testing.
The official monograph of Levofloxacin Hemihydrate drug No justification is submitted.
substance is available in USP and it describes HPLC method
for analysis while UV-visible spectroscopic method is
developed for analysis of drug product. Please provide
justification for adopting UV method for analysis instead of
HPLC method keeping in view that the HPLC can be
developed in accordance with the available USP monograph
of drug substance.

The submitted stability study data is of 3 months, please The firm has submitted stability data till 6th
submit stability data including accelerated and real time for month time point.
6 months.
Provide justify the quantity of drug substance used for No calculation is submitted.
potency adjustment and also provide complete calculations.
Provide documents for procurement of drug substance along Copy of GMP certificate No. ZJ20190108 issued
with the API manufacturing approval/GMP of drug by CFDA dated 17/09/2019 valid till 16/09/2024
substance manufacturer. is submitted.
• Scientific justification for applying UV spectrophotometric method for the drug product Assay test, during
stability studies, whereas USP monograph of drug substance specifies HPLC method for the Assay test.
• Submission of pharmaceutical equivalence studies against the innovator drug product.

A: Variant New Section:
501. Name, address of Applicant / Marketing M/s Variant pharmaceuticals (Pvt) Ltd, Plot No. 5, M-2,
Authorization Holder Pharmazone, 26 Km, Lahore Sharikpur Road, Sheikhupura.
Name, address of Manufacturing site. M/s Variant pharmaceuticals (Pvt) Ltd, Plot No. 5, M-2,
Pharmazone, 26 Km, Lahore Sharikpur Road, Sheikhupura.
☐ Importer
☐ Export sale
PANTO 40mg Tablet
name
Strength / concentration of drug of Active Each Enteric coated tablet contains:
Pharmaceutical ingredient (API) per unit Pantoprazole as sodium sesquihydrate…..40mg
Pharmaceutical form of applied drug Tablet.
Pharmacotherapeutic Group of (API) PPI
USP specifications
specifications
The status in reference regulatory PANTOPRAZOLE SODIUM 40mg tablet by Aurobindo
authorities Pharma pharma Ltd, USFDA Approved.
For generic drugs (me-too status) PROTIUM 40 mgTablets by by M/s Abbott Pharma (Pvt.)
Ltd. Reg. No. 021039
manufacturer General Tablet, General Capsule, General Sachet and General
dry powder injectable (pre-lyophilized)
Name and address of API manufacturer. Manufacturer:
JPR Labs Private Limited
(A unit of Mankind Pharma Limited)
Plot No.74/A, J.N. Pharma city, Thanam Village, Parawada
Mandal, Vizag - 531019, India
DMF Holder:
M/s Mankind Pharma Limited, 208, Okhla Industrial Estate
Phase-3, New Dehli-110020, India.

Module III (Drug Substance) Official monograph of Pantoprazole sodium is present in
USP/BP. The firm as submitted detail of nomenclature,
controls, tests for impurity & related substances, specifications,
Batches:(PAN/019/16,PAN/020/16, PAN/021/16)
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established against the
comparative dissolution profile innovator brand that is PROTIUM 40mg Tablet by M/s
ABBOTT PHARMA Pvt. Ltd, by performing quality tests
(Identification, Assay, Dissolution,). CDP has been performed
against the same brand that is PROTIUM 40mg Tablet by M/s
ABBOT PHARMA Pvt. Ltd, in Acid media (pH 1.2), &
Phosphate Buffer (pH 6.8). The values for f1 and f2 are in the
acceptable range.
of product range, accuracy, precision, specificity for drug product and
drug substance.
Manufacturer of API JPR Labs Private Limited
Plot No.74/A, J.N. Pharma city, Thanam Village, Parawada
Mandal, Visakhapatnam- 531019, Andra Pradesh, India.
API Lot No. PANVT064
Description of Pack
Batch No. T-001 T-002 T-003
No. of Batches 03

firm (if any)
8. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. 405/DD/DCA/VSP/2020 govt. of
API manufacturer issued by concerned Andhrapradesh Drugs Control Administration INDIA issued by
regulatory authority of country of origin. govt. of Andhrapradesh Drugs Control Administration INDIA
Copy of License Retention Certificate is submitted issued on
22/05/2020. The License I valid till 16/03/2025 as per the letter.
9. Documents for the procurement of API with • Copy of letter No.4111/2020/DRAP-AD-CD(I&E) dated
approval from DRAP (in case 18/03/2020 is submitted wherein the permission to import
of import). different APIs including AMLODIPINE BESYLATE for the
• Copy of attested Invoice # JPR/SAMPLE/15 AD date 30-
07-2020 is submitted (2kg).
chromatograms,
sheets etc.
testing
accelerated)
The submitted method of analysis for drug “We acquired the working standard from drug substance
substance describes the preparation of standard manufacturer for the testing of trial batches”.
solution by using the working standard. “The working standard was synthesized and characterized in-
However, as per the guidance document of Form house. One of the approved batches of Pantoprazole Sodium
5F, for testing of Pharmacopoeial Drug was considered for preparation of working standard which
Substance, the use of primary reference standard was characterized against the USP reference standard of
is recommended. Please clarify. Pantoprazole Sodium (USP lot No. R022R0)”.
“Impurity Standards of Pantoprazole Sodium were
synthesized and characterized in-House. Certificate of
analysis of Impurity standards are also provided under this
section”.
The firm ha submitted COA of working standard obtained
from the drug substance manufacturer as well as from the
drug product manufacturer for pantoprazole sodium (batch
No. PANVT064)
The submitted analytical method verification Analytical method verification studies from drug product
studies are from drug substance manufacturer manufacturer are submitted including data of certain
while the said studies should be performed by parameters like accuracy, precision, linearity, selectivity,
the drug product manufacturer. Therefore, LOD, LOQ and robustness.
submit the method verification studies
performed by drug product manufacturer.
Since the reference product’s literature shows • Seal coating material is prepared by mixing IPA and
that the applied product is manufactured by the Methocil E5 for 30-40 minutes.
enteric coating process followed by film coating • Enteric coating material: Take mixture of IPA and water
therefore, clarification is required regarding and tablet coat Beige Brown 2200 OHA (enteric coat) by
enteric and film coating material used in the means of stirring for 45 to 60 minutes.

formulation along with the complete description • Film coating is done by taking ready to use premix tablet
of coating procedure. coat and polishing solution by spraying on to the enteric
coated tablets.
Please submit release specifications of the Data not submitted.
applied product with justification.
Submission of complete calculations for potency The firm has submitted the calculation for potency
adjustment considering the COA from drug adjustment (45.46mg of powder which is equivalent to 40mg
product manufacturer are required. of pantoprazole).
Decision: Approved.
application.
Case No. II: Registration applications submitted of Form 5F (Human-Import)

New Cases (Form 5F-Human-Import):
502. Name, address of Applicant / Importer M/s Adcare Pharma, House No. D-145, 5th road, Satelite town
Rawalpindi.
Address: Adcare Pharma, House No. D-145, 5th road, Satelite
town Rawalpindi.
Godown: House No. D-145, 5th road, satellite town,
Rawalpindi.
Status: Drug License by way of Wholesale
Name and address of marketing authorization M/s Lunan Better Pharamceutical Co., Ltd., No. 243,
holder (abroad) Yingueshan road, Linyi city, Shandong province, China.
Name, address of manufacturer(s)
• Original legalized GMP certificate (NO. SD20180814) is submitted with validity of 25/11/2023.
• Original legalized CoPP (certificate No. 20200106) issued by Shandong Food and Drug Administration,
China on 11/12/2020.
The product is not available for free sale in the exporting country.
The facilities and operation conform to WHO-GMP.
Details of letter of authorization / sole agency agreement:
• Copy of letter of authorization is submitted
☒ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.31904 : 01/12/2020

Details of fee submitted PKR 100,000/- : 01/12/2020
The proposed proprietary name / brand name Sevocare 250mL for Inhalation
Strength / concentration of drug of Active Each 250mL bottle contains:
Pharmaceutical ingredient (API) per unit Sevoflurane……..100% (250mL)
Pharmaceutical form of applied drug Liquid for inhalation.
Pharmacotherapeutic Group of (API) General Anesthetics
Proposed unit price Rs. 19980/- per 250mL
The status in reference regulatory authorities Sevoflurane 100% Inhalation Vapour, liquid (250mL type III
amber colored glass bottle), MHRA Approved.
For generic drugs (me-too status) Sevorance Volatile Liquid For Inhalation by M/s Abbot, Reg.
No. 27374
its validation, detail of impurities and validations studies, batch
and product.
Name, address of drug substance M/s Shandong New Time Pharmaceutical Co., Ltd., No. 1
manufacturer North Outer Ring road, Feixian County, Shandong 273400,
China.
sources related to nomenclature, structure, general properties,
Stability Studies of Drug Substance • Real time stability studies have been conducted at 25oC±2
(Conditions & duration of Stability studies) and 60%RH±5% for 36 months of 3 batches
• Accelerated stability study is conducted at 40oC±2 and
75%RH±5% for 6 months of 3 batches
Batches: (100100, 1001002, 1001003)
compatibility studies of excipients with drug substance
drug product, specifications, analytical procedures for the
product along with the impurities, validation of analytical
procedures, detail of impurities and the validation studies,
Pharmaceutical Equivalence and Comparative
Dissolution Profile

Analytical method validation/verification of The firm has submitted analytical method verification studies
product including specificity, linearity and accuracy for drug product,
drug substance and impurities as well.
Container closure system of the drug product 250mL amber colored type III glass bottle sealed by an
aluminium screw cap with a low density polyethylene liner.
Stability study data of drug product, shelf life • Real time stability studies have been conducted at
and storage conditions 30oC±2 and65%RH±5% for 36 months of 3 batches
• Accelerated stability studies is conducted at 40oC±2 and
Batches: (090301, 090302, 090303)
Evaluation by PEC:
• The applicant holds the registration of “Isofurane Inhalant” 100ml bottle with registration no. 045727 from the
same manufacturer that is M/s Lunan Better Pharmaceutical Co., Ltd., China.
• As per the submitted CoPP the applied product is not available for free sale in the exporting country.
Submission of valid copy of drug sale license is The firm has submitted valid copy of DSL with the following
required. details.
License No: 01-374-0177-028459D
Address: Adcare Pharma, House No. D-145, 5th road, Satelite
town Rawalpindi.
Godown: House No. D-145, 5th road, satellite town,
Rawalpindi.
Submit filled, signed and stamped Form 5F with the The firm has submitted form 5F with the relevant documents.
relevant details which should be provided along with.,
since the submitted Form 5F does not contain any
information regarding the registration application.
Product specific sole agency agreement between the
product license holder and the applicant is required.
Since you are already granted the registration for The firm has stated that they have been granted the registration
Isoflurane 100ml bottle, therefore the application for of 100mL sevoflurane and now they are applying for 250mL.
250ml bottle shall be submitted, please submit revised The firm has submitted relevant documents for 250mL
form 5F along with the applicable fee. sevoflurane.
The submitted data is for 100mL bottle while the Submitted.
registration for 100mL bottle is already granted by the
Board. Therefore, you are required to provide the
relevant data.
Provide evidence of approval of the applied Sevoflurane 100% Inhalation Vapour, liquid (250mL type III
formulation by reference regulatory authorities (with amber colored glass bottle), MHRA Approved.
same filled volume/strength) which were adopted by
Registration Board in its 275th meeting.
Pharmaceutical equivalence data is not submitted.
• Submission of Free sale certificate in the country of origin i.e., China for the applied product in fill
volume of 250ml, issued by relevant regulatory authority or else Free sale certificate in any of the
reference regulatory authorities of the applied product from the the same finished drug product
manufacturer i.e., M/s Lunan Better Pharamceutical Co., Ltd., No. 243, Yingueshan road, Linyi city,
Shandong province, China.
• Submission of Pharmaceutical equivalence studies against the innovator product.
544. Name, address of Applicant / Importer M/s AMGOMED, Office # 4, First Floor Ghausia Plaza, Jinnah
Avenue Blue area Islamabad Pakistan

Details of Drug Sale License of importer License No: DSL-002-ICT/2013
Address: Amgomed office # 4, First floor Ghausia Plaza,
Jinnah Avenue Blue area Islamabad
Address of Godown: Office number 5, First floor Rose-I plaza,
I-8, Markaz Islamabad.
Name and address of marketing authorization M/s PT Fonko International Pharmaceuticals, Kawasan
holder (abroad) Industri Jababeka II, JI. Industri Selatan V, Blok PP No. 7,
Cikarang Selatan, Bekasi, Jawa Barat-Indonesia.
Name, address of manufacturer(s) M/s PT Fonko International Pharmaceuticals, Kawasan
Industri Jababeka II, JI. Industri Selatan V, Blok PP No. 7,
• Original legalized GMP certificate No. ST.03.05.33.0331.07.20.000233 (for export purpose) valid till
20/07/2022 issued by Indonesia Food and Drug Authority (for Oncology Small Volume Injection section).
• Firm has submitted original legalized CoPP (No. RG.01.05.32.321.07.20.1809) issued by National Agency
of Drug and Food Control Indonesia issued on 26/07/2020 for 300mg/50mL.
The product is available in market of exporting country for free sale.
The facilities and operations conform to WHO-GMP.
• Letter of authorization is submitted whereby M/s PT Fonko International Pharmaceuticals has appointed and
authorized M/s Glorious Dexa Singapore PTE. LTD., 80 Robinson road # 17-02 Singapore as exclusive
marketer and distributor of Fonko with the rights to commercialize Fonko’s products in Pakistan, and as an
owner of the product, M/s PT Fonko International Pharmaceuticals authorized M/s Gloroius Dexa Singapore
PTE. LTD. To appoint M/s Amgomed as distributor of Paclitaxel 6mg/ml concentrate for solution for
infusion in Pakistan.
☒ Importer
☐ Export sale
Details of fee submitted PKR 100,000/- : 18-03-2021
The proposed proprietary name / brand name Paclitaxel Concentrate solution for infusion 300mg/50ml
IV
Pharmaceutical ingredient (API) per unit Paclitaxel…….6mg
Pharmaceutical form of applied drug Concentrate for solution for IV infusion
Pharmacotherapeutic Group of (API) Antineoplastic

The status in reference regulatory authorities USFDA Approved. (30mg/5ml, 300mg/50ml, 100mg/16.7ml)
by M/s Hospira.
For generic drugs (me-too status) NANOXEL INJECTION (30mg/5ml, 100mg/16.7ml,
300mg/50ml) by M/s Atco Pharma Internagtional (Pvt)
Limited.
and product.
Name, address of drug substance manufacturer M/s Hetero Labs Limited Unit-I, Survey No. 10, I.D.A.,
Gadddpotharam Village, Jinnaram Mandal, Sangareddy
District-502319, Telangana, India.S
Batches: (PA17070001, PA17070002, PA17080003)
of analytical procedures, detail of impurities and the validation
studies, batch analysis, justification of specifications, reference
Compatibility studies with 5% dextrose and 0.9% sodium
chloride infusions. The dilution is stable for 48 hours.
Pharmaceutical Equivalence and Comparative The firm has submitted pharmaceutical equivalence studies
Dissolution Profile against the reference product Paclitaxel Injection 6mg/ml
(300mg/50ml B:Z026865AA, 100mg/16.7ml B:Z016851AA,
30mg/5ml B:Y036849AA) by specifying the physical
characters as well as by performing the quality tests performing
all the quality tests.
Analytical method validation/verification of The firm has submitted analytical method
product validation/verification studies for impurities, drug substance
and drug product.
Container closure system of the drug product Type I molded and clear glass vial with rubber stopper.

Batches: (C0017, D0001, D0005)
Evaluation by PEC:
Please provide detail of the product (approval status inHospira US Paclitaxel Injection (30mg/5mL vial/101453,
reference countries, detail of manufacturer etc) against100mg/1607mL vial/101452), and Hospira Paclitaxel
which the pharmaceutical equivalence studies are concentrate for solution for infusion 300mg/50mL vial /
performed. 101451) by M/s Hopsira Australia Pty Ltd. TGA Australia
approved.
Analytical method verification studies for drug The firm has submitted analytical method verification studies
substance performed by drug product manufacturer is for drug substance including impurities and residual solvents
required including specificity, precision and accuracy. (document no. FIP-AMT-P-002, FIP-AMT-R-0002, 0114\MV-
VAL\R, 089\MV-VAL\R)
Scientific justification is required since the aseptic “Manufacturing process of the applied product is using aseptic
processing/filling is preferred over terminal process considering the forced degradation study of drug
sterilizations for manufacturing of the applied substance where significant degradation was observed in
product. thermal testing (heated at 105oC±2. Hence, aseptic process is
preferred over terminal sterilization for manufacturing the
product.
facility.
545. Name, address of Applicant / Importer M/s AMGOMED
Office # 4, First Floor Ghausia Plaza, Jinnah Avenue Blue area
Islamabad Pakistan
of Drug and Food Control Indonesia issued on 26/07/2020 for 30mg/5mL.

☒ Importer
☐ Export sale
The proposed proprietary name / brand name Paclitaxel Concentrate solution for infusion 30mg/5ml IV
by M/s Hospira.
Limited.
and product.

Batches: (PA17070001, PA17070002, PA17080003)
characters as well as by performing th equality tests performing
and drug product.
Batches: (C0015, D0007, D0012)
Evaluation by PEC:
Please provide detail of the product (approval status in Hospira US Paclitaxel Injection (30mg/5mL vial/101453,
reference countries, detail of manufacturer etc) against 100mg/1607mL vial/101452), and Hospira Paclitaxel
approved.
product.

facility.
546. Name, address of Applicant / Importer M/s AMGOMED
Office # 4, First Floor Ghausia Plaza, Jinnah Avenue Blue area
Islamabad Pakistan
of Drug and Food Control Indonesia issued on 07/08/2020 for 100mg/16.7mL.
☒ Importer
☐ Export sale
The proposed proprietary name / brand name Paclitaxel Concentrate solution for infusion 100mg/16.7ml IV

by M/s Hospira.
Limited.
and product.
Batches: (PA17070001, PA17070002, PA17080003)
characters as well as by performing th equality tests performing

and drug product.
Batches: (C0016, D0002, D0006)
Evaluation by PEC:
Please provide detail of the product (approval status inHospira US Paclitaxel Injection (30mg/5mL vial/101453,
reference countries, detail of manufacturer etc) against100mg/1607mL vial/101452), and Hospira Paclitaxel
approved.
product.
facility.
547. Name, address of Applicant / Importer M/s Novartis Pharma (Pakistan) Limited, 15 West Wharf,
Karachi.
Address: Novartis Pharma (Pakistan) Limited, 15 West
Wharf, Dockyard Road, Karachi, Pakistan.
Address of Godown: C-21, SITE, Karachi.
Validity: 12-03-2023.
Status: License to sell drugs by way of wholesale
holder (abroad)
Name, address of manufacturer(s) M/s Novartis Pharma Stein AG, Schaffauserstrasse, 4332
Stein, Switzerland.
• Firm has submitted original & legalized CoPP certificate (No. 200005608) dated 07.12.2020 issued by
Swissmedic for Enerzair Breezhaler Inhalation Powder Hard Capsule 150/50/160mcg.
The CoPP confirms product is on market in exporting country.
• Firm has submitted Original & Legalized Letter of Authorization. As pe the letter M/s Novartis Pharma
(Pakistan) Limited is appointed to register and market Enerzair Breezhaler 150/50/160 mcgs inhalation
powder hard capsules product as sole agent in Pakistan.

☒ Importer
☐ Export sale
Differential Fee PKR 25,000/- -: 27-06-2021
The proposed proprietary name / brand name Enerzair Breezhaler Inhalation Powder Hard Capsule
150/50/160mcg
Pharmaceutical ingredient (API) per unit Indacaterol as acetate………….150mcg
Glycopyrronium as Bromide…50mcg
Mometasone Furoate…………160mcg
Pharmaceutical form of applied drug Inhalation Powder Hard Capsule
Pharmacotherapeutic Group of (API) Anti-Asthmatic
Proposed Pack size 30x1 Capsule + 1 Inhaler
The status in reference regulatory authorities Enerzair Breezhaler 114/46/136 micrograms, inhalation
powder, hard capsule by M/s
For generic drugs (me-too status) Could not be confirmed
Module-II (Quality Overall Summary) Firm has submitted QOS. Firm has summarized information
analytical procedures and its validation, detail of impurities and
validations studies, batch analysis and justification of
stability studies of drug substance and product.
Name, address of drug substance manufacturer Glycopyrronium Bromide:
Novartis Pharma Stein AG, Schaffauserstrasse, 4332 Stein,
Switzerland.
Mometasone Furoate:
MSD International, GmBH (Singapore Branch), 50 Tuas West
Drive Singapore 638408.
Indacaterole Acetate:
Novartis Pharma Schweizerhalle AG, Rothausstrasse 4133
Prattein, Switzerland

Batches: ()
Firm has submitted stability study data of all 3 drug substance.
Glycopyrronium Bromide:
• Real time stability studies have been conducted at 25oC±2
and 60%RH±5% for 60 months of 3 batches
• Data for forced degradation studies is submitted.
• Stability studies under light exposure is submitted.
Indacaterol Acetate:
• Data for forced degradation studies is submitted.
• Stability studies under light exposure is submitted.
Mometasone Furoate:
Time points: (0, 12, 36)
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) for 114/46/136 micrograms is equivalent to 114
micrograms indacaterol, 46 micrograms glycopyrronium, and
136 micrograms mometasone furoate (TGA Australia).
Pharmaceutical Equivalence and Comparative N/A
Dissolution Profile
Analytical method validation/verification of The firm has submitted analytical method validations studies
product for drug substances as well as for drug product.
Container closure system of the drug product Hard capsules consist of aluminium foil laminated with
Polyamide at one side and coated with Polyvinyl Chloride film
for forming component and backing component consists of
aluminium foil laminated with Polyethylene tetraphthalate.

Batches: (1010016696, 1010016697, 1010016698)
Evaluation by PEC:
Time points selected for stability testing (0, 12, 36) for “Mometasone furoate is an established drug substance and of
Mometasone Furoate are not according to ICH established quality as it is manufactured by MSD Singapore
guidelines, please clarify. and supplied to Novartis for use in production of the applied
product. The stability data submitted was from the recent
annual Mometasone Furoate drug substance stability batches
following the annual stability protocol and corresponding
annual test pull points (0, 12, 24, 36) and cover the complete
retest period of 36 months.
facility. The Board further advised the P.E&R division to include following information on the registration
letter of Dry Powder Inhaler Capsules:
548. Name, address of Applicant / M/s. Novartis Pharma (Pakistan) Limited, 15 West Wharf, Karachi,
Importer Pakistan.
Details of Drug Sale License of License No: 007
importer Address: Novartis Pharma (Pakistan) Limited, 15 West Wharf,
Dockyard Road, Karachi, Pakistan
Address of Godown: C-21, SITE, Karachi.
Validity: 12-03-2023.
Status: Drug license by way of wholesale
Name and address of marketing M/s Novartis EuroPharm Limited, Vista Building ELM Park, Merrion
authorization holder (abroad) Road, Dublin 4, Ireland.
Name, address of manufacturer(s) M/s Corden Pharma S.p.A., Reparto UP3, via G, Galilei 17, Caponago,
20867 Italy.
Name of exporting country Italy
Detail of certificates attached (CoPP, Freesale certificate, GMP certificate)
• Firm has submitted original & legalized CoPP certificate (No. 15/21/154697) dated 16-02-2021 issued by
European Medicines Agency for Sybrava Solution for injection in pre-filled syringe. The CoPP confirms that
this product is on market in exporting region as well as GMP compliant status of manufacturer.
• Original legalized GMP certificate No. IT/45/H/2020 is submitted.
• Firm has submitted original & legalized letter of Authorization. This letter specifies that the manufacturer
appoints M/s Novartis Pharma (Pakistan) Limited to register and market Sybrava 284mg/1.5ml as sole agent
in Pakistan.
☒ Importer
☐ Export sale

Dy. No. and date of submission Dy. No. Dated: 09-06-2021
Differential fee PKR 25000/- Dated: 27-05-2021
The proposed proprietary name / brand Sybrava Solution for injection in pre-filled syringe
name
Strength / concentration of drug of Each ml contains:
Active Pharmaceutical ingredient Inclisiran as Sodium…….189mg
(API) per unit
Pharmaceutical form of applied drug Solution for Injection in Pre-filled Syringe
Pharmacotherapeutic Group of (API) Lipid-Modifying agent
Reference to Finished product Innovator’s Specs
specifications
Proposed Pack size 1’s Pre-filled syringe per pack (284mg/1.5ml PSF)
The status in reference regulatory Sybrava has been approved in many stringent regulatory authorities
authorities such as Austria, Germany, France and Sweden among others.
Module-II (Quality Overall Summary) Firm has provided the summarized information related to nomenclature,
structure, general properties, solubility, physical form, manufacturers,
Name, address of drug substance Agilent Technologies Inc.,
manufacturer _ 5555 Airport Boulevard, Boulder, CO 80301, _ USA.
_ 7051 Eagle Boulevard Frederick, CO 80504, USA.
Module-III Drug Substance: Firm has submitted detailed drug substance data for both sources related
to nomenclature, structure, general properties, solubility, physical form,
impurities, specifications, analytical procedures and its validation,
Stability Studies of Drug Substance Firm has submitted stability study data of drug substance under the
(Conditions & duration of Stability freezer long-term storage conditions of -20°C ± 5 °C (till 60 months for
studies) Batch No. A05AL14003, 36 months for A05AL16001, 30 months for
M09c17001).
The accelerated data for 6 month is also submitted.
protocols, control of excipients, control of drug product, specifications,
analytical procedures, validation of analytical procedures for impurities
and drug substance, batch analysis, justification of specifications,
reference standard or materials, container closure system and stability.
Pharmaceutical Equivalence and Not Applicable.
Comparative Dissolution Profile

Analytical method Firm has submitted analytical method validation studies for drug
validation/verification of product substance and the drug product.
Container closure system of the drug USP Type I Glass syringe (2.25mL capacity) with staked needle and
product rigid needle shield which is sealed with a Type 1 bromobutyl
FluroTec® and B 2-40® coated plunger.
Stability study data of drug product, • Real time stability studies have been conducted at 30oC±2 and
shelf life and storage conditions 75%RH±5% for 06 months of 3 batches
Batches: (P319033, P319046, P320008)
Evaluation by PEC:
Inclisiran is a chemically modified small interfering RNA (siRNA) duplex. The siRNA duplex contains a 21-nucleotide
sense strand conjugated with triantennary acetyl galactosamine, (GalNAc) on the 3’ end. Inclisiran sodium is a white
to pale white powder and is freely soluble in water. The molecular formula and molecular weight of inclisiran salt form
is respectively C529H664F12N176Na43O316P43S6 and 17,284.75 g/mol (US-FDA).
The address of finished product manufacturer is not There are two production sites for M/S Corden Pharma as
same in CoPP and GMP certificate issued by AIFA mentioned in GMP certificate provided by the firm:
Italy, Please clarify. 1. Corden Pharma S.p.A., Reparto UP3, via G, Galilei 17,
Caponago, 20867 Italy
2. Corden Pharma Societa’ per Azioni Viale Dell’ Industria, 3-
20867, Capongo (MB), Italy
However, the applicant has submitted that the applied product
will be manufactured at site mentioned on serial No. 1 and the
same is confirmed from submitted CoPP as well.
Submission long term stability study data according to • Real time stability studies have been conducted at 30oC±2
the conditions of zone IV-A/B is required till shelf life and 75%RH±5% for 12 months of 3 batches
for the applied product. The submitted long term • Accelerated stability studies is conducted at 40oC±2 and
stability data is submitted till 6th month time point. 75%RH±5% for 6 months of 3 batches
Batches: (P319033, P319046, P320008)
Since the applied product is not terminally sterilized “When the applied product is subjected to terminal sterilization
and aseptic filling is given the preference, it showed impact on the purity as rapid degradation was
scientifically justify. observed when temperature was raised… Therefore, the
applied product cannot be manufactured using terminal
sterilization without incurring degradation and a clear impact
on product quality”.
The firm has submitted relevant data with conclusion as under;
facility. Firm shall submit long term stability studies data as per Zone IVA conditions till claimed shelf life,

Deferred Cases (Form 5F-Human -Import):
549. Name, address of Applicant / Importer M/s Biocare Pharmaceutica 807 Shadman-I, Lahore.
Details of Drug Sale License of importer DSL No.: 05-352-0063-032069D
Address: Biocare pharamceutica 80 shadman-I district Lahore.
Status: License to sell drugs as Distributor
Name and address of marketing M/s PT Dexa Medica, JI. Jend. Bambang Utoyo No. 138,
authorization holder (abroad) Palembang, Indonesia
Name, address of manufacturer(s) M/s PT Ferron Par Pharmaceuticals, Kawasan Industri Jababeka I,
JI. Jababeka VI Block J3, Cikarang, Bekasi, Indonesia.
Exporting country Indonesia
• Original legalized CoPP (certificate No. RG.01.05.32.321.08.19.0644) issued by National Agency of
Drug and Food Control, Indonesia on 05/08/2019.
The applied product is available in the market for free sale with a brand name of Levica.
The facilities and operation conform to WHO-GMP.
• The applicant has submitted copy of supply and distribution agreement signed by PT Dexa Medica and
Biocar Pharmaceutica for Levobupivacaine 5mg/10ml infusion.
☒ Importer
☐ Export sale
Dy. No. and date of submission Dy. No 4077 Dated 04/02/2021
The proposed proprietary name / brand L-Ascain solution for injection 50mg/10ml
name Alternate brand names:
Levica
L-Bup
Strength / concentration of drug of Each ml contains:
Active Pharmaceutical ingredient (API) Levobupivacaine as hydrochloride monohydrate……..5mg
per unit
Pharmaceutical form of applied drug Intrathecal or epidural solution for injection
Pharmacotherapeutic Group of (API) Anesthetic
Reference to Finished product In-house
specifications
Proposed Pack size 1’s×5 (50mg/10ml ampoule)
Proposed unit price Rs. 410/- per ampoule
Rs. 2010/- per pack of 5 ampoules

The status in reference regulatory Chircaine 5mg/ml infusion by M/s Abbvie Ltd., PL41042/0006,
authorities MHRA Approved.
container closure system and stability studies of drug substance and
drug product is submitted.
Name, address of drug substance M/s Pioneer Agro Industries (Pharmaceutical Division_ Plot No.
manufacturer 6,7,8,20 & 24 MIDC Industrial Area, Badlapur, Dist-Thane 421
503, Maharashtra State India.
Module-III Drug Substance: There are 02 polymorphic forms of Levobupivacaine
hydrochloride. Stable polymorph is having a specific rotation of
14o while the pseudopolymorph has a value of specific rotation
equal to 6.5o. The firm as submitted detail of nomenclature,
of drug substance
Stability Studies of Drug Substance • 66 months real time stability data at 30°C ± 2°C / 65% ±
(Conditions & duration of Stability 5%RH of 03 batches
studies) • 06 month accelerated stability data 40°C ± 2°C / 75% ± 5%RH
of 03 batches
Batches: LBH/004/05/09, LBH/005/05/09, LBH/006/06/09
Module-III Drug Product: No compatibility studies are required since the qualitative
composition of the drug product is similar to the reference product
(Sodium Chloride, Hydrochloric acid, Sodium hydroxide, WFI).
Detail of manufacturers, description of manufacturing process and
of drug product is submitted.
Pharmaceutical Equivalence and Pharmaceutical equivalence has been established against the
Comparative Dissolution Profile innovator’s product CHirocaine 5mg/ml injection by M/s Abbvie
S.r.l Italy (batch no.: 1026457) by performing all the quality tests.
Analytical method validation/verification Validation studies of analytical method with satisfactory results of
of product accuracy, specificity, linearity, precision etc are submitted.
Container closure system of the drug Type I 10ml glass ampoule
product
Stability study data of drug product, shelf • 24 months real time stability data at 30°C ± 2°C / 75% ±
life and storage conditions 5%RH of 03 batches
Batches: 2971434, 2580972, 2781351
Batch Size: 4717 ampoules
• 36 months real time stability data at 30°C ± 2°C / 75% ±
5%RH of 03 batches
Batches:
K-10427-00-F-SCU-1A,

K-10427-00-F-PSC-1A,
K-10427-00-F-PSC-2A
Batch Size: 18,868 ampoules
• 06 month accelerated stability data 40°C ± 2°C / 75% ± 5%RH
of 03 batches
(Batches: 2971434, 2580972, 2781351, K-10427-00-F-SCU-
1A, K-10427-00-F-PSC-1A, K-10427-00-F-PSC-2A)
• In-Use stability of the applied product in Diluent (0.9%
sodium chloride solution) with acceptable results till 7 days is
submitted.
Evaluation by PEC-I:
Product specific sole agency agreement is The applicant has submitted copy of supply and distribution
required. agreement signed by PT Dexa Medica and Biocare
Pharmaceutica for Levobupivacaine 5mg/10ml infusion.
API used for manufacturing of the applied “Since the applied product is in solution for injection form
product is Levobupivacaine Hydrochloride manufactured by solubilizing the API in water for injection so
Monohydrate while Levobupivacaine the monohydrate that is previously bound with the API crystal
Hydrochloride is used for manufacturing the will also become part of solution”.
reference product, please clarify.
Justification is required since the titration “Analytical method for drug substance is adopted from DMF and
method is adopted for analysis of drug this titration method is similar to the assay method of
substance as well as the applied product. Bupivacaine Hydrochloride given in USP monograph. However,
However, HPLC method is adopted for the method used for analysis of drug product is HPLC method
identification test. derived from the method present in USP for Ropivacaine
Hydrochloride with slight modification of column dimension
and flow rate’.
“Identification of drug substance in drug product was taken from
this assay procedure by HPLC”.
“The assay method for drug substance and drug product already
validated as per ICH guidelines”.
Justify the specification limit for R- Since Levobupivacaine is the s-isomer of racemic Bupivacaine
enantiomer (impurity) that is 0.5% of the and the Biopharmaceutical review of Chirocaine (reference
drug substance. product) reveals the limit for R-enantiomer as 1.5%.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20997_CHIROCAINE_biopharmr.pdf (accessed on
08/11/2021 at 4:45pm).
Decision of 313th meeting:

The Board deferred the case for submission method of analysis for R-enantiomer (dextro rotatory) and limits for the
estimated content.
The firm has provided specifications along with the method of analysis by HPLC for enantiomeric impurity (not more
than 0.5% in API as well as in finished drug product). The firm has submitted that the limit (not more than 0.5%) for
enantiomeric impurity is adopted from Pioneer Agro Industries as API manufacturer.
facility.

550. Name, address of Applicant / Importer M/S Excel Healthcare Laboratories Pvt Ltd., d-122, block-4
federal b area Karachi Pakistan
Address: D-122 Block-4, Federal B Area Karachi.
Godown: D-122 Block-4, Federal B Area Karachi.
Validity: 08-08-2022.
Renewal: N/A
Name and address of marketing M/s AFT Pharmaceuticals Limited, PO box 33203, Takapuna,
authorization holder (abroad) Auckland 0740, New Zealand
Name, address of manufacturer(s) M/s S.M. Farmaceutici S.R.L. Zona Industriale, 85050 TITO ,
Italy
Name of exporting country New Zealand
Detail of certificates attached (CoPP, Freesale certificate, GMP certificate)
• Firm has submitted original, legalized CoPP certificate (No. 104098) dated 5th December 2019
issued by Ministry of Health New Zealand for Maxigesic IV Solution for Injection.
The CoPP confirms free sale status of the product in exporting country.
• Firm has also provided GMP Certificate (N0. IT/138/H/2019) dated 23/7/2019 issued by AIFA
Italian medicine Agency on the basis of inspection conducted on 29/03/2019.
• The firm has submitted copy of certificate of Suitability No. R1-CEP 1995-050-Rev 04 for
Paracetamol. The certificate is verifiable from the website. The weblink is given below.
https://extranet.edqm.eu/4DLink1/4DCGI/Query_CEP?vSelectName=3&Case_TSE=none&vContains=1&
vContainsDate=1&vtsubName=atabay+kimya+sanayi&vtsubDateBegin=&vtsubDateBtwBegin=&vtsubDa
teBtwEnd=&SWTP=1&OK=Search (accessed on 03/11/2021 at 12:33pm)
• Firm has submitted Original Legalized letter of distribution certificate from M/s AFT Pharmaceutical
Ltd. The letter Confirms that the marketing authorization holder appoints M/s Excel Healthcare
Laboratories (Pvt) Ltd to register their products in Pakistan for Maxigesic IV Solution for infusion to
register, import, market, distribute, sell. The authorization letter is valid till 15th-01st-2025.
☒ Importer
☐ Export sale
The proposed proprietary name / brand Maxigesic IV Infusion 10mg/3mg
name
Pharmaceutical ingredient (API) per unit Paracetamol……….10mg
Ibuprofen as sodium dihydrate…..3mg
Pharmaceutical form of applied drug Clear and colourless solution for IV Infusion
Pharmacotherapeutic Group of (API) Analgesic/Antipyretic

specifications
Proposed Pack size 10 x 100ml vials
Proposed unit price Rs. 700/- per vial
The status in reference regulatory Maxigesic IV Infusion by M/s AFT Pharmaceuticals, TGA
authorities Australia
Module-II (Quality Overall Summary) Firm has submitted QOS. Firm has summarized information
analytical procedures and validation for drug substances as well
as for the impurities, batch analysis and justification of
stability studies drug product.
The firm has referred the certificate of suitability for
Paracetamol.
Name, address of drug substance Ibuprofen Sodium Dihydrate:
manufacturer M/s Solara Active Pharma Sciences Limited, R.S.No:33 & 34,
Mathur Road, Periyakalapet Puducherry 605014, India
Paracetamol:
M/s Atabay Kimya Sanayi Ve Ticaret AS Dilovasi Organize
Sanayi Bolgesi 4. Kisim Sakarya Caddesi, No. 28 Gebze.
Kocaeli 41400. Turkey.
Module-III Drug Substance: Firm has submitted detailed drug substance data for both sources
analytical procedures and validation for drug substances and
impurities, batch analysis and justification of specification, detail
of reference standard, container closure system and stability
studies of Ibuprofen Sodium dihydrate.
The firm has submitted copy of certificate of suitability for
Paracetamol
Stability Studies of Drug Substance Ibuprofen Sodium Dihydrate:
(Conditions & duration of Stability studies) • Real time stability studies have been conducted at 30oC±2
& 65%RH±5% for 12 months of 3 batches
Batches: B3ISP160009, B3ISP160010, B3ISP160009.
Pharmaceutical Equivalence and N/A

Container closure system of the drug Type II glass vial with bromobutyl stopper & aluminium cap.
product
Stability study data of drug product, shelf • Real time stability studies have been conducted at 30oC±2
life and storage conditions & 75%RH±5% for;
36 months of batches: C9280, C9281, C9282 &
24 months of batches: E0182, E0496
Batches: C9280, C9281, C9282, E0182, E0496
Evaluation by PEC:
Please submit S part of module II for Ibuprofen by The firm has provided S part for Ibuprofen of QOS as per
providing relevant information under relevant WHO-PD template. Firm has summarized information
section since you have referred to DMF and related to nomenclature, structure, general properties,
Module III for required information is different solubilities, physical form, manufacturers, description of
sections. manufacturing process and controls, impurities,
specifications, analytical procedures and validation for drug
substances as well as for the impurities, batch analysis and
closure system and stability studies for Ibuprofen sodium.
Provide summary of analytical procedures in The firm has summarised the relevant information of
section 2.3.P.5.2 of QOS for drug product. analytical procedures in section 2.3.P.5.2.
Justification is required since the acceptance The acceptance criteria for impurities is set from 95-105%
criteria for recovery is set from 95-105% for based on the experimental performances. The criteria 95-
analytical validation studies of Accuracy 105% is set for unknown impurity. For the rest of the
parameter for impurities. Refer the guideline as impurities the acceptance criteria is set from 98-102%.
well. The firm has not referred any guideline for establishing the
criteria.
Scientific justification is required since the assay “The product is designed as a hospital product and should be
results of 4-Aminophenol are out of specifications stored below 25oC”.
for all three batches of drug product at different “As described in Pharmaceutical Development, the product is
timepoints of stability study data conducted at temperature sensitive and stable for a shorter period (3
30oC±2 & 75%RH±5% and 40oC±2 and months) when stored at 40oC±2 and 75%RH±5% while at
75%RH±5%. 30oC±2 and 75%RH±5% the stability profile is slightly
longer from 12 to 18 months”.
“The hydrolysis of paracetamol producing impurity 4-
aminophenol depends therefore on the factors pH,
temperature and time. Hydrolysis is increased at higher pH,
higher temperature and with time”.
“Nevertheless, the level of impurity 4-aminophenol at 25°C
remains in compliance with the established specification of
maximum 0.05% up to the end of shelf life (24 months).
Therefore, the proposed shelf life is 24 months, when stored
at or below 25°C, including transport”.
The Board Deferred the case for;
• Scientific justification since the assay results of 4-Aminophenol are out of specifications for all three batches of drug
product at different timepoints of stability study data conducted at 30oC±2 & 75%RH±5% and 40oC±2 and
75%RH±5%.
• Furthermore, the Board directed the firm to provide indication of the applied product with respect to the dose of drug
substances in the formulation.

• The firm has stated that 4-aminophenol is generated by the hydrolysis of Paracetamol. Hydrolysis depends
upon the pH, temperature and time. Hydrolysis is increased at higher pH, temperature and with time. The
optimum pH to avoid hydrolysis is 5.5-6.0 while the limits is specifications are 6.3-7.3 because the pH of
Ibuprofen sodium dihydrate has a pH of 7.1-7.3 at a concentration as in the finished product. No buffer can
be used as paracetamol is incompatible with the buffers.
• Therefore, the pH increase can only be justified when the product is stored at 25oC since all the parameters of
the preparation are in conformance at a pH between 6.4 to 7.3.
• The product can be administered in any post operative setting to manage post operative acute pain. The firm
has not provided any reference for the indications.
• However, as per TGA Australia following is the indication.
facility, with 18 months shelf life and storage condition of “Do not store above 25oC.”
551.Name, address of Applicant / M/s Al-Habib Pharmaceuticals, 81 B Block, S.M.C.H.S Karachi.
Importer
Details of Drug Sale License of DSL No.: 1245
importer Address: Al-Habib Pharmaceuticals, 81-B, block B, SMCHS, Karachi.
Godown: Plot No. 10 sector 25 KIA, Karachi
Name and address of marketing M/s Jodas Expoim Pvt. Ltd. Plot No. 55, Phase-3, Biotech Park, Karkapatla
authorization holder (abroad) (V), Markook (M), Siddipet, Telangana State Pin-502 279 India.
Name, address of manufacturer(s) M/s Jodas Expoim Pvt. Ltd. Plot No. 55, Phase-3, Biotech Park, Karkapatla
(V), Markook (M), Siddipet, Telangana State Pin-502 279 India.
• Original legalized CoPP (certificate No. L.Dis.No.3349/E1/2020) valid till 08/08/2021 issued by Drugs
control Administration Telangana, India.
The product is available in free sale in exporting country.
The facilities and operations conform to Chinese-GMP.
•
☒ Importer
Intended use of pharmaceutical ☒ Domestic sale
For imported products, specify one ☒ Finished Pharmaceutical product import
the these ☐ Buk import and local repackaging
Dy. No. and date of submission Dy. No.7094 : 03-03-2021

The proposed proprietary name / AHP-Cita 500mg tablet
brand name
Active Pharmaceutical ingredient Capecitabine………500mg
(API) per unit
Pharmaceutical form of applied Film coated tablet
drug
Pharmacotherapeutic Group of Anti-cancer
(API)
Reference to Finished product In-house
specifications
The status in reference regulatory Xeloda film coated tablet 500mg by M/ s Hoffmann LA Roche, USFDA
authorities Approved.
For generic drugs (me-too status) CAPEGARD-500MG FILM COATED TABLETS by M/s AJ Mirza
Pharma, Reg. No. 72593
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template. Firm has
Summary) summarized information related to nomenclature, structure, general
manufacturing process and controls, impurities, specifications, analytical
specification, reference standard, container closure system and stability
Name, address of drug substance M/s Acebright (India) Pharma Private Limited (formerly Cdymax (India)
manufacturer Pharma Privtae Limited), No. 77D & 116/117, KIADB Industrial Area,
Jigani Bangalore-560 105, Kamataka, India.
Module-III Drug Substance: Firm has submitted detailed drug substance data for both sources related to
nomenclature, structure, general properties, solubilities, physical form,
impurities including I, II and unspecified impurity (with the details of
reference standards), specifications, analytical procedures, batch analysis,
reference standard, container closure system and stability studies of drug
substance.
(Conditions & duration of Stability and60%RH±5% for 24 months of 3 batches
studies) • Real time stability studies have been conducted at 30oC±2
and65%RH±5% for 12 months of 3 batches
• Accelerated stability studies is conducted at 40oC±2 and 75%RH±5%
for 6 months of 3 batches
Batch size: CD100139, CD100142, CD120006
composition, pharmaceutical development, compatibility of excipients with
the drug substance since the excipients used in manufacturing of applied
product are different from the excipients used in the manufacturing of the
reference product, manufacture, manufacturing process and process
control, process validation protocols, control of excipients, control of drug
product, specifications, analytical procedures, compatibility of all the
excipients with the API, validation of analytical procedures, batch analysis,

impurity testing, reference standard or materials, container closure system
and stability.
Pharmaceutical Equivalence and Comparative dissolution profile of the applied product against the reference
Comparative Dissolution Profile product Xeloda approved by USFDA (B:U9146B01) is submitted in pH
1.2, 4.5 and 6.8.
Analytical method Not submitted
validation/verification of product
Container closure system of the 10 tablets are packed in Alu/Alu blister, aluminium cold forming foil. 12
drug product blisters packed in printed carton.
Stability study data of drug product, • Real time stability studies have been conducted at 30oC±2
shelf life and storage conditions and65%RH±5% for 36 months of 3 batches
• Accelerated stability studies is conducted at 40oC±2 and 75%RH±5%
for 6 months of 3 batches
Batch size: NV10015CB50, NV10215CB50, NV10115CB50
Analytical method for assay/quantitative The firm has submitted complete analytical method validation report for
estimation of Capecitabine is present in residual solvents including specificity, accuracy, linearity, LOQ, LoD,
USP, therefore, method verification robustness and precision but has not submitted the analytical method
studies including specificity, accuracy verification studies for analysis of drug substance.
and method-precision should be
performed and subsequently be
presented in section 3.2.S.4.3 under
Validation of Analytical Procedures.
The official monograph for Capecitabine Justification is not submitted.
tablets is present in USP while the testing
of the applied product is done according
to In-House standard, please justify
scientifically by comparing the
specifications & methods described in
USP with the methods & specifications
of In-House standard.
The comparison of the developed Comparative dissolution profile of the applied product against the reference
formulation and the innovator / reference product Xeloda approved by USFDA (B:U9146B01) is submitted in pH 1.2,
/ comparator product including the 4.5 and 6.8. The values for F1 and F2 are in the acceptable limits.
results of all the quality tests shall be
submitted for establishing
pharmaceutical equivalence. Moreover,
data of Comparative dissolution profile
is submitted against the reference
product Xeloda without the submission
of calculations of f2 and f1 values, please
submit complete data.
Product specific sole agency agreement Copy of distribution agreement is submitted and M/s Al-Habib
is required. Pharmaceuticals is designated as Distributor by M/s Jodas Expoim Pvt Ltd
for different product s including the applied product.
Submit valid copy of drug sale license. DSL No: 1245
Address: Al Habib Pharmaceuticals, 81-B Block B, SMCHS Karachi.
Address of Godown:
1. Plot No. 10 Sector 25 KIA Karachi.
2. HT-8, Landhi Industrial Area, Karachi.

The Board deferred the case for the following;
• Submission of analytical method verification studies (including specificity, accuracy and method precision)
for analysis of drug substance performed by drug product manufacturer.
• Clarification / Scientific justification since the monograph of the applied product is present in USP and the
applied product is developed according to In-House specifications.
The firm has submitted:
• Analytical method verification protocol for Capecitabine drug substance as per USP along with the
verification studies including specificity, accuracy and precision and COAs of 03 batches according to USP
are also submitted.
• The firm has stated that the applied product also complies with the USP specifications and has submitted the
analytical method as per USP along with the COAs of 3 batches testing according to USP. Moreover, the
analytical method verification studies for drug product according to USP is also submitted.
Decision: Approved with USP specifications as per Policy for inspection of Manufacturer abroad and
verification of local storage facility. Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/
in product specifications, as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
Deferred Cases (Form 5F-Local Manufacturing):

552. Name, Address of Applicant / Marketing M/s Bio-Labs (Pvt).Ltd
Authorization Holder Plot No. 145 industrial Triangle Kahuta road Islamabad.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt).Ltd
Plot No. 145industrial Triangle Kahuta road Islamabad.
☐ Importer
☐ Export sale
Empamet 12.5/850mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin...……….12.5mg
per unit Metformin HCl………..850mg
Pharmacotherapeutic Group of (API) Antidiabetic
In-House
specifications
EMA approved.
authorities
For generic drugs (me-too status) Xenglu-Met 12.5/850mg by Hilton Pharma.

GMP status of the Finished product GMP certificate issued based on inspection conduct 23-4-2019,
manufacturer valid upto 22-4-2022.
Name and address of API manufacturer. Empagliflozin:
Shanghai Pharma Group Changzhou Kony pharmaceutical Co., Ltd.
Daixi Street, Luoyang Town, Wujin District, Changzhou, Jiangsu,
213105, China
Metformin HCl:
Aarti Drugs Limited, Plot No. 211 - 213, Road No.2 G.I.D.C.,
Sarigam, 396 155 Dist.: Valsad, Gujarat, INDIA.
properties, solubility, physical form, manufacturers, description of
physical form, manufacturers, description of manufacturing process
and controls, impurities, specifications, analytical procedures and
its validation for drug substance as well as for the impurities, batch
analysis and justification of specification, detail of reference
substance.
• 48 months real time stability studies conducted at 30°C ±
2°C / 65% ± 5%RH of 03 batches.
• 06 months accelerated stability studies conducted at 40°C
± 2°C / 75% ± 5%RH of 03 batches
Batches: EGF20151201, EGF20151202 & EGF20151203
Metformin HCl:
2°C / 65% ± 5%RH of 03 batches.
± 2°C / 75% ± 5%RH of 03 batches
Batches: MET10040109, MET10040110 & MET10040111
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical equivalence by
comparative dissolution profile performing all the quality test against the reference product
Synjardy 12.5/850mg.
Comparative dissolution for all the quality tests for their product
against the reference product. Synjardy 12.5/850mg. The results are
within the acceptable limits.
Analytical method validation/verification Firm has submitted report of validation of analytical method for the
of product drug product.
Manufacturer of API Empagliflozin:

213105, China
Metformin HCl:
Aarti Drugs Limited
Plot No. 211 - 213, Road No.2 G.I.D.C., Sarigam, 396 155 Dist.:
Valsad, Gujarat, INDIA.
API Lot No. EGF20180801, MEF/18122462
Description of Pack
Alu-Alu blister pack of 2 x 7’s
Batch No. EMT-016 EMT-017 EMT-017
No. of Batches 03
1. Reference of previous approval of Empaglif 10mg & 25mg tablet in 296th meeting
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificates;
of API manufacturer issued by concerned Empagliflozin:
regulatory authority of country of origin. Copy of GMP certificate No. JS20170734 valid till 25/12/2022.
Metformin HCl:
Copy of GMP certificate No. 1801541 valid till 09-01-2020.
3. Documents for the procurement of API Empagliflozin:
with approval from DRAP (in case of Firm has submitted copy of Form 6 “License to import drugs for
import). clinical trial, examination, test or analysis” dated 27/09/2018 for
Empagliflozin, Empagliflozin W/S, Empagliflozin Impurity A,
Empagliflozin Impurity B along with the attested invoice No.
PSPW-180904 dated 27/09/2018.
Metformin HCl:
Firm has submitted copy of Form 6 “License to import drugs for
clinical trial, examination, test or analysis” dated 27/03/2019 for
Metformin HCl along with the attested invoice No. EXP/2411/18-
19 dated 27/03/2019.
4. Data of stability batches will be supported Firm has submitted complete record of testing of all batches along
by attested respective documents like with chromatograms, raw data sheets, COA and summary data
5. Compliance Record of HPLC software Firm has submitted audit trail and HPLC CFR Compliance record.
testing

6. Record of Digital data logger for Firm has submitted record of digital data logger for temperature and
temperature and humidity monitoring of humidity monitoring of real time and accelerated stability chambers.
accelerated)
Analytical Method Verification/Validation • Analytical method verification studies performed by drug product
studies including specificity, accuracy and manufacturer including specificity, accuracy and precision are
repeatability (method precision) performed by submitted along with the relevant chromatograms and data sheets.
the Drug Product manufacturer for • The specificity parameter of validation/verification studies is
Empagliflozin as well as for Metformin performed by taking a blank solution instead of spiking/force
Hydrochloride should be submitted in section degradation against the test solution containing the sample. The
3.2.S.4.3 under Validation of Analytical firm has responded that the test is performed by taking blank
Procedures. solution because the impurities were analysed individually and
there is no peak for any impurity interacting with peak of drug
substance that is empagliflozin.
• The firm has not clarified the specificity test procedure selected
for Metformin HCl (analysis is done by using titration method)
wherein performance of blank determination is carried out.
Moreover, USP-43 describes the HPLC method for analysis for
content estimation of Metformin but the firm has performed the
assay by using titration method.
• The firm has not submitted revised method for analysis of
Metformin HCl as described by USP-43 nor the verifications
studies are submitted.
The Board deferred the case for submission of analytical method verification studies (including specificity, accuracy
and method precision) for drug substance performed by drug product manufacturer according to the official
monograph present tin USP-43.
The applicant has submitted protocol for analytical method verification studies and verification report for Metformin
HCl drug substance including linearity, precision, accuracy and specificity performed by drug product manufacturer
as per USP-43.
Decision: Approved with Innovator’ specifications.
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as per
application.
553. Name, Address Of Applicant / M/s Bio-Labs (Pvt).Ltd Plot No. 145industrial Triangle Kahuta
Marketing Authorization Holder road Islamabad.
☐ Importer
☐ Export sale

Empamet 5/500mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin ………..5mg
In-House
specifications
USFDA Approved
authorities
For generic drugs (me-too status) Xenglu-Met 5/500mg by Hilton Pharma.
GMP status of the Finished product GMP certificate issued based upon inspection conduct 23-4-2019,
213105, China
Metformin HCl:
substance.
2°C / 65% ± 5%RH of 03 batches.
± 2°C / 75% ± 5%RH of 03 batches
Metformin HCl:
2°C / 65% ± 5%RH of 03 batches.

± 2°C / 75% ± 5%RH of 03 batches
Synjardy 5/500mg.
against the reference product. Synjardy 5/500mg. The results are
Shanghai Pansopharm Technology Co., Ltd.
213105, China
Metformin HCl:
Aarti Drugs Limited
Plot No. 211 - 213, Road No.2 G.I.D.C., Sarigam, Dist.: Valsad,
Gujarat, INDIA.
API Lot No. EGF20180801, MEF/18122462
Description of Pack
Batch Size 1500 1500 1500 Tablets
Tablets Tablets
No. of Batches 03
the firm (if any)

Metformin HCl:
PSPW-180904 dated 27/09/2018.
Metformin HCl:
19 dated 27/03/2019.
testing
accelerated)

as per USP-43.
application.
554. Name, Address Of Applicant / M/s Bio-Labs (Pvt).Ltd
Marketing Authorization Holder Plot No. 145industrial Triangle Kahuta road Islamabad.
☐ Importer
☐ Export sale
name
Active Pharmaceutical ingredient (API) Empagliflozin ………..5mg
In-House
specifications
USFDA Approved
authorities
213105, China
Metformin HCl:

substance.
2°C / 65% ± 5%RH of 03 batches.
± 2°C / 75% ± 5%RH of 03 batches
Metformin HCl:
2°C / 65% ± 5%RH of 03 batches.
± 2°C / 75% ± 5%RH of 03 batches
Synjardy 5/1000mg.
213105, China
Metformin HCl:
Aarti Drugs Limited
Gujarat, INDIA.
API Lot No. EGF20180801, MEF/18122462
Description of Pack Alu-Alu blister pack of 2 x 7’s

Batch Size 1500 1500 Tablets 1500 Tablets
Tablets
No. of Batches 03
the firm (if any)
Metformin HCl:
PSPW-180904 dated 27/09/2018.
Metformin HCl:
19 dated 27/03/2019.
testing
accelerated)
the Drug Product manufacturer for

Empagliflozin as well as for Metformin • The specificity parameter of validation/verification studies is
Hydrochloride should be submitted in section performed by taking a blank solution instead of spiking/force
3.2.S.4.3 under Validation of Analytical degradation against the test solution containing the sample. The
Procedures. firm has responded that the test is performed by taking blank
solution because the impurities were analysed individually and
as per USP-43.
application.
555. Name, Address Of Applicant / M/s Bio-Labs (Pvt).Ltd
Marketing Authorization Holder Plot No. 145industrial Triangle Kahuta road Islamabad.
☐ Importer
☐ Export sale
name
Active Pharmaceutical ingredient (API) Empagliflozin ……….5mg
per unit Metformin HCl……….850mg

In-House
specifications
EMA Approved.
authorities
213105, China
Metformin HCl:
substance.
2°C / 65% ± 5%RH of 03 batches.
± 2°C / 75% ± 5%RH of 03 batches
Metformin HCl:
2°C / 65% ± 5%RH of 03 batches.
± 2°C / 75% ± 5%RH of 03 batches

Synjardy 5/850mg.
213105, China
Metformin HCl:
Aarti Drugs Limited
Gujarat, INDIA.
API Lot No. EGF20180801, MEF/18122462
Description of Pack
No. of Batches 03
the firm (if any)
of API manufacturer issued by concerned
Empagliflozin:
Copy of GMP certificate No. JS20170734 valid till 25/12/2022.
Metformin HCl:
PSPW-180904 dated 27/09/2018.
Metformin HCl:

19 dated 27/03/2019.
testing
accelerated)
as per USP-43.
application.

Case no. 03: Registration applications for local manufacturing of Human drugs
Deferred Cases (Human-Form 5):
556. Name and address of manufacturer / M/s. High-Q Pharmaceuticals, B 64, KDA-1, Karsaz
Applicant Road, Karachi
Brand Name +Dosage Form + Strength Telmas Tablet 40mg+10mg
Composition Each bilayer tablet contains:
Telmisartan ….40mg
Amlodipine as besylate…10mg
Diary No. Date of R& I & fee Dy. No. 1376, 24-11-2016 , Rs.20,000/- (23-10-2016)
Pharmacological Group Angiotensin II Receptor Antagonist; Calcium Channel Blocker
Type of Form Form-5
Finished product Specification Manufacturer
Pack size & Demanded Price 10’s,14’s, 20’s,30’s As per leader price
Approval status of product in Reference Telmisartan and amlodipine 40/10mg Tablet by M/s. Lupin Ltd,
Regulatory Authorities. USA
Me-too status Amtas Tablet by M/s Getz Pharma. Karachi.
GMP status 30-06-2020
Renewal of DML.
Remarks of the Evaluator.V • Brand name resemblance with Telmas of Global Pharma.
New brand name Elsart -AM.
• Evidence of bilayer machine.
DML renewal inspection report mentions
Double layer rotary compression machine is newly installed
with a capacity of around 50000 tablets per hour.
Approved in USFDA with box warning.
th
Decision of 313 meeting:
The Board deferred the case for consideration with the other cases submitted on Form 5 for human drug
products.
Decision of 316th meeting: Approved with Innovator’s specifications. Firm shall submit the fee of Rs.
7,500 for correction/pre-approval change/ in product specifications, as per notification No.F.7-11/2021-
Telmisartan …..80mg
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine 80/5mg Tablet by M/s. Lupin Ltd,
Regulatory Authorities. USA
Renewal of DML.

products.
Decision: Approved with Innovator’s specifications. Firm shall submit the fee of Rs. 7,500 for
correction/pre-approval change/ in product specifications, as per notification No.F.7-11/2021-
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine 40/5mg Tablet by M/s. Lupin
Regulatory Authorities. Ltd,USA.
Renewal of DML.
products.
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine 40/5mg Tablet by M/s. Lupin
Regulatory Authorities. Ltd,USA.
Renewal of DML.

products.
Brand Name +Dosage Form + Strength Telmath Tablet 40mg+12.5mg
Telmisartan….40mg
Hydrochlorthiazide….12.5mg
Diary No. Date of R& I & fee Dy. No.1375, 24-11-2014 , Rs.20,000/- (23-11-2014)
Pharmacological Group Calcium Antagonist: Diuretic
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s,28’s: As per brand leader
Approval status of product in Reference Micardis HCT USFDA Approved
Me-too status Velmon H by Martin Dow
Renewal of DML.
New brand name Co- Elsart .
• Approved in USFDA with box warning.
products.
Brand Name +Dosage Form + Strength Telmath Tablet 80mg+12.5mg
Telmisartan….80mg
Hydrochlorthiazide….12.5mg
Diary No. Date of R& I & fee Dy. No.1370, 24-11-2014 , Rs.20,000/- (23-11-2014)
Pharmacological Group Calcium Antagonist: Diuretic
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s,28’s: As per brand leader
Approval status of product in Reference Micardis HCT USFDA Approved
Me-too status Velmon H by Martin Dow

GMP status 30-06-2020 Renewal of DML.
New brand name Co- Elsart .
• Approved in USFDA with box warning.
products.
562. Name and address of manufacturer / Welmark Pharmaceuticals Plot. No. 122, Block B, Phase V,
Applicant Industrial Estate Hattar KPK.
Brand Name +Dosage Form + Strength Irofer 500mg/10ml
Composition Each ampoule of 10ml Contains:-
Iron as ferric carboxymaltose ……….500mg
Diary No. Date of R& I & fee Dy. No. 11699: 30.03.2018 PKR 20,000/:- 30.03.2018
Pharmacological Group Hematinic
Type of Form Form 5
Finished product Specification Firm has claimed manufacturer‘s spec.
Pack size & Demanded Price 10 ml ampoule,As per SRO
Approval status of product in Reference Ferinject 50mg/ml (ANSM, France)
Me-too status Ferinject 50mg/ml of RG Pharma Reg. No 72548
GMP status GMP inspection was conducted on 16.19.2017 and concluded as
overall the firm was GMP compliant as per DRAP guidelines.
Remarks of the Evaluator The Firm has claimed reference product which contains 500mg
and mentioned on deposit slip is 50mg. Accordingly the firm was
asked to submit clarification.
The firm in response submitted that by human error they
mentioned 50mg instead of 50mg/ml in deposit slip without
submission of undertaking.
Deferred for submission of applicable fee.
The firm has submitted Rs. 30,000/- vide challan number 362780712 dated 02/12/2021.
563. Name and address of manufacturer / M/s Universal Pharmaceuticals Pvt Ltd.
Applicant 131-A, Hayatabad Industrial Estate, Peshawar.
Brand Name +Dosage Form + Strength Loxicam 4mg Tablet
Diary No. Date of R& I & fee Dy.No 37921 dated 16-11-2018 Rs.20,000/-
Lornoxicam……….4mg
Pharmacological Group Anti-inflammatory
Type of Form Form 5
Finished Product Specification Mfg specs
Pack Size & Demanded Price 10’s, price as per SRO
Approval Status of Product in Reference Xefo 4 mg Filmtabletten by M/s Takeda Pharma AG, (Swiss
Regulatory Authorities Medic approved)
Me-too Status Acabel 4mg Tablet by M/s Continental Pharma (Reg No:061603)
GMP Status GMP status could not be confirmed

Remarks of the Evaluator-I
Decision of 296th meeting: Registration Board referred the case to QA & LT Division to conduct GMP
inspection of Firm on priority.
Submission by the firm: the firm has submitted inspection report dated 14th & 15th September, 2020. The
concludes as fair level of GMP compliance.
Deferred till rectification of the observations identified during last GMP and referred to QA & LT Division
for updated status of GMP.
The firm has submitted last inspection report dated 31/12/2021. The firm has rectified majority of
observations noted in the previous inspections and the management is committed to further improve their
cGMP compliance. The firm may be considered operating at satisfactory level of cGMP compliance as per
the report.
Brand Name +Dosage Form + Strength Loxicam 8mg Tablet
Lornoxicam………..8mg
Pharmacological Group Anti-inflammatory
Type of Form Form 5
Approval Status of Product in Reference Xefo 8 mg tablet (EMA approved)
Me-too Status Recam Tablet 8 mg by M/s Regal Pharmaceuticals
(Reg.#081952)
the report.
Brand Name +Dosage Form + Strength Uniterf Fort 250mg Tablet
Terbinafine as HCl………250mg
Pharmacological Group Antifungal
Type of Form Form 5

Finished Product Specification USP Specifications
Approval Status of Product in Reference Lamisil® Tablets 250mg by M/s NOVARTIS
Regulatory Authorities PHARMACEUTICALS UK LIMITED, MHRA Approved.
Me-too Status Logirid Tablet 250mg by M/s Lowitt Pharmaceutical (Pvt) Ltd, Reg
No. 80847
the report.
Decision of 316th meeting: Approved with Innovator’s specifications.
Brand Name +Dosage Form + Strength Dianil 2mg Capsule
Loperamide Hydrochloride…2mg
Pharmacological Group Antidiarrheals
Type of Form Form 5
Pack Size & Demanded Price 6×10, price as per SRO
Approval Status of Product in Reference Loperamide Capsules 2 mg by M/s Galpharm Healthcare
Regulatory Authorities Limited, MHRA Approved.
Me-too Status LOPAMIDE 2mg CA by M/s Medicaids, Reg. No. 11240
the report.
Decision of 316th meeting: Approved with Innovator’s specifications.
Brand Name +Dosage Form + Strength Parox-Q CR 25mg Tablet
Composition Each Enteric, film coated Controlled Release Tablet Contains:
Paroxetine as HCl……..25mg

Pharmacological Group Anti-depressants
Type of Form Form 5
Approval Status of Product in Reference Paxil CR 25mg Tablet by M/s Apotex Technologies USFDA
Me-too Status Paroxin CR Tablets 25mg by M/s Shrooq pharmaceuticals
(Reg#060470).
Remarks of the Evaluator-I The firm has revised the formulation from Film coated tablet to
Enteric Film Coated Controlled Released Tablet and submitted
Rs. 5000/- vide challan number 2008473 dated 24/01/2020.
Decision of 296th meeting: Deferred for;
• Submission of remaining fee of Rs. 15,000/- for revision of formulation as per the reference product.
• Moreover, Registration Board referred the case to QA & LT Division to conduct GMP inspection of
Firm on priority.
The firm has submitted following documents;
• Remaining fee of Rs. 15,000/- is submitted vide challan no. 2001284 dated 22/03/2021.
• Inspection report dated 14th & 15th September, 2020. The concludes as fair level of GMP compliance.
the report.
Brand Name +Dosage Form + Strength Parox-Q CR 12.5mg Tablet
Composition Each Enteric, film coated Controlled Release Tablet Contains:
Paroxetine as HCl………12.5mg
Pharmacological Group Anti-depressants
Type of Form Form 5
Approval Status of Product in Reference Paxil CR 12.5mg Tablet of M/s Apotex Technologies (USFDA
Me-too Status Panox CR Tablet 12.5mg of M/s Regal Pharma (Reg.#081953)
Remarks of the Evaluator-I The firm has revised the formulation from Film coated tablet to
Enteric Film Coated Controlled Released Tablet and submitted
Rs. 5000/- vide challan number 2008474 dated 24/01/2020.
Decision of 296th meeting: Deferred for;
• Submission of remaining fee of Rs. 15,000/- for revision of formulation as per the reference product.
• Moreover, Registration Board referred the case to QA & LT Division to conduct GMP inspection of
Firm on priority.
The firm has submitted following documents;
• Remaining fee of Rs. 15,000/- is submitted vide challan no. 2001285 dated 22/03/2021.
• Inspection report dated 14th & 15th September, 2020. The concludes as fair level of GMP compliance.

the report.
Case No. 4: Routine applications of veterinary (Local Manufacturing):

(New cases)
569. Name and address of manufacturer / M/s Wimits Pharmaceuticals (pvt) ltd.
Applicant Plot Number 129, Sundar Industrial Estate (P.I.E)
Raiwind Road Lahore.
Brand Name +Dosage Form + Strength Bromomit 5% Oral Solution
Diary No. Date of R& I & fee Dy. No. 44283 dated 28/12/2018 Fee Rs. 50,000/-
Bromhexine Hydrochloride…….50mg
Pharmacological Group Mucolytic
Type of Form Form 5
Pack Size & Demanded Price 500ml, 1000ml, Price decontrolled
Me-too Status BROMBAK SOLUTION 50mg/ml Solution by M/s
Attabak, Reg. No. 49786
GMP Status GMP certificate issued on the basis of inspection
Case No. 5: Routine applications submitted on Form 5A (Veterinary-Import):

Deferred Cases:
570. Name and address of Applicant M/s Fartal Pharmaceuticals Flat no. 409 shalimar pride
plaza near Mehran depo model colony Karachi
Detail of Drug Sale License Drug License by way of whole sales no. 0458 valid upto
01-Sep-2019
Manufacturer & Product License Holder M/s Laboratorios Microsules Uruguay S.A. Camino al
Paso Escobar s/n, Canelones Department
Name of exporting country Uruguay
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No 419 Dated 21-10-2015
Fee Rs. 100,000/- Dated 21-10-2015
Brand Name +Dosage Form + Strength Vitmic complemento
Vitamin B1…………………….0.1gm
Vitamin B2…………………….0.01gm
Nicotinamide…………………..0.1gm
Glucose anhydrous…………….10gm
Sodium Chloride……………….0.5gm
Potassium chloride……………..0.09gm
Calcium Chloride Hexahydrate………...0.03gm
Magnessium Chloride Hexahydrtae……0.015gm
Caffeine………………………................0.4gm

Finished Product Specification Firm claims in-house specification
Pharmacological Group Vitamin suplement
Shelf life 2 years
Demanded Price Decontrolled
Pack size 100mL, 250mL
International availability Uruguay
Me-too status Could not be confirmed
Stability studies Firm has submitted long term (24 months) at 25oC±20C,
60±5%RH & accelerated (06 months) stability data at
30oC, 60±5% RH for three batches.
Detail of certificates attached Original legalized of veterinary product registration
certificate issued by Ministry of Agriculture and
Fisheries Oriental Republic of Uruguay declaring the use
of the product in the country, valid till 02-08-2019.
Notarized Copy of GMP certificate dated 21-02-2019
expires dated 22-05-2019 is submitted.
Notarized copy of Power of attorney from Product
License holder is submitted
Remarks of the Evaluator. • Accelerated stability data is not submitted.
• As per submitted real time stability data, the assay
results of different APIs/ingredients are out of
specifications in all 03 batches (Batches: BJ140466,
BJ140567, BJ140768)
• Evidence of approval of the applied formulation in
reference regulatory authorities could not be
confirmed. However, the firm has submitted copy of
Overseas Site GMP Compliance report (date of
inspection: 02/06/2019) wherein the applied product
is endorsed to be manufactured by the firm.
• As per available database of me-too product, the
applied formulation is not registered in Pakistan.
Deferred for evidence of approval of applied formulation in reference regulatory authorities / agencies
which were adopted by the Registration Board in its 275th meeting or evidence of applied
formulation/drug already approved by DRAP (generic / me-too status) alongwith registration number,
The firm has stated that the availability of the exact formulation as the applied product in reference
agencies could not be confirmed as it is a novel product. However, Australian Pesticides and Veterinary
Medicines Authority has provided Australian GMP certificate.
The provided copy of GMP certificate No. M-7908 contains a list of products including the applied
product Vitmic Complemento.
Decision: Registration Board deferred the case for clarification from the firm regarding
pharmacological role of Caffeine in applied formulation and then will be forwarded to Dr. Qurban
Ali (member Registration Board) for review of applied formulation.
New Cases:
571. Name and address of Applicant M/s Vigilant Veterinary Services (pvt) ltd., Flat No. 1, first floor,
Sultan plaza, Main Bani Gala road, Islamabad.
Detail of Drug Sale License DSL No: 264-ICT/2013
Address: Vigilant Veterinary Services (pvt) Ltd, flat No. 1, first
floor, Sultan Plaza, Main Bani gala Road, Islamabad.
Address of Godown: N/A
*The firm has submitted receipt for renewal of DSL on 28/04/2021.

Name and address of manufacturer M/s VAPCO (veterinary and agricultural products manufacturing
co. ltd.)
Factory: King Hussein street, Al Dhulail area, Al Zarqa province,
Jordan.
Head office: P.O. Box 17058 Amman 11195, Jordan.
Marketing authorization holder M/s VAPCO (veterinary and agricultural products manufacturing
co. ltd.)
Jordan.
Name of exporting country Jordan
Fee including differential fee Rs. 100,000/- Dated 25-04-2017
Brand Name +Dosage Form + Strength Tilmivap Injection
Composition Each mL contains:
Tilmicosin as Phosphate……..300mg
Shelf life 3 years
Pack size 100ml vial
Me-too status Mico Sol Injection by M/s ELko Pharma, Reg. No. 080150.
Stability studies Firm has submitted long term (36 months) at 30oC 65±5%RH &
accelerated (06 months) stability data at 40oC, 75±5% RH for three
batches.
Detail of certificates attached ➢ Copy of GMP certificate No. 002770 dated 04/04/20217 issued
by Ministry of Agriculture, Veterinary Department Jordan is
submitted.
➢ Original legalized COPP certificate No. 002751 dated
04/04/2017 issued by Ministry of Agriculture, Veterinary
Department. The applied product is available in free sale in the
market of exporting country. The manufacturing facility is
compliant to WHO-GMP as per COPP. Certificate of
registration and free sale is also attached.
➢ Copy of authorization letter is submitted through which M/s
Vigilant Veterinary Services pvt ltd is appointed as agent for
different products including the applied product.
Remarks of the Evaluator:
Decision: Approved as per Policy for inspection of Manufacturer abroad and verification of local
storage facility
co. ltd.)
Jordan.

co. ltd.)
Jordan.
Brand Name +Dosage Form + Strength Floram 30% Injection
Florfenicol……..300mg
Finished Product Specification In-House
Shelf life 3 years
Me-too status Rivaflor 30 Injection by M/s Mylab, Reg. No. 078205.
batches.
submitted.
➢ Original legalized COPP certificate No. 5/5/10/010305 dated
November, 2019 issued by Ministry of Agriculture, Veterinary
compliant to WHO-GMP as per COPP. Legalized certificate of
The firm had initially applied for 50mL and 100mL vials against one application. Upon communication the
firm chose 100mL filled volume and submitted the stability study data accordingly.
Decision: Approved for 100ml fill pack size only with Innovator’s specifications. Firm shall submit the
fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as per notification
No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
co. ltd.)
Jordan.

co. ltd.)
Jordan.
Brand Name +Dosage Form + Strength Vermectin-Plus Injection
Ivermectin……..10mg
Clorsulon………100mg
Shelf life 3 years
Demanded Price decontrolled
Pack size 50ml vial
Me-too status Imec Plus Injection by M/s SJ&G, Reg. No. 069639.
batches.
submitted.
compliant to WHO-GMP as per COPP.
storage facility.
co. ltd.)
Jordan.
co. ltd.)
Jordan.

Brand Name +Dosage Form + Strength Enrosol 20% Oral Solution
Enrofloxacin……..200mg
Shelf life 3 years
Pack size 100ml, 1 Litre, 5 Litre, Polyethylene Bottle
Me-too status Dufafloxacin 20% Oral solutionby M/s NB Sons pvt ltd , Reg. No.
080922.
batches.
Detail of certificates attached ➢ Original legalized GMP certificate No. 002770 dated
Department Jordan is submitted.
co. ltd.)
Jordan.
co. ltd.)
Jordan.

Brand Name +Dosage Form + Strength Enrosol 10% Injection
Enrofloxacin……..100mg
Shelf life 3 years
Me-too status Enrolac-10 Injection by M/s Breeze Pharmaceuticals, Reg. No.
069606.
batches.
submitted.
Registration and free sale is also submitted (issued on
04/04/2017).
co. ltd.)
Jordan.
co. ltd.)
Jordan.

Brand Name +Dosage Form + Strength Piroplasmin Injection
Diminazine Aceturate…….75mg
Antipyrine………………..25mg
Vitamin B12……………...0.00004mg
Pharmacological Group Antiprotozoal
Shelf life 3 years
Me-too status Me-too could not be confirmed.
batches.
submitted.
compliant to WHO-GMP as per COPP. Legalized certificate of
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-
too status) alongwith registration number, brand name and name of firm.
co. ltd.)
Jordan.
co. ltd.)
Jordan.

Brand Name +Dosage Form + Strength Oxy-Doxy Water Soluble Powder
Oxytetracycline HCl……200mg
Doxycycline HCl……….100mg
Shelf life 3 years
Pack size 1kg PVC Jar, 5kg PVC Bucket, 25 kg bag
Me-too status Could not be confirmed.
batches.
submitted.
co. ltd.)
Jordan.
co. ltd.)
Jordan.
Brand Name +Dosage Form + Strength Tylovap 200mg Injection

Tylosin as tartarate……..200mg
Shelf life 3 years
Pack size 100mL vial
Me-too status Tylovet-20 Injectable solution, Registration No. 017932
batches.
submitted.
storage facility.
co. ltd.)
Jordan.
co. ltd.)
Jordan.
Brand Name +Dosage Form + Strength Vermectin 10mg Injection
Ivermectin……..100mg
Shelf life 3 years

Pack size 100mL vial
Me-too status Ivomad 1% Injection solution (10mg/ml) Injectable solution,
batches.
submitted.
storage facility
Case NO. 6: Miscellaneous Cases:

Following cases of M/s Semos Pharmaceuticals (Pvt) Ltd., (contract giver) were deferred in 296 th meeting for
assessment of overall manufacturing capacity of M/s Safe Pharmaceuticals private Limited (contract acceptor) .
The capacity assessment report of M/s Safe Pharmaceutical Private Limited was presented in 307 th meeting and
several products were approved.
PANEL INSPECTION OF MS. SAFE PHARMACEITICALS PRIVATE LIMITED
Physical Address: Plot No. CI-20 & 21 Sector-6/B North Karachi industrial area
Karachi.
Date of inspection: 13th March 2020
Purpose of inspection: To determine the manufacturing surplus capacity.
DRAP Islamabad reference letter No. & Date: F.1-2/2020/PEC, 24th February 2020
Names of inspectors 1. Dr. Najam-Us-Saquib Additional Director DRAP Karachi.
2. Abdul Rasool Shaikh Area FID Karachi
Names of firm’s representatives: Muhammad Farooq Memon, CE of the firm.
BRIEF ABOUT FIRM: Ms. Safe Pharmaceuticals (Pvt) Ltd: situated at Plot No. CI-20 &
21 Sector-6/B North Karachi industrial area Karachi was visited and inspected in the light
of the above letter to gauge their manufacturing surplus capacity. The firm is famous for
manufacturing certain generic products and as per approved design the firm has facilities to
manufacture Tablet (G), Tablet (Psychotropic), Capsule (G), Capsule (Cephalosporin),
Liquid Syrup, Sterile Liquid Injection General (ampoule/vial), Dry Powder Suspension (G),
Dry Powder Suspension (Cephalosporin), Sterile Lyophilized Dry Powder injection (G),
Sterile Dry Powder Injection (Cephalosporin). The firm bears DML No. 000349 by way of
formulation and that is valid till 02/2025. In all the approved sections the firm has 283
number of registrations excluding registrations for export and for contract manufacturing,
which is around 91. Among all the registrations around 210 are regularly manufactured as
per records reviewed during the visit. The firm was seen well-maintained at the time of
inspection with respect to sanitation & hygiene, documentation and good practices in
production, QC lab and stores. The firm was further inspected as per TORs and relevant
manufacturing, packaging and quality control records for previous year were reviewed in
detail and concluded as follows:

Manufacturing record/data was evaluated
from July, 2019 to June-2020 for the said
purpose.
The details of capacity calculations are as
under;-
SECTION WISE CAPACITY CALCULATION
CAPACITY OF DRY POWDER

INJECTION (CEPHALOSPORIN)
Step wise capacity of Cephalosporin Injectable manufacruring Capacity
Vials Washing:
50,000 Vials
Per single shift of 8 working hours (Load per Day)
Vials Washing:
1,250,000 Vials
Per month (25 working Days) with single shift of 8 working hours
Depyrogenation Capacity:
37,000 Vials
925,000 Vials
Per month (25 working Days) with single shift of 8 hours
Filling and Sealing Capacity:
50,000 Vials
1,250,000 Vials
Labeling Capacity:
50,000 Vials
Labeling Capacity:
1,250,000 Vials
Packing Capacity:
50,000 Vials
Per single shift of 8 working hours
Packing Capacity:
1,250,000 Vials
Note: Limiting step in this process is Depyrogenation process for calculation Utilized
Capacity
Quarter Wise capacity utilized in Cephalosporin Injectable Section
Actual Production Capacity Capacity utilized

Quarter in %
(Vials) (Vials)
2,775,00
3rd - 2019 903,031 32.54%
0
2,775,00
4th - 2019 478,236 17.23%
0
2,775,00
1st - 2020 774,297 27.90%
0
2,775,00
2nd - 2020 701,534 25.28%
0

11,100,0
Total 2,857,098 --
00
2,775,00
Average per Quarter 714,275 25.74%
0
Manufacturing Capacity Utilized (Average) = 25.74%

Manufacturing Capacity Available (Average) = 74.26%

INJECTION
(GENERAL/LYOPHILIZED)
SECTION
Step wise capacity of Cephalosporin Injectable manufacruring Capacity
Vials Washing: 30,000 Vials

18,500 Vials
462,500 Vials
15,000 Vials
375,000 Vials
Labeling Capacity:
15,000 Vials
Labeling Capacity:
375,000 Vials
Packing Capacity:
50,000 Vials
Packing Capacity:
1,250,000 Vials
Note: Limiting step in this process is

Filling & Sealing porcess for
calculation Utilized Capacity
Quarter Wise capacity utilized in Dry Powder General Section
Capacity
Quarter Actual Production (Vials) Capacity (Vials) utilized in %
3rd - 2019 60,907 375,000 16.24%

4th - 2019 171,929 375,000 45.85%
1st - 2020 100,486 375,000 26.80%
2nd - 2020 162,015 375,000 43.20%
Total 495,337 1,500,000 --
Average per Quarter 123,834 375,000 33.02%
Manufacturing Capacity Utilized 33.02%

(Average) =
Manufacturing Capacity Available 66.98%
(Average) =
CAPACITY OF LIQUID INJECTABLE

SECTION (Ampoules)
Step wise capacity of Liquid Injectable (Ampoule) Section Capacity
Ampoule Washing:
240,000 Ampoule
Ampoule Washing:
6,000,000 Ampoule
Ampoule Depyrogenation:
100,000 Ampoule
Ampoule Depyrogenation:
2,500,000 Ampoule
Mixing:
1,000 Litres
Mixing:
25,000 Litres
Ampoule Filling:
140,000 Ampoules (5ml)
Ampoule Filling:
3,500,000 Ampoules (5ml)
Terminal Sterilization:
120,000 Ampoules
3,000,000 Ampoules
Packing Capacity: 5's 40,000 Packs
10's 20,000 Packs
Per single shift of 8 working hours 25's 8,000 Packs
Packing Capacity: 5's 1,000,000 Packs
10's 500,000 Packs
Per month (25 working Days) with single shift of 8 hours 25's 200,000 Packs

Depyrogenation process and Terminal
Sterilization and all batch sizes are

designed according to these limitaitons.
Quarter Wise capacity of Liquid Injectable (Ampoule) Section
Actual
Capacity
Quarter Production Capacity utilized in %
(Ampoules)
(Ampoules)
3rd -2019 2,168,015 7,500,000 28.91%
4th -2019 3,135,400 7,500,000 41.81%
1st-2020 2,301,998 7,500,000 30.69%
2nd -2020 2,907,467 7,500,000 38.77%
Total 10,512,880 30,000,000 --
Average per Quarter 2,628,220 7,500,000 35.04%

Manufacturing Capacity Utilized 35.04%
(Average) =
Manufacturing Capacity Available 64.96%
(Average) =
CAPACITY OF LIQUID
INJECTABLE SECTION (Vials)
Step wise capacity of Liquid Injectable (Vials) Section Capacity

Vials Depyrogenation:
10,000 Vials
Vials Depyrogenation:
250,000 Vials
Mixing:
1,000 Litres
Mixing:
250,000 Litres
Vials Filling:
10,000 Vials (100ml)
Vials Filling:
250,000 Vials (100ml)
10,000 Vials
250,000 Vials
Labeling Capacity:
10,000 Vials
Labeling Capacity:
250,000 Vials
Packing Capacity: 10,000 Packs (Vials)

Packing Capacity:
250,000 Packs (Vials)

Depyrogenation process and Terminal
Sterilization process for calculating
Utilized Capacity
Quarter Wise capacity of Liquid Injectable (Vials) Section
Capacity
Quarter Actual Production (Vials) Capacity (Vials) utilized in %
3rd -2019 90,965 750,000 12.13%
4th -2019 127,219 750,000 16.96%
1st-2020 109,408 750,000 14.59%
2nd -2020 130,077 750,000 17.34%
Total 457,669 3,000,000 --
Average per Quarter 114,417 750,000 15.26%
Manufacturing Capacity Utilized 15.2

(Average) = 6%
Manufacturing Capacity Available 84.7
(Average) = 4%
CAPACITY OF QUALITY CONTROL DEPARTMENT
Quality Control Equipment Details
Capa
city
Capacity Capacity Average Capacity
S. utiliza
Equipment Qty. per day per month utilization/mo available
# tion
(tests) (tests) nth (tests) %age)
(%ag
e)
1 HPLC 3 3x2=6 150 75 50% 50%
UV
2 2 2 x 15 = 30 750 300 40% 60%
Spectrophotometer
3 FTIR 1 50 1250 450 36% 64%
4 pH Meter 1 50 1250 750 60% 40%
5 Balance 2 - - - - -

6 Moisture Analyzer 1 50 1250 500 40% 60%
Melting Point
7 1 20 500 125 25% 75%
Apparatus
Liquid Particle
8 1 40 1000 200 20% 80%
Counter
1 x 164 L
9 Cold Incubator 2 - - - -
1 x 53 L
10 Hot Incubator 1 1 x 53 L - - - -
11 Karl Fisher 1 25 625 375 60% 40%
12 Air Particle Counter 2 - - - -

Total number of registered products and registered products in aforementioned sections:
Total registered products: 309

Registered products in aforementioned sections 97
Existing contract manufactured products in aforementioned sections 45
Registered products (Export) in aforementioned sections 17
CAPACITY OF DRY POWDER INJECTION (CEPHALOSPORIN)

SAFE Pharma Contract Contract products
SAFE Pharma SAFE Pharma
Pending Products Pending
Registration Export Registration
Applications Registrations Applications
31 10 4 23 14

INJECTION
(GENERAL/LYOPHILIZED) SECTION

12 0 5 7 26

SECTION (Ampoules)

42 7 15 11 28

SECTION (Vials)

12 0 4 3 11
ACCESSMENT REPORT OF QC LAB ANALYTICAL EQUIPMENT OF MS. SAFE

PHARMACEUTICALS (PVT) LTD; KARACHI
In pursuance of the directions contained in DRAP Islamabad Letter No.F.1-2/2020-PEC; Dated: 20th November
2020, Ms. Safe Pharmaceuticals (Pvt) Ltd situated at Plot No. C-I-20 & 21, Sector-6-B North Karachi industrial
area was visited and inspected on 11th February 2012 by the panel comprising of Dr. Najam-Us-Saquib
Additional Director DRAP Karachi and Abdul Rasool Shaikh area FID DRAP Karachi. Muhammad Farooq
CEO of the firm and other technical staff from respective departments assisted during the course of inspection.
Following are the detailed observations and recommendations of the inspection.
OBSERVATIONS:
1. The firm has necessary equipment in their QC Lab for testing of their registered finished products, raw
materials, intermediates and inactive substances. Necessary log books and calibrations of each equipment were
reviewed and noted satisfactorily maintained.
2. It was further observed that every incoming material is tested as per available methods, likewise every in-
process/intermediate substances and finished products are also tested as per approved specifications.
3. The firm has around 309 registered products in their name and among them 152 brands are frequently
manufactured as per the available records reviewed during the inspection.
4. The Panel further noticed that 92 registered drugs amongst frequently manufactured brands, are tested as per
pharmacopeial specifications on their 03 HPLC Systems, and rests are tested through conventional but validated
specifications. The relevant documents in this regards were carefully reviewed and noted a fair level of
compliance.
5. It was further noticed that around four hours were required for a sample to be tested completely on each HPLC.
In a single working day average three samples were tested on their 03 available systems as per records reviewed
for the last couple of months.
6. Thus the firm has capacity to test around 06 drug samples with complete tests in a single working day whereas
almost half of the samples are completely tested as per pharmacopeia specifications.
7. During a detail inspection of their QC Lab facility the panel noted an ample testing capacity left for testing of
their under registered products.
CONCLUSION:
Based on the stated facts and keeping in view the attitude of the management towards continuous improvements
the panel finds the facility suitable with ample manufacturing and QC lab testing facilities which may better be
utilized in tool manufacturing as per prevailing policy.
Name & Signature of Firm’s Name of Signature of Panel Name of Signature of Panel
representative member member
Muhammad Farooq Dr. Najam-Us-Saquib Abdul Rasool Shaikh
CEO of firm Additional Director Area FID
DRAP Karachi DRAP Karachi
• The applicant has submitted that 13 products are already being manufactured on contract basis.
• The applicant has 7 approved sections.
GMP status:
Safe Pharma: Inspection date 04/03/2019

All the observations pointed out during inspection were discussed with the management of the firm and they were
committed to overcome before next periodic inspection. Based on the above observations and keeping in view
their attitude for better compliance, their current compliance level is rated as Good.
Based on the above stated observations their current compliance level is rated as GOOD.
Decision: Registration Board deferred the applications of contract manufacturing by M/s Safe
Pharmaceuticals Pvt Ltd. Plot No. C.I-20, Sector 6-B, Industrial Area, North Karachi, for submission of
following from M/s Safe Pharmaceuticals Pvt Ltd.:
• Plan & Schedule for capacity enhancement of Quality Control Lab, particularly the capacity in
terms of HPLC analysis.
• Plan & Schedule for the adoption of Pharmacopoeial specifications and analytical procedures for
all registered products.
580. Name and address of manufacturer / M/s Semos Pharmaceuticals Pvt Ltd. Plot No. 11, Sector 12-A,
Applicant North Karachi, Krachi-75850, Pakistan
Contract manufactured by
M/s Safe Pharmaceuticals Pvt Ltd.
Plot No. C.I-20, Sector 6-B, Industrial Area, North Karachi
Brand Name +Dosage Form + Strength Falcither 80mg/ml Injection
Artemether…80mg
Type of Form Form 5
Finished Product Specification International Pharmacopoeia
Pack size & Demanded Price 1ml ampoule x 6’s: As per SRO
Approval status of product in WHO Approved formulation
Me-too status Artegen 80mg Injection by Fassgen Pharma (Reg# 056462)
GMP status Semos Pharma: GMP inspection dated 04-07-2018 concluding
good GMP compliance.
Safe Pharma: The firm was inspected on 04.03.2019 with the
following conclusion: All the above observations pointed out
during inspection were discussed with the management of the
firm and they were committed to overcome before next periodic
inspection. Based on the above observations and keeping in view
their attitude for better compliance, their current compliance level
is rated GOOD.
Remarks of the Evaluator(IX) • The firm submitted that they have no product registered for
contract manufacturing.
• The firm submitted list of 08 approved sections.
• Safe Pharmaceuticals has approval letter of liquid injection
(general) section.
Decision of 296th meeting: Registration Board referred the case back to the panel to access overall capacity
of the analytical equipments of firm including HPLC keeping in view pharmacopeial and other requirements
of all registered drug products.
Brand Name +Dosage Form + Strength Artimos Injection 30mg/vial
Artesunate…30mg

Type of Form Form 5
Approval status of product in Artesunate dry powder vial 30mg. WHO approved
Me-too status Gen-M Injection 30mg. Reg. No. 76072
is rated GOOD.
• Safe Pharmaceuticals has approval letter of dry powder injection
(lyophilized) section.
th
Decision of 296 meeting: Registration Board referred the case back to the panel to access overall capacity
Artesunate…120mg
Type of Form Form 5
Me-too status Gen-M Injection 120mg. Reg. No. 76073
is rated GOOD.
Remarks of the Evaluator (IX)
• The firm submitted that they have no product registered for

Artesunate…60mg
Type of Form Form 5
Me-too status Artesunate Injection 60mg by Hilton Pharma (Reg# 015531)
is rated GOOD.
Brand Name +Dosage Form + Strength Densee 5Mg/ml Injection
Cholecalciferol…5mg
Pharmacological Group Vitamin- D
Type of Form Form 5
Finished Product Specification BP
Approval status of product in VITAMIN D3 GOOD 200,000 IU / 1 ml, IM solution for injection
Reference Regulatory Authorities. in ampoule & VITAMIN D3 GOOD 200,000 IU / 1 ml, oral
solution in ampoule (ANSM France Approved)
Me-too status Drol- D injection by Regal Pharma (Reg. # 082005)

is rated GOOD.
(general) section.
Brand Name +Dosage Form + Strength Deserve 40mg/2ml Injection
Composition Each 2ml contains
Drotaverine hydrochloride…40mg
Pharmacological Group Anti-spasmodic
Type of Form Form 5
Finished Product Specification Innovator’s specs
Approval status of product in Approved in 3 European Countries
Reference Regulatory Authorities. 1. NO-SPA 40 mg solution for injection by Sanofi Aventis
(OGYEI Hungary Approved)
2. NO-SPA 40 mg / 2 ml solution for injection by Sanofi Romania
(NAMMD Romania Approved)
3. No-Spa 20 mg/ml solution for injection by Chinoin
Pharmaceutical and Chemical Works Co. Ltd (Executive Agency
For Medicinal Products, Bulgaria Approved)
Me-too status NO-SPA Injection of Sanofi Aventis Pakistan
is rated GOOD.
(general) section.

Brand Name +Dosage Form + Strength Zumin 40mg Injection
Esomeprazole as sodium …40mg
Pharmacological Group PPI
Type of Form Form 5
Approval status of product in NEXIUM IV esomeprazole 40mg (as sodium) powder for
Reference Regulatory Authorities. Injection vial. (TGA approved)
Me-too status Somezol Injection 40mg by Bosch (Reg# 045386)
is rated GOOD.
Brand Name +Dosage Form + Strength Sucrose 100mg/5ml Injection
Iron sucrose…100mg
Pharmacological Group Haematinic
Type of Form Form 5
Finished Product Specification BP
Approval status of product in VENOFER iron 100mg/5mL (as iron(III) hydroxide sucrose
Reference Regulatory Authorities. complex) injection (TGA Approved)
Me-too status Iroject Injection by Medley Pharma (Reg#070173)
is rated GOOD.

(general) section.
• The reference product contains iron(III) hydroxide sucrose
complex which is equivalent to 20mg/ml elemental Iron. Iron
sucrose is gerneric term used for iron(III) hydroxide sucrose
complex in TGA Australia.
Contract manufactured by M/s Safe Pharmaceuticals Pvt Ltd.
Brand Name +Dosage Form + Strength Mecob 500mcg/ml Injection
Mecobalamin…500mcg
Pharmacological Group Vitamin B-12
Type of Form Form 5
Approval status of product in Comezengen injection 500 μg of M/s Tatsumi Chemical
Reference Regulatory Authorities. (PMDA Japan Approved)
Me-too status Flench injection of Tabros Pharma (Reg. # 029050)
is rated GOOD.
(general) section.
Brand Name +Dosage Form + Strength Noul 40mg Injection
Omeprazole as sodium…40mg
Type of Form Form 5

Approval status of product in Omeprazole 40mg powder for solution for injection of
Reference Regulatory Authorities. Sandoz, UK (MHRA Approved)
Me-too status Zegrid-40 Injection of Shaigan Pharma
is rated GOOD.
Brand Name +Dosage Form + Strength Pyrol 1000mg Injection
Composition Each 100ml vial contains:
Paracetamol…1000mg
Pharmacological Group Anti pyretic
Type of Form Form 5
Approval status of product in Paracetamol 10 mg/ml Solution for Infusion (100ml vial contains
Reference Regulatory Authorities. 1000mg paracetamol) (MHRA Approved)
Me-too status Provas Infusion 10mg/ml by Sami Pharma (Reg# 053223)
is rated GOOD.
(general) section.
th

Brand Name +Dosage Form + Strength Tram 100mg/2ml Injection
Composition Each 2ml ampoule contains:
Tramadol hydrochloride…100mg
Pharmacological Group Analgesics, Opiates
Type of Form Form 5
Approval status of product in Tramadol 50mg/ml solution for injection of AS Kalceks (MHRA
Reference Regulatory Authorities. approved)
Me-too status Tamadol 100mg/2ml Injection of Highnoon (Reg#013194)
is rated GOOD.
(general) section.
th

Agenda of Evaluator PEC-VI
a. New DML
b. New/Additional section(s)
CLB in its 275 meeting held on 25th January 2020 has considered and approved the following 3 additional
th
sections
a) Capsule (Cephalosporin)
b) Dry powder Injectable (Cephalosporin)
c) Oral Dry Powder Suspension (Cephalosporin)
1 molecule / 1 product
592. Name, address of Applicant / Marketing M/s Saffron Pharmaceutical 19 km, Sheikhupura Road,
Authorization Holder Faisalabad.
Name, address of Manufacturing site. M/s Saffron Pharmaceutical 19 km, Sheikhupura Road,
Faisalabad.
Status of the applicant ☒ Manufacturer √
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy no 31566, Dated 16.11.2021
Details of fee submitted Rs.30,000/- dated 20.10.2021 Deposit Slip # 55034843885
The proposed proprietary name / brand name OnCef 100mg/mL Drops (powder for suspension)
Strength / concentration of drug of Active Each mL contains
Pharmaceutical ingredient (API) per unit Cefadroxil Monohydrate equivalent to
Cefadroxil…………………….100 mg
Pharmaceutical form of applied drug Oral Drops
Pharmacotherapeutic Group of (API) Cephalosporin Antibacterial
Reference to Finished product specifications USP Specification
Proposed Pack size 1 x 10mL & 1 x 20mL
Proposed unit price As Per SRO
The status in reference regulatory authorities Approved by ANSM FRANCE
For generic drugs (me-too status) Duricef 100mg/mL Drops of GSK.
GMP status of the Finished product GMP certificate issued on 12.11.2020
manufacturer
Name and address of API manufacturer. Name: M/s ACS Dobfar S.p.A.
Address: Viale Addetta, 4/12, 20067 Tribiano (MI), Italia
(I)
and stability studies of drug substance and drug product.

drug substance.
Stability studies Cefadroxil Monohydrate: Firm has submitted stability
study data of 3 batches of drug substance at both accelerated
as well as real time conditions. The accelerated stability data
is conducted at 40°C ± 2°C / 75% ± 5% RH for 6 months.
The real time stability data is conducted at 30°C ± 2°C / 75
± 5% RH for 60 months.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence Studies s against the reference
dissolution profile product of “Duricef 100mg/ml Drops by M/s GSK”.
Analytical method validation/verification of Firm has submitted verification studies of the drug substance
product and the drug product.
Manufacturer of API Name: M/s ACS Dobfar S.p.A.
Address: Viale Addetta, 4/12, 20067 Tribiano (MI), Italia (I)
API Lot No. 550209 0018 0
Description of Pack API Container: Linear low density polyethylene. Inner and outer white
(Container closure system) Product Container: Alu-Alu blister packed in unit carton (2x6’s & 2x7’s)
Batch No. T-002 T-003 T-004
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last inspection report for Elixa
applications with stability study data of (Apixaban) 2.5mg & 5mg conducted on 08.10.2019,
the firm (if any) approved in 293rd meeting of Registration Board.
Following are details of few points;
• The HPLC software is 21CFR Compliant.

•
Audit trail reports were available and physically
checked by the inspection team.
• Firm has adequate monitoring and controls for
stability chambers.
• Software is installed for continuous monitoring of
chambers.
2. Approval of API/ DML/GMP certificate Copy of GMP certificate (Certificate# IT-API/51/H/2019)
of API manufacturer issued by issued by Italian Medicine Agency AIFA valid upto
concerned regulatory authority of 25.03.2022
country of origin.
3. Documents for the procurement of API Copy of commercial invoice attested by AD I&E DRAP,
with approval from DRAP (in case of Lahore has been submitted.
import). Cefadroxil Monohydrate:
Date of
Quantity
Batch No. approval
Imported
by DRAP
0004 0 1.50 Kg 27.07.2020
4. Data of stability batches will be Firm has submitted data of stability batches along with
supported by attested respective batch manufacturing record and analytical record.
documents like chromatograms,
sheets etc.
5. Compliance Record of HPLC software Firm has submitted audit trail reports on product testing.
testing
6. Record of Digital data logger for Firm has submitted Record of Digital data logger for
temperature and humidity monitoring of temperature & humidity monitoring of stability chambers
stability chambers (real time and (real time and accelerated)
accelerated)
DEFICIENCY SUBMITTED DATA
7. Drug Substance-Excipient Compatibility study:

Samples are to prepared a binary mixer of drug substance
3.2.P.2 Compatibility studies for the dry
and excipient as per table#1, packed in amber glass bottle,
powder for suspension shall be
and submitted to quality control for analysis at initial stage
performed as per the instructions
and after 1 month at accelerated conditions. Drug substance
provided in the individual label of the
excipient compatibility is to be assessed through HPLC
drug product.
analysis of binary mixer of excipient and drug substance in
the solid sate
8. Section 3.2.S.4.1 is required, which
specifies copies of the drug substance
specifications and analytical procedures Firm has submitted the analytical procedure of API & Drug
used for routine testing of the drug Product with USP Monograph
substance by both drug substance and
drug product manufacturer.
9. Submit raw data sheets to support the
calculation of results of assay throughout Firm has submitted the RAW Data Sheets with COAs
the stability studies.
10. Submit reference for the acceptance
limits of each test in the drug product and Firm has followed the official USP monograph for finished
drug substance specifications. Also product & API
provide justification in case acceptance

limits mentioned in official monograph
is not followed.
11. Which form of Cefadroxil monohydrate
Cefadroxil monohydrate is used in MICRONIZED form in
is used in Finish product as a micronized
Finish product.
form or otherwise?
Remarks OF Evaluator VI:
Decision: Approved.
• Manufacturer shall submit compatibility & in-use stability studies of applied product with the diluent
as recommended by innovator product.
in the registration application
593. Name, address of Applicant / Marketing M/s Saffron Pharmaceutical 19 km, Sheikhupura
Authorization Holder Road, Faisalabad.
Name, address of Manufacturing site. M/s Saffron Pharmaceutical 19 km, Sheikhupura
Road, Faisalabad.
Status of the applicant ☒ Manufacturer √
☐ Importer
☐ Export sale
Dy. No. and date of submission Dated 29.12.2021 Dy.No 33995
Details of fee submitted Rs.20,000/- dated 13.05.2020 Deposit Slip # 0228310
Rs.10,000/- dated 23.11.2021 Deposit Slip #
88095423419
The proposed proprietary name / brand name Doplet-3 Soft Gel Capsule
Strength / concentration of drug of Active Each Soft Gel Capsule contains
Pharmaceutical ingredient (API) per unit Cholecalciferol (Vitamin D3)…… 50000 IU
Pharmaceutical form of applied drug Oral Capsule
Pharmacotherapeutic Group of (API) Vitamin D3
Proposed Pack size 1×10’s, 2×7’s & 3×10’s
Proposed unit price As Per SRO
The status in reference regulatory authorities Approved by MHRA
For generic drugs (me-too status) DX3 50,000 IU Oral Capsule of Macter international
(Pvt.) Limited.,
GMP status of the Finished product manufacturer GMP certificate issued on 03.01.2022 (Good
Compliance)
Name and address of API manufacturer. Name: M/s Zhejiang NHU Company Ltd.
Address: No.428 Xinchang Dadao West Road,
Qixing Street, Xinchang County, Zhejiang Province,
China

template. Firm has summarized information related
to nomenclature, structure, general properties,
solubilities, physical form, manufacturers,
impurities, specifications, analytical procedures and
system and stability studies of drug substance and
drug product.
Module III (Drug Substance) Firm has submitted detailed data for drug substance
data related to nomenclature, structure, general
impurities, specifications, analytical procedures and
Stability studies Cholecalciferol: Firm has submitted stability study
data of 3 batches of drug substance at both accelerated
as well as real time conditions. The accelerated
stability data is conducted at 40°C ± 2°C / 75% ± 5%
RH for 6 months. The real time stability data is
conducted at 30°C ± 2°C / 75 ± 5% RH for 60 months.
description, composition, pharmaceutical
development, manufacture, manufacturing process
and process control, process validation protocols,
control of excipients, control of drug product,
specifications, analytical procedures, validation of
specifications, reference standard or materials,
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence Studies against the
dissolution profile reference product of “Dan D Soft Gel Capsule”.
Analytical method validation/verification of product Firm has submitted verification studies of the drug
substance and the drug product.
Manufacturer of API Name: M/s Zhejiang NHU Company Ltd.
Address: No.428 Xinchang Dadao West Road, Qixing Street,
Xinchang County, Zhejiang Province, China
API Lot No. 01201103VD
Description of Pack API Container: Linear low density polyethylene with aluminum foil
(Container closure system) bag vacuum packing
Product Container: Placed in Alu-Alu blister and packed in unit
carton.

Batch No. T-003 T-004 T-005
No. of Batches 03
1. Reference of previous approval of applications with Firm has referred to their last inspection report for
stability study data of the firm (if any) Elixa (Apixaban) 2.5mg & 5mg conducted on
08.10.2019, approved in 293rd meeting of Registration
Board.
Following are details of few points;
• The HPLC software is 21CFR Compliant.
• Audit trail reports were available and
physically checked by the inspection team.
• Firm has adequate monitoring and controls
for stability chambers.
• Software is installed for continuous
monitoring of chambers.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate (Certificate# ZJ20180077)
manufacturer issued by concerned regulatory issued by China Food & Drug Administration valid
authority of country of origin. upto 23.07.2023
3. Documents for the procurement of API with approval Copy of commercial invoice attested by AD I&E
from DRAP (in case of import). DRAP, Lahore has been submitted.
Choloecalciferol:
Date of
Quantity
Batch No. approval
Imported
by DRAP
01201103VD 06Kg 14.01.2021
4. Data of stability batches will be supported by attested Firm has submitted data of stability batches along
respective documents like chromatograms, with batch manufacturing record and analytical
Raw data sheets, COA, summary data sheets etc. record.
5. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports on product
audit trail reports on product testing testing.
6. Record of Digital data logger for temperature and Firm has submitted Record of Digital data logger for
humidity monitoring of stability chambers (real time temperature & humidity monitoring of stability
and accelerated) chambers (real time and accelerated)
SUBMITTED DATA REGARDING THE DEFICIENCIES
7. 3.2.P.2 You are following USP specification. Firm has submitted the USP specification &
Compare the USP pharmacopoeial test parameters Comparison of USP pharmacopoeial test parameters
along with specification limits with applied product along with specification limits
specification.
8. We performed the Identification & assay method on
UV spectrophotometer is internal validated testing
3.2.P.2 Clarification of the method of analysis of method & the validation is performed as per USP
finished drug product for quantification of Vitamin D general chapter <1225>
in Assay test, whether UV spectrophotometric We performed has Identification & assay method on
method or HPLC method. HPLC is pharmacopeia testing method & the
verification is performed as per USP general Chapter
<1226>

9. Dissolution test for the applied product is not Dissolution test is not included in USP monograph so
submitted. we performed only DT as per USP.
Remarks of Evaluator VI:
Decision: Deferred for justification of applying UV spectrophotometric method, for Assay test of finished drug
product, whereas USP monograph specifies HPLC method for the Assay analysis.
Case no. 03 Registration applications for local manufacturing of (veterinary) drugs

a. New Cases
b. Deferred Cases
594. Name and address of manufacturer / "M/s International Pharma Labs. Raiwind Road, Bhobtian
Applicant Chowk, Defence Road, 1-KM Towards Kahna, Lahore."
Brand Name +Dosage Form + Strength I Doxytyl Gold Powder
Composition "Each 1000gm Contains:
Doxycycline Hcl…200gm
Tylosine tartrate…100gm
Colistine Sulphate…480 MIU
Bromhexine HCl…5gm"
Diary No. Date of R& I & fee Dy.No 30858-A dated 13-09-2018 Rs.20,000/- Dated 13-09-
2018
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm,500gm,1Kg, 2.5kg, 5kg, 10kg,
25kg:Decontrolled
Me-too status (with strength and dosage Could not be confirmed
form)
GMP status Panel Inspection for renewal of DML conducted on 11-05-2018
recommended renewal of DML for the following sections:
• Oral Powder Sections(Veterinary)
• Oral Liquid Sections(Veterinary)
• Liquid Vial Injection Sections(Veterinary)
Panel has also recommended "M/s Inshal Pharmaceutical for
grant of additional sections:
• Amoxicillin/Penicillin Oral Powder Section(veterinary)
• Amoxicillin/Penicillin Liquid Vial Injectable
Section(veterinary)
Decision of 293rd meeting:
Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along
• The firm has submitted following me too reference for the applied product which is verifiable from the
available data base.
Emeria Shell Powder by M/s Inshaal Pharma Islamabad, Reg. No. 080515
Decision 312nd : Registration Board referred the case to QA & LT Division to conduct GMP inspection of
Firm on priority.
Evaluation by PEC VI: 13-1-2022, Inspection carried out for Renewal of DML, the panel recommends
renewal of DML
Decision: Approved with innovator’s specification along with change of brand name. Firm shall submit
fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as per notification
No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
Applicant Chowk, Defence Road, 1-KM Towards Kahna, Lahore.
Brand Name +Dosage Form + Strength I-Doxin 500 Powder

Composition "Each gm Contains:
Doxycycline Hcl…500mg"
Diary No. Date of R& I & fee Dy. No. 30858-C dated 13-09-2018 Rs.20,000/- Dated 13-09-
2018
Type of Form Form-5
25kg:Decontrolled
form)
GMP status same as recorded for above application
Fairo Dox 50 powder by M/s Mallard Pharma, Reg. No. 063782
Firm on priority.
renewal of DML
Brand Name +Dosage Form + Strength I-Bromoride Solution
Composition "Each 100ml Contains:
Bromhexine hydrochloride…5gm"
Diary No. Date of R& I & fee Dy. No. 30858-I dated 13-09-2018 Rs.20,000/- Dated 13-09-
2018
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 250ml, 500ml, 1000ml, 5000ml, 10,000ml:
Decontrolled
Me-too status (with strength and dosage Bromo 5 % W.S. Powder of Cherished Pharmaceuticals.
form)
Remarks of Evaluator Applied formulation is a solution while me too is powder.
Clarify/Justify.
rd
Decision of 293 meeting:
Deferred for evidence of applied formulation/drug i.e. bromhexine hydrochloride 5gm /100ml solution
already approved by DRAP (generic / me-too status) alongwith registration number, brand name and name
of firm.
Brom Shell Liquid by M/s Inshaal Pharma Islamabad, Reg.No. 075762
Firm on priority.

renewal of DML
Brand Name +Dosage Form + Strength I-Enicol Solution
Composition "Each ml Contains:
Florfenicol…200mg"
Diary No. Date of R& I & fee Dy.No 30858-F dated 13-09-2018 Rs.20,000/- Dated 13-09-
2018
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml,500ml,1000ml, 50,000ml,
10,000ml:Decontrolled
form)
Remarks of Evaluator it is a liquid solution as per dossier
Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
Pri-Florecol 20 oral liquid by M/s by M/s Prix Pharma, Reg. No. 080928
Firm on priority.
renewal of DML
Brand Name +Dosage Form + Strength I-Dicolist Powder
Composition "Each kg Contains:
Doxycycline …400gm
Tylosine tartrate…200gm
Colistine Sulphate…1000 MIU
Bromhexine Hcl…10gm"
Diary No. Date of R& I & fee Dy. No. 30858-B dated 13-09-2018 Rs.20,000/- Dated 13-09-
2018
Type of Form Form-5
25kg:Decontrolled
form)

Submission by the firm (PEC-I):
• The firm has revised the formulation which is given below;
Each Kg contains:
Doxycycline Hydrochloride…….400gm
Tylosine tartrate…………………200gm
Colistin Sulphate………………...500MIU
Bromhexine Hydrochloride……...10gm
• Moreover, the firm has submitted following me too reference for the applied product which is verifiable
from the available data base.
Fit Respi water soluble powder by M/s D-Maarson Pharma, Reg. No. 78268
• Fee Rs. 5000/- submitted vide Copy of challan No. 1995471 dated 06/03/2020.
Firm on priority.
renewal of DML
Decision: Approved as per following labelclaim with innovator’s specification.
Each Kg contains:
Doxycycline Hydrochloride…….400gm
Tylosine tartrate…………………200gm
Colistin Sulphate………………...500MIU
Bromhexine Hydrochloride……...10gm
Firm shall submit fee of Rs. 30,000 for correction/pre-approval change/ in applied strength, as per
Case no. 04 Registration applications of newly granted DML or New section (Veterinary)
a. New DML /section
b. Deferred Cases
599. Name and address of manufacturer / M/s Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Applicant Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Isodon Injection
Isoflupredon Acetate…....................2 mg
Diary No. Date of R& I & fee Dy no 34783, dated 30-12-2020, Rs 20,000/-
Pharmacological Group Steroid
Type of Form Form-5
Finished Product Specification Manufacturer's specification
Pack size & demanded price 50 ml; Decontrolled
Me-too status Predef 2X Injection (Reg. # 019978) by Bela-Pharm Gmbh &
Co.,KG, Germany. Imported by Ghazi Brothers
GMP status New Section Veterinary Liquid Injection Vial (Steroid)
Remarks of the Evaluator -VI • Clarification shall be submitted regarding applied dosage form
whether Injectable solution & Injectable suspension since
submitted me too reference is of Injectable suspension.
th
Decision: 297
Deferred for clarification regarding applied dosage form whether Injectable solution & Injectable suspension
since submitted me too reference is of Injectable suspension.
Evaluation by PEC VI: The firm submitted that
“Isodon injection 50ml shall be injectable suspension dosage form as per me too reference’’
The firm has did not submit fee for correction and change in master formulation.
Decision: Deferred for submission of master formulation. Firm shall submit the of Rs. 30,000 for
correction/pre-approval change in composition (correction/change of formulation from Injectable
solution to Injectable suspension), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
600. Name and address of manufacturer / Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National

Brand Name +Dosage Form + Strength Pred C Plus Injection
Prednisolone Acetate….................25 mg
Chlorpheniramine Maleate…….......10 mg
Pharmacological Group Steroid / Antihistamine
Type of Form Form-5
Me-too status Predmine Injection (Reg. # 057084) by Cherished
Remarks of the Evaluator-VI • Me too reference in applied fill volume could not be verified
Decision: 297th :
Deferred for evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm.
Evaluation by PEC VI: The firm is submitted M/S : Cherished Pharma , Product Name: Predmin Injection,
Reg no: 057084
Decision: Deferred for review of the applied formulation by expert working group on veterinary
drugs.
Brand Name +Dosage Form + Strength Alpha Pred Injection
9 Alpha Fluoro Prednisolone….......0.2 gm
Type of Form Form-5
Me-too status Abicorten Injectable solution (Reg. # 020756) by Fatro S.P.A.
Italy. Imported by Prix Pharma
Remarks of the Evaluator-VI • Me too reference in applied fill volume could not be verified
Decision 297th :
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /me-too
status) alongwith registration number, brand name and name of firm.
Evaluation by PEC VI: The firm is submitted revised me too without submitting fee for correction. M/S:
International Pharma Labs Product Name: Alpha Pre-Injection, Reg no: 099032, Packing: 10ml.
Brand Name +Dosage Form + Strength Pred DX Injection
Prednisolone…......….....................7.5 mg
Dexamethasone….........................2.5 mg
Type of Form Form-5

Me-too status CORTINOL-P Injection (Reg. # 014570) by Star laboratories,
Animal division Lahore
Remarks of the Evaluator-VI • Me too reference in applied fill volume could not be verified.
Decision 297th :
Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
Evaluation by PEC VI: The firm has submitted

CORTINOL-P microcrystalline suspension Injection (Reg. # 014570) by Star laboratories,
Animal division Lahore, in 50ml pack size.
Decision: Deferred for review of the product/molecule by expert working group on veterinary drugs.
a. Exemption from onsite verification of stability data

603. Name and address of manufacturer / M/s The Searle Company Limited
Applicant F-319, S.I.T.E., Karachi, Pakistan.
Brand Name +Dosage Form + Strength Tramal Plus Forte 75/650mg Tablets
Tramal Plus Forte 75/650mg Tablets
Composition Each Film coated tablet contains:
Tramadol/Paracetamol……………...75/650mg
Dy. No. 126 dated 04/03/2019, PKR 50,000/-: dated
Diary No. Date of R& I & fee
01/03/2019
Pack size & Demanded Price 10’s As per SRO
Approval status of product in Reference Approved by AEMPS and marketed in Spain, with the name
Regulatory Authorities. of DILIBAN Tablets
Me-too status Tonoflex P Forte by M/s Sami karachi
New GMP granted on 13/08/2020
GMP status

Drug Tramal Plus Forte 75/650mg Tablets
Name of Manufacturer M/s The Searle Company Limited, F-319, S.I.T.E., Karachi
Tramadol HCl:
Manufacturer: M/s SUPRIYA LIFESCIENCE., Ltd India
Manufacturer of API
Paracetamol:
Manufacturer: M/s Lianyungang Kangle Pharmaceutical Co., Ltd,China
Tramadol HCl: SLL/TDM/1019039
API Lot No.
Paracetamol: CW-1804412F
Description of Pack (Container
ALU-PVDC Blister in Unit Carton
closure system)
Real time : 30°C ± 2°C / 75% ± 5%RH
Frequency Accelerated: 0,3 & 6 months Real Time: 0,3,6 months
Product name Batch Nos. Batch size Date of Mfg. Date of initiation
Tramal Plus Forte 75/650mg Tablets 20PD-053 2500 Tablets Mar-2020 May-2020

REQUEST OF EXEMPTION ROM ON SITE INSPECTION
The firm has requested for exemption on the basis of it already approved product in M-289th.
1. Reference of last onsite panel inspection forThe firm has submitted documents for Reference of Previous
instant dosage form conducted during last Approval.
two years. M-289th meeting held on 14-16May 2019
Tapendol tablet 100mg
Approved.
Audit trails available
HPLC is 21CFR compliant.
2. Certificate of Analysis of API from both API The firm has submitted Certificate of Analysis of API from
Manufacturer and Finished Product both API Manufacturer and Finished Product
manufacturer. manufacturer.
3. Method used for analysis of API from both The firm has submitted Method used for analysis of API from
API Manufacturer and Finished Product both API Manufacturer and Finished Product
4. Stability study data of API from API The firm has submitted Stability study data of API from API
manufacturer manufacturer.
Tramadol HCl and Paracetamol:
Accelearated for 6 months at 40 and 75%
Real time for 36 months at 30 and 75%.
5. Approval of API/ DML/GMP certificate of Tramadol HCl:
API manufacturer issued by concerned GMP Certificate of Tramadol HCl:
regulatory Manufacturer: SUPRIYA LIFESCIENCE., Ltd
authority of country of origin. Valid Till: 23-Nov-2024
Paracetamol:
GMP Certificate of Paracetamol:
Manufacturer: Lianyungang Kangle Pharmaceutical Co., Ltd
Valid Till: 31-05-2022
6. Documents for the procurement of API with Tramadol HCl:
approval from DRAP (in case of import). Invoice
Invoice Num: SLL/E/19-20/913
Quantity: 2500 kgs
Paracetamol:
Invoice
Invoice Num: 18LF275
Quantity: 25 kgs
Batch: CW-1804412F
Attested by ADC Karachi 15-11-2019
7. Protocols followed for conduction of Protocols followed for conduction of stability study has
stability study submitted
8. Method used for analysis of FPP
Method used for analysis of FPP was submitted
9. Drug-excipients compatibility studies (where
applicable) Our product has same excipient as that of innovators
formulation.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing
three stability batches. Record of three stability batches for the stability studies of
Tramal Plus Forte 75/650mg Tablets such as.
Tramal Plus Forte 75/650mg Tablets
Batch No. Batch Size. Date of Mfg.

20PD-053 2500 Tablets Mar-2020
11. Record of comparative dissolution data The firm has submitted the record of comparative dissolution
(where applicable) data. Comparative dissolution data is prepared against
Tonoflex P forte tablets in 3 ph stages. F2 value shows 50 or
greater (50-100) reflects samness or equivalence of wo curves
and thus equivalence of the Invitro performance of two
products.
QA / QC DATA
attested respective documents like Data of 03 batches i.e. 20PD-053, 20PD-054, 20PD-055
chromatograms, Raw data sheets, COA, will be supported by attested respective documents like
summary data sheets etc. chromatograms was submitted

Compliance Record of HPLC software 21CFR & audit trail
reports on product testing has submitted
testing.
Record of Digital data logger for temperature and humidity
monitoring of stability chambers has submitted
chambers
Sr Short coming -Evaluator VI Justification
01 Testing Reports of API and Finished Product Testing Reports of API and Finished Product from Finished
from Finished Product Manufacturer is Product Manufacturer were provided.
required.
02 Compare the COA’s of API from Finish
We have not performed residual solvent test due to un
Product Manufacturer with COA of API
availability of GC instrument but for better compliance, GC is
Supplier and Justification is required for
in procurement phase.
Non-performance of test, if any.
03 Compare the excipients used in finish product Comparison of the excipients used in finish product
manufacturing with the innovator’s product manufacturing with the innovator’s product and justification is
and justification is required if there is any for any difference present is provided.
difference.
Decision: Approved.
application.
604. Name and address of manufacturer / M/s The Searle Company Limited
Applicant F-319, S.I.T.E., Karachi, Pakistan.
Brand Name +Dosage Form + Strength Telafen 25mg Tablets
Composition Telafen 25mg Tablets
Tenofovir Alafenamide……………...25mg
Diary No. Date of R& I & fee Dy. No. 127 dated 04/03/2019
Pharmacological Group Anti-Viral
Type of Form Form-5
Finished product Specification In-House
Pack size & Demanded Price 10’s As per SRO
Approval status of product in Reference Approved by USFDA and marketed in US, with the name of
Regulatory Authorities. VEMLIDY Tablets
Me-too status Scifovir by M/s Scilife Pharmaceutical

GMP status New GMP granted on 13/08/2020

Drug Telafen 25mg Tablets
Name of Manufacturer M/s The Searle Company Limited, F-319 SITE, Karachi
M/s Aurisco Pharmaceutical Co., Ltd
Manufacturer of API Address: Badu Industrial Park Zone, Tiantai, Zhejiang Province 317200, P.R
China
API Lot No. TAFA – 190101
HDPE Bottle in Unit Carton
closure system)
Real time : 30°C ± 2°C / 75% ± 5%RH
Frequency Accelerated: 0,3 & 6 months Real Time: 0,3,6 months
Telafen 25mg Tablets 20PD-081 2500 Tablets April-2020 May-2020
The firm has requested for exemption on the basis of it already approved product in M-289th.
1. Reference of last onsite panel inspection for The firm has submitted documents for Reference of Previous
instant dosage form conducted during last Approval.
two years. M-289th meeting held on 14-16May 2019
Tapendol tablet 100mg
Approved.
Audit trails available
HPLC is 21CFR compliant.
2. Certificate of Analysis of API from both API The firm has submitted Certificate of Analysis of API from
Manufacturer and Finished Product both API Manufacturer and Finished Product
3. Method used for analysis of API from both The firm has submitted Method used for analysis of API from
API Manufacturer and Finished Product both API Manufacturer and Finished Product
4. Stability study data of API from API The firm has submitted Stability study data of API from API
manufacturer manufacturer
Accelerated data for 6months with conditions 25’C 60%
Real time data for 12 months with conditions 2to 8’C.
5. Approval of API/ DML/GMP certificate of Tenofovir Alafenamide Fumarate:
API manufacturer issued by concerned GMP Certificate of Tenofovir Alafenamide Fumarate:
regulatory authority of country of origin. Manufacturer: M/s Aurisco Pharmaceutical Co., Ltd
Valid Till: 20-08-2024 issued from China food and drug
administration. Certificate No. ZJ20190101

6. Documents for the procurement of API with Tenofovir Alafenamide Fumarate:
approval from DRAP (in case of import). Form 7: Batch Certification
Invoice
Invoice Num: 19T-259
Quantity: 01 Carton = 0.5kg Net
Batch: TAFA-190101
ADC karachi attested on 21-8-2019.
7. Protocols followed for conduction of Protocols followed for conduction of stability study was
stability study submitted
8. Method used for analysis of FPP Inhouse method is used for analysis, with dissolution rate
NLT Q 80% in 15minutes
9. Drug-excipients compatibility studies (where Our product has same excipient as that of innovators
applicable) formulation.
Telafen 25mg Tablets
Telafen 25mg Tablets
20PD-081 2500 Tablets April-2020
11. Record of comparative dissolution data The firm has submitted the record of comparative dissolution
(where applicable) data. Comparative dissolution data is prepared against
Vemlidy 25mg tablets in 3 ph stages. The release of API in
15minutes is more than 85%. Hence there is no need to
calculate f2 factor.
QA / QC DATA
attested respective documents like Data of 03 batches will be supported by attested respective
chromatograms, Raw data sheets, COA, documents like chromatograms was submitted
Compliance Record of HPLC software 21CFR & audit trail
reports on product testing has submitted
testing.
and humidity monitoring of stability Record of Digital data logger for temperature and humidity
chambers monitoring of stability chambers has submitted
Sr Short coming, Evaluator-VI Justification
01 Testing Reports of API and Finished Product Testing Reports of API and Finished Product from Finished
from Finished Product Manufacturer is Product Manufacturer is provided.
required.
02 Compare the COA’s of API from Finish
We have not performed residual solvent test due to un
Product Manufacturer with COA of API
availability of GC instrument but for better compliance, GC is
Supplier and Justification is required for Non-
in procurement phase.
performance of test, if any
03 Stability Studies of API is not fall in Zone IV- As per Drug substance information for “Tenofovir
A. Alafenamide” available in the application having number NDA
207561 recommends condition is 5’C which lie under the
refrigerated condition that is why API manufacturer conducted
stability at 5’C+_3’C not as per zone IV A.

04 Compare the excipients used in finish product Comparison of the excipients used in finish product
manufacturing with the innovator’s product manufacturing with the innovator’s product and justification is
and justification is required if there is any for any difference present is provided.
difference.
application.
605. Name and address of manufacturer / M/s Jenner Pharmaceuticals (Pvt.) Ltd.
Applicant 26- km Lahore Sharaqpur Road Sheikhupura
Brand Name +Dosage Form + Strength Olumijent Tablets 2mg
Composition
Baricitinib……….2 mg
Dy.No 15698 dated 07-03-2019 Rs.50,000/- dated 06-03-
Diary No. Date of R& I & fee
2019
Pharmacological Group Baricitinib
Finished product Specification Innovators’s
Pack size & Demanded Price 10’s, 20’s, 30’s As per SRO
Approval status of product in Reference MHRA A:
Regulatory Authorities. Olumiant 2 mg Tablets Manufactured by Eli Lilly
Me-too status
Last GMP/Panel inspection conducted on 23-12-2020 for
GMP status
renewal of DML

Drug Olumijent Tablets 2mg
M/s Jenner Pharmaceuticals (Pvt.) Ltd. 26- km Lahore Sharaqpur Road
Name of Manufacturer
Sheikhupura
Manufacturer of API M/s Zhejiang Hongyuan Pharmaceutical China
API Lot No. BRCT 20190802

10’s, 20’s and 30’s tablets packed in alu-alu blister pack.
closure system)
Real time : 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0,1,2,3,4 & 6 months Real Time: 0,3,6 months
Olumijent tablets 2mg OLM-PB-023001 1000 tablets 04-2020 22-04-2020

Now the firm has requested for Exemption from On-site Investigation of their submitted stability data of Olumijent
tablets 2mg and provided the following documents in conjunction with the checklist approved by the Registration
Board in its 278th Meeting:
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their products
instant dosage form conducted during last “Lansodex Capsule 60mg and 30mg, Sofopas Tablet
two years. 400/90”, which were presented in 287th meeting of
Registration board. Registration Board decided to approve
registration of Lansodex Capsule 60mg and 30mg, Sofopas
Tablet 400/90 of M/s Jenner Pharmaceuticals (Pvt) Ltd,.
Sheikupura.
Date of inspection : 10-12-2018
According to the report generated following points were
confirmed
a) The HPLC used for analysis of stability batches is
Shimadzu 20 ATVP with auto sampler and gradient system
and it was 21 CFR compliant.
b) The firm has two separate Memmert (Germany) stability
chambers for real time and accelerated stability studies which
are equipped with data loggers.
2. Documents for the procurement of API with Copy of commercial invoices to import Baricitinib (31gm)
approval from DRAP (in case ofimport). attested by AD, I&E DRAP, Lahore has been submitted.
Detailed as under:
Batch No. : BRCT 20190802
Invoice No.: 30234066
Date of approval by DRAP: 26-07-2019
3. Documents for the procurement of reference Firm has declared that manufacturer of API of Baricitinib has
standard and impurity standards. supply impurities and working standard along with the
material
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate for Baricitinib (Certificate #
API manufacturer issued by regulatory 193300B0/012286) issued by Linhai Food and Drug
authority of country of origin. Association valid upto 02-07-2024.
5. Mechanism for Vendor pre-qualification The firm has submitted copy of document with title
“Rationale for selection of Manufacturing of the API „
Baricitinib‟”
6. Certificate of analysis of the API, reference The firm has submitted certificate of analysis for API
standards and impurity standards (Baricitinib Batch # BRCT 20190802), working standards and
impurity standards.
7. Documents for the procurement of The firm has submitted photocopy of Purchase
excipients used in product development? Order/Invoices for the procurement of excipients used in
product development.
8. List of qualified staff involved in product The firm has submitted photocopy of List of R& D
development with relevant experience. technical staffcomprising of 3 technical members.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of Product Development
development & stability testing of trial Protocol& Stability study protocols for the Olumijent tablets
batches. 2mg
Olumijent tablets 2mg such as.
Olumijent tablets 2mg

OLM-PB-023001 1000 tablets 04-2020
OLM-PB-023002 1000 tablets 04-2020
OLM-PB-023003 1000 tablets 04-2020
11. Record of remaining quantities of The firm has submitted reconciliation sheet mentioning
stability batches. followingdetails:
Batch No. Remaining Quantity
Accelerated Long Term
OLM-PB-023001 0 tablets 224 tablets
QA / QC DATA
12. Record of Digital data logger for The firm has submitted photocopies of digital graphs for Real
temperature and humidity monitoring of Time and Accelerated Conditions for complete stability
stability chambers (real time and studies of applied formulations.
accelerated)
13. Method used for analysis of API along The firm has submitted photocopy of raw material
with COA. specifications, raw material testing procedures for Baricitinib
14. Method used for analysis of FPP & complete The firm has submitted photocopy of Testing Method of
record of testing of stability batches (i.e. Finished Product for Olumijent Tablets 2mg along with
chromatograms, lab reports, raw data sheets relevant analytical record for stability studies.
etc.)
15. Reports of stability studies of API from The firm has submitted stability studies reports on API as
manufacturer. per Zone-IV-a conditions.
16. Analysis reports for excipients used. The firm has submitted photocopies of its Analytical reports
for all excipients used in product development of Olumijent
Tablets 2mg.
17. Drug-excipients compatibility studies. The firm has submitted that drug excipient compatibility
studies data is not applicable since firm has used qualitative
innovator formulation.
18. Record of comparative dissolution data. Firm has performed comparative dissolution study against
reference product Olumiant Tablets 2mg manufactured by Eli
Lilly, Netherlands a t 0 . 1 N H C l , p H 1 . 2 , P h o s p h a t e
Buffer pH 6.8 and Acetate Buffer pH 4.5
19. Compliance Record of HPLC software Firm has submitted audit trail reports of stability studies of
21CFR & audit trail reports on product applied formulations.
testing.
01 What is the time required for the release of Time required for the release of dissolution test is 30 minutes
dissolution test (NLT Q), also required its which is derived from USFDA chemistry review
justification SOP for analysis of finished product is attached, where these
acceptance criteria of dissolution test are mentioned.
Dissolution acceptance criterion is NLT 80% in 30 minutes
02 Compare the COA of API from finished Certificate of analysis of API from finished product
product manufacturer with COA of API manufacturer and COA of API from supplier are compared and
supplier and justification is required for non- found that finished product manufacturer performed all the tests
performance of test, if any as mentioned by manufacturer of API on COA of API.
03 Compare the excipients used in finished Excipients used by the finished product manufacturer in finished
product manufacturing with the innovator’s product manufacturing (Olumijent Tablets) and Excipients used
product and justification required if there is in the innovator’s product (Olumiant Tablets) are compared and
any difference found that both formulations contains same ingredients.

Copy of formulation of innovator brand from MHRA and
Excipient detail used in Finished product are attached.
04 The applied molecule may exist in more than API used in finished product manufacturing is of Polymorphic
1 polymorphic forms. What polymorphic form 1 according to XRD pattern.
form is used?
05 Valid GMP/DML of API manufacturer is DML of M/s Zhejiang Hong yuan Pharmaceutical China is
required issued by Zhejiang State food and Drug administration, China.
Valid till 13-01-2024
06 Submit the comparative dissolution profile Comparative Dissolution Profile of Olumijent Tablets 2mg and
Olumijent Tablets 4mg is performed in 0.1N HCl, pH 1.2,
Phosphate Buffer pH 6.8 and in Acetate Buffer pH 4.5 against
Innovator Brand Olumiant tablets 2mg (Batch No. D384977)
and Olumiant Tablets 4mg (Batch No. D385031) respectively
manufactured by Eli Lilly, Netherlands.
The complete comparative dissolution profile data is already
submitted to DRAP on 09-02-2022.

application.
606. Name and address of M/s Jenner Pharmaceuticals (Pvt.) Ltd.
manufacturer / Applicant 26- km Lahore Sharaqpur Road Sheikhupura
Brand Name +Dosage Form + Olumijent Tablets 4mg
Strength
Composition
Baricitinib ….4 mg
Diary No. Date of R& I & fee Dy.No 10550 dated 05-03-2019 Rs.50,000/- dated 04-03-2019
Pharmacological Group Baricitinib
Finished product Specification Innovators’s
Pack size & Demanded Price 10’s, 20’s, 30’s As per SRO
Approval status of product in MHRA:
Reference Regulatory Authorities. Olumiant 4 mg Tablets Manufactured by Eli Lilly Netherland
Me-too status
Last GMP/Panel inspection conducted on 23-12-2020 for
GMP status
renewal of DML
Now the firm has submitted stability data detailed as under:
Drug Olumijent Tablets 4mg
M/s Jenner Pharmaceuticals (Pvt.) Ltd. 26- km Lahore Sharaqpur Road
Sheikhupura
Manufacturer of API M/s Zhejiang Hongyuan Pharmaceutical China
API Lot No. BRCT 20190802
10’s, 20’s and 30’s tablets packed in alu-alu blister pack.
closure system)

Real time : 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0,1,2,3,4 & 6 months Real Time: 0,3,6 months
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data of Olumijent
tablets 4mg and provided the following documents in conjunction with the checklist approved by the Registration
Board in its 278th Meeting:
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their products
instant dosage form conducted during last “Lansodex Capsule 60mg and 30mg, Sofopas Tablet
two years. 400/90”, which were presented in 287th meeting of
Registration board. Registration Board decided to approve
registration of Lansodex Capsule 60mg and 30mg, Sofopas
Tablet 400/90 of M/s Jenner Pharmaceuticals (Pvt) Ltd,.
Sheikupura.
Date of inspection : 10-12-2018
According to the report generated following points were
confirmed
a) The HPLC used for analysis of stability batches is
Shimadzu 20 ATVP with auto sampler and gradient system
and it was 21 CFR compliant.
b) The firm has two separate Memmert (Germany) stability
chambers for real time and accelerated stability studies which
are equipped with data loggers.
2. Documents for the procurement of API with Copy of commercial invoices to import Baricitinib (31gm)
approval from DRAP (in case ofimport). attested by AD, I&E DRAP, Lahore has been submitted.
Detailed as under:
Batch No. : BRCT 20190802
Invoice No.: 30234066
Date of approval by DRAP: 26-07-2019
3. Documents for the procurement of reference Firm has declared that manufacturer of API of Baricitinib has
standard and impurity standards. supply impurities and working standard along with the
material
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate for Baricitinib (Certificate #
API manufacturer issued by regulatory 193300B0/012286) issued by Linhai Food and Drug
authority of country of origin. Association valid upto 02-07-2024.
5. Mechanism for Vendor pre-qualification The firm has submitted copy of document with title
“Rationale for selection of Manufacturing of the API „
Baricitinib‟”
6. Certificate of analysis of the API, reference The firm has submitted certificate of analysis for API
standards and impurity standards (Baricitinib Batch # BRCT 20190802), working standards and
impurity standards.
7. Documents for the procurement of The firm has submitted photocopy of Purchase
excipients used in product development? Order/Invoices for the procurement of excipients used in
product development.

8. List of qualified staff involved in product The firm has submitted photocopy of List of R& D
development with relevant experience. technical staffcomprising of 3 technical members.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of Product Development
development & stability testing of trial Protocol& Stability study protocols for the Olumijent tablets
batches. 4mg
Olumijent tablets 4mg such as.
OLM-PB-024001 1000 tablets 04-2020
OLM-PB-024002 1000 tablets 04-2020
OLM-PB-024003 1000 tablets 04-2020
11. Record of remaining quantities of The firm has submitted reconciliation sheet mentioning
stability batches. followingdetails:
Batch No. Remaining Quantity
Accelerated Long Term
QA / QC DATA
12. Record of Digital data logger for The firm has submitted photocopies of digital graphs for Real
temperature and humidity monitoring of Time and Accelerated Conditions for complete stability
stability chambers (real time and studies of applied formulations.
accelerated)
13. Method used for analysis of API along The firm has submitted photocopy of raw material
with COA. specifications, raw material testing procedures for Baricitinib
14. Method used for analysis of FPP & complete The firm has submitted photocopy of Testing Method of
record of testing of stability batches (i.e. Finished Product for Olumijent Tablets 4mg along with
chromatograms, lab reports, raw data sheets relevant analytical record for stability studies.
etc.)
15. Reports of stability studies of API from The firm has submitted stability studies reports on API
manufacturer. as per Zone-IV-a conditions.
16. Analysis reports for excipients used. The firm has submitted photocopies of its Analytical reports
for all excipients used in product development of Olumijent
Tablets 4mg.
17. Drug-excipients compatibility studies. The firm has submitted that drug excipient compatibility
studies data is not applicable since firm has used qualitative
innovator formulation.
18. Record of comparative dissolution data. Firm has performed comparative dissolution study against
reference product Olumiant Tablets 4mg manufactured by Eli
Lilly, Netherlands a t 0 . 1 N H C l , p H 1 . 2 , P h o s p h a t e
Buffer pH 6.8 and Acetate Buffer pH 4.5
19. Compliance Record of HPLC software Firm has submitted audit trail reports of stability studies of
21CFR & audit trail reports on product applied formulations.
testing.

Time required for the release of dissolution test is 30
minutes which is derived from USFDA chemistry
review (copy attached).
What is the time required for the
SOP for analysis of finished product is attached, where
01 release of dissolution test (NLT Q),
these acceptance criteria of dissolution test are
also required its justification
mentioned.
Dissolution acceptance criterion is NLT 80% in 30
minutes
Compare the COA of API from Certificate of analysis of API from finished product
finished product manufacturer with manufacturer and COA of API from supplier are
02 COA of API supplier and justification compared and found that finished product manufacturer
is required for non-performance of test, performed all the tests as mentioned by manufacturer of
if any API on COA of API.
Excipients used by the finished product manufacturer
in finished product manufacturing (Olumijent
Compare the excipients used in
Tablets) and Excipients used in the innovator’s product
finished product manufacturing with
(Olumiant Tablets) are compared and found that both
03 the innovator’s product and
formulations contains same ingredients.
justification required if there is any
Copy of formulation of innovator brand from MHRA
difference
and Excipient detail used in Finished product are
attached.
API used in finished product manufacturing is of
The applied molecule may exist in
Polymorphic form 1.
04 more than 1 polymorphic forms. What
Clarification regarding Polymorphic form from API
polymorphic form is used?
manufacturer is attached.
DML of M/s Zhejiang Hong yuan Pharmaceutical China
Valid GMP/DML of API manufacturer
05 is issued by Zhejiang State food and Drug
is required
administration, China. Valid till 13-01-2024
Comparative Dissolution Profile of Olumijent Tablets
2mg and Olumijent Tablets 4mg is performed in 0.1N
HCl, pH 1.2, Phosphate Buffer pH 6.8 and in Acetate
Buffer pH 4.5 against Innovator Brand Olumiant tablets
Submit the comparative dissolution
06 2mg (Batch No. D384977) and Olumiant Tablets 4mg
profile
(Batch No. D385031) respectively manufactured by Eli
Lilly, Netherlands.
The complete comparative dissolution profile data is
already submitted to DRAP on 09-02-2022.

Case no. 01 Registration applications for local manufacturing of (Human) drugs on Form-5 F
a. New cases
607. Name, address of Applicant / Marketing M/s Aspin Pharma (Pvt.), Ltd Plot No. 10 & 25, Sector 20
Authorization Holder Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Stallion Pharmaceuticals, PVT, LTD
581-Sundar Industrial Estate, Raiwind Road Lahore.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Aspibact 2.25 g Injection
Pharmaceutical ingredient (API) per unit Piperacillin Sodium Equivalent to Piperacillin ………. 2.0
g
Tazobactam Sodium Equivalent to Tazobactam ……….
0.25 g
Pharmaceutical form of applied drug Intravenous Sterile Dry Powder for Injection
Pharmacotherapeutic Group of (API) First Generation Beta Lactam Antibiotics (Penicillin)
The status in reference regulatory authorities Tanzo 2.25 g Injection, USFDA Approved.
For generic drugs (me-too status) Tanzo 2.25 g Injection by M/s Bosch, Reg. No. 039593
manufacturer Sterile Injection (Penicillin and Carbapenem Antibiotics)
section approved.
Name and address of API manufacturer. M/s Shandong / (Previously Qilu Pharmaceuticals Co.
Ltd) Anxin Pharmaceutical Co., Ltd.
849, Dongjia Town, Licheng District, Jinan, Shandong,
China
submitted.
Module III (Drug Substance) Official monograph of Piperacillin/Tazobactam is present

Batches: (P5001, P5002, P5003)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been established against
dissolution profile the brand leader that is Tanzo 4.5 g Injection by M/s Bosch
Pharma by performing quality tests (Identification, Assay
and Uniformity of dosage form).

Manufacturer of API M/s Shandong / (Previously Qilu Pharmaceuticals Co. Ltd)
Anxin Pharmaceutical Co., Ltd.
China
API Lot No. KA1007150016
Description of Pack Glass Vial with rubber stopper sealed with flip off seal and
(Container closure system) packed in unit carton (1×1’s)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. N5001 N5002 N5003
Batch Size 42,50
41,60 vials 63,80 vials
vials
Manufacturing Date 03-
03-2015 04-2015
2015
26-05-2015 12-06-2015
2015
No. of Batches 03
10. Reference of previous approval of applications Pitzo 2.25 g Injection for Healthtek Pharma Karachi.
with stability study data of the firm (if any) Pitzo 4.5 g Injection for Healthtek Pharma Karachi.

11. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 2018001 issued by Shandong
12. Documents for the procurement of API with • Copy of letter No.1612/2015/DRAP-AD-CD(I&E)
approval from DRAP (in case of import). dated 09/02/2015 is submitted wherein the permission
to import different APIs including
Piperacillin/Tazobactam for the purpose of test/analysis
and stability studies is granted.
• DHL No. XL-150202-Z dated 02-04-2015
chromatograms, summary data sheets.
etc.
14. Compliance Record of HPLC software 21CFR Firm has submitted audit trail record of product testing of
& audit trail reports on product testing HPLC for all test intervals.
(real time and accelerated) accelerated stability chambers.
Decision: Approved.
application.
608. Name, address of Applicant / Marketing M/s Aspin Pharma (Pvt.), Ltd
Authorization Holder Plot No. 10 & 25, Sector 20 Korangi Industrial Area,
Karachi.
Name, address of Manufacturing site. M/s Stallion Pharmaceuticals, PVT, LTD
581-Sundar Industrial Estate, Raiwind Road Lahore,
Punjab 54000.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Aspibact 4.5 g Injection
Pharmaceutical ingredient (API) per unit Piperacillin Sodium USP Equivalent to Piperacillin
………. 4.0 g
Tazobactam Sodium USP Equivalent to Tazobactam
………. 0.50 g

Pharmaceutical form of applied drug Intravenous Sterile Dry Powder for Injection
Pharmacotherapeutic Group of (API) First Generation Beta Lactam Antibiotics (Penicillin)
The status in reference regulatory authorities Tanzo 4.5 g Injection, USFDA Approved.
For generic drugs (me-too status) Tanzo 4.5 g Injection by M/s Bosch, Reg. No. 039439
manufacturer Sterile Injection (Penicillin and Carbapenem Antibiotics)
section approved.
Name and address of API manufacturer. M/s Shandong / (Previously Qilu Pharmaceuticals Co.
Ltd) Anxin Pharmaceutical Co., Ltd.
China
submitted.
Module III (Drug Substance) Official monograph of Piperacillin/Tazobactam is present
Batches: (P5001, P5002, P5003)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been established against
dissolution profile the brand leader that is Tanzo 4.5 g Injection by … Bosch
Pharma by performing quality tests (Identification, Assay
and Uniformity of dosage form).

Manufacturer of API M/s Shandong / (Previously Qilu Pharmaceuticals Co. Ltd)
Anxin Pharmaceutical Co., Ltd.
China
API Lot No. KA1007150016
Description of Pack Glass Vial with rubber stopper sealed with flip off seal and
(Container closure system) packed in unit carton (1×1’s)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. P5001 P5002 P5003
Batch Size 8,600
8,600 vials 10,630 vials
vials
Manufacturing Date 03-
03-2015 04-2015
2015
16-04-2015 04-06-2015
2015
No. of Batches 03
16. Reference of previous approval of applications Pitzo 2.25 g Injection for Healthtek Pharma Karachi.
with stability study data of the firm (if any) Pitzo 4.5 g Injection for Healthtek Pharma Karachi.
Mopen 500 mg Injection for Healthtek Pharma Karachi.
Mopen 1 g Injection for Healthtek Pharma Karachi.
17. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 2018001 issued by Shandong
18. Documents for the procurement of API with • Copy of letter No.1612/2015/DRAP-AD-CD(I&E)
approval from DRAP (in case of import). dated 09/02/2015 is submitted wherein the permission
to import different APIs including
Piperacillin/Tazobactam for the purpose of test/analysis
and stability studies is granted.
• DHL No. XL-150202-Z dated 02-04-2015
chromatograms, summary data sheets.
etc.
20. Compliance Record of HPLC software 21CFR Firm has submitted audit trail record of product testing of
& audit trail reports on product testing HPLC for all test intervals. We also have alliance HPLC
waters having refrigerated auto sampler. Model e2695
(real time and accelerated) accelerated stability chambers.

Observation response
• Provide copy of Batch Manufacturing BMR of all three batches of drug product for which
Record (BMR) for all the batches of drug product stability studies data is provided now
for which stability studies data is provided in
Module 3 section 3.2.P.8.3
• Copies of the Drug substance Copies of the Drug substance specifications and
specifications and analytical procedures used for analytical procedures used for routine testing of the
routine testing of the Drug substance /Active Drug substance /Active Pharmaceutical Ingredient by
Pharmaceutical Ingredient by Drug Product Drug Product manufacturer has been submitted
• Provide results of analysis of relevant COA, and results of analysis of relevant batch has been
batch(es) of Drug Substance performed by Drug provided.
Product manufacturer used during product
development and stability studies, along with
Certificate of Analysis (CoA) of the same batch
from Drug Substance / /Active Pharmaceutical
Ingredient manufacture.
Long term stability studies data as per Zone IV a Submitted
condition shall be submitted.
• Parameters of Accuracy & Precision have Parameters of Accuracy & Precision have been
not been performed in the submitted analytical performed in the submitted analytical method
method verification studies. verification studies.
Batch analysis certificates have been submitted for Batch analysis certificates of 4.5gm injection is
the strength of 2.25gm injection instead of 4.5gm provided.
injection.
Evidence of HPLC auto sampler. We also have alliance HPLC waters having refrigerated
auto sampler. Model e2695
Decision: Approved.
609. Name, address of Applicant / M/s Genetics Pharmaceuticals Pvt. Ltd.
Marketing Authorization Holder 539-A, Sundar Industrial Estate, Raiwind, Lahore
Contract manufacturing By
M/s Stallion Pharmaceuticals Pvt Ltd.
581-Sundar Industrial Estate, Lahore, Pakistan
Name, address of Manufacturing M/s. Stallion Pharmaceuticals (Pvt.) Ltd 581-Sundar Industrial Estate,
site. Lahore Pakistan
☐ Importer

Dy. No. and date of submission Dy.No 13637 dated 24-05-2021 Rs.50,000/- dated 01-12-2020
Details of fee submitted 2021 Rs.50,000/- dated 01-12-2020
The proposed proprietary name / Auxil 4.5gm Injection
brand name
Strength / concentration of drug of Each vial contains:
Active Pharmaceutical ingredient Piperacillin (as Piperacillin Sodium) ………4g
(API) per unit Tazobactam (as Tazobactam Sodium).......0.50g
Pharmaceutical form of applied Injection
drug
Pharmacotherapeutic Group of Antibiotics
(API) Penicillin: Broad-spectrum β-lactam antibiotic
Tazobactam: Beta-lactamase inhibitor
Reference to Finished product USP Specification

specifications
Proposed Pack size 1’s Vial
Proposed unit price --
The status in reference regulatory Approved in FDA
authorities (ZOSYN 4.5g Injection)
For generic drugs (me-too status) TANZO 4.5g Injection–M/s. Bosch Pharma
GMP status of the Finished product GMP certificate issued based upon inspection conducted in 06-12-
manufacturer 2019
Module-II (Quality Overall Firm has submitted QOS details as per WHO QOS PD template.
Summary)
Name and address of API M/s Shandong (Previously Qilu) Anxin Pharmaceutical Co., Ltd.
manufacturer. 10678 Wenliang Road, Dongjia Town, Licheng District, Jinan,
Shandong, China
Module-II (Quality Overall Firm has summarized information related to nomenclature, structure,
Summary) general properties, solubilities, physical form, manufacturers,
system and stability studies of both drug substances. Firm has
submitted data of drug product including its description, composition,
pharmaceutical development, manufacture, manufacturing process and
process control, process validation protocols, control of excipients,
validation of analytical procedures, batch analysis, justification of
nomenclature, structure, general properties, solubilities, physical form,
impurities, specifications, analytical procedures and its validation,
container closure system and stability studies of both drug substances.
Stability Studies of Drug Substance Firm has submitted accelerated and real time stability data of 3 batches
(Conditions & duration of Stability of API as per Zone IVA.
studies)

Pharmaceutical Equivalence and Firm has also submitted results of Pharmaceutical equivalence and
Comparative Dissolution Profile comparative dissolution profile of their product with the in Tanzo of
M/s Bosch Pharma novator product
Analytical method Firm has submitted report of validation of analytical method for the
validation/verification of product drug product.
Manufacturer of API M/s Shandong (Previously Qilu) Anxin Pharmaceutical Co., Ltd.
API Lot No. TSP12001517N
Description of Pack
USP Type III Colorless Glass Vials
Frequency Accelerated: 0, 1, 2, 3, 4, 5, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. P5001 P5002 P5003
No. of Batches 03
1. Reference of previous approval ofPitzo 2.25 g Injection for Healthtek Pharma Karachi.
applications with stability study data
Pitzo 4.5 g Injection for Healthtek Pharma Karachi.
of the firm (if any) Approved In 308meeting
2. Approval of API/ DML/GMP M/s Shandong (Previously Qilu) Anxin Pharmaceutical Co., Ltd.
certificate of API manufacturer 10678 Wenliang Road, Dongjia Town, Licheng District, Jinan,
issued by concerned regulatory Shandong, China has USFDA Drug establishment registration site and
authority of country of origin. is valid upto 31/2021.
The firm also has DML number 20160009 valid until 2025 issued by
Shandong Provincial drug administration China.
3. Documents for the procurement of Firm has submitted copy of invoice (invoice # NLLA/16/1424) cleared
API with approval from DRAP (in by DRAP Lahore office dated 03-04-2017 specifying import 100 Kg
case of import). Tazobactam Sodium (Batch # TSP12001517N)
4. Data of stability batches will be Firm has submitted complete record of testing of all batches along with
supported by attested respective chromatograms, raw data sheets, COA and summary data sheets.
data sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC Firm has submitted audit trail record of product testing of HPLC for all
software 21CFR & audit trail reports test intervals.
on product testing

temperature and humidity monitoring humidity monitoring of real time and accelerated stability chambers.
accelerated)
Observation, Evaluator-VI response

• Provide copy of Batch Manufacturing BMR of all three batches of drug product for which
Record (BMR) for all the batches of drug stability studies data is provided now
provided in Module 3 section 3.2.P.8.3
• Copies of the Drug substance Copies of the Drug substance specifications and analytical
specifications and analytical procedures used for procedures used for routine testing of the Drug substance
routine testing of the Drug substance /Active /Active Pharmaceutical Ingredient by Drug Product
Pharmaceutical Ingredient by Drug Product manufacturer has been submitted
• Provide results of analysis of relevant COA, and results of analysis of relevant batch has been
batch(es) of Drug Substance performed by Drug provided.
Product manufacturer used during product
development and stability studies, along with
Certificate of Analysis (CoA) of the same batch
from Drug Substance / /Active Pharmaceutical
Long term stability studies data as per Zone IV a Submitted
condition shall be submitted.
• Parameters of Accuracy & Precision Parameters of Accuracy & Precision have been performed
have not been performed in the submitted in the submitted analytical method verification studies.
analytical method verification studies.
Batch analysis certificates have been submitted Batch analysis certificates of 4.5gm injection is provided.
for the strength of 2.25gm injection instead of
4.5gm injection.
Evidence of HPLC auto sampler. We also have alliance HPLC waters having refrigerated
auto sampler. Model e2695
Decision: Approved.
610. M/s Axis Pharmaceuticals

Name, address of Applicant / Marketing
3-B Value Addition City, 1.5 Km Khurrianwala – Sahianwala
Road, Faisalabad – Pakistan
M/s Axis Pharmaceuticals
Name, address of Manufacturing site. 3-B Value Addition City, 1.5 Km Khurrianwala – Sahianwala
☒ Manufacturer
Status of the applicant ☐ Importer
Firm has provided GMP certificate issued on dated 06-07-
GMP status of the firm
2020.
Evidence of approval of manufacturing Firm has provided approval letter for the grant of Topical Semi-
facility Solid Section dated 20-07-2020.
☐ New Drug Product (NDP)
Status of application

☐ Domestic sale
Intended use of pharmaceutical product ☐ Export sale
Dy. No. and date of submission Form-5F, Dy. No. 19876, 15-7-2021
Details of fee submitted PKR 30,000/-: 25-06-2021 (deposit slip # 59181312924)
The proposed proprietary name / brand name Femecare – H Cream
Each gram contains:
Strength / concentration of drug of Active
Clotrimazole…………………. 10mg 1%w/w
Pharmaceutical ingredient (API) per unit
Hydrocortisone (as Acetate) … 10mg 1%w/w
Pharmaceutical form of applied drug White to Off-white homogenous cream.
Pharmacotherapeutic Group of (API) Antifungals (imidazole derivatives), combinations.
Reference to Finished product specifications BP specification
Proposed Pack size 20 grams, 15 grams, 10 grams
The status in reference regulatory authorities Hydrozole Cream (TGA approved).
For generic drugs (me-too status) Hydrozole Cream by GSK (Reg. # 029329).
Clotrimazole:
M/s Srikem Laboratories Pvt. Ltd.
Plot No. 17/24, 17/22,17/23,17/13, M.I.D.C. Taloja – 410
208. Navi Mumbai. INDIA
Name and address of API manufacturer.
Hydrocortisone Acetate:
M/s Zhejiang Xianju Pharmaceutical Co. Ltd.
Address: No.3 Donghai Fourth Avenue, Duqiao Medical &
Chemical Industry Zone, Linhai Zhejiang, 317016, China.
Module-II (Quality Overall Summary)
Firm has submitted detailed drug substance data related to
Module-III Drug Substance:
Firm has submitted validation studies of analytical method for
the testing of drug substance.
Firm has submitted stability study data of 3 batches of API at
Stability Studies of Drug Substance
accelerated and real time conditions. The real time stability
(Conditions & duration of Stability studies)
data is conducted as per zone IV-A conditions
Firm has submitted relevant information against the Module-
Module-III Drug Product: III, including Batch Manufacturing Record, Process Validation
Protocol, Finished product Analytical Method Validation
Report & Stability Studies Data.
Firm has submitted results of pharmaceutical equivalence for
all the quality tests for their product as per specification and
Dissolution Profile
comparative study against the comparator product i.e.
Hydrozole by M/s GSK.
Analytical method validation/verification of
Firm has submitted report of validation of analytical method
product
for the drug product.
Firm has submitted stability data of three batches at both
Stability Studies
accelerated and long-term conditions.
Clotrimazole:
Manufacturer of API
Srikem Laboratories Pvt. Ltd.

Plot No. 17/24, 17/22,17/23,17/13, M.I.D.C. Taloja – 410
208. Navi Mumbai. INDIA
Hydrocortisone Acetate:
Zhejiang Xianju Pharmaceutical Co. Ltd.
Address: No.3 Donghai Fourth Avenue, Duqiao Medical &
Chemical Industry Zone, Linhai Zhejiang, 317016, China.
Clotrimazole: 195002019 (QC#: RT-39/20)
API Lot No.
Hydrocortisone Acetate: 04.1222-190605 (QC#: R-126/20)
Description of Pack
Alu - tubes
Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. T-002 T-003 T-004
Batch Size 1.0 Kg 1.5 Kg 1.5 Kg
04 –
Manufacturing Date 04 – 2020 04 – 2020
2020
REQUEST OF EXEMPTION FROM ON-SITE INSPECTION
Product approved in 297th Meeting of Registration Board.
• Femecare Vaginal Cream 2%w/w
Reference of previous approval of applications • Silvixis Cream 1%w/w
with stability study data of the firm (if any) • Clobetanate Cream 0.05%w/w
• Axifen Gel 1%w/w
• Oricam Gel 0.5%w/w
Clotrimazole:
The firm has submitted copy of GMP Certificate of M/s Srikem
Approval of API/ DML/GMP certificate of API Laboratories issued from FDA maharashtar state india. The
manufacturer issued by concerned regulatory certificate is valid till 11-03-2023.
authority of country of origin. Hydrocortisone Acetate:
The firm has submitted copy of COPP of M/s Zhejiang Xianju
Pharmaceutical Co. Ltd issued from Zhejiang Medical Product
Administration. The certificate is valid till 23-03-2023.
The firm has submitted copy of attested commercial invoice by
Documents for the procurement of API with
AD (I&E) DRAP field office dated 10-08-2020 specifying import
of 0.225 Kg of Hydrocortisone Acetate and on 27-06-2019
specifying import of 75.0 Kg of Clotrimazole.
Data of stability batches will be supported by
Firm has submitted attested copy of complete record of testing of
all batches along with chromatograms, raw data sheets, COA and
summary data sheets.
data sheets etc.
Compliance Record of HPLC software 21CFR &
Record of Digital data logger for temperature and Record of Digital data logger for temperature and humidity
humidity monitoring of stability chambers (real monitoring of stability chambers (real time and accelerated) is
time and accelerated) submitted.
Short coming, Evaluator-VI Replies
Ingredients are similar to the Innovator product i.e. Hydrozole
• 2.3.P.2.1.1; 3.2.P.2. The excipients that
(TGA Approved) except Polysorbate 80. The said ingredient is
are different from the one present in
not novel, and is routinely used in development of topical
innovator product, compatibility studies of
dosage form. Compatibility studies are performed and is
drug substance with excipient shall be
submitted

provided for those excipients which are
different from reference product
Decision: Approved.
application.

611. Name, address of Applicant / M/s AGP Limited
Marketing Authorization Holder B-23-C, S.I.T.E., Karachi
Name, address of Manufacturing site. M/s AGP Limited
B-23-C, S.I.T.E., Karachi
☐ Importer
☒Generic Drug Product (GDP)
☐ Export sale
Dy. No. and date of submission Dy.No 20777 dated: 30th July 2021
Details of fee submitted PKR 30,000/-: dated: 24th May 2021
Rigix Oral Solution (Strawberry flavor)
name
Strength / concentration of drug of Each 5ml contains:
Active Pharmaceutical ingredient Cetirizine HCl………….5mg
(API) per unit
Pharmaceutical form of applied drug Clear colorless liquid with characteristic strawberry flavor and
odor.
Pharmacotherapeutic Group of (API) Antihistamine for systemic use
Reference to Finished product BP Specification
specifications Shelf life claimed is 24months.
Proposed Pack size 60ml and 120ml
Proposed unit price Rs. 78.09/- for 60ml
Rs. 124.17/- for 120ml
The status in reference regulatory Cetirizine Hydrochloride 5mg/5ml by Chain Drug Consortium
authorities LLC (Premier Value), USA,
USFDA Approved.
For generic drugs (me-too status) Zyrtec 5mg/5ml Oral Solution by
M/s GlaxoSmithKline. Reg. No. 016937
GMP status of the Finished product Renewal of DML on 30th June2020. Firm has oral liquid (general)
manufacturer section.
Name and address of API Cetirizine Hydrochloride:
manufacturer. M/s PRAVEEN LABORATORIES PVT. LTD, India,
Block No. 206, Village: Jolwa, Taluka: Palsana Dist.: Surat,
Gujarat, INDIA.

Module III (Drug Substance) Official monograph of Cetirizine Hydrochloride is present in BP.
properties, Solubilities, physical form, manufacturers, description
of manufacturing process and controls, tests for impurity & related
substances, specifications, analytical procedures and its
of drug substance
Stability studies API Stability study conditions:
: 25°C ± 2°C / 60% ± 5%RH for 60 months
30°C ± 2°C / 65% ± 5%RH for 60 months
analytical procedure and its verification studies, batch analysis and
Pharmaceutical equivalence and Pharmaceutical Equivalence is carried on with Zyrtec Oral
comparative dissolution profile Solution manufactured by GSK pakistan
Analytical method Method verification studies have submitted including System
validation/verification of product suitability, accuracy, precision, specificity, Limit of detection,
Limit of quantification.
Manufacturer of API Cetirizine Hydrochloride:
M/s PRAVEEN LABORATORIES PVT. LTD, India,
Block No. 206, Village: Jolwa, Taluka: Palsana Dist.: Surat, Gujarat, INDIA.
API Lot No. Cetirizine Hydrochloride:
MK40119136, MK40119137, MK40119138 & MK40119139
Description of Pack Amber glass bottle with ALU fitted with wad. Each bottle is packed in printed
(Container closure system) carton.
Intermediate: 30°C ± 2°C / 65% ± 5%RH
Intermediate: 6 months
Intermediate: 3, 6, 9, 12 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch Size 4.0 L 4.0 L 4.0 L
No. of Batches 03
1. Reference of previous approval of The board approved Glyzia-XR Tablet 50/500m of M/s AGP
applications with stability study data of limited B-23, SITE, Karachi in 285th meting held in October 2018.
the firm (if any) As per minutes, HPLC is 21 CFR compliant and have audit trails.

2. Approval of API/ DML/GMP Cetirizine Hydrochloride: Copy of GMP certificate No. S-
certificate of API manufacturer issued GMP/21092927 issued by Food and Drug Control Administration,
by concerned regulatory authority of India, valid till 09th Oct 2023.
country of origin.
3. Documents for the procurement of API ADC Attested Karachi invoice no Ex/060 date 1-1-2020
import).
4. Data of stability batches will be Data of 3 batches of 4 liter each with raw data sheets, COA, and
supported by attested respective chromatograms have been submitted.
etc.
5. Compliance Record of HPLC software Compliance Record of HPLC software 21CFR & audit trail
21CFR & audit trail reports on product reports on product testing was submitted
testing
6. Record of Digital data logger for Record of Digital data logger for temperature and humidity
temperature and humidity monitoring monitoring of stability chambers (real time and accelerated) was
of stability chambers (real time and submitted
accelerated)
Short coming, Replies
a) 2.3.P.8/ 3.2.P.8 Stability. The storage The Rigix oral solution (Cherry flavour) is also a brand of
condition “Do not store above 25C ” does innovator purchased by AGP few years back. The storage
not meet zone IV a condition. Please temperature conditions of Rigix oral solution (Cherry Flavour) is
Justify. “Do not store above 25℃. Therefore, we have conducted the
stability studies of Rigix Oral solution (Strawberry Flavour) at
30+- 2℃ / 65+-5% RH (real time for 12 months at initial, 6, 9th
and 12month.) of 3 batches.
40+- 2℃ / 75+-5% RH (Accelerated for 6months) of 3 batches.
b) Approval of valid API/ DML/GMP The other brand of innovators “Zyrtec” in USA has also the same
certificate of API manufacturer issued by storage condition i.e. Between 20 ℃ to 25 ℃.
concerned regulatory authority of country We hereby revise the storage condition as “Store below 30’C.” The
of origin is required. firm did not submit fee for correction.
The me-too product Zyrtec by GSK Pakistan has storage condition
“Do not store above 30’C.
Valid copy of GMP certificate of API manufacturer i.e. M/s
PRAVEEN LABORATORIES PVT. LTD, India,
Block No. 206, Village: Jolwa, Taluka: Palsana Dist.: Surat,
Gujarat, INDIA. valid till 19-9-2023. Certificate is issued b Food
and Drug Control Administration.
Decision: Deferred for justification of not performing long term stability studies testing at 3 rd month time
point.

b. Deferred cases
612. M/s Axis Pharmaceuticals
Name, address of Applicant / Marketing
3-B Value Addition City, 1.5 Km Khurrianwala – Sahianwala
M/s Axis Pharmaceuticals
Name, address of Manufacturing site. 3-B Value Addition City, 1.5 Km Khurrianwala – Sahianwala
☒ Manufacturer
Status of the applicant ☐ Importer
Firm has provided GMP certificate issued on dated 09-06-
GMP status of the firm
2020.
Firm has provided approval letter for the grant of Topical
Evidence of approval of manufacturing facility
Semi-Solid Section dated 20-07-2020.
☐ New Drug Product (NDP)
Status of application
☐ Domestic sale
Intended use of pharmaceutical product ☐ Export sale
Dy. No. and date of submission Form-5F Dy. No. 15757, 7-6-2021
Details of fee submitted PKR 20,000/-: 17-03-2021 (deposit slip # 1995689)
The proposed proprietary name / brand name Loxicaine Jelly 2%w/v
Strength / concentration of drug of Active Each mL contains:
Pharmaceutical ingredient (API) per unit Lidocaine Hydrochloride … 20mg
Pharmaceutical form of applied drug Clear, translucent homogenous gel.
Pharmacotherapeutic Group of (API) Topical Anesthetic.
Proposed Pack size 15 grams
The status in reference regulatory authorities Xylocaine Jelly (USFDA approved).
For generic drugs (me-too status) Xylocaine Jelly by Barrette Hodgson (Reg. # 009315).
GUFIC Biosciences Ltd.
Name and address of API manufacturer. National Highway No. 08, near Grid, AT&PO, Kabilpore, 396
– 424 Navasari, Gujrat, India.
Module-II (Quality Overall Summary)
Firm has submitted detailed drug substance data related to
Module-III Drug Substance:
Firm has submitted validation studies of analytical method for
the testing of drug substance.
Firm has submitted stability study data of 3 batches of API at
Stability Studies of Drug Substance
accelerated and real time conditions. The real time stability
(Conditions & duration of Stability studies)
data is conducted as per zone IV-A conditions
Firm has submitted relevant information against the Module-
Module-III Drug Product: III, including Batch Manufacturing Record, Process
Validation Protocol, Finished product Analytical Method
Validation Report & Stability Studies Data.

Firm has submitted results of pharmaceutical equivalence for
all the quality tests for their product as per specification and
Dissolution Profile
comparative study against the comparator product i.e.
Xylocaine Jelly by Barrette Hodgson.
Analytical method validation/verification of Firm has submitted report of verification of analytical method
product for the drug product.
Firm has submitted stability data of three batches at both
Stability Studies
GUFIC Biosciences Ltd.
Manufacturer of API National Highway No. 08, near Grid, AT&PO, Kabilpore, 396
– 424 Navasari, Gujrat, India.
API Lot No. B#: 2638 (QC#: R-428/19)
Description of Pack
Alu - tubes
Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. T-004 T-005 T-006
Batch Size 1.0 Kg 1.5 Kg 1.5 Kg
10 –
Manufacturing Date 10 – 2020 10 – 2020
2020
REQUEST OF EXEMPTION FROM ON-SITE INSPECTION
Product approved in 297th Meeting of Registration Board.
• Femecare Vaginal Cream 2%w/w
Reference of previous approval of applications • Silvixis Cream 1%w/w
with stability study data of the firm (if any) • Clobetanate Cream 0.05%w/w
• Axifen Gel 1%w/w
• Oricam Gel 0.5%w/w
Approval of API/ DML/GMP certificate of API
The firm has submitted copy of GMP Certificate of GUFIC
Biosciences Ltd.
The certificate is valid till 06-08-2022.
Documents for the procurement of API with The firm has submitted copy of attested commercial invoice
approval from DRAP (in case of import). by AD (I&E) DRAP field office dated 03-03-2020 specifying
import of 0.450 Kg of Lidocaine Hydrochloride.
Data of stability batches will be supported by
Firm has submitted attested copy of complete record of testing
of all batches along with chromatograms, raw data sheets,
COA and summary data sheets.
Compliance Record of HPLC software 21CFR
---
Record of Digital data logger for temperature
The digital data logger for temperature and humidity
monitoring of stability chambers has been submitted
Evaluation by PEC(VI):
Sr. # Observations communicated Response by the firm
1 Gels or Jellies are usually clear transparent semisolid

Evidence of approval of respective section
preparations. Both the terminologies are

interchangeable as indicated in the Pharmaceutical text.
Topical section is approved by DRAP.
(Gels(Some time called Jellies) are semi solid systems
consisting of dispersions of small or large molecules in
an aqueous liquid vehicle rendered jelly like by the
addition of a gelling agent)
Ref : Ansel Pharmaceutical Dosage form
2 Valid approval of drug substance DML / GMP Firm has submitted that Valid GMP certificate ( till 06-
of the drug substance / API manufacturer issued 08-2022)
by concerned regulatory authority of country of Copy attached.
origin is required.
3 Discussion on the potential for isomerism and Firm has submitted that no isomers identified or exist in
identification of stereochemistry (e.g. geometric Official Monograph (BP/USP) and DMF from API
isomerism, number of chiral centers and manufacturer.
configurations) is required. Structure of molecule is elucidated by different
analytical technics such as Infrared spectrum, Mass
spectrum, NMR spectrum, elemental analysis,
physiochemical reactions.
4 Summary of studies performed to identify Firm has submitted that Structure of molecule is
potential polymorphic forms (including elucidated by different analytical technics such as
solvates) is required. Infrared spectrum, Mass spectrum, NMR spectrum,
elemental analysis, physiochemical reactions.
5 Justification of Specification:
(A discussion shall be provided on the inclusion
Firm has submitted that the specifications parameters
of certain tests, evolution of tests, analytical
and testing method used for analysis are based on the
procedures and acceptance criteria, and
official monograph (BP/USP).
differences from the officially recognized
compendial standard).
6 API-Excipient Compatibility:
If the qualitative composition of the formulation Firm has submitted that Formulation was developed as
is not similar to innovator / reference product, per innovator product i.e Xylocaine (FDA approved).
the drug-excipient compatibility studies shall be No novel excipients was used in formulation.
provided.
Decision of 312nd : Deferred for consideration on its turn.
M/s Axis Pharmaceutical Pvt. Ltd.

Central Licensing Board in 275th meeting held on 25th June, 2020 approved one 01 additonal section in the name
of M/s Axis Pharmaceuticals Pvt. Ltd. 3-B, Value Additional City, 1.5-Km, Khurrinwala-Sahianwala Road,
Faisalabad.
S No. Section
1 Topical Semisolid (Cream/Ointment/Gel) Section
Following applications have been submitted for registration by the firm.

Section Molecules Products
Topical Semisolid (Cream/Ointment/Gel) Section 10 10
Evaluation by PEC: The firm requested to reconsider our application.
Decision: Approved.

Case no. 02 Registration applications for Import of (Human) drugs on Form-5F
a. New cases
613. Name, address of Applicant / Importer M/s Medical Equipment & System 60/61 FCC, Syed Maratib Ali
Road, Gulberg IV District Lahore, Pakistan
Details of Drug Sale License of License No: 05-352-0065-069537D
importer Address: House No 59-C/III, Gulberg III District Lahore
Address of Godown: NA
Validity: 14-04-2-23
Renewal: Firm has submitted a receipt of renewal but it does not
contain any date
Name and address of marketing M/s Guerbet, BP 57400,F-95943 Roissy CdG Cedex, France
authorization holder (abroad)
Name, address of manufacturer(s) M/s Guertbet, BP 57400,F-95943 Roissy CdG Cedex, France
(Responsible for manufacturing and Batch releasing)
Name of exporting country France
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized copy of CoPP
Freesale certificate, GMP certificate) certificate (No. 034191) dated 23-06-2020 issued CCI PARIS ILE-
DE-FRANCE for Lipiodol Ultra Fluide(480mg I/ml) solution
injectable . The CoPP confirms free sale status of the product in
exporting country as well as GMP status of the manufacturing site
through periodic inspection every year.
France. Furthermore the CoPP was valid till 22-06-2022.
Details of letter of authorization / sole Firm has submitted copy of letter of distribution certificate from.
agency agreement The letter species that the manufacturer appoints M/s Medical
Equipment & System register their products in Pakistan. The
authorization letter is valid till 11-04-2023.
☒ Importer
☐ Export sale
Dy. No. and date of submission Form-5F Dy. No. 22519: 1-07-2021
The proposed proprietary name / brand LIPIODOL Injection 10ml
name
Strength / concentration of drug of Active Each 10ml of ampoule contains:4800mg of iodine
Pharmaceutical ingredient (API) per unit Lipiodol in the form of ethyl ester of iodised fatty acids of poppy
seed oil contains 48% w/v 480mg of iodine per ml)
Pharmaceutical form of applied drug White lyophilized mass packed in moulded amber type-I vials.
Pharmacotherapeutic Group of (API) Non-water-soluble x-ray contrast media

specifications
The status in reference regulatory Injection (USFDA Approved).
authorities
For generic drugs (me-too status) Not applicable as it is an innovator product
Name, address of drug substance Manufacture: M/s SIMAFEX
manufacturer Address: 16 avenue des Fours a Chauz MARANS, 17230 France
drug substance.
(Conditions & duration of Stability accelerated as well as real time conditions. The real time stability
studies) data is conducted at 5oC ± 3oC. The stability study data is till 36
months.
Pharmaceutical Equivalence and Not submitted as The product is innovator.
Analytical method validation/verification Firm has submitted analytical method validation studies for the
of product applied product.
Container closure system of the drug USP type-I glass
product
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches The accelerated
life and storage conditions stability study data is conducted at 40oC ±2oC / 75% ± 5% RH for
6 months. The real time stability study data is conducted at 30oC
±2oC / 75% ± 5% RH. The real time stability study data of 2 batches
is for 12 months while the stability study data for 3rd batch is for 9
months only.
Evaluation by PEC VI:
Sr no Short coming Reply
1 • Different API and finish product
manufacturers are written in your

application. Please specify the one The firm has submitted valid GMP certificate of M/s Guerbet
which is actually manufacturing API 16-24 rue Jean Chaptal, Aulnay Sous Bois, 93600, France
and finish product. Also submit valid issued by EudraGMP. Valid till 2024
GMP certificate of both manufacturers. The firm has submitted valid GMP certificate of M/s Simafex
16, Avenue des Fours a Chaux, Marans, 1720, France issued
by EudraGMP. Valid till 2024
2 • Letter of authorization/agreement is Similar product was considered in M-291st meeting in
required clearly showing the validity. September 2019 from
Applicant: M/s A & Z Health Services. Suit No. 2, Block 27,

Industrial &
Trade Center, G-9/4, Islamabad, Pakistan.”
MAH: M/s Guerbet BP 57400, F-95943, Roissy CdG
CEDEX"
Brand name: Lipiodol Ultra-Fluide (480mg I/ml) Solution for
Injection
3 • 3.2.S.4 Control of Drug Substance
/3.2.P.5 Control of Drug Product. You
are following In-house specifications,
although the product is present in
pharmacopoeia. Justification is
required.

Decision: Deferred for clarification regarding sole agency agreement of applied product since same product
was considered in 291st meeting of Registration Board from applicant M/s A & Z Health Services. Suit No. 2,
Block 27, Industrial & Trade Center, G-9/4, Islamabad, Pakistan.”
b. Deferred cases
Case no. 01 Registration applications for local manufacturing of (Human) drugs on Form-5
c. New cases
614. Name and address of M/s Wilshire Laboratories Pvt. Ltd. 124/1, Quaid-e-Azam
manufacturer/Applicant Industrial Estate, Kot Lakhpat, Lahore
Brand Name + Dosage Form + Strength Famid 40mg/4ml Injection
Famotidine………………………40mg
Diary No. Date of R& I & fee Dy. No 52 dated 14-1-2015 Rs. 8000/- dated 06-06-2011, Rs.
12,000/- dated 14-01-2015
Pharmacological Group H2 blockers
Type of Form Form-5
Pack size & Demanded Price 40mg/4ml , 20mg/2ml, As per SRO
Approval status of product in Reference Pepcid Injection by M/s Merck & Co. INC (FDA Approved)
Me-too status FAMOT-40 Injection by M/s Shaigan Pharmaceuticals (Pvt) Ltd
GMP status Last GMP inspection was conducted on 08-08-2019 and the report
concludes satisfactory level of GMP
compliance. GMP Certificate has been issued with
validity of 3 years.
Evaluation by PEC-VI Firm has initially applied pack sizes in 2ml, and 4ml. Now firm
submitted for pack size in 4ml only.
Fee challans are duplicate.
authorities/agencies which were declared/approved by the Registration Board.
615. Name and address of manufacturer / M/s Benson Pharmaceuticals Pvt Ltd.
Applicant Plot # 119, Street #8, Sector I-10/3, Industrial Triangle, Islamabad
Brand Name +Dosage Form + Strength Foliben 5mg Tablets
Folic Acid…5mg
Pharmacological Group Foli acid derivative ATC Code B03BB01
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per PRC
Approval status of product in Reference MHRA Approved

Me-too status Folimic tablet 5mg by M/s Alliance Pharma
Decision:
GMP status Inspection date 11-08-2020, of M/s Benson Pharmaceuticals, Plot
no 3,main road, RCCI, National Industrial zone, rawat, Rawalpindi,
The firm is complying good level of GMP.
Remarks of Evaluator VI The firm has initially applied from “M/s Benson Pharmaceuticals
Pvt Ltd.Plot # 119, Street #8, Sector I-10/3, Industrial Triangle,
Islamabad ”, now firm has changed the premises on the DML to the
address “M/s Benson Pharmaceuticals, Plot no 3,main road, RCCI,
National Industrial zone, rawat, Rawalpindi” without submission of
fee.

Decision: Approved. Firm shall submit fee of Rs. 30,000 for pre-approval change in manufacturing site
address, vide Notification No.F.7-11/2012 B&A/DRAP dated 07-05-2021.
616. Name and address of manufacturer / M/s Epharm Laboratories.A-40, Road No. 1, S.I.T.E. Super
Applicant Highway Industrial Area, North Karachi
Brand Name +Dosage Form + Strength Ketomine 30mg/ml Injection
Ketorolac Tromethamine…30mg
Pharmacological Group Anti-Inflammatory
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per PRC
Me-too status Toralac Injection 30mg/ml bt M/s Vision Pharma
GMP status 27-4-2017, Overall GMP was satisfactory
Remarks of Evaluator VI Firm was asked why they did not perform terminal sterilization.
Firm has revised the procedure and submitted that now they have
performed terminal sterilization via autoclaving. But they did not
submit fee for correction.
Decision: Deferred for scientific rationale of performing terminal sterilization with reference to
innovator product.
617. Name and address of manufacturer /
M/s Medipak limited 132/1,Industrial Estate, Kot Lakhpat, Lahore
Applicant
Medisol BES
Brand Name +Dosage Form + Strength Balanced Electrolyte Solution
Opthalmic Irrigation Solution.
Diary No. Date of R& I & fee Diary No:19938, 3/11/2017, Rs: 20,000/- Dated 2/11/2017
Each 100 mL containing
sodium chloride …. 0.64g
potassium chloride ..0.075g
Composition calcium chloride dihydrate…0.048g
magnesium chloride hexahydrate 0.03g
sodium acetate trihydrate 0.39g
sodium citrate dihydrate…0.17g
Pharmacological Group Extraocular and intraocular irrigating solution
Type of Form Form 5
Finished product Specification Mfg.
Pack size & Demanded Price 500 ml LDPE, As per SRO
BSS*
Sterile Irrigating Solution (balanced salt solution)
USFDA Approved
025684; Balanced Salt Solution 500ml
Me-too status
M/s Alza Pharmaceuticals, Islamabad
17-10-2017, Satisfactory. Management was keen to maintain and
GMP status
improve the compliance to highest level.
• Section is present.
Remarks of the Evaluator. • The international availability of the applied formulation is in
polypropylene container whereas, firm has applied for LDPE
container.

Deferred for the following reasons:
• Submission of evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
Previous Decision (M-285):
• Submission of evidence of applied formulation in “LDPE
container” as approved in reference regulatory
authorities/agencies which were adopted by the Registration
Board in its 275th meeting.
Fresh Evaluation:
Firm has submitted that their product is already registered in 10 ml and 250 ml pack size with same formulation
Registration No. 014778 and manufacturing since 1994. The only difference is pack size.
To strengthen the case firm has provided the following:
I. Packaging Design Compatibility with salts and Blow Fill seal Technology.
II. Leachability factor
III. Physical and Chemical Factors
IV. SGS Testing Report
V. Shelf Life Stability Report of 250 ml pack size.
Decision of 288th: Deferred for confirmation from Medical Devices and Medicated Cosmetics Division,
whether applied formulation falls into classification of Medical devices or not as per prevailing rules.
Evaluation by PEC: A letter from MDMC division F.No.12-3/2012-MD states that as per USFDA website,
the above said formulation is registered as drug with three different pharmaceutical companies i.e M/s Akorn,
M/s B.Braun and M/s Alcon. Moreover, the formulation has not been found in GMDN Agency. Hence may
be dealt as drugs.
The product in this pack size and LDPE container closure could not be confirmed in Reference
Decision of 293rd : Deferred for confirming reason for not having pack size and container closure system in
reference regulatory authorities.
Evaluation by PEC VI: The firm has submitted USFDA reference and 6 months accelerated and 24 months real
time stability data in LDPE container.
USFDA Refernece:
“BSS* Sterile Irrigating Solution is a sterile balanced salt solution,
each mL containing sodium chloride (NaCl) 0.64%,
potassium chloride (KCl) 0.075%,
calcium chloride dihydrate (CaCl2•2H2O) 0.048%,
magnesium chloride hexahydrate (MgCl2•6H2O) 0.03%,
sodium acetate trihydrate (C2H3NaO2•3H2O) 0.39%,
sodium citrate dihydrate (C6H5Na3O7•2H2O) 0.17%,
sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5.
The osmolality is approximately 300 mOsm/Kg” Pack Size 500ml
BSS* Sterile Irrigating Solution is supplied in a glass bottle using a grey butyl stopper and aluminum seal
with a blue polypropylene flip-off cap.
BSS* Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and
aluminum seal packaged in a clear, multilayered plastic outer overwrap. 500 mL in a bag
STABILITY STUDY DATA SHEET
A clear and colorless solution free from visible particulate matter in
Description of pack semitransparent low density polyethylene (LDPE) bottles having hanger at
(container closure bottom. LOT/B. No and graduation mark from 100 to 500 ml is embossed Batch Size. 100 Liter
system) on bottle with least count of 100ml. Head of bottle is covered by eurocap
fitted with rubber disc. Bottle is packed in unit carton along with leaflet.
Parameters and tests
As per Product Specifications Mfg. Date Mar-18
mentioned
ACCELERATED STABILITY STUDY DATA:
o o
40 C ± 2 C & 25%RH
± 5% RH

Tests (Physical, Acceptance Criteria
Chemical, Initial 1 month 2 month 3 month 6 month
Microbiological)
Place the bottle on the palm of
hand and check with naked eye and
ensure that solution is clear, 3/26/2018 4/26/2018 5/26/2018 6/26/2018 9/26/2018
colorless free from visible
Appearance of Bottle particulate matter in Complies Complies Complies Complies Complies
semitransparent low density
polyethylene (LDPE) bottles.
Ensure that there should be Hanger
at bottom LOT/B. No and
graduation mark from 100 to 500 ml
is embossed with least count of
100ml.
It should be clear colorless Clear Clear Clear Clear Clear
Clarity of solution solution, free from visible Colorless Colorless Colorless Colorless Colorless
particulate matter Solution Solution Solution Solution Solution
pH 6.5 - 7.5 7.26 7.15 7.09 6.98 6.84
Filled Volume (ml) 500 - 510 ml 506 506 505 505 504
Water Loss (%) NMT 5.0% NA NA NA 0.26 0.45
Identifications
Sodium, Potassium, Should be Positive Positive Positive Positive Positive Positive
Calcium, Magnesium,
Chloride, Acetate &
Nitrate
ASSAY 143.1 - 157.00 157.00 158.00 159.00 160.00
Sodium (159 mmol/L) 174.9
98.74% 98.74% 99.37% 100.00% 100.63%
mmol/L or
90 - 110% of stated amount
9.0 - 9.80 9.80 9.90 9.90 10.00
Potassium (10.0 11.0
98.00% 98.00% 99.00% 99.00% 100.00%
mmol/L) mmol/L
or
118.8 - 129.00 129.00 130.00 130.00 131.00
Chloride (132 mmol/L) 145.2
97.73% 97.73% 98.48% 98.48% 99.24%
mmol/L or
11.7 - 6.40 6.40 6.42 6.42 6.44
Calcium (13 mmol/L) 14.3
98.46% 98.46% 98.77% 98.77% 99.08%
mmol/L
or
5.4 - 3.00 3.00 3.01 3.02 3.04
Magnesium 6.6
(6.0mmol/L) mmol/L 100.00% 100.00% 100.33% 100.67% 101.33%
or
41.4 - 46.00 46.00 45.70 45.40 44.90
Acetate + Citrate 50.6
(46mmol/L) mmol/L 100.00% 100.00% 99.35% 98.70% 97.61%
or

Particulate Max 25 0.00 N.A N.A N.A 0.00
Contamination Particles
Particle size ≥ /ml Max 0.00 N.A N.A N.A 0.00
10µ 03
Particle size ≥ 25µ Particles
/ml
Endotoxin < 0.5 EU/ml 0.06 N.A N.A N.A 0.09
Sterility Should be sterile. Passes N.A N.A N.A Passes

REAL TIME STABILITY STUDY DATA:
30oC ± 2oC & 35%RH
± 5% RH
Tests (Physical, Acceptance
Chemical, Criteria Initial 3month 6 month 9 month 12 month 18 month 24 month
Microbiologi
cal) 3/26/2018 6/26/2018 9/26/2018 12/26/2018 3/26/2019 9/26/2019 3/26/2020
Place the
bottle on the Complie
palm of hand s Complie Complie Complie Complie Complie Complie
and check s s s s s s
Appearance of with naked
Bottle eye and
ensure that
solution is
clear,
colorless
free from
visible
particulate
matter in
semitranspar
ent low
density
polyethylene
(LDPE)
bottles.
Ensure that
there should
be Hanger at
bottom.
LOT/B. No
and
graduation
mark from
100 to 500
ml is
embossed
with least
count of
100ml.
It should be Clear Clear Clear Clear Clear Clear Clear
Clarity of solution clear Colorle Colorle Colorle Colorle Colorle Colorle Colorle
colorless ss ss ss ss ss ss ss
solution, free Solution Solution Solution Solution Solution Solution Solution
from visible
particulate
matter
pH 6.5 - 7.5 7.26 7.20 7.13 7.08 7.03 6.92 6.85
Filled Volume (ml) 500 - 510 ml 506 506 506 506 506 506 505
Water Loss (%) NMT 5.0% NA 0.08 0.15 NA 0.28 NA 0.51
Identifications Should be Positive Positive Positive Positive Positive Positive Positive

Sodium, Potassium, Positive
Calcium,
ASSAY 143.1 - 174.9 157.00 157.00 157.00 158.00 158.00 158.00 159.00
Sodium (159 mmol/L or 98.74% 98.74% 98.74% 99.37% 99.37% 99.37% 100.00%
mmol/L)

90 - 110% of
stated amount
9.0 - 11.0 9.80 9.80 9.80 9.80 9.90 9.90 9.90
Potassium (10.0 mmol/L or 98.00% 98.00% 98.00% 98.00% 99.00% 99.00% 99.00%
mmol/L) 90 - 110% of
stated amount
118.8 - 145.2 129.00 129.00 129.00 130.00 130.00 131.00 132
Chloride (132 mmol/L or 97.73% 97.73% 97.73% 98.48% 98.48% 99.24% 100.00%
mmol/L) 90 - 110% of
stated amount
11.7 - 14.3 6.40 6.40 6.40 6.42 6.42 6.44 6.47
Calcium (13 mmol/L or 98.46% 98.46% 98.46% 98.77% 98.77% 99.08% 99.54%
mmol/L) 90 - 110% of
stated amount
5.4 - 6.6 3.00 3.00 3.00 3.01 3.01 3.03 3.03
Magnesium mmol/L or
(6.0mmol/L) 90 - 110% of 100.00 100.00 100.00 100.33% 100.33 101.00 101.00
stated amount % % % % % %
41.4 - 50.6 46.00 46.00 45.80 45.60 45.30 45.20 45.00
Acetate + Citrate mmol/L or
(46mmol/L) 90 - 110% of 100.00 100.00 99.57% 99.13% 98.48% 98.26% 97.83%
stated amount % %
Particulate Max 25 0.00 N.A N.A N.A N.A N.A 0.00
Contamination Particles /ml
Particle size ≥ 10µ Max 03 0.00 N.A N.A N.A N.A N.A 0.00
Particle size ≥ 25µ Particles /ml
Endotoxin < 0.5 EU/ml 0.0600 N.A N.A N.A N.A N.A 0.1
Sterility Should be Passess N.A N.A N.A N.A N.A Passess

sterile.
Decision: Deferred for the confirmation of the regulatory status of innovator product in Reference regulatory
Authorities whether the product falls in medical devices or drug category.
618. Name and address of manufacturer / M/s. Swiss Pharmaceuticals Pvt. Ltd. Ltd. A-159, SITE
Applicant Super Highway, karachi
Brand Name +Dosage Form + Strength Done 4mg Tablet
Composition Each film coated tablet contains
Risperidone……………….4mg
Diary No. Date of R& I & fee Dy. No.12180 ; 23-10-2018; Rs. 20,000/- 23-10-2018
Pharmacological Group Antipsychotic
Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, As per SRO
Approval status of product in Reference Risperidone 4mg Tablet by Accord-UK Ltd
Me-too status Rispron by M/s Martin Dow Pharmaceutical (Pakistan) Ltd,
Regn. No. 036400
GMP status Last inspection report dated 18/10/2018
concludes the GMP compliance as good.
Remarks of Evaluator VI
Decision: Approved. Registration letter will be issued after submission of latest GMP
certificates/Inspection reports conducted within last 3 years.
619. Name and address of manufacturer / M/s. Swiss Pharmaceuticals Pvt. Ltd. A-159, SITE Super
Applicant Highway, karachi
Brand Name +Dosage Form + Strength Talpram 20mg Tablet

Composition Each film coated tablet contains
Escitalopram as Oxalate……………….20mg
Diary No. Date of R& I & fee Dy. No. 12176 ; 23-10-2018; Rs. 20,000/- 23-10-2018
Pharmacological Group Anti-depressive
Form Form 5
Pack size & Demanded Price 14’s, 28’s, As per SRO
Approval status of product in CIPRALEX 20mg film coated tablets by H. Lundbeck A/S.
Reference approved by MHRA
Me-too status Espram by Pharmatec Pakistan (Pvt) Ltd. Regn. No. 057821
GMP status Last inspection report dated 18/10/2018

concludes the GMP compliance as good.
Remarks of Evaluator VI
Decision: Approved. Registration letter will be issued after submission of latest GMP
certificates/Inspection reports conducted within last 3 years.
b. Deferred cases
620. Name and address of manufacturer / M/s. Winbrains Research Laboratories, Plot No. 69/1, Block B,
Applicant Phase I & II, Industrial Estate , Hattar
Brand Name +Dosage Form + Strength Fexobrain Film Coated Tablets 120mg
Fexofenadine HCl….120mg
Diary No. Date of R& I & fee Dy. No. 437, 24-08-2015 , Request for Fee adjustment of Rs.
150,000/- extra paid due to not conveying contract extension
decision of our contract products.
Pharmacological Group H1 Receptor Antagonist
Type of Form Form-5
Pack size & Demanded Price 1x10’s, Alu-Alu Blister, As per SRO
Me-too status Fexo by Hilton Pharma
GMP status Last inspection conducted on 03-02-2017, “DML Renewal and
grant of additional section”.
Remarks of the Evaluator. • Evidence of fee adjustment not provided by the firm.
Decision of 275th: Deferred for evidence of fee adjustment.
Evaluation by PEC VI: Firm has submitted Rs 20,000 dated 20 April 2021 Slip No. 2107777
Decision: Approved
621. Name and address of manufacturer / M/s. Winbrains Research Laboratories, Plot No. 69/1, Block B,
Applicant Phase I & II, Industrial Estate , Hattar
Brand Name +Dosage Form + Strength Savebo Tablets 400mg
Sevelamer HCl…….400 mg
Diary No. Date of R& I & fee Dy. No. 436, 24-08-2015 , Request for Fee adjustment of Rs.
150,000/- extra paid due to not conveying contract extension
decision of our contract products.
Pharmacological Group Phosphate Binding Polymeric Amine
Type of Form Form-5
Finished product Specification Innovator
Pack size & Demanded Price 3x10’s , Alu-Alu Blister, As per SRO

Me-too status Sevela by Hilton
GMP status Last inspection conducted on 03-02-2017, “DML Renewal and
grant of additional section.
Remarks of the Evaluator. • Approved in USFDA & TGA as sevelamer hydrochloride.
Decision of 274th: Deferred for the evidence of adjustment of fee i.e. Rs. 150,000/-provided by Budgets and
Accounts.
Evaluation by PEC VI: Firm has submitted Rs 20,000 dated 20 April 2021 Slip No. 2107776
Decision: Approved.
622. Name, address of Applicant / Marketing M/s ICI Pakistan Limited

Authorization Holder S-33 Hawkes Bay Road, S.I.T.E., Karachi
Name, address of Manufacturing site. M/s NovaMed Pharmaceuticals (Pvt.) Limited,
28-Km Ferozepur Road, Lahore
☐ Importer
(Contract manufacturing agreement between both firms is
provided)
GMP status of the firm ICI Pakistan Limited: The firm is granted GMP certificate based
on inspection conducted on 13.11.2019.
NovaMed Pharmaceuticals (Pvt.) Limited: GMP certificate
issued on the basis of inspection conducted on 22/01/2019.
Evidence of approval of manufacturing Firm has submitted copy of section approval letter dated 08-04-
facility 2006 which specifies Capsule section (Cephalosporin).
☐ Export sale
Dy. No. and date of submission Dy. No. 33920 21-11-2020
The proposed proprietary name / brand ICEF Capsules 400mg
name
Strength / concentration of drug of Active Each capsule Contains:
Pharmaceutical ingredient (API) per unit Cefixime (as trihydrate)………400mg
Pharmaceutical form of applied drug White to off white powder contained in hard gelatin capsule
Pharmacotherapeutic Group of (API) 3rd generation Cephalosporin Antibiotic
Reference to Finished product Manufacturer Specifications
specifications
Proposed unit price Price as fixed by DPC
The status in reference regulatory Cefixime capsule 400mg (MHRA Approved)
authorities
For generic drugs (me-too status) Tysen 400mg Capsule by Himont

Road, Lahore.
summarized information related to nomenclature, structure,
Specifications, analytical procedures and its validation, batch
drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance data related to
drug substance.
(Conditions & duration of Stability substance at both accelerated as well as real time conditions. The
studies) accelerated stability data is conducted at 40°C ± 2°C / 75% ± 5%
± 2°C / 65 ± 5% RH for 36 months.
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical equivalence for all the
Comparative Dissolution Profile quality tests for their product against Cefspan 400mg Capsule.
Firm has submitted results of CDP for their product against Cefspan
400mg Capsule. Firm has tested CDP in three dissolution medium
and the results of f2 factor are within the acceptable limit.
Analytical method validation/verification Firm has submitted verification studies of the drug substance and
of product the drug product.
API Lot No. 00244/040/2020 , 00244/049/2020
Description of Pack
(Container closure system) Alu-alu blister
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH Accelerated: 40°C ± 2°C / 75% ± 5%RH

Frequency Accelerated: 0,1,2, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 13956 14050 14051
Batch Size 100,000 capsule 100,000 capsule 100,000 capsule

Date of Initiation 03-04.2020 20-05-2020 21-05-2020
No. of Batches 03
1. Reference of previous approval of The board granted the approval in 278th meeting held on 29-31 Jan
applications with stability study data of 2018 of Dasvir Tablet 60mg and 90mg.
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificate issued by Additional
of API manufacturer issued by concerned Director DRAP, Lahore dated 11-01-2019. The GMP certificate
regulatory authority of country of origin. was granted based on inspection dated 08-01-2019.
3. Documents for the procurement of API N/A
with approval from DRAP (in case of Material procured locally from Pharmagen
import).
by attested respective documents like with raw data sheets, COA and summary data sheets.
5. Compliance Record of HPLC software Firm has submitted audit trail record of product
21CFR & audit trail reports on product testing of HPLC
testing
6. Record of Digital data logger for Firm has submitted record of digital data logger for temperature
temperature and humidity monitoring of and humidity monitoring of real time and accelerated stability
accelerated)
Evaluation by PEC: The firm has submitted that monograph of Japanese pharmacopoeia confirms test of dissolution
only for cefixime capsule 50mg and 100mg. Dissolution test parameter for cefixime 400mg capsule is not available in
JP. Complete analytical method validation studies of analytical procedure for Icef 400mg capsule performed by the
manufacturer has already been provided. Moreover, our Innovators product Cefspan, Cebosh Caricef still follows
Inhouse specs.
Decision of 308th: Registration Board deferred the case for further deliberation regarding finished product
specifications of applied formulation/strength.
Evaluation by PEC (VI): The firm has requested that as cefixime 400mg capsule is not present in any pharmacopoeia
hence please grant us Innovator’s specifications.
Decision of 312nd : Registration Board deliberated that the product monograph is present in Japanese
pharmacopoeia however the dissolution test in JP specifies only 50mg and 100mg strength while the applied
product is cefixime 200mg capsule. Therefore, the Board deferred the case for further deliberation in
forthcoming meeting.
Evaluation by PEC (VI): The firm has submitted COA of 3 batches i.e. 13956, 14050, 14051 along with raw data
sheets according to the monograph in M-313th.
Decision: Approved with Manufacturer’s specifications notified vide letter No.F.14-1/2022-PEC dated 14th
March 2022.
application.
623. Name and address of manufacturer / M/s Vega Pharmaceuticals (Pvt.) Ltd., Plot No. 4, 30 Km, Multan
Applicant Road, Lahore.
Brand Name +Dosage Form + Strength Atenomax 100mg Tablets

Composition Each Film Coated Tablet contains:-
Atenolol ………..100mg
Type of Form Form 5
Pack size & Demanded Price 14’s; Rs. 130
Me-too status Rocard 100mg Tablets by Rock Pharmaceuticals Laboratories, (Pvt)
Ltd. (Reg. No. 064209)
GMP status Last inspection report dated 17-07-2017 declares good level of
GMP compliance.
Remarks of the Evaluator. In contrary to reference product approved by USFDA & MHRA of
coated tablet
Decision of 274th :
Deferred for clarification of dosage form whether uncoated or film coated.
Evaluation by PEC VI: The firm has provided Health Canada reference for atenolol film coated tablet.
http:/health-products.canada.ca/dpd-bdpp/index-eng.jsp/
Decision: Approved
624. Name and address of manufacturer / M/s Vega Pharmaceuticals (Pvt.) Ltd., Plot No. 4, 30 Km, Multan
Applicant Road, Lahore.
Brand Name +Dosage Form + Strength Atenomax 50mg Tablets
Composition Each Film Coated Tablet contains:-
Atenolol ………..50mg
Type of Form Form 5
Pack size & Demanded Price 14’s; Rs. 85
Me-too status Rocard 50mg Tablets by Rock Pharmaceuticals Laboratories, (Pvt)
Ltd. (Reg. No. 064208)
GMP status Last inspection report dated 17-07-2017 declares good level of
GMP compliance.
Remarks of the Evaluator. In contrary to reference product approved by USFDA & MHRA of
coated tablet
Decision of 274th :
Deferred for clarification of dosage form whether uncoated or film coated.
Evaluation by PEC VI: The firm has provided Health Canada reference for atenolol film coated tablet.
http:/health-products.canada.ca/dpd-bdpp/index-eng.jsp/
Decision: Approved
625. Name and address of manufacturer / M/s Bosch Pharamceuticals, Karachi, Bosch House # 221, Sector
Applicant 23, Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Aaram SR capsule 100mg
Composition Each sustained release capsule contains:
Diclofenac Sodium(as sustained release pellets)….100mg
Pharmacological Group Acetic acid derivative
Type of Form Form-5

Pack size & Demanded Price 20’s, As per PRC
Approval status of product in Reference Rhumalgan XL 100 mg modified-release capsules of (MHRA

Regulatory Authorities. approved)
Me-too status Med-Diclo 100mg Capsules of M/s Meditech Pharmaceuticals
GMP and follow up inspection
Firm is operating at acceptable level of GMP compliance.
Remarks of Evaluator Firm has submitted 2 sources of pellets
a) Vision Pharma Pakistan
b) Peltech Healthcare Pvt Ltd India
COA and Stability studies of both sources are submitted.
Decision of 285th: Deferred for GMP inspection report within the period of last one year. The Board further
advised to refer the case to QA & LT Division to conduct GMP inspection of the firm on priority. The
Board also directed the firm to select one source of pellets.
Evaluation of PEC VI: The firm has submitted GMP report of M/s Bosch Pharmaceuticals Limited, Plot
no 221-223, Sector, Korangi Industrial Area, Karachi dated 2-6-2021, operating at acceptable level of
compliance with good manufacturing practices.
Pellets source is M/s Vision Pharma, Khuta road, Islamabad. Stability studies and COA are provided
GMP of M/s Vision Pharma was issued cGMP certificate and is valid until 10Feb2022.
Decision: Approved
626. Name and address of manufacturer / M/s Bosch Pharamceuticals, Karachi, Bosch House # 221, Sector
Applicant 23, Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Aaram DR capsule 75mg
Composition Each dual release capsule contains:
Diclofenac Sodium(as enteric coated pellets)….25mg
Diclofenac sodium…50mg as sustained release pellets.
Diary No. Date of R& I & fee Dy.No.1443, 23-8-2017 Rs.20000/-
Pharmacological Group Acetic acid derivative
Type of Form Form-5
Pack size & Demanded Price 20’s, As per PRC
Me-too status
GMP status GMP report of M/s Bosch Pharmaceuticals Limited, Plot no
221-223, Sector, Korangi Industrial Area, Karachi dated 2-6-
2021, operating at acceptable level of compliance with good
manufacturing practices.
Remarks of Evaluator VI The firm has submitted
Pellets source is M/s Vision Pharma, Khuta road, Islamabad.
Stability studies and COA are provided.
GMP of M/s Vision Pharma was issued cGMP certificate and is
valid until 10Feb2022.
were declared/approved by the Registration Board.
627. Name and address of manufacturer / M/s. Synchro Pharmaceutic als 77-Industrial Estate, Kot Lakhpat,
Applicant Lahore
Brand Name +Dosage Form + Strength Synfant injection 40 mg /1 ml
Composition Each ml contains
Artemether…….. 40 mg
Diary No. Date of R& I & fee Dy.No.498 Rs.20000/- 26-08- 2016
Pharmacological Group Antimalarials)

Type of Form Form-5
Finished product Specification IP
Pack size & Demanded Price 01mlx10‘s As per SRO
Approval status of product in Reference WHO Approved formulation
Me-too status Paluther Injection Reg 14938
GMP status Liquid Injectable (General) section is available
cGMP certificate has been issued and is valid until 21-1-2023
Remarks of the Evaluator. •
Decision of 262nd : Deferred for 10 molecules per section.
Evaluation by PEC VI:-
Applicant Lahore
Brand Name +Dosage Form + Strength Synfant injection IM 80 mg /1 ml
Composition Each ml contains
Artemether…….. 80 mg
Pharmacological Group Antimalarials)
Type of Form Form-5
Approval status of product in Reference WHO Approved formulation
Me-too status Artesenate Injection REg 72458
nd
Decision of 262 : Deferred for 10 molecules per section.
Decision: Approved.
629. Name and address of manufacturer / M/s. Synchro Pharmaceuticals 77-Industrial Estate, Kot Lakhpat,
Applicant Lahore
Brand Name +Dosage Form + Strength BUCAINE INJECTION 05 MG /10 ml
Composition EACH 1 ML CONTAINS
BUPIVACINE 0.5 MG
Pharmacological Group LOCAL ANAESTHETIC
Type of Form Form-5
nd

Applicant Lahore
Brand Name +Dosage Form + Strength PROFOL INJECTION IV
Composition PROPOFOL 10MG/01ML
Pharmacological Group General ANAESTHETIC
Type of Form Form-5
Pack size & Demanded Price 200MG/20ML
Approval status of product in Reference Diprivan Inj. Propofol 200mg/20ml by M/s Astrazenica UK
Me-too status Diprivan by M/s ICI.
Evaluation by PEC VI:- The applied formulation is not confirmed whether it is in solution, emulsion or
suspension form.
Decision: Deferred for clarification whether the applied product is in solution form, emulsion or
otherwise, along with submission of evidence of approval of requisite manufacturing facility from CLB
and availability of requisite testing facility.
Applicant Lahore
Brand Name +Dosage Form + Strength RANIT INJECTION
Composition RANITIDINE (HCL)50MG/02 ML
Pharmacological Group H2 BLOCKER
Type of Form Form-5
Pack size & Demanded Price 01ml x 05‘s
Approval status of product in Reference Zantac Injection USFDA Approved
Me-too status Ranigen 50mg/2ml Injection
Decision: Deferred due to safety reason as per decision in 294th meeting of Registration Board.
Applicant Lahore
Brand Name +Dosage Form + Strength Transen injection
Composition Tranexamic acid 250mg/05ml
Pharmacological Group Antihaemorrhagi cs.
Type of Form Form-5
Pack size & Demanded Price 10mlx5ml‘s As per SRO
Me-too status Traxacid 250mg/ml Injection

Applicant Lahore
Brand Name +Dosage Form + Strength Roban injection IV
Composition Each Contains: Tropisetron (hcl) ……2mg/02ml
Type of Form Form-5
Finished product Specification Mfg
Pack size & Demanded Price 02ml x 1‘s As per SRO
nd
Applicant Lahore
Brand Name +Dosage Form + Strength Roban injection IV
Composition TROPISETRON (HCL) 05MG/05ML
Type of Form Form-5
Pack size & Demanded Price 05ml x 01‘s As per SRO
Approval status of product in Reference TGA Approved
Me-too status Tropiset Injection by CCL Pharma
nd
Decision: Approved with innovators specifications. Firm shall submit clarification regarding container
closure system, whether ampoule or vial, before issuance of registration letter.
Applicant Lahore
Brand Name +Dosage Form + Strength Transen injection
Composition TRANEXAMIC ACID 500MG/05ML
Type of Form Form-5
Pack size & Demanded Price 10mlx5ml‘s As per SRO
Approval status of product in Reference Tranexamic acid IV Apotex TGA Approved

Me-too status Enxamin Injection 500mg Reg no 52925
Decision: Approved. Firm shall submit clarification regarding container closure system, whether
ampoule or vial, before issuance of registration letter.
636. Name and address of manufacturer / M/s. Focus and Rulz Pharmaceuticals Pvt Ltd, 44-industrial
Applicant Triangle Kahuta Road, islamabad
Brand Name +Dosage Form + Strength Tramadol HCl capsules 50mg
Tramadol HCl….50mg
Diary No. Date of R& I & fee Dy. No. 7-3-2019, Rs 20,000 deposit slip no 0844252, 6-3-2019
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per SRO
Approval status of product in Reference MHRA Approved
Me-too status Acugesic 50mg Capsule by M/s Valor Pharmaceuticals
GMP status GMP certificate issued on 18-3-2019
Remarks of the Evaluator VI. • The dosage form written on challan form is tablet, but the
applied dosage form is capsules. The firm has given an
undertaking on stamp paper stating that it is written
mistakenly as tablet. You are requested to consider the
same fee challan for tramadol capsules 50mg.
Decision: Approved
637. Name and address of manufacturer / M/s Jinnah Pharmaceuticals Pvt Ltd. 13 km, Lahore Road, Multan
Applicant
Brand Name +Dosage Form + Strength J-Lac .3.355g /5ml Syrup
Lactitiol Monohydrate……………3.355g
Diary No. Date of R& I & fee Dy.No 16227 dated 06-03-2019 Rs. 20,000/- 07-03-2019
Pharmacological Group laxative
Type of Form Form-5
Pack size & Demanded Price Rs.180 for 120ml,
Approval status of product in Reference Lactitol Monohydrate by M/s Zambon Schweiz AG
Regulatory Authorities. (Swiss Medica) Switzerland Approved
Me-too status Lacasil By CCL Pharma (Reg. No.070552)
GMP status Last inspection conducted on 17-6-2021, panel recommends the
renewal of DML
Remarks of the Evaluator. • Evidence of fee adjustment is not provided by the firm.
Decision of 275th: Deferred for submission of evidence of availability of HPLC equipped with RI
detector, Source of lactitol, along with stability studies data, GMP certificate of supplier.
Evaluation by PEC VI: Firm has submitted inspection report dated 17-6-2021, stating that RI-detector is
fitted with RI-detector. Source of lactitol is M/s Shandong Lujin biological Technology Co, China.
Stability data and GMP certificate is not submitted.
Decision: Approved with innovators specification subject to submission of GMP certificate/DML and
stability data of lactitol.
638. Name and address of manufacturer / M/s Linta Pharmaceuticals Pvt Ltd. Plot No. 03, Street No S-5,
Applicant National Industrial Zone, Rawat, Islamabad"
Brand Name +Dosage Form + Strength Micolin Oral Gel 2.0% Dakrin, Micono.

Composition "Each gram of Gel Contains: Miconazole Nitrate eq. to
miconazole…20mg"
Diary No. Date of R& I & fee Dy.No 21762 dated 21-06-2018 Rs.20,000/- 21-06-2018 Rs.
5000/- for change of formulation
Pharmacological Group Antifungals For Topical Use D01AC02
Type of Form Form-5
Pack size & Demanded Price As per SRO, Alu tubes of 15g and 30g
Approval status of product in Reference Daktarin (Miconazole nitrate 2% w/w). MHRA Approved
Me-too status 070057 "Mycon Oral Gel Each gm contains: Miconazole as
Nitrate …. 2 % w/w BP .
"ValorPharmaceuticals,124/A,KahutaRoad,Islamabad
GMP status 12-06-2018, GMP Compliant.
Remarks of the Evaluator. • The reference formulation contains miconazole without
nitrate salt
st
Decision of 291 : Deferred for revision of formulation as per the reference product along with submission
of fee for revision of formulation
Evaluation by PEC VI: Firm has submitted as : Micolin Oral Gel 2%
Each gram of gel contains:
Miconazole Nitrate eq to Miconazole….20mg
639. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot no 224, 225/1 sector 23
Applicant korangi Industrial Area Karachi
Brand Name +Dosage Form + Strength Tenovir 300mg tablets
Tenofovir Disoproxil fumarate………300mg
Pharmacological Group Acyclic Nuceotide diester analog of adenosine monophosphate
Type of Form Form-5
Pack size & Demanded Price 1’s, 30’s, As per PRC
Approval status of product in Reference Tenofovir by Teva Pharma
Me-too status Tenofo-B by Getz
GMP status Last GMP inspection of M/s High-Q Pharmaceuticals was
conducted on 19-07-2017 and the report shows grant of GMP
certificate.
Decision of 291st :
Deferred for correction of label claim as per innovator’s product.
Evaluation by PEC VI: Firm has revised formulation as per reference product and submitted as :
Tenofovir Disoproxil Fumarate…..300mg eq to Tenofovir disoproxil fumarate….245mg
They also deposit slip no 50311780097 Rs 7500 dated 3-2-2022
Decision: Approved.
640. Name and address of manufacturer / M/S Medisave Pharmaceuticals Plot No: 578-579
Applicant Sundar Industrial Estate, Sundar Raiwind Road,
Lahore - Pakistan
Diary No. Date of R& I & fee Dy.No 26712-A dated 03-08-2018 Rs.20,000/- 3-08-2018
Brand Name +Dosage Form + Strength Amisave 100mg/2ml Injection (IM/IV)
Amikacin Sulphate…100mg
Pharmacological Group Aminoglycoside

Type of Form Form 5
Pack size & Demanded Price 2ml, As per SRO
Approval status of product in USFDA Approved (Amikacin sulphate eq to amikacin
Reference Regulatory Authorities. ….250mg/2ml)
Me-too status 081056; Ekasin 100mg Injection of M/s Epharm Karachi
GMP status Firm was granted GMP certificate based upon inspection
conducted on 11-12-2017 & 10-01-2018 and recommended for
renewal of DML.
Remarks of the Evaluator. (VI)
Decision 0f 292nd : Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board
Evaluation by PEC: The firm has revised their formulation as
Each 2ml ampoule contains:
Amikacin sulphate eq to amikacin….500mg
This is in line with the RRA product.
Decision 312nd: Approved. Registration board further decided that registration letter will be issued after
submission of applicable fee for revision of equivalency factor in composition as per notification No.F.7-
11/2021-B&A/DRAP dated 13-07-2021.
Evaluation by PEC-VI: It is submitted that by mistake the composition was written as
Whereas the applied composition is
USFDA Approved : Amikacin Sulfate Injection USP, 50 mg/mL (100mg/2mL vial) by M/s Fresenius,
Me-too: Amikacin Injection 100mg/Vial By M/S Care & Cure Marketing, Reg. No. 15780
Decision: Approved with following composition:
641. Name and address of manufacturer / M/S Medisave Pharmaceuticals Plot No: 578-579 Sundar
Applicant Industrial Estate, Sundar Raiwind Road, Lahore - Pakistan
Diary No. Date of R& I & fee Dy.No 26712-E dated 03-08-2018 Rs.20,000/- 3-08-2018
Brand Name +Dosage Form + Strength Ondasave 4mg/5ml Syrup
Composition Each 5ml of Syrup Contains: Ondansetron HCl eq. to
Ondansetron…4mg
Pharmacological Group Antiemetics And Antinauseants A04AA01 Serotonin (5HT3)
antagonists
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml, As per SRO
Approval status of product in Not provided
GMP status 11-12-2017 & 10-01-2018. GMP Certificate issued on 15-03-2018
Remarks of the Evaluator. (VI) Firm has oral liquid section.

nd
Decision 0f 292 : Deferred for the following reasons:
• Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along with
• Evidence of approval of applied formulation in reference regulatory authorities/agencies which were
adopted by the Registration Board.
Evaluation by PEC(VI): The firm has revised their formulation as
Each 5ml oral solution contains:

Desloratadine…2.5mg
This is inline with the RRA product i.e ZOFRAN 4mg/5ml oral solution USFDA Approved
Me too:- Ondan syrup 4mg/5ml by M/s Bio-mark Pharma (Reg#082628)
Decision 312nd : Approved with innovator’s specification*.
*Firm shall submit the required fee for the change in label claim before issuance of registration letter.
Evaluation by PEC-VI: It is submitted that by mistake the composition was written as
Each 5ml oral solution contains:
Desloratadine…2.5mg
Whereas the applied composition is
Each 5ml of oral solution contains:
Ondansetron HCl dihydrate eq. to Ondansetron…4mg
USFDA Approved : ZOFRAN® (ondansetron hydrochloride dihydrate) 4 mg/5ml oral solution, USFDA
approved
Me-too: Anomed 4mg/5ml Oral Solution, Allmed (Pvt) Ltd., Reg. No. 098256.
Decision: Approved with following composition:
Each 5ml of oral solution contains:
Ondansetron HCl dihydrate eq. to Ondansetron…4mg
Case no. 08 Miscellaneous cases/Priority cases
29-10-2021/Shortage Molecule Via Letter No. 05-12/2021 I & E Dated 16th August,2021 in 111th Meeting of
Authority
642. Name, address of Applicant / Importer M/s Al-Habib Pharmaceuticals, Plot #81, block B,
SMCHS, Karachi.
Address: M/s Al-Habib Pharmaceuticals, 81-B, block B,
SMCHS, Karachi.
Godown:
1. Plot No. 10 sector 25 KIA, Karachi
12-10-2021 issued by National Institute of Drugs,
WHO-GMP.
agreement whereby M/s M/s Laboratorios IMA S.A.I.C, authorizes
M/s Al-Habib Pharmaceuticals to Import and
commercialize different products including Fulvestrant
250mg injection
☒ Importer

☐ Export sale
☐ Buk import and local repackaging for export purpose
only
Dy. No. and date of submission Dy.No 24354 dated 03-09-2021 Rs.150,000/- dated 26-08-
2021
The proposed proprietary name / brand name FULL V
Pharmaceutical ingredient (API) per unit Fulvestrant ……………. 250mg
Pharmaceutical form of applied drug Injection
Pharmacotherapeutic Group of (API) Anti-Cancer (L02BA03 (WHO)
Proposed Pack size 2 vials of 250mg with 2 syringes
The status in reference regulatory authorities FASLODEX ® Fulvestrant 250 mg injection (USFDA
Approved) by AstraZeneca labs
For generic drugs (me-too status)
Name, address of drug substance manufacturer M/s ScinoPharm Taiwan, Ltd. (SPT)
No.1, Nan-Ke 8th Road
Shan-Hua, Tainan 74144
Taiwan
stability data is conducted at 5°C ± 3°C. The stability study

Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence has been established against
Dissolution Profile the reference product FASLODEX ® Fulvestrant 250 mg
injection by AstraZeneca labs.
Analytical method validation/verification of Firm has submitted analytical method validation studies
product for the applied product.
Container closure system of the drug product Glass containers: Type I, colorless glass vial 10ml
Stoppers: Plain plug 20 mm
Flip-off seals: Seal flip off 20 mm White
Stability study data of drug product, shelf life Firm has submitted stability study data of 3 batches 24
and storage conditions months real time stability data at 2 ° C - 8 ° C of 03 batches
06 month accelerated stability data 25 ± 2 ºC; HR 60 ± 5%.
of 03 batches
facility.
Karachi.
SMCHS, Karachi.
Godown:
30-10-2021 issued by National Institute of Drugs,
WHO-GMP.
agreement whereby M/s Laboratorios IMA S.A.I.C, authorizes M/s Al-
Habib Pharmaceuticals to Import and commercialize
different products including Azacitidine 100mg injection.
☒ Importer

☐ Export sale
☐ Buk import and local repackaging for export purpose
only
Dy. No. and date of submission Dy.No 24855 dated 08-09-2021 Rs.150,000/- dated 26-08-
2021
The proposed proprietary name / brand name AZZA (Azacitidine) (lyophilized powder for injection)
Strength / concentration of drug of Active Each Vial (lyophilized powder for injection) contains:
Pharmaceutical ingredient (API) per unit Azacitidine……………. 100 mg
Pharmacotherapeutic Group of (API) Anti-Cancer (L01BC07)
Proposed Pack size 1 Vial

The status in reference regulatory authorities VIDAZA® Azacitidine 100mg injection (USFDA
Approved) by Celgene Corporation
Name, address of drug substance manufacturer M/s ScinoPharm Taiwan, Ltd. (SPT)
No.1, Nan-Ke 8th Road
Shan-Hua, Tainan 74144
Taiwan
stability data is conducted at 30 ± 2°C/75±5%RH. The
stability study data is till 60 months. And accelearated
studies for 6 months at 40, 75

Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence has been established against
Dissolution Profile the reference product VIDAZA® Azacitidine 100 mg
injection by Celgene Corporation.
Container closure system of the drug product Type I, colorless glass vial
Bromobutyl elastomeric stopper
Seal Aluminum seal
Stability study data of drug product, shelf life Firm has submitted stability study data of 3 batches 24
and storage conditions months’ real time stability data at 30 ± 2 ºC; HR 75 ± 5%.
of 03 batches
06 month accelerated stability data 40 ± 2 ºC; HR 75 ± 5%.
of 03 batches
Sr Short coming Replies
no
1 3.2.S.4.1 & 2 Drug Substance specifications and The firm has submitted Drug Substance
analytical procedures by Drug Substance and Drug specifications and analytical procedures by Drug
Product Manufacturer both. Substance and Drug Product Manufacture
2 3.2.S.4.3 Analytical Method verification by Drug Analytical Method verification by Drug Substance
Substance and Drug Product Manufacturer both and Drug Product Manufacturer both (Accuracy,
(Accuracy, Specificity & Method precision): Specificity & Method precision has been submitted.
3 3.2.S.4.4 COA of Drug Substance performed by Drug COA of Drug Substance performed by Drug
Substance and Drug Product Manufacturer both of the Substance and Drug Product Manufacturer both of
same batch the same batch was submitted
4 3.2.S.7.2 The Protocols used and the results of Firm has submitted Protocols used and the results of
accelerated and long term stability studies: accelerated and long term stability studies:
5 3.2.P.2.2.6 Compatibility studies for the dry powder Compatibility studies for the dry powder injection
injection with Sterile water for injection.
facility.
Karachi.
Address: Al-Habib Pharmaceuticals, 81-B, block B, SMCHS,
Karachi.
Godown:

Name and address of marketing NAPROD LIFE SCIENCES PVT. LTD.
authorization holder (abroad) Factory: G-17/1, M.I.D.C., Tarapur, Boisar, Dist. Thane-401
506, INDIA
Name, address of manufacturer(s) NAPROD LIFE SCIENCES PVT. LTD.
Factory: G-17/1, M.I.D.C., Tarapur, Boisar, Dist. Thane-401
506, INDIA
Detail of certificates attached (CoPP, Free CoPP:
sale certificate, GMP certificate) Original legalized CoPP (certificate No.
84225/2019/11/28364/144053) valid till 03-04-2022 issued by
issued by Food and Drug Administration Mahrashtra Estate
Mumbai for Doxorubicin HCl for injection BP 50 mg/vial. The
CoPP confirms free sale status of the product in exporting
periodic inspection every year.
Details of letter of authorization / sole Firm has submitted Original Authorization letter from Naprod
agency agreement Life Sciences Pvt. Ltd. The letter species that the manufacturer
appoints M/s Al-Habib Pharmaceuticals, Plot #81, block B,
SMCHS, Karachi as a sole agent and distributor to register their
products in Pakistan .
☒ Importer
☐ Export sale
Dy. No. and date of submission Dy.No 26355 dated 22-09-2021 Rs.15,000/- dated 13-09-2021
The proposed proprietary name / brand NAPRODOX 50
name
Strength / concentration of drug of Active Each Vial (Lyophilized powder)contains:
Pharmaceutical ingredient (API) per unit Doxorubicin ……………. 50mg
Pharmacotherapeutic Group of (API) Anti-Cancer (Anthracycline) L01DB01
Reference to Finished product BP
specifications
Proposed Pack size 1 Vial
The status in reference regulatory ADRIAMYCIN RD (Doxorubicin) 50 mg injection (USFDA
authorities Approved) by Pfizer
For generic drugs (me-too status) ADRIBLASTINA-RD Doxorubicin) 50 mg injection by
Pfizer Laboratories Ltd. Pakistan

Name, address of drug substance M/s INTAS PHARMACEUTICAL LIMITED
manufacturer 2702/A, GIDC Estate,
Ankleshwar 393 002,
District: Bharuch,
India
(Conditions & duration of Stability studies) accelerated as well as real time conditions. The real time stability
data is conducted at 25 ± 2°C/ 60 ± 5 % RH. The stability study
Pharmaceutical Equivalence and Pharmaceutical equivalence has been established against the
Comparative Dissolution Profile reference product ADRIAMYCIN RD 50 mg injection by
Pfizer.
Container closure system of the drug 20 mm neck size 25ml Tubular, Flint made up of USP type-I
product glass Vial.
Rubber stopper
Aluminium flip off seal
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches 24 months’
life and storage conditions real time stability data at 30 ºC ± 2 ºC / 75 % ± 5 % RH.
06 month accelerated stability data 30 ºC ± 2 ºC / 75 % ± 5 %
RH.
Decision: Approved as per policy of insepctions of manufacturer abroad.

645. Name, address of Applicant / Importer M/s Ahsan Pharma
Room no.2 Delhi Muslim Building Aram Bagh Road, Karachi
Address: Room no.2 Delhi Muslim Building Aram Bagh Road,
Karachi.
Address of Godown: B-4, S.I.T.E. Karachi
Validity: 15th Oct 2022
Status: Drug License by the way of Wholesale
Name and address of marketing M/S Seacross Pharmaceutical Co., Ltd, Stanmore Place Howard
authorization holder (abroad) Road, Stanmore London HA7 1BT, UK
Product Licence/Marketing Authorization holder
SEACROSS PHARMACEUTICALS LIMITED
BEDFORD BUSINESS CENTRE,
61 - 63 ST.PETER’S STREET, BEDFORD,
BEDFORDSHIRE,
MK40 2PR, UNITED KINGDOM
Name, address of manufacturer(s) Manufacturer:
M/s Sichuan Huiyu Pharmaceutical Ltd. No. 5 Road Chengxi
economic area, Neijiang, Sichuan-641000, China. (GMP is issued
by CFDA and is valid until 27/5/2023)
Batch Release Site:
Seacross Pharmaceutical Co., Ltd Stanmore Place, Suite 205,
Howard Road, Stanmore HA7 1BT, United Kingdom
Manufacturer Licence Holder:
Name of exporting country UK
Detail of certificates attached (CoPP, CoPP: the firm has submitted CoPP from MHRA for Doxorubicin
Freesale certificate, GMP certificate) 2mg/ml Concentrate for Solution for Infusion, Certificate No:
PP10165864 dated 03-Apr-2020. The firm has submitted copy of
letter from MHRA regarding issuance of export certificates for
medicines for humans which will not be available as hard copy with
wet ink signature during the period pertaining to COVID-19
“The export certificate will be processed by the MHRA named
signatories and issued as electronic pdf copy. The certificate will
refer to this covering letter which should be attached to any
submissions.”
Details of letter of authorization / sole Firm has submitted Copy of Exclusive Distribution Agreement is
agency agreement submitted M/S Seacross Pharmaceutical Co., Ltd Stanmore
Business & Innovation Centre, Stanmore Place Howard Road,
Stanmore London HA7 1BT, UK authorizes M/s Ahsan Pharma
Room no.2 Delhi Muslim Building Aram Bagh Road, Karachi for
marketing and selling the Seacross products including the applied
product.
☒ Importer
☐ Export sale

The proposed proprietary name / brand Doxorubicin 2mg/ml Concentrate for Solution for Infusion,
name
Strength / concentration of drug of Each 5ml vial contains:
Active Pharmaceutical ingredient (API) Doxorubicin hydrochloride…….10mg
per unit
Pharmaceutical form of applied drug Concentrate for Solution for infusion
Pharmacotherapeutic Group of (API) Anthracyclines and related substance (L01DB01)
specifications
The status in reference regulatory MHRA Approved
authorities Each 5ml vial contains 10 mg of Doxorubicin hydrochloride.
Concentrate for solution for infusion
Name, address of drug substance M/s Sterling Biotech Ltd Jambusar State Highway Taluka Padra,
manufacturer District Vadodara India-391 421 Masar Village, Gujarat
Module-III Drug Substance: Firm has submitted
(EDQM has issued certificate of suitability which is deemed to
replace the data. )
Stability Studies of Drug Substance (EDQM has issued certificate of suitability which is deemed to
(Conditions & duration of Stability replace the data. )
studies)
Pharmaceutical Equivalence and Pharmaceutical Equivalence has been compared with Adriblastina
Comparative Dissolution Profile (Greece), Adriamycin (Denmark, Australia).

Container closure system of the drug Type-I glass vial
product
Stability study data of drug product, shelf 2 months accelerated studies at 25C, 60% has been submitted. Long
life and storage conditions term stability studies at 5C for 18months has been submitted.
Storage temperature is 2 to 8C.
Sr Short Coming Replies
no
1 The address of manufacturer on GMP and M/s Sichuan Huiyu changed the address as per requirements from
COPP is different. Clarification is needed. local official administrative office. The CPP was applied before the
address changed. However, the Eudra has updated the GMP to the
current address, and the GMP certificate number is also updated to
0004 from 0003 version.
2 GMP certificates of M/s Seacross Did not provided.
Pharmaceuticals and M/s Sterling Biotech
Ltd Jambusar are required.
3 3.2.P.8 You have provided Accelerated The product is thermal sensitive. The impurity content and assay
stability data for only 2 months. were out of specification at 2nd month of accelerated stability study,
Remaining months data is not provided. so the storage condition of the product should be at 2~8℃. The
product should be transferred on a controlled temperature during
shipping. The shelf life is based on the long-term stability study.
2 months accelerated studies at 25C, 60% has been submitted. Long

term stability studies at 5C for 18months has been submitted.
4 3.2.P.5.3 Validation of analytical The full validation reports, including specificity, repeatability and
procedures: For in-house methods, accuracy, for assay, degradation and related substance will be
analytical methods validation shall be provided by you tomorrow.
performed. All the officially recognized
compendial methods for assay,
dissolution and impurities (as applicable)
are required to be verified and verification
shall include a demonstration of
specificity, repeatability (method
precision) and accuracy
Decision of 312nd : Deferred for submission of complete stability study data of finished product as per Zone -IVA.
Evaluation by PEC VI: A letter from M/s Hiyu Pharmaceuticals China stated that Doxorubicin is a thermal sensitive
product, required to be stored in a refrigerator. The long-term stability data conditions according to ICH Q1 is 2 to 8
℃ which has been provided. It is not necessary to provide 30 ℃ stability data for Doxorubicin, as significant change
has occurred at 2nd month 25 ℃ condition.
Decision: Deferred for clarification regarding not submitting stability study data of finished product as per
Zone -IVA.
646. Name, address of Applicant / M/s Ahsan Pharma Room no.2 Delhi Muslim Building Aram
Importer Bagh Road, Karachi
Address: Room no.2 Delhi Muslim Building Aram Bagh Road,
Karachi.
Address of Godown: B-4, S.I.T.E. Karachi

Name and address of marketing M/S Seacross Pharmaceutical Co., Ltd, Stanmore Place Howard
authorization holder (abroad) Road, Stanmore London HA7 1BT, UK
Product Licence/Marketing Authorization holder
SEACROSS PHARMACEUTICALS LIMITED
BEDFORD BUSINESS CENTRE,
61 - 63 ST.PETER’S STREET, BEDFORD,
BEDFORDSHIRE,
MK40 2PR, UNITED KINGDOM
Name, address of manufacturer(s) Manufacturer:
M/s Sichuan Huiyu Pharmaceutical Ltd. No. 5 Road Chengxi
economic area, Neijiang, Sichuan-641000, China(GMP is issued by
CFDA and is valid until 27/5/2023)
Batch Release Site:
Manufacturer Licence Holder:
Name of exporting country UK
Detail of certificates attached (CoPP, CoPP: the firm has submitted CoPP from MHRA for Doxorubicin
Freesale certificate, GMP certificate) 2mg/ml Concentrate for Solution for Infusion, Certificate No:
PP10165864 dated 03-Apr-2020. The firm has submitted copy of
letter from MHRA regarding issuance of export certificates for
medicines for humans which will not be available as hard copy with
wet ink signature during the period pertaining to COVID-19
“The export certificate will be processed by the MHRA named
signatories and issued as electronic pdf copy. The certificate will
refer to this covering letter which should be attached to any
submissions.”
Details of letter of authorization / sole Firm has submitted Copy of Exclusive Distribution Agreement is
agency agreement submitted M/S Seacross Pharmaceutical Co., Ltd Stanmore
Business & Innovation Centre, Stanmore Place Howard Road,
Stanmore London HA7 1BT, UK authorizes M/s Ahsan Pharma
Room no.2 Delhi Muslim Building Aram Bagh Road, Karachi for
marketing and selling the Seacross products including the applied
product.
☒ Importer
☐ Export sale
The proposed proprietary name / brand Doxorubicin 2mg/ml Concentrate for Solution for Infusion,
name

Strength / concentration of drug of Each 25ml vial contains:
Active Pharmaceutical ingredient (API) Doxorubicin hydrochloride…….50mg
per unit
Pharmaceutical form of applied drug Concentrate for Solution for infusion
Pharmacotherapeutic Group of (API) Anthracyclines and related substance (L01DB01)
Reference to Finished product B Pharmacopoeia
specifications
Proposed Pack size 25ml x1’s
authorities
Name, address of drug substance Sterling Biotech Ltd Jambusar State Highway Taluka Padra, District
manufacturer Vadodara India-391 421 Masar Village, Gujarat
Module-III Drug Substance: Firm has submitted
(EDQM has issued certificate of suitability which is deemed to
replace the data. )
Stability Studies of Drug Substance (EDQM has issued certificate of suitability which is deemed to
(Conditions & duration of Stability replace the data. )
studies)
Pharmaceutical Equivalence and Pharmaceutical Equivalence has been compared with Adriblastina
Comparative Dissolution Profile (Greece), Adriamycin (Denmark, Australia).
Container closure system of the drug Type-I glass vial
product
Stability study data of drug product, shelf 2 months accelerated studies at 25C, 60% has been submitted. Long
life and storage conditions term stability studies at 5C for 18months has been submitted.
no
1 The address of manufacturer on GMP and M/s Sichuan Huiyu changed the address as per requirements from
COPP is different. Clarification is needed. local official administrative office. The CPP was applied before the
address changed. However, the Eudra has updated the GMP to the

current address, and the GMP certificate number is also updated to
0004 from 0003 version.
2 GMP certificates of M/s Seacross Did not provided.
Pharmaceuticals and M/s Sterling Biotech
Ltd Jambusar are required.
3 3.2.P.8 You have provided Accelerated The product is thermal sensitive. The impurity content and assay
stability data for only 2 months. were out of specification at 2nd month of accelerated stability study,
Remaining months data is not provided. so the storage condition of the product should be at 2~8℃. The
product should be transferred on a controlled temperature during
shipping. The shelf life is based on the long-term stability study.
2 months accelerated studies at 25C, 60% has been submitted. Long

term stability studies at 5C for 18months has been submitted.
4 3.2.P.5.3 Validation of analytical The full validation reports, including specificity, repeatability and
procedures: For in-house methods, accuracy, for assay, degradation and related substance will be
analytical methods validation shall be provided by you tomorrow.
performed. All the officially recognized
compendial methods for assay,
dissolution and impurities (as applicable)
are required to be verified and verification
shall include a demonstration of
specificity, repeatability (method
precision) and accuracy
Decision of 312nd : Deferred for submission of complete stability study data of finished product as per Zone -IVA.
Evaluation by PEC: A letter from M/s Hiyu Pharmaceuticals China stated that Doxorubicin is a thermal sensitive
product, required to be stored in a refrigerator. The long-term stability data conditions according to ICH Q1 is 2 to 8
℃ which has been provided. It is not necessary to provide 30 ℃ stability data for Doxorubicin, as significant change
has occurred at 2nd month 25 ℃ condition.
Decision: Deferred for clarification regarding not submitting of stability study data of finished product as per
Zone -IVA.
647. Name, address of Applicant / Importer M/s Amgomed, office No.04, first floor Ghausia
plaza, Jinnah Avenue blue area, Islamabad,
Details of Drug Sale License of importer DSL No.: DSL-002-ICT/2013
AMGOMED ,Office # no 4, First Floor Ghausia Plaza,
Godown: Office No. 5, first floor, Rose-1 plaza,
I-8 Markaz, Islamabad.
Validity: 30/01/2022 Status: Whole sale distributor
Name and address of marketing M/s SABA ILAC SAN. VE TIC.A.S
authorization holder (abroad) Küçükçekmece –
ISTANBUL / TURKEY
Name, address of manufacturer(s) M/s DEVA Holding A.S. Cerkezkoy Organize
Sanayi Bolgesi Karraagac Mah. Fatih Bulvari no:
26 Kapakli-Tekirdag/Turkey.
Exporting country Turkey
Original legalized CoPP (certificate no. 2020/1432) issued by Turkish Medicines and
Medical Agency valid till 29/05/2022. The applied product is available for free sale in the
market of exporting country. The facilities and operations conform to WHO-GMP.
Original legalized letter of authorization is submitted whereby M/s SABA ILAC SAN.
VE TIC.A.S .
authorized M/s Amgomed to apply for registration, for marketing, distribution and sale of

below mentioned product;
Adrimisin 10mg LYO.I.V.INTRAVESICAL. INJ
Adrimisin 50mg LIY . ENJ TOZ I FLAK
Pirucin 10mg /5ml LYO.I.V/INTRAVESICAL.ING
Pirucin 50mg /5ml LYO.I.V/INTRAVESICAL.ING
Carbodex 450mg/45ml solution for IV

☒ Importer
☐ Is involved in none of the above (contract
giver)
☐ Export sale
☐ Buk import and local repackaging for export
purpose only
Dy. No. and date of submission Dy. No 7450, Dated 8-3-2021
The proposed proprietary name / brand ADRIMICIN 50mg
name (Lyophilised powder for solution for I.V/
Intravesical Injection)
Strength / concentration of drug of Active Each vial contains :

Pharmaceutical ingredient (API) per unit Doxorubicin hydrochloride….50mg
Pharmaceutical form of applied drug Lyophilised powder for solution for I.V/
Intravesical Injection
Pharmacotherapeutic Group of (API) Anthracyclines and related substances (L01DB01)
specifications
Proposed Pack size 1’s/ VIAL
authorities
For generic drugs (me-too status) NAGUN 50 INJECTION. -

DOXORUBICIN HYDROCHLORIDE 50MG/ vial.
Registration No: 072574 by M/S. GHANI
BROTHERS,KARACHI

drug substance.
The firm has summarized information of drug product
development, manufacture, manufacturing process and
process control, process validation protocols, control of
analytical procedures, validation of analytical
and stability
Name, address of drug substance Manufacturer:
Manufacturer M/s Zhejiang Hisun Pharmaceutical Co,Ltd.56 Binhai
Road Jiaojiang District Taizhou City, Zhejiang Province
318000 China .
Module-III Drug Substance: Not applicable due to CEP.
The Doxorubicin HCl manufacturer is the holder of
“Certificate No.: R1-CEP
1999-151-Rev 05. Please refer to the Certificate of
Suitability, attached in Module 3.2.R.
Stability Studies of Drug Substance Not applicable due to CEP.
(Conditions & duration of Stability The Doxorubicin HCl manufacturer is the holder of
studies) “Certificate No.: R1-CEP
1999-151-Rev 05.
Module-III Drug Product: Firm
. has submitted data of drug product including its
process validation protocols, control of excipients,
control of drug product, specifications, analytical
analysis, justification of specifications, reference
standard or materials, container closure system and
Pharmaceutical Equivalence and stability.
Pharmaceutical equivalence has been established
Comparative Dissolution Profile against the reference product, Adriblastin 50 mg
(Powder for Injection)
(Pfizer/Austria)
Analytical method validation/verification The firm has submitted relevant data including
of product analytical method validation for the drug product
including the impurities.
Container closure system of the drug Adriamycin 50 mg Lyophilized Powder for Solution for
product I.V./Intravesical Injection is packaged in 50 cc colourless
glass vial (Type III) as a primary
packaging closed with butyl scored rubber stopper and
sealed with aluminum cap with red colored flip-off
component.

• Real time stability studies have been conducted at
Stability study data of drug product, shelf 30oC±2 and65%RH±5% for 36 months of 3
life and storage conditions batches
• Accelerated stability studies is conducted at
40oC±2 and 75%RH±5% for 6 months of 3 batches
Evaluation by
PEC-
VI no
1 GMP certificate/ DML of API manufacturer is required Please find attached below. The provided
DML/ GMP certificate could not be confirmed.
2 3.2.S.4 Control of Drug Substance: Detailed analytical I will share validation reports to you as soon as
procedures for the testing of drug substance shall be possible
provided. Analytical Method Verification studies
including specificity, accuracy and repeatability (method
precision) performed by the Drug Product manufacturer
for both compendial as well as non-compendial drug
3 3.2.S.4.3 Validation of analytical procedures Analytical . I will share validastion report to you as soon
Method Verification studies including specificity, as possible
accuracy and repeatability (method precision) performed
by the Drug Product manufacturer for both compendial as
well as non-compendial drug substance(s) shall be
submitted
4 3.2.S.7 Stability • The protocols used and the results of the Not Applicable due to CEP
accelerated and long-term stability studies shall be
summarized. Proposed storage conditions / statement and
re-test period (or shelf-life, as appropriate) shall also be
submitted.
5 3.2.P.2 Manufacturing Process Development The • . I will send the update 32p2 to you
selection and optimization of the manufacturing process tomorrow.
described in 3.2.P.3.3, in particular its critical aspects,
shall be explained. Any specific manufacturing process
development shall be provided e.g., sterilization shall be
explained and justified. Where relevant, justification for
the selection of aseptic processing or other sterilization
methods over terminal sterilization shall be provided
Decision of 313rd : Deferred for following:
a) Valid DML/GMP certificate of the API manufacturer is required.
b) Detailed analytical procedures for the testing of drug substance and Analytical Method Verification studies
including specificity, accuracy and repeatability (method precision) performed by the Drug Product manufacturer for
both compendial as well as non-compendial drug substance(s) shall be provided.
c) The protocols used and the results of the accelerated and long-term stability studies of the drug substance is
required.
d) 3.2.P.2 Manufacturing Process Development The selection and optimization of the manufacturing process
described in 3.2.P.3.3, in particular its critical aspects, shall be submitted.
Short-coming Evaluator-VI Replies
a) Valid DML/GMP certificate of the API manufacturer The firm has submitted GMP certificate No ZJ20190143
is required. of M/s Zhejiang Hisun Pharmaceutical Co Ltd, No 56,
Binhai road, Jiaojiang District, Taizhou City, Zejiang
Province and is valid upto 29-11-2024
b) 3.2.S.4 Detailed analytical procedures for the testing Firm has submitted Detailed analytical procedures for the
of drug substance and Analytical Method Verification testing of drug substance and Analytical Method
studies including specificity, accuracy and repeatability Verification studies including specificity, accuracy and

(method precision) performed by the Drug Product repeatability (method precision) performed by the Drug
manufacturer for both compendial as well as non- Product manufacturer for both compendial as well as non-
compendial drug substance(s) shall be provided. compendial drug substance
c) 3.2.S.7 Stability .The protocols used and the Firm has submitted the protocols used and the results of the
results of the accelerated and long-term stability studies accelerated and long-term stability studies of the drug
of the drug substance is required. substance
d) 3.2.P.2 Manufacturing Process Development Firm has submitted Manufacturing Process Development
The selection and optimization of the manufacturing The selection and optimization of the manufacturing
process described in 3.2.P.3.3, in particular its critical process described in 3.2.P.3.3, in particular its critical
aspects, shall be submitted. aspects
facility.
Agenda of Evaluator PEC-II

New DML
M/s Jasm Pharmaceutical (Pvt) Ltd, Plot 4-A, Export Processing Street, Risalpur Industrial Estate,
Nowshera.
The Central Licensing Board in its 276th meeting held on 03rd September, 2020 has considered and
approved the grant of Drug Manufacturing License Number (000920), M/s Jasm Pharmaceutical (Pvt)
Ltd, Plot 4-A, Export Processing Street, Risalpur Industrial Estate, Nowshera by way of Formulation
vide approval letter No. F. 3-5/2017-Lic dated 30th Sep, 2020
648. Name, address of Applicant / Marketing M/s JASM Pharmaceuticals (Pvt) Ltd.
Authorization Holder Address: Plot # 4A, Export Processing street, Risalpur Industrial
Estate, Nowshera. Khyber Pukhtunkhwa.
Name, address of Manufacturing site. M/s JASM Pharmaceuticals (Pvt) Ltd.
Address: Plot # 4A, Export Processing street, Risalpur Industrial
☐ Importer
☐ Export sale
Evidence of availability of manufacturing New license granted on 29/09/2020
section. Tablet, Capsule, Dry Powder, Liquid Syrup, Cream Ointment
(General Sections) Approved
The proposed proprietary name / brand Adovel Suspension 100 mg/5ml
name
Strength / concentration of drug of Active Each 5ml Contains:
Pharmaceutical ingredient (API) per unit Ibuprofen………….100 mg
Pharmaceutical form of applied drug Oral Suspension

BP
specifications
Proposed Pack size 90 ml / bottle or as per SRO
Approved by US FDA
authorities
For generic drugs (me-too status) Fenbro suspension of M/s Stanley Pharmaceuticals
(Reg.#04332)
manufacturer Tablet, Capsule, Dry Powder, Liquid Syrup, Cream Ointment
Name and address of API manufacturer. M/s Zenith Chemical Industries (Pvt) Limited.
Moza Dhonday, Jia Baga Raiwind Kahna Road Raiwind
Pakistan.
comparative dissolution profile brand leader that is Brufen Suspension 100 mg/5mL.

Manufacturer of API M/s Zenith Chemical Industries (Pvt) Limited.
Moza Dhonday, Jia Baga Raiwind Kahna Road Raiwind Pakistan.
API Lot No. ZIBU20-032
Description of Pack
90 ml / bottle packed in a Unit Carton.

Frequency Accelerated: 0, 3 & 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. P03 P15 P33
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate Ref No. 141/2019-Drap (AD-813875--
API manufacturer issued by concerned 228) issued by DRAP.
3. Documents for the procurement of API NA
import).
5. Compliance Record of HPLC software N/A
testing
6. Record of Digital data logger for Manual record has been submitted with one reading in a day
accelerated)
649. Name, address of Applicant / Marketing M/s JASM Pharmaceuticals (Pvt) Ltd
Name, address of Manufacturing site. M/s JASM Pharmaceuticals (Pvt) Ltd
☐ Importer
☐ Export sale

The proposed proprietary name / brand Adovel Suspension 200 mg/5ml
name
Pharmaceutical ingredient (API) per unit Ibuprofen ………………. 200 mg
Pharmaceutical form of applied drug Oral Suspension
BP
specifications
Approved by US FDA
authorities
For generic drugs (me-too status) Fenbro suspension of M/s Stanley Pharmaceuticals
manufacturer Tablet, Capsule, Dry Powder, Liquid Syrup , Cream Ointment
Name and address of API manufacturer. M/s Zenith Chemical Industries (Pvt) Limited.
Moza Dhonday, Jia Baga Raiwind Kahna Road Raiwind
Pakistan.
comparative dissolution profile brand leader that is Brufen DS Suspension .

Manufacturer of API M/s Zenith Chemical Industries (Pvt) Limited.
Moza Dhonday, Jia Baga Raiwind Kahna Road Raiwind Pakistan.

API Lot No. ZIBU20-032
Description of Pack
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate Ref No. 141/2019-Drap(AD-813875--
API manufacturer issued by concerned 228) issued by DRAP.
import).
chromatograms,
sheets etc.
testing
accelerated)
Firm’s response:
Section# Observation Firm’s response

3.2.S.4.2 • Analytical procedure applied Submitted.
by the drug substance manufacturer
shall be submitted.
3.2.P.1 • Justify the types & quantities Firm has stated that the selection of
of preservatives used in the proposed excipient was based upon the innovator
formulation. product & the quantity of each excipient
was justified within the allowable limits for
the desired function of the excipient as
declared in the Handbook of
pharmaceutical excipients.

Whereas the reference product does not
contain methyl paraben & propyl paraben
as proposed in the applied formulation.
3.2.P.2 Submit drug excipient compatibility Not submitted.
studies data since, the innovator
product referred by firm does not
contain the excipients proposed in
the applied formulation.
3.2.P.5.2 • Procedure for sample Firm has submitted revised analytical
dilution preparation is not as per the procedure as per BP monograph.
BP monograph for “Ibuprofen oral
suspension.”
3.2.P.8.3 • The calculation formula • Firm has submitted the calculation
applied for the Assay calculation is formula wherein determination of “weight
not as per that recommended by BP per ml” as recommended by the BP
monograph of “Ibuprofen oral monograph is not evident.
suspension” • Submitted raw data sheet still not
• Complete raw data sheets, declare the actual quantities of standard and
wherein details of sample and sample weighed for the preparation of
standard dilution making is evident, relevant solutions.
shall be submitted. • Firm has submitted preservative
• Test of preservative effectiveness studies at the most recent time
effectiveness has not been performed point (October 2021) of accelerated &
during stability studies. long-term stability studies, which is earlier
to the communication of this observation.
Decision: Registration Board deferred both the applications of “Adovel Suspension 200 mg/5ml” & “Adovel
Suspension 100 mg/5ml” for submission of Assay results at the next time point of long-term stability studies, as
per the method & calculation formula recommended by the BP monograph of “Ibuprofen suspension”.
☐ Importer
☐ Export sale
Celozin 125mg/5ml Dry Suspension
name

Pharmaceutical ingredient (API) per unit Ciprofloxacin…….…125mg
Pharmaceutical form of applied drug Dry powder suspension
Pharmacotherapeutic Group of (API) Quinolone Antibiotic
USP
specifications
Approved by US FDA
authorities
For generic drugs (me-too status) Mytil suspension of M/s Wilson
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt) Limited.
Pakistan
comparative dissolution profile brand leader that is Novidat Suspension 125 mg/5ml by Sami
Pharmaceuticals.

Manufacturer of API M/s Vision Pharmaceuticals (Pvt) Limited.
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan.
API Lot No. CPX1250

Description of Pack
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No.F.3-26/2019-Addl.Dir.(QA&LT-I)
API manufacturer issued by concerned Issued By DRAP Valid till 10/02/2022
import).
testing
accelerated)
Authorizatsion Holder Address: Plot # 4A, Export Processing street, Risalpur Industrial
☐ Importer
☐ Export sale

Celozin 250mg/5ml Dry Suspension
name
Pharmaceutical ingredient (API) per unit Ciprofloxacin…….…250mg
Pharmaceutical form of applied drug Dry powder suspension
Pharmacotherapeutic Group of (API) Quinolone Antibiotic
USP
specifications
Approved by US FDA
authorities
For generic drugs (me-too status) Mytil suspension of M/s Wilson
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt) Limited.

comparative dissolution profile brand leader that is Novidat Suspension 250 mg/5mL by
Sami Pharmaceuticals.

Manufacturer of API M/s Vision Pharmaceuticals (Pvt) Limited.
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan.
API Lot No. CPX1250
Description of Pack
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No.F.3-26/2019-Addl.Dir.(QA&LT-I)
API manufacturer issued by concerned Issued By DRAP Valid till 10/02/2022
import).
chromatograms,
sheets etc.
testing
accelerated)
Firm’s response:

3.2.S.4.2 • Justification shall be submitted for • Firm has submitted that we
applying UV spectrophotometric method for the followed the substance manufacturer
analysis of Ciprofloxacin taste masked pellets. analytical method validated and then used
• The dissolution parameters applied for for the analysis of substance.
the analysis of Ciprofloxacin pellets are different • In finished product specifications
form that recommended by USP monograph of followed the USP monograph and their
Ciprofloxacin for oral suspension. dissolution parameters for oral suspension.
3.2.P.1 • Clarification shall be submitted Firm has submitted that the proposed
regarding proposed excipients, whether they are excipients are part of diluents.
part of the formulation or diluent.
3.2.P.2.2.1 • Details of reference product, against • Firm has submitted comparative
which Pharmaceutical equivalence studies have dissolution study reports for both applied
been performed, shall be submitted. strengths against the Novidat suspension of
• Justification shall be submitted for not M/s Sami Pharmaceuticals.
performing CDP.
3.2.P.2.5 • Justification shall be submitted for • Firm has declared it as a clerical
preservative effectiveness studies, since no mistake.
preservative has been proposed in applied
formulation.
3.P.2.6 • Proposed diluent is not as recommended • Firm has submitted the revised
by the innovator product. information wherein diluent as
recommended by innovator has been
mentioned, while no analytical data has
been reported for the compatibility studies.
3.2.P.3.3 • The manufacturing process mentions the • Firm has submitted revised
steps of tablet manufacturing. description of manufacturing process for
applied dosage form.
3.2.P.3.5 • Submitted process validation protocol • Firm ha submitted revised process
does not mention any details of critical process validation protocol wherein details of
parameters and sampling plan. critical process parameters and sampling
plans are still not mentioned.
3.2.P.5.2 • Submitted analytical procedure does not • Firm has submitted revised
mention any details for dissolution test. analytical procedure including dissolution
• Evidence of availability of HPLC test.
equipped with the autosampler, capable of • Firm has submitted HPLC report
maintaining 10oC temperature shall be submitted. wherein Tray temperature for autosampler
has been mentioned as 10oC.
3.2.P.8 • Submitted raw data sheet for dissolution • Firm has submitted calculation
test does not declare the determination of density formula along with values of various
of reconstituted suspension, as required by the factors, density etc.
USP monograph, also the calculation formula has • The results of the dissolution test
not been mentioned. reported in the raw data sheet does not
• Raw data for the Assay test has not been coincide with the provided formula.
submitted. • Raw data sheets for assay test have
• In-use stability data shall be submitted. been submitted.
• Section 3.2.P.1 mentions water in
formulation, whereas submitted BMRs does not
declare use of water in the formulation.
• Evidence of reference product shall be
submitted wherein the excipients proposed in
applied formulation have been used.
Decision: Registration Board deferred both the applications of “Celozin 250mg/5ml Dry Suspension” &
“Celozin 125mg/5ml Dry Suspension” for following:
• Submission of compatibility studies with the diluent as recommended by the innovator product.
• Clarification regarding manufacturing area where the proposed diluent will be manufactured.

• Submission of process validation protocol wherein details of critical process parameters and sampling
plan shall have bene mentioned.
• Justification for the results of dissolution test since results of the dissolution test reported in the raw
data sheet does not coincide with the provided calculation formula.
• Submission of fee of Rs.7,500 for correction/pre-approval change in the method of manufacture &
drug product testing method, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot No., 384, Sundar industrial Estate, Raiwind Road, Lahore.
The Central Licensing Board in its 270th meeting held on 23rd May, 2019 has considered and approved the grant
of Drug Manufacturing License to M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot No., 384, Sundar industrial
Estate, Raiwind Road, Lahore by way of Formulation vide approval letter No. F. 1-56/2011 Lic dated 24th June,
2019 with following (03) sections.
S No. Name of Section
1. LVP (General) Section
2. SVP (General) Section
3. Ophthalmic (General) Section
652. Name, address of Applicant / Marketing M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder
Authorization Holder Industrial Estate, Lahore
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd.
Plot No. 384, Sunder Industrial Estate, Lahore
☐ Importer
GMP status of the firm GMP certificate issued on 17-07-2020
Evidence of approval of manufacturing facility Firm has submitted copy of section approval letter dated
24-06-2019 which specifies Ophthalmic general section.
☐ Export sale
The proposed proprietary name / brand name Dorzil Eye drop
Strength / concentration of drug of Active Each ml contains 22.26 mg of Dorzolamide hydrochloride
Pharmaceutical ingredient (API) per unit equivalent to 20 mg Dorzolamide.
Pharmaceutical form of applied drug Eye Drops, Solution
Pharmacotherapeutic Group of (API) Dorzolamide: Carbonic anhydrase inhibitors
ATC Code: S01EC03
Reference to Finished product specifications BP specification
Proposed Pack size 1 x 5 ml
The status in reference regulatory authorities USFDA Trusopt 20 mg/ml Eye drops, solution Santen
pharmaceuticals Co., Ltd Japan
For generic drugs (me-too status) Trusopt Ophthalmic Drops 2% 5ml by OBS Pharma
(Pvt) Karachi
Ltd, Pakistan

Regd. No. 021100
Pack size: 5 ml
Name and address of API manufacturer. Dorzolamide
Dorzolamide from Neuland Laboratories Limited, Unit-1
Sy. No: 347, 473, 474, 490 / 2 Veerabhadraswamy temple
road, Bonthapalli Village, Gummadidala Mandal,
Sangareddy District - 502 313 Telangana, India
drug substance and drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance data
drug substance.
Stability Studies of Drug Substance (Conditions Dorzolamide
duration of Stability studies) Long-term stability studies were performed at a storage
temperature of 30°C±2°C/65%±5% RH for 60 months.
Accelerated stability studies were performed at a
temperature of 40±2°C/75%±5% RH for 6 months.
Pharmaceutical Equivalence and Comparative Pharmaceutical Equivalence Studies against the
Dissolution Profile reference product of “Trusopt sterile ophthalmic
Solution” by Santen pharmaceuticals Co., Ltd. Imported
by OBS pharma
Stability studies Firm has submitted stability studies data of three batches
at both accelerated and long term conditions.
Dorzolamide
Dorzolamide from Neuland Laboratories Limited, Unit-1 Sy. No: 347, 473,
Manufacturer of APIs
474, 490 / 2 Veerabhadraswamy temple road, Bonthapalli Village,
Gummadidala Mandal, Sangareddy District - 502 313 Telangana, India
DZ10420013 (Dorzolamide)
API Lot No.

Low density polyethylene bottle with insert-cap assembly, HDPE screw-
Description of Pack
cap over a LDPE nozzle with tamper–evident LDPE dustcover sealing the
bottle cap.
Real time: 30oC ± 2oC / 35% HR ±5%
Accelerated: 40oC ± 2oC / NMT 25% HR
Real time: 3 months
Time Period
Accelerated: 0, 3 (Months)
Frequency
Real Time: 0, 3 (Months)
Batch No. PDDN0012021 PDDN0022021 PDDN0032021
applications with stability study
2. Approval of API/ DML/GMP Dorzolamide
certificate of API manufacturer Copy of GMP certificate in the name of Neuland Laboratories Limited,
issued by concerned regulatory Unit-1 Sy. No: 347, 473, 474, 490 / 2 Veerabhadraswamy temple road,
authority of country of origin. Bonthapalli Village, Gummadidala Mandal, Sangareddy District - 502 313
Telangana, India, valid upto 28-06-2022 issued by Drug Control
Administration, Government of Telangana, India.
3. Documents for the procurement of Copy of commercial invoice attested by AD I&E DRAP, Lahore, has been
API with approval from DRAP (in submitted.
case of import). Date of
Quantity
Batch No. approval
Imported
by DRAP
DZ10420013 1 kg 08-06-2021
(Dorzolamide)
The commercial invoice is in the name of M/s Pacific Pharmaceuticals
Ltd., 30th KM, Multan Road, Lahore.
4. Data of stability batches will be
supported by attested respective Firm has submitted data of stability batches along with batch
documents like chromatograms, manufacturing record and analytical record.
Raw data sheets, COA, summary
data sheets etc.
5. Compliance Record of HPLC
software 21CFR & audit trail Firm has submitted audit trail reports on product testing.
temperature & humidity Firm has submitted Record of Digital data logger for temperature &
monitoring of stability chambers humidity monitoring of stability chambers (real time and accelerated)
1.5.6 Drug product specifications have been Firm has now claimed European Pharmacopoeia
referred to as Innovator’s specifications Specifications
whereas Pharmacopoeial monographs are
available for applied product.
Dorzolamide HCl
3.2. • Drug substance manufacturer has • In BP/Ph. Eur there is potentiometric titration for
S.4.1 declared drug substance as of Ph. Eur API assay determination while in USP there is use of
grade for related substances whereas the HPLC for Assay determination, which is better

submitted Assay test is declared as per technique and equipment than the technique adopted
USP pharmacopoeia. by drug substance manufacturer.
• The analytical method for Assay • Copies of analytical procedure submitted from drug
submitted by drug product manufacturer product manufacturer.
is different form that proposed by the
drug substance manufacturer.
• Copies of the Drug substance
specifications and analytical procedures
used for routine testing of the Drug
substance /Active Pharmaceutical
Ingredient by Drug Product
3.2.P.5.1 • Submitted drug product specifications Microbial report for Preservative testing has been
does not include test of “Preservative submitted now.
Effectiveness testing”.
3.2. P.6 COA of primary / secondary reference Submitted
standard including source and lot number
shall be provided.
3.2. P.8 Following shall be submitted: • Firm has submitted 6 months stability data along
• Stability studies till 3rd month time point woith analytical record.
has been submitted only.
• Analytical record i.e., HPLC
chromatograms, raw data sheets &
COAs shall be submitted for complete
stability studies till 6th month time point.
2.3.R.1.1 • As per submitted BMRs terminal • No terminal sterilization has been performed, for
sterilization has not been performed. which firm has submitted that aseptic area
Justification shall be submitted in this manufacturing tank under LAF and aseptic blowing,
regard. filling/sealing multiple function cartage assembling
• The proposed batch size shall be 0.65µm+0.45µm+0.22µm in manufacturing for
justified against the minimum handling filtration of solution and 0.22 in filling BFS machine
capacity of the formulation tank. which already mention
in BMR so our product is sterile by filtration and
aseptic process.
Decision: Registration Board deferred the case for further deliberation regarding use of drug substance by M/s
Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder Industrial Estate, Lahore, for the manufacturing of stability
batches, which had been procured and imported by M/s Pacific Pharmaceuticals Ltd., 30th KM, Multan Road,
Lahore.
653. Name, address of Applicant / M/s Pacific Pharmaceuticals Ltd.

Marketing Authorization Holder Plot No. 384, Sunder Industrial Estate, Lahore
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd.
Plot No. 384, Sunder Industrial Estate, Lahore
☐ Importer
Evidence of approval of manufacturing Firm has submitted copy of section approval letter dated 24-06-2019
facility which specifies Ophthalmic general section.

☐ Export sale
The proposed proprietary name / brand Lanto Eye Drops
name
Strength / concentration of drug of One ml eye drops solution contains 50 micrograms of Latanoprost.
Active Pharmaceutical ingredient (API)
per unit
Pharmaceutical form of applied drug Ophthalmic Drops
Pharmacotherapeutic Group of (API) Ophthalmologicals, antiglaucoma preparations and miotics,
prostaglandin analogues. ATC code: S01EE01.
Reference to Finished product In-House specification
specifications
Proposed Pack size 1 x 2.5 ml
The status in reference regulatory Approved by US FDA

authorities
For generic drugs (me-too status) Xalatan Eye Drop 2.5ml by Pfizer Laboratories (Pvt) Ltd.
Name and address of API manufacturer. Cayman Pharma s r.o. ul. Práce 657, 277 11 Neratovice Czech
Republic
validation, batch analysis and justification of specification, reference
substance.
Stability Studies of Drug Substance Latanoprost:
(Conditions duration of Stability studies) Long-term stability studies were performed at a storage temperature
of -18°C for 24 months. Accelerated stability studies were performed
at a temperature of +5 °C for 6 months.
Pharmaceutical Equivalence and Pharmaceutical Equivalence Studies s against the reference product of
Comparative Dissolution Profile “Xalatan Eye Drop” 2.5ml
by Pfizer Laboratories (Pvt) Ltd.

Analytical method validation/verification Firm has submitted verification studies of the drug substance and the
Stability studies Firm has submitted stability studies data of three batches at both
accelerated and long term conditions.
Manufacturer of APIs Cayman Pharma s r.o. ul. Práce 657, 277 11 Neratovice Czech Republic
API Lot No. Batch # 2008S004

Description of Pack Eye Drops is available as 2.5 mL sterile solution in 5 mL LDPE bottle with
(Container closure system) polypropylene dropping nozzle with HDPE Cap
Real time: 5°C ± 3°C
Accelerated: 25°C ± 2°C / 60% RH ± 5% RH
Real time: 6 months
Time Period
Frequency
Real Time: 0, 3,6 (Months)
Batch No. PDAR0012021 PDAR0012021 PDAR0032021
1. Reference of previous approval of applications with N/A
stability study data of
the firm (if any)
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate (Certificate Ref. No.
manufacturer issued by concerned regulatory sukls23837/2017) issued by State Institute for Drug
authority of country of origin. Control is a Czech government agency valid upto 30-
03-2023.
3. Documents for the procurement of API with approval Copy of commercial invoice# FOZ-11/2021 attested
from DRAP (in case of import). by AD I&E DRAP, Lahore, has been submitted.
Latanoprost:
Date of
Quantity
Batch No. approval
Imported
by DRAP
2008S004 7g 24-02-2021
4. Data of stability batches will be supported by attested Firm has submitted data pf stability batches along with
respective documents like chromatograms, Raw data batch manufacturing record and analytical record.
N/A
6. Record of Digital data logger for temperature &
humidity monitoring of stability chambers N/A
3.2. S.4 The specifications submitted from drug substance Firm has submitted revised specifications as
manufacturer are not as per USP monograph of per USP monograph.
“Latanoprost”.
3.2.S.4.4 COA from drug substance manufacturer, of the Submitted
relevant batch used in the production of stability
trial batches, shall be submitted.
3.2.S.7 Evidence of availability of cold storage area i.e., Firm has submitted that we have cold storage
Freezer for the storage of drug substance. room in which one freezer is available.

(Pictorial images have been shared of a
freezer.)
3.2. Pharmaceutical equivalence of the applied drug Pharmaceutical equivalence study has been
P.2.2.1 shall be established with the innovator / reference / submitted against the reference product of
comparator product and results of all the quality Xaltan.
tests (mentioned in any official pharmacopoeia or
section 3.2.P.5.1 of this application) of the
developed formulation and the innovator / reference
/ comparator product shall be submitted.
3.2. Submitted manufacturing method does not include No terminal sterilization has been performed,
P.3.3 terminal sterilization step. Justification shall be for which firm has submitted that aseptic area
submitted in this regard. manufacturing tank under LAF and aseptic
blowing, filling/sealing multiple function
cartage assembling
0.65µm+0.45µm+0.22µm in manufacturing
for filtration of solution and 0.22 in filling
BFS machine which already mention
in BMR so our product is sterile by filtration
and aseptic process.
3.2.P.5.2 Detailed analytical procedures used for testing the Submitted.
drug product shall be provided.
3.2.P.5.3 Analytical method validation studies shall be Submitted.

submitted.
3.2.P.6 Details of primary reference standard, against Firm has referred to USP batch no. R079T0
which the working standard has been standardized, of Latanoprost as primary reference standard.
shall be submitted.
3.2.P.8.3 • The innovator product i.e., Xaltan ophthalmic • It was a typographical error. We
solution of M/s Upjohn, approved by US FDA, have conducted the stability as per
recommends the storage conditions as “Store guidelines recommended
unopened bottle(s) under refrigeration at 2° to temperature for refrigerator item.
8°C (36° to 46°F)”. Justification shall be Firm has submitted stability sheets
submitted for conducting stability studies at wherein storage conditions have
real time (30˚C ± 2˚C / 35% ± 5% RH) and been revised as per refrigerating
accelerated (40˚C ± 2˚C / 25% ± 5% RH). storage conditions Firm has now also
• Analytical record for the complete stability submitted data logger record
studies shall be submitted. accordingly.
• Compete batch manufacturing record for the • Analytical record for the stability
stability batches shall be submitted studies has been submitted.
• BMRs have been submitted.

application.
654. Name, address of Applicant / Marketing M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder
Industrial Estate, Lahore

☐ Importer
Evidence of approval of manufacturing facility Firm has submitted copy of section approval letter dated
24-06-2019 which specifies Ophthalmic (General)
Section
☐ Export sale
The proposed proprietary name / brand name Glucozole-T 5ml Eye Drops
Strength / concentration of drug of Active Each ml Contains:
Pharmaceutical ingredient (API) per unit Dorzolamide as Dorzolamide HCl ………. 20mg
Timolol as Timolol Maleate ……… 5mg
Pharmaceutical form of applied drug Eye drops, solution
Pharmacotherapeutic Group of (API) Dorzolamide
Carbonic anhydrase inhibitors
ATC Code: S01EC03
Timolol: nonselective beta-adrenergic
receptor blocker
ATC Code: S01ED01
The status in reference regulatory authorities Approved by US FDA
For generic drugs (me-too status) Cosopt sterile ophthalmic Solution Solution by: Santen
pharmaceuticals Co., Ltd. Japan
Regd. No. 025294
Pack size: 5 ml
Name and address of API manufacturer. Dorzolamide HCl: M/sNeuland Laboratories Limited,
Unit-1 Sy. No: 347, 473, 474, 490 / 2 Veerabhadraswamy
temple road, Bonthapalli Village, Gummadidala Mandal,
Sangareddy District – 502 313 Telangana, India
Timolol maleate: FDC Limited, 142-48, Swami
Vivekananda Road Jogeshwari (West) Mumbai-400 102.
closure system and stability studies of drug substance and
drug product.

Module-III Drug Substance: Firm has submitted detailed data for drug substance data
Stability Studies of Drug Substance (Conditions Dorzolamide HCl: Long-term stability studies were
duration of Stability studies) performed at a storage temperature of
30°C±2°C/65%±5% RH for 36months. Accelerated
stability studies were performed at a temperature of
40±2°C/75%±5% RH for 6 months.
Timolol maleate: Long-term stability studies were
performed at a storage temperature of
30°C±2°C/65%±5% RH for 36months. Accelerated
stability studies were performed at a temperature of
40±2°C/75%±5% RH for 6 months.
Pharmaceutical Equivalence and Comparative Pharmaceutical Equivalence Studies against the
Dissolution Profile reference product of “Cosopt” of M/s Santen
Pharmaceuticals.
Stability studies Firm has submitted stability studies data of three batches
at both accelerated and long-term conditions.
Dorzolamide HCl: M/s Neuland Laboratories Limited,
Manufacturer of APIs temple road, Bonthapalli Village, Gummadidala Mandal,
Dorzolamide HCl: DZI0420013
API Lot No.
Timolol maleate: 021D026
Description of Pack Low Density Polyethylene Bottle
Real time: 30°C ± 2°C / 35% ± 5%RH
Accelerated: 40°C ± 2°C / NMT 25% RH
Real time: 6 months
Time Period
Frequency
Batch No. TD0109O TD0209O TD0309O
Batch Size 10 liters 10 liters 10 liters

1. Reference of previous approval of applications with N/A
2. Approval of API/ DML/GMP certificate of API
Dorzolamide HCl:
Copy of GMP certificate in the name of M/s Neuland
authority of country of origin. Laboratories Limited valid upto 28-06-2022 issued by
DCA Tealngana.
Timolol maleate:
Copy of GMP certificate (certificate#NEW-WHO-
GMP/CERT/KD/72416/2018/11/24412) in the name of
M/s FDC Limited valid upto 08-08-2021 issued by FDA
Maharashtra.
3. Documents for the procurement of API with Copy of commercial invoice attested by AD I&E
approval from DRAP (in case of import). DRAP, Lahore, has been submitted.
Date of
Quantity
Batch No. approval
Imported
by DRAP
011909031 5875 03-10-2019
Firm has submitted that Invoice stated the address Mis

Pacific Pharmaceuticals Ltd. 30th Km Multan Road,
Lahore
4. Data of stability batches will be supported by Firm has submitted data of stability batches along with
attested respective documents like chromatograms, batch manufacturing record and analytical record.
N/A
6. Record of Digital data logger for temperature & Firm has submitted Record of Digital data logger for
humidity monitoring of stability chambers temperature & humidity monitoring of stability chambers
(real time and accelerated) (real time and accelerated)
In response to the following shortcomings communicated to firm vide letter no. F.1-1/2020/PEC-DRAP (AD PEC-II),
firm has submitted that due to some errors in our previous data we have submitted the updated stability batches data
along with 6 months stability report. Kindly consider this updated data and withdraw or neglect our previous data at
the date of submission of dossier.
Details of revised stability data are as under:

Dorzolamide HCl: M/s Neuland Laboratories Limited,
Manufacturer of APIs temple road, Bonthapalli Village, Gummadidala Mandal,
Dorzolamide HCl: DZI0420013
API Lot No.
Timolol maleate: 021D026
Description of Pack Low Density Polyethylene Bottle
Real time: 30°C ± 2°C / 35% ± 5%RH
Accelerated: 40°C ± 2°C / NMT 25% RH
Real time: 6 months
Time Period
Frequency
Batch No. PDEN0012021 PDEN0022021 PDEN0032021
Batch Size 5 liters 5 liters 5 liters

# Documents to be provided Status
1. Reference of previous approval N/A
of applications with stability
2. Approval of API/ DML/GMP Dorzolamide HCl:
certificate of API manufacturer Copy of GMP certificate in the name of M/s Neuland
issued by concerned regulatory Laboratories Limited valid upto 28-06-2022 issued by
authority of country of origin. DCA Telangana.
Timolol maleate:
Copy of GMP certificate (Certificate#NEW-WHO-
GMP/CERT/KD/72416/2018/11/24412) in the name of
M/s FDC Limited valid upto 08-08-2021 issued by FDA
Maharashtra.
3. Documents for the Copy of commercial invoice attested by AD I&E DRAP,
procurement of API with Lahore, has been submitted.
approval from DRAP (in case Date of
Quantity
of import). API Batch No. approval
Imported
by DRAP
Dorzolamide DZT0420013 1Kg 08-06-
2021
Timolol 1386/186 0.025gm 08-06-
2021
Submitted invoices are in the name of M/s Pacific

Pharmaceuticals Ltd. 30th Km Multan Road, Lahore.
4. Data of stability batches will be Firm has submitted data of stability batches along with
supported by attested batch manufacturing record and analytical record.
respective documents like
chromatograms, Raw data
sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC
software 21CFR & audit trail N/A
6. Record of Digital data logger
for temperature & humidity Firm has submitted Record of Digital data logger for
monitoring of stability temperature & humidity monitoring of stability chambers

1.5.6 Drug product specifications have It was a typographic error. Product is according to the
been referred to as Innovator’s European pharmacopoeial monographs.
specifications whereas
Pharmacopoeial monographs are
available for applied product.
Dorzolamide HCl
3.2. • Drug substance manufacturer • In BP/Ph. Eur there is potentiometric titration for
S.4.1 has declared drug substance as API assay determination while in USP there is use
of Ph. Eur grade, whereas the of HPLC for Assay determination, which is better
submitted Assay method is as technique and equipment than the technique
per USP pharmacopoeia. adopted by drug substance manufacturer.

• Copies of the Drug substance Copies of analytical procedure submitted from drug
specifications and analytical product manufacturer.
procedures used for routine
testing of the Drug substance
/Active Pharmaceutical
3.2.S.4.3 • Analytical Method Verification Submitted.
studies including specificity,
accuracy and repeatability
(method precision) performed
by the Drug Product
3.2.S.4.4 • Provide results of analysis of Submitted.
Product manufacturer used
during product development and
stability studies, along with
Certificate of Analysis (CoA) of
the same batch from Drug
Substance / /Active
manufacture.
3.2. S.7 Drug substance stability data as per Submitted as per Zone-IVa.
Zone IV a condition shall be
submitted.
Timolol maleate
3.2. • Copies of the Drug substance Submitted
S.4.1 specifications and analytical
procedures used for routine
testing of the Drug substance
/Active Pharmaceutical
3.2. • Analytical Method Verification Submitted
S.4.3 studies including specificity,
accuracy and repeatability
(method precision) performed
by the Drug Product
3.2. • Provide results of analysis of Submitted.
S.4.4 relevant batch(es) of Drug
Product manufacturer used
stability studies, along with
Certificate of Analysis (CoA) of
the same batch from Drug
Substance / /Active
manufacture.
3.2. S.7 Submitted stability reports are not Submitted
readable.

3.2. Process validation protocol shall be Submitted
P.3.5 submitted.
3.2. Analytical method verification Analytical method verification studies have been
P.5.3 studies performed by drug product submitted for Dorzolamide only.
3.2. P.6 COA of primary / secondary Submitted
reference standard including source
and lot number shall be provided.
3.2. P.8 Following shall be submitted: • BMR for three trial batches have been submitted.
• Complete batch manufacturing • No terminal sterilization has been performed, for
record of stability trial batches. which firm has submitted that aseptic area
• Documents for the procurement manufacturing tank under LAF and aseptic
of API with approval from blowing, filling/sealing multiple function cartage
DRAP (in case of import). assembling 0.65µm+0.45µm+0.22µm in
manufacturing for filtration of solution and 0.22 in
filling BFS machine which already mention in
temperature & humidity
BMR so our product is sterile by filtration and
aseptic process.
• Submitted analytical record
• Firm has applied “Solution preparation tank” of 100
reflect that chromatographic
litres for the manufacturing of 5 litre batch size
conditions for the Assay analysis
stating that design capacity of active manufacturing
of Dorzolamide have not been
tank ranges from 5 litres to 100 litres so, 5 litres
performed as per
batch can be easily processed.
recommendations of USP
monograph, since the gradient Submitted HPLC chromatograms reflect that the
run time as per monograph is of chromatographic conditions for the Assay test have not
30 minutes while the firm has been complied as per USP monograph in terms of the
run HPLC chromatogram, for run time for which firm has replied that although the
about 12 minutes only. injection run time is 30minute but the peaks separation
of Dorzolamide is about 12 minutes. In the
chromatograms sample run time is about 20minute but
there is no any further peak found. So, it Is not big issue,
in future will follow up to 30minutes.
Firm has submitted fee of Rs. 30,000/- for revision of stability data as per following details:
Rs. 7,500/- vide deposit slip#5349893974 dated 01-03-2022
Rs. 22500/- vide deposit slip#92601467 dated 09-03-2022
Decision: Registration Board deferred the case for further deliberation regarding use of drug substance by M/s
Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder Industrial Estate, Lahore, for the manufacturing of stability
batches, which had been procured and imported by M/s Pacific Pharmaceuticals Ltd., 30th KM, Multan Road,
Lahore.

655. Name, address of Applicant / Marketing M/s Carer Pharmaceuticals Industries, Plot # 27, Main Road,
Authorization Holder Rawat Industrial Estate, Rawat
Name, address of Manufacturing site. M/s Carer Pharmaceuticals Industries, Plot # 27, Main Road,
Rawat Industrial Estate, Rawat
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Gabril 150mg capsule
Pharmaceutical ingredient (API) per unit Pregabalin…………….150mg
Pharmacotherapeutic Group of (API) Anticonvulsants
The status in reference regulatory authorities Lyrica 150mg capsule of Upjohn UK limited (USFDA
Approved)
For generic drugs (me-too status) ZEEGAP 150mg Capsule of M/s Hilton pharma
manufacturer Tablet (General), Dry Powder Suspension (General), Sachet
(General), Ampoule (General), Capsule (General) section
approved.
Name and address of API manufacturer. M/s Zhejiang Huahai Pharmaceutical Co., Ltd. Address:
Chuannan, Duqiao, Linhai, Zhejiang, 317016, China
manufacturers, impurities, specifications, analytical
closure system and stability studies of drug substance and
Module III (Drug Substance) The firm has submitted details regarding nomenclature,
manufacturers, analytical procedures and its verification,
drug substance.
Stability studies of drug substance The firm has submitted 06 months accelerated and 36
months real time stability study data of drug substance.

Module-III (Drug Product): The firm has submitted details of manufactures, description
Pharmaceutical equivalence and comparative The firm has submitted pharmaceutical equivalence of
dissolution profile developed formulation (Batch # T-001) against the
innovator product that is Lyrica 100 mg Capsule by Pfizer
Pharma performing quality tests (Identification, Assay,
Dissolution).
CDP has been performed with the same comparator product
that is Lyrica 150 mg Capsule by Pfizer Pharma in acid
media (pH 1.2), acetate buffer pH 4.5 & Phosphate Buffer
(pH 6.8). The values for f1 and f2 are in the acceptable range.
Analytical method validation/verification of Firm has submitted report of verification studies of
product analytical method for the drug substance.
Firm has submitted report of validation of analytical method
for the drug product.
Manufacturer of API M/s Zhejiang Huahai Pharmaceutical Co., Ltd. Address: Chuannan, Duqiao, Linhai,
Zhejiang, 317016, China
API Lot No. D5248-19-069
Description of Pack
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of approval of DML for M/s
API manufacturer issued by concerned Zhejiang Huahai pharmaceutical co., Ltd, China issued by
regulatory authority of country of origin. Zheijiang Drug Administration. It is valid till 12-01-2025.
approval from DRAP (in case of import). Pregabalin (1.114 Kg, Batch # D5248-19-069) dated 12-12-
2020. The invoice is not attested by AD (I & E) of concerned
office.

5. Compliance Record of HPLC software The firm has not submitted compliance record of 21 CFR
21CFR & audit trail reports on product testing and audit trail reports on product testing.
and humidity monitoring of stability and humidity monitoring of stability chambers.
Decision: Approved.
• Manufacturer will place first three commercial batches on long term stability studies throughout proposed shelf life
and on accelerated studies for six months as per the commitment submitted in the registration application.
• Manufacturer will perform process validation of first three commercial batches as per the commitment submitted in
b. New Sections:
656. Name, address of Applicant / Marketing M/s Islam Pharmaceuticals 7KM Pasrur Road Sialkot
Name, address of Manufacturing site. M/s Islam Pharmaceuticals 7KM Pasrur Road Sialkot
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.26035 Dated: 20/09/2021
Details of fee submitted PKR 30,000/- Dated: 16/09/2021
Sterile Water for Injection 5ml
name
Strength / concentration of drug of Each 5ml ampoule contains:
Active Pharmaceutical ingredient (API) Sterile Water for Injection USP…….5ml
per unit
Pharmaceutical form of applied drug Clear and colorless solution filled in clear glass ampoules with red
color breaking ring
Pharmacotherapeutic Group of (API) Diluent/Solvent
USP
specifications
Proposed Pack size 5ml×100’s
The status in reference regulatory Sterile water for injection, Pfizer Limited
authorities Ramsgate Road Sandwich Kent MHRA Approved.
For generic drugs (me-too status) Sterile water for injection 5ml by M/s N. S pharma.
Reg. No. 086464

GMP status of the Finished product New Section for liquid ampoule (SVP) General was granted after
manufacturer inspection vide letter No.
F. 1-19/2014-Lic (Vol-1)
Dated: 18/12/2020
Name and address of API manufacturer. N/A
description of manufacturing process and controls, Total organic
carbon, Particulate matter, specifications, batch analysis and
justification of specification, container closure system and stability
studies of drug product is submitted.
Module III (Drug Substance) Official monograph of Water for injection is present in USP. The
of manufacturing process and controls, tests for Total Organic
Carbon by TOC analyzer, specifications, analytical procedures,
batch analysis and justification of specification.
Stability studies N/A
procedure and batch analysis and justification of specification,
drug product.
comparative dissolution profile brand leader that is Sterile WFI 5ml by N.S. Pharma. by performing
quality tests (Appearance, Conductivity, Particulate matter, TOC
and Volume Variation).
All parameters results are in the acceptable range.
Analytical method N/A
validation/verification of product
Manufacturer of API N/A
API Lot No. N/A
Description of Pack
USP Type-I Glass ampoules in card board web, packed in unit carton (5ml×100’s)
Batch No. 21ARn042 21ARn043 21ARn044
Batch Size 2000 ampoules 2000 ampoules 2000 ampoules
No. of Batches 03

applications with stability study data of (New Section)
the firm (if any)
14. Approval of API/ DML/GMP certificate Copy of GMP certificate No. 115/2020-DRAP (AC1949403-534)
of API manufacturer issued by concerned issued by DRAP valid till 09/07/2022.
15. Documents for the procurement of API
with approval from DRAP (in case of N/A
import).
16. Data of stability batches will be
supported by attested respective Submitted
sheets etc.
21CFR & audit trail reports on product N/A
testing
temperature and humidity monitoring of Submitted
accelerated)
Remarks of EvaluatorII:
Decision: Approved.
657. Name, address of Applicant / M/s Islam Pharmaceuticals 7KM Pasrur Road Sialkot
Marketing Authorization Holder
☐ Importer
☐ Export sale
SpaX 40mg/2ml Injection
name
Strength / concentration of drug of Each 2ml ampoule contains:
Active Pharmaceutical ingredient (API) Drotaverine Hydrochloride …….40mg
per unit
Pharmaceutical form of applied drug Light yellow to yellow color solution filled in amber glass ampoule
with white one point cut mark
Pharmacotherapeutic Group of (API) Anti-Spasmodic

Innovator
specifications
The status in reference regulatory No-SPA injection 40mg/2ml by M/s CHINOIN Pharmaceuticals
authorities and chemical, works private Co. Ltd HUNGARY, EMA Approved.
For generic drugs (me-too status) Drotalite Injection 40mg/2ml by M/s Elite Pharma.
Reg. No. 046342
GMP status of the Finished product New Section for liquid ampoule (SVP) General was granted after
manufacturer inspection vide letter No.
F. 1-19/2014-Lic (Vol-1)
Dated: 18/12/2020
Name and address of API manufacturer. M/s Integrin Life Sciences Pvt. Ltd. Plot # 69-71 & 75-77, APIIC
Industrial Park, Tirumalagiri Village, Jaggiahpita Mandal,
Karishna District 521 175, Andhra Pardesh INDIA.
Module III (Drug Substance) Drotaverine Hydrochloride is as per Manufacturer Specifications.
of manufacturing process and controls, tests for related substances
by HPLC (individual impurity and Total Impurities), specifications,
Batches:(DVHPD-00114, DVHPD-00214, DVHPD-00314)
comparative dissolution profile brand leader that is No-Spa 40mg/2ml injection by Snofi-Aventis
Pakistan Ltd. by performing quality tests (Appearance,
Identification, Assay, pH and Volume Variation).
Analytical method Method validation studies have submitted including, Specificity,
validation/verification of product Limit of Detection, Limit of Quantitation, linearity, range,
accuracy, precision, Robustness.

Manufacturer of API M/s Integrin Life Sciences Pvt. Ltd. Plot # 69-71 & 75-77, APIIC Industrial
Park, Tirumalagiri Village, Jaggiahpita Mandal, Karishna District 521 175,
Andhra Pardesh INDIA.
API Lot No. DVH/0051020
Description of Pack USP Type-I amber Glass ampoules in PVC Tray, packed in unit carton
(Container closure system) (2ml×25’s)
No. of Batches 03
applications with stability study data of (New Section)
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. 67/DD/DCA/ELR/2021 issued by
of API manufacturer issued by concerned DCA valid till 08/04/2022.
3. Documents for the procurement of API • Copy of letter No.14850/2020/DRAP-AD-VIII (I&E) dated
with approval from DRAP (in case of 16/10/2020 is submitted wherein the permission to import
import). different APIs including Drotaverine HCl for the purpose of
• AirWay Bill No.157-6746 4235
dated 10/11/2020
sheets etc.
testing
accelerated)
Section Observation Firm’s response
#
3.2.S.4. Drug substance manufacturer has submitted We M/s Islam pharmaceuticals revised the assay
2 HPLC method for the Assay test whereas M/s method from titration to HPLC method as
Islam pharma has submitted titration method submitted by Drug substance manufacturer,
for the Assay test. method verification studies conducted and API
test performed according to HPLC method.

Revised HPLC test method, method verification
protocol and report, API test results have been
submitted.
3.2.S.7 Long term stability conditions mentioned in Long term stability conditions mentioned in
summary & conclusion are different from that summary and conclusion are different from
declared in the stability data submitted in declared in stability data because in DMF the
section 3.2.S.7.3. manufacturer mentioned Zone II conditions and
provided stability data for long term stability
studies at 25oC/60%RH.
After receiving DMF we asked the drug
substance manufacturer to provide Zone-IVA
(30oC/65%RH) stability data which is submitted
under stability data in section 3.2.S.7.3.
3.2. P.1 • Justification shall be submitted for use of • Different trial batches were prepared during
excipients other than that used by the product development studies and observed pH
reference product. issues (details are given under section
• Justification shall be submitted for the use 3.2.P.2.2.1 Formulation development).
of anti-microbial preservatives in the Only the proposed formulation showed stable
applied formulation. pH before and after autoclaving and met the
• Drug excipient compatibility studies shall specified limits of tests.
be submitted, since the excipients used in • Propylene glycol and Benzyl alcohol are also
the applied formulations is different from used as solvent to enhance the solubility of
that used in the reference product. poorly water-soluble ingredients and are used
as solvent in our formulation,
Reference: (Handbook of pharmaceutical

excipients, 7th Edition by RayMond C Rowe)
Mistakenly only one function (antimicrobial
preservative) was written under section
3.2.P.1 which is corrected and attached as
Annexure-III.
• Drug Excipient compatibility Studies are
submitted but no details have been provided
regarding stress conditions and tests applied
for the drug excipient compatibility study.
3.2.P.5. • The sample concentration applied for the • Same sample concentration as declared in
3 performance of the “Precision” parameter assay method was applied for performance of
is not as that declared in the Assay method “precision” parameter in method validation
for drug product submitted in section studies. By a typographic mistake the
3.2.P.5.3 concentration was written 0.08mg/ml instead
• In the performance of Linearity & of 0.8mg/ml in method validation report for
Accuracy parameter, concentrations of “precision” parameter which is evident from
sample solutions in terms mg/ml have not the raw data of method validation for applied
been declared. product. Corrected method validation report
and raw data showing correct concentration
as per assay method is submitted.
• Method validation report containing
concentration of sample solutions in mg/ml
for linearity and accuracy parameters is
submitted.
3.2. P.6 Potency of working standard declared in the CoA of both In-House working standard and
COA is different form that applied in the Working standard provided by Drug Substance
calculation of Assay results of trial batches. manufacturer are provided under section 3.2.P.6
Reference standard or materials.
We M/s Islam pharmaceuticals used Working
standard provided by Drug substance

manufacturer for assay test of trial batches and the
potency of WS on as is basis is used for
calculation. Copy of CoA provided by Drug
substance manufacturer is submitted.
Potency of WS on dried basis 99.8%, LOD =
2.41%,
Potency on as is basis = 99.8-2.41 = 97.39%.
2.3. • Submit the minimum handling capacity of Minimum handling capacity of mixing vessel
R.1.1 the mixing vessel used for the production used in production of trial batches is 1.5 liters.
of trial batches.
Decision: Approved.
☐ Importer
☐ Export sale

Troket 30mg/ml Injection
name
Pharmaceutical ingredient (API) per unit Ketorolac Tromethamine …….30mg
Pharmaceutical form of applied drug Clear and colorless solution filled in clear glass ampoules
with red and blue ACF rings and blue color OPC mark
Pharmacotherapeutic Group of (API) Anti-inflammatory agent, non-steroid
USP
specifications
The status in reference regulatory Ketorolac Tromethamine injection 30mg/ml by M/s
authorities Peckforton Pharmaceuticals Limited Crewe Hall, Crewe,
Cheshire, CW1 6UL, United Kingdom, MHRA Approved.
For generic drugs (me-too status) Toradol Injection 30mg/ml by M/s Barrett Hodgson
Pakistan (Pvt.) Ltd.
Reg. No. 015000

GMP status of the Finished product New Section for liquid ampoule (SVP) General was granted
manufacturer after inspection vide letter No.
F. 1-19/2014-Lic (Vol-1)
Dated: 18/12/2020
Name and address of API manufacturer. M/s PERKIN LABORATORIES, plot No. 94 TSIIC,
Industrial estate, Medchal Dist. 501401, Telangana,
INDIA
submitted.
Module III (Drug Substance) Official monograph of Ketorolac Tromathamine is present
controls, , specifications, analytical procedures and its
Batches:(KM-1102215, KM-1102315, KM-1102415)
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established against
comparative dissolution profile the brand leader that is Toradol 30mg/ml injection by Sami
Pharmaceuticals by performing quality tests (Appearance,

Manufacturer of API M/s PERKIN LABORATORIES, plot No. 94 TSIIC, Industrial estate,
Medchal Dist. 501401, Telangana, INDIA
API Lot No. KM-1104620
Description of Pack USP Type-I Glass ampoules in PVC Tray, packed in unit carton

Batch Size 2500 2500 ampoules 2500 ampoules
ampoules
11-05-2021 11-05-2021
2021
No. of Batches 03
applications with stability study data of the (New Section)
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. 3879/Stores/2019 issued by
API manufacturer issued by concerned DCA valid till 10/01/2021.
3. Documents for the procurement of API with • Copy of letter No.14850/2020/DRAP-AD-VIII (I&E)
import different APIs including Ketorolac Tromethamine
for the purpose of test/analysis and stability studies is
granted.
• AirWay Bill No. 176-26046624
Dated: 21/12/2020
chromatograms,
etc.
testing
1.6.5 Valid GMP certificate issued by the Copy of GMP certificate No. 77981/TS/2022 issued
relevant regulatory authority shall be by DCA Telangana valid till 02/01/2023 has been
submitted for the drug substance submitted.
manufacturer.
3.2. S.4.1 Limits for the test of pH are different As per USP monograph of Ketorolac Tromethamine,
between the drug substance Limit for pH is 5.7 – 6.7 which is mentioned in test
manufacturer & drug product method and specifications submitted by Drug
manufacturer. product manufacturer.
Drug substance manufacturer mentioned the pH limit
5.7-6.0 in his specification, However in CoA of drug
substance and stability study data submitted by Drug
substance manufacturer the limit for pH is mentioned
5.7 – 6.7 (as per USP), copy of CoA provided by

Drug substance manufacturer for ketorolac
Tromethamine having pH limit as per USP (5.7 – 6.7)
is submitted
3.2. S.4.2 Sample and standard solution USP monograph of Ketorolac Tromethamine
concentration mentioned in the Assay recommends concentration of reference and sample
test method from drug substance solution to be 0.4mg/ml for assay test. For Assay test
manufacturer are different from that Drug substance manufacturer referred to related
recommended by USP monograph of substances sample and standard preparation which is
“Ketorolac tromethamine”. 20mg sample dissolved in 50ml of solvent. The
resultant concentration becomes 0.4mg/ml which is
same as recommended by USP.
3.2.S.7 Long term stability conditions Long term stability conditions mentioned in
mentioned in summary & conclusion summary and conclusion are different from declared
are different from that declared in the in stability data because in DMF the manufacturer
stability data submitted in section mentioned Zone II conditions and provided stability
3.2.S.7.3. data for long term stability studies at 25oC/60%RH.
After receiving DMF we asked the drug substance
manufacturer to provide Zone-IVA (30oC/65%RH)
stability data which is submitted under stability data
in section 3.2.S.7.3.
3.2.P.1 • Justify the role of Ethyl alcohol as Ethyl alcohol is also used as solvent and penetration
antimicrobial preservative in the enhancer to enhance the solubility of ingredients and
applied formulation. it is used as solvent/solubility enhancer in our
• Reference for use of Citric acid as formulation. By mistake only one function of ethyl
anti-oxidant in the innovator alcohol (antimicrobial preservative) was written
formulation shall be submitted. under section 3.2.P.1 which is corrected and
submitted.
3.2.P.2.2.1 Complete testing has not been Complete testing was performed during
performed during Pharmaceutical Pharmaceutical equivalence studies (mentioned in
equivalence studies. finish product reports under batch analysis), sterility
and endotoxin test were not reported in
pharmaceutical equivalence report which is
corrected and revised report containing all test and
results are submitted.
3.2.P.3.2 Justify the proposed quantity of drug The quantity of drug substance is written mg per
substance in mg/ml against the label 1.1ml to achieve the deliverable volume (NLT 1ml)
claim. per unit in section 3.2.P.3.2. However, to clear the
ambiguity, quantity of drug substance is corrected to
mg/1ml and submitted
3.2.P.3.3Justify the performance of terminal Firm has referred to a patent wherein terminal
sterilization by autoclave while ethyl sterilization has been performed for Ketorolac
alcohol is used in the formulation injection containing Ethyl alcohol.
2.3.R.1.1 • Justify the performance of • Firm has referred to a patent wherein terminal
terminal sterilization by autoclave sterilization has been performed for Ketorolac
while ethyl alcohol is used in the injection containing Ethyl alcohol.
formulation. • Minimum handling capacity of mixing vessel
• Submit the minimum handling used in production of trial batches is 1.5 liters.
capacity of the mixing vessel used
for the production of trial batches.
Decision: Deferred for scientific rationale of performing terminal sterilization, with reference to the
innovator product.

☐ Importer
☐ Export sale
The proposed proprietary name / brand name Nalphine 20mg/ml Injection
Pharmaceutical ingredient (API) per unit Nalbuphine hydrochloride ……. 20mg
Pharmaceutical form of applied drug Clear and colorless solution filled in clear glass
ampoules with blue color breaking ring
Pharmacotherapeutic Group of (API) Opioid agonist-antagonist
The status in reference regulatory authorities Nalbuphine Hydrochloride injection 10mg/ml by M/s
Hospira Pharmaceuticals, USFDA Approved.
For generic drugs (me-too status) Kinz Injection 10mg/ml by M/s Sami Pharmaceuticals
(Pvt) Ltd. Reg. No. 018686
GMP status of the Finished product manufacturer New Section for liquid ampoule (SVP) General was
granted after inspection vide letter No.F. 1-19/2014-
Lic (Vol-1) Dated: 18/12/2020
Name and address of API manufacturer. M/s Micro orgo-chem, C-1/B-57, LIC Sector, GIDC
Vapi-396 195, Gujarat, INDIA.
of manufacturing process and controls, specifications,
and controls, specifications, analytical procedures and
Batches:(MO/NBP/1401, MO/NBP/1402,
MO/NBP/1403)

dissolution profile against the Kinz 20mg/ml injection of Sami
Pharmaceuticals by performing quality tests
(Appearance, Identification, Assay, pH and Volume
Variation).
Analytical method validation/verification of Method validation studies have been submitted.
product
Manufacturer of API M/s Micro Orgo-chem, C-1/B-57, LIC Sector, GIDC Vapi-396 195, Gujarat, INDIA.
API Lot No. MO/NBP/2003
Description of Pack
USP Type-I Clear Glass ampoules in PVC Tray, packed in unit carton (1ml×5’s)
No. of Batches 03
1. Reference of previous approval of applications Not submitted
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. S-GMP/1991608 issued
manufacturer issued by concerned regulatory by FDCA valid till 23/09/2021.
3. Documents for the procurement of API with • Copy of letter No.14850/2020/DRAP-AD-VIII
approval from DRAP (in case of import). (I&E) dated 16/10/2020 is submitted wherein the
permission to import different APIs including
Nalbuphine HCl for the purpose of test/analysis and
5. Compliance Record of HPLC software 21CFR & Data logger record of HPLC has been submitted.

☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No 25697 Dated: 15/09/2021
The proposed proprietary name / brand name Nalphine 10mg/ml Injection
Pharmaceutical ingredient (API) per unit Nalbuphine hydrochloride ……. 10mg
Pharmacotherapeutic Group of (API) Opioid agonist-antagonist
The status in reference regulatory authorities Nalbuphine Hydrochloride injection 10mg/ml by M/s
Hospira Pharmaceuticals, USFDA Approved.
For generic drugs (me-too status) Kinz Injection 10mg/ml by M/s Sami Pharmaceuticals
(Pvt) Ltd. Reg. No. 018686
Lic (Vol-1) Dated: 18/12/2020
Name and address of API manufacturer. M/s Micro orgo-chem, C-1/B-57, LIC Sector, GIDC
Vapi-396 195, Gujarat, INDIA.

Batches:(MO/NBP/1401, MO/NBP/1402,
MO/NBP/1403)
dissolution profile against the Kinz 10mg/ml injection of Sami
Pharmaceuticals by performing quality tests
(Appearance, Identification, Assay, pH and Volume
Variation).
product
Manufacturer of API M/s Micro Orgo-chem, C-1/B-57, LIC Sector, GIDC Vapi-396 195, Gujarat,
INDIA.
API Lot No. MO/NBP/2003
Description of Pack
USP Type-I Clear Glass ampoules in PVC Tray, packed in unit carton (1ml×5’s)
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. S-GMP/1991608 issued
manufacturer issued by concerned regulatory by FDCA valid till 23/09/2021.
Nalbuphine HCl for the purpose of test/analysis and

5. Compliance Record of HPLC software 21CFR & Data logger record of HPLC has been submitted.
2.3.S.1.1 INN name has been declared as • By a typographic mistake International Non-
“Nalbuphine hydrochloride Proprietary Name (INN) written as “Nalbuphine
dihydrate”. Clarification shall be Hydrochloride dehydrate”. However, in CTD under
submitted in this regard, since no section 1.5.1 Generic name with chemical name &
water molecule is evident in the synonyms of the applied drug, INN is declared as
submitted drug substance structure. “Nalbuphine Hydrochloride”.
• Correction in section 2.3.S.1.1 International Non-
Proprietary Name (INN) as “Nalbuphine
Hydrochloride” have been made.
3.2. S.4 • Justification shall be submitted • In assay test by titration method we used crystal violet
for the performance of Assay as indicator instead of
test by applying “Titration” • 1-naphtholbenzein because 1-naphtholbenzein was
method. not available due to supply chain issues during
• Analytical method for Assay of COVID, so we used alternative indicator crystal
drug substance submitted by violet. Both the indicators are permissible in non-
drug product manufacturer is aqueous titrations. The Assay method was validated.
different form that proposed by
drug substance manufacturer.
3.2.S.4.4 Numerical value for the results of Result of water content test in numerical value are added
Water content test shall be written to the CoA of drug substance.
in the COA of drug substance
performed by drug product
manufacturer.
3.2.P.8 • Submit stability studies data for • Stability study data for 06-month time point for both
complete till 6th month time Accelerated and long-term stability is submitted.
point for both accelerated and
long-term stability conditions. • Raw data sheets for complete stability studies with
• Following shall be submitted: details of sample and standard solution preparation
i. Raw data sheets for complete and calculation formula applied submitted.
stability studies wherein • Valid GMP certificate of Drug substance issued by
details of standard solution relevant regulatory authority is submitted.
preparation, sample solution
preparation, calculation
formula applied.
ii. Valid GMP certificate of
drug substance issued by the
relevant regulatory
authority.
• Submitted BMRs does not • Copy of BMR pages containing condition of terminal
reflect the conditions of sterilization are submitted.
terminal sterilization. • As it was planned to manufacture the stability
• Dispensing of raw materials for batches in Feb-2021 so dispensing was done in Feb-
the trial batch manufacturing 2021 but accidently ampoule filling and sealing
was performed in February machine operator fall ill and was suspected with

2021, whereas the COVID and was quarantined until fully recovered.
compounding was done in Due to his illness the compounding of batches was
April, 2021. Clarification shall delayed.
be submitted for this delay.
Decision: Registration Board deferred both the applications of “Nalphine 10mg/ml Injection” & “Nalphine
20mg/ml Injection” for the justification of specified pH range of “3.0 – 4.5” for the drug product, since the
innovator product i.e., “Nubain injection” approved by U SFDA, specifies the pH range of 3.5 to 3.7.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Care-D 5mg/ml Injection
Pharmaceutical ingredient (API) per unit Cholecalciferol …….5mg (200000IU)
Pharmaceutical form of applied drug Pale yellow solution filled in clear glass ampule with
blue color “color breaking ring”.
Pharmacotherapeutic Group of (API) Vitamin D
The status in reference regulatory authorities Vitamin D3 Good 200000 IU/ml (5mg/ml) by M/s
Bouchara-Recordati, ANSM France Approved.
For generic drugs (me-too status) Indrop-D 5mg/ml by M/s Neutro Pharma (Pvt) Ltd.
Reg. No. 023170
Lic (Vol-1) Dated: 18/12/2020
Name and address of API manufacturer. M/s Zhejiang NHU Company Ltd. No.418 Xinchang
Dadao West Road, Qixing Street, Xinchang County
CHINA.

Batches:(VD3-201304001, VD3-201304002, VD3-
201305001)
dissolution profile against the brand leader that is Indrop-D 5mg/ml
injection by Neutro Pharma
product
Manufacturer of API M/s Zhejiang NHU Company Ltd. No.418 Xinchang Dadao West Road, Qixing
Street, Xinchang County CHINA
API Lot No. 01201103VD
Description of Pack
USP Type-I clear Glass ampoules in PVC Tray, packed in unit carton (1ml×1’s)
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. ZJ20180077 issued by
manufacturer issued by concerned regulatory PRC valid till 23/07/2023.

Cholecalciferol for the purpose of test/analysis and
• AirWay Bill No. 607-91230053
Dated: 02/12/2020
5. Compliance Record of HPLC software 21CFR & --

2.3. Manufacturing process mentions The applied product was sterilized by filtration method
P.3.3 steam sterilization of filled and test of finish product and stability studies are
ampoules. Justification shall be concluded on product sterilized by filtration method,
submitted for terminally sterilizing some portion was autoclaved to check the effect of
vitamin containing formulation. autoclavation on pH and color of product.
Revised BMR for commercial manufacturing has been
submitted.
3.2.S.4.4 • Analytical record for the drug • Analytical record for the drug substance analysis
substance analysis performed by performed by M/s Islam Pharma, has been submitted.
M/s Islam Pharma, shall be • Firm has submitted revised COA form drug substance
submitted. manufacturer declaring compliance with EP standard.
• COA of drug substance
manufacturer narrates “Comply
with USP standard”, whereas
section 3.2.S.4.1 claims BP
specifications. Clarification shall
be submitted in this regard.
3.2.S.5 COA of primary / secondary COA of primary reference standard of Ph. Eur has been
reference standard including source submitted.
and lot number shall be provided.
3.2.S.7 • Submitted drug substance We contacted the drug substance manufacturer and he
accelerated stability studies data accepted that it was a typographic mistake. Drug
mentions the humidity substance manufacture submitted the revised DMF
conditions as 60%+10%, containing the temperature and humidity conditions as
whereas ICH recommended per ICH guidelines.
conditions are 60% RH ± 5%
RH. Justification shall be
• Submitted drug substance long
term stability studies data
mentions the humidity
conditions as
Temp,6+2oC/RH60%+10%.
whereas ICH recommended
conditions are 5+3oC.
Justification shall be submitted in
this regard.0

3.2. P.1 Innovator product approved by Applied product is also available in BP (only difference
ANSM of France declares use of is of strength of product) and BP mentions Ethyl oleate
“Medium chain triglycerides”, as as excipient, so it is permissible to use ethyl oleate in
excipient, whereas composition preparation of cholecalciferol injection.
table submitted by firm declares
use of “Ethyl oleate”, as solvent,
which is a Long chain triglyceride.
Justification shall be submitted for
this variation.
3.2. In Pharmaceutical equivalence Initially Pharmaceutical equivalence study of comparator
P.2.2.1 studies test of the applied product is product was missed along with applied product test and
declared as 04-05-2021 while test was later performed along with 3-month stability studies.
date for comparator product is
declared as 02-09-021. Justification
shall be submitted for this gap in
analysis.
3.2.P.3.2 Justify the quantity of 5.03mg of Firm has justified the quantity of 5.03mg per ampoule
Choleclaciferol per ampoule against the potency adjustment for the Assay of drug
declared in the batch formula. substance i.e., 99.45%.
3.2.P.3.3 Manufacturing process mentions • The applied product was sterilized by filtration
terminal sterilization by autoclave method and test of finish product and stability studies
of filled ampoules. Justification are concluded on product sterilized by filtration
shall be submitted for terminally method, some portion was autoclaved to check the
sterilizing vitamin containing effect of autoclavation on pH and color of product.
formulation. • Firm has submitted machine usage log book of
terminal sterilizer wherein sampe portion has been
recorded as 25 ampoules for the batches of applied
product.
• Revised BMR for commercial scale manufacturing
has been submitted.
3.2.P.5.2 • Submitted analytical procedure Analytical procedure under reference as BP 2020 is
declares the reference as “BP written to indicate that the test method applied to the
2020”. Justification shall be product is as per BP 2020, it does not declare the product
submitted for the applicability as BP specification. Correction in analytical procedure is
of BP monograph for applied made.
formulation.
3.2.P.5.4 Submitted COAs declare that Analytical procedure under reference as BP 2020 is
product meets the requirement of written to indicate that the test method applied to the
release protocol as per Innovator product is as per BP 2020, it does not declare the product
specifications, whereas section as BP specification. Correction in analytical procedure is
3.2.P.5.2 refers to BP monograph. made.
3.2. The said section declares that As only difference between applied product and BP
P.5.6 Assay test performed as per BP method for cholecalciferol injection is strength so the BP
method for cholecalciferol 2020 assay and identification test method was applied to
injection. Justification shall be test product, method verification studies were also
submitted for the applicability of conducted.
BP monograph since the applied
strength is different from that
defined in the BP monograph of
“Coleclaciferol injection”.
Moreover, the submitted analytical
method is also not as per BP
monograph of “Coleclaciferol
injection”.

3.2. P.6 • Submitted working standard Firm has declared it as a typographic error and has
COA mentions the Batch# of referred to the HPLC chromatograms wherein correct
CRS as 6247, whereas CRS# has been written.
submitted COA of CRS declare As cholecalciferol API was tested against BPCRS hence
the batch# as 4267. it was standardized at the same time and was used in
• The batch# and Assay results testing of stability studies.
are same as that for the Drug
substance COA submitted in
section 3.2. S.4.4.
3.2. P.8 • Submit stability studies data till Submitted.
6th month time point for both
accelerated and long-term
stability conditions.
• Following shall be submitted:
i. Raw data sheets for
complete stability studies
wherein details of standard
solution preparation,
sample solution
preparation, calculation
formula applied.
Decision: Approved.
• Registration Board further decided that registration letter will be issued upon verification of sterilization
method applied by the firm for the stability batches of applied product.
application.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name No-Vom 8mg/4ml Injection
Pharmaceutical ingredient (API) per unit Ondansetron as Hydrochloride ………. 8mg
Pharmacotherapeutic Group of (API) Anti-emetics

The status in reference regulatory authorities Setronon injection 8mg/4ml by M/s Teva
Pharmaceutical Works Private Limited Company, H-
2100 Gödöllo, Tánasics Mihaly. Út 82. Hungary,
MHRA Approved.
For generic drugs (me-too status) ONSET Injection 8mg/4ml by M/s Pharmedic
Laboratories (Pvt) Ltd.
Reg. No. 025996
Lic (Vol-1) Dated: 18/12/2020
Name and address of API manufacturer. M/s Anugraha Chemicals, No. D-47 to D-50 & C-62 to
C-63 KSSIDC INDUSTRIAL ESTATE,
Doddabullapur, banghaluru rural District-561203,
India
Batches:(VD3-201304001, VD3-201304002, VD3-
201305001)
dissolution profile against the brand leader that is Onset injection by
Neutro Pharma
product
Manufacturer of API M/s Anugraha Chemicals, No. D-47 to D-50 & C-62 to C-63 KSSIDC
INDUSTRIAL ESTATE, Doddabullapur, banghaluru rural District-561203, INDIA
API Lot No. AOND/RD/20005

Description of Pack
Glass ampoules in PVC Tray, packed in unit carton (4ml×1’s)
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. DCD/SPL. CL-I/CR-
manufacturer issued by concerned regulatory 1510/2020-21 issued by DCD valid till 15-02-2020.
Ondansetron HCl for the purpose of test/analysis and
• AirWay Bill No. 176-BLR2449 9241
Dated: 21/12/2020

1.5.2 Submitted label claim is not as per Label claim in this section was given mg per ampoule which
the innovator product. is corrected to mg per ml (2mg/ml) and submitted.
1.6.5 Valid GMP certificate issued by the Valid GMP certificate issued by Drug control department,
relevant regulatory authority shall govt. of Karnataka valid upto 05-02-2022 has been
be submitted. submitted.
2.3 QOS section shall be submitted as Revised QOS as per WHO QOS PD template is submitted
per the WHO QOS PD template or
the template provided in “Guidance
document for submission of
application on form 5-F (CTD) for
registration of pharmaceutical drug
products for human use” available
on official website of DRAP
www.dra.gov.pk, since the

submitted QOS includes the
screenshots of Module III.
2.3. S.1.2 The submitted structure and Structure and molecular weight of Ondansetron
molecular weight is not correct Hydrochloride di-hydrate is corrected as per USP is
submitted.
2.3. P.1 Justify the proposed quantity per In composition of FPP under section 2.3.P.1 (b) the quantity
unit ml of Ondansetron HCl against of API was written per 4.2ml (0.2ml excess volume) which
the submitted label claim of is corrected and submitted.
Ondansetron.
2.3. P.3.2 Justify the proposed quantity per As per USP monograph for “Ondansetron injection” it
batch of Ondansetron HCl against declares that it contains Ondansetron hydrochloride
the submitted label claim of equivalent to Ondansetron.
Ondansetron. The result of Ondansetron Hydrochloride on as is basis is
89.94% and it contains 11.07% W/W of Hydrochloride
content calculated by molecular weight.
After deduction of Hydrochloride content (11.07%) content
from 89.94 the potency of API is 79.98% which is used in
calculation of quantity of Ondansetron in No-Vom injection.
As the potency of API is 79.98% on as is basis so each 10mg
of Ondansetron Hydrochloride di-hydrate is equivalent to
8mg of Ondansetron, so for 100000 ampoules 1Kg
Ondansetron HCl 2H2O will be required.
3.2. S.1.2 The submitted structure and Structure and molecular weight of Ondansetron
molecular weight is not correct Hydrochloride di-hydrate is corrected as per USP is
submitted.
3.2. S.4.4 • Analytical record for the drug Analytical report for drug substance analysis performed by
substance analysis performed by M/s Islam Pharma is submitted
M/s Islam Pharma, shall be
submitted.
• Provide results of analysis of
Substance from Drug Substance
manufacture, used during
product development and
stability studies
3.2. S.5 • Submitted working standard • We M/s Islam Pharma used USPCRS and working
COA from M/s Anugraha standard standardized against USPCRS for analysis of
chemicals declare the validity API and product analysis.
date as 15-03-2019, whereas • CoAs of USPCRS and working standard are submitted
drug substance & drug product which is valid till 24-01-2022.
analysis has been performed
Justification shall be submitted in
this regard.
3.2. P.1 • Justify the proposed quantity of Quantities of API and Excipients were mistakenly written as
10.5mg per unit ml of (mg/ampoule) under this section which are corrected to
Ondansetron as HCl against the mg/ml and submitted
submitted label claim of
Ondansetron
3.2. • Justification shall be submitted • As per DRAP guidance Document# PE&R/GL/AF/004,
P.2.2.1 for not performing Dated: 01-10-2020, pharmaceutical equivalence studies
Pharmaceutical equivalence can be performed against innovator / reference /
studies against the innovator comparator product. The pharmaceutical equivalence
product i.e., Zofran Injection of studies were performed against the comparator ONSET
M/s Novartis. injection manufactured by Pharmedic Laboratories.

• Submitted analytical record • By mistake it was written “C18” in HPLC method of
reflects use of C18 coloumn, analysis for No-Vom injection which is showed on
whereas USP monograph analytical record, whereas the recommended L10 column
recommends use of L10 coloumn was used in analysis for No-Vom injection which is
for Assay analysis. Justification written in raw data files and pictures of L10 Column (XB-
shall be submitted for this CN) as a proof of availability of USP recommended
variation. column are submitted
3.2. P.3.2 • A batch formula for proposed Batch formula for proposed commercial batch size
commercial batch size shall be indicating equivalency factor of salt form is submitted
provided.
• The composition for the drug
substance shall be clearly
indicated in terms of the
equivalency factor for salt form.
3.2.P.5.2 • The calculation formula USP formula for calculation of assay calculates the quantity
proposed in the Assay test is not of Ondansetron in each ml of injection where as we M/s
as recommended by USP Islam pharmaceuticals are calculating results in percentage
monograph of “Ondansetron of Ondansetron.
injection”. Both the USP calculation formula and formula used by M/s
Islam pharma when converted to percentage, produce same
results.
3.2.P.5.4 • Submitted analytical record • It was mistakenly written C18 in HPLC method which
reflects use of C18 coloumn, is showed on analytical record, whereas the
whereas USP monograph recommended L10 column was used in analysis for No-
recommends use of L10 coloumn Vom injection which is written in raw data files and
for Assay analysis. Justification pictures of Column (XB-CN) indicating the availability
shall be submitted for this of USP recommended column.
variation. • On CoA of WS content of Ondansetron HCl (89.94%)
• Submitted raw data sheet applies was mentioned and content of HCl (11.07%) was not
the potency of WS on as is basis deducted which is corrected and submitted.
= 79.98%, whereas the WS COA
submitted in section 3.2.P.6
declares the Potency on as is
basis = 89.94%. Justification
shall be submitted for this
variation.
3.2.P.6 • The batch# and Assay results are Ondansetron HCl API was tested against USPCRS hence it
same as that for the Drug was also standardized at the same time and was used as WS
substance COA submitted in in testing of stability batches so the Batch No. and assay
section 3.2. S.4.4. results of both drug substance and WS are same.
3.2.P.8 • Submit stability studies data till • Stability study data for 06-month time point for
6th month time point for both accelerated and long-term stability studies including
accelerated and long-term performance of system suitability test as per USP
stability conditions. monograph is submitted as
• Performance of system • Raw data sheets for 3rd month time point analysis
suitability test during assay containing potency of WS applied are submitted.
analysis, as recommended by
USP monograph of
“Ondansetron HCl injection”.
• Submitted raw data sheets of
3rd month time point analysis
does not mention the potency
of WS, applied in the
calculation of Assay results.

• Justify the proposed 0.2ml 0.2ml excess volume was proposed in trial batches was to
excess fill volume for each ensure the deliverable volume NLT 4ml in each ampoule.
ampoule. CoA submitted in section 3.2.S.4 declares the potency of
• Submitted BMR declares the API on dried and HCl free basis whereas the potency of
dispensing of drug substance on Ondansetron in Ondansetron HCl di-hydrate on as is basis is
the basis of 79.98% potency of 79.98% which is used in manufacturing of stability batches.
Ondansetron HCl, whereas COA
submitted in section 3.2.S.4
declares the potency as 99.86%
on dried basis. Justify the
dispensed quantity of
Ondansetron HCl for each batch
with reference to above cited
variation in potency.
Decision: Approved.
• Registration Board further decided that registration letter will be issued upon submission of following
a. Pharmaceutical equivalence studies against the innovator product i.e., Zofran injection of M /s
Novartis.
b. Valid GMP certificate of the drug substance manufacturer issued by the relevant regulatory authority.
Name, address of Manufacturing site. M/s Islam Pharmaceuticals
7KM Pasrur Road Sialkot
☐ Importer
☐ Export sale
Neurone 3ml Injection
name
Pharmaceutical ingredient (API) per unit Vitamin B1 (Thiamine HCl) USP…….100mg
Vitamin B6 (Pyridoxine HCl) USP…….100mg
Vitamin B12(Cyanocobalamin)USP….1000mcg
Pharmaceutical form of applied drug Red color clear solution filled in amber glass ampoules
with white color breaking ring
Pharmacotherapeutic Group of (API) Vitamin B compound

The status in reference regulatory authorities Neurobion solution for injection by M/s Merck
Selbstmedikation GmbH. Germany Approved
For generic drugs (me-too status) Neurobion injection by M/s Martin Dow Marker Ltd.
Reg. No. 001485
GMP status of the Finished product New Section for liquid ampoule (SVP) General was
manufacturer granted after inspection vide letter No.
F. 1-19/2014-Lic (Vol-1)
Dated: 18/12/2020
Name and address of API manufacturer. Thiamine HCl & Pyridoxine HCl:
M/s Jiangxi Tianxin Pharmaceuticals Co., Ltd
Cyanocobalamin:
M/s Hebei North China Pharmaceutical Huahang
submitted.
Module III (Drug Substance) Official monograph of Pyridoxine Hydrochloride,
Thiamine Hydrochloride and Cyanocobalamin is present in
USP. The firm as submitted detail of nomenclature,
controls, tests for related compounds by HPLC and
impurities by Residue on Ignition, specifications,
analytical procedures and its verification, batch analysis
substance.
Stability studies Thiamine Hydrochloride:
Batches:(TH130130130, TH130130131, TH130130132)
Pyridoxine Hydrochloride:
Batches:(PH2084024, PH2084025, PH2084026)
Cyanocobalamin:
Batches:(000707, 011013, 020716)
Batches:(C190601C, C190602C, C190603C)

dissolution profile the brand leader that is Neurobion injection by Martin Dow
Marker Ltd. by performing quality tests (Appearance,
product Specificity, Limit of Detection, Limit of Quantitation,
linearity, range, accuracy, precision, Robustness.
Manufacturer of API Thiamine HCl & Pyridoxine HCl:
M/s Jiangxi Tianxin Pharmaceuticals Co., Ltd
Cyanocobalamin:
M/s Hebei North China Pharmaceutical Huahang Pharmaceutical Co., Ltd.
API Lot No. Thiamine Hydrochloride: TH20115047
Pyridoxine Hydrochloride:PH18114018
Cyanocobalamin: C201101
Description of Pack
USP Type-I amber Glass ampoules in PVC Tray, packed in unit carton (3ml×25’s)
No. of Batches 03
applications with stability study data of the (New Section)
firm (if any)
2. Approval of API/ DML/GMP certificate of Pyridoxine HCl and Thiamine HCl:
API manufacturer issued by concerned Copy of GMP certificate No. JX20170016 issued by PRC
regulatory authority of country of origin. valid till 07/05/2022
Cyanocobalamin:
Copy of GMP certificate No. HE20 190092M issued by
PRC valid till 01/09/2024
3. Documents for the procurement of API with • Copy of letter No.14850/2020/DRAP-AD-VIII (I&E)
import different APIs including Pyridoxine HCl,
Thiamine HCl and Cyanocobalamin for the purpose of
• DHL No. XMLPI 6.2/90-1604
dated 19/11/2020 &
DHL No. V4955EL4OKM

Dated: 18-12-2020

3.2.P.1 • Submit the justification for • Benzyl alcohol is also used as solvent to enhance the
including anti-microbial solubility of ingredients and it is used as solvent in our
preservative in applied formulation. Mistakenly only one function
formulation. (antimicrobial preservative) was written under section
• Justify the quantities of each 3.2.P.1.
API mentioned in composition • Quantities of each API is written per 3.15ml to achieve
table against the label claim. the volume NLT 3ml per unit. Quantities of API are
corrected to per 3ml.
3.2.P.3.2 • Justify the quantities of each API • Quantities of each API is written per 3.15ml to achieve
mentioned in composition table the volume NLT 3ml per unit. Quantities of API are
against the label claim. corrected to per 3ml.
• Submit the batch formulation for • Batch formulation for commercial batch size is
commercial batch size. submitted
3.2.P.3.3 • Manufacturing process mentions • The applied product was sterilized by filtration method
terminal sterilization by and test of finish product and stability studies are
autoclave of filled ampoules. concluded on product sterilized by filtration method,
Justification shall be submitted some portion was autoclaved to check the effect of
for terminally sterilizing vitamin autoclavation on pH and color of product.
containing formulation.
3.2. P.5.2 • Justification shall be submitted As applied product is not available in official monographs
for applying UV and USP method of analysis for Cyanocobalamin API and
spectrophotometric method for injection is also by UV method, so in-house UV method was
the analysis of Cyanocobalamin developed and validated for analysis of cyanocobalamin.
in the finished product.
3.2. P.5.3 • Justify the performance of Specificity parameter for cyanocobalamin was performed by
specificity parameter for preparing a placebo solution including Pyridoxine HCl &
cyanocobalamin, without Thyamine HCl along with excipients.
analyzing the sample solution Specificity parameter for Pyridoxine HCl & Thyamine HCl
containing Pyridoxine HCl & was performed by preparing a placebo solution including
Thiamine. cyanocobalamin along with excipients.
• Justify the performance of
specificity parameter for
Pyridoxine HCl & Thiamine
without analyzing the sample
solution of injection.
3.2. P.8 • Submit stability studies data 6th month stability data has been submitted.
till 6th month time point for Benzyl alcohol is used as solvent in applied product
both accelerated and long-term formulation, additionally the said test is recommended for
stability conditions. multi dose sterile products while applied product is single

• Submitted stability studies dose solution for injection and not stored after opening so
data does not include test for test was not performed.
“Antimicrobial effectiveness”,
as recommended by USP
general chapter <51>. Justify
this disparity since proposed
formulation contains “benzyl
alcohol” as an antimicrobial
agent.
• Justify the performance of • The applied product was sterilized by filtration method
terminal sterilization by and test of finish product and stability studies are
autoclave method for the concluded on product sterilized by filtration method,
vitamin containing formulation. some portion was autoclaved to check the effect of
autoclavation on pH and color of product.
• Firm has submitted machine usage log book of terminal
sterilizer wherein sample portion has been recorded as
25 ampoules for the batches of applied product.
• Revised BMR for commercial manufacturing has been
submitted.
Decision: Deferred for the scientific justification of the claimed role of Benzyl alcohol as solvent and not as
preservative in the applied formulation.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Mekob 0.5mg/ml Injection
Pharmaceutical ingredient (API) per unit Mecobalamin USP …….0.5mg
Pharmaceutical form of applied drug Red color clear solution filled in amber glass ampoules
with white color breaking ring
Pharmacotherapeutic Group of (API) Vitamin B12
Reference to Finished product specifications --
The status in reference regulatory authorities Methycobal Injection 0.5mg/ml by M/s Eisai Co, Ltd
Tokyo, Japan, PMDA Japan Approved.
For generic drugs (me-too status) Biocobal injection 0.5mg/ml by M/s Surge Laboratories
(Pvt) Ltd.
Reg. No. 033385

granted after inspection vide letter No.F. 1-19/2014-Lic
(Vol-1) Dated: 18/12/2020
Name and address of API manufacturer. M/s North China Pharmaceutical Huaheng
Pharmaceuticals Co., Ltd. Xingyuan Street, Biological
Industry Zone, Nanbaishe Town, Zhao County,
Shijiazhuang, CHINA.
analytical procedures and its verification, batch analysis
dissolution profile against the brand leader that is Indrop-D 5mg/ml
injection by Neutro Pharma
product
Manufacturer of API M/s North China Pharmaceutical Huaheng Pharmaceuticals Co., Ltd. Xingyuan
Street, Biological Industry Zone, Nanbaishe Town, Zhao County,
Shijiazhuang, China.
API Lot No. 031901003
Description of Pack USP Type-I amber Glass ampoules in PVC Tray, packed in unit carton

No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. HE20190092M issued by
manufacturer issued by concerned regulatory SFDAvalid till 01/09/2024.
Ondansetron HCl for the purpose of test/analysis and
data sheets etc.
2.3 QOS section shall be submitted as per the Revised QOS as per WHO QOS PD template is
WHO QOS PD template or the template submitted.
provided in “Guidance document for
submission of application on form 5-F
(CTD) for registration of pharmaceutical
drug products for human use” available
on official website of DRAP
www.dra.gov.pk, since the submitted
QOS includes the screenshots of Module
III.
2.3. P.1 Justify the proposed quantity per unit ml Potency of API is 87.03% on as is basis and after
of Mecobalamin against the submitted adjustment of water content each 0.575mg of
label claim of Mecobalamin. mecobalamin API is equivalent to 0.5mg of
mecobalamin.
3.2. S.4.2 • Analytical procedure submitted from • As Mecobalamin API monograph is available in
Drug substance manufacturer is based both USP and JP, test method for mecobalamin
upon JP monograph whereas drug in USP is same as JP including appearance,
product manufacturer has submitted solubility, Identification, LOD and Assay.
analytical procedure based upon the Additionally, all the limits for different tests of
USP monograph. Justification shall be API are same in both pharmacopoeia except
submitted for this variation. assay and results of analysis as per USP fall in
• Provide results of analysis of relevant limits as specified by JP as well including assay
batch(es) of Drug Substance from test (Specification of Drug substance
Drug Substance manufacture, used manufacturer).

during product development and • Tests and specifications in JP and USP with their
stability studies results are presented in tabular form with
specification of USP and JP.
3.2.S.4.4 • COA of drug substance is from a • “The full name is Hebei North china
different manufacturer than that pharmaceutical huaheng Pharmaceutical
declared in section 1.6.5 & 3.2.S.2.1. Co, Ltd, which is written on CoA under
• COA from drug substance section 3.2.S.4.4 and it was a typographic
manufacturer concludes compliance mistake that Hebei was not written with name
with JP monograph whereas COA in section 1.6.5 and 3.2.S.2.1” and sent an
from drug product manufacturer updated DMF. Copy of corrected name under
concludes compliance with USP above mentioned sections is submitted.
monograph. Justification shall be • As Mecobalamin API monograph is available
submitted for this disparity. in both USP and JP, most of the tests and limits
of API are same in both pharmacopoeia and
results of our analysis fall in limits as specified
by JP as well (Specification of Drug substance
manufacturer).
• Tests in JP and USP with their results are
presented in tabular form with specification of
USP and JP.
• Furthermore, we undertake that will perform
and follow the JP specifications and procedure
for analysis of API.
3.2.S.4.5 • The section declares that product • Declaration that product complies with JP
complies the specification as per JP, specification under this section refers to the
whereas analytical procedure & COA specification of API by Drug substance
submitted from drug product manufacture.
manufacturer is as per USP • As Mecobalamin API monograph is available in
monograph. both USP and JP, most of the tests and limits of
API are same in both pharmacopoeia and results
of our analysis fall in limits as specified by JP as
well
3.2.P.1 • Submit evidence of qualitative • We M/s Islam pharmaceuticals used D-Mannitol
composition of the Innovator product (Available in literature of Innovator as
as a reference for the excipients used in excipient), EDTA is used as complexing agent
the proposed formulation. for stability of Mecobalamin and
Phenylmercuric nitrate as preservative.
• As the applied product is sterilized by filtration

so there are chances of some spores to cross the
filter and to remain in solution for injection,
Phenylmercuric nitrate is allowed to be used in
conc. of 0.001% in preparation of solution for
injections to provide a large margin of safety
against bacterial contamination. A research
article by J. E. Devison Jun-29-1951(The use of
antiseptics in the sterilization of solutions for
Injection).
3.2.P.3.3 • Manufacturing process mentions The applied product was sterilized by filtration
terminal sterilization by autoclave of method and tests of finish product and stability
filled ampoules. Justification shall be studies are conducted on product sterilized by
submitted for terminally sterilizing filtration method, some portion was autoclaved to
vitamin containing formulation. check the effect of autoclavation on pH and color
of product.
3.2.P.5.1 • Literature of the innovator product • As literature of innovator product was not
approved by PMDA of japan declares available at the time product development, pH

the specifications for pH as 5.3-7.3, of innovator product was determined by pH
whereas firm has proposed pH range of meter and set the pH of our product close to
5.0-7.0. Justification shall be submitted innovator actual pH.
for this variation. • pH of mekob injection at filled ampoule stage
• Submitted specification does not and stability studies (03 month and 06 month)
include test for “Antimicrobial is around 6.6. which is well within the limits of
effectiveness”, as recommended by Innovator given in literature.
USP general chapter <51>. Justify this • Limit of pH is changed from 5.0 - 7.0 to 5.3-
disparity since proposed formulation 7.3 in specification.
contains “phenyl mercuric nitrate” as • Test for “Antimicrobial effectiveness” is
an antimicrobial agent. recommended for multi-dose sterile products to
check the effectiveness of antimicrobial agent
after opening of injection and storage for
second dose, mekob is single dose solution for
injection so this test was not performed.
3.2.P.5.3 • Submitted analytical procedure In Analytical procedure under Reference “USP

declares the reference as “USP 43”. 43/in-house” is written to indicate that the Assay
Evidence of USP monograph for and identification test applied to the product is as
“Methylcobalamin injection” shall be per USP 43 “drug substance test method” which is
submitted. also elaborated under section 3.2.P.5.6
Justification of specification and standard is
declared as “Innovator”.
Analytical procedure revised.
3.2.P.6 • The batch# and Assay results on • Mecobalamin API was tested against USPCRS
working standard COA are same as hence it was also standardized at the same time
that for the Drug substance COA and was used as WS in testing of stability batches
submitted in section 3.2. S.4.4. so the Batch No. and assay results of both drug
substance and WS are same.
3.2.P.8 • Submit stability studies data till 6th • Stability study data for 06-month time point for
month time point for both accelerated accelerated and long-term stability studies is
and long-term stability conditions. submitted.
• Submitted stability studies data does • Test for “Antimicrobial effectiveness” is
not include test for “Antimicrobial recommended for multi-dose sterile products to
effectiveness”, as recommended by check the effectiveness of antimicrobial agent
USP general chapter <51>. Justify after opening of injection and storage for
this disparity since proposed second dose, mekob is single dose solution for
formulation contains “phenyl injection and not stored after opening so this
mercuric nitrate” as an antimicrobial test was not performed.
agent.
• Justify the performance of terminal • The applied product was sterilized by filtration
sterilization by autoclave method for method and tests of finish product and stability
the vitamin containing formulation. studies are conducted on product sterilized by
filtration method, some portion was autoclaved
to check the effect of autoclavation on pH and
color of product.
• Firm has submitted machine usage log book of
terminal sterilizer wherein sampe portion has
been recorded as 25 ampoules for the batches
of applied product.
• Registration Board further decided that registration letter will be issued upon verification of sterilization
method applied by the firm for the stability batches of applied product.

application.
Case no. 02 Registration applications of import cases

a. Deferred cases:
665. Name, address of Applicant / Importer M/s Biocare Pharmaceutica. 807 Shadman-1, Lahore
Validity: 17-04-2022.
Renewal: N/A. Valid Drug sales License is attached with CTD
dossier Module 1.
Name and address of marketing authorization License Holder/Supplier: World Medicine İlaç San. Ve Tic.
holder (abroad) A.S.
Address:- Temmuz Mahallesi, Camiyolu Cad. No:50 Güneşli /
İstanbul, Turkey Tel:- +90 212 474 70 50
Name, address of manufacturer(s) Manufactured By:- Mefar İlaç Sanayii A.Ş. (World Medicine
Contract manufacturer)
Address Manufacturing site: Ramazanoglu Mah. Ensar Cad.
No : 20 Kurtkoy / Pendik, TR 34906 Istanbul, Turkey, Post
Code: 34906
TEL: (+90) 216 378 44 00
Detail of certificates attached (CoPP, Freesale CoPP: Firm has submitted legalized CoPP certificate
certificate, GMP certificate) (No.2020/2332) dated 12-08-2020 issued by Republic of
Turkey Ministry of health Turkish Medicines and Medical
Device Agency. The CoPP confirms free sale status of the
manufacturing site through periodic inspection every year.
Pakistan. Furthermore, the CoPP was valid till 12-8-2022.
GMP Certificate:
Legalized copy of GMP certificate# (TR/GMP/2018/333)
issued by Turkish Medicines & Medical Devices Agency valid
upto 01-2023.
Details of letter of authorization / sole agency Firm has submitted copy of legalized distribution agreement
agreement signed by both parties Biocare Pharmaceutica & World
Medicine İlaç San. Ve Tic. A.S. Agreement cleanly mention
manufacturer World Medicine İlaç San. Ve Tic. A.S appoints
M/s Biocare Pharmaceutica to register/market/sell/Distribute
their product Fluzamed (Fluconazole) 200 mg/100 ml in
Pakistan. Agreement validity is 5 years with automatically 1
year renewal clause.
☒ Importer

☐ Export sale
Details of fee submitted PKR 50000 /-: 30-12-2020
proposed proprietary name / brand name FLUZAMED
Strength / concentration of drug of Active
200 mg/100 ml (2 mg/ml) Fluconazole per vial
Pharmaceutical form of applied drug Solution for IV Infusion
Pharmacotherapeutic Group of (API) Antimycotics for Systemic Use, Triazole derivatives,
Antifungal
Reference to Finished product specifications In-House / Innovator Specification
Proposed unit price Rs 1008/- single dose vial
The status in reference regulatory authorities Fluconazole 200 mg/100 ml (2mg/ml) Fresenius Kabi USA
(USFDA Approved-076145) & Diflucan (Fluconazole) 200
mg/100 ml injection vial by Pfizer Australia Pty Ltd (TGA
Approved).
It is also approved by EMA (European Medicine Agency), UK
MHRA & PMDA (Japan).
substance.
Name, address of drug substance manufacturer M/s Synergene Active Ingredients Pvt. Ltd.
Address: Flat No.402, Bhanu Enclave, Sunder Nagar,
Erragadda, Hyderabad-500038, Telangana, INDIA.
(Conditions & duration of Stability studies) accelerated as well as real time conditions. The accelerated
study is complete for 3 batches at 40±2 °C/75±5%RH. The real
time Zone IVA stability data is conducted at
30±2°C/65±5%RH. The stability study data is till 60 months.

Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence has been established by
Dissolution Profile conducting all the quality tests against the Pfizer reference
product Triflucan (Fluconazole) Solution for IV Infusion 200
mg- 100 ml (2 mg/ml).
Container closure system of the drug product 100 ml marked type I transparent glass vial closed with grey
bromo-butyl rubber stopper and transparent Aluminum/plastic
flip off cap.
Stability study data of drug product, shelf life • 24 months real time stability data at 30°C ± 2°C /
and storage conditions 65% ± 5%RH of 03 batches (Zone IVA)
• 06 month accelerated stability data 40°C ± 2°C
/ 75% ± 5%RH of 03 batches
Evaluation by PEC:
1.5.6 Pharmacopoeial reference of the finished Firm has declared it an error and has submitted revised
product has been declared as European Form 5F, wherein product specifications have been
Pharmacopoeia, whereas no EP referred as “In-House”. Moroever firm has submitted
monograph is available for the applied following commitment from the manufacturing
product. authorization holder:
“We, World Medicine İlaç San. Ve Tic. A.S.
Temmuz Mahallesi, Camiyolu Cad. No:50 Güneşli /
İstanbul, Turkey, as marketing authorization holder
hereby declare that for Fluzamed (Fluconazole) 200
mg/100 ml Solution for IV Infusion product; BP
pharmacopoeia only has monograph for IV Infusion
product as same with our product. Our specifications
meet requirements for BP. We can revise it to BP
specifications after registration. Monograph for USP
Fluconazole Injection removed current
pharmacopoeia. It is Official 1-May-2018 to 7-Nov-
2018. Our specifications were determined according
to ICH and international requirements. Therefore, we
confirm after registration we will provide our product
Fluzamed (Fluconazole) 200 mg/100 ml solution for
IV infusion under BP Specification/reference standard
and write BP in Pack accordingly.”
1.3.5 Original legalized COPP/Free sale Submitted
certificate, translated in English, shall be
submitted.
2.3 Table for literature references for the Drug Relevant information has been submitted as per the
Substance and Drug Product, declare that WHO QOS PD template.
EP monograph exists for the applied drug
product. Evidence of above cited
monograph shall be submitted.

2.3.S.3 Relevant information against this section
shall be submitted in Module II, instead of
referring to other modules.
2.3.S.4.2 • Analytical method has been submitted
for Fluconazole solution for injection
instead of drug substance
“Fluconazole”.
2.3.S.4.3 • Information has been submitted for
Fluconazole solution for injection
instead of the drug substance
“Fluconazole”
All the tables in the WHO QOS PD template shall be
filled as such instead of replacing them with any other
format. Also, the information in the module II shall be
submitted under relevant sections, instead of referring
it to other modules.
3.2. The US FDA approved label of Firm has submitted revised pH limits of 4.0-8.0 as per
P.2.2.1 Fluconazole injection in 0.9% Sodium innovator.
chloride, recommends pH range of 4.0-8.0, The results of pH test in submitted batch analysis, falls
whereas Comparative Results of analysis in the same range as of innovator.
of Test and Reference Products, specifies
the pH range of 3.0 – 7.5. Justification shall
3.2. Test for content of sodium, chloride, as Considered the purpose of being in the product, it is
P.5.1 recommended by USP monograph for seen that there is no need for relevant control.
applied product, has not been included in
the specifications.
3.2. Submitted procedure for Assay test is not Firm has claimed in-house specifications and has also
P.5.2 per any of the USP, IP or JP monograph for submitted undertaking as mentioned against section
“Fluconazole Injection.” Justification shall 1.5.6
3.2. The section mentions that “Analytical test
P.5.6 methods are validated in-house methods”.
Justification shall be submitted for
applying in-house methods, whereas
pharmacopoeial monographs are available
for the applied product.
3.2.P.8 Significant changes have been observed in MA holder has submitted that there is no out of limit
the accelerated stability studies of situation/changes in the accelerated stability data of
following batch: the 1514001 numbered batch. There was typo/error in
• 1514001 previous file, it has been corrected.
rd
Decision of 313 meeting: Deferred for following:
• Justification of applying in-house specifications for the drug product analysis, whereas USP & BP monograph is
available for the applied product.
• Justification of significant change in the accelerated stability studies data of batch# 1514001.
• Registration Board further directed the firm to submit comparison between in-house, USP & BP specifications.

Firm’s response:
Observation Firm’s response

Justification of applying in- We, World Medicine ilac as marketing authorization holder hereby declare that
house specifications for the for Fluzamed (Fluconazole) 200 mg/1 00 ml Solution for IV Infusion, BP
drug product analysis, whereas pharmacopoeia only has monograph for IV Infusion product as same with our
USP & BP monograph is product. Our specifications meet requirements for BP. We can revise it to BP
available for the applied specifications after registration. Monograph for USP Fluconazole Injection
product. removed current pharmacopoeia. It is Official 1-May-2018 to 7-Nov-2018.
Our specifications were determined according to ICH and international
requirements. Therefore, we confirm after registration we will provide our
product Fluzamed (Fluconazole) 200 mg/100 ml solution for IV infusion under
BP Specification/reference standard and write BP in Pack accordingly.
Firm has also submitted revised drug product specifications as per BP
monograph.
Justification of significant We, World Medicine ilac as marketing authorization holder hereby declare that
change in the accelerated for Fluzamed (Fluconazole) 200 mg/1 00 ml Solution for IV Infusion; there is
stability studies data of batch# no out-of-limit situation/changes in the accelerated stability data of the
1514001. 1514001 numbered batch. However, compared with other batches:(1314001,
1314002, 1314003, 1814001), there is an increase of 5%. According to ICH
guidelines, this 5% difference increase in results is considered significant
change. When the results of the analysis performed within manufacturer are
checked again, raw data were examined and no analysis/application errors
were detected. When significant changes such as this 5% are observed in the
stability data, according to the ICH-QI guidelines, the change in the limit is
within our follow-up.
Comparison of specifications is submitted as under:

Decision: Approved with BP specifications as per Policy for inspection of Manufacturer abroad and
verification of local storage facility. Firm shall submit fee of Rs. 7,500 for correction/pre-approval change
in product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
666. Name, address of Applicant / Importer M/s Biocare Pharmaceutica. Address:- 807 Shadman-1, Lahore
Validity: 17-04-2022.
Name and address of marketing authorization License Holder/Supplier: World Medicine İlaç San. Ve Tic. A.S.
holder (abroad) Address:- Temmuz Mahallesi, Camiyolu Cad. No:50 Güneşli /
İstanbul, Turkey Tel:- +90 212 474 70 50
Name, address of manufacturer(s) Manufactured By:- Mefar İlaç Sanayii A.Ş.

Address Manufacturing site : Ramazanoglu Mah. Ensar Cad. No:
20 Kurtkoy / Pendik, TR 34906 Istanbul, Turkey, Post Code:
34906 TEL: (+90) 216 378 44 00
Detail of certificates attached (CoPP, Freesale CoPP: Firm has submitted legalized CoPP certificate
certificate, GMP certificate) (No.2020/2331) dated 12-08-2020 issued by Republic of Turkey
Ministry of health Turkish Medicines and Medical Device
Agency. The CoPP confirms free sale status of the product in
exporting country as well as GMP status of the manufacturing
site through periodic inspection every year.
Pakistan. Furthermore, the CoPP was valid till 12-8-2022.
Details of letter of authorization / sole agency Firm has submitted copy of legalized distribution agreement
agreement signed by both parties Biocare Pharmaceutica & World Medicine
İlaç San. Ve Tic. A.S. Agreement cleanly mention manufacturer
World Medicine İlaç San. Ve Tic. A.S appoints M/s Biocare
Pharmaceutica to register/market/sell/Distribute their product
Sertofen (Dexketoprofen Trometamol) 50 mg/2ml in Pakistan.
Agreement validity is 5 years with automatically 1-year renewal
clause.
☒ Importer
☐ Export sale
Details of fee submitted PKR 50000 /-: 30-12-2020
proposed proprietary name / brand name SERTOFEN/ DEXTANOL/ DEXKETO

Strength / concentration of drug of Active Each 2 ml of ampoule contains 73.8 mg Dexketoprofen
Pharmaceutical ingredient (API) per unit Trometamol equivalent to 50 mg Dexketoprofen.
Pharmaceutical form of applied drug Solution for Intramuscular (IM) or Intravenous (IV) Injection.
Pharmacotherapeutic Group of (API) Propionic acid derivatives. Analgesics, antipyretics, Non-
steroidal anti-inflammatory drugs (NSAIDs)
Reference to Finished product specifications In-House / Innovator specification
Proposed Pack size 5 ampoules Pack (5 Amp)
Proposed unit price Rs 600/Pack of 5 ampoules.
Rs. 120 per ampoule
The status in reference regulatory authorities Dexketoprofen Trometamol 50mg/2ml (IM/IV) solution for
injection is an EMA
(European Medicine Agency) approved
Name, address of drug substance manufacturer ZHEJIANG RAYBOW PHARMACEUTICAL CO., LTD.
Address: No. 18, Nanyangsan Road, Linhai, Taizhou City,
Zhejiang Province, China 317036
(Conditions & duration of Stability studies) accelerated as well as real time conditions. The accelerated study
is complete for 3 batches at 40±2 °C/75±5%RH. The real time
Zone IVA stability data is conducted at 30±2°C/65±5%RH. The
stability.
Pharmaceutical Equivalence and Comparative Pharmaceutical equivalence has been established by conducting
Dissolution Profile all the quality tests against the reference original product
Arveles® (Dexketoprofen Trometamol) 50 mg/2ml Solution for
Injection of Menarini International Ltd.

Container closure system of the drug product The primary packaging for product Sertofen (Dexketoprofen
Trometamol) 50 mg/2 ml
Solution for Injection is a type amber colored glass ampoule
which has 2 ml nominal capacity.
Stability study data of drug product, shelf life • 24 months real time stability data at 30°C ± 2°C / 65% ± 5%RH
and storage conditions of 03 batches (Zone IVA)
5%RH of 03 batches
Evaluation by PEC:
Observations Firm’s response
• 1.5.6. Pharmacopoeial reference of the finished product has Firm has declared it an error and has submitted
been declared as European Pharmacopoeia, whereas no EP revised Form 5F, wherein product
monograph is available for applied product. specifications have been referred as “In-
House”.
• 2.3. Table for literature reference for the drug substance Relevant information has been submitted as per
& product, declare that USP & EP monograph exists for the WHO QOS PD template.
the drug substance, while EP monograph also exist for
applied drug product. Explanation/Evidence of above
cited monograph shall be submitted.
• 2.3.S.3. Relevant information against this section shall be
submitted in Module II, instead of referring to other
Modules.
• Analytical method has been submitted for Fluconazole
solution for injection instead of the drug substance
“Fluconazole”.
• Information has been submitted for Fluconazole
solution for injection instead of the drug substance
“Fluconazole”
• [Module 2 (QOS)]. All the table in the WHO QOS PD
template shall be filled as such instead of replacing
them with any other format. Also, information in the
module II shall be submitted under relevant sections,
instead of referring it to other Modules.
• 3.2.S.4.2. Justification shall be submitted for applying Titration is used to determine Assay in routine
titration method for the Assay test. test, although it is not a specific method but we
use a HPLC method to determine organic
impurities which can achieve overall specificity
according to ICH Q6A.
• 3.2.S.4.3. Analytical method verification studies for drug API supplier performs the analytical method
substance, including specificity, accuracy and repeatability validations of the drug substance. Our company
(method precision) performed by the manufacturer shall be take the analysis results of API supplier as
submitted. reference. Our company does not repeat these
tests.
• 3.2.S.4.4. Provide results of analysis of relevant batch(es) Submitted.
of drug substance performed by drug product manufacturer
used during product development and stability studies,
along with certificate of analysis of the same batch from
drug substance / Active pharmaceutical ingredients
manufacturer.
• 3.2.P.2.2.1. Pharmaceutical equivalence of the applied Pharmaceutical equivalence studies against the
drug shall be established with the reference product of Arveles Soultion for
innovator/reference/comparator product and results of all infusion has been submitted.
the quality test (mention in any official pharmacopoeia or
section 3.2.P.5.1 of this application) of the developed
formulation and the innovator/reference/comparator

• 3.2.P.3.1. The manufacturing site address mention Manufacturing address revised as per the details
under this section is different from that declared in of COPP
CoPP.
• 3.2.P.3.3. Submitted manufacturing process does The API Dexketoprofen trometamol cannot
not include step of terminal sterilization. tolerate high temperature and ester bond can be
Justification shall be submitted for not performing broken with high temperature.
terminal sterilization.
• 3.2.P.5.1. Submitted drug product specifications declare Firm has revised the pH range to 7.0 – 8.0. The
the pH range as 6.5-8.5, whereas the reference product has complete analyses of our product are examined,
declared pH range of 7.0-8.0. Justification shall be the pH limit is within the range of 7.0 -8.0.
Decision of 313rd meeting: Deferred for submission of analytical method verification studies of drug substance
performed by the drug product manufacturer.
Firm’s response: Firm has submitted analytical method verification studies for drug substance performed by the drug
product manufacturer including parameters of specificity, accuracy and precision.
Decision: Approved with Innovator’s specifications as per Policy for inspection of Manufacturer abroad and
verification of local storage facility. Firm shall submit fee of Rs. 7,500 for correction/pre-approval change in
product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
667. Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt.) Ltd 793-D, Block C,
Faisal Town Lahore
Details of Drug Sale License of importer License No: 05-352-0065-016174-D
Address: 793-D, Block -C, Faisal Town Lahore
Address of Godown: NA
Name and address of marketing authorization M/s Beacon Pharmaceuticals Limited
holder (abroad) Plant address: Kathali Bhaluka Mymensingh Bangladesh
Office Address: 9/A Toyenbee Circular Road Motijheel
Dhaka Bangladesh
Name, address of manufacturer(s) M/s Beacon Pharmaceuticals Limited
Plant address: Kathali Bhaluka Mymensingh Bangladesh
Office Address: 9/A Toyenbee Circular Road Motijheel
Dhaka Bangladesh
Name of exporting country Bangladesh
Detail of certificates attached (CoPP, Free sale certificate, GMP certificate):
CoPP: Firm has submitted original legalized COPP (DA/6-110/2016/3306) issued on 01-June-2020 Government
of the people’s republic of Bangladesh, Ministry of Health & Family welfare, Directorate General of Drug
Administration Oushad Bhaban, Mohkhali Dhaka-1212, Bangladesh.
GMP: Firm has submitted Legalized GMP certificate (Certificate No. DA/6-110/06/4950) issued by M/s Beacon
Pharmaceuticals limited valid upto 16-07-2021.
Details of letter of authorization / sole agency Firm has submitted copy of letter of distribution certificate
agreement from Beacon Pharmaceuticals limited. The letter specifies
that the manufacturer appoints M/s Himmel Pharmaceuticals
Pvt. Ltd. to register their products in Pakistan. The
authorization letter is valid till June, 2025.
☒ Importer

☐ Export sale
The proposed proprietary name / brand name Tofacinix 5mg tablet
Strength / concentration of drug of Active Each tablet contains Tofacitinib citrate INN equivalent to
Pharmaceutical ingredient (API) per unit Tofacitinib 5mg
Pharmacotherapeutic Group of (API) Anti-rheumatic, immunosuppressant
Reference to Finished product specifications In house
Proposed Pack size 30’s in Alu-Alu Blister
Proposed unit price As per current pricing policy of DRAP
The status in reference regulatory authorities Xeljanz XR Tablet 5 mg (Pfizer labs)
Name, address of drug substance manufacturer Beijing Mesochem Technology Co., Ltd. Floor 23, Building
9, Lippo Plaza Economic and Technological Development
Zone Beijing
stability data is conducted at 25±2ºC, 60%±5%RH. The

Pharmaceutical Equivalence and Comparative Comparative analysis Studies against the reference product
Dissolution Profile Xeljanz XR Tablet 5 mg (Pfizer labs) has been submitted
Container closure system of the drug product Alu-Alu Blister
Stability study data of drug product, shelf life and Firm has submitted stability study data of 3 batches.
storage conditions Accelerated stability studies have been conducted at
40°C±2°C and 75%±5% RH for 6 months.
Real time stability studies conducted at 30°C±2°C and 65%
± 5% for 24 months.
Evaluation by PEC:
Section #. Deficiencies Firm’s response
3.2.S.4 • Copies of the Drug substance specifications
• COA s form and both drug substance and drug product
analytical procedures used for routine
manufacturer
testing ofsubmitted.
• Analytical
Drug substance/Active Pharmaceutical Ingredient
method verification report submitted from M/s
by both Drug Product manufacturer is required.
Beacon Pharma.
• Analytical Method Verification •studies including
Submitted COA declares the polymorphic form as A.
specificity, accuracy and repeatability (method
precision) performed by Drug Product
• Provide results of analysis of relevant batch(es) of
Drug Substance performed by Drug Product
manufacturer used during product development
and stability studies, along with Certificate of
Analysis (CoA) of the same batch from Drug
Substance/Active Pharmaceutical Ingredient
manufacture.
• Submitted COA does not reflect the polymorphic
form of the drug substance.
3.2.P.2 Compatibility studies of the Drug Substance(s) with • We have used Pregelatinized Starch
excipients shall be submitted, since the qualitative (Starch 1500) BP, Croscarmellose
composition of the formulation is not similar to Sodium BP, Magnesium Stearate BP,
innovator / reference product. Colloidal Anhydrous Silica (Aernsil
200) BP, Microcrystalline Cellulose
(Avecil PH I 02) BP, Opadry II Blue
(85G506--t2) in the formulation in
Tofacinix 5mg Tablet
• These excipients are complying with
Current Pharmacopoeial Monograph
(British Pharmacopoea & United States
Pharmacopoea). These excipients are
pharmaceutically inert substance and we
have used these excipients bellow the
IIG limit of FDA Orange Book as well
as we have done extensive a1dysis of the
product after formulation and found
satisfactory result of assay, dissolution
results & impurity profile.
• Also we have done stability study during
development stage and found
satisfactory result of the product.
• So we can conclude that these excipicnts
are not incompatible with API.

3.2.P.2.2.1 • Comparative dissolution studies have been • Firm has submitted new CDP study data
performed against Xeljanz XR tablet, whereas in three dissolution mediums (i.e., pH
applied product is immediate release tablet. 1.2, pH 4.5 & pH 6.8), wherein results of
• Submitted CDP data declare the extended release f2 factor are in acceptable range.
profile of the applied drug, whereas the label
claim is of immediate release tablet.
3.2.P.5.2 • US FDA review document of the Innovator • For dissolution method we have used US
product, specifies the dissolution limit as “NLT FDA data base for medium, apparatus,
Q in 15 minutes” in 0.1N HCl, whereas volume and time point.
submitted specifications declare the dissolution • However, please note that, for
limits as “NLT 75% in 30 minutes” using water comparative dissolution time points
as dissolution medium. were selected as 5, I 0, 15, 20 & 30
• Justify the variation in time point of dissolution minutes. Based on the US FDA
& rpm of paddle apparatus. Dissolution guidelines, dissolution time
point covered 30 minutes in method of
analysis.
Decision of 313rd meeting: Registration Board deferred the application for justification for adopting dissolution
parameters & specifications for batch release, in variation from that recommended by the US FDA for innovator’s
product.
Firm’s response: Firm has submitted comparative dissolution studies for the extended release tablet instead of the
applied product.
Decision: Deferred for submission of stability studies data of at least two batches at 0 & 1-month timepoint of
accelerated and long-term stability studies with revised specification of dissolution of “NLT Q in 15 minutes” in
0.1N HCl dissolution medium.
668. Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt) Ltd. 793-D, Block C,
Faisal Town Lahore.
Address: 793-D, Block -C, Faisal Town Lahore.
Status: by way of distributor
Office Address: 9/A Toyenbee Circular Road Motijheel Dhaka
Bangladesh
Bangladesh
of the people‘s republic of Bangladesh, Ministry of Health & Family welfare, Directorate General of Drug
Pharmaceuticals limited.
• Firm has submitted copy of letter of distribution certificate from Beacon Pharmaceuticals limited. The letter
specifies that the manufacturer appoints M/s Himmel Pharmaceuticals Pvt. Ltd. to register their products in
Pakistan. The authorization letter is valid till June, 2025.
☒ Importer


☐ Export sale
Dy. No. and date of submission Dy. No 2037744 Dated 03-03-2020
Details of fee submitted Rs.100,000/- Dated 03-03-2020
The proposed proprietary name / brand name Briganix 180 Tablet
Strength / concentration of drug of Active Each tablet Contains:
Pharmaceutical ingredient (API) per unit Brigatinib…...……180mg
Pharmacotherapeutic Group of (API) Anticancer

Proposed Pack size 30’s in HDPE bottle
The status in reference regulatory authorities Alunbrig 90mg tablet (Takeda uk ltd.)
For generic drugs (me-too status) --
and drug product.
Name, address of drug substance M/s AnHui youcare kaiyue pharmaceutical co. ltd.
manufacturer gongye dadao, taihe bengbu city, anhui China
of drug substance.
Stability Studies of Drug Substance Firm has submitted long term stability study data of 3 batches of
(Conditions & duration of Stability studies) drug substance at 25°C ± 2°C / 60 ± 5% RH for 24 months. The
accelerated stability data is conducted at 40°C ± 2°C / 75 ± 5% RH
for 6 months.
report, control of excipients, control of drug product,

stability.
Pharmaceutical Equivalence and Comparative analysis Studies against the reference product of
Comparative Dissolution Profile Alunbrig tablet of M/s Takeda Pharma has been submitted.
Analytical method validation/verification of Firm has submitted analytical method verification studies of the
product drug product.
Container closure system of the drug product White HDPE bottle
Stability study data of drug product, shelf life Firm has submiited stability study data of 3 batches.
and storage conditions Accelerated stability studies have been conducted at 40oC±2oC and
75%±5% RH for 6 months.
Real time stability studies conducted at 30oC±2oC and 65% ± 5%
for 24 months
669. Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt) Ltd. 793-D, Block C, Faisal
Town Lahore.
Address: 793-D, Block -C, Faisal Town Lahore.
Status: by way of distributor
Bangladesh
Bangladesh
of the people‘s republic of Bangladesh, Ministry of Health & Family welfare, Directorate General of Drug
Pharmaceuticals limited.
• Firm has submitted copy of letter of distribution certificate from Beacon Pharmaceuticals limited. The letter
specifies that the manufacturer appoints M/s Himmel Pharmaceuticals Pvt. Ltd. to register their products in
Pakistan. The authorization letter is valid till June, 2025.
☒ Importer

☐ Export sale

Dy. No. and date of submission Dy. No 2037744, Dated 03-03-2020
Details of fee submitted Rs.100,000/- Dated 03-03-2020
The proposed proprietary name / brand name Briganix 90 Tablet
Strength / concentration of drug of Active Each tablet Contains:
Pharmaceutical ingredient (API) per unit Brigatinib…...……90mg
Pharmacotherapeutic Group of (API) Anticancer
Proposed Pack size 30’s in HDPE bottle
The status in reference regulatory authorities Alunbrig 90mg tablet (Takeda uk ltd.)
For generic drugs (me-too status) --
and drug product.
Name, address of drug substance M/s AnHui youcare kaiyue pharmaceutical co. ltd.
manufacturer gongye dadao, taihe bengbu city, anhui China
of drug substance.
Stability Studies of Drug Substance Firm has submitted long term stability study data of 3 batches of
(Conditions & duration of Stability studies) drug substance at 25°C ± 2°C / 60 ± 5% RH for 24 months. The
accelerated stability data is conducted at 40°C ± 2°C / 75 ± 5% RH
for 6 months.
report, control of excipients, control of drug product,
stability.
Pharmaceutical Equivalence and Comparative analysis Studies against the reference product of
Comparative Dissolution Profile Alunbrig tablet of M/s Takeda Pharma has been submitted.
Analytical method validation/verification of Firm has submitted analytical method verification studies of the
product drug product.

Container closure system of the drug product White HDPE bottle
Stability study data of drug product, shelf life Firm has submitted stability study data of 3 batches.
and storage conditions Accelerated stability studies have been conducted at 40oC±2oC and
75%±5% RH for 6 months.
Real time stability studies conducted at 30oC±2oC and 65% ± 5%
for 24 months
Section #. Deficiencies Firm’s response
• section declares that “Brigatinib• does
The3.2.S.1.3.3 nothas
Firm exhibit
submitted revised COA from both Drug substance & Drug
Polymorphism”, whereas EMA assessmentproduct report of
manufacturer
the wherein Polymorphic From has been declared as
innovator product declare that “Polymorphism “A” & has
test
been
of XPRD has been included.
observed for Brigatinib.” Clarification shall be
submitted for this variation.
• EMA3.2.S.4 • Firm has
assessment report of the innovator product
submitted revised COA from both Drug substance & Drug
recommend test of “Solid form confirmation (XRPD)”,
product manufacturer wherein Polymorphic From has been declared as
whereas drug substance specifications “A” && test
COA of XPRD has been included.
• Tabulated
submitted form drug substance manufacturer does not
results of Analytical method validation studies have been
include any such test for Solid form confirmation.
submitted from M/s Beacon Pharma.
• Analytical Method Verification studies including
specificity, accuracy and repeatability (method
precision) performed by the Drug Product manufacturer
shall be submitted.
• Provide results of analysis of relevant batch(es) of Drug
Substance performed by Drug Product manufacturer
used during product development an+d stability studies,
along with Certificate of Analysis (CoA) of the same
batch from Drug Substance/Active Pharmaceutical
3.2.P.2 Compatibility studies of the Drug • We have used Pregelatinized Starch (Starch 1500)
Substance(s) with excipients shall be BP, sodium Starch Glycolate (Primojel)
submitted, since the qualitative • BP, Ludipress, Magnessium Stearate BP,
composition of the formulation is not Colloidal Anhydrous Silica (Aerosil 200) BP &
similar to innovator / reference product. Microcrystalline Cellulose (Avecil PH I 02) in the
formulation of Briganix 90mg Tablet as
excipients.
• These excipients are complying with Current
Pharmacopoeia Monograph (British
Pharmacopoeia & United States Pharmacopoeia).
These excipients are pharmaceutically inert
substance and we have used these excipients
below IIG limit of FDA Orange Book as well as
we have done extensive analysis of the product
after formulation and found satisfactory result of
Assay , dissolution results & impurity profile.
• Also we have done stability study during
development stage and found satisfactory result of
the product.
• So, we can conclude that these excipients are not
incompatible with the API
• US3.2.P.5.1
FDA review document of the Innovator • For dissolution
product, method, we have used US FDA data base for medium,
specifies the dissolution limit as “NLT Q inapparatus,
20 minutes”,
volume and time point.
whereas submitted specifications declare • the dissolution
However, please note that, for comparative dissolution time points were
limits as “NLT 70 (Q)% in 45 minutes”. Also, the speed
selected as 5, 10, 15, 20, 30 & 45 minutes. Based on the US FDA data
of paddle apparatus recommended by US FDA base,isdissolution
70rpm, time point covered 45 minutes in method of analysis.

whereas submitted drug product testing method declares
speed of paddle apparatus as 75rpm.
• Justify the variation in time point of dissolution & rpm
of paddle apparatus.
Decision of 313rd meeting: Registration Board deferred the applications of Briganix 90 Tablet & Briganix 180 Tablet
for submission of COAs of last three commercial batches of drug substance from Drug substance manufacturer.
Firm’s response:
Firm has submitted 3 COAs of drug substance from M/s AnHui Youcare Kaiyue Pharmaceutical co. ltd.
gongye dadao, taihe bengbu city, anhui China, wherein Polymorphic form has been decalred as “A”.
Decision: Registration Board approved both “Briganix 90 Tablet” & “Briganix 180 Tablet” with Innovator’s
specifications as per Policy for inspection of Manufacturer abroad and verification of local storage facility. Firm
shall submit fee of Rs. 7,500 for each product for the correction/pre-approval change in product specifications,
670. Name, address of Applicant / Importer M/s GHAZALI BROTHERS 19-SR-7, Campbel Street, Azzainab
Court, 1st Floor, Karachi- Pakistan
Address: 19-SR-7, Campbel Street, Azzainab Court, 1st Floor,
Karachi- Pakistan
Name and address of marketing M/s Shandong luoxin pharmaceutical group stock co., ltd, Luoqi
authorization holder (abroad) road, linyi high and new technology industries Development zone
shandong province, pr China.
Name, address of manufacturer(s) M/s Shandong luoxin pharmaceutical group stock co., ltd, Luoqi
road, linyi high and new technology industries Development zone
shandong province, PR China.
• The firm has submitted Original legalized CoPP (certificate No. Shandong20200016(5) for Calcium
Folinate for Injection 100mg issued by Shandong Drug Administration valid till 31/12/2020.
The applied product is available for free sale in exporting country.
• CCPIT legalized barcode: 201100B0/040270 Dated: 02/July/2020
• Drug manufacturing license No. Lu20160194 valid till 31/12/2020.
• Copy of GMP certificate No. SD20191020 valid till 10/12/2024.
• Firm has submitted Exclusive Distribution Agreement wherein M/s SHANDONG LUOXIN
PHARMACEUTICAL GROUP STOCK CO. LTD Luoqi Road, Linyi National High and New
Technology Industries Development Zone, Shandong Province, PR China authorized M/s GHAZALI
BROTHERS 19-SR-7, Campbel Street, Azzainab Court, 1st Floor, Karachi- Pakistan for marketing and
selling for Calcium folinate injection 100mg..
☒ Importer
☐ Export sale

☐ Bulk import and local repackaging
☐ Bulk import and local repackaging for export purpose
only
Dy. No. and date of submission Dy. No. 7594 : 05-08-2020
The proposed proprietary name / brand name CALFOLINATE for Injection 100mg
Strength / concentration of drug of Active Each vial contains :
Pharmaceutical ingredient (API) per unit Folinic Acid as calcium folinate pentahydrate.......100mg
Pharmaceutical form of applied drug Off-white to yellow loose cake or powder (lyophilized) for
solution for IV/IM injection
Pharmacotherapeutic Group of (API) Detoxifying agents for antineoplastic treatment
Reference to Finished product specifications Chinese Pharmacopeia
Proposed unit price As per DRAP’s pricing policy
The status in reference regulatory authorities Leucovorin Calcium 100mg base/vial by M/s Teva Pharms
USA, USFDA Approved.
For generic drugs (me-too status) CALFONATE INJECTION 100MG by M/s GHAZALI
BROTHERS, Reg. No. 70936
and stability studies of drug substance and Drug Product.
Name, address of drug substance manufacturer M/s Zhejiang Davi Pharmaceutical Co., Ltd. No.818 Xinzhu
Road, Economic Development Area, Huzhou City, Zhejiang
Province 313000, The People’s Republic of China
properties, solubility, physical form, manufacturers,
Stability Studies of Drug Substance • Real time stability studies have been conducted at
(Conditions & duration of Stability studies) 25oC±2 and 60%RH±5% for 24 months of 3 batches
Batches: CAN161201, CAN161202, CAN161203

Pharmaceutical Equivalence and Comparative Not submitted.
Dissolution Profile
Container closure system of the drug product Injection vials made of low borosilicate glass tubing,
bromobutyl rubber stopper for sterile powder for injection
and aluminum-plastics combination caps for injection vials
and storage conditions 25oC±2 and 60%RH±5% for 36 months of 3 batches
Batches: 514082033, 514082043, 514082053
Evaluation by PEC:
Calcium folinate equivalent to Folinic acid 100mg Shandong Luoxin Response: We apologize for the
is the actual quantity of base used in the mistakes of the names shown in batch formula. The
formulation while in section 2.3.P.3.2 under batch mistakes have been rectified following your
formula, Calcium Folinate (calculates as folic comments, please find the revised Section 2.3.P.3.2
acid) and in section 3.2.P.3.2 under Batch Formula and 3.2.P.3.2 in Attachment 1 and 2. The name claimed
is written. Since Folic Acid and Folinic Acid are in the label and carton is also revised following your
two different chemical compounds therefore you comments.
are required to rectify the mistake and submit the The firm has submitted relevant sections with correct
information under relevant sections. label claims and batch formulas.
The submitted real time stability studies for drug The firm has submitted stability data of 03 batches
product are conducted at 25oC±2 and 60%RH±5% with the following details;
while real time stability studies of 03 batches till • Real time stability studies have been conducted at
claimed shelf life according to the conditions of 30oC±2 and 65%RH±5% for 24 months of 3
Zone IV-A (30oC±2 and 65%RH±5%) are batches
required. • Accelerated stability study is conducted at
40oC±2 and 75%RH±5% for 6 months of 3
batches
Batches: 518042042, 518102041, 518102042
Pharmaceutical equivalence of the applied product Pharmaceutical equivalence is submitted against
should be established by performing all the quality Leucovorin Calcium by M/s Westward-Hikma, USA
tests against the innovator’s product and should be by performing all the quality tests. (Batch: 1909A01).
presented in the relevant sections.
The official monograph for Calcium folinate The firm has submitted a comparison of specifications
(Leucovorin Calcium) is present in USP while the of Chinese Pharmacopoeia and USP. Limits are same
testing of the applied product is done according to in both monographs but the method used are different.
In-House standard/Chinese Pharmacopoeia, USP describes the tests of 7 impurities for separately
please justify scientifically by comparing the while Chinese pharmacopoeia does not describe
specifications & methods described in USP with individual impurities but it gives total impurity limit
the methods & specifications of In-House standard NMT 2.5% which is similar to USP. Moreover, the
since the methods of analyses used are different. limit for unspecified impurity in USP is 0.5% while
according to C.P. is 1%.
The test for specificity parameter of “The difference of excipient and brand of reagents used
validation/verification of analytical method is in the testing were taken into account during the
performed by performing the tests on the sample verification of analytical procedure, the specificity was
solution against placebo solution, please refer the verified by comparing the interference on the sample
guideline for the procedure adopted while the solution against placebo”.
specificity test is performed by spiking with
appropriate level of impurities or exposing the
drug product sample to relevant stress conditions
as recommended by USP.
• Decision of 313rd meeting: The Board deferred the case for:

• Submission of impurity profiling according to USP for the applied product.
• Submission of Drug-excipient compatibility studies.
• Confirmation of the area where the applied product would be manufactured.
• Firm’s response: Firm has submitted following:
• Site master file
• Analytical record for excipients
• Decision of 316th meeting: The Board deferred the case for:
• Submission of impurity profiling according to USP for the applied product.
• Submission of Drug-excipient compatibility studies.
• Confirmation of the area where the applied product would be manufactured.
Case no. 03 New Registration applications on Form 5F (Human)

a. New Cases (Human)
671. Name, address of Applicant / Marketing M/s Pacific Pharmaceuticals Limited. 30 km, Multan Road,
Authorization Holder Lahore, Pakistan
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Limited. 30 km, Multan Road,
Lahore, Pakistan
☐ Importer
GMP status of the firm GMP certificate issued on basis of inspection conducted on 28-08-
2019
Evidence of approval of manufacturing Firm has submitted copy of section approval letter dated 14-02-
facility 2020 which specifies Soft gel capsule general section.
☐ Export sale
The proposed proprietary name / brand Rivaroxaban 20mg Tablet
name
Pharmaceutical ingredient (API) per unit Rivaroxaban ……... 20mg
Pharmaceutical form of applied drug Solution for Injection
Pharmacotherapeutic Group of (API) Anti thrombic agent
Reference to Finished product In-house specification

specifications
Proposed Pack size 10’s,14’s; As per SRO
The status in reference regulatory Approved by MHRA of UK
authorities
For generic drugs (me-too status) Xarelto 20mg tablet (Reg.# 072550) of M/s Bayer Health Care

Name and address of API manufacturer. M/s Jiangxi Synergy Pharmaceutical Co Ltd., Jiangxi Fengxin
Industrial Park, China
drug substance.
(Conditions duration of Stability studies) substance at both accelerated as well as real time conditions. The
RH for 6 months. The real time stability data is conducted at 5°C ±
3°C for 48 months.
Pharmaceutical Equivalence and Pharmaceutical Equivalence Studies against the comparator
Comparative Dissolution Profile product of Xarelto 20mg tablet of M/s Bayer.
Analytical method validation/verification Firm has submitted verification studies of the drug substance and
of product the drug product.
Stability studies Firm has submitted stability studies data of three batches at both
Manufacturer of APIs M/s Jiangxi Synergy Pharmaceutical Co Ltd., Jiangxi Fengxin Industrial Park, China
API Lot No. 20181001S

Description of Pack Alu-Alu blister
Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Accelerated: 0,1,2,3,4,6 (Months)
Frequency
Batch No. TRV0103P TRV0203P TRV0303P
# Documents to Be Status
Provided

1. Reference of
previous approval of
applications with N/A
stability study data of
the firm (if any)
2. Approval of API/ Copy of GMP certificate (Certificate# JS20170678) issued by China Food &
DML/GMP Drug Administration valid upto 18-06-2022.
certificate of API
manufacturer issued
by concerned
regulatory authority
of country of origin.
3. Documents for the Copy of commercial invoice attested by AD I&E DRAP,
procurement of API Lahore, has been submitted.
with approval from
DRAP (in case of Date of
Quantity
import). Batch No. Invoice No. approval
Imported
by DRAP
20181001S JXSG190638 0.6Kg 07-08-2019
4. Data of stability
batches will be
supported by attested
respective Firm has submitted data of stability batches along with batch manufacturing
documents like record and analytical record.
chromatograms, Raw
data sheets, COA,
summary data sheets
etc.
5. Compliance Record
of HPLC software
21CFR & audit trail Firm has submitted audit trail certificate of Agilent HPLC
reports on product
testing.
6. Record of Digital
data logger for
temperature &
Firm has submitted Record of Digital data logger for temperature & humidity
humidity monitoring
of stability chambers
(real time and
accelerated)
Section# Observtaion Firm’s response
3.2.S.4.1 Various test and their acceptance criterias are • At the time of submission
different between specifications of drug substance specification were IH but after the
manufacturer and drug product manufacturer. availability of monograph of raw
material and finish product, we are
willing to adopt the pharmacopoeial
specification.
3.2.S.4.2 Complete analytical procedure from drug • Submitted.
substance manufacturer shall be submitted.
3.2.S.4.3 Analytical method verification studies for the Drug • Firm has submitted analytical method
substance shall be submitted, performed by M/s verification studies for drug
Pacific Pharmaceuticals. substance.
3.2.P.5.1 The USFDA Biopharmaceutics review document • At the time of submission product
for the reference product i.e., Xarelto tablet, specifications was IH but after the
declares the limit of dissolution specifications as availability of monograph of finish

“NLT Q at 15 minutes”, whereas finished product product we are following
specifications submitted by you specifies the pharmacopoeial parameter (BP
dissolution time as 45 minutes. Clarification shall monograph is submitted.)
be submitted for this variation. • BP monograph of Rivaroxaban tablets
has recommended 30 minutes
timepoint for dissolution test.
3.2.P.5.3 • Submit analytical method validation report for Firm has submitted analytical method
drug product analytical method verification studies based upon BP
monograph of Rivaroxaban tablets.
3.2.P.8.3 • Submitted stability data summary sheets • There was a typographical error in the
reflect significant changes in the results of report, now raw data sheets with
Assay test. stability report is submitted.
• Raw data sheets for the stability studies
analysis shall be submitted.
application.
672. Name, address of Applicant / Marketing M/s Islam Pharmaceutical, 7Km Pasrur Road Sialkot,
Authorization Holder Islamabad from M/s Bio-Labs (Pvt) Ltd
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No 145, Industrial Triangle,
☐ Importer

☐ Export sale
The proposed proprietary name / brand name Tyron Injection 1g
Pharmaceutical ingredient (API) per unit Cefotaxime Sodium eq. to Cefotaxime….1g
Pharmaceutical form of applied drug
Sterile powder for injection

The status in reference regulatory authorities MHRA approved
For generic drugs (me-too status) Cefotaxime 1g Injection by Friends Pharma,
Lahore….048893

GMP status of the Finished product GMP certificate is valid upto 03-07-2022.
manufacturer
Name and address of API manufacturer. Qilu Antibiotics pharmaceutical Co. Ltd. North of
Huayuan Road (W), Linyi County, Shandong, P.R. China
manufacturers,
summarized
drug substance.
The accelerated stability data is conducted at 40 O ± 2 O C
conducted at 30OC ± 2 O C / 65% ± 5% RH for 36 months.
(Batch No. 3078GL81F, 3079GL81F & 3080GL81F)
dissolution profile product Claforan 1g Injection
Manufacturer of API Qilu Antibiotics pharmaceutical Co. Ltd. North of Huayuan Road (W),
Linyi County, Shandong, P.R. China
API Lot No. 0046l81F
Description of Pack
Type-II glass vial

Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. VP-019 VP-1556 VP-1713
Batch Size 1,40,000 40,000 Packs 5000 Packs
Vials
15-06-2018 23-12-2018
2019
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API GMP certificate (Certificate# SD20170590) OF Qilu
manufacturer issued by concerned regulatory Antibiotics Pharmaceutical Co. Ltd issued by China Food &
authority of country of origin. Drug Administration, valid up to 30-07-2022.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice approved
approval from DRAP (in case of import). by AD DRAP I&E Islamabad dated 13-02-2021 for the
import of 50 Kg of Ceftazidime (batch# 0046L81F)
4 Data of stability batches will be supported by Firm has submitted record of testing of all batches along
attested respective documents like with chromatograms, raw data sheets, COA and summary
chromatograms, Raw data sheets, COA, data sheets. The firm has 2 stability chambers having
summary data sheets etc. capacity
5. Compliance Record of HPLC software 21CFR & Not submitted
(real time and accelerated). stability chambers.

1.5.6 The said section declares Pharmacopoeial reference as Innovator’
specifications, whereas USP & BP monograph is available for applied
product.
2.3 Table for literature references for the drug substance & drug product does
not declare the status in Pharmacopoeias other than USP.
3.2. Copies of the Drug substance specifications and analytical procedures
S.4.1 used for routine testing of the Drug substance /Active Pharmaceutical
Ingredient by Drug Product manufacturer is required.
3.2.S.4.3 Analytical Method Verification studies including specificity, accuracy
and repeatability (method precision) performed by the Drug Product
3.2. COA submitted from drug substance manufacturer declares the
S.4.4 specifications as of USP, whereas the analytical method submitted is as
per BP monograph for “Cefotaxime sodium”.
Tests of Endotoxin Sterility have not been performed by the M/s Bio-Labs
at the stage of drug substance analysis. Justification shall be submitted in
this regard.
COA form M/s Bio Labs does not clarify whether Assay results are
whether “As is” Dried basis” or “as acid form”.
Provide results of analysis of relevant batch(es) of Drug Substance
performed by Drug Product manufacturer used during product
development and stability studies, along with Certificate of Analysis
(CoA) of the same batch from Drug Substance / /Active Pharmaceutical
3.2. S.5 COAs of reference standard from USP, EDQM & drug substance
manufacturer have been submitted. Clarification shall be submitted
regarding which standard was actually applied for the drug substance
analysis by M/s Bio-Labs.
3.2.S.7 Drug substance stability studies have been performed as per BP
specifications, whereas the submitted COA is as per USP monograph.
3.2. Pharmaceutical equivalence report does not include all tests as per
P.2.2.1 Pharmacopoeial monographs of “Cefotaxime for injection”
3.2. A flow diagram shall be presented giving the steps of the process and
P.3.3 showing where materials enter the process.
3.2.P.5.1 Signed & stamped copy of drug product specifications and drug product
analytical procedure shall be submitted by M/s Bio-Labs.
Drug product specifications does not include all the tests declared in the
USP monograph of “Cefotaxime for injection”.
3.2.P.5.3 Sample preparation procedure mentioned in analytical method
verification report, is not as per the USP monograph for the applied
product.
Submitted HPLC chromatograms of analytical method verification
studies reflect that the analysis has not been performed as per the
chromatographic conditions of USP monograph of “Cefotaxime for
injection”
3.2.P.5.4 Batch analyses release results for relevant batches upon which stability
studies have been performed, shall be submitted.
3.2. P.8 According to submitted stability protocol and data sheets, following tests
recommended by USP monograph of “Cefotaxime for injection” have not
been performed:
Constituted Solution

Loss on Drying
Particulate matter in injections
Justification shall be submitted in this regard.
According to submitted stability data sheets, there is a gap of more than 1
month between the manufacturing date and “initial” time point of stability
studies of batch # VP-019 & VP-1713. Justification shall be submitted in
this regard.
According to submitted long term stability data sheets & analytical record
of batch # VP-1713, the 24-month time point has been performed 3
months earlier from the due date. Justification shall be submitted in this
regard.
Documents for the procurement with approval from DRAP of relevant
batch# of API used for manufacturing of the stability batches of drug
Submit raw data sheets for stability studies, reflecting the details of
Standard weight, Sample dilution preparation, Potency of Reference
standard and Calculation formula applied for the Assay test.
Submitted HPLC chromatograms of stability studies reflect that the
analysis has not been performed as per the chromatographic conditions of
USP monograph of “Cefotaxime for injection”, since USP monograph
recommends a gradient system run of mobile phase of 56 minutes whereas
submitted chromatograms declare the run time of 10 minutes.
Complete Batch Manufacturing Records of drug product stability batches shall be submitted.
Upon communication of above observations firm has submitted Drug substance data from a new manufacturer i.e., M/s
Nectar Lifesciences Ltd., Chandigarh, India, without any due justification.
• Justification of revising the drug substance data.
• Clarification regarding the source of drug substance with which the stability batches of drug product
have been manufactured.
• Evaluation of newly submitted data.
• Submission of fee of Rs. 75,000/- for pre-approval change of source of drug substance as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
☐ Importer
☐ Export sale
Evidence of approval of manufacturing facility Firm has submitted copy of section approval letter dated 27-
02-2011 which specifies Dry Powder Injection
(Cephalosporin) for M/s Bio labs.

The proposed proprietary name / brand name Celine Injection 500mg IV
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium eq. to Ceftriaxone … 500mg
For generic drugs (me-too status) Topcef Injection of Ceftriaxone Sodium by Pride
Pharmaceuticals
manufacturer
Name and address of API manufacturer. M/s. Sinopharm Weiqida Pharmaceuticals Co Ltd, First
medical zone, economic and technological development
zone, datong, China.
manufacturers,
summarized
(Batch No. 011302001, 011302002, 011302003)

dissolution profile product Rocephin 500mg injection.

Manufacturer of API M/s. Sinopharm Weiqida Pharmaceuticals Co Ltd, First medical zone,
economic and technological development zone, datong, China
API Lot No. 2081704066
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. VP-1436 VP-1462 VP-1319
Batch Size 40,000 Vials 40,000 Vials 40,000 Vials
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API GMP certificate (Certificate# SX20180229) of M/s
manufacturer issued by concerned regulatory Sinopharm Weiqida Pharmaceuticals Co Ltd. issued by
authority of country of origin. Shangxi Food & Drug Administration, valid up to 05-06-
2023.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). (invoice#W200910) approved by AD DRAP I&E
Islamabad dated 07-07-2020 for the import of Ceftriaxone
sodium from M/s Sinopharm Weiqida Pharmaceuticals Co
Ltd.
4 Data of stability batches will be supported by --

Remarks:
☐ Importer

☐ Export sale
The proposed proprietary name / brand name Celine Injection 1g IV
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium eq. to Ceftriaxone … 1gm
Pharmaceuticals
manufacturer
manufacturers,
summarized

(Batch No. 011302001, 011302002, 011302003)
dissolution profile product Rocephin 1gm injection.

API Lot No. 2081704052
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. VP-1613 VP-1560 VP-1457
No. of Batches 03

2023.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). (invoice#W200910) approved by AD DRAP I&E
Islamabad dated 07-07-2020 for the import of Ceftriaxone
sodium from M/s Sinopharm Weiqida Pharmaceuticals Co
Ltd.
4 Data of stability batches will be supported by --
☐ Importer

☐ Export sale
The proposed proprietary name / brand name Celine Injection 250mg IM
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium Eq. to Ceftriaxone … 250mg
Pharmaceuticals 025876

manufacturer
manufacturers,
summarized
(Batch No. 011302001, 011302002, 011302003)
dissolution profile product

API Lot No. Q011711032
Description of Pack Glass vial

Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. VP-1522 VP-1523 VP-1660
No. of Batches 03
2023.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice specifying
approval from DRAP (in case of import). import of 1200Kg Ceftriaxone sodium (sterile) from
Sinopharm dated 22-12-2017. The invoice specifies
multiple batches of ceftriaxone. In which the quantity of lot
No. Q011711032 is 250kg. The invoice is cleared by Ad
(I&E) DRAP.
4 Data of stability batches will be supported by Firm has submitted complete record of testing of all
attested respective documents like batches along with chromatograms, raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
5. Compliance Record of HPLC software 21CFR N/A
1.5.6 The said section declares Pharmacopoeial Firm has submitted revised Form 5F with USP
reference as Innovator’ specifications, whereas specification.
USP & BP monograph is available for applied Relevant fee shall be submitted
product.
3.2.S.4 • Justification shall be submitted regarding • Firm has declared drug substance
drug substance specifications & analytical specifications as per USP.
procedure proposed by the drug substance • Firm has submitted revised specifications
manufacturer, whether it is as per USP or from drug substance manufacturer i.e., M/s.
Chinese pharmacopoeia. Sinopharm Weiqida Pharmaceuticals Co
• Assay limits proposed in the drug substance Ltd., with Assay limits as per USP.
specifications proposed by the drug • Analytical method verification studies report
substance manufacturer are not as per USP has been submitted.
monograph for “Ceftriaxone sodium”.

• Copy of drug substance specifications and
analytical procedure applied by Drug
product manufacturer shall be submitted.
• Analytical Method Verification studies
by the Drug Product manufacturer shall be
submitted.
3.2.S.4.4 • Assay limits are different between the COA • Firm has submitted that drug substance
from drug substance manufacturer and COA manufacturer is following EP and drug
from Drug product manufacturer. product manufacturer is following USP.
• COA of drug substance submitted from M/s That’s why limits are different but results are
Bio-Labs reflect that “Sterility tests” & well within limits.
“Bacterial Endotoxin tests” have not been • Firm has submitted Sterility test & bacterial
performed. Justification shall be submitted endotoxin reports for the the drug substance
in this regard. from M/s Bio-Labs.
• COA of drug substance submitted from M/s • Firm has submitted that the Assay results are
Bio-Labs does not clarify whether the for the Ceftriaxone base only.
declared Assay results are for Ceftriaxone or COA of drug substance submitted from M/s Bio
for Ceftriaxone sodium. Lab & M/s Sinopharm
• Provide results of analysis of relevant
batch(es) of Drug Substance performed by
Drug Product manufacturer used during
along with Certificate of Analysis (CoA) of
the same batch from Drug Substance /
/Active Pharmaceutical Ingredient
manufacture.
3.2.S.5 COA of primary / secondary reference standard Firm has submitted COA of working standard
including source and lot number shall be from M/s Bio-labs
provided
3.2.P.2.2.1 Test of water determination has not been Firm has submitted revised Pharmaceutical
performed in “Pharmaceutical equivalence” equivalence studies wherein test of water
studies. determination has been added.
3.2.P.2.6 The said section details the compatibility study Firm has stated that for Ceftriaxone IM,
“after reconstitution with water for injection”, Lignocaine HCl is used as diluent
whereas diluent for applied product is
Lignocaine HCl.
3.2.P.5.1 • Submit the document of Drug product • Firm has submitted revised specifications and
specifications and Drug product testing analytical procedure as per USP monograph.
method in use by M/s Bio-Labs.
• Submitted drug product specifications does
not declare the “Water determination test”.
3.2.P.6 Submit readable copy of COA of primary / Firm has submitted COA of working standard
secondary reference standard applied for the from M/s Bio-labs
analysis during stability studies.
3.2.P.8 • Documents for the procurement of API with • Firm has submitted copy of commercial
approval from DRAP for the relevant batch# invoice specifying import of 1200Kg
of drug substance which has been used to Ceftriaxone sodium (sterile) from Sinopharm
formulate stability batches. dated 22-12-2017. The invoice specifies
• Submit raw data sheets for stability studies, multiple batches of ceftriaxone. In which the
reflecting the details of Standard weight, quantity of lot No. Q011711032 is 250kg.
Sample dilution preparation, Potency of The invoice is cleared by Ad (I&E) DRAP.
Reference standard and Calculation formula • Firm has submitted raw data sheets and
applied for the Assay test. stability summary sheets, wherein previously

• According to submitted stability protocol test of sterility, particulate matter and water
and data sheets, following tests content has been included
recommended by USP monograph of • BMRs have been submitted.
“Ceftriaxone for injection” have not been
performed:
i. Constituted Solution
ii. Water determination test
iii. Particulate matter in injections
• Complete Batch Manufacturing Records of
drug product stability batches shall be
submitted.
Decision: Registration Board approved the applications of “Celine Injection 250mg IM”, “Celine Injection 1g IV”
& “Celine Injection 500mg IV” with USP specifications.
• Firm shall submit fee of Rs. 7,500 for each product for correction/pre-approval change in product
676. Name, address of Applicant / Marketing M/s Scilife Pharma (Pvt.) Ltd., 16, K.O.C.H.S.
Authorization Holder Amir Khusro Road, Karachi-75350, Pakistan
Name, address of Manufacturing site. M/s Scilife Pharma (Pvt.) Ltd., Plot # FD-57/58-A2,
Korangi Creek Industrial Park, Karachi
☐ Importer
☐ Export sale
Details of fee submitted Rs. 20,000/- dated 31-05-2021 & Rs. 10,000/- dated 10-06-
2021
SciAmpa-M 5+850 mg tablet
name
Pharmaceutical ingredient (API) per unit Empagliflozin………………..5mg
Metformin HCl…………..850mg
Pharmacotherapeutic Group of (API) Anti-hyperglycemic agents (A10BD20)
Reference to Finished product specifications Manufacturer’s
Proposed Pack size 7’s, 10’s, 14’s, 20’s & 28’s
The status in reference regulatory Synjardy 5+850 mg tablet (EMA Approved).
authorities
For generic drugs (me-too status) XENGLU-MET 5+850 Mg Tablet of Hilton Pharma (Reg
#093103)

GMP status of the Finished product Renewal of license granted on 01/06/2021
manufacturer Tablet, Capsule, Ointment/Cream, Sachet, Dry Powder
Inhalaer & Dry Powder suspension (General) sections
approved.
Last inspection conducted on 16-11-2021 and concludes

that firm was considered to be operating at Good level of
compliance
Name and address of API manufacturer. API manufacturer of Empagliflozin
Name: Fuxin Long Rui Pharmaceutical CO., Ltd.
Address: Fluoride Industrial Park, Fumeng County (Yi Ma
Tu), Fuxin
City, Liaoning Province -123000, China
API manufacturer of Metformin Hydrochloride

Name: Shouguang Fukang Pharmaceutical Co., Ltd.
Address: North-East of Dongwaihuan Road, Dongcheng
Industrial Area
submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance data for both
Stability studies Firm has submitted stability study data of 3 batches of both
API at accelerated as well as real time conditions.
The real time stability data of Empagliflozin conducted at

30±2°C, 65%±5% RH. The stability study data is till 26
months.
The real time stability data of Metformin hydrochloride

conducted at 30±2°C, 75%±5% RH. The stability study
Pharmaceutical equivalence and Firm has submitted Compartitive dissolution profile against
comparative dissolution profile Xenglu Met 5+850mg Tablet of Hilton Pharma

Manufacturer of API API manufacturer of Empagliflozin
Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu), Fuxin

Address: North-East of Dongwaihuan Road, Dongcheng Industrial Area
API Lot No. 0000006044 / 0000006965
Description of Pack
Batch No. 122B20 123B20 124B20
No. of Batches 03
applications with stability study data of the Glusimet XR 50/500mg Tablets & Glusimet XR
firm (if any) 50/1000mg Tablets which was conducted on 16th July,
2020 and was presented in 296th meeting of Registration
Board held on 8th - 10th September, 2020.
The firm has 21 CFR compliant HPLC software
The firm has audit trail reports available.
The firm possesses stability chambers with digital data
loggers.
2. Approval of API/ DML/GMP certificate of Empagliflozin
API manufacturer issued by concerned Copy of DML certificate No. Liao20150233 issued by FDA
regulatory authority of country of origin. of Liaoning Province valid till 20/12/2022.
Metformin HCl: Copy of GMP certificate No.

SD20190888 issued by CFDA valid till 12/03/2024.
3. Documents for the procurement of API with Empagliflozin: Firm has submitted copy of form 5, invoice
approval from DRAP (in case of import). (invoice# HN19011801-H) Dated: 18-01-2020, cleared by
DRAP Karachi office dated 30-01-2020 specifying import
10Kg Empagliflozin (Batch# E-20190920-D02-E06-01).
Metformin HCl: Firm has submitted copy of Form 5 &
invoice (invoice# 20FK04Z4106B) Dated: 05-05-2020
from Shouguang Fukang Pharmaceutical Co., Ltd.

cleared, cleared by DRAP Karachi office dated 30-01-2020
specifying import 3000Kg Metformin HCl (Batch# A-
32612004031 & A-32612004032 ).

chromatograms,
etc.
testing
677. Name, address of Applicant / Marketing M/s Scilife Pharma (Pvt.) Ltd., 16, K.O.C.H.S.
Authorization Holder Amir Khusro Road, Karachi-75350, Pakistan
Name, address of Manufacturing site. M/s Scilife Pharma (Pvt.) Ltd., Plot # FD-57/58-A2,
Korangi Creek Industrial Park, Karachi
☐ Importer
☐ Export sale
Details of fee submitted Rs. 20,000/- dated 31-05-2021 & Rs. 10,000/- dated 10-06-
2021
SciAmpa-M 5+1000 mg tablet
name
Pharmaceutical ingredient (API) per unit Empagliflozin………………..5mg
Metformin HCl…………..1000mg
Pharmacotherapeutic Group of (API) Anti-hyperglycemic agents (A10BD20)
Reference to Finished product specifications Manufacturer’s

The status in reference regulatory Synjardy 5+1000 mg tablet (EMA Approved).
authorities
For generic drugs (me-too status) XENGLU-MET 5MG +1GM Tablet of Hilton Pharma
(Reg #093102)
GMP status of the Finished product Renewal of license granted on 01/06/2021
manufacturer Tablet, Capsule, Ointment/Cream, Sachet, Dry Powder
Inhalaer & Dry Powder suspension (General) sections
approved.
Last inspection conducted on 16-11-2021 and concludes

that firm was considered to be operating at Good level of
compliance
Name and address of API manufacturer. API manufacturer of Empagliflozin
Address: Fluoride Industrial Park, Fumeng County (Yi Ma
Tu), Fuxin

Address: North-East of Dongwaihuan Road, Dongcheng
Industrial Area
submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance data for both
Stability studies Firm has submitted stability study data of 3 batches of both
API at accelerated as well as real time conditions.
The real time stability data of Empagliflozin conducted at

30±2°C, 65%±5% RH. The stability study data is till 26
months.
The real time stability data of Metformin hydrochloride

conducted at 30±2°C, 75%±5% RH. The stability study

Pharmaceutical equivalence and Firm has submitted Compartitive dissolution profile against
comparative dissolution profile Xenglu Met 5+1000mg Tablet of Hilton Pharma
Manufacturer of API API manufacturer of Empagliflozin
Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu), Fuxin

Address: North-East of Dongwaihuan Road, Dongcheng Industrial Area
API Lot No. 0000006044 / 0000006965
Description of Pack
Batch No. (127B20) (128B20) (129B20)
No. of Batches 03
applications with stability study data of the Glusimet XR 50/500mg Tablets & Glusimet XR
firm (if any) 50/1000mg Tablets which was conducted on 16th July,
Board held on 8th - 10th September, 2020.
loggers.
2. Approval of API/ DML/GMP certificate of Empagliflozin
API manufacturer issued by concerned Copy of DML certificate No. Liao20150233 issued by FDA
regulatory authority of country of origin. of Liaoning Province valid till 20/12/2022.
Metformin HCl: Copy of GMP certificate No.

SD20190888 issued by CFDA valid till 12/03/2024.

3. Documents for the procurement of API with Empagliflozin: Firm has submitted copy of form 5, invoice
approval from DRAP (in case of import). (invoice# HN19011801-H) Dated: 18-01-2020, cleared by
DRAP Karachi office dated 30-01-2020 specifying import
10Kg Empagliflozin (Batch# E-20190920-D02-E06-01).
Metformin HCl: Firm has submitted copy of Form 5 &
invoice (invoice# 20FK04Z4106B) Dated: 05-05-2020
from Shouguang Fukang Pharmaceutical Co., Ltd. cleared,
cleared by DRAP Karachi office dated 30-01-2020
specifying import 3000Kg Metformin HCl (Batch# A-
32612004031 & A-32612004032).
chromatograms,
etc.
testing
Decision: Decision: Approved with Innovator’s specifications.
678. Name, address of Applicant / Marketing M/s CCL Pharma Private Limited, Plot No 62 Quaid e
Authorization Holder Azam Industrial Estate, Lahore
Name, address of Manufacturing site. M/s CCL Pharma Private Limited, Plot No 62 Quaid e Azam
☐ Importer
☐ Export sale
Details of fee submitted Rs. 75,000/- dated 10-06-2021
Ertu-Met 2.5/500 Tablet
name
Active Pharmaceutical ingredient (API) Ertugliflozin…….2.5mg
per unit Metformin HCl….500mg

Pharmaceutical form of applied drug Pink colored oblong biconvex shaped film coated tablet.
Pharmacotherapeutic Group of (API) Anti-Diabetic
Innovator
specifications
Proposed Pack size 5's, l0's, l4's,20's,28's,30's, 50's and 100's
Segluromet by M/s Merck Sharp Dohme,USA
authorities
GMP status of the Finished product GMP certificate issued on basis of inspection conducted on 30-04-
manufacturer 2019.
Evidence of approval of manufacturing GMP certificate issued including tablet section.
facility
Name and address of API manufacturer. Metformin: M/s Wanbury Limited. Doctors Organic Chemical
Division K Illindalapamr- 534217, lragavaram Mandal, West
Godavari District Andhra Pradeshl India.
Erugliflozin: Shanghai Pharma Group Changzhou Kony
Pharmaceutical Co., Ltd Daixi Street, Luoyang Town, Wujin
District, Changzhou, Jiangsu, China
Summarized information related to nomenclature, structure, general
submitted.
Module III (Drug Substance) Official monograph of Metformin Hydrochloride is present in BP
while Ertugliflozin is not present is official pharmacopoeia. The
Real time: 30°C ± 2°C / 65% ± 5%RH
Ertugliflozin Batches: (ETG20l6l201, ETG20l6l202,
ETG20l70101)
Metformin HCl Batches: (MS-0220601
Lot A, MS-0220601 Lot B, MS-0230601 Lot A, MS-0230601 Lot
B, MS-0240601 Lot A, MS-0240601 Lot B)
comparative dissolution profile brand leader that is Segluromet 2.5mg/500mg tablet by CCL

CDP has been performed against the same brand that is Segluromet
2.5mg/500mg tablet by CCL Pharma in Acid media (pH 1.2),
Acetate Buffer (pH 4.5) & Phosphate Buffer (pH 6.8). The values
f2 are in the acceptable range.
Manufacturer of API Metformin: M/s Wanbury Limited, India.
Erugliflozin: Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd, China
API Lot No. Ertugliflozin: ETG20190101
Metformin HCl: MT01170220
Description of Pack
(Container closure Alu-Alu blister packed in unit carton
system)
Batch No. ERA-T2/20 ERA-T3/20 ERA-T4/20
No. of Batches 03
1. Reference of previous approval of The firm has referred to theon-site nepsction report of ERTU Tablet,
applications with stability study data of which was approved in 312th meeting. Following observations were
the firm (if any) recorded:
• FPP testing had been conducted on HPLC R&D # 19 for Ertu
tablet 5mg and Ertu tablet 15mg which were not 21 CFR
compliant. FPP testing of 0 and 3rd month testing of Ertu tablet
5mg and Ertu tablet 15mg was conducted on HPLC R&D # 19
which were not 21 CFR compliant and 6th month FPP testing
of Ertu tablet 5mg and Ertu tablet 15mg was conducted on
HPLC QC# 122 which is 21 CFR compliant.
• The audit trail was enabled. Log of data was available on the
HPLCs and data was also checked through hard copies of
chromatograms.
• Adequate monitoring and control was available for stability
chamber
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. JS20170734 issued by CFDA valid till
of API manufacturer issued by concerned 25/12/2022 for Ertugliflozin.
regulatory authority of country of origin. Copy of GMP certificate No. 3083/stores/2019 issued by DCA
valid till 06/02/2022 for Metformin HCl.

3. Documents for the procurement of API • Copy of letter No.3964/2019/DRAP dated 21/03/2019 is
with approval from DRAP (in case of submitted wherein the permission to import different APIs
import). including Ertugliflozin for the purpose of test/analysis and
• Copy of letter No. 3452/2020/DRAP dated 05/03/2020 is
submitted wherein permission to import Metformin is granted.
chromatograms,
sheets etc.
testing
accelerated)
679. Name, address of Applicant / Marketing M/s CCL Pharma Private Limited, Plot No 62 Quaid e Azam
☐ Importer
☐ Export sale
name
Pharmaceutical form of applied drug Pink colored oblong biconvex shaped film coated tablet.
Innovator
specifications
authorities

manufacturer 2019.
Approval of manufacturing facility GMP certificate issued including tablet section.
submitted.
Real time: 30°C ± 2°C / 65% ± 5%RH
ETG20l70101)
B, MS-0240601 Lot A, MS-0240601 Lot B)
2.5mg/1000mg tablet by CCL Pharma in Acid media (pH1.2) ,
for f1 and f2 are in the acceptable range.

Description of Pack
system)
Batch No. ERB-T2/20 ERB-T3/20 ERB-T4/20
No. of Batches 03
1. Reference of previous approval of The firm has submitted history of 5-D Inspections.
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. JS20170734 issued by CFDA valid
of API manufacturer issued by concerned till 25/12/2022 for ertugliflozin.
valid till 06/02/2022 for Metformin
submitted wherein permission to import metformin is granted.
chromatograms,
sheets etc.
testing
accelerated)

☐ Importer
☐ Export sale
Ertu-Met 7.5mg/500mg tablet
name
Pharmaceutical form of applied drug Purple colored oblong biconvex shaped film coated tablet.
Innovator
specifications
authorities
manufacturer 2019.
submitted.

Real time: 30°C ± 2°C / 65% ± 5%RH
ETG20l70101)
B, MS-0240601 Lot A, MS-0240601 Lot B)
Description of Pack
system)
Batch No. ERC-T2/20 ERC-T3/20 ERC-T4/20
No. of Batches 03
the firm (if any)

chromatograms,
sheets etc.
testing
accelerated)
☐ Importer
☐ Export sale
name
Pharmaceutical form of applied drug Purple colored oblong biconvex shaped film coated tablet.
Innovator
specifications

authorities
manufacturer 2019.
submitted.
Real time: 30°C ± 2°C / 65% ± 5%RH
ETG20l70101)
B, MS-0240601 Lot A, MS-0240601 Lot B)

Description of Pack
system)
Batch No. ERD-T2/20 ERD-T3/20 ERD-T4/20
No. of Batches 03
the firm (if any)
chromatograms,
sheets etc.
testing
accelerated)
Section Observation Firm’s response

#

1.5.2 Presented label claim shall declare the Revised label claim has been
complete drug substance name and its submitted as under:
equivalent amount for the active moiety shall Ertumet 2.5/1000mg
be mentioned. Each film coated tablet contains:
Ertugliflozin L-pyroglutamic acid
equivalent to 2.5mg Ertugliflozin
Metformin hydrochloride ……
1000mg
Ertumet 2.5/500mg
500mg
Ertumet 7.5/500mg
Metformin
hydrochloride…….500mg
Ertumet 7.5/1000
1000mg
2.3.S.4. Provide summarized results of analysis of Submitted.
4 relevant batch(es) of Drug Substance
performed by Drug Product manufacturer.
2.3.P.1 Justify the proposed quantity per unit of Firm has submitted the justification
Ertugliflozin as pyroglutamic acid against based upon the molecular factor of
the label claim of applied product. Ertugliflozin L-pyroglutamic acid
Ertugliflozin L-Pyroglutamic acid
3.2.S.4 • Submitted specifications and analytical • The content of Ertugliflozin is
procedure describes the test for content obtained from Ertugliflozin L-
of “Ertugliflozin L-pyroglutamic acid, pyroglutamic acid after raw
whereas the Innovator’s product material analysis.
literature recommends test of • Run time is 12 min, after 3min
“Ertugliflozin potency” in the drug conc of both acetonitrile and
substance specifications. buffer is same till 12min.
• The drug substance analytical method Updated RMTM is submitted.
submitted by M/s CCL pharmaceuticals • In calculation formula, it is typo
declare the run time as 12 minutes in the mistake, as presented in
chromatographic conditions of Assay manufacturer method, there is L-
test, whereas the gradient program is for pyroglutamic acid potency.
3 minutes only. Clarification shall be RMTM is submitted.
submitted in this regard. • Raw data sheet for LPGA
• The calculation formula in the test for L- • Analytical record of Ertugliflozin
pyroglutamic acid applies the potency of L-pyroglutamic Acid is
Ertugliflozin working standard instead submitted.
of the L-pyroglutamic acid. • Run time is 12 min, after 3min
• Analytical record i.e., Raw data sheet, conc of both acetonitrile and
FTIR spectrum, chromatograms etc, buffer is same till 12min.

shall be submitted for the analysis of • As per standard industrial
‘Ertugliflozin L-pyroglutamic Acid’ practice, the content of
performed by M/s CCL Ertugliflozin were obtained from
Pharmaceuticals. Ertugliflozin L-pyroglutamic
• The chromatogram of the specificity acid by applying theoretical
parameter reflects the peak of factor of LPGA. In future we will
Ertugliflozin L-PGA at about 4 minutes, consider your valuable point and
whereas the chromatographic condition use COA in which manufacturer
of Assay test specifies the gradient declared the "Ertugliflozin
program for 3 minutes only. potency".
• COA from both drug substance and drug
product manufacturer does not declare
the “Ertugliflozin potency” as
recommended by the innovator product.
3.2. S.5 COA of reference standard of L- Submitted.
Pyroglutamic acid shall be submitted.
3.2.S.7 Justification shall be submitted for not Firm has now submitted stability
performing test of L-PGA content studies with LPGA content.
throughout the stability studies.
Metformin HCl
3.2.S.4. • Specificity parameter has not been • We are performing the
3 performed in method verification verification studies through
studies. titration method and therefore
• Declare the exact concentrations specificity is not performed.
(mg/ml) of solution which is used for the • Verification studies submitted is
accuracy and precision parameter testing performed through titration
during the method verification studies. method and in titration method
conc. of solution is not exactly
known.
3.2.P.1 • Presented label claim is not as per the Firm has revised label claim as
innovator product since it does not presented against section 1.5.2
reflect the content of Ertugliflozin L-
pyroglutamic acid.
• Justify the proposed quantity per unit of
Ertugliflozin as pyroglutamic acid
against the label claim of applied
product.
3.2.P.3. As per Innovator’s literature the Metformin Mixing of Ertugliflozin-LPGA &
3 granules are prepared separately and are then Metformin HCI at granular stage
dry blended with Ertugliflozin L-PGA at didn't affect the finish product and
extra-granular stage, whereas submitted accelerated and long-term studies
manufacturing method describes mixing of showed that there is no impact of this
Ertugliflozin-LPGA & Metformin HCl at change observed.
granular stage. Justification shall be
submitted for this variation.
3.2.P.5. Analytical method validation studies for the Analytical method validation studies
3 drug product analysis method shall be have been submitted now.
submitted.
3.2.P.6 Submitted COA of working standard of The content of Ertugliflozin has been
Ertugliflozin-LPGA does not declare the determined through factor
content of LPGA and also the potency in calculations as a regular practice and
terms of Ertugliflozin has not been record has been submitted. We have
determined. raised your valuable point to our
manufacturer, we will submit updated
COA as soon we received.

3.2.P.8 • Justification shall be submitted for • We have used potency on OAB
applying potency of working standard on basis, as we checked there isn’t
anhydrous basis in Assay calculation any drastic impact on final
instead of using the value of potency on potency but we will use as is
as is basis. potency in future batches.
• Justification shall be submitted for • The product stability results show
applying the theoretical factor of LPGA, that there is no drastic impact on
instead of applying the actual potency of formulation studies of
Ertugliflozin in working standard. Ertugliflozin tablet. In future we
will calculate L-Pyroglutamic
acid content separately and also
calculate Ertugliflozin
accordingly for further use.
• You are advised to justify the quantity of • The product stability results
“Ertugliflozin-LPGA” dispensed for show that there is no drastic
formulation of each trial, with reference impact on formulation studies of
to the %age content of “Ertugliflozin” in Ertugliflozin tablet. In future we
the drug substance of “Ertugliflozin- will calculate L-Pyroglutamic
LPGA”. acid content separately and also
• Compliance record of HPLC software calculate Ertugliflozin
2ICFR & Audit trail reports on product accordingly for further use.
testing shall be submitted. • Submitted.
• Record of digital data logger for
stability chamber (real time &
accelerated)
Decision: Registration Board approved the applications of “Ertu-Met 2.5/500 Tablet”, “Ertu-Met 2.5/1000
Tablet”, “Ertu-Met 7.5mg/500mg tablet” &” Ertu-Met 7.5/1000 Tablet” with Innovator’s specifications and
label claims as under:
Ertumet 2.5/1000mg
Each film coated tablet contains: Ertugliflozin L-pyroglutamic acid equivalent to 2.5mg Ertugliflozin
Metformin hydrochloride …… 1000mg
Ertumet 2.5/500mg
Ertugliflozin L-pyroglutamic acid equivalent to 2.5mg Ertugliflozin
Ertumet 7.5/500mg
Ertugliflozin L-pyroglutamic acid equivalent to 7.5mg Ertugliflozin
Metformin hydrochloride…….500mg
Ertumet 7.5/1000
Each film coated tablet contains: Ertugliflozin L-pyroglutamic acid equivalent to 7.5mg Ertugliflozin
Firm shall submit fee of Rs. 75,000 for each product for correction/pre-approval change in label claim, as per
682. Name, address of Applicant / Marketing "M/s Hilton Pharma (Pvt.) Ltd. Plot No. 13-14, Sector-
Authorization Holder 15, Korangi, Industrial Area, Karachi.”
Name, address of Manufacturing site. "M/s Hilton Pharma (Pvt.) Ltd. Plot No. 13-14, Sector
15, Korangi, Industrial Area, Karachi.”

☐ Importer
☐ Export sale
PKR 25,000/- (Slip No. 08786312 Dated: 03/06/2021)
The proposed proprietary name / brand name Trixen XR 25mg/5mg/1000mg Tablets
Strength / concentration of drug of Active Each film-coated extended-release tablet contains:
Pharmaceutical ingredient (API) per unit Empagliflozin ……………….. 25mg
Linagliptin …………………… 5 mg
Metformin HCl …………… 1000mg
Pharmaceutical form of applied drug Film-coated extended-release tablet
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s, 30’s
The status in reference regulatory authorities Trijardy® XR Tablets 25mg/5mg/1000mg by M/s
Boehringer Ingelheim, FDA Approved.
GMP status of the Finished product Section for Tablets (General) was granted after renewal of
manufacturer Drug Manufacturing Licence inspection vide letter No.
F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Name and address of API manufacturer. Linagliptin:
M/s Lee Pharma Limited, India
Sy No. 10/G-1, Gadda Potharam (Village)
Jinnaram (Mandal), Medak (District) Telangana, 502319,
INDIA.
Empagliflozin:
Jiangsu Yongan Pharmaceuticals Co., Limited.
No.18, 237 Provincial Road, Economic Development Zone,
Huaian, Jiangsu, China.
Metformin Hydrochloride:
IOL Chemicals and Pharmaceuticals Limited 85 Industrial
Area ‘A’ Ludhiana-141003 Punjab. India.

submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance data on CTD
format related to nomenclature, structure, general properties,
specifications and analytical procedures, batch analysis and
Linagliptin:
Batches:(LI0316005, LI0316006, LI0316007)
Empagliflozin:
Batches:(130701, 130702, 130801)
Metformin HCl:
Stability Study Data for R&D Scale Batches: Batches:(
MET/99/017, MET/99/019, MET/99/021)
Stability Study Data for Plant Scale Commercial
Batches kept in HDPE Drum
Batches:( 4250/1203/18/A-0071, 4250/1203/18/A-0071,
4250/1203/18/A-0073)
Pharmaceutical equivalence and comparative The firm has submitted the comparative dissolution with
dissolution profile innovator product i.e., Trijardy® XR Tablets and
dissolution profile similarity factor, F2 found greater than
50.

product Specificity, linearity, range, accuracy, precision
Repeatability, Intermediate precision, Robustness, System
Suitability.
Manufacturer of API Linagliptin:
Sy No. 10/G-1, Gadda Potharam (VillageJinnaram (Mandal), Medak (District)
Telangana, 502319, INDIA.
Empagliflozin:

No.18, 237 Provincial Road, Economic Development Zone, Huaian, Jiangsu,
China.
IOL Chemicals and Pharmaceuticals Limited 85 Industrial Area ‘A’ Ludhiana-
141003 Punjab. India.
API Lot No. Linagliptin: LIFP20007
Empagliflozin: 4500-202006001
Metformin HCl:
4250/1203/20/A-0561PM
4250/1203/20/A-0562PM
4250/1203/20/A-0563PM
4250/1203/20/A-0564PM
4250/1203/20/A-0565PM
4250/1203/20/A-0566PM
4250/1203/20/A-0567PM
Description of Pack
Alu-Alu blister packed in printed carton along with leaflet.
Batch No. TRI-427510-2 TRI-427610-3 TRI-427710-4
No. of Batches 03
applications with stability study data of the “HILVEL 400mg + 100mg (Sofosbuvir +Velpatasvir)”,
firm (if any) which was conducted on 14th December, 2017 and was
presented in 277th meeting of Registration Board held on 27-
29th December, 2017.
Registration Board decided to approve registration of
“HILVEL 400mg / 100mg (Sofosbuvir + Velpatasvir” by
M/s. Hilton Pharma (Pvt.) Ltd., Karachi. Manufacturer will
place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated
iii. The HPLC software is 21 CFR compliant.
iv. Audit trail on the testing reports of Hilvel Tablets
Adequate monitoring and control are available for stability
chamber. Chamber are controlled and monitored through

2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No.
API manufacturer issued by concerned Linagliptin: 57308/TS/2021 issued by Drugs control
regulatory authority of country of origin. administration Telangana (DCA) valid till 16.04.2022.
Empagliflozin: 237 issued by People’s Republic of China
Huai’an Pharmaceutical Industry Association valid till
14.01.2024.
Metformin HCl: Pb. 2020/1192 issued by Food and
Drugs Administration, Punjab. valid till 31.12.2021.
3. Documents for the procurement of API with The firm has provided the copy of procurement invoices of
approval from DRAP (in case of import). all three APIs, attested by AD I&E Karachi, details are as
follow.
API Name Invoice No.
Linagliptin 1085/LP/2020-21
Empagliflozin ZY20070101G/W
Metformin HCl IOLCP/20-21/0131
(real time and accelerated).
☐ Importer
☐ Export sale
Details of fee submitted PKR 50,000/- (Slip No. 13561999667 Dated:
06/05/2021)
PKR 25,000/- (Slip No. 83495956827 Dated:
03/06/2021)
The proposed proprietary name / brand name Trixen XR 5mg/2.5mg/1000mg Tablets

Pharmaceutical ingredient (API) per unit Empagliflozin …………………… 5mg
Linagliptin ……………………. 2.5 mg
Metformin HCl ……………… 1000mg
Pharmaceutical form of applied drug Film-coated extended release tablet

The status in reference regulatory authorities Trijardy® XR Tablets 5mg/2.5mg/1000mg by M/s
GMP status of the Finished product Section for Tablets (General) was granted after renewal
manufacturer of Drug Manufacturing License inspection vide letter
No.
F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Jinnaram (Mandal), Medak (District) Telangana,
502319, INDIA.
Empagliflozin:
No.18, 237 Provincial Road, Economic Development
Zone, Huaian, Jiangsu, China.
IOL Chemicals and Pharmaceuticals Limited 85
Industrial Area ‘A’ Ludhiana-141003 Punjab. India.
format related to nomenclature, structure, general
impurities, specifications and analytical procedures,
Linagliptin:

Batches:(LI0316005, LI0316006, LI0316007)
Empagliflozin:
Batches:(130701, 130702, 130801)
Metformin HCl:
Stability Study Data for R&D Scale Batches:
Batches:( MET/99/017, MET/99/019, MET/99/021)
Batches:( 4250/1203/18/A-0071, 4250/1203/18/A-
0071, 4250/1203/18/A-0073)
and stability.
dissolution profile similarity factor, F2 found greater
than 50.

Repeatability, Intermediate precision, Robustness,
System Suitability.
Sy No. 10/G-1, Gadda Potharam (Village Jinnaram (Mandal), Medak
(District) Telangana, 502319, INDIA.
Empagliflozin:
China.
Metformin HCl:
4250/1203/20/A-0561PM
4250/1203/20/A-0562PM
4250/1203/20/A-0563PM
4250/1203/20/A-0564PM
4250/1203/20/A-0565PM
4250/1203/20/A-0566PM
4250/1203/20/A-0567PM
Description of Pack

Real time: 03 months
Time Period
Frequency
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of their
applications with stability study data of the product “HILVEL 400mg + 100mg (Sofosbuvir
firm (if any) +Velpatasvir)”, which was conducted on 14th December,
Board held on 27-29th December, 2017.
M/s. Hilton Pharma (Pvt.) Ltd., Karachi. Manufacturer
will place first three production batches on long term
stability studies throughout proposed shelf life and on
accelerated studies for six months.
Adequate monitoring and control are available for
stability chamber. Chamber are controlled and
monitored through software having alarm system for
alerts as well.
Empagliflozin: 237 issued by People’s Republic of
China Huai’an Pharmaceutical Industry Association
valid till 14.01.2024.
3. Documents for the procurement of API with The firm has provided the copy of procurement invoices
approval from DRAP (in case of import). of all three APIs, attested by AD I&E Karachi, details are
as follow.
chromatograms,
etc.

☐ Importer
☐ Export sale
PKR 25,000/- (Slip No. 21516952 Dated: 03/06/2021)
The proposed proprietary name / brand name Trixen XR 10mg/5mg/1000mg Tablets
Pharmaceutical ingredient (API) per unit Empagliflozin ………………… 10mg
Linagliptin ……………………. 5 mg

The status in reference regulatory authorities Trijardy® XR Tablets 10mg/5mg/1000mg by M/s
manufacturer of Drug Manufacturing Licence inspection vide letter
No.
F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020

502319, INDIA.
Empagliflozin:
Linagliptin:
Batches:(LI0316005, LI0316006, LI0316007)
Empagliflozin:
Batches:(130701, 130702, 130801)
Metformin HCl:
Batches:( 4250/1203/18/A-0071, 4250/1203/18/A-
0071, 4250/1203/18/A-0073)
and stability.

than 50.

System Suitability.
Empagliflozin:
China.
Metformin HCl:
4250/1203/20/A-0561PM
4250/1203/20/A-0562PM
4250/1203/20/A-0563PM
4250/1203/20/A-0564PM
4250/1203/20/A-0565PM
4250/1203/20/A-0566PM
4250/1203/20/A-0567PM
Description of Pack
Time Period
Frequency
No. of Batches 03

M/s. Pharma (Pvt.) Ltd., Karachi. Manufacturer will
place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated
alerts as well.
as follow.
chromatograms,
etc.

☐ Importer

☐ Export sale
Details of fee submitted PKR 50,000/- (Slip No. 52011768358 Dated:
06/05/2021)
PKR 25,000/- (Slip No. 569153936965 Dated:
03/06/2021)
The proposed proprietary name / brand name Trixen XR 12.5mg/2.5mg/1000mg Tablets
Pharmaceutical ingredient (API) per unit Empagliflozin ……………… 12.5mg
Linagliptin ………………….. 2.5 mg

The status in reference regulatory authorities Trijardy® XR Tablets 12.5mg/2.5mg/1000mg by M/s
manufacturer of Drug Manufacturing Licence inspection vide letter
No.
F. 2-14/85-Lic (Vol-V) Dated: 30/06/2020
502319, INDIA.
Empagliflozin:

Linagliptin:
Batches:(LI0316005, LI0316006, LI0316007)
Empagliflozin:
Batches:(130701, 130702, 130801)
Metformin HCl:
Batches:( 4250/1203/18/A-0071, 4250/1203/18/A-
0071, 4250/1203/18/A-0073)
and stability.
than 50.
System Suitability.
Empagliflozin:
China.
Metformin HCl:
4250/1203/20/A-0561PM
4250/1203/20/A-0562PM
4250/1203/20/A-0563PM

4250/1203/20/A-0564PM
4250/1203/20/A-0565PM
4250/1203/20/A-0566PM
4250/1203/20/A-0567PM
Description of Pack
Time Period
Frequency
No. of Batches 03
M/s. Hilton Pharma (Pvt.) Ltd., Karachi. Manufacturer
will place first three production batches on long term
stability studies throughout proposed shelf life and on
accelerated studies for six months.
iii. The HPLC software is 21 CFR compliant.
iv. Audit trail on the testing reports of Hilvel Tablets
alerts as well.

as follow.
chromatograms,
etc.

Section# Observation
3.2.S • Module 3.2.S shall be presented •
separately for each drug substance.
3.2.S.4.1 • Analytical method & specifications •
applied by the drug product
manufacturer for the analysis of each
drug substance shall be submitted.
3.2.S.4.3 • Analytical method verification studies •
of each drug substance shall be
submitted, performed by M/s Hilton
Pharma.
3.2.S.4.4 • Analytical record for the drug substance •
analysis performed by M/s Hilton, shall
be submitted.
3.2.P.1 • Proposed quantity/batch of E
Empagliflozin & Linagliptin shall be f
justified against the declared label claim c
per tablet. p
q
w
d
o
d
3.2.P.5.1 Sampling time points in the dissolution
test of Metformin HCl are not as per those
recommended in the literature of
innovator product i.e., Trijardy XR
tablets, approved by US FDA.

3.2.P.5.3 • Performance of specificity parameter in •
the analytical method verification
studies shall be justified with reference
to the USP general chapter <1225> &
ICH Q2 guidelines.
3.2.P.5.4 • Same results have been reported for the A

dissolution test of Metformin HCl for j
all three batches. •
3.2.6. • Justification shall be submitted for T

using reference standard of d
Empagliflozin from Ruyuan HEC, since E
the drug substance has been provided by a
M/s Jiangsu Yongan. H
s
•
•
•

•
3.2.P.8.3 • Complete stability studies till 6th month •

time point shall be submitted.
• Analytical record for the stability
studies shall be submitted e.g.,
chromatograms, raw data sheets, COAs
etc.
• The submitted BMR does not reflect •
performance of Uniformity of dosage
units test by way of Assay for
Empagliflozin & Linagliptin before
proceeding for final film coating step. •
Decision: Registration approved the applications of “Trixen XR 25mg/5mg/1000mg Tablets”, “Trixen XR

5mg/2.5mg/1000mg Tablets”, “Trixen XR 10mg/5mg/1000mg Tablets”, “Trixen XR
12.5mg/2.5mg/1000mg Tablets”.
• Manufacturer will change the specifications for the dissolution test as recommended in the
literature of innovator product i.e., Trijardy XR tablets, approved by US FDA.
686. Name, address of Applicant / Marketing The Searle Company Limited F-319, S.I.T.E.,
Authorization Holder Karachi, Pakistan.
Name, address of Manufacturing site. The Searle Company Limited, F-319, S.I.T.E.,
Karachi, Pakistan.
☐ Importer
☐ Export sale

The proposed proprietary name / brand name Emsyn-Met XR 12.5mg + 1000mg Tablets
Strength / concentration of drug of Active Emsyn-Met XR Tablets
Pharmaceutical ingredient (API) per unit Each Film coated tablet contains:
Empagliflozin……………...12.5mg
Metformin hydrochloride (Extended
Release)…………………….1000mg
Pharmaceutical form of applied drug Blue colored, Oblong shaped, Biconvex, Film coated
Tablets, Plain from both sides
The status in reference regulatory authorities Approved by US FDA and marketed in USA, with the
name of Synjardy XR Tablets
For generic drugs (me-too status) Xenglu-Met XR Manufactured by Hilton Pharma (Pvt.)
Ltd
Strength: Empagliflozin 12.5mg + Metformin 1000mg
Reg. No. 105270
manufacturer Tablet (General & General Antibiotic) section
approved.
Anhui Youcare Kaiyue Pharmaceutical Co., Ltd.
Industrial Avenue area A, Economic Development
Zone, Taihe County, Anhui Province, China
Metformin HCL
Aarti Drugs Limited Mahendra Industrial Estate Plot
No. – 109 –D Road No.29, Sion (East), Mumbai – 400
022. INDIA.
Empagliflozin
Batches: (20151116, 20151208, 20160104)

Metformin HCL
Batches: (MEF/1510145,MEF/1510146,
MEF/1510147)
product.
dissolution profile against the brand leader that is Synjardy XR Tablet US
FDA Approved by performing quality tests
dosage form).
Synjardy XR Tablet US FDA Approved in Acid media
(pH 1.2) & Phosphate Buffer (PH 4.5) And (pH 6.8).
Manufacturer of API Emagliflozin:
Anhui Youcare Kaiyue Pharmaceutical Co., Ltd. Industrial Avenue area A,
Economic Development Zone, Taihe County, Anhui Province, China
Manufacturer of API Metformin HCL
Aarti Drugs Limited Mahendra Industrial Estate Plot No. – 109 –D Road No.29,
Sion (East), Mumbai – 400 022. INDIA
API Lot No. (Emagliflozin) 20190501001
API Lot No:
MEF/10020674
(Metformin HCL)
Description of Pack
Real Time: 3, 6, 9, 12, 18 & 24m (Months)
Batch No. 20PD-065 20PD-066 20PD-067
Manufacturing Date April 2020 April 2020 April 2020
Date of Initiation Jun 2020 Jun 2020 Jun 2020
No. of Batches 03

1. Reference of previous approval of applications The firm has submitted documents for Reference of
with stability study data of the firm (if any) Previous Approval
2. Approval of API/ DML/GMP certificate of API EMPAGLIFLOZIN
manufacturer issued by concerned regulatory GMP Certificate of Empagliflozin
authority of country of origin. Manufacturer: Anhui Youcare Kaiyue Pharmaceutical
Co., Ltd
METFORMIN HCl:
GMP Certificate of Metformin HCl from Aarti Drugs
Limited
3. Documents for the procurement of API with EMPAGLIFLOZIN
approval from DRAP (in case of import). Invoice From Timesnow international Co.Ltd
Quantity: 1 Bag
Batch: 20190501001
Mfg Date: 14-May-2019
Exp: 13 May 2021
METFORMIN HCL:
Invoice From Arti Drug Ltd
Quantity: 3000Kg
Batch: MEF/ 1002067
MEF/10020674
Submitted
chromatograms,
Submitted
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Emsyn-Met XR 10mg + 1000mg Tablets

Empagliflozin……………...10mg
Metformin hydrochloride (Extended Release)
…………………….1000mg
Pharmaceutical form of applied drug Orange colored, Oblong shaped, Biconvex, Film coated
Tablets, Plain from both sides
Ltd
Strength: Empagliflozin 10mg + Metformin 1000mg
Reg. No.105268
approved
Metformin HCL
022. INDIA.
Empagliflozin
Batches: (20151116, 20151208, 20160104)

Metformin HCL
Batches:(MEF/1510145,MEF/1510146,
MEF/1510147)
product.
dosage form).
Manufacturer of API Metformin HCl
API Lot No:
MEF/10020674
(Metformin HCL)
Description of Pack
Batch No. 20PD-068 20PD-069 20PD-070
No. of Batches 03

Co., Ltd
METFORMIN HCL:
Limited
Quantity: 1 Bag
Batch: 20190501001
Exp: 13 May 2021
METFORMIN HCL:
Quantity: 3000Kg
Batch: MEF/ 1002067
MEF/10020674
chromatograms,
☐ Importer
☐ Export sale

Release)…………………….1000mg
Pharmaceutical form of applied drug Light Green colored, Oblong shaped, Biconvex, Film
coated Tablets, Plain from both sides
Ltd
Reg. No. 105271
approved.
Metformin HCL
022. INDIA.
Empagliflozin
Batches: (20151116, 20151208, 20160104)

Metformin HCl

Batches:(MEF/1510145,MEF/1510146,
MEF/1510147)
product.
dosage form).
Manufacturer of API Metformin HCL
API Lot No:
MEF/10020674
(Metformin HCL)
Description of Pack
Batch No. 20PD-056 20PD-057 20PD-058
No. of Batches 03

Co., Ltd
METFORMIN HCl:
Limited
Quantity: 1 Bag
Batch: 20190501001
Exp: 13 May 2021
METFORMIN HCL:
Quantity: 3000Kg
Batch: MEF/ 1002067
MEF/10020674
Submitted
chromatograms,
Submitted
Name, address of Manufacturing site. The Searle Company Limited F-319, S.I.T.E.,
Karachi, Pakistan.
☐ Importer
☐ Export sale
Release)…………………….1000mg

Pharmaceutical form of applied drug Apple Green colored, Oblong shaped, Biconvex, Film
coated Tablets, Plain from both sides
Ltd
Reg. No.105268
approved.
Metformin HCL
022. INDIA.
Empagliflozin
Batches: (20151116, 20151208, 20160104)

Metformin HCL
Batches:(MEF/1510145,MEF/1510146,
MEF/1510147)

product.
dosage form).
Manufacturer of API Metformin HCl
API Lot No:
MEF/10020674
(Metformin HCL)
Description of Pack
Real Time: 0,3, 6, 9, 12, 18 & 24m (Months)
Batch No. 20PD-088 20PD-089 20PD-090
No. of Batches 03
Co., Ltd

METFORMIN HCL:
Limited
Quantity: 1 Bag
Batch: 20190501001
Exp: 13 May 2021
METFORMIN HCL:
Quantity: 3000Kg
Batch: MEF/ 1002067
MEF/10020674
Submitted
chromatograms,
Submitted
Section Observations Firm’s response

#
Empagliflozin
3.2. • Analytical procedure and • Firm has submitted analytical procedure
S.4.1 specifications applied by the drug as per the method applied by the drug
product manufacturer shall be substance manufacturer.
submitted. • Complete analytical method including
• The specifications and analytical test of Assay has been submitted from
procedure submitted from the drug drug substance manufacturer.
substance manufacturer does not
contain test for Assay.
3.2. Analytical method verification studies Firm has submitted analytical method
S.4.3 shall be submitted performed by the verification report, performed by M/s Searle.
3.2. Provide results of analysis of relevant Submitted as per following details.
S.4.4 batch(es) of Drug Substance performed Drug substance Batch#
by Drug Product manufacturer used Emagliflozin 20190501001
stability studies, along with Certificate
of Analysis (CoA) of the same batch
from Drug Substance /Active
manufacture.
3.2. S.5 COA of primary / secondary reference Submitted.
standard including source and lot
number shall be provided.
Metformin HCl

3.2. • Analytical procedure and • Firm has submitted analytical procedure
S.4.1 specifications applied by the drug as per the method applied by the drug
product manufacturer shall be substance manufacturer.
submitted. • Complete analytical method including
• The specifications and analytical test of Assay has been submi
procedure submitted from the drug
substance manufacturer does not
contain test for Assay.
3.2. Analytical method verification studies Firm has submitted analytical method
S.4.3 shall be submitted performed by the verification report, performed by M/s Searle.
3.2. Provide results of analysis of relevant Submitted as per following details.
S.4.4 batch(es) of Drug Substance performed Drug substance Batch#
by Drug Product manufacturer used Metformin HCl MEF/10020674
stability studies, along with Certificate
of Analysis (CoA) of the same batch
from Drug Substance /Active
manufacture.
3.2.S.5 COA of primary / secondary reference Submitted.
standard including source and lot
number shall be provided.
3.2.P.1 • Role of each excipient shall be With the reference of query, this is to inform
submitted. you that Polyethylene Oxide is highly
• Innovator product formulation sensitive to oxidation leading to chain
includes Polyethylene oxide, cleavage of reduction of viscosity during
whereas it is not included in the storage. High temperature speeds up the
applied formulation. autooxidation of Polyethylene Oxide and can
impact its stability. Due to these properties of
Polyethylene Oxide and its short shelf life,
Hypromellose was taken in EmsynMet XR
tablet and dissolution profile has been
achieved by a single polymer.
Polyethylene Oxide and Hypromellose are
both hydrophilic extended-release matrices
and use as the rate-controlling polymer. The
benchmark of the innovator product, Janumet
XR 1000mg tablet also includes only
Hypromellose as a rate-controlling polymer.
3.2.P.2 Drug excipient compatibility study The above excipients had been chosen on the
shall be submitted since composition of basis of core formulation of Metformin HCl
Metformin core tablet is different from XR tablet of innovator product, Janumet XR
that of the innovator product. tablet which shows these excipients are
compatible with Metformin HCl.
3.2.P.5. Submitted analytical procedure does Drug product analytical method has been
2 not include the details for the test of submitted including test of content
“Content Uniformity” for uniformity.
Empagliflozin.
3.2.P.5. Specificity parameter has been Firm has submitted data for stress conditions
3 performed by injecting the placebo, i.e., heat, acid hydrolysis, base hydrolysis and
diluent, mobile phase & standard oxidation as per ICH guidelines and USP
solution. Whereas USP chapter <1225> chapter 1225 to demonstrate that the method
& ICH Q2 (R1) guidelines suggests is capable to identify and quantify the
spiking the drug substance with degraded compounds.
appropriate levels of impurities or

exposing the drug product sample to
relevant stress conditions (e.g., light,
humidity, acid or base hydrolysis,
oxidation). Justification shall be
submitted for this variation in method.
Clarification shall be submitted for this
variation.
3.2. P.6 Working standard of Empagliflozin has We, The Searle Company Limited has been
been standardized against the reference manufacturing the Empagliflozin Tablets
standard from M/s Beijing Huikang 10mg and Empagliflozin Tablets 25mg since
Boyuan, whereas the drug substance 2019. Beijing Huikang Boyuan is one the
has been procured from the M/s Anhui approved source for Empagliflozin that’s why
Youcare Kaiyue Pharmaceutical Co., trail of standardization include the reference
Ltd. Justification shall be submitted in standard from the source other than Anhui
this regard. Youcare Kaiyue.
• Justification of 10% extra amount • In normal routine coating process, there is

of Empagliflozin in master always some loss of coating dispersion as
formulation (which is required to 100% coating material doesn’t reach the
be based on study/scientific tablet rather some quantity gets loss
rationale) for which firm has stated during spraying of coating due to
that it was taken to compensate the continuous coating air blowing and
loss during coating. exhaust. This loss is compensated by
• Quantity of batch after active taking extra coating material and same is
coating, mentioned in the product the case with Empagliflozin. It is coated
development record is not correct. over the tablets in the form of coating
• The submitted product dispersion. That’s why 10% extra
development record does not reflect quantity of API coating material has been
performance of dissolution for taken.
Metformin HCl before proceeding • In correct quantity of batch after active
for seal & active coating step. coating is a typographical error. Firm has
Justification shall be submitted for submitted product development record
proceeding further without with correct quantity.
establishing the Dissolution profile • We, The Searle Company Limited has
of Metformin HCl. established dissolution profile during trial
• The submitted product that’s why we perform dissolution testing
development record does not reflect at final stage.
performance of Uniformity of • We, The Searle Company Limited,
dosage units test by way of Assay performed content uniformity test as per
for Empagliflozin before routine practice at final stage i.e., after
proceeding for final film coating film coating.
step. Justification shall be
submitted for proceeding further
without establishing the content of
Empagliflozin.
Decision: Registration board approved the applications of “Emsyn-Met XR 12.5mg + 1000mg Tablets”,
“Emsyn-Met XR 10mg + 1000mg Tablets”, “Emsyn-Met XR 25mg + 1000mg Tablets” & “Emsyn-Met XR
25mg + 1000mg Tablets” with Innovator’s specifications.

690. Name, address of Applicant / Marketing M/s The Schazoo Pharmaceutical Laboratories Pvt.
Authorization Holder Ltd.
Name, address of Manufacturing site. M/s The Schazoo Pharmaceutical Laboratories Pvt.
Ltd.
20Km Kalalwala Stop, 20Km Lahore Jaranwala Road,
District Sheikhupura-Pakistan
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The proposed proprietary name / brand name EPAMET 12.5/1000 mg Tablets
Empagliflozin…………….12.5 mg
Metformin Hydrochloride ………...1000 mg
Pharmaceutical form of applied drug Light brown colored film coated, elliptical biconvex
tablets engraved SPL on both sides of break line and
on other side of tablet
Reference to Finished product specifications Schazoo Specs.
The status in reference regulatory authorities JARDIANCE MET tablet by M/s Boehringer
Ingelheim Pharma GmbH & Co. KG. Germany
USFDA Approved.
For generic drugs (me-too status) Diampa-M Film coated tablet by M/s Getz Pharma
Pvt.Ltd.
manufacturer Tablet (General & General Antibiotic, Capsule, Oral
liquid, Liquid injectable, Eye Drops/Nasal Drops, Oral
Dry Powder suspension) section approved.
Name and address of API manufacturer. Empagliflozin
Zhejiang Hongyuan Pharmaceutical Co., Ltd
Chem & APIs. Industrial Zone, Linhai, Zhejiang,
China
TEL : +86-576-89053379
FAX: +86-576-85589655
Metformin Hydrochloride
AARTI DRUGS LIMITED

Plot No.211-213, Road No.2
G.I.D.C., Sarigam, Dist: Valsad
Gujarat – INDIA 396155.
TEL: +91(0260) 2780269
FAX: +91 (0260) 2780268
Batches: (EMT-LT1-20, EMT-LT2-20, EMT-LT3-20)
product.

dissolution profile against the brand leader that is Jardiance Met 12.5/1000
mg tablet by Boeringer Ingelhein Germany by
performing quality tests (Appearance, disintegration
time, Identification, Assay, Dissolution).
Jardiance Met 12.5/1000 mg tablet by Boeringer
Ingelhein Germany in Acid media pH 1.2, pH 4.5 &
Phosphate Buffer pH 6.8. The values for f1 and f2 are
Manufacturer of API Empagliflozin
M/s Zhejiang Hongyuan Pharmaceutical Co., Ltd
Chem & APIs. Industrial Zone, Linhai, Zhejiang, China.
M/s AARTI DRUGS LIMITED

Gujarat – INDIA
API Lot No. Empagliflozin: EPG20190102
Metformin Hydrochloride: MEF/19102354
Description of Pack Alu-PVC/PVDC, finally packed in bleach board carton with a Leaflet.
(Container closure system) (3 x 10's)
Batch No. EMT-LT1-20 EMT-LT2-20 EMT-LT3-20
No. of Batches 03
1. Reference of previous approval of applications Hypet Eye drop
with stability study data of the firm (if any) Reg. # 110659
2. Approval of API/ DML/GMP certificate of API Empagliflozin: GMP Certificate #: ZJ20180032
manufacturer issued by concerned regulatory Metformin Hydrochloride:
authority of country of origin. Copy of GMP certificate No. G/25/2038 granted on
the date 21-Mar-2014 valid till 20-Mar-2024
3. Documents for the procurement of API with Empagliflozin:
Invoice #: 30207569 from Hangzhou China
Invoice #:EXP/1700/19-20-18/10/2019 from AARTI

Drugs Ltd.

Submitted
chromatograms,
Submitted
691. Name, address of Applicant / Marketing M/s The Schazoo Pharmaceutical Laboratories Pvt.
Authorization Holder Ltd.
Name, address of Manufacturing site. M/s The Schazoo Pharmaceutical Laboratories Pvt.
Ltd.
20Km Kalalwala Stop, 20Km Lahore Jaranwala Road,
District Sheikhupura-Pakistan

☐ Importer
☐ Export sale
The proposed proprietary name / brand name EPAMET 12.5/500 mg Tablets
Empagliflozin…………….12.5 mg
Metformin Hydrochloride………...500 mg
Pharmaceutical form of applied drug Light Blue colored film coated, elliptical biconvex
tablets engraved Schazoo on one side of tablet
Reference to Finished product specifications Schazoo Specs.
The status in reference regulatory authorities JARDIANCE MET tablet by M/s Boehringer
Ingelheim Pharma GmbH & Co. KG. Germany
USFDA Approved.
For generic drugs (me-too status) Diampa-M Film coated tablet by M/s Getz Pharma
Pvt.Ltd.
manufacturer Tablet (General & General Antibiotic, Capsule, Oral
liquid, Liquid injectable, Eye Drops/Nasal Drops, Oral
Dry Powder suspension) section approved.
Name and address of API manufacturer. Empagliflozin
Zhejiang Hongyuan Pharmaceutical Co., Ltd
Chem & APIs. Industrial Zone, Linhai, Zhejiang,
China
TEL : +86-576-89053379
FAX: +86-576-85589655
AARTI DRUGS LIMITED
Gujarat – INDIA 396155.
TEL: +91(0260) 2780269
FAX: +91 (0260) 2780268

Batches: (EPT-LT1-20, EPT-LT2-20, EPT-LT3-20)
product.
dissolution profile against the brand leader that is Jardiance Met 12.5/500
mg tablet by Boeringer Ingelhein Germany by
performing quality tests (Appearance, disintegration
time, Identification, Assay, Dissolution).
Jardiance Met 12.5/500 mg tablet by Boeringer
Ingelhein Germany in Acid media pH 1.2, pH 4.5 &
Phosphate Buffer pH 6.8. The values for f1 and f2 are
Manufacturer of API Empagliflozin
M/s Zhejiang Hongyuan Pharmaceutical Co., Ltd
Chem & APIs. Industrial Zone, Linhai, Zhejiang, China.
M/s AARTI DRUGS LIMITED
Gujarat – INDIA
API Lot No. Empagliflozin: EPG20190102
Metformin Hydrochloride: MEF/19102354
Description of Pack Alu-PVC/PVDC, finally packed in bleach board carton with a Leaflet.
(Container closure system) (3 x 10's)

Batch No. EPT-LT1-20 EPT-LT2-20 EPT-LT3-20
No. of Batches 03
1. Reference of previous approval of applications Hypet Eye drop
with stability study data of the firm (if any) Reg. # 110659
2. Approval of API/ DML/GMP certificate of API Empagliflozin: GMP Certificate #: ZJ20180032
manufacturer issued by concerned regulatory Metformin Hydrochloride:
authority of country of origin. Copy of GMP certificate No. G/25/2038 granted on
the date 21-Mar-2014 valid till 20-Mar-2024
3. Documents for the procurement of API with Empagliflozin:
approval from DRAP (in case of import). Invoice #: 30207569 from Hangzhou China
Invoice #:EXP/1700/19-20-18/10/2019 from AARTI
Drugs Ltd.
Submitted
chromatograms,
Submitted
Remarks OF EvaluatorII:

3.2.S.4.3 Analytical method verification studies Firm has submitted analytical
shall be submitted for both drug verifcation studies for both drug
substances, performed by the M/s The substances.
Schazoo Pharmaceutical Laboratories
3.2.P.5.2 Justify the dissolution specification NLT Firm has referred to the US FDA general
75%(Q) after 30 minutes, since the dissolution database for selction of
USFDA review document of the innovator dissolution parameters, whereas the
product i.e., Synjardy tablet, specifies observation was made while referring to
dissolution specifications as NLT Q in the available literature of innovator
20minutes for both Empagliflozin & product review by US FDA.
Metformin HCl.
Decision: Registration Board approved the applications of “EPAMET 12.5/1000 mg Tablets”, & “EPAMET
12.5/500 mg Tablets” with Innovator’s specifications.

692. Name and address of manufacture / M/s Getz Pharma (Pvt.) Ltd. 29-30, Sector 27, Korangi
Brand Name + Dosage Form and Strength EMCLIDE Tablets 10mg + 5mg
Composition Empagliflozin…….10mg
Linagliptin……5mg
Dairy No. date of R &I fee Dy. No. dated 21-12-2015; Rs. 50000/- dated 21-12-2015
Combinations of oral blood glucose lowering drugs
Pharmacological Group
(Anti diabetic)
Type of form Form 5D
Finished product specifications Manufacturer Specs.
Pack size and Demand Price 14’s: Rs. 5000/-
Approval status of product in Reference GLYXAMBI Tablets 10mg + 5mg by Boehringer Ingelhein
Regulatory Authorities Pharmaceuticals, USA.
Me-too-status
Last GMP Inspection dated 26-06-2021 concludes that
GMP Status M/s Getz Pharma Pvt. Ltd. is considered to be operating at an
acceptable level of compliance of GMP requirements.
Drug EMCLIDE Tablets 10mg + 5mg
M/s Getz Pharma Pvt. Ltd
29-30, Sector 27, Korangi Industrial Area, Karachi
Empagliflozin: Jiangsu Yongan Pharmaceutical Co. Ltd., China
Manufacturer of API
Linagliptin: Fuxin Long Rui Pharmaceutical Co. Ltd., China
Empagliflozin: 20161218
API Lot No.
Linagliptin: 160530
Description of Pack
Alu-Alu blisters
Real time : 30°C ± 2°C / 75% ± 5%RH
Real time: 6 months
Time Period
Real time: 0,3,6 (months)
Frequency
Accelerated: 0,3,6 (months)
Batch No. 396DS04 396DS05 396DS07
No. of Batches 03
Date of Submission 28-06-2018
S. Documents To Be Provided Status
No.
Firm has referred to onsite inspection report of their
product for Estine (Ebastine) Tablets 10mg & 20mg
on 6th May, 2019. Further, the said panel inspection
Reference of previous approval of applications
1. report was discussed in 289th Drug Registration Board
with stability study data of the firm
meeting held on 14th – 16th May 2019. The case was
approved and the inspection report confirms
following points:

• The HPLC software is 21CFR Compliant as per
record available with the firm.
stability chamber. Chambers are controlled and
monitored through software having alarm system
for alerts as well.
• Related manufacturing area, equipment,
personnel and utilities are GMP compliant.
Empagliflozin:
Firm has submitted COA of Empagliflozin (Batch #
20161218) from M/s Jiangsu Yongan Pharmaceutical
Co. Ltd., China. COA (Batch # 20161218) from M/s
Getz Pharma (Pvt.) Ltd is also submitted.
Certificate of Analysis of API from both API
2.
Manufacturer and Finished Product manufacturer.
Linagliptin:
Firm has submitted COA of Linagliptin (Batch #
160530) from M/s Fuxin Long Rui Pharmaceutical
Co. Ltd., China. Copy of COA (Batch # 160530) from
M/s Getz Pharma (Pvt.) Ltd is also submitted.
Method used for analysis of API from both API
3. Yes
Manufacturer and Finished Product manufacturer
Empagliflozin:
The firm has submitted copy of accelerated, 06
Months (40°C ± 2°C & 75±5%RH) & long term, 24
Months (30°C ± 2°C & 65±5%RH) stability study
reports of 03 batches.
4. Stability study data of API from API manufacturer
Linagliptin:
The firm has submitted copy of accelerated, 06
Empagliflozin:
License (DML # Su20160324) of M/s Jiangsu Yongan
Pharmaceutical Co. Ltd., China issued by Jiangsu
Drugs Administration, China. The certificate is valid
Approval of API/ DML/GMP certificate of till 06-12-2025.
5. API manufacturer issued by concerned
regulatory authority of country of origin.Linagliptin:
License (DML # LIAO20150233) of Fuxin Long Rui
Pharmaceutical Co. Ltd., China issued by Liaoning
Medical Products Administration, China. The
Firm has submitted import License No. 0570/17-
DRAP (K) dated 28-02-2017 confirming import of
500g Empagliflozin from M/s Jiangsu Yongan
Documents for the procurement of API with Pharmaceutical Co. Ltd., China for Batch No.
6.
approval from DRAP (in case of import). 20161218.


300g Linagliptin from M/s Fuxin Long Rui
Pharmaceutical Co. Ltd., China for Batch No. 160530.
Protocols followed for conduction of

7. Yes
stability study
Firm has submitted that same excipients has been used

as used by innovator ‘GLYXAMBI Tablets 10mg +
Drug-excipients compatibility studies (where
9. 5mg’. However, there is only difference in film
applicable)
coating materials Therefore, Drug-excipients
compatibility studies were not performed.
The firm has manufactured three stability batches of
Empagliflozin + Linagliptin Tablets 10mg + 5mg and
has submitted copy of complete batch manufacturing.
Complete batch manufacturing record of three Details are as under:
10. stability batches. Emclide Tablet 10mg + 5mg
Batch No. Bach size Mfg. Date
396DS04 2500 Tablets 23.05.2017
396DS05 2500 Tablets 30.05.2017
396DS07 2500 Tablets 22.06.2017
Firm has submitted Comparative dissolution study of
their product with Innovator’s Brand “GLYXAMBI”.
Product of
Feature Reference
Getz
product
Pharma
GLYXAMBI Emclide
Record of comparative dissolution data Brand name Tablets 10mg + Tablet 10mg
11.
(where applicable) 5mg + 5mg
Batch No. 907587 396SD01
Comparative dissolution studies have been performed

in following mediums:
Data of 03 batches will be supported by attested
12. respective documents like chromatograms, Raw Yes
Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports of stability
13.
audit trail reports on product testing. studies of applied formulation.
Record of Digital data logger for temperature and Firm has submitted record of digital data logger for
14. humidity monitoring of stability chambers (real temperature and humidity monitoring of stability
time and accelerated) chambers.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Emclide

(Empagliflozin & Linagliptin) 10mg/5mg Tablets by M/s Getz Pharma Pvt. Limited, 29-30/27, Korangi
Industrial Area , Karachi.

Reference No: F.1-2/2020-PEC dated 24th February 2020.
Investigation Date and Time: 2nd December 2021. (Forenoon)
Investigation Site: Factory premises of M/s Getz Pharma Pvt. Limited, 29-30/27, Korangi
Background:
Chairman Registration Board considered the applications of M/s Getz Pharma Pvt. Limited, 29-30/27,
Korangi Industrial Area, Karachi for registration of Emclide (Empagliflozin & Linagliptin) 10mg/5mg Tablets and
constituted a three member panel to investigate the authenticity / genuineness of data (import of raw material and
stability data). Panel was advised to conduct inspection of the firm and to submit report for further consideration.
3. Dr. Rafeeq Alam Khan, Meritorious Professor, Dean Faculty of Pharmacy, Ziauddin Karachi. (Member
Registration Board)
4. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data and integrity and security of data in respective databases were also audited.
The details of investigation may be summarized as under:
Q. No. Question Observation by panel

1. Do you have documents confirming Firm has submitted import License No. 0570/17-
the import of API including approval DRAP (K) dated 28-02-2017 confirming import of
from DRAP? 500g Empagliflozin from M/s Jiangsu Yongan
Pharmaceutical Co. Ltd., China for Batch No.
20161218.

300g Linagliptin from M/s Fuxin Long Rui
Pharmaceutical Co. Ltd., China for Batch No.
160530.
2. What was the rationale behind There is proper vendor evaluation process being
selecting the particular manufacturer implemented by the firm and the rationale behind
of API? vendor selection is controlled through Postal Audit
checklist / Physical Site Inspection and availability
of valid GMP Certificate / DML by competent
authority.
3. Do you have documents confirming Firm has imported Empagliflozin reference
the import of reference standard and standard Batch No. 151010 and working standard
impurity standards? Batch No. PH20160315 from M/s Jiangsu Yongan
Pharmaceutical Co. Ltd., China vide invoice No.
16CAGZ001 dated 30.05.2016.
Firm has imported Empagliflozin impurity
standards Batch No. EPG-ZA-160404 & EPG-ZB-
160408 from M/s Jiangsu Yongan Pharmaceutical
Co. Ltd., China vide invoice No. 17CAGZCDO302
dated 16.04.2017.
Firm has imported Linagliptin reference standard
Batch No. 150519 from M/s Fuxin Long Rui
Pharmaceutical Co. Ltd., China vide invoice No.
HN160607-E dated 01.06.2016.

4. Do you have certificate of Analysis of The firm has certificate of analysis for APIs,
the API, reference standards and reference standards and working standards.
impurity standards?
5. Do you have GMP certificate of API Empagliflozin:
manufacturer issued by regulatory Firm has provided copy of Drug Manufacturing
authority of country of origin? License (DML # Su20160324) of M/s Jiangsu
Yongan Pharmaceutical Co. Ltd., China issued by
Jiangsu Drug Administration, China. The certificate
is valid till 06-12-2025.
Linagliptin:
Firm has provided copy of Drug Manufacturing
License (DML # LIAO20150233) of Fuxin Long
Rui Pharmaceutical Co. Ltd., China issued by
Liaoning Medical Products Administration, China.
The certificate is valid till 20-12-2022.
6. Do you use API manufacturer method The firm has used method of testing adopted from
of testing for testing API? API manufacturer’s testing method.
7. Do you have stability studies reports Empagliflozin:
on API? The firm has provided copy of accelerated, 06
Linagliptin:
The firm has provided copy of accelerated, 06
8. If yes, whether the stability testing has The stability testing has been performed as per SIM
been performed as per SIM method method and degradation products have been
and degradation products have been quantified.
quantified?
9. Do you have method for quantifying Yes, the firm has method for quantifying the
the impurities in the API? impurities in the API adopted from API
manufacturer.
10. Do you have some remaining The firm has remaining quantities of the APIs,
quantities of the API, its reference reference standards of impurities and working
standard and impurities standards? standards.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients
excipients? which include Mannitol, Pregelatinized Starch,
Corn Starch, Co-Povidone, Crospovidone, Purified
Talc & Magnesium stearate.
12. Do you have documents confirming The firm has necessary documents confirming the
the import of the used excipients? import of the used excipients.
13. Do you have test reports and other The firm has test reports and other records on the
records on the excipients used? excipients used.
14. Do you have written and authorized The firm has written and authorized protocols for
protocols for the development of the development of Emclide Tablets 10mg + 5mg.
Product?
15. Have you performed Drug-excipient Firm has used same excipients as used by innovator
compatibility studies? ‘GLYXAMBI Tablets 10mg + 5mg’. However,
there is only difference in film coating materials
Therefore, Drug-excipients compatibility studies
were not performed.

16. Have you performed comparative Firm has submitted comparative dissolution profile
dissolution studies? of their product with Innovator’s Brand
“GLYXAMBI”. The details are as follows:
Product Getz Pharma
GLYXAMBI Emclide
Brand name Tablets 10mg Tablets 10mg
+ 5mg + 5mg
Batch No. 907587 396SD01

The release is more than 85% within 15 minutes in
all 03 mediums, therefore, F2 waiver is applicable.
17. Do you have product development The firm has dedicated product development
(R&D) section (R&D) section with requisite manufacturing and
analysis facilities.
18. Do you have necessary equipment The firm has necessary equipment available in
available in product development product development section for development of
section for development of Product? Emclide Tablets 10mg + 5mg.
19. Are the equipment in product The available equipment in product development
development section qualified? section are qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration with
calibration / re-qualification program re-qualification program for the equipment used in
for the equipment used in PD section? PD section.
21. Do you have qualified staff in productThe firm has qualified staff in product development
development section with proper section with proper knowledge and training in
knowledge and training in product product development. There are 50 Scientists
development? (Pharmacist & Chemist) working only in R&D
Section.
22. Have you manufactured three stability The firm has manufactured three stability batches of
batches for the stability studies of Empagliflozin + Linagliptin Tablets 10mg + 5mg
Product as required? and has submitted copy of complete batch
manufacturing. Details are as under:
Emclide Tablet 10mg + 5mg
Batch No. Batch size Mfg. Date
396DS04 2500 Tablets 23.05.2017
396DS05 2500 Tablets 30.05.2017
396DS07 2500 Tablets 22.06.2017
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability
batch size of stability batches? batches is the capacity of their R&D equipment
where probable simulation of manufacturing
procedure of production batches are expected as
well as quantity of tablets required per testing
frequencies.
24. Do you have complete record of The firm has complete record of production of
production of stability batches? stability batches. All the Log Books are properly
maintained.

25. Do you have protocols for stability The firm has detailed protocols for stability testing
testing of stability batches? of stability batches having protocol number:
Emclide Tablet 10mg + 5mg
Batch No. Protocol No.
396DS04 FS-097-17
396DS05 FS-098-17
396DS07 FS-099-17
26. Do you have developed and validated The firm has developed and validated the method
the method for testing of stability for testing of stability batches.
batches?
27. Do you have method transfer studies The firm has developed and validated method of
in case when the method of testing testing for finished product and complete Method
being used by your firm is given by Validation Report is available. Method transfer is
any other lab? not applicable.
28. Do you have documents confirming The firm has proper documents confirming the
the qualification of equipments / qualification of equipment / instruments being used
instruments being used in the test and in the test and analysis of APIs and the finished
analysis of API and the finished drug? drug.
29. Do your method of analysis stability The firm has performed forced degradation (FD)
indicating? study on their product Emclide Tablets 10mg + 5mg
for the conformance of its stability indicating
nature.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per
Compliant? record available with the firm. The firm have
number of HPLC with Empower 3 and DB software
having following features:
• Have Audit trail
• Have backup system
• Have Data traceability
• Have Data achieving system
• Have data integrity
• Have Data security
• System Security Policy
31. Can you show Audit trail reports on Audit trail on the testing reports is available.
Product testing?
32. Do you have some remaining The firm informed that stability studies of 03
quantities of degradation products and batches have been completed and remaining
stability batches? quantities of stability batches are not available.
33. Do you have stability batches kept on The firm informed that stability studies of 03
stability testing? batches have been completed and stability data till
24 months interval is available.
34. Do you have valid calibration status The firm has valid calibration status for the
for the equipments used in Product equipment used in production and analysis of
production and analysis? Emclide Tablets 10mg + 5mg.
35. Do proper and continuous monitoring Adequate monitoring and control are available for
and control are available for stability stability chamber. Chambers are controlled and
chamber? monitored through software having alarm system
for alerts as well.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel
equipment, personnel and utilities be and utilities are in compliance.
rated as GMP compliant?

Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by
the firm for registration of Emclide (Empagliflozin & Linagliptin) 10mg/5mg Tablets is verifiable
to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well
suited for the manufacturing of Emclide (Empagliflozin & Linagliptin) 10mg/5mg Tablets
Recommendations:
The firm may kindly be granted necessary registration of Emclide (Empagliflozin & Linagliptin)
10mg/5mg Tablets.

693. Name and address of manufacturer / M/s High Q Pharmaceuticals B-64, Karsaz Road, KDA-1,
Applicant Karachi
Brand Name +Dosage Form + Strength Lasodex 30 mg Capsules
Diary No. Date of R& I & fee Dy No. 1369, Rs: 50,000/- 24-11-2016
Dexlansoprazole (dual delayed release pellets)….30mg
Pharmacological Group Drugs For Peptic Ulcer And Gastro-Oesophageal Reflux
Disease (Gord)
Proton Pump Inhibitors
ATC Code: A02BC06
Type of Form Form 5-D
Finished Product Specification Manufacturer Specs.
Pack size & Demanded Price 3x10’s Alu alu blister, AS per brand leader
Approval status of product in Dexilant-USFDA approved
Me-too status Not applicable
GMP status
Dissolution parameters stated in finished product testing
method are not as recommended by USFDA.
Drug Lasodex 30 mg Capsules
Name of Manufacturer M/s High Q Pharmaceuticals B-64, Karsaz Road, KDA-1, Karachi
M/s Alphamed Formulations Pvt. Ltd
Manufacturer of API
Survey No. 225, Sampanbole Village , Shamirpet Mandal, India
API Lot No. BVA16002 (Not mentioned on Commercial invoice)
Description of Pack
Real time : 30°C ± 2°C / 75% ± 5%RH
Real time: 6 months
Time Period
Frequency Real time: 0,3,6 (months)

Accelerated: 0,3,6 (months)
Batch Size 700 Caps 700 Caps 700 Caps
No.
9. COA of API Yes
10. Approval of API by regulatory authority yes
of country of origin or GMP certificate
of API manufacturer issued by
11. Protocols followed for conduction of Yes
stability study and details of tests.
chromatograms, laboratory reports, data
sheets etc.
13. Documents confirming import of API
Yes (date 31-01-2017) 0.9kg
etc.
14. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
authenticity of data / documents.
15. Commitment to continue real time Yes
stability study till assigned shelf life of
the product.
16. Commitment to follow Drug Yes
Specification Rules, 1978.
REMARKS OF EVALUATOR2
Brand name resemblance with Lansodex of Getz.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Lasodex

(Dexlansoprazole) 30mg and Lasodex (Dexlansoprazole) 60mg Capsules by M/s High-Q Pharmaceuticals,
Plot # 224 & 225/1, Korangi Industrial Area, Karachi.
Reference No: F.13-11/2017-PEC (Pt) dated 25th September, 2019
Investigation Date and Time: 23rd September, 2021.
Investigation Site: Factory premises of M/S. High-Q Pharmaceuticals, Korangi Industrial
Area, Karachi.
Background:
Chairman Registration Board considered the applications of M/S. High-Q Pharmaceuticals, Korangi Industrial
Area, Karachi for registration of Lasodex (Dexlansoprazole) 30mg & Lasodex (Dexlansoprazole) 60mg Capsules
and constituted a three member panel to investigate the authenticity / genuineness of data (import of raw material
and stability data). Panel was advised to conduct inspection of the firm and to submit report for further
consideration.
1. Prof. Dr. Rafeeq Alam Khan, Dean. Faculty of Pharmacy, Ziauddin University, Karachi (Member
Registration Board).
2. Dr. Saif-ur-Rehman Khattak, Director/ FGA, CDL, Karachi.
3. Ms. Sanam Kauser, Assistant Director, CDL, DRAP, Karachi.

Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing
of stability batches and stability studies on these batches.
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved,
ongoing studies, printed data and integrity and security of data in respective databases were also audited. The
details of investigation may be summarized as under:
Sr. No. Question Observation by panel
1. Do you have documents confirming the The firm has purchased 3kg Dexlansoprazole dual
import of API? delayed release pellets 22.5%w/w from M/s.VISION
PHARMACEUTICALS and used in stability batches
of 30 mg and 60mg Lasodex Capsules.
2. What was the rationale behind selecting the A SOP for induction and approval of new vendors is in
particular manufacturer of API? place and implemented. M/s. Vision Pharma was
inducted following the SOP. In addition, this vendor
has GMP certificate issued by DRAP which is valid
uptil 10th Feb 2022.
3. Do you have documents confirming the Invoice of API , working standard of API & Impurity
import of API reference standard and standard is available.
impurity standards?
4. Do you have certificate of Analysis of the CoA of the API, working standard and impurity
API, reference standards and impurity standard available.
standards?
5. Do you have any approval of API or GMP The firm has GMP certificate of (M/s Vision
certificate of API manufacturer issued by Pharmaceuticals, Islamabad-Pakistan) issued by DRAP
regulatory authority of country of origin? which is valid till 10th February, 2022.
6. Do you use API manufacturer method of Testing method of API manufacturer is used for the
testing? testing of Dexlansoprazole pellets.
7. Do you have stability studies reports on API? Reports are available.
8. If yes, whether the stability testing has been The stability testing has been performed as per SIM
performed as per SIM method and method by API manufacturer
degradation products have been quantified? The test for degradation products is not included in the
stability report shared by the manufacturer of API,
however, the firm has performed this test during
stability studies; the results are found compliant to
specification.
9. Do you have method for quantifying the Method for quantifying the impurities is available
impurities in the API?
10. Do you have some remaining quantities of The firm has some remaining quantity of the API and
the API, its reference standard and impurities its reference standard.
standards?
11. Have you used pharmaceutical grade Not applicable, as no excipient is added before
excipients? encapsulation i.e., the API is received as dual delayed
release pellets and are filled in capsule shells as such.
However the capsules shells used were of
pharmaceutical grade
12. Do you have documents confirming the Not Applicable
import of the used excipients?
13. Do you have test reports and other records on Test reports and other documents are available for
the excipients used? empty gelatine capsules.
14. Do you have written and authorized protocols The firm has written and authorized protocol for
for the development of API tablets / development of Lasodex 30mg / 60mg capsules.
capsules?
15. Have you performed Drug-excipient Not applicable, as no excipients are added before
compatibility studies? encapsulation.

16. Have you performed comparative dissolution The firm has performed comparative dissolution
studies? studies on their capsules with dexilant capsules
(Takeda Japan). The profiles for both strengths are
comparable to dexilant capsules.
17. Do you have product development (R&D) The firm has product development (R&D) section with
section requisite manufacturing facilities while testing is done
in fully equipped central lab
18. Do you have necessary equipment available All the necessary equipment are available in product
in product development section for development section however, the encapsulation is
development of Dexlansoprazole Capsules? done in production area using qualified encapsulation
machine.
19. Are the equipment in product development The equipment in product development section (R&D)
section qualified? are qualified.
20. Do you have proper maintenance / calibration PD equipment are included in site equipment
/ re-qualification program for the equipment maintenance, calibration and qualification program.
used in PD section?
21. Do you have qualified staff in product The firm has adequately qualified and trained staff in
development section with proper knowledge product development section.
and training in product development?
22. Have you manufactured three stability The firm has manufactured three stability batches each
batches for the stability studies of capsules as for 30mg and 60mg capsules.
required?
23. What was the criteria for fixing the batch size The batch size was fixed considering the factors like (i)
of stability batches? Complexity of process; in this case it is simple i.e., just
filling of pellets in capsules and controlling the fill
weight, (ii) start-up waste, (iii) Number of capsules
required for one full specification testing, (iv)Number
of complete testing to be performed as per approved
test frequency for accelerated and real time samples
and (v) suitable quantity for reference.
24. Do you have complete record of production The firm has complete record of production of stability
of stability batches? batches.
25. Do you have protocols for stability testing of The firm has detailed protocols for stability testing of
stability batches? stability batches.
26. Do you have developed and validated the The firm has validated HPLC methods provided by
method for testing of stability batches? Manufacturer of the API with the necessary force
depredation studies.
27. Do you have method transfer studies in case Full validation studies are performed.
when the method of testing being used by
your firm is given by any other lab?
28. Do you have documents confirming the The firm has documents confirming the qualification of
qualification of equipment / instruments equipment / instruments being used in the test and
being used in the test and analysis of analysis of Dexlansoprazole API and the finished
product’s API and the finished drug? product.
29. Do your method of analysis stability Analytical method used in stability studies is stability
indicating? indicating as evidenced by force degradation studies.
30. Do your HPLC software is 21CFR HPLC software is 21CFR compliant.
compliant?
31. Can you show Audit Trail reports on API Audit Trail reports of API (Dexlansoprazole pellets)
testing? and Laxodex Capsules are available.
32. Do you have some remaining quantities of The firm has remaining quantity of stability batches
degradation products and stability batches? only.
33. Do you have commitment batches kept on Three batches each of 30mg and 60mg capsules are
stability testing? kept on real time & accelerated stability testing.

34. Do you have valid calibration status for the The firm has valid calibration status for the equipment
equipment used in API tablets production in used in production and analysis of Dexlansoprazole
analysis? Capsules.
35. Do proper and continuous monitoring and The firm has adequate monitoring and control available
control are available for stability chamber? for stability chambers.
36. Do related manufacturing area, equipment, Related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are GMP compliant
compliant?
37. Specific Queries by PEC/Board As per direction of the PEC results of dissolution
To verify the dissolution testing of pellets at testing of the pellets at pH 5.5 were reviewed.
pH 5.5 for confirmation of dual delayed It was concluded that the results lie within the limits
release action. (less than 35% in three hours).
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Lasodex 30mg and Lasodex 60mg (Dexlansoprazole) Capsules are verifiable to
satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suited for
the manufacturing of Lesodex 30mg and Lasodex 60mg (Dexlansoprazole) Capsules.
Recommendations:
1. Since Lasodex 30mg and Lasodex 60mg (Dexlansoprazole) Capsules are modified release (delayed
release) capsules therefore, post registration bioequivalence studies should be conducted on the product
before marketing.
2. Firm must develop specific identification test for dexlansoprazole in the pellets and the finished product.
3. The firm may kindly be granted necessary registration of Lasodex 30mg and Lasodex 60mg
(Dexlansoprazole) Capsules.
Note: The firm has submitted written undertaking for post registration bioequivalence studies on the capsules
(copy enclosed).
694. Name, address of Applicant / “M/s Sami Pharmaceuticals Pvt Limited.
Marketing Authorization Holder F-95, S.I.T.E, Karachi, Pakistan”
Name, address of Manufacturing site. “M/s Sami Pharmaceuticals Pvt Limited.
F-95, S.I.T.E, Karachi, Pakistan”
☐ Importer
Evidence of approval of New license granted on 29/09/2020
manufacturing facility Tablet, Capsule, Dry Powder, Liquid Syrup, Cream Ointment
Details of fee submitted Rs.50,000 dated 06-11-2019

The proposed proprietary name /
Elezo-BF 150mg/1mg/25mcg Capsule
brand name
Strength / concentration of drug of Each Capsule Contains:
Active Pharmaceutical ingredient Iron Polysaccharide eq. to elemental Iron…….150mg
(API) per unit Folic Acid…….1mg
Vitamin B12…….25mcg
Pharmaceutical form of applied drug Capsule
Pharmacotherapeutic Group of (API) Mineral, Iron
specifications
Proposed unit price Not submitted
The status in reference regulatory Firm has referred to the “Ferrex 150 forte capsules” of US,
authorities along with its reference form Nation Drug Code list. Firm
has also referred to the decision of registration Board
regarding Iron containing formulations.
manufacturer Tablet, Capsule, Dry Powder, Liquid Syrup, Cream Ointment
Name and address of API Iron Polysaccharide: M/s Aromatic & Industrial Chemicals
manufacturer. Pvt. Ltd.
Address: B-15, Kalyan Badlapu Rd., MIDC Area, Ambarnath-
421S0L D􀀙t. Thane, Thane
Folic Acid:
HEBEi JIHENG {Group) PHARMACEUTICAL Co., Ltd
Address: No. 1 Weiwu Street, Henshui Industrial Park, Henshui
City, Hebei Province, P.R. China 053000
Vitamin B12 (Cyanocobalamin):
HEBEi HUARONG PHARMACETICAL CO., LTD.
Address: East Road, North Circle, Shijiazhuang, China
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template.
Summary) Summarized information related to nomenclature, structure,
Stability studies Firm has submitted accelerated & long-term stability studies of
Iron polysaccharide as per Zone IVa conditions.
procedure (including dissolution testing at acidic and buffer

Pharmaceutical equivalence and Firm has submitted that Dissolution test not performed as
comparative dissolution profile dissolution test for this combination is not available in
pharmacopeia and FDA dissolution database
Analytical method Method verification studies have submitted including linearity,
validation/verification of product range, accuracy, precision, specificity.
Manufacturer of API Iron Polysaccharide: M/s Aromatic & Industrial Chemicals Pvt. Ltd.
Address: B-15, Kalyan Badlapu Rd., MIDC Area, Ambarnath- 421S0L D􀀙t. Thane,
Thane
Folic Acid:
HEBEi JIHENG {Group) PHARMACEUTICAL Co., Ltd
Address: No. 1 Weiwu Street, Henshui Industrial Park, Henshui City, Hebei Province,
P.R. China 053000
Vitamin B12 (Cyanocobalamin):
HEBEi HUARONG PHARMACETICAL CO., LTD.
Address: East Road, North Circle, Shijiazhuang, China
API Lot No. Iron Polysaccharide:PIC/180505
Folic Acid: 021805013
Vitamin B12 (Cyanocobalamin): 01170810
Description of Pack
(Container closure Alu-Alu foil
system)
Manufacturing Date November-2018 November-2018 November-2018
No. of Batches 03
1. Reference of previous approval of Firm has referred last onsite panel inspection for instant dosage
applications with stability study data form conducted during last two years- DELANZO DR
of the firm (if any) (Dexlansoprazole) 30mg & 60mg Capsules on 02nd April,
2018, by following panel:
According to the report following points were
confirmed.
loggers.
2. Approval of API/ DML/GMP Iron Polysaccharide: GMP certificate (Certificate#6084148)
certificate of API manufacturer issued issued by FDA Maharashtra India, valid upto 22-09-2019 has
by concerned regulatory authority of been submitted.
country of origin.

Folic Acid: GMP certificate (Certificate#HE20170030) issued
by HEBEI Drug Administration, valid upto 126-05-2022 has
been submitted.
Vitamin B12 (Cyanocobalamin): GMP certificate
(Certificate#HE20180094) issued by HEBEI Drug
Administration, valid upto 18-11-2023 has been submitted.
3. Documents for the procurement of • Firm has submitted copy of Ad I&E attested invoice dated
API with approval from DRAP (in 06-06-2018 for the import of Iron (III) hydroxide
case of import). polymaltose.
• Firm has submitted copy of Ad I&E attested invoice dated
30-10-2018 for the import of Folic acid.
• Firm has submitted copy of Ad I&E attested invoice dated
25-09-2017 for the import of Vitamin B 12.
sheets etc.
testing
accelerated)

3.2.S.4 • Submit drug substance • Drug substance specifications & analytical method
specifications & for all three drug substances are submitted
analytical method • Analytical method verification studies for all three
applied by M/s Sami, for drug substances are submitted
all the three drug
substances.
• Submit analytical
method verification
studies for all three drug
substances, performed
by M/s Sami
Pharmaceuticals.
3.2.S.7 Long term stability studies Submitted
of Cyanocobalamin & Folic
acid are not as per Zone IV a
condition.
3.2.P.2.2.1 Pharmaceutical equivalence Pharmaceutical Equivalence along with the reference
of the applied drug shall be product is submitted. The Assay results of Folic acid &
established with the Cyanocobalamin have been reported a sunder:
innovator / reference / Drug Reference Sami’s
comparator product and substance product product
results of all the quality tests Folic acid 109.64% 119.22%
(mentioned in any official Cyanocobalam 109.26% 119.71%
pharmacopoeia or section in
3.2.P.5.1 of this application)
of the developed
formulation and the

innovator / reference /
comparator product shall be
submitted.
3.2. Describe the particulars of drug substance on the basis of which 20% overage has been
P.2.2.2 claimed for Folic acid & Cyanocobalamin
The unusual assay limits were due to the overages in Cyanocobalamin and Folic acid.
Initially the upper limit was set to 150% due to 20% overage. Now, based on stability
data, the upper limit of assay has been revised to 125%.and we will cut down the
overages accordingly. Revised specifications and testing procedure are submitted.
Reply • Some active pharmaceutical ingredients including several vitamins in certain
dosage forms or packaging condition may be susceptible to degrade or deteriorate
and may not remain their native form over the shelf life of product. Degradation
or deterioration of vitamins is one of the major factors that lead manufacturer to
require excess amount of vitamins in their products, to ensure the amount of the
drug substance meets the requirement of 100% of the label claim amount
throughout the shelf life of the product. (Referred Pharmacopeial Forum
Vol.42.42 (3) [May-June 2016], Stimuli to the Revision Process, Factors to
Consider in Setting Adequate Overages of Vitamins and Minerals in Dietary
Supplements).
• ELEZO BF Capsules was developed as per the formulation of reference listed drug
(RLD) i.e. Ferrex 150 Forte Capsule manufactured by Mis.Contract Pharmacal
Corp. Hauppauge, NY 11788 USA. During chemical testing of RLD product,
assay of Folic Acid (Vitamin B9) was observed around 110% and assay of
Cyanocobalamin (Vitamin B12) was observed around 110%. On the basis of assay
results of RLD product, formulation of ELEZO BF Capsules was suggested with
20% overage for both Folic Acid (Vitamin B9) and Cyanocobalamin (Vitamin
B12) to compensate any process loss followed by the expected loss in assay during
stability studies due to nature of the molecules.
• The stability trending of our product shows about 4.29 to 6.41 % loss in assay of
Folic Acid (Vitamin 89) under accelerated condition as well as 2.37 to 4.05% loss
under long term condition, and 9.41 to 13.03% loss in assay of Cyanocobalamin
(Vitamin B12) under accelerated condition as well as 2.47 to 4.59% loss under
long term condition.
• Moreover, 20% overage was not fixed, as mentioned above, it is a global practice
to take overages for vitamins during development studies and this was also evident
in assay results of the RLD product as well.
• However, after evaluation of the stability data and till the latest time period i.e. 24
months, we recommend to reduce the overage of Folic Acid (Vitamin B9) from
20% to 7% and Cyanocobalamin (Vitamin B12) from 20% to 13%.
3.2. P.5.1 • Justify the unusual Assay limits of Cyanocobalamin & Folic acid.
• Submitted drug product specifications does not include test of dissolution.
Reply • Assay limits were set considering the overage of Cyanocobalamin, folic acid and
based on USP specifications for Cyanocobalamin Gel that is 90 to 155 %.
• On the basis of analysis of stability data, we have revised the Assay limit of
cyanocobalamin & Folic acid from 90%-150% to 90-125% from 9th month interval
to onwards.
• While we have come to conclude that the product is stable till 24 months therefore
we will further reduce the overages up to 90 to 120 %, please find submitted
revised specifications.
• Dissolution test for cyanocobalamin not performed due to following reasons:
“It falls in BCS Class Ill and having a good solubility
The dissolution of the product is ensured by its Disintegration time which is
established within 10-15 mins during its shelf life through stability studies (stability
summaries are attached for your reference).

Label claim of Cyanocobalamin in applied formulation is 25mcg/ capsule and the
concentration of the API in dissolution test is about 0.05 PPM which is difficult to
detect
As per USP general chapters for dissolution of water-soluble multivitamins and
mineral tablets, it is recommended to perform dissolution of One index water-soluble
vitamin, one index element, and folic acid (if present)
Definition of Index Vitamin and Index element as per USP:
Index water-soluble vitamin:

"Riboflavin is the index vitamin when present in the formulation. For formulations
that do not contain riboflavin, pyridoxine is the index vitamin. If neither riboflavin nor
pyridoxine is present in the formulation, the index vitamin is niacinamide (or niacin),
and in the absence of niacinamide (or niacin), the index vitamin is thiamine. If none
of these four water-soluble vitamins are present in the formulation, the index vitamin
is ascorbic acid."
Index element:
"Iron is the index element when present in the formulation. For formulations that do
not contain iron, the index element is calcium. If neither iron nor calcium is present,
the index element is zinc. In the absence of all three of these elements, magnesium is
the index element."
Therefore, we performed dissolution of Folic acid and Iron content only.
3.2. P.5.6 • Relevant information • The specification of Elezo BF Capsule is
shall be submitted. developed in-house based on ICH Q6
“Specifications “as well as based on general
chapter of pharmacopeia. The test includes
appearance, average weight, disintegration time,
Assay and dissolution etc
3.2. P.8 • Submitted stability data • All vitamins are degraded on accelerated
reflects significant conditions due to heat sensitive, Significant change
change in the Assay observed in 06 months accelerated stability
results of Folic acid & however at long term conditions all results within
Cyanocobalamin, 3% from initial value and have no significant
during accelerated change is observed till 24 months.
stability studies. • According to ICH Q1E, if significant change
Justification shall be occurs between 3 and 6 months testing at
submitted in this regard. accelerated storage condition, the proposed retest
period or shelf life should be based on long term
data.
• Currently we have 24th month long term data and
have no significant change; See below the
statement of ICH Q1E;

Decision: Deferred for submission of complete details regarding Pharmacological, Pharmacodynamic &
clinical indications of the applied product.

695. Name, address of Applicant / Marketing M/s Gray's Pharmaceuticals. Plot No. 2, street No.N-3,
Authorization Holder National Industrial Zone, Rawat Islmabad.
Road, Islamabad
☐ Importer
☐ Export sale
Evidence of approval of manufacturing Firm has submitted copy of section approval letter dated 23-
facility 07-2012 which specifiesLyophilized vials (General) for M/s
Bio-Labs Pharma
Bacticil 50mg Injection IV
name
Pharmaceutical ingredient (API) per unit Tigecycline (Lyophilized powder) ……… 50mg
Pharmaceutical form of applied drug Lyophilized Powder for Injection
Pharmacotherapeutic Group of (API) Antibacterial agent
USP
specifications
Approved by US FDA
authorities
For generic drugs (me-too status) Tigewel Injection of M/s Welwrd Pharma (Reg.# 082530)
GMP status of the Finished product GMP certificate issued on 13-08-2020.
manufacturer
Name and address of API manufacturer. Fuan Pharmaceutical Group Chongqing Bosen Pharmaceutical
Co. Ltd .No .1 human Yi Road, Changshou District,
Chongqing 401254,P.R China.
manufacturers,

Real time: 6oC ± 2 oC,RH for 36 months
Accelerated: 25oC ± 2oC/60% ± 5%RH for 6 months
Batches: (Til00701V, Til00702V, Til00703V)
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical equivalence for
comparative dissolution profile all the quality tests for their product against the comparator i.e.
BTig 50mg injection by Bosch pharmaceuticals.
Analytical method validation/verification Method verification studies have been submitted.
of product
Manufacturer of API Fuan Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co. Ltd. No .1 human Yi Road, Changshou
District, Chongqing 401254, P.R China.
API Lot No. Ti191201
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-131 L-138 L-242
Batch Size 1000 Vials 1000 Vials 700 vials
No. of Batches 03
firm (if any)

2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate (No.
API manufacturer issued by concerned CQ20180031) issued by Chongqing food and drug
regulatory authority of country of origin. administration valid upto 09-10-2023.
3. Documents for the procurement of API with • Firm has submitted copy of Licenses to Import Drug
approval from DRAP (in case of import). substance Tigecycline issued by AD I&E DRAP, Islamabad
dated 05-08-2019 & 02-04-2020.
4 Data of stability batches will be supported by Submitted

testing
and humidity monitoring of stability and humidity monitoring of real time and accelerated stability
chambers (real time and accelerated). chambers.
• 3.2. S.4 limits for test of pH submitted in the drug • Firm has submitted revised documents
Acceptance
substance specifications is not as per the USP monograph for submitted without justifying the
“Tigecycline”. deviations observed in previously
• The details of coloumn temperature, mobile phase submitted data.
preparation, system suitability solution mentioned in the • Temperature for autosampler not
Assay test method by Drug substance manufacturer is not as reflected in analytical method.
per the USP monograph for “Tigecycline”. • Firm has submitted Bioburden test
• Submitted COA from M/s Bio-labs reflect that tests of report from M/s Bio Lab for another
Bacterial Endotoxin & sterility have not been performed. batch than that submitted earlier.
• Copies of the Drug substance specifications and analytical • Drug substance specifications and
procedures used for routine testing of the Drug substance analytical procedure has been
/Active Drug Product manufacturer is required. submitted from M/s Bio-Labs, but
• Analytical Method Verification studies including specificity, these documents are not formal and
accuracy and repeatability (method precision) performed by does not bear any document no., issue
the Drug Product manufacturer shall be submitted. date or effective date.
• Provide results of analysis of relevant batch(es) of Drug • Analytical method verification studies
Substance performed by Drug Product manufacturer used have been submitted from M/s Bio-
during product development and stability studies, along with Labs.
Certificate of Analysis (CoA) of the same batch from Drug • COA from API manufacturer has been
Substance / /Active Pharmaceutical Ingredient manufacture. submitted, which declares the product
• Evidence of availability of Auto sampler in HPLC, wherein name as “Tigecycline lyophilized”,
10oC temperature conditions could be maintained. whereas COA of M/s Bio-Lab declares
it as “Tigecycline” only.
• No Evidence of availability of Auto
sampler in HPLC, wherein 10oC
temperature conditions could be
maintained.
• COA3.2.S.5
of primary / secondary reference standard including COA of working standard has been
source and lot number shall be provided. submitted from M/s Fuan Pharmaceutical,
China.
3.2. S.7 • The USP monograph for “Tigecycline” Firm has submitted stability studies data of
recommends storage condition as at drug substance for the same batches as
refrigerated temperature, whereas submitted earlier, wherein only conditions

stability studies data has been submitted of storage have been changed as required
as per room temperature conditions. for a refrigerated item, while the analytical
• Specifications for pH & specific optical values for all the tests are same as
rotation applied in stability studies is presented earlier.
different from that submitted in section
3.2.S.4.4.
3.2.P.1 • Inclusion of lactose monohydrate in the MHRA approved reference given.
composition shall be justified since
innovator product approved by US FDA
& EMA is formulated without use of any
excipient.
3.2.P.2.1 • Compatibility studies of the Drug MHRA approved reference given.
Substance(s) with Lactose shall be
provided since innovator product
approved by US FDA & EMA is
formulated without use of any excipient.
• • Following not given
3.2. P.5 of fill weight/vial shall be submitted.
Specifications
• • Specifications
Specifications does not include test of “Particulate matter”. of fill weight/vial shall be submitted.
• Evidence of availability of Auto sampler in • HPLC,
Evidencewherein

Item No. Detail of Item Pages: Minutes of 316 Meeting of Registration Board Held On 15, 16, 17 & 18 MARCH, 2022

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Item No. Detail of Item Pages: Minutes of 316 Meeting of Registration Board Held On 15, 16, 17 & 18 MARCH, 2022

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MINUTES OF 316th MEETING OF REGISTRATION BOARD

HELD ON 15th, 16th, 17th & 18th MARCH, 2022

Item Detail of Item Pages

Drug Regulatory Authority of Pakistan

Minutes of 316th meeting of Registration Board (15-18 March, 2022) |1

The meeting was attended by the following: -

Minutes of 316th meeting of Registration Board (15-18 March, 2022) |2

Decision: Registration Board confirmed the minutes of 315th meeting.

Minutes of 316th meeting of Registration Board (15-18 March, 2022) |3

Pharmaceutical Evaluation Cell (PEC)

Sr. No Name of Evaluator Title

9. Mr. Shahid Nawaz Evaluator PEC-XIII

10. Mr. Ahsan Hafiz Evaluator PEC-XIV

11. Mr. Akbar Ali Evaluator PEC-XVI

12. Mr. Zia Ullah Evaluator PEC-XVII

13. Mst. Saima AD PE&R

14. Mr. Syed Ajwad Bukhari AD PE&R

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4. Do you have certificate of Analysis of the API, Not provided.

5. Do you have any approval of API or GMP -do-

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