Minutes For 260th Meeting Registration Board

Minutes for 260th Meeting Registration Board held on 28-29th June, 2016.
Item No. Detail of Item Page No(s)
Item No.I Confirmation for minutes of 259th Registration Board meeting 04
Item No.II Pharmaceutical Evaluation & Registration Division 05 - 375
Item No.III Biological Drugs Division 376 - 483
Item No.IV Quality Assurance & Laboratory Testing Division 484 – 490
Item No.V Additional cases 491 - 493
Minutes for 260th Meeting Registration Board 1

260th meeting of Registration Board was held on 28-29th June, 2016 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by Mr.
Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division, DRAP. The meeting
started with recitation of the Holy Verses. The meeting was attended by the following:-
1. Lt General (R) Karamat Ahmed Karamat. Member
2. Brig (R). Dr. Muzammil Hasan Najmi, Member

Associate Dean, Basic Sciences Division,
Foundation University Medical College, Rawalpindi
3. Mr.A.Q.Javed Iqbal Member
4. Sheikh Sarfraz Ahmad Member

Additional Draftsman, M/o Law and Justice
5. Mr.Ghulam Mujtaba, Assistant Director Member
Representative of IPO
6. Dr.Muhammad Arshad Member
President, Pakistan Veterinary Medical Council
7. Dr.Amanullah Khan Member
Director Drugs Testing Laboratory
Government of Baluchistan, Quetta
8. Dr.Muhammad Khalid Khan Member
Government of Khyber Pakhtunkhwa, Peshawar
9. Mr.Abdus Salam Shah Member
Government of Sindh, Karachi
10. Mr.Saleem Butt Member
Government of Punjab, Rawalpindi
11. Shaikh Ansar Ahmad, Member
Director Biological Drugs Division, DRAP
12. Dr.Noor Muhammad Shah Member
Director Medical Device Division, DRAP
13. Dr.Abdur Rasheed Member
Chairman, Quality Control
QA&LT Division, DRAP
14. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary

Dr.Muhammad Khalid Khan attended the meeting on 28.06.2016 while Dr.Muhammad
Arshad and Mr.Abdus Salam Shah participated on 29.06.2016 only.
Dr.Masud-ur-Rehman (DDG Biological), Zaheer-ud-Din M Babar (DDC R.I/R IV),

Muhammad Akhter Abbas (DDC/Incharge, PEC), Dr.Hafsa Karam Elahi (DDC,PEC),
Muhammad Amin (DDC R.V / DDC,PEC), Tehreem Sara (DDC RRR), Adnan Faisal Saim
(DDC,QC), Babar Khan (ADC R.II/RIII), Dr.Ghazanfar Ali Khan (ADC RRR), Salateen
Waseem Phillips (ADC,PEC), Muhammad Ansar (ADC,PEC) and Muneeb Cheema
(ADC,Biological) assisted relevant Directors and Secretary of the Board with agenda.
Shafiq Ahmad Abbasi, Ayub Siddique, Nadeem Alamgeer and Abuzar Faizi Rattu
attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively.
In addition to routine agenda, following was also discussed and decided:
 Registration Board deliberated that only those drugs will be registered for import from
India, which are as allowed / permissible as per Import Policy Order, 2016 (Ministry of
Commerce).

Item No. I: Confirmation of minutes of 259th meeting Registration Board.
259th meeting of Registration Board was held on 30-31st May, 2016. Draft minutes were
circulated to all members (who attended the meeting) on 15.06.2016 through e-mail with the
request to forward their comments (if any) within 05 days. 02 members forwarded their
comments / observations, as follows:
 Dr.Amanullah Khan, Director DTL, Quetta:

Item No.III, Case No.01:
It may be decided as per decision of Registration Board.
 Dr.Noor Muhammad Shah, Director Medical Device, DRAP:

While discussing observation of Dr.Amanullah regarding registration of Injection Ropegra, the
members were informed that the Board endorsed the statement of registration of the product in
parawise comments submitted before the court and change in source was accordingly approved.
Member including the undersigned stated that Board has its own wisdom and procedure for
registration of drugs instead of endorsing of parawise comments. It was also submitted that as
necessary requirements were fulfilled, registration should have been granted for the new source
instead of change of source.
Keeping in view comments of Dr.Amanullah Khan, Director DTL, Quetta, respective
case is again placed as agenda item (Item No.II, Case No.01).
Decision: Registration Board deliberated that points observed by Director Medical

Device, DRAP has already been discussed in previous meetings. Hence
Registration Board confirmed minutes of 259th meeting Registration Board.

Item No. II: Pharmaceutical Evaluation & Registration Division.
Case No.01: New committee(s) for on-site inspection of stability data or any other
assignments.
Registration Board in 258th meeting considered following proposal of Dr.Muhammad

Khalid Khan, Director DTL, Peshawar forwarded in response to draft minutes of 257 th
Registration Board meeting. Dr.Amanullah Khan, Director DTL, Quetta has also endorsed these
observations.
As per decision of the Registration Board to verify stability data as per site and in this
connection already one committee was constituted which is working. However as a member
of Registration Board I do feel that only one committee is not sufficient to look after the
entire Pharma of the country therefore to avoid unnecessary delay for onsite verification of the
data the board may constitute new committee(s) in the public interest compromising of members
of the Registration Board only. Registration Board may also develop rationalized check list for
onsite verification of the data with clear, time Bound Terms of Reference.
Registration Board after deliberation deferred the case and advised Pharmaceutical Evaluation
Cell to bring complete details / data of stability datas submitted by the manufacturers in forthcoming
meeting. Accordingly, following data is submitted for consideration of Registration Board.
S.No Name of Drug & Composition No of applicants / manufacturers

1. Capsule Dex-Lansoprazole 30mg, 60mg 02
2. Tablet Sofosbuvir 400mg 03
3. Tablets Cinacalcet 30 mg, 60 mg 01
4. Tablet Mirabegron 25mg, 50mg 01
5. Tablet Sitagliptin+Metformin XR 50/500, 01
50/1000, 100/1000
In 259th meeting, Registration Board decided as follows:
Registration Board deliberated the matter in detail and decided that already constituted panel
(Brig (R) Muazmmil Najmi, Dr.Obaidullah and Dr.Saif-ur-Rehman Khattak) will continue to
inspect pharmaceutical units for onsite investigation to confirm genuineness/ authenticity of
stability data and associated documents, import of API, quality, specification, test analysis,
facilities for Anti-retroviral drugs. For rest of formulations, following panels are constituted for
aforementioned purposes.
 Sind and Balochistan: Director DTL Karachi; Director DTL Quetta and area

FID, DRAP.
 Punjab: Director DTL Lahore; Director DTL Peshawar and

area FID, DRAP.
 Islamabad, AJK and KPK: Director DTL Rawalpindi; Director DTL Peshawar and
area FID, DRAP.
Registration Board also approved above panels for confirmation genuineness/

authenticity of stability data and associated documents, import of API, quality, specification, test
analysis, facilities for various applications.
Decision: Registration Board deliberated the matter and decided that already
constituted panel (Brig (R) Muazmmil Najmi, Dr.Obaidullah and Dr.Saif-ur-Rehman
Khattak) will continue to inspect pharmaceutical units for onsite investigation to confirm
genuineness/ authenticity of stability data and associated documents, import of API,
quality, specification, test analysis, facilities for Anti-retroviral drugs. For rest of
formulations, following panels are constituted for aforementioned purposes.
 Sind and Balochistan: Director DTL Quetta (Chairman), Director DTL

Karachi (Member); and area FID, DRAP
(Member / Convener).
 Punjab: Director DTL Peshawar (Chairman), Director DTL
Lahore; and area FID, DRAP (Member/Convener).
 Islamabad, AJK and KPK: Director DTL Peshawar (Chairman), Director DTL
Rawalpindi and area FID, DRAP (Member/Convener).
Case No.02: Price fixation under the Drug Pricing Policy-2015.
Drug Pricing Committee referred the under mentioned five cases of price fixation for
policy guidelines from the Policy Board of the Authority for price fixation of drugs whose plain
formulations or injections in vials/ampoules are available in the market at much lower prices and
the companies have applied for price fixation of sustained release formulations or injections in
prefilled syrings or modification in dosage administration / drug delivery device respectively.
These formulations are not new chemical entities and DPC could not find any guideline in the
Drug Pricing Policy -2015 to fix prices of these formulations at much higher prices. Therefore,
DPC decided to refer the following cases of price fixation to the Policy Board of the Authority
for policy guideline whose prcice fixation is not covered under the Drug Pricing Policy –2015.

S. Drugs / Composition Reasons for referring to the Policy Board for policy guideline
No.
1. Panadol Joint Tablets Plain tablets of Panadol 500mg of the same company are available
Each modified release tablet @ Rs.180.00/200’s (Rs.0.90/- per tablet) and the company is
contains:- demading Rs.200.00/20’s (Rs.10.00/- per tablet) for modified
Paracetamol Ph release of 665mg tablets.
Eur….665mg
Demanded price of 665mg modified release tablets @ Rs.10/- per
M/s GSK, Karachi tablet is much high in comparison to price of 500mg plain tablet of
(M-243) the same company available @ Rs.0.90/- per tablet.
It is not a new chemical entity. Reference price is neither available

nor applicable. DPC decided to refer the matter to Policy Boar for
policy guideline.
2. Sayana Press Injection PFS The company is already marketing injection of
104mg/0.65ml Medroxyprogesterone acetate 150mg per 1ml in vial dosage form @
(Medroxyprogesterone Rs.153.16/1ml x 1’s under the brand name “Depo-Provera”.
acetate)
Pre-filled injection system Now the company has applied for price fixation of same drug
contains Depo- (Medroxyprogesterone acetate) for 104mg per 0.65ml under the
medroxyprogesterone acetate brand name “Sayana Press Injection PFS” and demaned maximum
(DMPA) 104mg/0.65ml retail price of Rs.1078/- per injection in Pre-filled syringe.
 Imported by Pfizer Demanded price of Sayana Press Injection @ Rs.1078/- per

Pakistan Limited, injection is much higher in comparison to already available brand
Karachi “Depo-Provera” of the same company @ Rs.153.16 per injection
 Imported from (vial).
Manufacturer: Pfizer
Manufacturing It is not a new chemical entity. Reference price is neither available
Belgium NV, nor applicable. DPC decided to refer the matter to Policy Boar for
Rijksweg 12, 2870 policy guideline.
Puurs, Belgium.
Main indications:
Contraceptive, depot
effective for at least 13
weeks.

No.
3. Ritalin LA Capsules 20mg The company is already marketing Methyphenidate hydrochloride
Each capsule contains:- 10mg Tablets in plain tablet dosage form @ Rs.140.00 per pack of
Methyphenidate 10 tablets under the same brand name “Ritalin Tablets”.
hydrochloride…..20mg
(M-245) Now the company has applied for price fixation of same drug
 Imported by M/s. (Methyphenidate hydrochloride) for 20mg per capsule under the
Novartis Pharma brand name “Ritalin LA Capsules 20mg ” and demaned maximum
(Pakistan) Ltd. retail price of Rs.2400.00/- for a pack of 30 capsules (Rs.80/- per
Karachi/ capsule).
 Imported from M/s.
Elan Holdings Inc, Demanded price of Ritalin LA Capsules 20mg @ Rs.2400.00/- for
Georgiam, USA. a pack of 30 capsules (Rs.80/- per capsule) is much higher in
comparison to already available brand “Ritalin Tablets 10mg” of
the same company @ Rs.140.00 per pack of 10 tablets (plain)
(Rs.14/- per tablet).

policy guideline.
hydrochloride….320mg
(Pakistan) Ltd. retail price of Rs.3200.00/- for a pack of 30 capsules (Rs.106.67/-
Karachi/ per capsule).
Georgiam, USA. a pack of 30 capsules (Rs.106.67/- per capsule) is much higher in

policy guideline.

No.
hydrochloride…..40mg
(Pakistan) Ltd. retail price of Rs.3900.00/- for a pack of 30 capsules (Rs.130/- per
Karachi/ capsule).
Georgiam, USA. a pack of 30 capsules (Rs.130/- per capsule) is much high in

policy guideline.
Policy Board of the Authority in its 14 th meeting held on 10th & 11th September, 2015 had
referred the matter to the Drug Registration Board to decide a specialized dosage form whether it
is a new drug or not and its price is to be granted. Accordingly as a new product or a same
product but different strength / different pack size as both are separately mentioned in the Drug
Pricing Policy-2015.
Decision: Mr.Abdul Ghaffar, DDC (Pricing) apprised Registration Board about the
case. The Board deferred the case for decision of DRAP’s Policy Board in
instant case for further deliberation.

RRR Division
Case No.03: Renewal of registered drug and Post-registration variation approval.
In 243rd Meeting of the Registration Board a following decision was made post-
registration variation was made and the extract is as under:
“Registration Board deliberated that transfer from one importer to another (with no change in
manufacturing site), change of brand name and change of name of manufacturer will be
considered as post-registration variation. Moreover, this approval will not be considered as
renewal of the product and firm will apply for renewal of product as per procedure and will be
processed as per import policy for finished drugs.”
Although decision was made as above but notification to this effect for not considering
post-registration variations towards renewal products was not issued and the firms are still
considering/applying renewal of registration from their date of post-registration variations.
Case was deliberated in 259th Registration Board meeting and decided to bring the issue
as agenda in the forthcoming meeting for discussion.
Decision: Registration Board deliberated on the matter at length and decided post-
registration variations shall not be considered towards renewal of products
w.e.f 01-10-2016. However, it was observed that renewal applications already
submitted or to be submitted till 30.09.2016 shall be considered from post
registration varioation, if appled by the firm.
Case No.04: Renewal of Registered drugs.
Number of applications submitted for renewal of drugs which are incomplete or have
shortcoming especially with reference to the submitted prescribed renewal fees. The following
applications for renewal of drugs are submitted on Form 5-B after the expiry of validity of the
certificate of registration but within sixty days after validity of certificate of registration. The
applications for renewal are incomplete with reference to renewal application fee or having some other
deficiency.
Rule 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of certificate of
registration). A certificate of registration under this chapter, [shall unless earlier suspended or
cancelled, be in force for a period of five years from the date of [Registration of the drug] and may
thereafter be renewed for period not exceeding five years and a certificate to this effect shall be
issued within one month] at a time.

Provided that an application for the renewal of registration shall not be entertained unless it has
been made within sixty days after the expiry of the registration and when an application has been
made aforesaid the registration shall subject to the orders passed on the application for the renewal
continue in force for the next period of five years and a certificate to this effect shall be issued within
one month].
Provided further that in case of an imported drug, the renewal may be granted and a renewal
certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so in the
public interest.
Following cases are placed below for the consideration of Registration Board.
a. M/s Prix Pharma Lahore.
S. Reg/No Products/Name Initial Date of Application receiving

No Registration date
and fee submitted date/
and due date
1 014568 Farbenda Oral Suspension 22-2-1994 Due date (21-2-2014)
Each ml contains 17-3-2014
Albendazole…. 100 mg Fee of Rs. 40,000/-
deposited on 17-03-2014
Decision: Firm submitted renewal application within 60 days of expiry period of

registration time i.e; 17-03-2014 with fee of Rs. 40000/-, therefore
Registration Board decided to grant renewal of above product till 21-02-2019
subject to adherence to the Import Policy for Finished Drugs.
b. M/s Navegal Laboratories Rawalpinid.
S. Reg/No Products/Name Date of Application receiving date

No transfer of and fee submitted date/
Reg. and due date
1 015732 Naveten 1 mg tablet 21-1-2008 Due date (20-1-2013)
Each tablet contains 19-2-2013
Ketotifen Fumerate.. 1 mg Fee of Rs. 60,000/-
deposited on 19-02-2013
2 015731 Piram 20 mg capsule do
Each capsule contains do
Piroxicam…..20 mg
3 018979 Zantidon 150 mg tablets do
Each tablet contains do
Ranitidine HCl… 150 mg

registration time i.e. 19-02-2013 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1 to 3 till 20-01-2018.
c. M/s Nabiqasim Industries (Pvt) Ltd Karachi.
S. Reg/No Products/Name Initial Date Application receiving date

No of and fee submitted date/ and
Registratio due date
n
1 053139 Deplat-AP Tablet 1-12-2008 Due date (30-11-2013)
Clopidogrel Fee of Rs. 20,000/- deposited
(as bisulphate)…. 75 mg on 10-12-2013
Aspirin BP….. 75 mg
(Manufacturer’s Specification)
2 053135 Lungair 4 mg tablet do
Each chewable tablet contains do
Montelukast Acid (as sodium)
………. 4 mg
3 053142 Valset 250 mg tablet do do
Each tablet contains
Valproic Acid (as sodium)
………. 250 mg
4 053133 Ordiab 5/500 tablet do do
Glipizide……. 5.00 mg
Metformin Hydrochloride…
500 mg
5 053138 Clarithro 125mg/5ml Oral do do
Drops
Each 5ml contains
Clarithromycin …….. 125 mg
6 053140 Lumether tablet do do
Artemether ……… 20.00 mg
Lumefantrine…… 120.00 mg
7 053136 Lungair 4 mg Sachet do do
Each chewable tablet contains
Montelukast Acid (as sodium)
………. 4 mg

registration time i.e; 10-12-2013 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1 to 7 till 30-11-2018.
d. M/s Mediate Pharmaceuticals (Pvt) Ltd Karachi.
S. Reg/No Products/Name Initial Date Application receiving

No of Reg. date
and fee submitted
date/ and due date
1 006919 Mefenemic tablet 9-3-2004 Due date (8-3-2014)
Mefenamic Acid……. 250 mg Fee of Rs. 10,000/-
deposited on 11-3-
2014. Remaining fee of
Rs/ 10,000 deposited
on 18-5-2016
2 012123 Tr.Iodine Solution do do
Each contains
Iodine……… 5 gm
Potaqssium Iodide……. 10 gm
3 012449 Benephal Capsule do do
Each Capsule contains
Cephalexin……….. 250 mg
4 012451 Lakenine Capsule do Do
Each capsule contains
Ampicillin Trihydrate eq.to
Ampicillin Base…..250 mg
5 006920 Seladrine tablet do Do
Chloroquine Phosphate eq.to
Chloroquine base……. 80 mg
6 004327 Seladrine tablet do Do
Chloroquine Phosphate250 mg
7 011342 Frusemide tablet do Do
Frusemide……….. 40 mg
8 010526 Trupentine Liniment do Do
Contains
Soft Soap……….. 75 gm
Turpentine Oil…… 650 ml
Purified water…….. 225 ml
(Fresh boiled& cooled
Camphor……….. 50 gm

9 010287 Polter past Ointment do Do
Each 400 gm contains
Heavy Kaolin……..52.7 gm
Boric Acid………….04.5 gm
Methylsalicylate…….. 00. 2ml
Thymol…………….. 50.0 mg
Pepermint Oil…… 0.05 ml
Glycerol………….. 42.5 gm
10 004488 Aspera-Co tablet do Do
Aspirin…………… 300 mg
Paracetamol……….. 200 mg
Caffeine…………. 30 mg
11 009043 Feverol Suspension do Do
Each 5ml contains
Paracetamol………… 120 mg
12 010289 Decmasil tablet do Do
Magnesium Trisilicate.. 500 mg
13 011180 Duocarte Solution do Do
Contains
Salicylic Acid…….. 16.7%
Lactic Acid………. 16.7%
14 012125 Decsazone tablet do Do
Dexamethasone……… 0.5 mg
15 012124 Aminophylline tablet do Do
Aminophylline………. 100 mg
16 006917 Dep-Roll tablet do Do
Aspirin…………. 300 mg
17 010286 Inchthazmol Glycerin do Do
Each contains
Inchthazmol Glycerin….10%/w/w
18 012448 Benaphal Capsule do Do
Cephalexin………… 500 mg
19 009352 Cetadrine tablet do Do
Ephedrine………….. 30 mg
20 009042 Anatrate Syrup do Do
Each 5ml contains
Sodium Citrate……. 37.625 Kgs
Citric Acid………. 14.200 Kgs

21 004489 Predamenium tablet 4 mg do Do
Chlorpheniramine Maleate…. 4mg
22 009044 Freshmasil Syrup do Do
Each 5ml contains
Ammonium Chloride….. 100 mg
Sodium Citrate…… 60 mg
Chlorpheniramine Maleate…… 2mg
Ephedrine HCL….. 7 mg
Menthol…………. 1 mg
23 010525 Mercurochrone Solution do Do
Contains
Mercurochrone Solution….1%/w/w
Clean Skin Lotion
Contains
Calamine………….. 15%
24 004601 Ascorbic Acid tablet do Do
Ascorbic Acid……… 50 mg
25 007032 Cake-Sea 500 tablet do Do
Ascorbic Acid……. 500 mg
26 006918 Paracetamol tablet do Do
Paracetamol ………. 500 mg
27 010524 Gentian Violate Paint do Do
Contains
Crystal Violet in water…. 0.5%/w/w
28 007033 Mad folic tablet do Do
Folic Acid………. 5 mg
29 009353 Kotria tablet do Do

Trimethoprim………. 80 mg
Sulphamethoxazole……. 400 mg
30 004328 Paracambind tablet do Do

Paracetmol ………..300 mg
Aspirin……….. 200 mg
31 010577 Clean Skin Solution do Do

Contains
Calamine………..15%

32 012450 Lakcine Capsule do Do
Ampicillin Thydrate eq.to
Ampicillin Base ……500 mg
33 006921 Sodamint tablet do Do
Sodium Bi Carbonate… 300 mg
34 004602 Kaleup tablet do Do
Calcium Lactate…… 300 mg
35 004603 Sulphadiazine tablet do do
Sulphadiazine……. 500 mg

registration time i.e; 11-03-2014 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1-35 till 08-03-2019.
e. M/s Shaheen Pharmaceuticals Swat.
S. Reg/No Products/Name Initial Date of Application receiving

No Registration date
and fee submitted date/
and due date
1 068418 Butone Elixir 2-12-2010 Due date (1-12-2015)
Each 5ml contains 3-12-2015 Fee of
Phenobarbitone…….20 mg Rs/10,000 deposited on
(shaheen Specification) 3-12-2015 remaining fee
of Rs 10,000/- deposited
on 15-2-2016

registration time i.e. 03-12-2015 with full fee, therefore Registration Board
decided to grant renewal of above product till 01-12-2020.

Registration-I
Case No.05: Request for change of manufacturer of Kefei ® Injection (Reg.No.059054) by

M/S. RG Pharmaceutical (Pvt.) Ltd, Karachi.
M/s. RG Pharmaceutical (Pvt) Ltd., Karachi had applied for change of

manufacturer/manufacturing site for their following already registered imported human product
from M/s. Guangzhou Lifetech Phrmaceutical Co. Ltd., China to M/s. Reyoung Pharmaceutical
Co., Ltd No. 06 Erlangshan Road, Yiyuan County, Shandong Province, P.R China:-
S. No. Reg. No. Name of Products.
1. 059054 KeFei ® Injection
Each vial contains:-
Levocarnitine for injection 1.0gm.
The firm have deposited required fee Rs.100,000/- and submitted following supporting
documents:-
i) Application on Form 5A.
ii) Copies of initial registration letters & renewal status.
iii) Original & legalized CoPP & GMP from China regarding new manufacturing facility.
iv) Site master plan of the manufacturer.
In 259th meeting The Registration Board observed that following points needs to be
clarified before taking decision:-
i. Brand name owner.
ii. Sole agency agreement from the new proposed manufacturer.
iii. NOC from previous manufacturer for the proposed change.
iv. Approval status by reference regulatory authorities.
The firm has submitted sole agency agreement from the new proposed manufacturer and
NOC from previous manufacturer mentioning that change of manufacturer of Kefei ® Injection
as requested above.
The availability of the drug as lypolized powder could not be confirmed in reference
countries like USA, EMA etc. Moreover, the Board observed that there is need to establish the
product license holder as in the CoPP given by the firm product license holder is mentioned for
generic name and brand name Kefei is not mentioned.
Decision: Registration Board advised to provide evidence of approval of the drug

(lyophilized form) by regulatory authorities of reference countries and also to

clarify the product license holder, who is authorized to make such request
alongwith supporting document.
Case No.06 Application for registration of drug of M/S. ICI, Karachi - remanded back
by Drug Appellate Board in its 144th Sitting.
The Appellate Board in its 144th sitting held on 22-12-2015 has, interalia, decided
to remand back the case filed by M/s. ICI, Karachi regarding rejection of transfer of registration
applications of following products:-
S. No. Reg. No. Brand Name

1 063792 Alba 10 Plus Suspension
2 075666 Alba 10 suspension
3 026563 Alba-25 suspension
4 063787 Albasan Plus 2.5 Suspension
5 069607 Alpro Suspension
6 059134 Bendol 2.5 Suspension
7 059153 Bendol 10 Suspension
8 059129 Clobendol 2.5 Suspension
9 063798 Cypercid Liquid
10 035082 Creezan suspension
11 059165 Cypermet Liquid
12 059161 Darsul Liquid
13 063559 Devotyl Liquid
14 063549 Enrolac 10 Liquid
15 075663 Enrocam Liquid
16 059113 Levanil Drench
17 075671 Motil Liquid
18 059144 Noworm Plus Suspension
19 059130 Oxanil Drench
20 063800 Oxfenox Plus Suspension
21 058800 Oxyfen S.C Drench
22 063790 Oxypro Drench
23 059124 Paranil Plus Suspension
24 059143 Paranil Gold Suspension
25 063556 Pulmopro Liquid
26 059109 Disulf Liquid
27 075656 Resporal Liquid
28 075667 Solvita-S Solution
29 002821-E Sist-Mix Drench
30 075665 Tryton suspension
31 075669 Tolzur Plus Liquid
32 075670 TY-Dox Plus Liquid
33 059107 Tenex Plus 8.75 Drench

34 057131 Toltrox Oral Solution
35 063791 Triclev 8.75 Drench
36 058780 Trisole S.C Drench
37 063563 Vorcid Suspension
38 059141 Wantox Drench
39 059110 Wantox Plus Drench
40 059103 Wantonil Plus Suspension
41 059155 Zurox Oral Solution
42 059150 Alincospectin Water Soluble Powder
43 075662 Almoxin-C Water Soluble Powder
44 075677 Avicox Water Soluble Powder
45 063555 Clarinal Powder
46 059154 Colicid Water Soluble Powder
47 063548 Colint Water Soluble Powder
48 059181 Comox Water Soluble Powder
49 059131 Cyclo-Mix 20 Premix
50 075668 Coxikil Water Soluble Powder
51 063796 Diurex Powder
52 059115 Doxityl WSP
53 059166 Doxi-Mix 50 Powder
54 063799 Etholon Powder
55 063788 Lincamox-S Water Soluble Powder
56 059159 Linco-Mix II Premix
57 075673 Macrodox Water Soluble Powder
58 059146 Neo-Stin Water Soluble Powder
59 075659 NCO-60 Water Soluble Powder
60 075660 Rapid-TD Water Soluble Powder
61 063797 Somcox Powder
62 057126 Sulfa-Vito Water Soluble Powder
63 057130 Sulzin Powder
64 075658 Super Leva Water Soluble Powder
65 075672 Super Flush Water Soluble Powder
66 059119 Trifon Powder
67 075657 Triclofon Powder
68 057129 Tydox Water Soluble Powder
69 059160 TY-Mix 10 Premix
70 049532 Ventilax Water Soluble Powder
71 059157 Vitavit-Adek Feed Premix
72 063553 Voladol Premix
73 059117 ZPS-100 Powder
74 052371 Almoxin 15% L.A Injection
75 063564 Amivit Injection
76 063551 Amcolox L.A Injection
77 059135 Amoxicure L.A Injection
78 063550 Amoxilist LA Injection

79 002820-E Bi-Sel E Injection
80 002819-E Bi-Strep Injection
81 057146 Biosign Injection
82 063552 Cal.D Lyte Injection
83 059175 Cefpro Injection
84 063557 Ceftron Injection
85 059174 Coligent Injection
86 071050 Control-CRD Injection
87 063786 Dayfos Injection
88 075654 Dimox Injection
89 059156 Diaminac Granules for Injection
90 059132 Diclonac Plus Inj.
91 059138 Dimenol Injection
92 063795 Dipyrene Plus Injection
93 059182 Dectron Injection
94 059147 Distilled Water for Injection
95 059106 Disulf Injection
96 057142 Dorvet Injection.
97 069606 Enrolac-10 Injection
98 059178 Enro-Pro10 Injection
99 059125 Flunix Injection.
100 059126 Fostel Injection
101 059136 Genton Injection 10%
102 075664 Genton 5% Injection
103 063558 Gentamix Injection
104 059151 Gencotyl Injection
105 059148 Gentrax Injection
106 059133 HIT-CRD Injection
107 059152 Ivoron Injection
108 059127 Ivoron Super Injection
109 063554 Melonac Injection
110 075652 Melonac Plus Injection
111 063794 Megaflux Injection.
112 059142 Mectin Plus Injection
113 057147 Metagen Injection
114 063547 Moxin Injection
115 059114 Onyx 50 Injection
116 075653 Oxytron LA Injection
117 059137 Onyx 100 Injection
118 059128 Onyx LA Injection
119 059149 Orasone Injection
120 075661 Oxytron 100 Injection
121 059145 OTC Forte LA Injection
122 057095 Pred Gold Injection
123 063561 Progent Injection

124 059162 Provet 40 Lac Dry Injection
125 075676 Pyraminol Injection
126 075674 Solodex Injection
127 075675 Supernova Infusion
128 059120 Spectral Injection
129 059158 Strepciben 5gm powder for Inj.
130 059176 Strepcin Injection
131 059180 Top-Vet Injection
132 059123 Triben Injection
133 057135 Triface Injection
134 057137 Tylo 2DHS Powder for Injection
135 002822-Ex Tri-Vit+ Injection
136 059108 Tylogent Injection
137 063789 Tylox-P Injection
138 059163 Tycolimet Injection
139 059173 Tylo-Pro 10 Injection
140 059177 Tylo-Pro 20 Injection
141 063793 Tryton Injection
142 075655 Tylox-20 Injection
143 059179 VAD3 Injection
144 059164 V-Sel Injection
145 057128 Variax Injection
146 063560 Vigorin Injection
147 044980 Albenda 250 Bolus
148 059104 Benvet Plus 250 Bolus
149 069605 Bendol 250 Bolus
150 059111 Bendol 500 Bolus
151 059139 Bengral Granules
152 059105 Benvet 600 Bolus
153 063562 Clovet Bolus
154 044978 Dart 350Bolus
155 059112 Deworm Bolus
156 059116 Fendamax Plus Bolus
157 059118 Nitron Bolus
178 002378-EX Oxyclozanide Super 750mg Bolus
159 059140 Paranil Bolus
160 044979 Zanisol Bolus
161 059122 Incramilk Granulated Powder
The Brief of the case presented in Registration Board meeting No. 245th held on 29-30th
September, 2014, is as under:-
M/s. ICI Pakistan Limited, Karachi had applied jointly with M/s. Breeze Pharma (Pvt)
Limited, Islamabad to the Central Licensing Board for acquisition of their license

premises situated at 125, 126, 127-A, Industrial Triangle, Kahuta Road, Islamabad, on
the basis of a registered Lease agreement, they have applied for transfer of
registrations of above mentioned 161 products from M/s. Breeze Pharma (Pvt)
Limited, Islamabad to their name and deposited an amount of Rs.3,320,000/-, as the
required fee in the DRAP account.
M/s. ICI Pakistan Limited, Karachi later informed that as the Central Licensing Board
vide its orders communicated under letter dated 4th February, 2014, decided that
instead of transfer of DML No.000659 (Formulation) M/s. ICI Pakistan Limited shall
apply for grant of fresh DML after surrendering of Licence and Inspection Book issued
to M/s. Breeze Pharma (Pvt) Limited, Islamabad, so their application for transfer of
registration has been rendered redundant and stands effectively aborted, as neither of
the parties agrees to such terms and the same would cause a drastic shortage of the
concerned drugs in the market against the spirit and requirements of the law and
relevant rules. They have therefore requested that the amount of Rs.3,320,000/-
deposited as above be refunded and returned to them to foreclose the issue.
The applications for the grant of registrations are submitted under rule 26 of the Drugs
(Licensing, Registering & Advertising) Rules, 1976. The fee is deposited under sub-
rule 3 of the rule 26. The Rule 26 (6) stats “Any Fee deposited under sub-rule (3) shall
not be refunded”. Moreover, the applications were submitted for transfer of
registration which can not be approved as the central licensing Board has not acceded
to their request.
Registration Board in its 245th meeting held on 29-30th September, 2014, after detailed
deliberations and keeping in view decision of the Central Licensing Board rejected the
applications of M/s. ICI Pakistan Limited, Karachi for transfer of registrations of 161
products from M/s. Breeze Pharma (Pvt) Limited, Islamabad to their name.
The proceedings, observation and decision of the Appellate Board is as under:-
The appellant submitted the following arguments, as already stated in their appeal that:
i. They never applied for transfer of registration. They applied for grant of
registration.
ii. Against their request for refund of fee, they received letter that the Registration
Board has rejected their applications for transfer of registration of 161 products.

iii. They were trying to acquire a running business.
iv. Sub-Rule (3) of rule 26 of the Drugs (Licensing, Registration & Advertising)
Rules, 1976, which stipulates that the fee deposited in no case be refunded, stood
omitted by SRO 662(I)/2005 dated 25-06-2005.
v. Why their application submitted in 2013 were considered while applications for
registration of January, 2011, were pending.
b. The respondents stated that the firm applied for the transfer registrations to the 161
products, which were registered in the name of Breeze Pharma (Pvt.) Ltd; to their name. Refund
is not allowed under rule 26 (6) of the Drugs (Licensing, Registration and Advertising) Rules,
1976.
c. The Board observed that:
i. No explicit decision was made by the Registration Board on the specific of the
Appellant for refund of the fee.
ii. The Appellant prematurely applied for transfer of grant of registration, as the case
may be, before the final decision on their request by the Central Licensing Board.
iii. Appeal was applied based on a decision communicated vide letter No.F.3-4/2014-
Reg-I(M-245) dated 06-11-2014, wherein their request for transfer of registration
of 161 products from M/s. Breeze Pharma (Pvt.) Ltd; Islamabad to their name was
rejected. But the Appellant was contesting their request of refund instead of
rejection of their request for transfer.
Decision of Appellate Board:-
In light of the above, the Board decided to remand back the case to Registration Board
for precise and specific decision on the request of the Appellant for refund of their fee. The
Registration Board in its 259th meeting deferred the case for having clear rule positions
particularly with reference to issue of refund of registration fee.
The applications for the grant of registrations are submitted under Rule 26 of the Drugs
(Licensing, Registering & Advertising) Rules, 1976. Earlier, the fee was deposited under Sub-
rule 3 of the Rule 26 which specify registration fees to be submitted. The Sub-rule 3, however,
was omitted vide SRO 662(I)/2005 dated 25-06-2005, while the Sub-rule 6 of Rule 26, which
states that “Any Fee deposited under sub-rule (3) shall not be refunded”, is intact.
Decision: Registration Board observed that sub-rule 3 of Rule 26 of Drugs (Licensing,

Registering & Advertising) Rule 1976 can not be read in isolation. Sub-rule 3
is an integral part of Rule 26 and also referred in sub-rule 3(b). When sub-
rule 3 was omitted, a consequential amendment was to be made in sub-rule 6
where the reference of sub-rule 3 should have been substituted with the
reference to sub-rule 3(b). This consequentianal amendment was not carried
out which is very nominal consequential omission and does not render the
contents of sub-rule(6) in-effective. Therefore, the fee is not to be refunded as
the applications have already been rejected by Registration Board.

Case No.07: Show cause notices issued to the firms having registration of products
containing Ciprofloxacin for veterinary use.
The Registration Board in its 249th meeting had decided to issue show cause
notices for cancellation of all the drug formulation having Ciprofloxacin for veterinary use for
the reason of development of resistance in human. Accordingly show cause notices were issued
to the firms having registrations of aforementioned drug formulations. A number of firms have
responded with their point of view including request for personal hearings.
The case was placed before the Registration Board in its 257th meeting and the Board
directed to place comments of all firms / stake holders before the Board in its next meeting.
Accordingly the responses of the firms are being placed before the Board. The salient points, of
the responses received are summarized as under:-
i) The Board may considered taking legal measures to avert unnecessary use and
ensuring compliance of withdrawal period after treatment.
ii) Opinion of technical expert/veterinary expert committee may be taken before
making any decision in this regard.
iii) Transfer of drug resistance from animal bacteria to human bacteria is not reported
strongly.
iv) Putting ban on over the counter sale of such antibiotic.
v) Under Section 7 (11) of Drugs Act, 1976, detail of the, information or enquiry
conducted or comprehensive data/record/documents, on the basis of which the
decision was taken, may be communicated for response.
vi) A few firms also agreed to withdraw and requested for grant of registration of
other products.
vii) Most of the firm requested for opportunity for personal hearing.
Registration Board deferred the case in its 258th meeting due to paucity of time. The case
was again taken by in its 259th meeting held on 30th -31st May, 2016 and the Board decided to call
the firm's having registration of such products for personal hearing.
Notices for personal hearing to the firms have been issued.
Decision: Representatives of M/s. Tarobina Corporation, SB Pharma, Bio Labs,

Vetcon Pharmaceuticals, Attabak Pharmaceuticals, Cheris Pharma, and
Grand Pharma appeared before the Board. The firm representatives were of
the view that there is need together credible scientific data for establishing
the claim of development of resistance in human due to veterinary use of
ciprofloxacin. However, firm’s representatives agreed to proposal of de-

registration as the drug is not used in veterinary practices in reference
countries. They further requested that in order to save from financial losses
may be given sufficient time to liquidate the existing stocks and substitute
registration of another product may be given to them on priority. Keepining
in view above discussion, the Board in princiale agreed to de-register all the
products having Ciprofloxacin for veterinary use. However modalities for
implementation to this effect will be further deliberated in forthcoming
meeting.
Case No.08: Request for Registration of Drug(s) under Drug Act, 1976 by M/s. Unicare
Enterprises, Faisalabad.
The Registration Board in its 237th meeting held on 26-02-2013 constituted a sub-
committee for evaluation of applications of veterinary product for ensuring completion of codal
formalities. The Board further authorized Chairman, Registration Board for taking decision on
recommendations of the committee.
The sub-committee in its meeting held on 25-04-2013 approved the following products of M/s.
Unicare Enterprises, Faisalabad, manufactured by M/s. Laboratorios Karizoo S.A. Caldes De Montbui,
Barcelona, Spain, subject to inspection of manufacturer abroad, verification of storage facilities as per
policy:-
S. No. Name of Drug(s) Demanded Demanded

Pack sizes Shelf life
1. Lincosol 40% Oral Powder Decontrolled 03 years
Each gm contains:- 100gm
Lincomycin (as lincomycin 500gm
hydrochloride)…………400mg 1 Kg
(Antimicrobial). 2.5 Kg
5 Kg
10 Kg
2. Kariflox 10% Oral Solution Decontrolled 03 years
Each ml contains:- 1 Liter
Enrofloxacin…100mg/ml solution 5 Liter
(Antimicrobial). 10 Liter
25 Liter
3. Amoxicilina 500 Karizoo Decontrolled 02 years
Each gm contains:- 200gm
Amoxicillin Trihydrate….500mg 400gm
(Antimicrobial). 1 Kg
2.5 Kg
5 Kg
10 Kg

The firm has deposited fee of Rs. 1,00,000/- per product. The storage facility of the
importer has already been verified by the Area FID and as per new Import Policy of Medicine,
the product approved by regulatory authorities of Western European counties including Spain
may be exempted from inspection of manufacturing facilities.
While processing M/s. Unicare Enterprises, Faisalabad request for issuance of registration letter
of above drugs, it was noted that the pack sizes mentioned on CoPP are as under:-
Lincosol 40% Oral Powder 100gm, 1Kg

Kariflox 10% Oral Solution No pack size mentioned
Amoxicilina 500 Karizoo 200gm, 400gm & 1Kg
While the firm has demanded no of pack sizes which are not included in the CoPP of
exporting country.
The case was considered in 259th meeting of the Registration Board and the Board
decided as under:-
a. Approved the pack size of the products which are already mentioned in their CoPP.
b. For pack sizes not mentioned in the CoPP, the Board deferred the case for further
deliberation.
With reference to Kariflox 10% Oral Solution the firm has now submitted a copy of
Summary of Products Characteristics (SPC) which it claims to be part of CoPP. As per clause 6
of SPC the packs sizes of 250ml, 1 Liter 5 Liter are mentioned. The firm has requested to grant
them the same packing.
Decision: Registration Board decided as under:-

i. For the product Kariflox 10% Oral Solution, the pack size mentioned
in SMPC i.e. 250ml, 1 liter and 5 liters is approved.
ii. It was also decided that in future the pack size approved by the
reference regulatory authority, or those approved by the regulatory
authority of exporting country as mentioned in CoPP, SMPC shall be
considered for approval.

Case No.09: Request for Registration of Surgical Sutures by M/S. Zenith
International, Karachi.
Registration Board in its 243rd meeting deferred following products for expert opinion.
1. M/s. Zenith “Trugut” Chromic Catgut As per PRC 05 Rs.15000 +

International, (Absorbable Surgical Suture years
Karachi. / U.S.P) (With or Without Rs.85000 =
Needle) (All sizes) Rs.100000/-
Manufactured by
M/s. Sutures (Surgical Suture).
India (Pvt) Ltd.
Bangalore, India.
The product, however, was not sent for expert opinion as the firm did not provide the EC
certificate. The firm subsequently claimed that EC Authority do not issue CE certificate to any
manufacturer for Chromic Catgut since several years. They further claimed that their principal is
exporting this product to USA. The Board in 254th meeting, while considering the case, advised
that the firm should provide an appropriate certificate from the concerned regulatory authority as
evidence of it’s free sale.
The firm later provided a legalized and attested free sale certificate issued by Indian
authorities. The case was considered in the 259 th meeting the Registration Board and the Board
deferred the case for confirmation of importability from India as per Import Policy Order, 2106.
The product is not included in the list of items not importable from India.
Decision: Registration Board decided to defer the case for ascertaining the approval
status by reference regulatory authorities. Moreover, the sizes also need to be
specified and clarification is required with regards to differentiation of the
sutures with needle and without needle.
Case No.10: Deferred drugs for expert opinion regarding for the use of formulation of
phenylbutazone.
Registration Board in its 257th meeting held on 24-25th March, 2016 deferred following
case for taking expert opinion of veterinary experts regarding use of the formulation in veterinary
practice.

S. No Name of Name of Drug (s) Demanded Shelf
Manufacturer Composition & Life
Therapeutic Group. Price &
Pack Size.
1. M/s Prix Pri-Phen 20 Injection 50ml 02
Pharmaceutica years
(Pvt) Ltd. Plot # Each ml injection contains:-
5 Pharmacity, 30- Phenylbutazone.…….200mg
Km Multan
(NSAID)
Road, Lahore.
The opinion of the experts is as under:-
Prof. Dr. M. Shoaib Akhtar, Prof. Dr. Muhammad Ashraf Brig (R). Dr.
Professor of Pharmacology, (T.I), Muzammil Hasan
Faculty of Pharmacy, Najmi,
University of Sargodha. Professor of Emeritus, Associate Dean,
Basic Sciences
Department of Pharmacology
Division, Foundation
and Toxicology,
University Medical
University of Veterinary College, Rawalpindi.
Animal Sciences, Lahore.
According to the published i) Phenylbutazone is a Awaited.

literature Phenylbutazone has nonsteroidal anti-
been one of the earliest inflammatory drug with
NSAIDS approved for use in same indications as
horses and dogs for the relief of other NSAIDs.
the relief of inflammatory ii) In veterinary practice
conditions associated with the it is quite effective and
musculoskeletal system. It is is commonly used in
available in the form of tablet, horses.
paste gel and parenteral iii) FDA also has
(injectable) formulations. approved its
However, there is no preparations for use in
Phenylbutazone product for Horses and Dogs.
approved use in food animals in iv) The drug is not for
USA. But it can be used as use in
extra label drug in dairy cattle cattle/buffalo/sheep/
as well in less than 20 months goat as zero tolerance
old animals. policy in meat/milk/eggs
Therefore, keeping in view the due to chances/ problem
literature attached, I feel like of lethal idiosyncrative
recommending the use of this agranulocytosis by

drug formulation (Pri-Phen 20 Phenylbutazone reported
Injection) use in veterinary in human.
practice, especially in equines, v) Phenylbutazone is
cats and dogs. However, when banned for use in any
used in food producing species, animal intended for
the withdrawal time periods human consumption
must be taken care due to the because it causes serious
toxicity problems associated and lethal idiosyncratic
with the drug residues. adverse effects in
human.
vi) Effect of
Phenylbutazone is bone-
marrow toxicity, leading
to agranulocytosis.
vii) Product "Pri-Phen
20 Injection" may be
approved for use in
equines and dogs only.
The Registration Board deferred the case in its 259th meeting for confirmation of approval
status by reference regulatory authorities.
As per information available on the website Phenylbutazone is not permitted for use in
food producing animals by USFDA and EMA.
Decision: Registration Board, in view of the expert opinion and status of use of
phenylbutazone in reference regulatories authorities decided as under:-
i. Rejected the application of Pri-Phen 20 Injection as drug is not
recommended for use in food producing animals.
ii. Issue show cause notices to all registered veterinary drug formulation
containing phenylbutazone.
Case No.11: Import of Phenylbutazone by M/S. International Pharma Labs. Lahore for
manufacturing of already registered drugs.
M/s. International Pharma Labs. Lahore has informed that their imported consignment of
Phenylbutazone raw material for manufacturer of their registered drug Phenylbutazone Injection
(Registration No.041231) has been withheld by the Assistant Drugs Controller, Lahore office

with the advise to get clarification from DRAP on whether use of Phenylbutazone in veterinary
product has been discontinued or not. The firm has requested for necessary clarification.
As per record of this office no formal instruction has been issued for discontinuation of
Phenylbutazone for veterinary use. However, the product is under review by the Registration
Board alongwith number of other veterinary drugs but, so far, no decision has been taken.
Since 218th meeting held 2009, the Registration Board used to refer the cases of
combinations, containing Phenylbutazone, to the Veterinary Expert Committee. As per available
record of VEC meetings (74th to 76th meeting) no recommendations were finalized.
The Registration Board in its 259th meeting deferred the case till decision of preceding case.
Decision:- Registration Board decided to defer the case till finalization of under
consideration issue of the registration of phenylbutazone containing
products.
Case No.12: Lack of interest for getting registration of approved oncology products by
M/S. Novartis Pharma, Karachi.
The Registration Board in its 236th meeting held on 20th November, 2012
approved the registration of following imported drugs in the name of M/s. Novartis Pharma
(Pakista) Limited, Karachi Manufactured by firm as mentioned in column II subject to inspection
of manufacturer abroad, verification of storage facilities and price fixation / calculation etc, as
per policy:-
S. No. Name of applicant & Name of Drug(s) Demanded Shelf Remarks

Manufacturer Price life
1. M/s. Novartis Pharma Oxaliplatin “Ebewe” Rs.30000/ Per 03 Rs.28,500/ Per vial
(Pakistan) Limited, 150mg Injection vial years
Karachi. / Each vial contains:- 7th DPC (DRAP)
M/s. Ebewe Pharma Oxaliplatin…150mg Complete address
Ges.m.b.H. Nfg. KG (Anticancer). of the manufacturer
MondseestraBe has been mentioned
Unterach, Austria. on registration letter
as per CoPP.

2. M/s. Novartis Pharma Neoflubin 50mg/2ml Rs.13262.70/1’ 03 Rs.9280.00/1’s
(Pakistan) Limited, injection s years
Karachi./ Each vial contains:- 14th DPC
M/s. Ebewe Pharma Fludarabine Complete address
Ges.m.b.H. Nfg KG Phosphate……50mg/2ml of the manufacturer
Unterach, Austria. (Anticancer). has been mentioned
on registration letter
as per CoPP.
3. M/s. Novartis Pharma Ebetrexat 2.5mg Tablets Rs.403.43/Per 03 The firm is not
(Pakistan) Limited, Each tablet contains:- 30’s years interested in the
Karachi./ Methotrexate registration.
M/s. Salutas Pharma Disodium….2.75mg
GmbH, Otto-von- (equivalent to 2.5mg
Guericke, Germany. Methotrexate)
License Holder:- (Anticancer Specialty)
M/s. Hexal AG,
Holzkirchen,
Germany.
4. M/s. Novartis Pharma Folcium 50mg/5ml Rs.1171.98/1’s 02 -do-

(Pakistan) Ltd, Injection years
Karachi. / Each 5ml ampoule
M/s. Ebewe Pharma contains: -
Ges.m.b.H Nfg. KG Folinic Acid as Calcium
MondseestraBe 11 Folinate......50mg.
AT-4866 Unterach
Austria. (Anticancer) not by FDA
& EMA

Karachi. / Each 10ml vial contains: -
M/s. Ebewe Pharma Folinic Acid as Calcium
Ges.m.b.H Nfg. KG Folinate......100mg.
MondseestraBe 11 (Anticancer Adjuvants)
AT-4866 Unterach
Austria.

Karachi. / Each 30ml vial contains: -
M/s. Ebewe Pharma Folinic Acid as Calcium
Ges.m.b.H Nfg. KG Folinate......300mg.
MondseestraBe 11 (Anticancer)
AT-4866 Unterach
Austria.
The firm later informed that they are only interested in registration of products at Sr. 1 &
2 above, and are not interested in the rest of the products.
Accordingly the registration letter of above 02 products have been issued, while the firms
intention for not getting registration of rest of the above products is submitted for consideration
of the Registration Board.
Decision:- As the product are important anti-cancer drugs, so the Board decided to ask
firm the reason / clarification for withdrawing registration of these products.
Case No.13: Request For Change Of Manufacturer Of Clipper Tablet (Reg.No.066104) By

M/S. Chiesi Pharmaceutical (Pvt.) Ltd, Lahore.
M/s. Chiesi Pharmaceuticals (Pvt.) Ltd; Lahore has applied for change of
manufacturer/manufacturing site for their following already registered imported human products,
as per details given below:-
S. Reg. No. Name of Products. Existing Approved New proposed site
No. sites
1. 066104 Clipper Tablets M/s. Chiesi M/s. DOPPLE
Each tablet contains:- Farmaceutici S.p.A, FARMACEUTICI
Beclomethasone Italy. S.R.L. con
Dipropionate ………. 5mg stabilimento sito in
VIA MARTIRI
DELLE FOIBE, 1-
29016
CORTEMAGGIORE
(PC) ITALIA.
The firm have deposited required fee of Rs.100, 000/- (Pages 60-61 & 83-84/Corr) and
submitted following supporting documents:-
ii) Copies of initial registration letter and the firm had applied within the validity of
registration on 21-06-2011.

iii) Fresh original & legalized CoPP from authorities of Italy for proposed
manufacturing site (Pages 100-102/Corr).
The firm have deposited required fee of Rs.100, 000/- and submitted following supporting
documents:-
ii) Copies of initial registration letter and the firm had applied within the validity of
registration on 21-06-2011.
iii) Fresh original & legalized CoPP from authorities of Italy for proposed
manufacturing site.
Decision: Registration Board deferred for confirmation of approval status in of

formulation by regulatory authorities of reference countries.
Case No.14 Request for change of manufacturer of Seroxat Tablet 20mg (Reg.No.
019501) by M/s. GlaxoSmithKline Pakistan Limited, Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi has applied for change of

manufacturer/manufacturing site for their following already registered imported human products,
as per details given below:-
S. No. Reg. No. Name of Products. Existing Approved New proposed site
sites
1. 019501 Seroxat Tablet 20mg M/s. S.C. Product License
Each tablet contains:- Europharma S.A. holder / marketing
Paroxetine HCl …… 20mg Brasov Romania. authorization
holder:
M/s. Smithkline
Beecham Limited,
980 Great West
Road, Brentford,
Middlesex, TW8
9GS, United
Kingdom.
Manufacturer
/Packagers:
M/s.
Glaxosmithkline
Pharmaceuticals
S.A. Ulica
Grunwaldzka 189,
Poznan, PL-60-322,
Poland.

The firm have deposited required fee of Rs.100, 000/- and submitted following
supporting documents:-
ii) Copies of initial registration letters & renewal status. (265-270/Corr).
iii) Original & legalized CoPP from Medicine and Healthcare Products Regulatory
Agency of UK for proposed manufacturing site (Pages 272-297/Corr).
The firm have deposited required fee of Rs.100, 000/- and submitted following supporting
documents:-
ii) Copies of initial registration letters & renewal status.
iii) Original & legalized CoPP from Medicine and Healthcare Products Regulatory
Agency of UK for proposed manufacturing site.
Decision:- Registration Board approved change of manufacturing site and product

license holder of Seroxat Tablet 20mg (Reg.No. 019501) as under:-
Product License holder:
M/s. Smithkline Beecham Limited, 980 Great West Road, Brentford,
Middlesex, TW8 9GS, United Kingdom.
Manufacturer & Packagers:
M/s. Glaxosmithkline Pharmaceuticals S.A. Ulica Grunwaldzka 189, Poznan,
PL-60-322, Poland.
Case No. 15. Request of M/S. CCL Pharmaceuticals (Pvt.) Ltd., Lahore for change of
manufacturing sites of their registered drug(s).
M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore have requested to approve the change of
manufacturing site of their following registered imported anti-cancer products form M/s. Laboratorios
IMA S.A.I.C (Palpa 2870, CABA) Argentina to M/s. Glenmark Generics S.A. Calle 9 Ing Meyer Oks N° 593
(B1629MAX) Parque Industrial Pilar, Buenos Aires, Argentina:-
S. No. Reg. No. Name of drug(s) & Composition.

1. 044851 Toxiplatin 150mg Injection
Carboplatin ……….150mg
2. 044852 Toxiplatin 450mg Injection
Carboplatin ……….450mg
3. 052286 Cytotecan Injection 40mg
Each 2ml vial contains:-
Irinotecan Hydrochloride Trihydrate 40mg

M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore have deposited fee Rs.50,000 + 50,000 =
3,00,000/- and submitted following supporting documents:-
i) Copies of initial registration letters.

ii) Copy of change of manufacturer name from M/s. Servycal S.A., Argentina to
M/s. Glenmark Generics S.A., Argentina.
iii) Copies of last renewal.
iv) Original and legalized approval from regulatory authority of Argentina.
v) Copy of GMP Certificate.
vi) Original & Legalized Certificate of Pharmaceutical Products.
vii) Applications on Form 5-A.
viii) Credentials of the Manufacturer.
ix) Site Master File.
x) Copy of NOC for CRF.
M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore initially submitted Rs.50, 000/ per
products claiming that these are not available locally. However, later the firm has submitted the
balance fee Rs.50, 000/- per products also.
Decision: As the proposed change has been approved by the regulatory authority of
exporting countries, so the Board approved change of manufacturing site of
above products from M/s. Laboratorios IMA S.A.I.C (Palpa 2870, CABA)
Argentina to M/s. Glenmark Generics S.A. Calle 9 Ing Meyer Oks N° 593
(B1629MAX) Parque Industrial Pilar, Buenos Aires, Argentina subject to
inspection of manufacturer abroad as per policy on same terms & condition.
Case No.16: Request of M/s. Ghazi Brothers, Karachi for change of name of
manufacturer/manufacturing sites of their registered drug(s).
M/s. Ghazi Brothers, Karachi has applied for change of name of manufacturers for their
following already registered products as under:-
S. Reg. Name of Existing Name Requested changes
No. No. Drugs/Composition
1. 046647 Neomix 325 Soluble M/s. Pfizer Suzhou M/s. Zoetis Suzhou
Powder Animal Health Manufacturing Co.
Each gm contains:- Products Co. Ltd., Ltd., No.180 Zhu
Neomycin China. Yuan Road, Suzhou
Sulphate…….715mg New District,
(equivalent to Jiangsu, China.
Neomycin base
500mg)

2. 044992 Excede Injectable M/s. Pharmacia & M/s. Zoetis Inc.
Each ml contains:- Upjohn Company, 2605 East Kilgore
Ceftiofur crystalline Subsidiary of Pfizer Road, Kalamazoo,
free acid equivalent Inc. USA. Michigan, 49007,
to 200mcg Ceftiofur USA.
in a Miglyol and
cottonseed oil based
suspension
The firm has further requested for change of manufacturing site of their registered products
Draxxin Injection as per following details:-
S. Reg. Name of Existing Source Requested/proposed

No. No. Drugs/Composition changes
1. 044919 Draxxin Injection M/s. Pfizer Global M/s. Laboratorios
Each ml contains:- Manufacturing, Pfizer Ltda
Tulathromycin….100mg France. Guarulhos, Avenida
Monothioglycerol…5mg Presidente Tancredo
de Almeida Neves,
1555 Guarulhos, SP
P.P. Box 017112-
070 Brazil.
The firm have deposited required fee Rs.100,000 x 3 = Rs.300,000/- and submitted following
supporting documents:-
i) Application on Form-5A.
ii) Copies of initial registration letters.
iii) Copies to renewal status.
iv) Original & Legalized CoPP's for Neomix 325 Soluble Powder (China), for Excede
Injectable (USA) for Draxxin 100mg injection (Brazil)
v) Copy of GMP Certificate for Neomix 325 Soluble Powder) for Excede Injectable &
for Draxxin 100mg injection.
vi) NOC for (Draxxin 100mg Injection).
vii) Site master plans of concerned firms (Draxxin 100mg injection).
Decision: Registration Board decided as under:-

i. For Neomix 325 Soluble (Reg.No.046647), approved change of the name
of manufacturer from M/s. Pfizer Suzhou Animal Health Products Co.
Ltd., China to M/s. Zoetis Suzhou Manufacturing Co. Ltd., No.180 Zhu
Yuan Road, Suzhou New District, Jiangsu, China on same terms &
conditions.
ii. For Excede Injectable (Reg.No. 044992), approved change of the name
of manufacturer from M/s. Pharmacia & Upjohn Company, Subsidiary

of Pfizer Inc. USA to M/s. Zoetis Inc. 2605 East Kilgore Road,
Kalamazoo, Michigan, 49007, USA on same terms & conditions.
iii. For Draxxin Injection (Reg.No. 044919), approved the change of

manufacturing site from M/s. Pfizer Global Manufacturing, France to
M/s. Laboratorios Pfizer Ltda Guarulhos, Avenida Presidente Tancredo
de Almeida Neves, 1555 Guarulhos, SP P.P. Box 017112-070 Brazil
subject to inspection of manufacturer abroad on same terms &
conditions.

Registration-IV
Case No.17: Registration of Drugs For Export Purpose.
The following firm has applied for registration of drugs for the purpose of export only:-
S. # Name of Name of Drug (s)/Composition.

Manufacturer
1 M/s. Fassgen Valdis Tablets
Pharmaceuticals, Each film coated tablet contains:-
Hattar Ledipasvir…………………90mg
Sofosbuvir……………….400mg
The firm submitted all the relevant documents along with the fee of Rs.20,000/- per
product and requested for registration of drugs for export purpose only.
Decision: Registration Board approved above product for export registration.

However firm will deposit remaining balance Fee of Rs. 30,000/- and
Chairman, Registration Board will permit issuance of registration letter.
Registration is subject to following conditions:
 Manufacturer will export the product after complying all the

requirements as required under Drug Act, 1976 and relevant rules
including No objection certificate from concerned DRAP office.
 Manufacturer will also furnish export documents endorsed from custom
authorities (if required for any query) in order to ensure the export of the
product.
Case No.18: Request of M/s. Welmed Pharmaceuticals Gadoon for extension in contract
manufacturing permission.
Registration Board in 254th meeting deferred following application of M/s. Welmed

Pharmaceuticals Gadoon Swabi for extension of contract manufacturing period (where contract
manufacturer was also changed) for confirmation of already extended contract manufacturing
permissions.

S.No Name of Existing Reg.No Name of Product Date of Remarks
Applicant manufacturer applicatio
ns/Fee
1. M/s. Welmed M/s. 056233 W-Pime 500mg Injection 30-06-2015 30-06-2015
Pharmaceutical Welmark Each vial contains:- Dy No.66 Firm has
Gadoon Swabi. Hattar Cefipime….500 mg Rs.50,000/- requested
(USP Specification) for
change of
contract
manufacturer
to Bio-Lab
(Pvt) Ltd.,
Islamabad
2. -do- -do- 056234 W-Pime 1 gm Injection 30-06-2015 -do-

Each vial contains:- Dy No.69
Cefipime…………1 gm Rs.50,000/-
(USP Specification)
3. -do- -do- 056238 Mectrum 1gm Injection 30-06-2015 -do-

Cefoperazone Sodium Rs.50,000/-
≡ Cefoperazone.500 mg
Sulbactam …….500mg
(Welmark Specification)
4. -do- -do- 056239 Mectrum 2 gm Injection 30-06-2015 -do-

Cefoperazone Sodium Rs.50,000/-
≡ Cefoperazone.1000 mg
Sulbactam ….1000mg
(Welmark Specification)
The firm subsequently requested that they would like to exclude the products Medifotax
Injection 500mg & 1gm, contract manufacturing permission for which has already been given
from M/s. Mediate Pharmaceuticals, Karachi and they may be granted extension/change of
manufacturer permission of above products instead. The case was considered in 258 th meeting
and deferred on the ground that the firm has not made any specific request for withdrawal /
cancellation of their products Medifotax Injection (500mg & 1gm), so matter needs to be
clarified from the firm. The case is accordingly deferred.
Now the firm stated to cancel the registration of Medfotax Injection (Cefotaxime 500mg,

1gm) (Reg.No. 056228, 056229) and issue the extension letter of above mentioned drugs.
The firm has only two Sections and it, therefore, entitles to contract manufacturing of 10
products as per policy of 5 products per section. So far the firm has been granted registration of 8
products.
Decision: Registration Board did not agree to the firm’s proposal for withdrawal /
cancellation of their already registered two products for making way to get
the approval of fresh one as replacement. The Board further decided to allow
permission for extension of contract manufacturing alongwith change of
manufacturer (from M/s. Wnsfeild Pharmaceuticals Hattar to M/s. Bio-Labs,
Islamabad) for only two of the above mentioned products of firm choice till
30.06.2020. The Chairman Board was authorized to allow issuance of
permission letter after taking firm’s choice for the products.
Case No.19: Registration of Frodine Syrup.
Registration Board in 243rd meeting held on 9th May, 2014 deferred following drug of
M/s. Wisdom Pharmaceuticals, Peshawar for confirmation of controlled drug section and
international availability of the product
M/s. Wisdom Frodine Syrup

1 Pharmaceuticals, Each 5ml contains:-
Peshawar Pholcodine……………….….5mg
Chlorpheniramine Maleate…..2mg
Registration Board in 250th meeting considered the comments of review committee and
decided as under:-
International availability Remarks
BRONCALENE ADULTES Chlorphénamine (maléate de) ;

chlorphénamine (maléate de) ; pholcodine
pholcodine Adults:
0,01300g/100 ml (0.65mg/5ml); Dose: 0.01300g/100 ml (0.65mg/5ml);
0,08g/100ml (4mg/5ml) 0.08g/100ml (4mg/5ml)
Oral Syrup 0.0133gm/100ml (0.665mg/5ml);
0.08g/100ml (4mg/5ml) (sugar free
sweetened with saccharine sodium)
Children: 0.01gm/100ml (0.5mg/5ml);
0.05g/100ml (2.5mg/5ml)
(Ref: ANSM France)

Decision of 250th Registration Board meeting :
i. Applicants shall shift their formulation as per formulation approved in ANSM France (new
registration application with complete fee) if manufacturing facility is approved by CLB.
ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be
adopted.Otherwise show cause notices shall be issued for deregistration of drugs in this
formulation.
iii. All such application shall be processed on priority basis.
Now M/s. Wisdom Pharmaceuticals Peshawar has made an application with the revised
formulation alongwith complete fee of Rs.20000/- . The revised formulation is as under:-
1 M/s. Wisdom Frodine Syrup

Pharmaceuticals, Each 5ml contains:-
Peshawar Pholcodine……………….….4mg
Chlorpheniramine Maleate…..0.65mg
Decision: Registration Board decided to approve the change in formulation of Frodine

Syrup in accordance with the revised standard formulation.
Case No.20: Request of firms for issuance of registration of deferred drugs.
The following registration applications of various firms were deferred by Registration

Board meetings in its 234th meeting for the reason mentioned against each.
1. M/s. Winbrain Razole 20mg Tablets 10’s As Per Deferred as per policy of 5
Research Each tablet contains:- SRO products per section for new
Laboratories, Omeprazole…….20mg license/new section (product is
Hattar (Proton Pump recommended by the me-too
1. Tablet General Inhibitor) committee)
2. Caps
General,
3. Dry powder
Susp General
2. -do- Diclo-K 50mg Tablets 2x10’ As Per Deferred as per policy of 5

Each tablet contains:- s SRO products per section for new

Diclofenac license/new section (product is
Potassium……50mg recommended by the me-too
(Analgesic) committee)
3. -do- Diclo-K 75mg Tablets 2x10’ As Per Deferred as per policy of 5

Each tablet contains:- s SRO products per section for new
Diclofenac license/new section (product is
Potassium……75mg recommended by the me-too
committee)
4. -do- Pepzole 40mg Tablets 14’s As Per Deferred as per policy of 5
Each tablet contains:- SRO products per section for new
Pantoprazole (as license/new section (product is
Sodium Sesquihydrate) recommended by the me-too
…40mg committee)
5. -do- Lodepress 20mg 10’s As Per Deferred as per policy of 5

Tablets SRO products per section for new
Each tablet contains:- license/new section (product is
Paroxetine as recommended by the me-too
HCl…..20mg committee)
(Antidepressant)
6. -do- Am-Telma 5/40mg 14’s As Per Deferred as per policy of 5
tablets SRO products per section for new
Each tablet contains:- license/new section (product is
Amlodipine………5mg recommended by the me-too
Telmisartan……..40mg committee)
(Antihypertensive)
7. -do- Loxit 60mg Capsules 10’s As Per Deferred as per policy of 5

Each capsule contains:- 14’s SRO products per section for new
Duloxetine as license/new section (product is
HCl….60mg recommended by the me-too
(Antidepressant) committee)
8. -do- Gabapen 300mg 10’s As Per Deferred as per policy of 5
Capsules SRO products per section for new
Each capsule contains:- license/new section (product is
Gabapentin……100mg recommended by the me-too
(Anticonvulsant) committee)
9. M/s. Weather G-Pentin 300mg 10’s -do- Deferred as per policy of 5
Folds Capsule products per section for new
Pharmaceuticals, Each capsule contains: - license/new section (product is
Hattar Gabapentin …… 300mg recommended by the me-too
1. Dry powder (Analgesic) committee)
Susp General,
2. Caps, General
10. -do- Effexor 75mg Capsule 10’s -do- Deferred as per policy of 5

Each capsule contains:- products per section for new
Venlafaxine HCl 75mg license/new section (product is
(Psychotherapeutic) recommended by the me-too
committee)
11. -do- Tizadine 6mg Capsule 10’s -do- Deferred as per policy of 5
Tizanidine …….. 6mg license/new section (product is
(Muscle relaxants) recommended by the me-too
committee)
12. -do- Helcobal 500mcg 10’s -do-` Deferred as per policy of 5
Capsule 10x1 products per section for new
Each capsule contains:- 0’s license/new section (product is
Mecobalamine. 500mcg recommended by the me-too
(Coenzyme-type vitamin committee)
B12)
13. -do- Floxapen 250mg 10’s -do- Deferred as per policy of 5

Capsule products per section for new
Flucloxacilline .. 250mg recommended by the me-too
(Pencillin) committee)
14. -do- D-Lox 30mg Capsules 14’s As Per Approved
Each capsule contains:- SRO
Duloxetine as
HCl.30mg
(Antidepressant)
15. -do- D-Lox 60mg Capsules 10’s As Per Deferred as per policy of 5
Each capsule contains:- 14’s SRO products per section for new
Duloxetine as license/new section. (product is
HCl.60mg recommended by the me-too
(Antidepressant) committee)
16. -do- Artham DS Capsule 8’s -do- Deferred as per policy of 5

Artemether …… 40mg license/new section (product is
Lumefantrine ….. recommended by the me-too
240mg committee)
(Anti-malarial)
17. -do- Ciprofold 250mg 10’s -do- Deferred as per policy of 5
Capsule products per section for new
Ciprofloxacin as HCl. recommended by the me-too
250mg committee)
(Anti infective
Quinolones)
18. -do- Tranxam 500mg Not -do- Deferred as per policy of 5

Capsule menti products per section for new
Each capsule contains:- oned license/new section (product is
Tranexamic acid.. recommended by the me-too
500mg committee)
19. -do- Tranxam 250mg Not -do- Deferred as per policy of 5

Capsule menti products per section for new
Each capsule contains:- oned license/new section (product is
Tranexamic acid.. recommended by the me-too
250mg committee)
(Antifibrinolytic)
20. -do- P-Zole 40mg Capsule 14’s -do- Deferred as per policy of 5
Pantoprazole…… 40mg license/new section (product is
(Antipeptic ulcerants) recommended by the me-too
committee)
21. M/s. Welwrd Artiwel 280mg Tablets 8’s As Per Deferred as per policy of 5
Pharmaceuticals, Each tablet contains:- SRO products per section for new
Hattar Artemether……….40m license/new section (product is
1. Dry Powder g recommended by the me-too
Inj. Sterile Lumefantrine…… committee)
2. Tablet General 240mg
3. Capsule (Antimalarial)
General
4. Dry Powder
Suspension
General
5. Sachet
General
22. -do- Estowel 10mg Tablets 10’s As Per Deferred as per policy of 5
Each tablet contains:- 14’s SRO products per section for new
Escitalopram (as license/new section (product is
oxalate).10mg recommended by the me
(Anti Psychotic)
23. -do- Weldiclof 100mg SR 2x10’ As Per Deferred as per policy of 5

Tablets s SRO products per section for new
Each film coated tablet license/new section (product is
contains:- recommended by the me-too
Diclofenac SR committee)
…..100mg
(NSAID)
24. -do- Lansowel 30mg 14’s As Per Approved with fulfillment of

Capsules SRO requirements of source, GMP

Each capsule contains:- certificate, stability data and
Lansoprazole Pellets Fee. Rs.15000/-
equivalent to
Lansoprazole…30mg
(Proton Pump Inhibitor
25. -do- W-Pentone Injection Per As Per Highly sensitive product.

Each vial contains:- vial SRO Product specific inspection is
Thiopentone recommended by the experts.
Sodium ..5.00mg
(Anesthetic agent)
26. -do- Zimtac 250mg Injection Per As Per Deferred as per policy of 5
I.V vial SRO products per section for new
Each vial contains:- license/new section (product is
Cefotaxime sodium recommended by the me-too
equivalent to committee)
Cefotaxime……..250mg
(Cephalosporin)
27. -do- Zimtac 500mg Injection Per As Per Deferred as per policy of 5
Cefotaxime……..500mg
(Cephalosporin)
28. -do- Zimtac 1gm Injection Per As Per Deferred as per policy of 5
Cefotaxime……..1gm
(Cephalosporin)
29. -do- Weltraxone 250mg Per As Per Deferred as per policy of 5

Injection IV vial SRO products per section for new
Ceftriaxone Sodium recommended by the me-too
Ceftriaxone ……
250mg
(Cephalosporin)
30. -do- Weltraxone 500mg Per As Per Deferred as per policy of 5

Ceftriaxone ……
500mg
(Cephalosporin)
31. -do- Weltraxone 1gm Per As Per Deferred as per policy of 5

Ceftriaxone …1gm
(Cephalosporin)
In 234th meeting the Board adopted 5 products per section policy and 5 products per section of
each firm were accordingly approved while rest of the applications were deferred. Subsequently
in 236th meeting 5 more products per section per firm were approved among the products
deferred in 234th meeting. The above products are the remaining applications which were left
after the approval of 10 products (in 234 & 236th meeting) as mentioned above paras.
The firms have requested for issuance of registration letters for the products at S.No.1-25
while for the products at S.No.26-31, the applicant M/s. Welwrd has not made any request.
As per record of the section number of registration granted to various sections of the above
firms is as under:-
Name of Firms Section Already registered
M/s. Winbrain Reserch Labs Capsules 8 products
M/s. Weather Fold Capsule 10 products
M/s. Welwrd Tablets 10 products

Pharmaceuticals,
Liquid Injectable 10 products
Capsule 8 products
Decision: Registration Board in principal agreed to allow two products in Capsule

Section of M/s. Welwrd Pharmaceuticals, Hattar from among their above

applications. The choices for the products are to be taken from the firm
before placing the case for consideration of the Board for final decision.
Remaining products will be taken up as per their turn.
The case of applications of M/s. Winbrain Research Laboratories, Hattar

was discussed alongwith following case No.21 and decision is recorded there
in.
Case No.21 Request of M/s. Winbrain Research Laboratories, Hattar for issuance of
registration letter.
M/s. Winbrain Research Laboratories, Hattar has requested for issuance of registration
letters of their following product approved in 234th meeting of Registration Board with conditions
mentioned against each .
S.No Name of Name of Products Pack Demand Dated Decision of

Manufacturer size ed MRP Registration
Board
1. M/s. Winbrain Brainzole 30mg 14’s As Per 2-6- Approved with
Research Capsules SRO 2011 fulfillment of
Laboratories, Each capsule contains:- requirements of
Hattar Lansoprazole Pellets source, GMP
1. Tablet equivalent to certificate,
General Lansoprazole…..30mg stability data and
2. Caps (Proton Pump Inhibitor) Fee. Rs.15000/-
General,
3. Dry powder
Susp General
2. -do- Esobrain 20mg 14’s As Per -do- Approved with
Capsules SRO fulfillment of
Each capsule contains:- requirements of
Esomeprazole Pellets source, GMP
equivalent to certificate,
Esomeprazole….20mg stability data and
(Proton Pump Inhibitor) Fee. Rs.15000/-
3. -do- Omebrain 40mg 14’s As Per -do- Approved with

Capsules SRO fulfillment of
Each capsule contains:- requirements of
Omeprazole Pellets source, GMP

equivalent to certificate,
Omeprazole……..40mg stability data and
(Proton Pump Inhibitor) Fee. Rs.15000/-
4. -do- Loxit 30mg Capsules 14’s As Per -do- Approved
Each capsule contains:- SRO
Duloxetine as
HCl….30mg
(Antidepressant)
The registration letter was not issued as the firm has not fulfillment the requirements while the
product as S.No.4 was referred for price fixation. The firm has now requested to issue registration
letter by providing the documents referred in the minutes. Moreover the price of product as S.No. 4
has also been fixed.
The firm already has registration of 8 products in the capsule section.

Decision: Registration Board in principal agreed to allow two products in capsule
section of M/s. Winbrain Research Laboratoire, Hattar from among their
above applications (referred in the instant case and case No.20). The choices
for the products are to be taken from the firm before placing the case for
consideration of the Board for final decision. Remaining products will be
taken up as per their turn.

Registration-V
Case No.22: Export of Non Me-Too Product
a. M/s. Highnoon Laboratories Ltd, Lahore
M/s. Highnoon Laboratories Ltd, Lahore has requested for registration of following
product for export purpose only:-
S. No Name of Products
1. Daploz 5mg Tablets
Each film coated tablet contains:
Dapagliflozin propanediol monohydrate equ to;
Dapagliflozin…………..5mg
2. Daploz 10mg Tablets
Dapagliflozin propanediol monohydrate equ to;
Dapagliflozin……….…..10mg
3. Cana 300mg Tablets
Canagliflozin hemihydrates equivalent to;
Canagliflozin…..……….300mg
4. Cana 100mg Tablets
Canagliflozin hemihydrates equivalent to;
Canagliflozin…..……….100mg
5. Daclata 60mg tablets
Daclatasvir dihydrochloride equ to:-
Daclatasvir……………...60mg
6. Daclata 30mg tablets
Daclatasvir dihydrochloride equ to:-
Daclatasvir……………..30mg
The firm has submitted the following documents.
a. Fee of Rs. 50000/- each product for this purpose.
b. Form-5.
c. Copy of GMP inspection.
d. Export orders.
c. NOC for CRF.
e. Approval of section by CLB.
Decision: Registration Board approved grant of above registrations exclusively for

export purpose. Registration is subject to following conditions:

product
b. M/s. CCL Pharmaceuticals (Pvt) Ltd , Lahore
M/s. CCL Pharmaceuticals (Pvt) Ltd , Lahore has requested for registration of following
product for export purpose only:-
S. No Name of Products
1. Carci Suspension 500mg/5ml
Each 5ml contains:
Carbocisteine…………..500mg
2. Carci Suspension 200mg/5ml
Each 5ml contains:
3. Carci Capsule 500mg
Each Capsule contains:
The firm has submitted the following documents.

a. Fee of Rs. 50000/- each product for this purpose.
b. Form-5.
c. Copy of GMP inspection.
d. Export orders.
c. NOC for CRF.
e. Approval of section by CLB.
Decision: Registration Board approved grant of above registrations exclusively for

export purpose. Registration is subject to following conditions:

product
Case No.23 Registration applications of M/S Gallop Water Sciences, Lahore deferred in
253rd meeting of Registration Board.

Following applications of M/s Gallop Water Sciences, Lahore were deferred in 253rd
meeting of registration board
1. G-SOL PAEDS Form-5 • Int availability Deferred for

IV Infusion Dy. No: 3472 not confirmed. confirmation of
Each 100ml contains: dated 18-05-  Me-too: Macsol approval by
Dextrose 2015 Paeds of M/s Mac reference
anhydrous….4.3g 20,000/- & Rains Lahore. regulatory
Sodium Rs.50/- Rs.40/- authority.
Chloride……..0.18g 500ml, 200ml
Caloric & Electrolytic
solution
2. G-Lyte M Form-5  Internationally, Deferred for
IV Infusion Dy. No: 3473 not available in confirmation of
Each 100ml contains: dated 18-05- this strength. approval by
 Me-too: reference
Sodium 2015
Plabolyte-M of regulatory
Chloride……..0.216gm 20,000/- authority.
M/s Otsuka,
Potassium Rs.100/- Karachi
Chloride…..1.5gm Rs.70/-
Calcium Chloride 2 H2O 1000ml, 500ml,
…..…0.022
Sodium Acetate 3 H2O
…0.313gm
Dextrose………..5.0gm
Electrolytic & Caloric
solution
3. Mannitol Form-5  Internationally Deferred for
IV Infusion Dy. No: 3458 Not available in confirmation of
Each 100ml contains: dated 18-05- this strength approval by
 Me-too: Mactol reference
Mannitol…….17.5gm 2015
of M/s Mac & regulatory
Sorbitol…….2.5gm 20,000/- authority.
Rains, Lahore
Osmotic diuetic Rs.200/- 500ml
Subsequently the firm requested for replacement of above applications with the following
new ones which were presented in 255th meeting of the board. Case was decided as follows:
566 G-SOL 10% Form 5 Otsuka The Board deferred the

Japan application for
formulation clarification whether the
Rs. 20,000/- (Pladix) firm wants to withdraw
vide Dy. No. their previously deferred
Each 100 ml contains 1140 dated 06- application in view of the
Dextrose anhydrous 10gm 11-2015 newly submitted
FDA
approved applications or otherwise.
Dextrose
Caloric solution Pack size of 10%
1000ml / 70
(Manufacture PKR Medisol
Specification) 10%
(Medipak)
567 G-SOL 5% Form 5 Otsuka The Board deferred the

Japan application for
Rs. 20,000/- formulation clarification whether the
vide Dy. No. (Pladix) firm wants to withdraw
Each 100 ml contains 1140 dated 06- their previously deferred
Dextrose anhydrous 5gm 11-2015 application in view of the
FDA newly submitted
approved applications or otherwise.
Caloric solution Pack size of Dextrose
500ml / 55 5%
(Manufacture PKR
Specification) Medisol 5%
(Medipak)
568 G-Sol RL 500 ml Form 5 MHRA The Board deferred the

approved application for
Each 100 ml contains Rs. 20,000/- clarification whether the
vide Dy. No. firm wants to withdraw
Sodium Chloride 0.60gm 1141 dated 06- their previously deferred
Potassium Chloride 11-2015 application in view of the
0.04gm Medisol newly submitted
Hartmann applications or otherwise.
Calcium Chloride Pack size of IV infusion
0.027gm 500ml / 56
PKR (Medisol )
Sodium lactate 0.32 gm
Electrolyte Solution

(Manufacture
Specification)
The firm has requested that the registration of the products deferred in 253 rd meeting may
be considered in routine as per DRAP Policy and two products may be processed on priority
basis against the quota of ten products per section. This request of the firm was considered in
257th meeting of registration board and following decision was taken:-
Decision: Registration Board acceded to the request of the firm and approved products at
serial no. 559 and 560 whereas product at serial no 558 was deferred for clarification
whether the firm wants to withdraw their previously deferred application in view of the
newly submitted applications or otherwise.
It is submitted that a typographic error was made in the minutes of 257th registration
board meeting and products at Sr no. 559 and 560 was mentioned inadvertently instead of
product at Sr. No 567 & 568. The firm has been issued registration letter with correction in
minutes.
Decision: Registration Board noted the information and endorsed the action taken.
Case No.24: Pending registration of Vinqo 500mg & 1gm Injection of M/s Wilshire
Laboratories (Pvt) Ltd, Lahore.
Registration Board in 258th meeting discussed the following case of M/s. Wilshire
Laboratories (Pvt) Ltd, Lahore. Following products of M/s Wilshire Laboratories (Pvt) Ltd,
Lahore were discussed in 236th meeting of Drug Registration Board but deferred for further
clarification about manufacturing facility. Then the case was included in 243 rd meeting of the
board again deferred for further clarification about the manufacturing facility.
S.No Product Name Generic Name Date of Remarks

Submission
1 Vinqo 500mg inj Vancomycin 04.06.2011 Applied as a new
Hydrochloride 500mg section product
2 Vinqo 1gm inj Vancomycin 04.06.2011 Applied as a new
Hydrochloride 1gm section product

Registration Board its 243rd meeting discussed the case and for further deliberation on
manufacturing area requirements.. Registration Board in its 248th meeting decided the
manufacturing Area requirement for Vancomycin:
“As it is not a Penicillin Derivative, hence manufacturers, having in-house lyophilization

facilities, may be allowed to produce it in General Injectable Area”
Decision: Registration Board deferred the case for getting details of manufacturing
process of the applicant and to decide the case in the light of decision taken by the board
in 248th meeting.
The above decision needs to be reconsidered as Registration Board in 257 th meeting has
granted the same registration to M/s. Fynk Pharma, Lahore and referred decision of 248 th
meeting of the board is not the same as depicted in 258 th meeting of the board. Rather, board in
2418th meeting had deferred the product for further deliberations.
Decision: Regsitration Board approved the above drugs in favour of M/s Wishire
Laboratories (Pvt) Ltd, Lahore.
Case No.25: Change of brand name for Epinol CF tablet of M/s. CCL Pharmaceuticals
(Pvt) Ltd; Lahore
M/s. CCL Pharmaceuticals (Pvt) Ltd: Lahore has requested for change of brand name of their
following product and they have informed that the proposed brand name already in syrup form:-
S. No. Names of Drug(s) with Reg. No. New proposed names

formulation
1. Epinol CF Tablet 023982 Pulmonol CF Tablet

Each tablet contains:
Paracetamol……………500mg
Pseudoephedrine HCl….60mg
Chlorpheniramine
Maleate……….4mg
The management of the firm has submitted following documents:

i. Fee of Rs. 20,000/- for each product.
ii. Undertaking on stamp paper.
iii. Copies of initial letter of registration & renewal status.
iv. CRF clearance certificate.

It is submitted that the composition of Epinal tablets as mentioned above is different form
pulmonol syrup. Composition of pulmoul is as under.
S.No. Reg. No Name of Product with composition
1 000874 Pulmonol Syrup
Each 5ml Contains:-
Chlorpheniramine maleate B.P……5mg
Terpin Hydrate USP……………….10mg
Potassium Bicarbonate B.P………...0.1mg
Ammonium Chloride B.P…………..25mg
Menthol B.P………………………...1mg
Aminophylline Ph.Eur………………32mg
Potassium guaiacol sulfonate U.S.P…...5mg
Potassium citrate B.P………………..0.1mg
Tr. Senega B.P……………………….0.05ml
Tr. Ipecac B.P………………………...0.025ml
Extract Glycyrrhiza b.P………………..0.1ml
Flavor & Base……………..q.s
Decision: Registration Board considered the request of the firm in the light of SOPs /
guidelines for change of brand name of the drugs and did not accede to the
request as composition of formulation of the drug (Epinol CF Tablet) was
different from the composition of Pumonol Syrup.
Case No.26: Registration of M/S N.B.S Pharma, Lahore
Following products of M/s N.B.S Pharma, Lahore were considering 215 th meeting of
registration board and decided as follows.
Sr.No Name of Drug Decision

1. Povidone-1 Solution Approved subject to the submission of
Each 100ml contains:- the last Inspection report.
Povidone Iodine USP 7.5gm equivalent to
0.75% available iodine (USP)
It is submitted that the above cases were discussed in 215 th meeting of registration board
and decision of the board has been reflected in the above table. The firm has now submitted the
differential free of Rs. 12000 and submitted the inspection report dated 12.11.2014. which
shows details of the section as under:-
External Preparation Section:-

This section comprised of preparation and filling rooms, equipped with preparation
vessels of different sizes. Silver san mixer and filling machines was installed HVAC
system was provided in this area and was functional at the time of inspection. Re-packing
area was equipped with filling machine and different size vessels. HVAC system was
installed production area furnish with epoxy.
Decision: Registration Board deferred the case for GMP status of the firm and
confirmation of section either from Licensing division or from panel /
renewal inspection report.
Case No.27: Registration of M/s Chishti Pharma ; Sahiwal
M/s Chishti Pharmaceuticals Industries, Sahiwal has requested to issue following

registration approved in 206th meeting.

1. Imperial Crepe Bandage. Approved.
Contains:-
Crepe Bandage BPC.
The firm has submitted following documents :-
i. Copy inspection report (GMP)

ii. Copy of Bank challan of Rs. 8000/-
iii. Differential fee of Rs. 12000/-as balance fee.
Decision: Registration Board deferred the case for submission of new Form-5 and
verification of record regarding issuance of registeration letter, as product
was considered by Registration Board in 2007.
Case No.28: Registration Of M/S Schazoo Pharma, Lahore.
M/s the Schazoo Pharmaceuticals Laboratories (Pvt) Ltd, Sheikhupura had requested for
permission to export drugs containing precursor Chemical Ephedrine to M/s. Rahullah Nasrat Limited,
Afghanistan as detail below:-
S.No Name and composition Reg. No Pack Size Quantity Quantity of

requested to Ephedrine
export
1. Rhinosone-P Nasal Spray 040892 15ml 50000 Bottles 3.75-kg
Each 100ml Contains:-
Naphazoline
Nitrate…..125mg
Ephedrine HCl…..500mg
Prednisolone
Acetate….2.5mg
2. Rhinosone-P Nasal Spray 000834 15ml 100000 7.5-kg
Each 100ml Contains:- Bottles
Naphazoline
Nitrate…..125mg
Ephedrine HCl…..500mg
9 alpha- Fluoro
Prenisolone 21-
Acetate….2.5mg
The firm was asked for the clarification of the both compounds of Prednisolone . They
have replied with official reference i.e. The USP monograph of 9 Alpha-Floropredinsolone
Acetate shows it is an veterinary drugs but the ear drops applied by the firm are for human
consumption.Moreover, the subject formulation is not available in reference regulatory
authorities as specified by the board in 249th meeting.
Decision: Registration Board deferred the case for further deliberation and
presentation by the firm before Registration Board.
Case No. 29: Registration of M/S Dyson, Lahore
M/s. Dyson Pharma, Lahore has requested to issue following registration considered in
236th meeting.

1 Dyprog Tablets 5mg Approved subject to submission of

Each tablet contains:- comparative dissolution profile and
Norethisterone….5mg related documents. The firm shall be
B.P Specs granted non-anabolic steroids in this
section.
2 Dyston Tablets 10mg -do-
Each film coated tablet contains:-
Dydrogesterone….10mg
USP Specs
3 Dyestro Tablets 0.625mg -do-

Conjugated Estrogens …..0.625mg
USP Specs
4. Dyestadiol Tablets -do-

Cyproterone acetate….2mg
Ethinylestradiol….35mcg
The firm has submitted following documents:-
i. Differential Fee of Rs. 12000/per product

ii. Comparative dissolution profile
iii. Undertaking as per decision of Registration Board in 251st meeting.
Decision: Registration Board deferred the case for further deliberation in next
meeting.
Case No.30: Registration application of M/s. English Pharmaceutical, Lahore deferred in

241st meeting.
Registration Board in 241st meeting discussed the case of M/s English Pharma, Lahore
and decided as follows:-

M/s. English Pharmaceuticals Industries, Lahore were deferred in its 237 th meeting for
verification of complete formulation with originator (Detrusitol Capsule SR 4 mg by Pfizer) and
Comparative Dissolution profile with originator.
Name of products & Composition Pack Demanded

size price
Terol 4mg SR Capsules 3×10’s Rs.2300/-
Each capsule contains:-
Tolterodine HCl equiv. to
Tolterodine SR…4mg
The firm has provided following documents:-
1. Comparative dissolution profile.

2. Sample of Detrusitol Capsule SR 4 mg by Pfizer confirming that product is I pellet
form
3. GMP certificate of manufacturer.
4. Stability studies.
5. Certificate of analysis.
Decision (241 meeting): - Registration Board deferred the submitted data to following experts for
evaluation and authorized its Chairman for decision on recommendation of experts:
I. Prof.Dr.mehmood Ahmad, Islamia university, Bahawalpur

II. Prof.Dr.Zafar Iqbal, University of Peshawar.
III. Director DTL, Lahore.
In view of above, experts have furnished comments as under:-
S.NO Name of the drugs with Comments of the experts

composition
1. Mr. Jamil Anwar Director, As per information/ data provided by M/s.
Drugs Testing Laboratory, English Pharmaceutical industries Lahore for
Lahore registration of the product Terol (Tolterodine
HCl to Tolterodine 4mg) SR Capsule, the
standard Analytical Procedures for the finished
product has been studies. The stability data foe
accelerated stability program (6 Months) and
long term stability program (12 months) has
been performed for 1,3 and after 7 hours
dissolution profile. The study has been carried
out by M/s. Heterol, India.

The comparative study with the brand leader
i.e. M/s Pgizer’s product- Detrusitol 4mg SR
capsules, Bach No A..1566F, carried out by
M/s. English Pharmaceutical Industries, Lahore
with the comparable results at 01,1 and after 7
hours.
The Good Manufacturing Practices (GMP),
dated 22.08.2012 for M/s. Heterol, India is
attached with information/ data provided by
M/s. English Pharmaceuticals industries,
Lahore.
In the light of above and as per data/
information provided, the registration of
“Terol 4mg SR Capsule” is recommended
subject to the provision of Good Manufacturing
Practices of M/s English Pharmaceutical,
Lahore, and the firm may be directed to submit
the dissolution profile of Terol 4mg SR
Capsules before marketing.
Dr. Mehmood Ahmad, Granules with white to off white colour were
Islamia University seen in enclosed gelatin shells upon physical
Bahwalpur. examination. Dissolution studies were
conducted in USP type-1 basket with rotation
speed of 100 ± 4rpm at 37± 2°C. Standard
solution was made in mobile phase comprising
of buffer solution and acetonitrile. Stability
studies i.e real time at 30°± 75% RH for 2
years and accelerated at 40°C ± 75% RH for 06
month were conducted. During stability testing
various parameters were evaluated like
physical description, identification via HPLC
chromatogram, dissolution testing and assay.
Product passed all aforementioned parameters
and remained stable during the stability period.
Therefore, based on the presented results it is
recommended that the capsule Terol 4mg can
be registered.
3. Dr Zafar Iqbal Reply Awaited
Decision: Registration Board deliberated the reports and deferred the case for opinion
of Prof.Dr.Mehmood Ahmad regarding use of basket system for performing
dissolution studies instead of paddle system and to issue reminder to Dr.
Zafar Iqbal for furnishing expert opinion.
Case No.31: M/s Feroza International Lahore- Extension of contract manufacturing.

M/s Feroza International Lahore has informed that their below mentioned products were
approved in 212th meeting of registration board but letter was not issued. The firm has requested to
grant extension.
Sr Name of Drug
No.
1 Leetab Infusion 500mg
Levofloxacin…………………….500gm
2 Haemofer 200mg Injection
Each 5ml Contains:-
Iron as iron sucrose……………..200mg
3 Neuramin 500mcg injection
Each ml contains:-
Mecobalamine…………..500mcg
Following documents have been submitted.

 Fee of Rs: 50,000 per product.
 Form -5 with contract agreement with M/s English Pharma, Lahore.
 Copy of contract agreement between two parties.
 GMP certificate of M/s English Pharma, Lahore.
It is submitted that the above products of the firm were approved in 212 meeting and extension
was granted till 30.6.2010. However, the form did not apply for extension for the further period.
Now the firm has requested to grant approval for extension under new toll policy for the period
of five years.
Decision: Registration Board deferred for confirmation of composition of applied

products at S.No.02 and confirmatuion from record regarding non-issuance
of registration letters as claimed by the firm.

Pharmaceutical Evaluation Cell
Out of Queue Applications for New Molecule, Anticancer, HIV Aids and other life saving drugs.
Registration Board in 257th meeting decided to consider registration applications of

various classes of drugs on priority. Decision is as follows:
“Registration Board deliberated that drugs for treatment of chronic ailments and drugs which
are in short availability should have priority review process and consideration by the Board to
ensure their free availability. The Board decided that drugs for treatment of cancer, viral
diseases, thalaesemia, immunosuppresants, vaccine and sera, new molecules / formulations,
blood factors and bags will be given priority consideration.”
Registration Board considered (out of queue) following registration applications as

evaluated by Pharmaceutiacl Evaluation Cell. However the Board advised to inform DRAP’s
Policy Board regarding above mentioned decision.
List of human imported drugs Anticancer, Immunosuppressant, New molecules and Blood
bags applications with complete fee.
Muhammad Ansar Evaluator-I (PEC)
S/N Name and Brand Name Type of Remarks on Remark Decision

address of (Proprietary name + Form the s of the
manufacturer / Dosage Form + Initial formulation Evaluat
Applicant Strength) date, diary (if any) or.
Composition Fee including
Pharmacological including International
Group differential status in
Finished product fee stringent
Specification Demanded drug
Price / regulatory
Pack size agencies /
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
1. M/s. AJ Mirza Emeset 4mg/2ml Form -5-A MHRA.Ondan COPP Approved

Pharma (Pvt) Injection setron 2mg/ml valid as per
Ltd., Karachi. / Diary No. by M/s upto 13- Import
Each ml contains:- 136/ R&I Hameln 12-2013. Policy for
Manufactured Ondansetron Dated 15- GMP Finished
By Hydrochloride USP 06-2011 complian Drugs.
M/s Cipla Ltd Equivalent to Rs.15000 Local. Zofran t as per Firm will
D.P Pally Ondansetron…2mg & 350000 by M/s GSK. COPP. provide
(Narsapur Water for Injection dated 15- GMP valid
Road). Near BP……..q.s. 10-2012 dy valid legalized
Gandimaisamma No.951. upto 30- CoPP and
X Road, Anti emetic for As per 12-2016. Chairman
Hydarabad India chemotherapy induced PRC. Registratio
emesis. n Board
will permit
Manufacturer’s further
Specifications processing
of case.
36 months
2. M/s. AJ Mirza Emeset 4mg Tablets Form 5A MHRA.Ondan COPP Deferred
Pharma (Pvt) Dy.No 79 setron 4mg
issued on for the
Ltd., Karachi. Each film coated tablets 15-06-2011 tablet by M/s
12-06- submissio
Manufactured contains:- Rs.15000/ Accord 2008 by n of valid
by Ondansetron 15-10-2012 India. legalized
M/s. Cipla Ltd., Hydrochloride USP Rs.35000/- Local. Zofran GMP COPP, as
L-147 to L0147- Equivalent to 4mg by M/s complian it was
1, Verna Ondansetron……4mg As per PRC GSK. t as per expired at
Industrial Estate, COPP. time of
Verna Goa, Anti emetic for GMP 29- submissio
India. chemotherapy induced 06-2017. n of
emesis. registratio
n
application
Manufacturer’s .
Specifications
36 months
3. M/s. Merixil Capecitabine Form 5A MHRA. COPP Approved
Pharma Labosuan/Mericap Dy. No. Capecitabine issued by as per
Office No 28, 500mg Tablet 261 Dated 500mg f/c by Spain Import
2nd Floor, Rose 27-07-2011 M/s Accord. dated 12- Policy for
Plaza I-8 Each film coated tablet Rs. 15000/- 01-2016. Finished
Markaz, contains:- 09-12-2014 Local. Xeloda Brand Drugs
Islamabad. Capecitabine….500mg Rs. 85000/- 500mg by M/s Name for
Manufactured dy No. 225. Roche. Pakisatn
By adjuant treatment of Mericap
M/s. patients following Tablet.

Laboratorios surgery of stage III As per PRC GMP
Normon, S.A. colon cancer, meta- complian
Ronda De static colo-rectal t as per
Valdecarrizo, 6, cancer COPP.
Tres Cantos, GMP
28760, Madrid, issued
Spain. USP Specifications 13-06-
2014.
4. M/s. Merixil Temoeirgen 100mg Form 5A MHRA. COPP Approved
Pharma Capsules Temodal 5mg, issued on as per
Office No 28, Dy. No. 20mg, 100mg, 04-02- Import
2nd Floor, Rose Each capsule contains:- 721 dated 140mg, 180mg 2015 by Policy for
Plaza I-8 Temozolomide…100mg 18-08-2011 & 250mg by HPRA Finished
Markaz, Rs. 15000/- M/s Merck Ireland. Drugs
Islamabad. For newly diagnosed 08-12-2014 GMP
Product Glioblastoma Rs 85,000/- Local. complian
License Holder multiforme dy No. 226. Temoside t as per
M/s Fair-Med concomitantly with 20mg, 100mg COPP.
Healthcare radiotherapy. As per & 250mg by GMP
GmbH SRO M/s AJ. Mirza. issued
Planckstrasse Manufacturer’s dated 28-
13, 22765 Specifications 02-2014
Hamburg, by Irish
Germany. 24 Months Medicine
Manufactured Board.
by
M/s. Eirgen
Pharma Ltd.
64/65 Westside
Business Park
Old Kilmeaden
Road,
Waterford,
Ireland.
5. M/s. Oncogene Anaskebir 1mg Coated Form 5A MHRA. COPP Deferred

Pharmaceuticals Tablet Anastrozole issued on for the
, Karachi Dy No. 1mg f/c by 29-08- submissio
Each film coated tablet 1198 dated M/s consilent. 2012 and n of
Product License contains:- 28-11-2012 valid following:
Holder Anastrozole……1mg Rs.100,000 Local. upto 28- a. valid
M/s. /- Anastrozole 08-2013. legalized
Laboratorios Manufacturer’s 1mg by M/s GMP COPP, as
Aspen S.A. Specifications Rs.3300/Pa Pfizer complian already it
Remedios ck t as per was valid

3439/43, (Treatment of CoPP. upto 28-
C1407HJC, harmone recpotor Stability 08-2013.
Buenos Aires, positive advanced data as b. Stability
Argentina. breast cancer in post per data as per
Manufactured menopausal women) condition conditions
by s of Zone of Zone
M/s IV-A not IV-A.
Laboratorios attached. Druds
Eczane Pharma DSL is c. Sales
S.A. Laprida 43 not License.
Localidad attached. d.
Avellaneda. Clarificat Clarificati
Prov. Bs. As ion on
Craveri S.A.I.C- regardin regarding
Arengreen 830, g the the
CABA Blipack place of manufactu
S.A-Av. Juan B. manufact ring site as
Justo 7669, ure. it is
Caba. different
in Form5A
and CoPP.
6. M/s. Oncogene Kebirzol 2.5mg Coated Form 5A MHRA. Femra The Deferred
Pharmaceuticals Tablets 2.5mg f/c product for the
, Karachi Dy No. tablet by M/s is not submissio
Each tablet contains:- 1197 dated Novartis. actually n /
Product License Letrozole……2.5mg 28-11-2012 in the clarificatio
Holder Rs.100,000 Local. Femra market n of
M/s. (Adjuant treatment of /- 2.5mg by M/s of following
Laboratorios post-menopausal Novartis. country a. The
Aspen S.A. women with harmone Rs.5000/pa of origin product is
Remedios recpotor positive ck as not
3439/43, invasive early breast mentione actually in
C1407HJC, cancer). d in the market
Buenos Aires, COPP. of country
Argentina. USP Specifications DSL is of origin
Manufactured not as
by attached. mentioned
M/s GMP in COPP.
Laboratorios certificat b. Drug
Eczane Pharma e is not Sales
S.A. Laprida 43 attached. License.
Localidad Complet c.
Avellaneda. e Complete
Prov. Bs. As descripti description
Craveri S.A.I.C- on of the of the
Arengreen 830, tablet is tablet.

CABA Blipack not d.
S.A-Av. Juan B. provided Clarificati
Justo N 7.669, as film on is
CABA. coated. required
Clarificat for
ion is manufactu
required rer and
for market
manufact authorizati
urer and on holder.
market e. Stability
authoriza data as per
tion conditions
holder. of Zone
Stability IV-A.
data as f.
per Clarificati
condition on
s of Zone regarding
IV-A not the
attached. manufactu
Clarificat ring site as
ion it is
regardin different
g the in Form5A
place of and CoPP
manufact
ure.
7. M/s. Amgomed, Farmatide 50mg Tablets Form 5A MHRA. Photocop Deferred
Office # 5, 1st Bicalutamide y of for the
Floor Rose 1, Each film coated Dy No.510 50mg f/c by legalized submissio
Plaza I-8 tablets contains:- dated M/s Sun COPP n of valid
Markaz, Bicalutamide 09-06-2014 pharma. issued legalized
Islamabad. ………….50mg Rs.100,000 dated 30- COPP.
/- Local. 01-2014
Manufactured Adjuant to radial Calutide 50mg (Photoco
by prostectomy or radio- As per by M/s AJ. py)
M/s. West therapy in patients with SRO Mirza. GMP
Pharma, locally advanced complian
Producoes de prostate cancer t as per
Especialiaes COPP.
Farmaceuticas, (Photoco
SA Rua Joao de USP Specifications py)
Deus, n. 11,
Amadora, 2700- 03 years
486, Portugal.

8. M/s. Lundbeck Brintellix 10mg Tablets Form 5-A MHRA. Orignal Approved
Pakistan (Pvt) Brintellix 5, legalized as per
Ltd., 40 T/4, Each film coated tablet Dy No.569 10 & 20mg f/c COPP Import
Blessing Street, contains:- 30-06-2014 tablet by M/s issued by Policy for
Block 6, Vortioxetine Rs.50,000/- Lundbeck. EMA on Finished
P.E.C.H.S, hydrobromide …10mg dated 04- Drugs
Karacki. Market equivalent to 10mg Rs.265/tabl 02-2014
Authorization Vortioxetine et GMP
Holder. complian
M/s. H. (Receptor Antagonist). t as per
Lundbeck A/S, New Molecule CoPP.
Ottiliavej 9,
2500 Valby, Manufacturer’s
Denmark. Specifications
Manufacturer
also responsible 30 months
for batch
release QC,
Primary &
Secondary
Packaging.
M/s. H.
Lundbeck A/S,
Ottiliavej 9,
2500 Valby,
Denmark.
Site Responsible
for Quality
Control
M/s Eurofins
Pharma A/S,
Ornebjergvej 1,
2600 Glostrup,
Denmark.
Site for Primary
& Secondary
Packaging.
M/s Elaiapharm,
2881, route des
Cretes, Z.I. Les
Bouillides,
Sophia
Antipolis,
06560, France.
9. M/s. Lundbeck Brintellix 20mg Tablets Form 5-A MHRA. Orignal Approved

Pakistan (Pvt) Brintellix 5, legalized as per
Ltd., 40 T/4, Each film coated tablet Dy No.570 10 & 20mg f/c COPP Import
Blessing Street, contains:- 30-06-2014 tablet by M/s issued by Policy for
Block 6, Vortioxetine Rs.50,000/- Lundbeck. EMA on Finished
P.E.C.H.S, hydrobromide …20mg dated 03- Drugs
Karacki. equivalent to 20mg Rs.398/tabl 02-2014
Vortioxetine et. GMP
Authorization complian
Holder. (Receptor Antagonist). t as per
M/s. H. New Molecule CoPP.
Lundbeck A/S,
Ottiliavej 9, Manufacturer’s
2500 Valby, Specifications
Denmark.
Manufacturer 30 months
also responsible
for batch
release QC,
Primary &
Secondary
Packaging.
M/s. H.
Lundbeck A/S,
Ottiliavej 9,
2500 Valby,
Denmark.
Site Responsible
for Quality
Control
M/s Eurofins
Pharma A/S,
Ornebjergvej 1,
2600 Glostrup,
Denmark.
Site for Primary
& Secondary
Packaging.
M/s Elaiapharm,
2881, route des
Cretes, Z.I. Les
Bouillides,
Sophia
Antipolis,
06560, France.
10. M/s. CCL Praxed Injection 100mg Form 5A MHRA. Dossier Deferred
Pharmaceuticals Alimta 100mg is a for the

(Pvt) Ltd., 65- Each vial contains:- Dy No.Nil & 500mg photocop submissio
Industrial Estate, Pemetrexed (as dated 30- powder for y. n of
Kot Lakhpat, disodium) 06-2014 conc. For Fee following.
Lahore ………..100mg Rs.50,000/- infusion by Rs.50,00 a.
M/s Eli Lilly. 0 is a Verificatio
M/s. Glenmark (Malignant pleural As per photocop n of Fee
Generics S.A. mesothelioma non- Brand Local. Alimta y. Rs.50,000
Calle 9 Ing. small cell lung cancer) leader 100mg & Different as it is a
Meyer Oks No 500mg by M/s ial fee photocopy
593 Pilar Manufacturer’s Eli Lilly. not .
(B1629 MAX), Specifications provided. b.
Buenos Aires, Photocop Differentia
Argentina. y of l fee as
03 years COPP molecule
issued is me too.
dated 06- c. Valid
12-2013. legalized
(valid for COPP
12 d. Stability
months) data as per
Brand conditions
Name of Zone IV
Proxed. A.
GMP
complian
t as per
CoPP.
Stability
data for
one
batch is
attached.
11. M/s. CCL Praxed Injection 500mg Form 5A MHRA. Dossier Deferred
Pharmaceuticals Alimta 100mg is a for the
(Pvt) Ltd., 65- Each vial contains:- Dy No.Nil & 500mg photocop submissio
Industrial Estate, Pemetrexed (as dated 30- powder for y. n of
Kot Lakhpat, disodium) 06-2014 conc. For Fee following.
Lahore ………..500mg Rs.50,000/- infusion by Rs.50,00 a.Verificat
M/s Eli Lilly. 0 is a ion of Fee
M/s. Glenmark (Malignant pleural As per photocop Rs.50,000
Generics S.A. mesothelioma non- Brand Local. Alimta y. as it is a
Calle 9 Ing. small cell lung cancer) leader 100mg & Different photocopy
Meyer Oks No 500mg by M/s ial fee .
593 Pilar Manufacturer’s Eli Lilly. not b.Different
(B1629 MAX), Specifications provided. ial fee as
Buenos Aires, Photocop molecule

Argentina. y of is me too.
03 years COPP c. Valid
issued legalized
dated 06- COPP
12-2013. d. Stability
(valid for data as per
12 conditions
months) of Zone IV
Brand A.
Name
Proxed.
GMP
complian
t as per
CoPP.
Stability
data for
one
batch is
attached.
12. M/s. Revive Pemex Injection 500mg Form 5A MHRA. COPP Approved
Health Care, Alimta 100mg valid as per
Office 503, 5th Each vial contains:- Dy no 24 & 500mg upto 10- Import
Floor, 6 Main Pemetrexed (As dated 04- powder for 05-2017. Policy for
Gulberg, Jail Pemetrexed Disodium) 07-2014 conc. For GMP Finished
Road, Lahore. …….500mg Rs.100,000 infusion by complian Drugs
Excipients…….q.s /- M/s Eli Lilly. t as per
Manufactured COPP.
By (Malignant pleural As per Local. Alimta
M/s. United mesothelioma non- SRO. 100mg & Free
Biotech (P) Ltd., small cell lung cancer) 500mg by M/s sales
Village Eli Lilly. certificat
Bagbania, Manufacturer’s e issued
Baddi-Nalagarh Specifications dated 26-
Road, District- 02-2016.
Solan (H.P) 24 months
174101, India. GMP
valid
upto 17-
09-2017.
13. M/s. Revive Cagin 50mg Injection Form 5A MHRA. Free Deferred
Health Care, Cancidas 50 sales as Anti-
Office 503, 5th Each vial contains:- Dy No.26 powder for certificat fungal
Floor, 6 Main Caspofungin Acetate dated 04- conc. For e issued drugs are
Gulberg, Jail eq. to 07-2014 infusion by dated 26- not

Road, Lahore. Caspofungin…….50mg Rs.50,000/- M/s MSD. 02-2016. importable
COPP from India
M/s. United (Antifungal/Supportive As per PRC valid as per
Biotech (P) Ltd., cancer therapy) upto 10- Import
Village New Molecule 5-2017. Policy
Bagbania, GMP Order,
Baddi-Nalagarh Manufacturer’s valid 2016.
Road, District- Specifications. upto 17-
Solan (H.P) 09-2017.
174101, India. 24 months
14. M/s. Revive Doxulip 20mg Injection Form 5A MHRA. COPP Approved
Health Care, Caelyx valid as per
Office 503, 5th Each ml contains:- Dy. No. 27 2mg/ml upto10- Import
Floor, 6 Main Doxorubicin dated 04- (10ml) by M/s 05-2017. Policy for
Gulberg, Jail Hydrochloride 07-2014 Janssen. Finished
Road, Lahore. USP..2mg Rs.100,000 GMP Drugs
(As pegylated /- Local. complian
Manufactured Liposomal) Doxopeg t as per
by As per 20mg/10ml by COPP.
M/s. United Alone for meta-static PRC. M/s Free
Biotech (P) Ltd., breast cancer, Ferozsons. sales
Village advanced ovarian certificat
Bagbania, cancer. In e issued
Baddi-Nalagarh combination with dated 26-
Road, District- Bortezomide for 02-2016.
Solan (H.P) treatment of
174101, India. progressive multiple GMP
myeloma. valid
upto 17-
Manufacturer’s 09-2017.
Specifications
24 months
15. M/s. Revive Temotec 100mg Form 5A
MHRA. COPP Approved
Health Care, Capsules Temodal 5mg, valid as per
Office 503, 5th Dy. No 28 20mg, 100mg, upto 10- Import
Floor, 6 Main Each capsules contains:-dated 04- 140mg, 180mg 05-2017. Policy for
Gulberg, Jail Temozolomide 07-2014 & 250mg by Finished
Road, Lahore. USP…………..100mg Rs.100,000 M/s Merck GMP Drugs
/- complian
Manufactured For newly diagnosed Local. t as per
by Glioblastoma As per Temoside COPP.
M/s. United multiforme SRO 20mg, 100mg
Biotech (P) Ltd., concomitantly with & 250mg by Free
Village radiotherapy M/s AJ. Mirza. sales
Bagbania, issued

Baddi-Nalagarh Manufacturer’s dated 26-
Road, District- Specifications 12-2015.
Solan (H.P)
174101, India. 24 months GMP
valid
upto 17-
09-2017.
16. M/s. Revive Ambilip 50mg Injection Form 5A MHRA. COPPDefered as

Health Care, Ambisome valid
the
Office 503, 5th Each vial contains:- Dy No.29 50mg Powder upto 10-
product
Floor, 6 Main Liposomal dated 04- for Infusion by 05-2017.
does not
Gulberg, Jail Amphotericin B 07-2014 M/s Gilead. fall in the
Road, Lahore. USP………50mg Rs.100,000 GMP priority
/- Local. complian list.
M/s. United Antifungal Anfogen t as per Moreover
Biotech (P) Ltd., As per 50mg, COPP. Anti-
Village Manufacturer’s SRO. Ferozsons fungal
Bagbania, Specifications Free drugs are
Baddi-Nalagarh sales not
Road, District- 24 months issued importable
Solan (H.P) dated 26- from India
174101, India. 02-2016. as per
Import
GMP Policy
valid Order,
upto 17- 2016
09-2017.
17. M/s. Revive Oncotar 100mg Form 5A MHRA. COPP Approved
Health Care, Injection Cytarabine valid as per
Office 503, 5th Dy. No 30 100mg/ml by upto 10- Import
Floor, 6 Main Each ml contains:- dated 04- M/s Pfizer. 05-2017. Policy for
Gulberg, Jail Cytarabine injection 07-2014 Finished
Road, Lahore. BP………100mg Rs.100,000 Local. GMP Drugs
Water for injection s /- Cytarine complian
Manufactured IP………….q.s. 100mg, 500mg t as per
by As per PRC & 1gm by M/s COPP.
M/s. United Acute myeloid Atco.
Biotech (P) Ltd., leukaemia and for FSC
Village other acute leukaemias issued
Bagbania, for children and adults dated 26-
Baddi-Nalagarh 02-2016.
Road, District- USP Specifications
Solan (H.P) GMP
174101, India. 24 months valid
upto 17-

09-2017.
18. M/s. Revive Unicristin 1mg injection Form 5A MHRA. COPP Approved
Health Care, Vincristine valid as per
Office 503, 5th Each ml contains:- Dy. No 25 Sulphate upto 10- Import
Floor, 6 Main Vincristine Sulphate dated 04- 1mg/ml by 05-2017. Policy for
Gulberg, Jail USP…..1mg 07-2014 M/s Hospira. GMP Finished
Road, Lahore. Rs.100,000 complian Drugs
Indicated for /- Local. Vinfate t as per
Manufactured leukemias, malignant by M/s Aster. COPP.
by lymphomas, multiple As per FSC
M/s. United myeloma, solid tumors SRO issued
Biotech (P) Ltd., dated 26-
Village USP Specifications 02-2016.
Bagbania, GMP
Baddi-Nalagarh 24 months valid
Road, District- upto 17-
Solan (H.P) 09-2017
174101, India.
19. M/s. Novartis Afinitor 2mg Form 5A FDA. Afinitor Dossier Deferred
Pharma Dispersible Tablets 2mg, 3mg & is for the
(Pakistan) Dy No. Nil 5mg Disperz photocop verificatio
Limited, 15Each dispersible tablet dated 16- Tablets by M/s y fee Rs. n of fee
West Wharf, contains:- 07-2014 Novartis. 50,000 is and
Karachi. Everolimus…………… Rs.50,000/- photocop submissio
…2mg y. n of valid
Manufactured Rs. Photocop legalized
by. (for harmone receptor 126,000/30 y of CoPP.
M/s. Novartis positive advaced breast ’s. COPP
Pharma Stein cancer, neuro-endocrine provided.
AG, Stein, tumors of pancreatic GMP
Switzerland. origion, gastro-intestinal attached.
or lung origin renal cell
carcinoma)
30 months
20. M/s. Novartis Afinitor 3mg Form 5A FDA. Afinitor Deferred
Pharma Dispersible Tablets 2mg, 3mg & Dossier for the
(Pakistan) Each dispersible tablet Dy No. 88 5mg Disperz is verificatio
Limited, 15 contains:- dated 16- Tablets by M/s photocop n of fee
West Wharf, Everolimus…………… 07-2014 Novartis. y fee Rs. and
Karachi. …3mg Rs.50,000/- 50,000 is submissio
photocop n of valid
Manufactured (for harmone receptor Rs.189000/ y. legalized
by. positive advaced breast 30’s Photocop CoPP.

M/s. Novartis cancer, neuro-endocrine y of
Pharma Stein tumors of pancreatic COPP
AG, Stein, origion, gastro-intestinal provided.
Switzerland. or lung origin renal cell GMP
carcinoma) attached.
Manufacturer’s
Specifications
30 months
21. M/s. Novartis Afinitor 5mg Form 5A FDA. Afinitor Dossier Deferred
Pharma Dispersible Tablets 2mg, 3mg & is for the
(Pakistan) Dy No. 87 5mg Disperz photocop verificatio
Limited, 15 Each dispersible tablet dated 16- Tablets by M/s y fee Rs. n of fee
West Wharf, contains:- 07-2014 Novartis. 50,000 is and
Karachi. Everolimus…………… Rs.50,000/- photocop submissio
…5mg y. n of valid
Manufactured Rs.315000/ Photocop legalized
by. (for harmone receptor 30’s y of CoPP.
M/s. Novartis positive advaced breast COPP
Pharma Stein cancer, neuro-endocrine provided.
AG, Stein, tumors of pancreatic GMP
Switzerland. origion, gastro-intestinal attached.
or lung origin renal cell
carcinoma)
Manufacturer’s
Specifications
30 months
22. M/s. Macter Gefwin 250mg Tablets Form 5A MHRA. Iressa COPP Deferred
International Dy. No 250mg f/c not for the
Limited, F-216, Each Film Coated 3121 Dated tablet by M/s provided submissio
SITE, Karachi. Tablets contains:- 07-08-2014 AstraZeneca. n of
Manufactured Gefitinib………..250m Rs.50,000/- GMP not following:
by g attached. a. valid
M/s. Atlanta Excipients………qs Rs.As per Stability legalized
Biological (Pvt) PRC data as COPP
Ltd.,Village- (Advanced or meta- per b. Stability
Kotla, static non small cell condition data as per
Barotiwala, lung cancer) s of Zone conditions
Baddi, Distt. IV-A not of Zone
Solan, (H.P) attached. IV-A.
India. Finished c. Finished
product product
specifica specificati

tions are ons.
not d. Sole
provided. Agency
Sole agreement.
Agency
agreeme
nt is not
attached
23. M/s. Macter Cytonib Tablet 100mg Form 5A MHRA. COPP Deferred
International Dy. No 872 Glivec 100mg valid for the
Limited,F-216, Each tablets contains:- Dated & 400mg f/c upto 22- clarificatio
SITE, Imatinib 29-08-2014 by M/s 08-2014 n of
Karachi. / Mesylate………100mg Rs.50,000/- Novartis. but the following:
Marketing addresse a. COPP
Authorization: (Philadelphia Local. Glivec s of as the
M/s. Atlanta chromosome positive 100mg & Market addresses
Biological (Pvt) chronic myeloid 400mg by M/s authoriza of Market
Ltd.,Poddar leukemia) Novartis tion authorizati
Court 9th Floor, Pharma. holder on holder
Gate No.1, 18 Manufacturer’s and and
Rabindra Sarani, Specifications manufact manufactu
Kolkata-700001, 02 years urer are rer are not
India. not as as per
Manufacturing per COPP.
facility: COPP.
M/s. Ladley b. Stability
Formulations GMP not data as per
Village Kotla, provided. Zone IV-
Barotiwala, Stability A.
Distt. Solan data as
(H.P), India. per Zone
IV-A not
provided.
24. M/s. Macter Bortemore 3.5mg Form 5A MHRA. COPP Deferred

International Injection Dy. No 873 Velcade 3.5mg valid up for the
Limited,F-216, dated 29- (as mannitol to 22-08- submissio
SITE, Each vial contains:- 08-2014 boronic ester) 2014 but n /
Karachi. / Bortezomib………… Rs.50,000/- Powder for the clarificatio
Marketing 3.5mg solution for addresse n of the
Authorization: As per injection. s of following
M/s. Atlanta (Lumphocutic PRC. Market a.
Biological (Pvt) leukemia, indolent authoriza addresses
Ltd., Poddar non-Hodgkin’s tion of market
Court 9th Floor, lymphoma, multiple holder authorizati
Gate No.1, 18 myeloma). and on holder

Rabindra Sarani, manufact and
Kolkata-700001, 02 years urer are manufactu
India. not as rer are not
Manufacturing per as per
facility: COPP. COPP.
M/s. Ladley Stability b.Stability
Formulations data not data as per
Village Kotla, attached. conditions
Barotiwala, Finished of Zone IV
Distt. Solan product A.
(H.P), India. specifica c.Finished
tions are product
not specificati
provided. ons.
Internati d.
onaly the Internation
product aly the
is present product is
as present as
mannitol mannitol
boronic boronic
ester. ester.
Clarificat e.whether
ion the
whether product is
the in liquid
product form or
is in powder
liquid form.
form or
powder
form.
25. M/s. Requip PD 2mg Form 5A MHRA.. COPP Approved

GlaxoSmithKlin Tablets Aimpart Excel issued as per
e Pakistan Dy No. 2mg, 4mg and dated10- Import
Limited, 35- Each prolonged release 6581 R&I 8mg 07-2014 Policy for
Dockyard Road, tablets contains:- dated 8- prolonged vide No. Finished
West Wharf, Ropinirole 09-2014 release tablets 014/1680 Drugs
Karachi-74000. hydrochloride Rs.50,000/- by M/s by Spain.
equivalent to 2mg Zantiva GMP
Market ropinirole free base Will be complian
Authorization submitted t as per
Holder (Non-ergoline D2/D3 later COPP.

M/s. dopamine agonist)
Glaxosmithkline New formuation
, S.A. Severo
Ochoa, 2 28760- 18 months
Tres Cantos
(Madrid) Spain.
Manufactured
by
M/s Glaxo
Wellcome, S.A.
Avda. De
Extremadura, n
3 09400-Aranda
De Duero
(Burgos) Spain.
26. M/s. Requip PD 4mg Form 5A MHRA.. COPP Approved

GlaxoSmithKlin Tablets Aimpart Excel issued as per
e Pakistan Dy No.656 2mg, 4mg and dated10- Import
Limited, 35- Each prolonged release R&I dated 8mg 07-2014 Policy for
Dockyard Road, tablets contains:- 08-09-2014 prolonged vide No. Finished
West Wharf, Ropinirole Rs.50,000/- release tablets 014/1678 Drugs
Karachi-74000. hydrochloride by M/s by Spain.
equivalent to 4mg Will be Zantiva GMP
Market ropinirole free base submitted complian
Authorization later t as per
Holder (Non-ergoline D2/D3 COPP.
Glaxosmithkline New formuation
, S.A. Severo
Ochoa, 2 28760- (24 months)
Tres Cantos
(Madrid) Spain.
Manufactured
by
M/s Glaxo
Wellcome, S.A.
Avda. De
Extremadura, n
3 09400-Aranda
De Duero
(Burgos) Spain.
27. M/s. Requip PD 8mg 08-09-2014 MHRA COPP Approved

GlaxoSmithKlin Tablets Rs.50,000/- Aimpart Excel issued as per
e Pakistan 2mg, 4mg and dated10- Import

Limited, 35- Each prolonged release 8mg 07-2014 Policy for
Dockyard Road, tablets contains:- prolonged vide No. Finished
West Wharf, Ropinirole release tablets 014/1679 Drugs
Karachi-74000. hydrochloride by M/s by Spain.
equivalent to 8mg Zantiva GMP
Market ropinirole free base complian
Authorization t as per
Holder (Non-ergoline D2/D3 COPP.
Glaxosmithkline New formulation
, S.A. Severo
Ochoa, 2 28760-
Tres Cantos (24 months)
(Madrid) Spain.
Manufactured
by
M/s Glaxo
Wellcome, S.A.
Avda. De
Extremadura, n
3 09400-Aranda
De Duero
(Burgos) Spain.
28. M/s. Bayer Visanne (Dienogest) Form 5A Germany. COPP Approved

Pakistan 2mg Tablets Visanne issued as per
(Private) Dated 10- (Dienogest) dated 11- Import
Limited, C-21, Each tablet contains:- 09-2014 2mg Tablets 06-2014. Policy for
S.I.T.E., Karachi Dienogest………….2m vide diary GMP Finished
g No. 667 issued Drugs
Product license Rs.50,000/- dated 26-
holder: (Steroid Hormones) 04-2013.
M/s. Jenapharm New Molecule Not Approval
GmbH & Co. mentioned status
KG, Otto- Manufacturer’s require
Schott-Strasse Specifications to be
15 D-07745 provided.
Jena Germany 36 months Now the
Bulk firm has
Manufacturer, requeste
Packaging and d for the
final release: finished
M/s. Bayer import
Weimar GmbH from
& Co. KG Germany
DÖbereinerstras .

se 20 99427
Weimar,
Germany.
29. M/s. PharmEvo Bicatero 50mg Tablets Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Bicalutamide valid for the
Plot No. A-29, Each film coated tablets Dy. No 673 50mg f/c by upto 19- submissio
North West contains:- Dated 11- M/s Sun 09-2014. n of
Industrial Zone, Bicalutamide 09-2014 pharma. GMP Stability
Port Qasim, USP……….50mg Rs.100,000 complian data as per
Karachi /- Local. t as per conditions
(Adjuant to radial Calutide 50mg COPP. of Zone
Manufactured prostectomy or radio- As per PRC by M/s AJ. IV-A &
By. therapy in patients with Mirza. Photocop valid
M/s. Hetero locally advanced y of legalized
Labs Limited prostate cancer) GMP COPP.
Unit – VI Sy valid
No. 410 & 411, USP Specifications upto 19-
APIIC 09-2014.
Formulation 02 years
SEZ, Polepally Stability
Village, data is
Jadcherla not as
Mandal, per
Mahaboob condition
Nagar (Dist) s of Zone
509301, Andhra IV-A.
Pradesh, India.
30. M/s. PharmEvo Bentero 100mg Form 5 A FDA. COPP Deferred

(Pvt) Ltd., Injection Bendamustine valid for the
Plot No. A-29, Dy. No 676 powder for upto 30- submissio
North West Each vial contains:- dated 11- infusion by 12-2015. n of
Industrial Zone, Bendamustin 09-2014 M/s Hospira. a.Stability
Port Qasim, Hydrochloride………… Rs.100,000 Photocop data as per
Karachi 100mg /- y of conditions
Water for GMP 19- of Zone
Manufactured injections……….Ph.Eu As per 09-2014. IV-A.
By. r….q.s. SRO b.valid
M/s. Hetero Stability legalized
Labs Limited (Lumphocutic data is COPP.
Unit – VI Sy leukemia, indolent not as c.Separate
No. 410 & 411, non-Hodgkin’s per application
APIIC lymphoma, multiple condition for the
Formulation myeloma) s of Zone registratio
SEZ, Polepally IV-A. n

Village, Manufacturer’s application
Jadcherla Specifications Firm has for WFI.
Mandal, not
Mahaboob 02 years applied
Nagar (Dist) for
509301, Andhra separate
Pradesh, India. registrati
on of
water for
injection.
31. M/s. PharmEvo Bortero 3.5mg Injection Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Velcade 3.5mg valid for the
Plot No. A-29, Each vial contains:- Dy. No 673 (as mannitol upto 30- submissio
North West Bortezomib…….3.5mg dated 11- boronic ester) 12-2015 n of
Industrial Zone, Water for Injection 09-2014 Powder for a.Stability
Port Qasim, Ph.Eur….q.s Rs.100,000 solution for Photocop data as per
Karachi / injection. y of conditions
(Lumphocutic GMP of Zone
Manufactured leukemia, indolent As per valid IV-A.
By. non-Hodgkin’s SRO. upto 19- b.valid
M/s. Hetero lymphoma, multiple 09-2014. legalized
Labs Limited myeloma) COPP.
Unit – VI Sy Stability c.Separate
No. 410 & 411, Manufacturer’s data not application
APIIC Specifications provided. for the
Formulation registratio
SEZ, Polepally 02 years Internati n
Village, onaly the application
Jadcherla product for WFI.
Mandal, is present
Mahaboob as
Nagar (Dist) mannitol
509301, Andhra boronic
Pradesh, India. ester.
Firm has
not
applied
for
separate
registrati
on of
water for
injection.
32. M/s. PharmEvo Capetero 500mg Tablets Form 5A MHRA. COPP Deferred

(Pvt) Ltd., Capecitabine valid for the
Plot No. A-29, Each film coated tablets Dy. No 678 500mg f/c by upto 19- submissio
North West contains:- dated 11- M/s Accord. 09-2014. n of
Industrial Zone, Capecitabine 09-2014 a.Stability
Port Qasim, USP………500mg Rs.100,000 Local. Xeloda Photocop data as per
Karachi. (adjuant treatment of /- 500mg by M/s y GMP conditions
patients following Roche. valid of Zone
Manufactured surgery of stage III As per upto 19- IV-A.
By. colon cancer, meta- SRO. 09-2014. b.valid
M/s. Hetero static colo-rectal legalized
Labs Limited cancer) Stability COPP.
Unit – VI Sy is not as c.Separate
No. 410 & 411, USP Specifications per application
APIIC condition for the
Formulation 02 years s of Zone registratio
SEZ, Polepally IV A. n
Village, application
Jadcherla for WFI.
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
33. M/s. PharmEvo Capetero 150mg Tablets Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Capecitabine valid for the
Plot No. A-29, Each film coated tablets dy. NO 675 Accord 150mg upto 19- submissio
North West contains:- dated 11- f/c by M/s 09-2014. n of
Industrial Zone, Capecitabine 09-2014 Accord. Stability
Port Qasim, USP………150mg Rs.100,000 Photocop data as per
Karachi /- y GMP conditions
(adjuant treatment of valid of Zone
Manufactured patients following As per upto 19- IV-A &
By. surgery of stage III SRO 09-2014. valid
M/s. Hetero colon cancer, meta- legalized
Labs Limited static colo-rectal Stability COPP.
Unit – VI Sy cancer) is not as
No. 410 & 411, per
APIIC USP Specifications condition
Formulation s of Zone
SEZ, Polepally 02 years IV A.
Village,
Jadcherla
Mandal,
Mahaboob

Nagar (Dist)
509301, Andhra
Pradesh, India.
34. M/s Anoro Ellipta Form-5AMHRA. Ano Already Approved
GlaxoSmithKlin Dry Powder Inhaler Ellipta by M/s approved as per
e PakistanEach pre-dispensedDy. No: GSK in 254th Import
Limited 35-dose contains. 693 dated meeting Policy for
Dockyard Road, Umeclidinium…….62.5 18-09-2014 but later Finished
West Wharf,mcg 50,000/- on Drugs
Karachi. Vilanterol (asdated 18- deleted
trifenatate)…25mcg 09-2014 in 256th
(Long acting muscarinic meeting
M/s Glaxo antagonist (LAMA), MRP will as the
Operations UK and a long-acting beta-2 be decision
Limited, Ware agonist (LABA) submitted on new
UK New Molecule later molecule
s was not
clear.
COPP
issued on
06-08-
2014.
35. M/s. Novartis Sandostatin 0.2mg/ml Form 5A MHRA. COPP Approved
Pharma Multi-dose Vial Dy. No 701 Sandostatin issued by as per
(Pakistan) dated 22- 1000mcg/5ml Swiss Import
Limited, 15 Each 5ml vial contains:- 09-2014 by M/s medica Policy for
West Wharf, Octreotide……………. Rs.50,000/- Novartis. Switzerla Finished
Karachi. 1mg nd on Drugs
Rs.9400/5 21-03-
Product Acromegaly/Carcinoid ml vial 2014.
License Holder. Tumors / Vasoactive GMP 07-
M/s. Novartis Intestinal tumors 04-2014.
Pharma Schweiz
AG, 6343,
Risch,
Switzerland. Manufacturer’s
Manufactured Specifications
By
M/s Novartis 48 months
Pharma Stein
AG
Schaffhauserstr
asse 4332 Stein,
Switzerland
36. M/s. Novartis Sandostatin 0.5mg/ml Form 5A MHRA. COPP Approved
Pharma Ampoule Dy. NO Sandostatin issued on as per

(Pakistan) 700 Dated 500mcg/1ml 21-03- Import
Limited, 15 Each 1ml ampoule 22-09-2014 by M/s 2014 by Policy for
West Wharf, contains:- Rs.50,000/- Novartis. Switzerla Finished
Karachi. Octreotide……………. nd. Drugs
0.5mg Rs.23,000/ GMP 07-
Product 5 04-2014
License Holder. Acromegaly/Carcinoid ampoules.
M/s. Novartis Tumors / Vasoactive
Pharma Schweiz Intestinal tumors
AG, 6343, Risch
, Switzerland. Manufacturer’s
Manufactured Specifications
By 36 months
M/s Novartis
Pharma Stein
AG
Schaffhauserstr
asse 4332 Stein,
Switzerland
37. M/s. Kivexa Tablets Form 5A
MHRA. COPP Approved
GlaxoSmithKlin Each film coated tablets Kivexa by M/s issued as per
e Pakistan contains:- Dy No. 729 ViiV dated 16- Import
Limited, 35- Abacavir 600mg (as R&I dated 05-2014 Policy for
Dockyard Road, abacavir sulfate) and 30-09-2014 vide no. Finished
West Wharf, Lamivudine………..300 Rs.50,000/- 10/14/76 Drugs
Karachi. mg 509 by
Will be EMA.
Market (HIV Indicated for the submitted GMP
Authorization management of HIV later. complian
Holder infection) t as per
M/s ViiV New formulation & COPP.
Healthcare UK Anti HIV
Limited, 980
Great West 36 months
Road, Brentford,
Middlesex, TW8
9GS, United
Kingdom
Manufactured
by M/s. M/s
GlaxoSmithKlin
e
Pharmaceuticals
SA, ul.
Grunwaldzka

189, 60-322
Poznan, Poland.
Site Responsible
for Primary &
Secondary
Packaging
M/s Glaxo
Wellcome S.A.,
Avenida
Extremadura 3,
Aranda de
Duero, Burgos,
09400, Spain.
38. M/s. Tivicay Tablets Form 5-A MHRA. Legalize Approved
GlaxoSmithKlin Dy.No.45 Tivicay by d COPP as per
e Pakistan Each film coated tablet R&I Dated M/s ViiV was Import
Limited, 35- contains:- 16-10-2014 issued by Policy for
Dockyard Road, Dolutegravir (as Rs.50,000/- EMA Finished
West Wharf, Dolutegravir Sodium) dated. Drugs
Karachi. ……50mg Price will 19.08-
be provided 2014
Market (HIV. Indicated for the later
Authorization management of HIV
Holder infection)
M/s ViiV New Molecule
Healthcare UK
Limited, 980 24 months
Great West
Road, Brentford,
Middlesex, TW8
9GS, United
Kingdom
Manufactured
by M/s. Glaxo
Operations UK
Ltd, Priory
Street, Ware,
Hertfordshire
SG12 ODJ,
United
Kingdom.
Site Responsible
for Primary &
Secondary
Packaging

M/s Glaxo
Wellcome S.A.,
Avenida
Extremadura 3,
Aranda de
Duero, Burgos,
09400, Spain.
39. M/s. RG Pyramax 180mg/60mg Form 5A WHO Free Approved
Pharmaceutica Each film coated tablets approved sales as per
(Pvt) Ltd., contains:- Dy No. 84 formulation certificat Import
Progressive Artesunate………… dated 10- for treatmente issued Policy for
Square, Block 6, 60mg 11-2014 of malaria dated 17- Finished
Shahra-e-Faisal, Pyronaridine Rs.50,000/- 08-2011 Drugs
Karachi-75400./ tetraphosphate……… vide No.
M/s. Shin Poong 180mg Rs. 2014-
Pharmaceutical (Pyronaridine in142/tablet A1-0403.
Co. Ltd., 70, combination with GMP
Sandan-ro artesunate, an certificat
19beon-gil, artemisinin derivative). e issued
Danwon-gu New Molecule / dated 17-
Ansan-si formualtion 07-2013
Gyeonggido, 02 years vide No.
Korea. 2013-
D1-2253.
40. M/s. Premier Gemtero 1.0g Injection Form 5A MHRA. COPP/Fr Deferred
Agencies, Gemcitabine ee sales for the
60-Muslimabad, Each vial contains:- DY. No 71 1g Powder for certificat submissio
Jamshed Gemcitabine dated 13- injection by e not n of valid
Quarters M.A. Hydrochloride 11-2014 M/s Ranbaxy attached. legalized
Jinnah Road equivalent to Rs.100,000 GMP COPP and
Extension, Gemcitabine 1.0g for / certificat Stability
Karachi.-74800 injection e is not data as per
As per attached. conditions
Manufactured (Advanced or met- SRO Stability of Zone
by static bladder cancer data is IV-A.
M/s. Hetero in combination with not as
Labs Limited , cisplatin, locally or per
Unit-VI, Sy. meta-static condition
No.410 & 411, adenocarcinoma of s of Zone
APIIC pancreas) IV-A.
Formulation
SEZ, Polepally USP Specifications
Village,
Jadcherla 02 years
Mandal,
Mahaboob

Nagar (Dist)
509301, Andhra
Pradesh, India.
41. M/s. Premier Gemtero 200mg Form 5A MHRA. COPP/Fr Deferred
Agencies, Injection Gemcitabine ee sales for the
60-Muslimabad, Dated 13- 200mg certificat submissio
Jamshed Each vial contains:- 11-2014 Powder for e not n of valid
Quarters M.A. Gemcitabine vide diary injection by attached. legalized
Jinnah Road Hydrochloride No. 73 M/s Hospira GMP COPP and
Extension, equivalent to Rs.100,000 certificat Stability
Karachi Gemcitabine 200mg for /- e is not data as per
injection attached. conditions
Manufactured As per Stability of Zone
by (Advanced or met- SRO. data is IV-A.
M/s. Hetero static bladder cancer not as
Labs Limited , in combination with per
Unit-VI, Sy. cisplatin, locally or condition
No.410 & 411, meta-static s of Zone
APIIC adenocarcinoma of IV-A.
Formulation pancreas)
SEZ, Polepally
Village, USP Specifications
Jadcherla
Mandal, 02 years
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
42. M/s. Premier Paclitero 30mg/5ml Form 5A MHRA. COPP Deferred
Agencies, Injection Paclitaxel valid for the
60-Muslimabad, Dy. No 74 6mg/ml Conc. upto 30- submissio
Jamshed Each vial contains:- Dated 13- for solution for 12-2015. n of valid
Quarters M.A. Paclitaxel 11-2014 infusion by legalized
Jinnah Road USP………..30mg/5ml Rs.100,000 M/s Medac Photocop COPP and
Extension, / (5ml, 16.7ml, y of Stability
Karachi.-74800 (Monotherapy for 50ml & GMP data as per
meta-static breast As per 100ml). upto 19- conditions
Manufactured cancer. In SRO 09-2014. of Zone
by combination with Local. IV-A.
M/s. Hetero Gemcitabin for meta- Panataxel Stability
Labs Limited , static adenocarcinoma 100mg, data not
Unit-VI, Sy. of pancreas) 150mg, 300mg as per
No.410 & 411, & 30mg by condition
APIIC USP Specifications M/s s of Zone
Formulation Ferozsons. IV A.
SEZ, Polepally 02 years

Village,
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
43. M/s. Premier Paclitero 100mg/16.7ml Form 5A MHRA. COPP Deferred

Jamshed Each vial contains:- dated 13- for solution for 12-2015. n of valid
Quarters Paclitaxel 11-2014 infusion by legalized
M.A. Jinnah USP………..100mg/16. Rs.100,000 M/s Medac Photocop COPP and
Road Extension, 7ml / (5ml, 16.7ml, y of Stability
Karachi.-74800 50ml & GMP data as per
(Monotherapy for As per 100ml). valid conditions
M/s. Hetero meta-static breast SRO upto 19- of Zone
Labs Limited , cancer. In Local. 09-2014. IV-A.
Unit-VI, Sy. combination with Panataxel
No.410 & 411, Gemcitabin for meta- 100mg, Stability
APIIC static adenocarcinoma 150mg, 300mg data not
Formulation of pancreas) & 30mg by as per
SEZ, Polepally M/s condition
Village, USP Specifications Ferozsons. s of Zone
Jadcherla IV A.
Mandal, 02 years
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
44. M/s. Premier Paclitero 300mg Form 5A MHRA. COPP Deferred

Jamshed Each vial contains:- dated 13- for solution for 12-2015. n of valid
Quarters Paclitaxel 11-2014 infusion by legalized
M.A. JinnahUSP………..300mg/50 Rs.100,000 M/s Medac Photocop COPP and
Road Extension, ml /- (5ml, 16.7ml, y of Stability
Karachi 50ml & GMP data as per
(Monotherapy for As per 100ml). valid conditions
M/s. Hetero meta-static breast SRO upto 19- of Zone
Labs Limited , cancer. In Local. 09-2014. IV-A.
Unit-VI, Sy. combination with Panataxel Stability
No.410 & 411, Gemcitabin for meta- 100mg, data is
APIIC static adenocarcinoma 150mg, 300mg not as

Formulation of pancreas) & 30mg by per
SEZ, Polepally M/s condition
Village, USP Specifications Ferozsons. s of Zone
Jadcherla IV A.
Mandal, 02 years
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
45. M/s. Mekinist 0.5mg Tablets Form 5A MHRA. The firm Approved
GlaxoSmithKlin Mekinist f/c has as per
e Pakistan Each film coated tablets 03-12-2014 tablet 0.5mg & provided Import
Limited, 35- contains:- vide diary 2mg by M/s 2 Policy for
Dockyard Road, Trametinib dimethyl/ No.188 Novartis. COPPs. Finished
West Wharf, sulfoxide equivalent to Rs.50,000/- The first Drugs
Karachi. 0.5mg trametinib COPP
As per PRC issued
Manufactured Mono therapy or in dated 19-
by :- combination with 09-2014
M/s. Debrafenib for by EMA
GlaxoSmithKlin patients with un- says that
e Manufacturing resectable or met- “The
S.p.A., Strada static melanoma product
Provinciale is not
Asolana, 90, New molecule. actualy
43056 San Polo in the
di Torrile, Manufacturer’s market
Parma, Italy. Specifications of
Primary & exportin
Secondary 02 years g
Packaging country
Site:- ”
M/s. Glaxo GMP
Wellcome S.A. complian
Avenida t as per
Extremadura, 3, COPP.
09400 Aranda The 2nd
de Duero, COPP
Burgos, Spain. issued
Market dated 21-
Authorization 09-2015
Holder says that
Glaxo Group the
Ltd, 980 Great product
West Road, is on free
Brentford, sale in

Middlesex TW8 the
9GS, United exportin
Kingdom. g
country.
46. M/s. Mekinist 2mg Tablets Form 5A MHRA. The firm Approved
GlaxoSmithKlin Mekinist f/c has as per
e Pakistan Each film coated tablets Dy. No 187 tablet 0.5mg & provided Import
Limited, 35- contains:- Dated 02- 2mg by M/s 2 Policy for
Dockyard Road, Trametinib dimethyl/ 12-2014 Novartis. COPPs. Finished
West Wharf, sulfoxide equivalent to Rs.50,000/- The first Drugs
Karachi. 2mg trametinib COPP
As per PRC issued
Manufactured Mono therapy or in dated 19-
by :- combination with 09-2014
M/s. Debrafenib for by EMA
GlaxoSmithKlin patients with un- says that
e Manufacturing resectable or met- “The
S.p.A., Strada static melanoma product
Provinciale is not
Asolana, 90, New molecule. actualy
43056 San Polo in the
di Torrile, Manufacturer’s market
Parma, Italy. Specifications of
Primary & exportin
Secondary 02 years g
Packaging country
Site:- ”
M/s. Glaxo GMP
Wellcome S.A. complian
Avenida t as per
Extremadura, 3, COPP.
09400 Aranda The 2nd
de Duero, COPP
Burgos, Spain. issued
Market dated 21-
Authorization 09-2015
Holder says that
Glaxo Group the
Ltd, 980 Great product
West Road, is on free
Brentford, sale in
Middlesex TW8 the
9GS, United exportin
Kingdom. g
country.

47. M/s. Care Microbar HD Powder Form 5A COPP Deferred
Takers the for Suspension valid up for the
Healthcare Each 100gm contains:- Dy No. 233 to 2-5- confirmati
Company, Barium Sulpahte dated 15- 2015. on as X-
131-B, M.A. B.P…………..95gm 12-2014 GMP Ray
Johar Town, Palatable Base Rs.50,000/- vslif upto Contrast
Lahore. q.s……………..100gm 2-5- Media is
(X-Ray Contrast Media) 2015. not
M/s. Eskay 03 years included
Speciality for priority
Chemicals, considerati
Plot No. 207-B on
& 208 Surat
Special
Economic Zone,
Road No.-4,
G.I.D.C., At &
Post Sachin,
Surat, India.
48. M/s. Incruse Ellipta Form-5A Already Approved

GlaxoSmithKlin approved as per
e Pakistan Dry Powder Inhaler Dy. No: in 254th Import
Limited, 35- Each pre-dispensed 234 dated meeting Policy for
Dockyard Road, dose contains. 15-12-2014 but later Finished
West Wharf, Umeclidinium 50,000/- on Drugs
Karachi-74000. (equivalent to 74.2 mcg dated 15- deleted
of umecidinium 12-2014 by the
Manufactured bromide)…….62.5mcg Board in
by Will be 256th
M/s. Glaxo (Long acting muscarinic submitted meeting
Operations UK antagonist (LAMA) later as the
Limited, Priory decision
Street, Ware New molecule. on new
Hertfordshire molecule
SG12 ODG, s is not
United clear.
Kingdom. COPP
Issued on
Market 28-10-
Authorization 2014
Holder

M/s Glaxo
Group Ltd, 980
Great West
Road, Brentford,
Middlesex TW8
9GS, United
Kingdom.
49. M/s. Novartis Zykadia 150mg Hard Form 5A MHRA. COPP Deferred
Pharma Gelatin Capsules Zykadia valid for the
(Pakistan) Dy. No 243 150mg capsule upto 07- clarificatio
Limited, 15 Each capsule contains:- dated 17- by M/s 07-2016 n
West Wharf, Ceritinib…………..150 12-2014 Novartis. issued by regarding
Karachi. mg Rs.50,000/- US FDA. approval
status of
Manufactured (Anaplastic lymphoma Rs.450,000 product by
By kinase positive /50’s regulataor
M/s. Novartis advanced non small capsules. y authority
Pharma Stein cell lung cancer) of
AG, Stein, Switzerlan
Switzerland. Manufacturer’s d.
Specifications
24 months
50. M/s. Novartis Jakavi 10mg Tablet Form 5A MHRA. Jakavi Dossier Deferred
Pharma 5, 10, 15 & is for the
(Pakistan) Each tablet contains:- Dy No. Nil 20mg by M/s photocop verificatio
Limited, 15 Ruxolitinib………..10m dated 24- Novartis. y fee n of fee,
West Wharf, g 12-2014 Rs.50,00 submissio
Karachi. Rs.50,000/- 0 is n valid
(Myelo fibrosis, photocop legalized
M/s. Novartis polycythemia vera) Rs.418520/ y. COPP
Pharma Stein 56’s tablets Photoco
AG, Stein, Manufacturer’s py COPP
Switzerland. Specifications issued
dated07-
24 months 11-2014.
GMP
complian
t as per
COPP.
Stability
data as
per
condition
s of Zone
IV-B

attached.
51. M/s. PharmEvo Temotero 250mg Form 5A MHRA. COPP Deferred

(Pvt) Ltd., Capsule Temodal 5mg, valid for the
Plot No. A-29, DY. 272 20mg, 100mg, upto 30- submissio
North West Each hard gelatin dated 24- 140mg, 180mg 12-2015. n of
Industrial Zone, capsule contains:- 12-2014 & 250mg by stability
Port Qasim, Temozolomide……… Rs.100,000 M/s Merck Photocop data as per
Karachi …..250mg / y of conditions
Local. GMP of Zone IV
M/s. Hetero (For newly diagnosed As per Temoside valid A and
Labs Limited Glioblastoma SRO 20mg, 100mg upto 19- valid
Unit – VI Sy multiforme & 250mg by 09-2014. legalized
No. 410 & 411, concomitantly with M/s AJ. Mirza. COPP
APIIC radiotherapy) Stability
Formulation is not as
SEZ, Polepally Manufacturer’s per
Village, Specifications condition
Jadcherla s of Zone
Mandal, 02 years IV A.
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
52. M/s. PharmEvo Temotero 5mg Capsule Form 5AMHRA. COPP Deferred
(Pvt) Ltd., Temodal 5mg, valid for the
Plot No. A-29, Each hard gelatin Dy. No 273 20mg, 100mg, upto 30- submissio
North Westcapsule contains:- dated 24- 140mg, 180mg 12-2015. n of
Industrial Zone, Temozolomide……… 12-2014 & 250mg by stability
Port Qasim, …..5mg Rs.100,000 M/s Merck Photocop data as per
Karachi /- y of conditions
(For newly diagnosed GMP of Zone IV
Manufactured Glioblastoma As per valid A and
By. multiforme SRO upto 19- valid
M/s. Hetero concomitantly with 09-2014. legalized
Labs Limited radiotherapy) COPP
Unit – VI Sy Stability
No. 410 & 411, Manufacturer’s is not as
APIIC Specifications per
Formulation condition
SEZ, Polepally 02 years s of Zone
Village, IV A.
Jadcherla
Mandal,
Mahaboob

Nagar (Dist)
509301, Andhra
Pradesh, India.
53. M/s. PharmEvo Temotero 20mg Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Capsule Temodal 5mg, valid for the
Plot No. A-29, Dy. NO 20mg, 100mg, upto 30- submissio
North West Each hard gelatin 270 Dated 140mg, 180mg 12-2015. n of
Industrial Zone, capsule contains:- 24-12-2014 & 250mg by stability
Port Qasim, Temozolomide……… Rs.100,000 M/s Merck Photocop data as per
Karachi …..20mg /- y of conditions
Local. GMP of Zone IV
Manufactured (For newly diagnosed As per Temoside valid A and
By. Glioblastoma SRO 20mg, 100mg upto 19- valid
M/s. Hetero multiforme & 250mg by 09-2014. legalized
Labs Limited concomitantly with M/s AJ. Mirza. COPP
Unit – VI Sy radiotherapy) Stability
No. 410 & 411, is not as
APIIC Manufacturer’s per
Formulation Specifications condition
SEZ, Polepally 02 years s of Zone
Village, IV A.
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
54. M/s. PharmEvo Temotero 100mg Form 5A MHRA. Original Deferred

(Pvt) Ltd., Capsule Temodal 5mg, not for the
Plot No. A-29, Dy. No 271 20mg, 100mg, provided. submissio
North West Each hard gelatin dated 24- 140mg, 180mg Photocy n of
Industrial Zone, capsule contains:- 12-2014 & 250mg by COPP stability
Port Qasim, Temozolomide……… Rs.100,000 M/s Merck valid data as per
Karachi …..100mg /- upto 30- conditions
Local. 12-2015. of Zone IV
Manufactured (For newly diagnosed As per Temoside Photocop A and
By. Glioblastoma SRO 20mg, 100mg y of valid
M/s. Hetero multiforme & 250mg by GMP legalized
Labs Limited concomitantly with M/s AJ. Mirza. valid COPP
Unit – VI Sy radiotherapy) upto 19-
No. 410 & 411, 09-2014.
APIIC Manufacturer’s
Formulation Specifications Stability
SEZ, Polepally is not as
Village, 02 years per

Jadcherla condition
Mandal, s of Zone
Mahaboob IV A.
Nagar (Dist)
509301, Andhra
Pradesh, India.
55. M/s. Gene-Tech ADPEM 500 Injection Form 5A MHRA. COPP Deferred
Laboratories, Alimta 100mg valid for the
Head Office. Each vial contains:- Dy No.255 & 500mg upto 08- submissio
246/B, PECHS, Pemetrexed Disodium R&I dated powder for 02-2015. n of
Block-6, eq. to Pemetrexed…….. 24-12-2014 conc. For No. following
Karachi. …………500mg Rs.100,000 infusion by HFW-H a. Stability
Mannitol /- M/s Eli Lilly. (DRUG) data as per
Manufactured USP…………..500mg 22/05 conditions
by Rs.70,000/ Local. Alimta (Vol.VI) of Zone IV
M/s. Adley (Malignant pleural vial 100mg & A
Formulations, mesothelioma non- 500mg by M/s GMP b.Sole
Vill. Kotla, PO. small cell lung cancer) Eli Lilly. certificat agency
Borotiwala, e valid agreement
Tehsil: Baddi, 24 months upto 08- c. Drug
Distt. Solan, 02-2015 Sales
Himachal (H.P) No. License.
Pradesh, India. HFW-H
(DRUG)
22/05
(Vol.VI)
56. M/s. Gene-Tech CAPAD 500mg Tablets Form 5A MHRA. COPP Deferred
Laboratories, Capecitabine valid for the
Head Office. Each film coated tablet Dy No.256 500mg f/c by upto 08- submissio
246/B, PECHS, contains:- R&I dated M/s Accord. 02-2015. n of
Block-6, Capecitabine 24-12-2014 No. following
Karachi. USP…………..500mg Rs.100,000 Local. Xeloda HFW-H a. Stability
/- 500mg by M/s (DRUG) data as per
Manufactured (adjuant treatment of Roche. 22/05 conditions
by patients following Rs.2083/10 (Vol.VI) of Zone IV
M/s. Adley surgery of stage III ’s A
Formulations, colon cancer, meta- GMP b.Sole
Vill. Kotla, PO. static colo-rectal certificat agency
Borotiwala, cancer) e valid agreement
Tehsil: Baddi, upto 08- c. Drug
Distt. Solan, 24 months 02-2015 Sales
(DRUG)

22/05
(Vol.VI)
57. M/s. Gene-Tech BORTIAD 2.0mg Form 5-A COPP Deferred

Laboratories, Injection valid for the
Head Office. Dy No.257 upto 08- submissio
246/B, PECHS, Each vial contains:- R&I dated 02-2015. n of
Block-6, Bortezomib…………… 24-12-2014 No. following
Karachi. …..2.0mg Rs.100,000 HFW-H a.
/- (DRUG) Approval
Manufactured (Lymphocytic 22/05 status by
by leukemia, indolent Not (Vol.VI) reference
M/s. Adley non-Hodgkin’s mentioned regulatory
Formulations, lymphoma, multiple GMP authorities
Vill. Kotla, PO. myeloma) certificat b.Stability
Borotiwala, e valid data as per
Tehsil: Baddi, 24 months upto 08- conditions
Distt. Solan, 02-2015 of Zone IV
Himachal (H.P) No. A.
Pradesh, India. HFW-H c.Sole
(DRUG) agency
22/05 agreemend
(Vol.VI) d.Drug
Approval Sales
status in License.
reference
countries
is not
provided.
Internati
onaly the
product
is present
as
mannitol
boronic
ester.
Clarificat
ion
whether
the
product
is in
liquid
form or
powder

form.
58. M/s. Gene-Tech ADGEF 250mg Tablet Form 5-A

MHRA. Iressa COPP Deferred
Laboratories, 250mg f/c valid for the
Head Office. Each film coated tablet Dy No.261 tablet by M/s upto 08- submissio
246/B, PECHS, contains:- R&I dated AstraZeneca. 02-2015. n of
Block-6, Gefitinib…………… 24-12-2014 No. following
Karachi. 250mg Rs.100,000 Local. HFW-H a. Stability
/- (DRUG) data as per
Manufactured (Advanced or meta- 22/05 conditions
by static non small cell Rs.140,000 (Vol.VI) of Zone IV
M/s. Adley lung cancer) /15’s pack A
Formulations, GMP b.Sole
Vill. Kotla, PO. 24 months certificat agency
Borotiwala, e valid agreement
Distt. Solan, 02-2015 Sales
(DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
59. M/s. Gene-Tech ADMINE 100mg Tablet Form 5-A MHRA. COPP Deferred
Laboratories, Glivec 100mg valid for the
Head Office.Each film coated tablet Dy No.259 & 400mg f/c upto 08- submissio
246/B, PECHS, contains:- R&I dated by M/s 02-2015. n of
Block-6, Imatinib Mesylate 24-12-2014 Novartis. No. following
Karachi. Eq. to Rs.100,000 HFW-H a. Stability
Imatinib………… /- Local. Glivec (DRUG) data as per
M/s. Adley 100mg 100mg & 22/05 conditions
Formulations, Rs.11083/1 400mg by M/s (Vol.VI) of Zone IV

Vill. Kotla, PO. (Philadelphia 0’s pack Novartis A
Borotiwala, chromosome positive Pharma. GMP b.Sole
Tehsil: Baddi, chronic myeloid certificat agency
Distt. Solan, leukemia) e valid agreement
Himachal (H.P) upto 08- c. Drug
Pradesh, India. Manufacturer’s 02-2015 Sales
Specifications No. License.
HFW-H
24 months (DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
60. M/s. Gene-Tech ADMINE 400mg Tablet Form 5-A MHRA. COPP Deferred
Laboratories, Glivec 100mg valid for the
Head Office. Each film coated tablet Dy No.260 & 400mg f/c upto 08- submissio
246/B, PECHS, contains:- R&I dated by M/s 02-2015. n of
Block-6, Imatinib Mesylate 24-12-2014 Novartis. No. following
Karachi. Eq. to Rs.100,000 HFW-H a. Stability
Imatinib………… /- Local. Glivec (DRUG) data as per
M/s. Adley 400mg 100mg & 22/05 conditions
Formulations, Rs.46667/1 400mg by M/s (Vol.VI) of Zone IV
Vill. Kotla, PO. (Philadelphia 0’s pack Novartis A
Borotiwala, chromosome positive Pharma. GMP b.Sole
Tehsil: Baddi, chronic myeloid certificat agency
Distt. Solan, leukemia) e valid agreement
HFW-H
24 months (DRUG)
22/05
(Vol.VI)

Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
61. M/s. Gene-Tech ERLOTAD 100mg Form 5A MHRA. COPP Deferred

Laboratories, Tablet Tarceva 25mg, valid for the
Head Office. Dy No. 258 100mg & upto 08- submissio
246/B, PECHS, Each film coated tablet R&I dated 150mg f/c 02-2015. n of
Block-6, contains:- 24-12-2014 tablets by M/s No. following
Karachi. Erlotinib Hydochloride Rs.100,000 Roche. HFW-H a. Stability
Eq. to /- (DRUG) data as per
M/s. Adley Erlotinib…………….10 Local. Tarceva 22/05 conditions
Formulations, 0mg As per 25mg, 100mg (Vol.VI) of Zone IV
Vill. Kotla, PO. SRO & 150mg f/c A
Borotiwala, (Non small cell lung tablets by M/s GMP b.Sole
Tehsil: Baddi, cancer or pancreatic Roche. certificat agency
Distt. Solan, cancer) e valid agreement
HFW-H
24 months (DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not

provided.
62. M/s. Gene-Tech ERLOTAD 150mg Form 5A MHRA. COPP Deferred

Laboratories, Tablet Tarceva 25mg, valid for the
Head Office. Dy No. 254 100mg & upto 08- submissio
246/B, PECHS, Each film coated tablet R&I dated 150mg f/c 02-2015. n of
Block-6, contains:- 24-12-2014 tablets by M/s No. following
Karachi. Erlotinib Hydochloride Rs.100,000 Roche. HFW-H a. Stability
Eq. to /- (DRUG) data as per
Manufactured Erlotinib…………….15 Local. Tarceva 22/05 conditions
by 0mg As per 25mg, 100mg (Vol.VI) of Zone IV
M/s. Adley SRO & 150mg f/c A
Formulations, (Non small cell lung tablets by M/s GMP b.Sole
Vill. Kotla, PO. cancer or pancreatic Roche. certificat agency
Borotiwala, cancer) e valid agreement
Distt. Solan, Manufacturer’s 02-2015 Sales
Himachal (H.P) Specifications No. License.
Pradesh, India.. HFW-H
24 months (DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
63. M/s. Group 9 Sport Vis TM pre-filled Form 5A Free Deferred

Pakistan, syringe for peri-articular sales for the
MI, 19-C Rahat injection Dy 284 certificat clarificatio
Commercial Each pre-filled syringe dated 29- e valid n as the
Lane 2, DHA contains:- 12-2014 upto complete
Phase-6, 1.2ml 1% low Rs.50,000/- dated 01- description
Karachi. molecular weight 10-2016 as applied
sodium hyaluronatein by swiss on Form

M/s. MDT phosphate buffered medic 5A is not
Int,SA, saline but same as
Rue du 31 (Peri-articular injection) complete mentioned
Decembre, 36 descripti on free
1207 Geneva, 36 months on as sales
Switzerland. applied certificate.
Manufacturing New molecule on Form Firm will
site address: 5A is not provide
Hyaltech Ltd., mentione either
Starlaw d on free CoPP or
Business Park sales. FSC and
EH54 8SF Medical GMP
Livingston, Device
United
Kingdom.
64. M/s. Langene Letrax 2.5mg Tablet Form 5A MHRA. Femra Non Deferred
Biotech, 2.5mg f/c legalized for the
Head Office. Each film coated tablet Dy No. 01 tablet by M/s copy of submissio
246/B, PECHS, contains:- dated 01- Novartis. COPP n of
Block-6, Letrozole (micronized) 01-2015 dated 17- following
Karach-75400. …….……..2.5mg Rs.100,000 Local. Femra 09-2014 a. Valid
/- 2.5mg by M/s attached. legalized
M/s. Aburaihan (Adjuant treatment of Novartis. DSL is COPP.
Pharmaceutical post-menopausal Rs.6000/30 not b. Drugs
Company, women with harmone ’s Pack. attached. Sales
No.1, Hojr ebne recpotor positive Stability License.
Oday Ave, invasive early breast data as c. Stability
Tehranpars cancer) per data as per
Tehran-I.R. Iran. condition conditions
Manufacturer’s s of Zone of Zone
Specifications IV-A is IV-A
not d. Sole
03 years provided. agency
Sole agreement.
agency
agreeme
nt is not
provided.
65. M/s. Care Microbar CAT 2 Liquid Form 5A COPP Deferred

Takers the Suspension valid for the
Healthcare Each 100ml contains:- Dy No. 12 upto 2-5- confirmati
Company, 131- Barium Sulpahte dated 08- 2015. on as X-
B, M.A. Johar B.P…………..7gm 01-2015 GMP Ray
Town, Lahore. Palatable Base Rs.50,000/- valid Contrast
q.s……………..100ml upto 2-5- Media is

M/s. Eskay (X-Ray Contrast Media) 2015. not
Speciality 03 years included
Chemicals, for priority
Plot No. 207-B considerati
& 208 Surat on
Special
Economic Zone,
Road No.-4,
G.I.D.C., At &
Post Sachin,
Surat, India.
66. M/s. Care Microbar for Enema Form 5A COPP Deferred
Takers the (Disposable Kit) valid for the
Healthcare Powder for Rectal Dy No. 11 upto 2-5- confirmati
Company, 131- Suspension dated 08- 2015. on as X-
B, M.A. Johar Each 100gm contains:- 01-2015 GMP Ray
Town, Lahore. Barium Sulpahte Rs.50,000/- valid Contrast
B.P…………..92gm upto 2-5- Media is
M/s. Eskay Base 2015. not
Speciality q.s…………………… included
Chemicals, ….100gm for priority
Plot No. 207-B (X-Ray Contrast Media) considerati
& 208 Surat 03 years on
Special
Economic Zone,
Road No.-4,
G.I.D.C., At &
Post Sachin,
Surat, India.
67. M/s. PharmEvo Iritero Injection Form 5A MHRA. COPP/Fr Deferred

(Pvt) Ltd., 40mg/2ml Campto ee sales for the
Plot No. A-29, Dy. No 14 20mg/ml, certificat submissio
North West Each vial contains:- dated 08- conc. For e is not n of
Industrial Zone, Irinotecan 01-2015 solution 40mg, attached. following
Port Qasim, Hydrochloride Rs.100,000 100mg, & GMP a. Stability
Karachi …….40mg /- 300mg. certificat data as per
e is not conditions
Manufactured (Advanced Colorectal As per attached. of Zone
By. cancer) SRO Stability IV-A.
M/s. Hetero data is b. Valid
Labs Limited Manufacturer’s not as Legalized
Unit – VI Sy Specifications per CoPP.
No. 410 & 411, 03 years condition
APIIC s of Zone
Formulation IV-A.

SEZ, Polepally
Village,
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
68. M/s. PharmEvo Iritero Injection Form 5 A MHRA. COPP/Fr Deferred

(Pvt) Ltd., 100mg/5ml Campto ee sales for the
Plot No. A-29, Dy. No 13 20mg/ml, certificat submissio
North West Each vial contains:- dated 08- conc. For e is not n of
Industrial Zone, Irinotecan 01-2015 solution 40mg, attached. following
Port Qasim, Hydrochloride Rs.100,000 100mg, & GMP a. Stability
Karachi …….100mg /- 300mg. certificat data as per
e is not conditions
Manufactured (Advanced Colorectal As per attached. of Zone
By. cancer) SRO Stability IV-A.
M/s. Hetero data is b. Valid
Labs Limited not as Legalized
Unit – VI Sy Manufacturer’s per CoPP.
No. 410 & 411, Specifications condition
APIIC s of Zone
Formulation 03 years IV-A.
SEZ, Polepally
Village,
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
69. M/s. Biomedics Ipraneb 500 mcg /2ml Form 5A

MHRA. COPP Approved
Medical System, Nebuliser Solution Atrovent 2ml issued by as per
F-597, F-Block, Dy No.20 250mcg/ml by Malaysia Import
Satellite Town, Each 2ml vial contains:- dated 14- M/s Drug Policy for
Rawalpindi. Ipratropium 01-2015 Boehringer. Control Finished
Bromide……………… Rs.50,000/- Authorit Drugs
Manufactured …….500mcg/2ml y on
by Rs.450/Via dated 31-
M/s. Ain (Anticholinergics) l 2ml 10-2014
Medicare New Formulation vide
SDN.BHD, Number
Jalan 6/44, Manufacturer’s 1879/201

Kawasan Specifications 4.
Perindustrian GMP
Pengkalan 02 years certificat
Chepa 2, 16100 e issued
Kota Bharu dated 29-
Kelantan Darul 10-2014
Naim, Malaysia. vide No.
413/14
valid
upto 04-
01-2017
Stability
data on
the
condition
s of
water
loss is
attached
being
semi
permeabl
e
container
s.
70. M/s. Ali Gohar Simbrinza Eye Drops, Form 5-A EMA. Original Deferred
& Company Suspension Dy No.33 Simbrinza by legalized for the
(Pvt) Limited, Contains:- 23-02-2015 M/s Alcon COPP submissio
State Life Brinzolamide…………. Rs.50,000/- was n of
Building 1B, I.I 10mg/ml issued by stability
Chundrigar Brimonidine Tartrate EMA on data as per
Road, Karachi. 2mg eq.to dated conditions
Manufacture by. Brimonidine…….1.3mg 01-09- of zone IV
M/s. Alcon- / ml 2014. A.
Couveur N.V. 24 months GMP
Rijksweg 14, B- (Ophthalmic) issued by
2870, Puurs, balgium
Belgium. New Formulation on dated
Site for Quality 17-05-
Control, Primary 2013
& Secondary Stability
Packaging. data not
M/s Alcon as per
Research Ltd Zone IV
(Subsidiary of A.
Alcon

Laboratories,
Inc), ASPEX
manufacturing
Facility, 6201
South Freeway,
Fort Worth, TX
76134-2099,
USA
Market
Authorization:
Alcon
Laboratories
(UK) Ltd,
Frimley
Business Park,
Frimley,
Camberley
GU16 7SR,
United
Kingdom.
71. M/s. Novartis Signifor LAR Powder Form 5-A MHRA. Orignal Deferred
Pharma for Suspension for Signifor legalized for the
(Pakistan) Injection Dy No.314 Powder for COPP clarificatio
Limited, 15 R&I dated injection was n/submissi
West Wharf, Each vial contains:- 29-05-2015 20mg, 40mg issued by on of
Karachi. Pasireotide……………. Rs.50,000/- & 60mg by Europea following
20mg M/s Novartis n a. Status
Manufactured (as pasireotide pamoate) Rs.450,000 Medicine of
By / 1’s Agency manufactu
M/s. Novartis (Treatment of on ring site
Pharma AG, Acromegaly) 19-02- for the
Lichtstrasse 35, New Molecule 2015. manufactu
4056 Basel, The ring of
Switzerland. Manufacturer’s GMP sterile
Market Specifications certificat products
Authorization: e says as GMP
Novartis 36 months that the states that
Europharm site is site is
Limited, licensed licensed to
Wimblehurst to manufactu
Road, Horsham, manufact re
West Sussex ure medicinal
RH12 5AB, medicina products
United Kingdom l excluded
products sterile
excluded products.

sterile b.
products. Registratio
n
application
of Solvent
on
separate
application
.
Limited, 15 dated 29- injection was n/submissi
West Wharf, Each vial contains:- 05-2015 20mg, 40mg issued by on of
By /1’s Agency manufactu
M/s. Novartis (Treatment of on ring site
Pharma AG, Acromegaly) (36 19-02- for the
Lichtstrasse 35, months) 2015. manufactu
4056 Basel, New Molecule The ring of
Switzerland. GMP sterile
Market Manufacturer’s certificat products
Authorization: Specifications e says as GMP
Novartis that the states that
Europharm 36 months site is site is
products sterile
excluded products b.
sterile Registratio
products. n
application
of Solvent
on
separate
application
.

Limited, 15 R&I dated injection was n/submissi
West Wharf, Each vial contains:- 29-05-2015 20mg, 40mg issued by on of
By (Treatment of 0/1’s Agency manufactu
M/s. Novartis Acromegaly) on ring site
Pharma AG, New Molecule 19-02- for the
Lichtstrasse 35, 2015. manufactu
4056 Basel, Manufacturer’s The ring of
Switzerland. Specifications GMP sterile
Market certificat products
Authorization: 36 months e says as GMP
Novartis that the states that
Europharm site is site is
products sterile
excluded products b.
sterile Registratio
products. n
application
of Solvent
on
separate
application
.
74. M/s. ICIMartxel 500mg Form 5A MHRA. COPP Approved
Pakistan Lyophilized Powder for Alimta 100mg issued on as per
Limited, injection solution for Dy. No & 500mg 29-12- Import
Life Sciencesintravenous infusion 330 dated powder for 2014 by Policy for
Business, ICI 01-06-2015 conc. For Argentin Finished
House, 5 West Each vial contains:- Rs.100,000 infusion by a is valid Drugs.
Wharf, Karachi Pemetrexed as /- M/s Eli Lilly. for 12 Firm will
disodium………….500 month. provide
Manufactured mg As per Local. Alimta valid
by SRO 100mg & GMP legalized
M/s. Eriochem (Malignant pleural 500mg by M/s complian CoPP and
S.A. mesothelioma non- Eli Lilly. t as per chairman
Ruta 12, Km small cell lung cancer) COPP. will permit
452 (3107), further
Colonia Manufacturer’s Stability processing

Avellaneda, Specifications data as of case
Departamento per
Parana, Entre 24 months condition
Rios, Argentina. s of Zone
IV-B.
75. M/s. Pharmatec Oramorph 2mg/ml Form 5A MHRA. Certificat Approved
Pakistan (Pvt) Syrup Dy. No 320 Oramorph e of as per
Ltd., D-86/A dated 01- 10mg/5ml by Medicina Import
Mangopir Road, Each ml contains:- 06-2015 M/s l product Policy for
S.I.T.E, Karachi. Morphine Rs.100,000 Boehringer. 03-03- Finished
Manufactured Sulphate………..2mg /- 2015. Drugs
By GMP
M/s. (Natural Opium Rs.648/100 issued
L.MOLTENI & Alkaloids) ml dated 07-
C, DEI F.LLI 22-2014.
ALITTI New formulation
SOCIETA’DI
ESERCIZIO Manufacturer’s
S.P.A. S.S.67 Specifications
(TOSCO
ROMAGNOLA 36 months
) LOCALITA
GRANATIERI-
50018, ITALY.
76. M/s. Pharmatec Oramorph 20mg/ml Form 5A MHRA. Certificat Approved
Pakistan (Pvt) Oral Solution Dy. No 319 Oramorph e of as per
Ltd., D-86/A dated 01- 20mg/ml by Medicina Import
Mangopir Road, Each ml contains:- 06-2015 M/s l product Policy for
S.I.T.E, Karachi. Morphine Rs.100,000 Boehringer 03-03- Finished
/ Sulphate………..20mg /- 2015. Drugs
Manufactured GMP
By (Natural Opium Rs.829/20 issued
M/s. Alkaloids) ml dated 07-
L.MOLTENI & 22-2014.
C, DEI F.LLI New formulation
ALITTI
SOCIETA’DI Manufacturer’s
ESERCIZIO Specifications
S.P.A. S.S.67
(TOSCO 36 months
ROMAGNOLA
) LOCALITA
GRANATIERI-
50018, ITALY.
77. M/s. Merixil Biopac 30mg/5ml Form 5A MHRA. COPP Approved
Pharma, Injection Dy No. 349 Paclitaxel issued on as per

Office # 28, dated 15- 6mg/ml Conc. 11-08- Import
Second Floor, Each ml contains:- 06-2015 for solution for 2014 by Policy for
Rose Plaza, I-8 Paclitaxel………….… Rs.100,000 infusion by Health Finished
Markaz, 6mg . M/s Medac Canada. Drugs
Islamabad. (5ml, 16.7ml,
Manufactyured (Monotherapy for As per 50ml & GMP
By meta-static breast SRO. 100ml). Complia
M/s. Biolyse cancer. In nt as per
Pharma combination with Local. COPP.
Corporation, 59 Gemcitabin for meta- Panataxel
Welland Vale static adenocarcinoma 100mg,
Road, ST of pancreas) 150mg, 300mg
Catharines & 30mg by
Ontario L2S M/s
3Y2, Canada. USP Specifications Ferozsons.
30 months
78. M/s. Genome Wego Single 09-07-2015 (Photoco Deferred
Pharmaceuticals Disposable Blood Bag Rs.50,000/- py) of for the
(Pvt) Ltd., Plot # Each 100ml of CPDA Certificat submissio
16/1, Phase IV, contains:- e for n of
Industrial Estate, Citric acid Exportati following
Hattar, Distt, monohydrate……..… on of a. Valid
Haripur./ 0.327g Medical legalized
Sodium citrate Products COPP
M/s. Shandong dihydrate………… issued by b. Stability
Weigao Group 2.63g Governm data as per
Medical Sodium biphosphate ent of water loss
Polymer Co., monohydrate…0.222g China on conditions
Ltd. 10 Mashan Dextrose dated.20- as per ICH
Road High-Tech monohydrate….3.19g 05-2014 Guidelines
Industrial Adenine………0.0275g Original .
Development Water for GMP
Zone, Weihai, injection…………q.s is not
Shandong (Medical consumables) attached
Province,
People’s Blood Bag
Republic of
China. 02 years
79. M/s. Genome Wego Double 09-07-2015 (Photoco Deferred


Hattar, Distt, monohydrate.…0.327g on of a. Valid
Haripur./ Sodium citrate Medical legalized
M/s. Shandong dihydrate………2.63g Products COPP
Weigao Group Sodium biphosphate issued by b. Stability
Medical monohydrate…..0.222g Governm data as per
Polymer Co., Dextrose ent of water loss
Ltd. 10 Mashan monohydrate….3.19g China on conditions
Road High-Tech Adenine………0.0275g dated.20- as per ICH
Industrial Water for 05-2014 Guidelines
Development injection……………q.s Original .
Zone, Weihai, (Medical consumables) GMP
Shandong is not
Province, Blood Bag attached
People’s
Republic of 02 years
China.
80. M/s. Genome Wego Triple Disposable 09-07-2015 (Photoco Deferred

Pharmaceuticals Blood Bag Rs.50,000/- py) of for the
Hattar, Distt, monohydrate…0.327g on of a. Valid
Medical monohydrate…0.222g Governm data as per
Ltd. 10 Mashan monohydrate…..3.19g China on conditions
Road High-Tech Adenine……0.0275g dated.20- as per ICH
Development injection…………q.s Original .
Shandong is not
People’s
China.
81. M/s. Genome Wego Quadruple 09-07-2015 (Photoco Deferred

Hattar, Distt, monohydrate…0.327g on of a. Valid

Medical monohydrate…0.222g Governm data as per
Ltd. 10 Mashan monohydrate…3.19g China on conditions
Road High-Tech Adenine…0.0275g dated.20- as per ICH
Development injection…………q.s Original .
Shandong is not
People’s
China.
82. M/s. Bayer Sivextro 200mg Film Form 5-A Original Deferred
Pakistan (Pvt) Coated Tablets legalized for the
Limited, C-21, Dy No.98 COPP submissio
S.I.T.E, Karachi. Each film coated tablet 30-07-2015 was n of
contains:- Rs.50,000/- issued by following
Manufacturing Tedizolid EMA on a.
& Primary, Phosphate……….200m Not dated 22- clarificatio
Secondary g mentioned 05-2015. n of
Packaging and complete
Quality (Oxazolidinone/antibioti The details of
Control by: c) GMP is release site
M/s. Patheon New Molecule issued by as release
Inc. Whitby Health site is not
Regional Manufacturer’s Canda mentioned
Operations Specifications dated 21- on COPP.
(WRO) 111 04-2015
Consumers 03 years valid
Drive Whitby, upto 1
Ontario LIN year.
5Z5, Canada.
Market Release
Authorization. is not
Cubist (UK) mentione
Ltd, Unit 1 d in
Horizon COPP
Business however
Village, 1 the firm
Brooklands has
Road, submitte
Weybridge, d the
Surrey KT13 declarati

ORU, United on for
Kingdom the same.
Released
by:
M/s.
Bayer
Pharma
AG
Mullerstr
asse 178
13353
Berlin,
Germany
83. M/s. Bayer Sivextro Powder for Form 5-A MHRA. Original Deferred
Pakistan (Pvt) Concentrate for Sivextro by legalized for the
Limited, C-21, Solution for infusion Dy No.42 M/s Merck COPP submissio
S.I.T.E, Karachi. 200mg dated 30- was n of
07-2015 issued by following
Manufactured, Each vial contains:- Rs.50,000/- EMA on a.
Quality Tedizolid dated 22- clarificatio
Control & Phosphate……….200m Not 05-2015. n of
Primary g mentioned complete
Packaging by: (Oxazolidinone/antibioti The details of
M/s. Patheon c) GMP is release site
Italia S.p.A. 2 New Molecule issued by as release
Trav. SX Via itlay 21- site is not
Morolense, 5 Manufacturer’s 08-2014. mentioned
03013 Specifications on COPP.
Ferentino, FR, Final
Italy. Site 03 years Release
Responsible for &
quality secondar
Control. y
Redox s.n.c di package
Arosio Antonia site is
e. C., Viale not
Stucchi, 62/26, mentione
20900 Monza d in
(MB), Italy. COPP
Market however
Authorization. the firm
Cubist (UK) has
Ltd, Unit 1 submitte
Horizon d the
Business declarati

Village, 1 on for
Brooklands the same.
Road, Seconda
Weybridge, ry
Surrey KT13 Packagi
ORU, United ng
Kingdom &Releas
ed by:
M/s.
Bayer
Pharma
AG
Mullerstr
asse 178
13353
Berlin,
Germany
.
84. M/s. AJ Mirza Cytomid 250mg Tablet Form 5A MHRA COPP Approved
Pharma (Pvt) Approved valid as per
Ltd., 7-Ground Each uncoated tablet Diary No. upto 16- Import
Floor, Shafi contains:- 179 R&I 10-2016. Policy for
Court, Flutamide dated 20- Finished
Merewether USP………….250mg 08-2015 GMP Drugs
Road, Civil Excipients…………… Rs.100,000 complian
Lines, Karachi. ….q.s. /- t as per
COPP.
Manufactured (Treatment of RS. 4200/-
by Advanced prostate 100’s GMP
M/s. Cipla Ltd., cancer) valid
Verna Industrial upto 16-
Estate, Verna, Manufacturer’s 10-2016.
India. Specifications
85. M/s. Novartis Caflam Capsule Form 5-A COPP Deferred

Pharma Each capsule contains:- Dy No.106 was for the
(Pakistan) Diclofenac 03-08-2015 issued by submissio
Limited, 15 potassium……….50mg Rs.50,000/- Swiss n of
West Wharf, (Anti-inflammatory and 20’s Medic following
Karachi./ analgesic) /Rs.560 Switzerla a.
Product nd on confirmati
Licence New Molecule 26-01- on of
Holder: 2015 approval
M/s. Novartis 30 months Product status in

Pharma Schweiz is on the reference
AG, 6343 Risch, market countries
Switzerland. of as COPP
Address of exportin issued by
Manufacturing g Germany
Site: country. says that
M/s. Catalent The product is
Germany certifyin not on the
Eberbach GmbH g market for
Gammelsbacher authority use in the
Strasse 2 69412 arragge exporting
Eberbach/Baden for countries
, Germany. periodic b.
inspectio clarificatio
n not n of
applicabl regulatory
e. free sales
GMP status in
certificat exporting
e issued country.
by
German
authoriti
es on 07-
11-2013
The
COPP
issued by
Germany
says that
product
is not on
the
market
for use in
the
exportin
g
countries
86. M/s. Novartis Farydak 10mg Capsule Form 5A MHRA. COPP Deferred
Pharma Farydak 10mg, issued by for the
(Pakistan) Each capsule contains:- Dy. No 304 15mg & 20mg US FDA clarificatio
Limited, 15 Panobinostat………..10 Dated 08- by M/s for three n of free
West Wharf, mg 09-2015 Novartis. strengths sales
Karachi. Rs.50,000/- and valid status in
(Multiple Myeloma in upto 31- the

Manufactured combination with Rs.950,000 07-2017. exporting
by Bortezomib & /6’s The country.
M/s. Novartis Dexamethasone). Capsules product
Farmaceutica New Molecule is not
SA, Barbera del available
Valles, Spain. Manufacturer’s for free
Specifications sale in
the
36 months country
of origin.
GMP
issued
dated 12-
03-2013
(Pakistan) Each capsule contains:- Dy. No 302 15mg & 20mg US FDA clarificatio
Limited, 15 Panobinostat………..15 dated 08- by M/s and valid n of free
West Wharf, mg 09-2015 Novartis. upto 31- sales
Karachi. Rs.50,000/- 07-2017. status in
(Multiple Myeloma in The the
M/s. Novartis combination with Rs.125500 product exporting
Farmaceutica Bortezomib & 0/6’s is not country.
SA, Barbera del Dexamethasone). capsules available
Valles, Spain. New Molecule for free
sale in
Manufacturer’s the
Specifications country
of origin.
36 months GMP
issued
dated 12-
03-2013
(Pakistan) Each capsule contains:- Dy. No. 15mg & 20mg US FDA clarificatio
Limited, 15 Panobinostat………..20 301 Dated by M/s and valid n of free
West Wharf, mg 08-09-2015 Novartis. upto 31- sales
Karachi. Rs.50,000/- 07-2017. status in
(Multiple Myeloma in The the
M/s. Novartis combination with Rs. product exporting
Farmaceutica Bortezomib & 1560,000/6 is not country.
SA, Barbera del Dexamethasone). ’s capsule available
Valles, Spain. New Molecule for free
sale in

Manufacturer’s the
Specifications country
of origin.
36 months GMP
issued
dated 12-
03-2013
89. M/s. Lenara 2.5mg Tablets Form 5A

MHRA. Femra COPP Approved
Pharmawell 2.5mg f/c issued as per
(Pvt) Ltd. 244-YEach film coated tablet Dated 15- tablet by M/s dated 30- Import
Block, contains:- 09-2015 Novartis. 06-2015 Policy for
Commercial Letrozole…….2.5mg vide diary vide no. Finished
Area Phase III, No. 399 Local. Femra 2015- Drugs.
DHA, Lahore. (Adjuant treatment of Rs.100,000 2.5mg by M/s D1-1817. Panel shall
post-menopausal /- Novartis. GMP confirm
M/s. women with harmone issued the
Kwangdong recpotor positive Rs.6,0000/ dated 27- anticancer
Pharmaceutical invasive early breast 30’s 07-2015 facility for
Co. Ltd., 114, cancer). vide no. the
Sandan-ro, 2015- manufactu
Pyeongtack-Si, (USP Specs) D1-2068. ring of the
Gyeonggi-do, Stability drug at the
Republic of 36 months data as time of
Kora. per foreign
condition inspection
s of Zone
IV B
attached.
90. M/s. Novartis Entresto to Uperio Form 5A COPP Approved
Pharma 200mg was as per
(Pakistan) Dy No. 329 issued by Import
Limited, 15 Each film coated tablet dated 30- Swiss Policy for
West Wharf, contains:- 09- Medic Finished
Karachi. Sacubitril/Valsartan 2015Rs.50, Switzerla Drugs
226.206mg 000/- nd on
Product (Corresponds to 17-09-
License Sacubtril/Valsartan free Rs.27240/2 2015
Holder:- anhydrous acid) 200mg 8tablets GMP
M/s. Novartis Sacubitril/Valsartan complian
Pharma Stein Sodium salt Hydrate, t as per
AG, Stein, Crystal modification A COPP.
Switzerland. Scubitril/ COPP
Manufacturer: Valsartan 200mg mentioni
M/s. Novartis Corrosponds to ng two
Pharma Stein Sacubitril 97.2mg and manufact

AG, Stein, Valsartan 102.8mg urers
Switzerland. without
(Treatment of Heart detaisl of
M/s. Novartis Failure) manufact
Singapore New Molecule uring
Pharmaceutical 24 months processe
Manaufacturing s.
Ptc. Ltd., 10
Tuas Bay Lane
637461
Singapore,
Singapore.
91. M/s. Highnoon Pirfenex 200mg Tablet Form 5-A COPP Deferred
Laboratories Each film coated tablet Dy No.287 and for the
Limited, 17.5 contains:- 30-09-2015 GMP confirmati
KM, Multan Pirfenidone……… Rs.100,000 was on of
Road, Lahore. / 200mg /- issued by approval
M/s. Cipla Ltd., India on status in
Village Malpur, (Idiopathic Pulmonary dated 21- reference
Baddi District Fibrosis) 04-2015 countries.
Solan, Himachal New Molecule valid up
Pradesh, India. to 29-08-
24 months 2017
92. M/s. Merixil Temoeirgen 20mg Form 5A MHRA. COPP Approved

Pharma, Capsules dy. No. 381 Temodal 5mg, issued on as per
Office # 28, dated 09- 20mg, 100mg, 04-02- Import
Second Floor, Each capsule contains:- 10-2015 140mg, 180mg 2015. Policy for
Rose Plaza, I-8 Temozolamide……….2 Rs.100,000 & 250mg by GMP Finished
Markaz, 0mg /- M/s Merck complian Drugs
Islamabad. t as per
Manufactured (For newly diagnosed Local. COPP.
by Glioblastoma As per Temoside
M/s. Eirgen multiforme SRO /5’s 20mg, 100mg
Pharma Ltd. concomitantly with & 250mg by
64/65 Westside radiotherapy) M/s AJ. Mirza.
Business Park
Old Kilmeaden Manufacturer’s
Road, Specifications
Waterford,
Ireland. 24 months
93. M/s. Gene-Tech Osateofil Solution for Form 5A MHRA. COPP Deferred
Laboratories, Injection Bondronat No. for the
Head Office. Dy No. 397 2mg/2ml by 2014- submissio
246/B, PECHS, Each vial contains:- R&I dated M/s Roche 146-1 n of

Block-6, Ibandronate 15-10-2015 issued following
Karachi. Sodium………2mg/2ml Rs.100,000 dated 29- a. Stability
/- 09-2014 data as per
Manufactured (Nitrogen –containing valid conditions
by group of Rs.8650/vi upto 2 of Zone IV
M/s. Nanjing Bisphosphonates) al years. A.
Hencer b. Drugs
Pharmaceutical Prevention of skeletal GMP sales
Co. Ltd., No. 18 muscle events in certificat license
Jichang Road, patients with Breast e valid c. Sole
Lishui Cancer and Bone upto 08- agency
Economic & Metastasis 04-2018 Agreement
Technological No.
Development 3 years CN2013
Zone, Nanjing 0099.
City, Jiangsu
Province, China.
94. M/s. Merixil Exemestane Normon Form 5A COPP Deferred
Pharma, 25mg Tablet Dy. No 547 not for the
Office # 28, dated 22- provided. submissio
Second Floor, Each coated tablets 12-2015 n of
Rose Plaza, I-8 contains:- Rs.100,000 following
Markaz, Exemestane…………… /- a. Stability
Islamabad. / 25mg data as per
M/s. As per ICH
Laboratorios (Treatment of SRO/3x10’ guidelines
Normon, S.A. postmanupausal s tablets b. Valid
Ronda De woman with oestrogen legalized
Valdecarrizo, 6, positive invasive COPP.
Tres Cantos, breast cancer)
28760, Madrid,
Spain. Manufacturer’s
Specifications
24 months
95. M/s. Merixil Zoledronic Acid Form 5A MHRA. COPP Approved
Pharma, Normon 4mg/5ml Zoledronic issued on as per
Office # 28, Injectable Dy. No. Acid 4mg/5ml 24-02- Import
Second Floor, 546 R&I by M/s 2016. Policy for
Rose Plaza, I-8 Each 5ml concentrate dated 22- Intrapharm. Finished
Markaz, vial contains:- 12-2015 GMP Drugs
Islamabad. Zoledronic acid Rs.100,000 complian
Manufactured Monohydrate 4.264mg /- t as per
By eq to zoledronic COPP.
M/s. acid……….4mg As per
Laboratorios SRO GMP

Normon, S.A. (Prevention of skeletal issued
Ronda De related events (e.g 13-06-
Valdecarrizo, 6, tumor induced 2014.
Tres Cantos, hypercalcemia) in
28760, Madrid, adult patients with
Spain. advanced
malignancies involving
bone).
Manufacturer’s
Specifications
24 months
96. M/s. Merixil Ondansetron Normon Form 5A MHRA.Ondan COPP Approved
Pharma, 8mg Injection Dy. No 548 setron 2mg/ml issued on as per
Office # 28, Dated 22- by M/s 25-02- Import
Second Floor, Each 4ml vial contains:- 12-2015 Hameln 2016. Policy for
Rose Plaza, I-8 Ondansetron…………. Rs.100,000 Finished
Markaz, 8mg /- GMP Drugs
Islamabad. (as hydrochloride Complia
Manufactured dihydrate) As per nt as per
by SRO/ 1x5 COPP.
M/s. Anti emetic for ampoules
Laboratorios chemotherapy induced GMP
Normon, S.A. emesis. issued
Ronda De dated 13-
Valdecarrizo, 6, 06-2014.
Tres Cantos, Manufacturer’s
28760, Madrid, Specifications
Spain. 36 months
97. M/s. Medi Mark Xmeron 50mg Injection Form 5-A China Deferred
Pharmaceuticals Each ml contains:- Dy No. Council for
, Rocuronium 23-12-2015 for the confirmati
Liaqut Chowk, Bromide……..10mg Rs.100,000 Promotio on
Sahiwal./ (Muscle relaxants, /- n of whether
M/s. Zhejiang peripherally acting Internati formulatio
Xianju agents) onal n is
Pharmaceuticals 24 months Trade already
Co. Ltd., No.6, china registered
Xingye Road, chamber or
Modern Block, of otherwise
Ecnomic Zone, internati
Xianju, onal
Zhejiang, China. commerc
e issued
Original

legalized
COPP
25-09-
2015
valid
upto 24-
09-2016.
FSC
issued by
Xianju
Food and
Drug
Administ
ration of
China
25-09-
2015
valid
upto 24-
09-2016
98. M/s. Revive Oncotar-500 Injection Form 5A MHRA. Free sale Approved
Health Care, Cytarabine issued as per
Office 503, 5th Each ml contains:- Dy. NO 500mg/5ml by dated 26- Import
Floor, 6 Main Cytarabine 616 dated M/s Hospira. 02-2016. Policy for
Gulberg, Jail BP…………….100mg 31-12-2015 COPP Finished
Road, Lahore. Rs.50,000/- Local. valid up Drugs
(Acute myeloid & 50,000 Cytarine to 10-05-
Manufactured leukaemia and for dated 24- 500mg by M/s 2017
by other acute leukaemias 06-2016. Atco
M/s. United for children and adults Photocop
Biotech (P) ) y of
Limited, As per PRC GMP is
Bagbania, USP Specifications legalized
Baddi-Nalagarh 2 years valid
Road, District- upto 17-
Solan (Himachal 09-2017.
Pradesh)
174101, India.
99. M/s. Revive Egymelan 50mg Form 5A MHRA. COPP Approved

Health Care, Injection Melphalan valid as per
Office 503, 5th Dy. No 617 50mg powder upto 10- Import
Floor, 6 Main Each vial contains:- dated 31- for injection 05-2017. Policy for
Gulberg, Jail Melphalan 12-2015 by M/s Aspen. Finished
Road, Lahore. Hydrochloride Rs.50,000/- Photocop Drugs
eq. to Melphalan y of

Manufactured (Anhydrous)…….50mg As per GMP
By SRO. valid
M/s. United (Multiple Myeloma upto 17-
Biotech (P) and Ovarian Cancer) 09-2017.
Limited, New Molecule
Bagbania,
Baddi-Nalagarh Manufacturer’s
Road, District- Specifications
Solan (Himachal 2 years
Pradesh)
174101, India.
100. M/s. Revive K-Styrn 15gm Sachet Form-5A Japan. Free sale Deferred
Health Care, Polystryene issued for
Office 503, 5th Each sachet contains:- Dy No.613 Sulphonate dated 26- confirmati
Floor, 6 Main Calcium Polystyrene 31-12-2015 Sachet 15gm. 02-2016. on
Gulberg, Jail Sulfonate………15gm Rs.50,000/- COPP whether
Road, Lahore. valid up formulatio
(Potassium Binder) to 10-05- n is
Manufactured 2017. already
by Manufacturer’s registered
M/s. United Specifications Leglalize or
Biotech (P) Ltd., 02 years d otherwise
Village photocop
Bagbania, y of
Baddi-Nalagarh GMP
Road, District- valid
Solan (H.P) upto 17-
174101, India. 09-2017
101. M/s. Revive Amphotin Lip-50 Form 5A

MHRA. Free sale Deferred
Health Care, Injection Abelcet issued as the
Office 503, 5th Dy No. 614 5mg/ml dated 26- product
Floor, 6 Main Each vial contains:- 31-12-2015 Amphotericin 02-2016. does not
Gulberg, Jail Amphotericin B Lipid Rs.50,000/- B lipid COPP fall in the
Road, Lahore. Complex…50mg complex(10ml valid priority
As per PRC , 20ml) upto 10- list.
M/s. United (Antifungal) Concen. For 5-2017 Moreover
Biotech (P) Ltd., infusion by Anti-
Village Manufacturer’s M/s Teva. Legalize fungal
Bagbania, Specifications d drugs are
Baddi-Nalagarh 2 years photocop not
Road, District- y of importable
Solan (Himachal GMP from India
Pradesh) valid as per
174101, India. upto 17- Import

09-2017. Policy
Order,
2016
102. M/s. Revive Vonaz 200 Injection Form 5A MHRA. Vfend Free sale Deferred
Health Care, 200mg powder issued as Anti-
Office 503, 5th Each ml contains:- Dy No. 615 for infusion by dated 26- fungal
Floor, 6 Main Voriconazole….200mg dated 31- Pfizer. 02-2016. drugs are
Gulberg, Jail 12-2015 COPP not
Road, Lahore. (Antifungal) Rs.50,000/- valid importable
upto 10- from India
M/s. United Manufacturer’s As per PRC 5-2017. as per
Biotech (P) Ltd., Specifications GMP Import
Village 2 years valid Policy
Bagbania, upto 17- Order,
Baddi-Nalagarh 09-2017. 2016.
Road, District-
Solan (Himachal
Pradesh)
174101, India.
103. M/s. Revive Colicraft 1,000,000 IU Form 5A MHRA. COPP Deferred
Health Care, powder for solution for Colomycin issued for
Office 503, 5th Injection Dy No. 619 1MIU by M/s dated 04-confirmati
Floor, 6 Main 31-12-2015 Forest. 05-2016. on
Gulberg, Jail Each vial contains:- Rs.50,000/- whether
Road, Lahore. Colistimethate Sodium Firm is formulatio
…1,000,000 I.U As per PRC GMP n is
Manufactured complian already
by (Antibiotic)/Polymyxin t as per registered
M/s. ) COPP. or
GENFARMA otherwise
LABORATORI USP Specifications
O, S.L. Site
address Avda. 03 years
De la
Constitucion,
198-199
Poligono
Industrial Monte
Boyal,
Casarrubios del
Monte 45950
(Toledo)
Espana, Spain.
Market
Authorization
Holder.

M/s G.E.S
Genericos
Espanoles
Laboratorio, S.A
Colquide,6-
Portal, Spain
104. M/s. Servier Implicor Film Coated Form 5A COPP Deferred
Research and Tablets (Photoco for the
Pharmaceuticals Each film coated tablet Dy no. 172 py) was submissio
Pakaistan contains:- dated 10- issued by n of
Private Limited, Metoprolol 02-2016 France following
65 Main Tartrate………….50mg Rs.100,000 on dated a. Valid
Boulevard Ivabradine…………… /- 18-09- legalized
Gulberg, ……….5mg 2015. COPP
Lahore. (Antianginal) GMP b.Stability
18 months photocop data as per
M/s. Les y conditions
Laboratoirie attached of zone IV
Industrie, 905, Stability A.
route de Saran data is c.
45520 Gidy, not as Approval
France. per status in
condition reference
s of Zone countries.
IV A
however
stress
stability
data
attached.
105. M/s. AJ Mirza Finpecia Film Coated Form 5A COPP Defered as
Pharma (Pvt) Tablets valid the
Ltd., 7-Ground Dy No.174 upto 16- product
Floor, Shafi Each film coated tablets dated 12- 10-2016. does not
Court, contains:- 02-2016 GMP fall in the
Merewether Finasteride Rs.100,000 complian priority
Road, Civil USP…………1mg /- t as per list.
Lines, Karachi. COPP.
M/s. Cipla Ltd, (Anti Androgenic) As per
S-103 to S-105, 36 months SRO
S-107 to S-112,
L-138, L-147,
L-147/1 to L-
147/3, L-147/A,
Verna Industrial
Estate, Verna,

Goa.
106. M/s. Genix Genitinib 100mg Hard Form 5A MHRA. COPP, Deferred
Pharma Gelatin Capsule Glivec 100mg GMP & for the
(Private) Dy. No 206 & 400mf f/c stability submissio
Limited, 44-45- Each capsule contains:- dated 04- tablet by M/s data not n of
B, Korangi Imatinib Mesilate 03-2016 Novartis. attached. following
Creek Road, eq. Rs.100,000 Form 5A a.Valid
Karachi-75190. / Imatinib………………. /- is Legalized
Manufactured .100mg incomple COPP
by :- te. b. Stability
M/s. NOBILUS (Philadelphia Finish data as per
ENT chromosome positive product conditions
Swarszewska chronic myeloid specifica of Zone IV
45, 01-821 leukemia) tions are A.
Warsaw, not c.
Poland. Shelf Life 2 years attached. Completio
Supplying (Vol. 1 of 3 ) n of Form
Agent: 5A.
M/s. Labosuan d. Finish
S.L. calle product
Einsten 8-28108 specificati
Alcobendas, ons.
Madrid, Spain.
107. M/s. Genix Genitinib 400mg Hard Form 5A MHRA. COPP, Deferred
Pharma Gelatin Capsule Glivec 100mg GMP & for the
(Private) Dy. No 313 & 400mg f/c stability submissio
Limited, 44-45- Each capsule contains:- dated 04- by M/s data not n of
B, Korangi Imatinib Mesilate 03-2016 Novartis. attached. following
Creek Road, eq. Rs.100,000 Form 5A a.Valid
Karachi-75190. / Imatinib………………. /- Local. Glivec is Legalized
Manufactured .400mg 100mg & incomple COPP
by :- 400mg by M/s te. b. Stability
M/s. NOBILUS (Philadelphia Novartis Finish data as per
ENT chromosome positive Pharma. product conditions
Swarszewska chronic myeloid specifica of Zone IV
45, 01-821 leukemia) tions are A.
Warsaw, not c.
Poland. attached. Completio
Supplying Shelf Life 2 years n of Form
Agent: 5A.
M/s. Labosuan d. Finish
S.L. calle product
Einsten 8-28108 specificati
Alcobendas, ons.

Madrid, Spain.
108. M/s. Genix Genoxaltin 50mg Form 5A MHRA. COPP Deferred
Pharma Powder for Infusion Oxaliplatin issued for the
(Private) Dy. 208 50mg & dated 19- clarificatio
Limited, 44-45- Each vial contains:- dated 100mg powder 03-2016 n of
B, Korangi Oxaliplatin………..50m 02-03-2016 for solution for COPP strength
Creek Road, g Rs.100,000 infusion by strength 5mg/ml on
Karachi-75190. / /- M/s Actavis. is COPP
Manufactured Treatment of mentione whereas
by: metastatic colorectal Not d as the firm
M/s. Samyang cancer) provided. 5mg/ml has
Genex Pack applied in
Corporation, sizes are powder
1688-3, Sinil- Shelf Life 3 years not form in
dong Daedeok- mentione Form 5A.
gu Daejeon 306- d on
220, Korea. COPP.
Analytical GMP
Testing & complian
Batch Release t as per
by: COPP.
M/s. Aq Vida Single
GmbH Kaiser- COPP
Wilhelm-Str.89 for 2
20355 Hamburg, products.
Germany.
Marketing
Authorization
Holder:
M/s. Labosuan
S.L. calle
Einsten 8-28208
Alcobendas,
Madrid, Spain.
109. M/s. Genix Genoxaltin 100mg Form 5A MHRA. COPP Deferred

Pharma Powder for Infusion Oxaliplatin issued for the
(Private) Dy. No 209 50mg & dated 19- clarificatio
Limited, 44-45- Each vial contains:- dated 02- 100mg powder 03-2016 n of
B, Korangi Oxaliplatin………..100 03-2016 for solution for COPP strength
Creek Road, mg Rs.100,000 infusion by strength 5mg/ml on
Karachi-75190. / /- M/s Actavis. is COPP
Manufactured Treatment of mentione whereas
by: metastatic colorectal d as the firm
M/s. Samyang cancer) 5mg/ml has
Genex Shelf Life 3 years GMP applied in

Corporation, complian powder
1688-3, Sinil- t as per form in
dong Daedeok- COPP. Form 5A.
gu Daejeon 306-
220, Korea.
Analytical
Testing &
Batch Release
by:
M/s. Aq Vida
GmbH Kaiser-
Wilhelm-Str.89
20355 Hamburg,
Germany.
Marketing
Authorization
Holder:
M/s. Labosuan
S.L. calle
Einsten 8-28208
Alcobendas,
Madrid, Spain.
110. M/s. Genome Zoledron Lyophilized Form 5A MHRA. Docume Approved
Pharma, Powder for Solution for Zoledronic nts are as per
House # 593-B, Infusion Dy. No 246 Acid 4mg/5ml not Import
Street # 10, dated 14- by M/s legalized Policy for
Chaklala Each vial contains:- 03-2016 Intrapharm. . Finished
Scheme III, Zoledronic Acid (as Rs.100,000 COPP Drugs
Rawalpindi. Zoledronic acid /- issued on
monohydrate) As per 31-07-
Manufactcured ……………………4mg SRO 2015 by
by M/s. Republic
"Belmedprepara (Prevention of skeletal of
ty" RUE, 30 related events(e.g Belarus.
Fabritsius Str. tumor induced GMP
220007 Minsk, hypercalcemia) in complian
Republic of adult patients with t as per
Belarus. advanced COPP.
malignancies involving GMP
bone). valid
upto 10-
Manufacturer’s 10-2017.
Specifications
02 years

111. M/s. Genome Gemcitabel Lyophilized Form 5A Docume Approved
Pharma, Powder for Solution for nts are as per
House # 593-B, Infusion Dy. No 237 not Import
Street # 10, R&I 14-03- legalized Policy for
Chaklala Each vial contains:- 2016 . Finished
Scheme III, Gemcitabine Rs.100,000 COPP Drugs.
Rawalpindi./ Hydrochloride … /- issued on Firm has
Manufactcured 1000mg 31-07- provided
by M/s. 2015 by valid
"Belmedprepara (Advanced or met- AS per Republic legalized
ty" RUE, 30 static bladder cancer SRO of CoPP
Fabritsius Str. in combination with Belarus.
220007 Minsk, cisplatin, locally or GMP
Republic of meta-static complian
Belarus. adenocarcinoma of t as per
pancreas) COPP.
GMP
valid
USP Specifications upto 10-
02 years 10-2017.
112. M/s. Genome Gemcitabel Lyophilized Form 5A Docume Approved
House # 593-B, Infusion Dy. No. not Import
Street # 10, 236 dated legalized Policy for
Chaklala Each vial contains:- 14-03-2016 . Finished
Scheme III, Gemcitabine Rs.100,000 COPP Drugs.
Rawalpindi. Hydrochloride ..200mg / issued on Firm has
31-07- provided
Manufactcured (Advanced or met- 2015 by valid
by M/s. static bladder cancer As per Republic legalized
"Belmedprepara in combination with SRO of CoPP
ty" RUE, 30 cisplatin, locally or Belarus.
Fabritsius Str. meta-static GMP
220007 Minsk, adenocarcinoma of complian
Republic of pancreas) t as per
Belarus. COPP.
USP Specifications GMP
valid
02 years upto 10-
10-2017.
113. M/s. Genome Methobel Lyophilized Form 5A Docume Approved
House # 593-B, Injection Dy. 238 not Import
Street # 10, R&I dated legalized Policy for
Chaklala Each vial contains:- 14-03-2016 . Finished

Scheme III, Methotrexate as Rs.100,000 COPP Drugs.
Rawalpindi./ sodium……..50mg / issued on Firm has
Manufactcured 31-07- provided
by M/s. (Antineoplastic drug) As per PRC 2015 by valid
"Belmedprepara Republic legalized
ty" RUE, 30 USP Specifications of CoPP
Fabritsius Str. 02 years Belarus.
220007 Minsk, GMP
Republic of complian
Belarus. t as per
COPP.
GMP
valid
upto 10-
10-2017.
114. M/s. Genome Anastrozole-Belmed Form 5A MHRA. Docume Approved
Pharma, Film Coated Tablets Anastrozole nts are as per
House # 593-B, Dy. No 239 1mg f/c by not import
Street # 10, Each film coated tablets dated 14- M/s consilent. legalized
Policy for
Chaklala contains:- 03-2016 . Finished
Scheme III, Anastrozole………….1 Rs.100,000 Local. COPP Drugs, as
Rawalpindi. mg / Anastrozole issued on
firm has
Manufactcured 1mg by M/s 09-02- provided
by M/s. (Treatment of As per PRC Pfizer 2015 by valid
"Belmedprepara harmone recpotor Republiclegalized
ty" RUE, 30 positive advanced of CoPPprovi
Fabritsius Str. breast cancer in post Belarus.ded.
220007 Minsk, menopausal women GMP Panel shall
Republic of ) complianconfirm
Belarus. t as perthe
Manufacturer’s COPP. anticancer
Specifications GMP facility for
valid the
02 years upto 10-manufactu
10-2017.ring of the
drug at the
time of
foreign
inspection
115. M/s. LDS (Pvt) Temozol 20 Capsules Form 5A MHRA. COPP Approved
Ltd., Dy.No. 314 Temodal 5mg, valid up as per
57/1 A Satellite Each hard gelatin R&Idated 20mg, 100mg, to 2-8- import
Town, capsule contains:- 22-04-2016 140mg, 180mg 2016. Policy for
Rawalpindi- Temozolomide……… Rs.50, & 250mg by Finished
Pakistan. ……20mg 000/- & M/s Merck GMP Drugs
Manufactured 50,000 18- valid

by:- (For newly diagnosed 03-2016. Local. upto 02-
M/s. Glioblastoma Temoside 08-2016.
Khandelwal multiforme 20mg, 100mg
Laboratories concomitantly with & 250mg by
Pvt. Ltd., Plot radiotherapy) M/s AJ. Mirza.
B-1, Wagle
Industrial Estate, Manufacture’s
Thane-400 604, Specifications
Maharashtra,
India. 24 months
116. M/s. LDS (Pvt) Temozol 100 Capsules Form 5A MHRA. COPP Approved
Ltd., Dy No.315 Temodal 5mg, valid as per
57/1 A Satellite Each hard gelatin R&I 20mg, 100mg, upto 02- import
Town, capsule contains:- 22-04-2016 140mg, 180mg 08-2016. Policy for
Rawalpindi- Temozolomide……… Rs.50,000/- & 250mg by Finished
Pakistan. ……100mg & M/s Merck GMP Drugs
Rs.50,000 valid
Manufactured (For newly diagnosed dated 18- Local. upto 02-
by:- Glioblastoma 03-2016. Temoside 08-2016.
M/s. multiforme 20mg, 100mg
Khandelwal concomitantly with & 250mg by
Laboratories radiotherapy) M/s AJ. Mirza.
Pvt. Ltd., Plot
B-1, Wagle Manufacturer’s
Industrial Estate, specifications.
Thane-400 604,
Maharashtra, 24 months
India.
117. M/s. LDS (Pvt) Doxorubin 50 Form 5A MHRA. COPP Deferred

Ltd., Hydrochloride for Dy. 311 Doxorubicin validfor the
57/1 A Satellite injection Dated 22- 50mg by M/s upto 02-
clarificatio
Town, 04-2016 Teva 08- n of the
Rawalpindi- Each vial contains:- Rs.50,000/- 2016 .
following
Pakistan. / Doxorubicin &Rs.50,00 Local. Adrim a.Fresh
Manufactured Hydrochloride 0 dated 18- by M/s Atco GMP Sole
by:- USP……………….50 03-2016. valid agency
M/s. mg upto 02- agreement
Khandelwal Lactose USP………q.s. Rs.1625/Vi 08- as
Laboratories al 2016 . clarificatio
Pvt. Ltd., Plot (Small cell lung n of the
B-1, Wagle cancer, Breast cancer, status of
Industrial Estate, bladder carcinoma, registratio
Thane-400 604, Hodgkin’s disease) n letter as
India. the

USP Specifications products
are already
30 months approved
in 227th
meeting
with M/s
Scarlet.
118. M/s. LDS (Pvt) Epichlor 10 Powder for Form-5A MHRA. COPP Approved
Ltd., injection (Lyophilized) Epirubicine valid up as per
57/1 A Satellite Each vial contains:- Dy No. 404 10mg & 50mg to 2-8- import
Town, Epirubicin R&I-dated powder for 2016 Policy for
Rawalpindi- Hydrochloride 18.03.2016 solution for GMP Finished
Pakistan. / BP…………10mg injection by valid Drugs
Manufactured Rs50000/- M/s Actavis upto 02-
by:- (Used in Neoplastic dated 18- 08-2016.
M/s. conditions breast, 03-2016 Local. .
Khandelwal ovarian, Gastric, lung Balance Anthracin
Laboratories and Colorectal Rs50000/- 50mg & 10mg
Pvt. Ltd., Plot carcinomas, Malignant dated 22- by M/s Atco
B-1, Wagle lymphomas) 04-2016
Industrial Estate,
Thane-400 604, 36 months
India.
119. M/s. LDS (Pvt) Epichlor 50 Powder for Form 5A MHRA. COPP Approved
Ltd., injection (Lyophilized) Epirubicine valid as per
57/1 A Satellite Dy. No 313 10mg & 50mg upto 02- import
Town, Each vial contains:- R&I dated powder for 08-2016. Policy for
Rawalpindi- Epirubicin 22-04-2016 solution for GMP Finished
Pakistan. / Hydrochloride Rs.50,000/- injection by valid Drugs
Manufactured BP…………50mg & M/s Actavis upto 02-
by:- Rs.50,000 08-2016.
M/s. (Used in Neoplastic dated 18- Local.
Khandelwal conditions breast, 03-2016. Anthracin
Laboratories ovarian, Gastric, lung 50mg & 10mg
Pvt. Ltd., Plot and Colorectal Rs. 2540/- by M/s Atco
B-1, Wagle carcinomas, Malignant per vial
Industrial Estate, lymphomas)
Thane-400 604,
India. Manufacture’s
Specifications
36 months
120. M/s. LDS (Pvt) Doxorubin 10 Form 5A MHRA. Photocop Deferred

Ltd., Hydrochloride for Dy. 312 Doxorubicin y of for the

57/1 A Satellite injection Dated 22- 10mg by M/s COPP clarificatio
Town, 04-2016 Teva valid n of the
Rawalpindi- Each vial contains:- Rs.50,000/- upto 02- following
Pakistan. Doxorubicin &Rs.50,00 Local. Adrim 08-2016. a.Fresh
Manufactured Hydrochloride 0 dated 18- by M/s Atco Photocop Sole
by:- USP………….10mg 03-2016. y of agency
M/s. Lactose USP…q.s. GMP agreement
Khandelwal Rs.490/Via valid as
Laboratories (Small cell lung l upto 02- clarificatio
Pvt. Ltd., Plot cancer, Breast cancer, 08-2016. n of the
B-1, Wagle bladder carcinoma, status of
Industrial Estate, Hodgkin’s disease) registratio
Thane-400 604, n letter as
India. the
USP Specifications products
are already
30 months approved
in 227th
meeting
with M/s
Scarlet.
121. M/s. LDS (Pvt) Oncomide 1000 Powder Form 5A MHRA. Photocop Deferred
Ltd., for injection Dy. No 316 Cyclophospha y of for the
57/1 A Satellite dated 22- mide 1000mg COPP clarificatio
Town, Each vial contains:- 04-2016 by M/s Baxtervalid n of the
Rawalpindi- Cyclophosphamide Rs.50,000/- upto 02- following
Pakistan. / anhydrous 1.07gm & 18-03- Local. Zyman 08-2016 a.Fresh
Manufactured Equivalent to 2016 by M/s Al- Photocop Sole
by:- Cyclophosphamide…..1 Rs.50,000. Habib y of agency
M/s. .00gm GMP agreement
Khandelwal Rs.230/vial valid as
Laboratories (Chronic Lymphocytic upto 02- clarificatio
Pvt. Ltd., Plot Leukaemis &Acute 08-2016. n of the
B-1, Wagle Lymphocytic status of
Industrial Estate, Leukaemis) registratio
Thane-400 604, n letter as
India. USP Specifications the
products
36 months are already
approved
in 227th
meeting
with M/s
Scarlet.

122. M/s. LDS (Pvt) Bortemib 3.5 Powder Form 5A MHRA. COPP Deferred
Ltd., for Injection Dy. NO Velcade 3.5gm valid for the
57/1 A Satellite (Lyophilized) 407 dated powder for upto 02- clarificatio
Town, 18-03-2016 solution for 08- n as
Rawalpindi- Each vial contains:- Rs.50,000/- injection. 2016 . product is
Pakistan. Bortezomib………… GMP approved
Manufactured 3.5mg Rs.27500/v valid by
by:- ial upto 02- reference
M/s. (Lumphocutic 08- regulatory
Khandelwal leukemia, indolent 2016 . authorities
Laboratories non-Hodgkin’s Internati as
Pvt. Ltd., Plot lymphoma, multiple onaly the mannitol
B-1, Wagle myeloma) product boronic
Industrial Estate, is present ester form.
Thane-400 604, Manufacturer’s as
India. Specifications mannitol
boronic
24 months ester.
123. M/s. LDS (Pvt) Unilistin Colistimethate Form 5-A Antibioti Deferred
Ltd., Sodium for Injection cs are as the
57/1 A Satellite BP 1 Million IU Dy.No.318 not product is
Town, Each vial contains:- 25-04-2016 importab a me too
Rawalpindi- Colistimethate Sodium Rs.50,000/- le from not a new
Pakistan./ BP……1,000,000 IU India. drug.
Manufactured Sole
by:- agency
M/s. United agreeme
Biotech (P) Ltd., nt is not
Bagbania, provided.
Baddi-Nalagarh FSC
Road, District issued
Solan, Himachal dated 26-
Pradash-174 1-2016.
101, India. Stability
data as
per zone-
IV is not
provided
Finish
product
specifica
tions are
not
provided.

124. M/s. Genix Leeza 2.5mg Tablets Form 5A MHRA. Femra Fee Rs Approved
Pharma 2.5mg f/c 100,000 as per
(Private) Each film coated tablets Dy No. tablet by M/s is a Import
Limited, 44-45- contains:- R&I Dated Novartis. photocop Policy for
B, Korangi Letrozole………….2.5 19-09-2016 y. Finished
Creek Road, mg Rs.100,000 Local. Femra Dossier Drugs.
Karachi-75190. / /- 2.5mg by M/s is a Panel shall
Manufactured (Adjuant treatment of Novartis. duplicate confirm
by :- post-menopausal . the
M/s. Jiangsu women with harmone COPP anticancer
Hengrui recpotor positive valid facility for
Medicine Co. invasive early breast upto 18- the
Ltd., UNo.38 cancer) 02-2018. manufactu
Huanghe Road, GMP ring of the
Lianyungang USP Specifications. complian drug at the
Economic and 02 years t as per time of
Technological COPP. foreign
Development GMP inspection.
Zone, Jiangsu, valid Chairman
China. upto 18- Registrati
02-2018. Board is
authorized
for the
issuance
of
Registratio
n letter
after
verificatio
n of fee
from
Budget &
Accounts.
125. M/s. Graton Zoltran Injection Form 5A MHRA. Free Approved

Pharma, 4mg/5ml Zoledronic sales as per
Suit No. 102, Dy. No 348 Acid 4mg/5ml certificat import
The Plaza, Each vial contains:- Dated 20- by M/s e issued Policy for
Clifton 2 Zoledronic 04-2016 Intrapharm. on 27- Finished
Talwar, Karachi. acid……..4mg Rs.100,000 01-2016. Drugs
Manufactured / GMP
by (Prevention of skeletal valid
M/s. Yangtze related events(e.g As per upto 13-
River tumor induced SRO 03-2018
Pharmaceutical hypercalcemia) in

Group Sichuan adult patients with
Hairong advanced
Pharmaceutical malignancies involving
Co. LTd., bone).
Dujiangyan
High Tech Manufacturer’s
Development Specifications
Zone, Sichuan, 2 years
China.
126. M/s. Graton Grataxel 100mg/16.7ml Form 5A MHRA. COPP Approved

Pharma, injection Paclitaxel 18-04-
Suit No. 102, Dy. No. 6mg/ml Conc. 2016.
The Plaza, Each vial contains:- 1026 Dated for solution for
Clifton 2 Paclitaxel………….100 18-04-2016 infusion by
Talwar, Karachi. mg Rs.100,000 M/s Medac
Manufactured / (5ml, 16.7ml,
by (Monotherapy for 50ml &
M/s. Yangtze meta-static breast 100ml).
River cancer. In As per
Pharmaceutical combination with SRO Local.
Group Co. Ltd Gemcitabin for meta- Panataxel
1 South , static adenocarcinoma 100mg,
Yangtze River of pancreas) 150mg, 300mg
Road, Taizhou, & 30mg by
Jiangsu, 225321 USP Specifications M/s
China. Ferozsons.
03 years
127. M/s. Roche Esbriet Hard Capsules Form 5-A FDA. Esbriet Orignal Deferred
Pakistan Each hard capsules Dy No.350 by M/s legalized for the
Limited, contains:- 29-04-2016 Genetech. COPP is submissio
37-C, Bock-6, Pirfenidone…..267mg Rs.50,000/- not n of
P.E.C.H.S. provided. following
Karachi./ (Anti-fibrotic agent) a.valid
M/s. Made for legalized
Roche New Molecule COPP
Registration b.Stability
Limited, 4 years data as per
Welwyn Garden conditions
City, UK by F. of Zone IV
Hoffmann-La A.
Roche Ltd.,
Basel,
Switzerland
manufacturing
Site Catalent

Pharma
Solutions LLC,
Winchester
(KY), USA.
128. M/s. Revive Octreotide 50mcg Form 5A FDA. Free sale Approved
Health Care, Injection Sandostatin issued as per
Office 503, 5th Dy No. 357 50mcg/ml by dated 26- import
Floor, 6 Main Each vial of ampoule dated M/s Novartis. 02-2016. Policy for
Gulberg, Jail contains:- 29-04-2016 COPP Finished
Road, Lahore. Octreotide acetate Rs.50,000/- Local. valid Drugs
equivalent to 0.05mg & 50,000 Sandostatin upto 10-
Manufactured milligrams of octreotide dated 24- 0.05mg/ml & 5-2017.
by ……50mcg 06-2016. 0.1mg/ml by GMP
M/s. United M/s Novartis. valid
Biotech (P) (Acromegaly/Carcinoi As per upto 17-
Limited, d Tumors/Vasoactive SRO 09-2017.
Bagbani, Baddi, Intestinal tumors)
Nalagarh Road,
District, Solan,
India. Manufacturer’s
Specifications
03 years
129. M/s. Revive Octreotide 100mcg Form 5A FDA. Free sale Approved
Health Care, Injection Sandostatin issued as per
Office 503, 5th Dy. 356 100mcg/ml by dated 26- import
Floor, 6 Main Each vial of ampoule Dated 29- M/s Novartis. 02-2016. Policy for
Gulberg, Jail contains:- 04-2016 COPP Finished
Road, Lahore. Octreotide acetate Rs.50,000/- Local. valid Drugs
equivalent to octreotide & 50,000 Sandostatin upto 10-
Manufactured …100mcg dated 24- 0.05mg/ml & 5-2017.
by 06-2016. 0.1mg/ml by GMP
M/s. United (Acromegaly/Carcinoi M/s Novartis. valid
Biotech (P) d Tumors/Vasoactive upto 17-
Limited, Intestinal tumors) As per 09-2017
Bagbani, Baddi, SRO.
Nalagarh Road, Manufacturer’s
District, Solan, Specifications
India. 03 years
130. M/s. Revive Vasmed Injection Form-5 A MHRA. Free sale Approved
Health Care, Vasopressin certificat as per
Office 503, 5th Each ampoule Dy No 354. 20IU/ml by e issued import
Floor, 6 Main contains:- 29-04-2016 M/s par on 26- Policy for

Gulberg, Jail Synthetic Rs.50,000/- Sterile. 02-2016. Finished
Road, Lahore. Vasopressin….20 IU COPP Drugs
As per PRC valid
Manufactured (Synthetic Hormone) upto10-
by New Molecule 5-2017.
M/s. United GMP
Biotech (P) Ltd., USP specifications valid
Village upto 17-
Bagbania, 03 yearts 09-2017.
Baddi-Nalagarh
Road, District-
Solan (H.P)
174101, India.
131. M/s. Revive Vinotec 50mg Injection Form 5A MHRA. Free sale Approved
Health Care, Navelbine issued as per
Office 503, 5th Each vial of 5ml Dy. No 359 10mg/ml dated 26- import
Floor, 6 Main contains:- Dated 29- (5ml) by M/s 11-2015. Policy for
Gulberg, Jail Vinorelbine as Tartrate 04-2016 Pierre. COPP Finished
Road, Lahore. eq. to Rs.50,000/- valid Drugs
Vinorelbine…….50mg & 50,000 Local. Vilne upto 10-
Manufactured dated 24- by M/s Ghani 5-2017.
by (Stage III & IV small 06-2016. Brothers GMP
M/s. United cell lung cancer, valid
Biotech (P) Ltd., Advance Breast cancer As per upto 17-
Village for stage III & IV) PRC. 09-2017.
Bagbania,
Baddi-Nalagarh USP Specifications
Road, District-
Solan (H.P) 03 years
174101, India.
132. M/s. Revive Colicraft 2,000,000 IU Form 5A MHRA. COPP Deferred
Health Care, Lypholized powder for Colomycin was for
Office No.503, solution for Injection Dy No.358 1MIU & 2 issued by confirmati
5th Floor, 6 Main R&I dated MIU by M/s Spain on on
Gulberg, Jail Each vial contains:- 29-04-2016 Forest. dated 04- whether
Road, Lahore. Colistimethate Sodium Rs.50,000/- 05-2016. formulatio
…2,000,000 I.U GMP n is me too
M/s. As per complian or
GENFARMA (Antibiotic)/Polymyxin PRC. t as per otherwise
LABORATORI ) COPP
O, S.L. Site dated 04-
address Avda. USP Specifications 05-2016.
De la
Constitucion, 03 years
198-199,
Poligono

Industrial Monte
Boyal,
Casarrubios del
Monte 45950
(Toledo)
Espana, Spain.
133. M/s. Amgomed, Irinotecan medac Form 5A MHRA. COPP Approved

Office # 5, 1st 100mg/5ml Injection Campto issued as per
Floor Rose 1, Dy. No 362 20mg/ml dated 18- import
Plaza I-8 Each vial contains:- Dated 29- (100mg/5ml) 04-2016. Policy for
Markaz, Irinotecan……..100mg 04-2016 Conc. For GMP Finished
Islamabad. Rs.100,000 solution for complian Drugs
(Advanced Colorectal /- infusion by t as per
Market cancer) M/s Pfizer. COPP.
authorization As per
holder SRO/5ml Local. CPT-11
M/s. MEDAC, Manufacturer’s injection by
Gesellschaft fur Specifications M/s Medinet.
klinische
Spezialpraparate 03 years
mbH,
Fehlandtstrasse
3 20354
Hamburg,
Germany.
Labelling,
Secondary
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin

GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
134. M/s. Amgomed, LipAd Injection Form 5A MHRA. Free sale Approved
Office # 5, 1st Caelyx issued as per
Floor Rose 1, Each vial contains:- Dy. No 362 2mg/ml conc. dated 12- import
Plaza I-8 20mg Doxorubicin dated 29- For solution 04-2016. Policy for
Markaz, Hydrochloride in 10ml 04-2016 for infusion. Finished
Islamabad. pegylated liposomal Rs.100,000 GMP of Drugs
/- Local. the
Manufactured (Alone for meta-static Doxopeg by manufact
by breast cancer, As per M/s uring
M/s. CSPC advanced ovarian SRO. Ferozsons. place not
Ouyi cancer. In provided.
Pharmaceutical combination with
Co. Ltd., No.88, Bortezomide for
Yangzi Road, treatment of
Shijiazhuang progressive multiple
City of China. myeloma.)
Manufacturer’s
Specifications
24 months
135. M/s. Amgomed, Temomedac 100mg Form 5A
MHRA. COPP Approved
Office # 5, 1st Capsule Temodal 5mg, issued as per
Floor Rose 1, Dy. No 363 20mg, 100mg, dated 18- import
Plaza I-8 Each capsule contains:-
Dated 29- 140mg, 180mg 04-2016. Policy for
Markaz, Temozolomide……… 04-2016 & 250mg by GMP Finished
Islamabad. 100mg Rs.100,000 M/s Merck complian Drugs
/- t as per
Market (For newly diagnosed Local. COPP.
authorization Glioblastoma As per Temoside
holder multiforme SRO. 20mg, 100mg
M/s. MEDAC, concomitantly with & 250mg by
Gesellschaft fur radiotherapy) M/s AJ. Mirza.
klinische
Spezialpraparate Manufacturer’s
mbH, Specifications
Fehlandtstrasse 03 years
3 20354
Hamburg,
Germany.

Labelling,
Secondary
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
136. M/s. Amgomed, Paclitaxel medac Form 5 A MHRA. COPP Approved

Office # 5, 1st 100mg/16.7ml Injection Paclitaxel issued as per
Floor Rose 1, Dy. NO 6mg/ml Conc. dated 18- import
Plaza I-8 Each vial contains:- 364 dated for solution for 04-2016. Policy for
Markaz, Paclitaxel………… 29-04-2016 infusion by GMP Finished
Islamabad. 100mg Rs.100,000 M/s Medac complian Drugs
Market /- (5ml, 16.7ml, t as per
authorization (Monotherapy for 50ml & COPP.
holder meta-static breast As per 100ml). Single
M/s. MEDAC, cancer. In SRO/16.7m COPP
Gesellschaft fur combination with l. Local. for two
klinische Gemcitabin for meta- Panataxel products
Spezialpraparate static adenocarcinoma 100mg, .
mbH, of pancreas) 150mg, 300mg
Fehlandtstrasse ) & 30mg by
3 20354 M/s
Hamburg, USP Specifications Ferozsons.
Germany.
Labelling, 03 years
Secondary

Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
137. M/s. Amgomed, Paclitaxel medac Form 5A MHRA. COPP Approved

Office # 5, 1st 300mg/50ml Injection Paclitaxel issued as per
Floor Rose 1, Dy.363 6mg/ml Conc. dated 18- import
Plaza I-8 Each vial contains:- dated 29- for solution for 04-2016. Policy for
Markaz, Paclitaxel………… 04-2016 infusion by GMP Finished
Islamabad. 300mg Rs.100,000 M/s Medac complian Drugs
Market /- (5ml, 16.7ml, t as per
authorization (Monotherapy for 50ml & COPP.
holder meta-static breast As per 100ml). .
M/s. MEDAC, cancer. In SRO/50ml.
Gesellschaft fur combination with Local.
klinische Gemcitabin for meta- Panataxel
Spezialpraparate static adenocarcinoma 100mg,
mbH, of pancreas) 150mg, 300mg
Fehlandtstrasse & 30mg by
3 20354 M/s
Hamburg, USP Specifications Ferozsons.
Germany.
Labelling, 03 years
Secondary
Packaging,
Quality

Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
138. M/s. Amgomed, Topotecan medac 4mg Form 5A FDA. COPP Approved
Office # 5, 1st Injection Topotecan 1, 3 issued as per
Floor Rose 1, Dy. No 360 & 4mg dated 18- import
Plaza I-8 Each vial contains:- Dated 29- solution for 04-2016. Policy for
Markaz, Topotecan as 04-2016 injection by GMP Finished
Islamabad. Hydrochloride……..4m Rs.100,000 M/s Sandoz. complian Drugs
g /- t as per
Market Local. COPP.
authorization (Small cell Lung As per Hycamtin by
holder Cancer treatment) SRO. M/s GSK
M/s. MEDAC,
Gesellschaft fur Manufacturer’s
klinische Specifications
Spezialpraparate 03 years
mbH,
Fehlandtstrasse
3 20354
Hamburg,
Germany.
Labelling,
Secondary
Packaging,
Quality
Control/testing

& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
139. M/s. Amgomed, Ocladra 2mg/ml Form 5A MHRA. Litak COPP Approved
Office # 5, 1st injection (5ml vial) 2mg/ml issued on as per
Floor Rose 1, Dy. No 361 Solution for 22-01- import
Plaza I-8 Each vial contains:- Dated 29- injection 2016 Policy for
Markaz, Cladribine 04-2016 5ml/10mg by . Finished
Islamabad. Hydrochloride……..10 Rs.50,000/- M/s Lipomed. GMP Drugs
mg complian
Manufactured As per t as per
by (Treatment of Hairy PRC. COPP.
M/s. Mustafa cell Leukaemia)
Nevzat (MN),
Ilac San. Ve Tic. Manufacturer’s
A.S. Specifications
Cobancesme 03 years
Mah. Sanyi Cad.
No.13
Yenibosna/Istan
bul, Turkey.
140. M/s. Servier VIACORAM 3.5/2.5 Form 5-A Original Deferred

Research and Tablet Dy No. 371 legalized for the
Pharmaceuticals Each tablet contains:- 05-05-2016 COPP is submissio
Pakaistan Perindopril Rs.50,000/- not n of
Private Limited, Arginine………..3.5mg provided following
65 Main Amlodipine…………… Valid

Boulevard ……2.5mg legalized
Gulberg, (ACE inhibitors and COPP/
Lahore. / calcium channel GMP
M/s. Servier blockers) certificate
Deutschland & stability
GmbH New formulation data as per
Elsenheimerster 02 years conditions
80687 Munich, of Zone IV
Germany. A.
141. M/s. Merixil Lutrate 3month Depot Form 5A MHRA. COPP Approved
Pharma, (22.5mg) Injection Lutrate issued on as per
Office # 28, Dy. No. 22.5mg & 12-04- import
Second Floor, Each vial contains: 387 Dated 3.75mg 2016. Policy for
Rose Plaza, I-8 Leuprorelin acetate 04-05-2016 powder and Finished
Markaz, powder for prolonged Rs.100,000 solvent for GMP Drugs
Islamabad. release suspension for /- prolonged complian
injection….…22.5 mg release t as per
Manufactured suspension for COPP.
by (Palliative treatmentof As Per injection.
M/s. GP locally advanced & SRO/Kit GMP
Pharma, metastatic prostate (New issued
Polígono cancer) The molecule) dated 29-
Industrial Els commercial 10-2014
Vinyets -Els kit includes
Fogars, Sector 2. Manufacturer’s i.Glass Vial
Carretera Specifications. of
Comarcal C244, Leuprorelin
Km, 22 08777 Shelf life : 36months ii.Prefilled
Sant Quintí De glass
Mediona syringe 2ml
Barcelona, containing
Spain. solvent.
iii.Polycarb
onate
HDPE
Adaptor
system
with
syringe
with
needle.
142. M/s. Merixil Sterile Solvent For Form 5A MHRA. COPP Approved
Pharma, Lutrate Depot 3 month Dy. No 385 Lutrate issued on as per
Office # 28, Depot (22.5mg) Dated 04- 22.5mg & 12-04- import
Second Floor, 05-2016 3.75mg 2016. Policy for

Rose Plaza, I-8 Each pre filled syringe Rs.100,000 powder and (Same Finished
Markaz, 2ml contains:- /- solvent for COPP Drugs
Islamabad. prolonged for
Manufactured 0.8% mannitol solution release powder
by in water for injection. Free of suspension for and
M/s. GP Cost along injection. solvent)
Pharma, For reconstitution with For
Polígon purpose Lutrate
Industrial Els Manufacturer’s Depot 3 GMP
Vinyets -Els Specifications month issued
Fogars, Sector 2. Depot dated 29-
Carretera Shelf life: 36 months (22.5mg) 10-2014
Comarcal C244,
Km, 22 08777
Sant Quintí De
Mediona
Barcelona,
Spain.
143. M/s. Merixil Lutrate 1month Depot Form 5A MHRA. COPP Approved
Pharma, (3.75mg) Injection Lutrate issued as per
Office # 28, Dy. No 139 22.5mg & dated 12- import
Second Floor, Each vial contains: Datedm 04- 3.75mg 04-2016. Policy for
Rose Plaza, I-8 Leuprorelin acetate 05-2016 powder and (Original Finished
Markaz, powder for prolonged Rs.100,000 solvent for Embassy Drugs
Islamabad. release suspension for /- prolonged attested)
Manufactured injection….…3.75 mg release
by As per suspension for GMP
M/s. GP (Palliative treatmentof SRO/Kit injection. complian
Pharma, locally advanced & t as per
Polígon metastatic prostate The Local. COPP.
Industrial Els cancer) commercial Lectrum
Vinyets -Els kit includes 3.75mg by Embassy
Fogars, Sector 2. i.Glass Vial M/s Sandoz attested
Carretera Manufacturer’s of with solvent GMP
Comarcal C244, Specifications Leuprorelin issued
Km, 22 08777 ii.Prefilled dated 29-
Sant Quintí De Shelf life : 36months glass 10-2014
Mediona syringe 2ml
Barcelona, containing
Spain. solvent.
iii.Polycarb
onate
HDPE
Adaptor

system
with
syringe
with
needle..
144. M/s. Merixil Sterile Solvent For Form 5 A MHRA. Same Rejected
Pharma, Lutrate Depot 1 month Lutrate applicati as already
Office # 28, Depot (3.75mg) Dy. No 386 22.5mg & on approved
Second Floor, dated 04- 3.75mg applied at
Rose Plaza, I-8 Each pre filled syringe 05-2016 powder and for S.No.142
Markaz, 2ml contains: Rs.100,000 solvent for Lutrate
Islamabad. / 0.8% mannitol solution /- prolonged Depot 3
Manufactured in water for injection. release month
by suspension for Depot
M/s. GP For reconstitution Free of injection. (22.5mg)
Pharma, purpose Cost COPP
Polígon Local. issued
Industrial Els Manufacturer’s Lectrum dated 12-
Vinyets -Els Specifications 3.75mg by 04-2016.
Fogars, Sector 2. M/s Sandoz
Carretera Shelf life: 36 months with solvent GMP
Comarcal C244, complian
Km, 22 08777 t as per
Sant Quintí De COPP.
Mediona
Barcelona, GMP
Spain. issued
dated 29-
10-2014.
145. M/s. Revive Amphotin 50mg Form-5-A MHRA. Free sale Defered as
Health Care, Injection (Lyophilized) Fungizone issued the
Office No.503, Dy No.374 50mg powder dated 26- product
5th Floor, 6 Main Each vial contains:- dated 04- for solution by 02-2016. does not
Gulberg, Jail Amphotericin B 05-2016 M/s E.R COPP fall in the
Road, Lahore. (Lyophilized) Rs.50,000/- Squibb. valid priority
……….50mg & upto list.
M/s. United Rs.50,000 Local. GMP Moreover
Biotech (P) (Anti-fungal) dated 24- Medinet valid Anti-
Limited, 06-2016. upto 17- fungal
Bagbani, Baddi, Manufacturer’s 09-2017. drugs are
Nalagarh Road, Specifications As per not
District, Solan, SRO importable
India. 02 years from India
as per
Import
Policy

Order,
2016
146. M/s. Revive Zimta 4mg/5ml Conc. Form 5A MHRA. COPP Approved
Health Care, for solution for Zoledronic issued as per
Office No.503, Injection Dy. No 376 Acid 4mg/5ml dated 04- import
5th Floor, 6 Main Dated 04- Conc. for 05-2016. Policy for
Gulberg, Jail Each vial contains:- 05-2016 solution for GMP Finished
Road, Lahore. Zoledronic Rs.50,000/- Injection by complian Drugs
Acid………….4mg & 50,000 M/s t as per
Manufactured dated 24- Intrapharm. COPP.
By (Prevention of skeletal 06-2016.
M/s. Alfa related events (e.g Local. Zometa
Wassermann tumor induced by M/s
S.p.A VIA hypercalcemia) in Novartis
Enrico Fermi, 1- adult patients with
65020 Alanno advanced
(PE), Italy malignancies involving
Final Product bone).
release by
M/s Biomendi, Manufacturer’s
S.A. Poligono Specifications
Industrial de
Bernedo, s/n, 02 years
Bernedo, 01118
Alava, Spain.
147. M/s. Servier Triveram 20/5/5 Tablets Form 5-A Original Deferred
Research and Each film coated tablets legalized for the
Pharmaceuticals contains:- Dy. No.382 COPP / submissio
Pakaistan Atorvastatin………… 05-05-2016 GMP is n of
Private Limited, ……20mg Rs.50,000/- not following
65 Main Perindopril provided. a.Approva
Boulevard Arginine………5mg l status by
Gulberg, Amlodipine…………… reference
Lahore. …..5mg regulatory
M/s. Les authorities
Laboratoirie (Statin/ACE b.valid
Industrie, 905, Inhibitors/Calcium legalized
route de Saran Antagonist) COPP
45520 Gidy, New formulation c.Stability
France. data as per
02 years conditions
of Zone IV
A.
148. M/s. Servier Triveram 20/10/5 Form 5-A Original Deferred

Research and Tablets legalized for the
Pharmaceuticals Each film coated tablets Dy. No.385 COPP is submissio
Pakaistan contains:- 05-05-2016 not n of
Private Limited, Atorvastatin………… Rs.50,000/- provided. following
65 Main ……20mg a.Approva
Boulevard Perindopril l status by
Gulberg, Arginine………10mg reference
Lahore./ Amlodipine…………… regulatory
M/s. Les …..5mg authorities
Laboratoirie b.valid
Industrie, 905, (Statin/ACE legalized
route de Saran Inhibitors/Calcium COPP
45520 Gidy, Antagonist) c.Stability
France. data as per
New formulation conditions
of Zone IV
02 years A.
149. M/s. Servier Triveram 10/5/5 Tablets Form 5-A Original Deferred
Research and Each film coated tablets legalized for the
Pharmaceuticals contains:- Dy No.384 COPP is submissio
Pakaistan Atorvastatin………… 05-05-2016 not n of
Private Limited, ……10mg Rs.50,000/- provided. following
65 Main Perindopril a.Approva
Boulevard Arginine………5mg l status by
Gulberg, Amlodipine…………… reference
Lahore./ …..5mg regulatory
M/s. Les authorities
Laboratoirie (Statin/ACE b.valid
Industrie, 905, Inhibitors/Calcium legalized
route de Saran Antagonist) COPP
45520 Gidy, c.Stability
France. New formulation data as per
conditions
02 years of Zone IV
A.
Research and tablets legalized for the
Pharmaceuticals Each film coated tablets Dy No.386 COPP is submissio

France. data as per
of Zone IV
02 years A.
Research and tablets legalized for the
Pharmaceuticals Each film coated tablets Dy No.383 COPP is submissio
France. data as per
of Zone IV
02 years A.
152. M/s. Servier Viacoram 7/5 Tablets Form 5A Original Deferred
Research and Each tablets contains:- Legalize for the
Pharmaceuticals Perindopril Dy No.381 d COPP submissio
Pakaistan Arginine………7mg 05-05-2016 is not n of
Private Limited, Amlodipine…………… Rs.50,000/- provided following
65 Main …..5mg a.Approva
Boulevard l status by
Gulberg, (ACE reference
Lahore./ Inhibitors/Calcium regulatory
M/s. Servier channel blockers, ATC) authorities
Deutschland New formulation b.valid
GmbH legalized
Elsenheimerster 02 years COPP
80687 Munich, c.Stability
Germany. data as per
conditions
of Zone IV
A.
153. M/s. Atco Bendamustine Form 5A FDA. COPP Deferred

Laboratories Hydochloride Injection Bendamustine valid for the
Limited, B-18, 100mg Dy. No 308 powder for upto 03- submissio
S.I.T.E. Karachi. Dated 06- infusion by 01-2015. n of GMP
Each vial contains:- 05-2016 M/s Hospira. GMP status of
Manufactured Bendamustine Rs.50,000/- certificat the firm as
by Hydochloride………..1 e not CoPP does
M/s. Fresenius 00mg Rs.25000/v provided. not reflect
Kabi Oncolony Mannitol Ph. Eur…… ial Stability GMP
Limited, Village 120mg data as status.
KIshanpura, per
P.O. Guru (Lumphocutic condition
Majra, Tehsil leukemia, indolent s of Zone
Nalagarh, Distt. non-Hodgkin’s IV-B
Solan (H.P) 174 lymphoma, multiple attached.
101, India. myeloma)
Manufacturer’s
Specifications
24 months
154. M/s. Amgomed, Amtron 8 mg (2mg/ml) Form 5A MHRA.Ondan COPP Deferred
Office # 5, 1st solution for injection setron 2mg/ml issued on for
Floor Rose 1, Dy. No by M/s 01-04- clarificatio
Plaza I-8 Each 8mg/4ml ampoule 1039 dated Hameln 2014 by n of date
Markaz contains: 26.09.2016 Portagal. of
Islamabad. Ondansetron Rs.100000/ Local. Zofran submissio
Product ………..8mg/4ml - by M/s GSK GMP n of
License Holder complian application
M/s Farmoz- (Antimetics used in As per t as per
Sociedade cancer induced SRO/ pack COPP.
Tecnico vomiting) of 5
Medicinal’ S.A.
Rua da Tapada Manufacturer’s
Grande, 2, Specifications
Abrunheira 03years
2710-089 Sintra,
Portugal.
Manufactured
by.
M/s
Laboratorios
Vitoria, S.A.
(Fab) Rua Elias
Garcia, 28-
Venda Nova
2700-327

Amadora,
Portugal & M/s.
Atlantic Pharma,
Producoes
Farmacueticals,
SA Rua da
Tapand, n 2
Abruheeira
Sintra, 2710-
089, Portugal
155. M/s. Cyclocure 25mg Form 5A
MHRA. COPP Deferred
Pharmawell Capsule Neoral Soft issued as firm has
(Pvt) Ltd. 244-Y Dated 11- Gelatin dated 03- not
Block, Each soft gel capsule 09-2015 Capsule 25mg 08-2015 submitted
Commercial contains:- vide diary by M/s vide no. real time
Area Phase III, Cyclosporin………….2 No. 309 Novartis 2015052 stability
DHA, Lahore. 5mg Rs.100,000 9 valid data upto
/- upto 2 assigned
M/s. North (Immunosuprent) years. shelf life,
China Co. Ltd, Rs.1940 GMP of Zone IV
No. 115 Hainan (Manufacturer’s Specs) /50’s valid A.
Road, upto 26-
Economic & 24 months 06-2017
Techonological vide no.
Development HF20120
Zone, 014.
Shijiazhuang, Stability
China data as
per
condition
s of Zone
IVA
attached.
156. M/s. Cyclocure 50mg Form 5A COPP Deferred
Pharmawell Capsule issued as firm has
(Pvt) Ltd. 244-Y Dated 11- dated 03- not
Block, Each soft gel capsule 09-2015 08-2015 submitted
Commercial contains:- vide diary vide no. real time
Area Phase III, Cyclosporin………….5 No. 310 2015052 stability
DHA, Lahore. 0mg Rs.100,000 7 valid data upto
/- upto 2 assigned
M/s. North (Immunosuprent) years. shelf life,
China Co. Ltd, Rs.3881 GMP of Zone IV
No. 115 Hainan (Manufacturer’s Specs) /50’s valid A.
Road, upto 26-
Economic & 24 months 06-2017

Techonological vide no.
Development HF20120
Zone, 014.
Shijiazhuang, Stability
China data as
per
condition
s of Zone
IVA
attached
157. M/s. Triumeq Tablet Form 5A COPP Approved
GlaxoSmithKlin issued
e Pakistan Each film coated tablets Dy No. 404 dated10-
Limited, 35- contains:- R&I dated 02-2016
Dockyard Road, Dolutegravir as 24-05-2016 vide No.
West Wharf, sodium……50mg Rs.50,000/- 01/16/95
Karachi-74000. Abacavir as 860 by
sulfate…….600mg Will be EMA.
Market Lamivudine…….300m submitted GMP
Authorization g later complian
Holder t as per
M/s ViiV Anti-HIV, COPP.
Healthcare UK new molecule
Limited, 980
Great West 36 months
Road, Brentford,
Middlesex, TW8
9GS, United
Kingdom
Manufactured
by M/s. Glaxo
Operations UK
Ltd, Priory
Street, Ware,
Hertfordshire
SG12 ODJ,
United
Kingdom.
Site Responsible
for Primary &
Secondary
Packaging
M/s Glaxo
Wellcome S.A.,
Avenida

Extremadura 3,
Aranda de
Duero, Burgos,
09400, Spain.
158. M/s Johnson & Stratafix Knotless tissue Form 5A Certificat Deferred
Johnson control device e to for the
Pakistan Pvt Dy No. 679 foreign expert
Ltd, Karachi Each unit of device dated 11- Governm opinion
Name of contains:- 04-2014 ent No. from
Distributor Polydioxanone/PGA- Rs.50,000. 1171-6- Expert
M/s Ethicon, PCL/Polypropylene 2013 Committee
LLC 475 C Not issued for
Street Los (Class III Medical mentioned dated 14- Medical
Frailes device) 06-2013 Devices
Industrial Park New Molecule valid (ECMD).
Guaynabo, PR, upto 2
USA 00969 years.
Name of Medical
Manufacturer:- Device
M/s Surgical
Specialities
Puerto Rico,
Inc; Angiotech
PR Inc. Doing
business as
Angiotech
Puerto Rico,
Inc; Road 459
KM 0.6
Montana
Industrial Park
Aguadilla, PR,
USA 00603.
Product Code Product Description
SXMD1B100 PS-1 2-0 PGA-PCL 30CM
SXMD1B101 PS-2 3-0 PDO 45CM
SXMD1B102 PSL 0 PGA-PCL 60CM
SXMD1B402 RB-1 3-0 PGA-PCL 20CM
SXMD1B403 RB-1 2-0 PGA-PCL 20CM
SXMD1B404 RB-1 0 PGA-PCL 20CM
SXMD1B405 SH 2-0 PGA-PCL 20CM

SXMD1B406 SH 0 PGA-PCL 20CM
SXMD1B407 CT-1 2-0 PGA-PCL 45CM
SXMD1B408 CT-1 0 PGA-PCL 45CM
SXMD1B409 CT-1 1 PGA-PCL 45CM
SXMD2B150 2PS-l 3-0 UNO MONODERM 30X30
SXMD2B400 2MH -0- UNDYED MONODERM 14X14
SXMD2B401 2MH -0- UNDYED MONODERM 36X36
SXMD2B402 2R8-1 2-0 U MND 16X1613MM LOR
SXMD2B403 2RB-l 3-0 U MND 16X1613MM LOR
SXMD2B404 2FS-2 2-0 UNDYED MONODERM 7X7
SXMD2B405 2FS-2 3-0 UNDYED MONODERM 7X7
SXMD2B406 2FS-2 2-0 UNDYD MONODERM 14X14
SXMD2B410 2FS-l 2-0 UND MONODERM 30X30
SXMD2B411 2FS 2-0 UNDYD MONODERM 14X14
SXMD2B414 2CP-2 -0- UNDYD MONODERM 14X14
SXPD1B100 PS-2 2-0 PDO 45CM
SXPD1B101 PS-2 3-0 PDO 45CM
SXPD1B400 CT-1 0 PDO 20CM
SXPD1B401 CT-1 0 PDO 30CM
SXPD2B200 20S-6 #2 PDO 24X24
SXPD2B201 20S-6 #2 POD 30 X 30
SXPD2B202 20S-8 #2 PDO 36 X 36
SXPD2B400 2MO-4 #2 PDO 36 X 36
SXPD2B401 2CT-1 -2- PDO 14X 14
SXPD2B402 2CT-1 #2 PD024X24
SXPD2B403 2CT -1 #2 PDO 30 X 30
SXPD2B404 2CT-3-1- PDO 14X14 13MM LDR
SXPD2B405 2CTX #2 PDO 36 X 36
SXPD2B406 2MH -0- PDO 7X7 13MM LEADER
SXPD2B407 2MH -0- PDO 14X1413MMLEADER
SXPD2B409 2MH-1-PDO 14X14
SXPD2B408 2MH -0- PDO 24 X 24
SXPD2B410 2MH #1 PDO 24 X 24
SXPD2B411 2MH #1 PDO 30 X 30
SXPD2B412 2MH -0- PDO 36 X 36
SXPD2B413 2SH-0- PDO 10 X 10 13MM LEADER
SXPD2B414 2SH -0- PDO 14 X 14 13MMLEADER

SXPD2B415 2CP-2 #I PDO 24X24
SXPD2B416 2CP-2 #2 PDO 24 X 24
SXPD2B417 2FS 2-0 PDO 14X14
SXPD2B418 2FS -0- PDO 14 X 14
SXPD2B419 2FS 2-0 PDO 24 X 24
SXPD2B420 2FS -0- PDO 24 X 24
SXPD2B421 2FS-2 4-0 PDO 7 X 7
SXPD2B422 2FS-2 3-0 PDO 7X7
SXPD2B423 2FS-2 3-0 PDO 14 X 14
SXPD2B424 2V-26 3-0 PDO 24 X 24
SXPD2B425 2V-26 3-0 PDO 14X14
SXPD2B426 2V-4 3-0 PDO 24X24
SXPL1B400 DE12 0 PPN 30CM
SXPL2B400 2CT-1 -2- CL PPN 24X24
SXPL2B401 2CT-3 -1- CL PPN 14X1413MM LDR
SXPP1A100 STRATAFIX SYMM PDS PLUS 45cm; PS-1; 3-0; Plastics
SXPP1A101 STRATAFIX SYMM PDS PLUS 45cm; PS-2; 3-0; Plastics
SXPP1A200 STRATAFIX SYMM PDS PLUS 45cm; OS-6; 0; Ortho
SXPP1A201 STRATAFIX SYMM PDS PLUS 45cm; OS-6; 1; Ortho
SXPP1A300 STRATAFIX SYMM PDS PLUS 45cm; CTXB; 1; Ethiguard
SXPP1A301 STRATAFIX SYMM PDS PLUS 45cm; CTB-1; 1; Ethiguard
SXPP1A302 STRATAFIX SYMM PDS PLUS 45cm; CTXB; 0; Ethiguard
SXPP1A400 STRATAFIX SYMM PDS PLUS 45cm; CTX; 1
SXPP1A401 STRATAFIX SYMM PDS PLUS 45cm; CT-1; 0
SXPP1A402 STRATAFIX SYMM PDS PLUS 45cm; CTX; 0
SXPP1A403 STRATAFIX SYMM PDS PLUS 45cm; CT-1; 2-0
SXPP1A405 STRATAFIX SYMM PDS PLUS 45cm; CT; 1
SXPP1A406 STRATAFIX SYMM PDS PLUS 45cm; CT; 0
SXPP1A408 STRATAFIX SYMM PDS PLUS 45cm; CT-2; 2-0
SXPP1A409 STRATAFIX SYMM PDS PLUS 45cm; SH; 2-0
SXPP1A410 STRATAFIX SYMM PDS PLUS 45cm; SH; 3-0
SXMP1B101 MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS-1
SXMP1B104 MONOCRYL PLUS70CM M -2 USP 3/0 SGLE ARMED PS-1
SXMP1B105 MONOCRYL PLUS15 CM M -2 USP 3/0 SGLE ARMED PS-2
SXMP1B110 MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS

SXMP1B114 MONOCRYL PLUS 30CM M -1.5 USP 4/0 SGLE ARMED PS-1
SXMP1B115 MONOCRYL PLUS 45CM M -1.5USP 4/0 SGLE ARMED PS- 1
SXMP1B116 MONOCRYL PLUS 70CM M -1.5 USP 4/0 SGLE ARMED PS- 1
SXMP1B117 MONOCRYL PLUS 30CM M -1.5 USP 4/0 SGLE ARMED PS-2
SXMP1B118 MONOCRYL PLUS 45CM M -1.5USP 4/0 SGLE ARMED PS- 2
SXMP1B119 MONOCRYL PLUS 70CM M -1.5 USP 4/0 SGLE ARMED PS- 2
SXMP1B120 MONOCRYL PLUS 45CM M1.5 USP 4/0 SGLE ARMED PS-4
SXMP1B408 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED SH
SXMP1B411 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED CT-1
SXMP1B412 MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED CT-1
SXMP1B415 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED CT-2
SXMP1B420 MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED PSL
SXMP1B421 MONOCRYL PLUS 70 CM M3 USP 2/0 SGLE ARMED PSL
SXMP1B424 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED RB-1
SXMP1B427 MONOCRYL PLUS 20CM M2 USP3/0 SGLE ARMED SH
SXMP1B428 MONOCRYL PLUS 70CM M2 USP3/0 SGLE ARMED SH
SXMP1B429 MONOCRYL PLUS 45CM M2 USP3/0 SGLE ARMED CT-1
SXMP1B430 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED BB
SXMP1B431 MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED BB
SXMP1B432 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED ST-4
SXMP1B433 MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED ST-4
SXMP1B434 MONOCRYL PLUS 15CM M1.5 USP4/0 SGLE ARMED RB-1
SXMP1B437 MONOCRYL PLUS 70CM M1.5 USP4/0 SGLE ARMED SH
SXPP1B101 PDS PLUS VIO 45CM M3 UPS/2-0 SGLE ARMED FS
SXPP1B102 PDS PLUS VIO 70CM M3UPS/2-0 SGLE ARMED FS
SXPP1B103 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED PS-2
SXPP1B104 PDS PLUS VIO 30CM M2 UPS/3-0 SGL ARMED PS-2

SXPP1B109 PDS PLUS VIO 70 CM M2 UPS/3-0 SGLE ARMED PS
SXPP1B110 PDS PLUS VIO 70 CM M2 UPS/3-0 SGLE ARMED PS-1
SXPP1B111 PDS PLUS VIO 15 CM M2 UPS/4-0 SGLE ARMED PS-2
SXPP1B114 PDS PLUS VIO 70CM M1.5 UPS/4-0 SGLE ARMED PS-2
SXPP1B117 PDS PLUS VIO60CM M2 UPS/4-0 SGLE ARMED PS-1
SXPP1B118 PDS PLUS VIO 45CM M2 UPS/4-0 SGLE ARMED PS
SXPP1B201 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED OS-6
SXPP1B202 PDS PLUS VIO 45CM M3.5 UPS/0 SGLE ARMED CP-2
SXPP1B205 PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED MO-4
SXPP1B401 PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED CT X
SXPP1B402 PDS PLUS VIO 90CM M4 UPS/1 SGLE ARMED CTX
SXPP1B403 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED CP-2
SXPP1B404 PDS PLUS VIO 20CM M3.5 UPS/0 SGLE ARMED V-34
SXPP1B405 PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED CT-2
SXPP1B407 PDS PLUS VIO 45CM M3.5 UPS/0 SGLE ARMEDCT-1
SXPP1B409 PDS PLUS VIO 15CM M3 UPS/2-0 SGLE ARMED CT-1
SXPP1B413 PDS PLUS VIO 15CM M3UPS/2-0 SGLE ARMED CT-2
SXPP1B415 PDS PLUS VIO 15CM M3 UPS/2-0 SGLE ARMED SH
SXPP1B418 PDS PLUS VIO 20CM M3 UPS/2-0 SGLE ARMED V-7
SXPP1B419 PDS PLUS VIO 30CM M3 UPS/2-0 SGLE ARMED UR-6
SXPP1B422 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED RB-1
SXPP1B423 PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED RB-1
SXPP1B424 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED ST-4
SXPP1B426 PDS PLUS VIO 70CM M1.5UPS/4-0 SGLE ARMED SH
SXPP1B427 PDS PLUS VIO 15CM M1.5UPS/4-0 SGLE ARMED RB-1

SXPP1B428 PDS PLUS VIO 30CM M1.5 UPS/4-0 SGLE ARMED RB-1
SXPP1B429 PDS PLUS VIO 30CM M4UPS/1 SGLE ARMED CT-1
SXPP1B430 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED CT-1
SXPP1B431 PDS PLUS VIO 70CM M4UPS/1 SGLE ARMED CT-1
SXPP1B451 PDS PLUS VIO 70 CM M3.5UPS/0 SGLE ARMED M05
SXPP1B452 PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED EN-S
Muhammad Ansar Evaluator-I

Replies of the import cases deferred in 259th meeting of the Registration Board.
159. M/s Tablet Form 5A TGA. The firm Now the Approved
Merixil Azastrole 1mg Azastrole has firm has as per
Pharma, 18-04- 1mg submitted submitted import
Office Each film 2014 that in Policy for
#28, 2nd coated tablet vide Arimede Legalized registration Finished
floor Rose contains:- diary No. x 1mg by Free sale dossier Drugs.
Plaza, I-8, Anastrozole… 314 R&I M/s ICI issued license to Product is
Markaz, ….1mg Rs.100,0 dated 30- manufactur approved
Islamabad 00. 12-2013. e by TGA
. (Treatment of Stability therapeutic which is a
harmone As per data as per goods reference
Manufact recpotor SRO/3x1 conditions (Legalized) regulatory
ured by positive 0’s of Zone IV- , the anti- authority.
M/s Eris advanced A neoplastic
Pharmace breast cancer Legalized agents
utical in post GMP tablet
(Australia menopausal certificate section is
) Pty Ltd, women) issued mentioned
6 Eastren dated 25- in its
Road Manufacturer’s 02-2013. attachment
South Specifications s
Melbourn furthermor
e VIC e the firm
3205, has replied
Australia. that the
(230) product is
TGA
approved
brand and
also same
is available
on the site
of TGA.

160. M/s Tablet Gynotril Form 5A TGA. The firm Now the Approved
Merixil 2.5mg Gynotril has firm has as per
Pharma, 18-04- 2.5mg submitted submitted import
#28, 2nd coated tablet vide Femara Legalized registration Finished
floor Rose contains:- diary No. 2.5mg by Free sale dossier Drugs.
Plaza, I-8, Letrozole……. 313 R&I M/s issued license to Product is
Markaz, 2.5mg Rs.100,0 Novartis dated 30- manufactur approved
. (Adjuant Stability therapeutic which is a
(231) treatment of As per data as per goods reference
Manufact post- SRO/3x1 conditions (Legalized) regulatory
ured by menopausal 0’s of Zone IV- , the anti- authority.
M/s Eris women with A neoplastic
Pharmace harmone Legalized agents
utical recpotor GMP tablet
(Australia positive certificate section is
) Pty Ltd, invasive early issued mentioned
6 Eastren breast cancer) dated 25- in its
Road 02-2013. attachment
South USP s
Melbourn Specifications furthermor
e VIC e the firm
3205, has replied
Australia. that the
(231) product is
TGA
approved
brand and
also same
is available
on the site
of TGA.
161. M/s Tablet Bicalox Form 5A TGA. The firm Now the Approved
Merixil 50mg Bicalox has firm has as per
Pharma, 18-04- 50mg submitted:- submitted import
#28, 2nd coated tablet vide Casodex Legalized registration Finished
floor Rose
contains:- diary No. 50mg by Free sale dossier Drugs.
Plaza, I-8,
Bicalutamide… 315 R&I M/s ICI issued license to Product is
Markaz, ….50mg Rs.100,0 dated 30- manufactur approved
. Adjuant to Stability therapeutic which is a
radial As per data as per goods reference
Manufact prostectomy or SRO/ conditions (Legalized) regulatory
ured by radio-therapy of Zone IV- , the anti- authority.

M/s Eris in patients with A neoplastic
Pharmace locally Legalized agents
utical advanced GMP tablet
(Australia prostate cancer certificate section is
) Pty Ltd, issued mentioned
6 Eastren dated 25- in its
Road USP 02-2013. attachment
South Specifications s
Melbourn furthermor
e VIC e the firm
3205, has replied
Australia. that the
(232) product is
TGA
approved
brand and
also same
is available
on the site
of TGA.
162. M/s Zam Daivobet Gel. Form 5A Denmark The firm Now the Approved
Zam Daivobet has firm has as per
Corporati Each gm 26-12- Gel by submitted:- replied the import
on, Suit contains:- 2013 M/s product is Policy for
No. 205- Calcipotriol… vide LEO. Free sales Denmark Finished
206, …..…50mcg diary No. certificate approved Drugs.
Beaumont Betamethasone 469 R&I 10-12- which is
Plaza, Dipropionate… Rs.50,00 2012(legali reference
Beaumont …....0.5mg 0 zed country.
Road, photocopy)
Karachi .
Manufact Topical Rs.1600/ GMP
ured by Vitamin D 15gm issued
M/s LEO analogue & tube dated 01-
Pharma Steroid. 06-2010.
A/S
Industripa Manufacturer’s
rken 55 Specifications
DK-2750
Ballerup,
Denmark.
(189)
163. M/s Letroze 2.5mg Form 5A TGA. The firm Now the Approved
Amgomed tablet Gynotril has firm has as per
, office 11-04- 2.5mg submitted submitted import
No. 05, 1st Each film 2014 the GMP Policy for

floor, coated tablet vide Femara COPP legalized Finished
Rose 1 contains:- diary No. 2.5mg by Legalized which Drugs.
Plaza, I-8, Letrozole……. 297 R&I M/s issued shows the
Markaz, 2.5mg Rs.100,0 Novartis dated 19- details of
Islamabad 00 11-2013. sections i.e
. (Adjuant Firm is firm has
From treatment of GMP non sterile
Manufact post- As per compliant antineoplas
ured By menopausal SRO/30 as per tic tablet
M/s West women with tablets COPP section.
Pharma, harmone Legalized
Producoes recpotor issued
de positive dated 19-
Especialia invasive early 11-2013.
es breast cancer) Stability
Farmaceut data as per
icas, SA USP conditions
Rua Joao Specifications of Zone IV-
De Deus, A.
n. 11,
Amadora,
2700-486,
Portugal.
(227)
164. M/s Vesna Injection Form 5A MHRA. The firm Now the Approved
Revive 200mg Mesna has firm has as per
Healthcar 02-08- 200mg/2 submitted submitted import
e, Office Each 1ml 2013 ml by Legalized the COPP Policy for
503, 5th contains:- vide M/s COPP valid for the Finished
Floor, 6 Sodium-2- diary No. Claris upto 10-09- Vesna Drugs.
Main Sulphanylethan 1001 Lifescien 2013. valid upto
Gulberg, esulphonate R&I ces UK. Stability 10-05-2017
Jail Road, BP……100mg Rs.100,0 data as per which
Lahore, 00 conditions shows that
Pakistan. Antineoplastic of Zone IV- the product
Agent A. is available
Manufact As per Legalized in alone.
ured by USP SRO/2ml GMP dated
M/s Specifications ampoule 13.09.2010.
United
Biotech
(P) Ltd.
FC/B-1
(Extn.)
Mohan

Cooperati
ve
Industrial
Estate,
Mathura
Road,
New
Delhi-
110044,
India.
(129)
The following product of M/s. Revive Health Care, Lahore was discussed in the 243rd meeting of
the board and was approved.
It is submitted that there is a typographical mistake in the formulation the Sodium 2-

Sulphanylethansulphonate 100mg were written inadvertently.
M/s. Revive Health Care, Ifomid-M 1gm Injection As per 02 years Approved as
Lahore. / Each vial contains:- SRO/PRC per import
M/s. United Biotech (P) Ifosfamide…………….1gm Policy for
Limited, Bagbani, Baddi, Sodium 2- Finished
Nalagarh Road, District, Sulphanylethansulphonate Drugs.
Solan, India. BP……………..……
100mg
(ATC Class: L01AA06).
The correct formulation is as under
165. M/s. Revive Health Care, Ifomid-M 1gm Injection As per 02 years valid COPP Approved as
Lahore. / Each vial contains:- SRO/PRC valid upto per import
M/s. United Biotech (P) Ifosfamide…………….1g 10-05-2017 Policy for
Limited, Bagbani, Baddi, m Finished
Nalagarh Road, District, Drugs.
Solan, India. (ATC Class: L01AA06).

Replies of product deferred in 254th meeting of the Board.
166. Importer KETOFAST Form- International Deferred for: Legalized Deferred for
M/s Efroz Cataplasma 5A availibility Evidence of GMP the
Chemical not approval of issued confirmation
Industries (Pvt) Each sheet (9x13cm2, Dy confirmed. same dosage dated 28- of approval
Limited, 12-C 11.7gm) contains: No : form, generic 01-2016 status by
Block 6, Ketoprofen…..25.07mg 468 Kefentech and strength by Korea. reference
P.E.C.H.S. off dated Plaster by in reference Legalized regulatory
Shahrah-e- NSAID 26-01- M/s Matrix drug agency. COPP authorities
Faisal, Karachi 11 Reg Confirmation issued
Manufacturer Manufacturer 15000/- #047624. of address of dated 26-
M/s Dae Hwa dated the 05-2016
Pharmaceuticals 26-01- manufacturer by Korea.
Co., Ltd 11 of the Product is
495- Hanu-ro-, 85000/- applied in free
Hoenseong-eup, dated product as sale in
Hoenseong, 19-02- the address Korea.
Gangwon-do, 14 mentioned Local
Republic of on Form-5A Kefentech
Korea. Rs. & GMP is by M/s
500/- different Matrix.
Per 6’s from the
Sheets address
mentioned in
the COPP.
Moreover,
address of
manufacturer
on sole
agency
agreement is
different
from address
of above
mentioned
documents.
Clarfication
that applied
drug is
generic
product
hence
clinical data
and clinical
justification

is not
required.
Stability data
as per
WHO/ICH
Zone-IV A.

Routine Import Applications
Veterinary Import applications Routine
Decision
167. M/s. Ghazi Spectramast DC Form 5-A FDA. COPP Approved

Brothers, Suspension Ceftifur issued by as per
Karachi- Each 10ml Plastet Rs. 50,000/- 500mg by US FDA import
75350. / Disposable Syringe vide Dy. No. M/s M/s. dated 20- Policy for
M/s. Pharmacia contains:- 628 dated 29- Pharmacia 03-2013. Finished
& Upjohn Ceftiofur 05-2013 & Upjohn GMP Drugs.
Company A Equivalents (as the compliant
Division of hydrochloride sale) Decontrolled/ as per
Pfizer Inc. …500mg 10ml COPP.
Kalamazoo,
Michigan, (Antibiotic).
U.S.A.
Manufacturer’s
362 specifications
168. M/s. Ghazai Spectramast LC Form 5-A FDA. COPP Approved
Brothers, Suspension Ceftifur issued by as per
Karachi- Rs. 50,000/- 250mg by US FDA import
75350. / Each 10ml Plastet vide Dy. No. M/s M/s. dated 09- Policy for
M/s. Pharmacia Disposable Syringe 627 dated 29- Pharmacia 10-2015. Finished
& Upjohn contains:- 05-2013 & Upjohn GMP Drugs.
Company A Ceftiofur compliant
Division of Equivalents to Decontrolled/ as per
Pfizer Inc. Ceftiofur …125mg 10ml COPP.
Kalamazoo,
Michigan, (Antibiotic).
U.S.A.
Manufacturer’s
363 specifications
24 Months
169. M/s. Ghazi ADEFORTEX Form 5-A Free sale Approved
Brothers, Injectable Solution Local. issued as per

Ghazi House, Dy. No. 211 Duravit dated 19- import
D-35. K.D.A. Each mL contains:- R&I Rs. AD3E 12-2012. Policy for
Scheme No.1, Vitamin A (Palmitic 50,000/- dated Injection GMP Finished
Miran ester of Vitamin A) 19-03-2014 & by M/s issued Drugs.
Muhammad …………… Rs. 50,000 Mylab. dated 06-
Shah Road, 500,000 I.U dated 30-07- 02-2013.
Karachi-75350 Vitamin D3 (Pure 2016 dy No.
Cholecalciferol) 822.
Product …..75,000 I.U
License Vitamin E (Alpha- Decontrolled/
Holder:- Tocopherol 100ml
M/s. Agrovet Acetate)
Market S.A., ……………..50mg
Av. Canada
3792 San Luis, Vitamin
Lima, Peru. Supplement.
Manufacturer
Under Product Manufacturer’s
License Specifications
Holder:-
M/s. Pharmadix 03 years
Corp. S.A.C.
Urbanizacion
La Aurora-Ate
Lima 3-Peru.
426
170. M/s. Ghazi Ovuprost Aqueous Form 5-A Free sales Approved
Brothers, Injectable Solution Delzamazin certificate as per
Karachi. Rs. 50,000/- by M/s Prix issued import
Each mL contains:- vide Dy. No. dated 11- Policy for
M/s. Bayer Cloprostenol (as 53 dated 6- 10-2012. Finished
New Zealand Sodium)…..250ug 01-2014 & GMP Drugs.
Limited, Rs.50,000 issued
Hillcrest, Gynaecologicals- dated 30-07- dated 15-
Auckland, New Oxytocics. 2016 dy 05-2013.
Zealand. No.820.
B.P Specifications
410 Decontrolled/
171. M/s. Ghazi Ectomethrn 200 Form 5-A Free sales Approved
Brothers, Emulsion liquid. certificate as per
Ghazi House, Rs. 50,000/- Local. issued import
D-35. K.D.A. Each mL vide Dy. No. Cypothern dated 29- Policy for
Scheme No.1, emulsifiable 212 dated 19- 200 10-2013. Finished
Miran concentrate 03-2014 & Rs Solution GMP Drugs.

Muhammad contains:- 50,000 dated by star compliant
Shah Road, Cypermethrin…...2 30-07-2016 issued
Karachi-75350 00mg Dy No.821. dated29-
10-2013.
Product License Ectoparasiticide. Decontrolled/
Holder:- 10ml, 20ml,
M/s. Agrovet Manufacturer’s 50ml, 100ml,
Market S.A., Specifications 250ml, 500ml
San Luis, Lima, & 1 litre.
Peru.
Manufacturer
Under Product
License
Holder:-
M/s. Pharmadix
Corp. S.A.C.
Urbanizacion
La Aurora-Ate
Lima 3-Peru.
429
172. M/s. Ghazi Cevasametrina 20 Form 5-A Free sales Approved
Brothers, Emulsion solution. Local. certificate as per
Ghazi House, Rs. 50,000/- Cypothrin issued import
D-35. K.D.A. Each 100mL vide Dy. No. 20 by Star dated 26- Policy for
Scheme No.1, emulsifiable 209 dated 19- labs 09-2012. Finished
Miran concentrate 03-2014 & GMP Drugs.
Muhammad contains:- Rs.50,000 compliant
Shah Road, Cypermethrin…...2 dated 30-07- as per
Karachi 0g 2016 dy No. FSC
823. dated 26-
Product License Ectoparasiticide. 09-2012.
Holder. Decontrolled/
M/s Cevasa S.A Manufacturer’s 20ml, 50ml,
23rd Street N Specifications 100ml,
293 Pilar 500ml & 1
Industrial Park, litre.
Pilar State of
Buenos Aires,
Argentina.
Manufactured
by.
Midori S.R.L,
Stephenson
3294,

Tortuguitas,
Buenos Aires,
Argentina
425
Human Import Applications Routine
173. M/s Novartis Micocept Form 5-A COPP Approved

Pharma Capsule issued as per
(Pakistan), Dairy No. dated 17- Import
Limited 15 Each Capsule 1263 12-2014 policy for
West Wharf, Contains: dated 21-12- by TGA. Finished
Karachi Mycophenolate 2012 GMP Drugs and
Mofetil………...25 Rs.100000/- compliant complianc
Manufactured 0mg as per e of
by Rs.2925/- CoPP. Import
M/s Sandoz (Immunosuppressan /50tabs CoPP Policy
Private Ltd. t) Rs.58.50/Tab valid upto Order,
MIDC Plot No. 20-03- 2016
8-A/2 & 8-B Manufacturer’s 2015 by
TTC Industrial Specifications India.
area Kalwe GMP
Block Village valid upto
Dighe Navi , 20-03-
Mumbai, India. 2015.
195
174. M/s Novartis Micocept Form 5-A COPP
Pharma Film coated tablets issued
(Pakistan), Dairy No. dated 17-
Limited 15 Each film coated 1264 12-2014
West Wharf, tablet Contains: dated 21-12- by TGA.
Karachi Mycophenolate 2012 GMP
Mofetil……..500m Rs.100000/- compliant
M/s Sandoz g as per
Private Ltd. Rs.6000/- CoPP.
MIDC Plot No. (Immunosuppressan /50tabs CoPP
8-A/2 & 8-B t) Rs.120/Tab valid upto
TTC Industrial 20-03-
area Kalwe Manufacturer’s 2015 by
Block Village Specifications India.
Dighe Navi , GMP
Mumbai, India. valid upto
20-03-
94 2015.

175. M/s Umar Femaplex 2.5mg Form 5A MHRA. COPP Approved
Pharma Pvt tablet Femra issued as per
Ltd, C 5/6, Dy No. 1071 2.5mg f/c dated 25- Import
Auqaf Plaza Each film coated dated 20-08- tablet by 06-2013. Policy for
Dabgari tablet contains:- 2013 M/s GMP Finished
Garden, Letrozole….2.5mg Rs.100,000/ Novartis. compliant Drugs.
Peshwar. (Adjuant as per Panel shall
Manufactured treatment of post- As per SRO Local. COPP. confirm
by menopausal Femra the
M/s women with 2.5mg by anticancer
Genepharma harmone recpotor M/s facility for
S.A, 18th Km, positive invasive Novartis. the
Marathonosave early breast manufactu
nue-15351, cancer). ring of the
Pallini-Greece. USP Specifications drug at the
time of
131 foreign
inspection.
176. M/s Umar Zymoplex 20mg Form 5A MHRA. COPP Approved
Pharma Pvt tablet Soltamox issued as per
Ltd, C 5/6, Dy No. 1070 20mg tablet dated 25- Import
Auqaf Plaza Each tablet dated 20-08- by M/s 06-2013. Policy for
Dabgari contains:- 2013 Aurobindo. GMP Finished
Garden, Tamoxifen Citrate Rs.100,000/ compliant Drugs.
Peshwar. eq to Local. as per Panel shall
Manufactured Tamoxifen…….20 As per SRO Cytotam by COPP. confirm
by mg M/s AJ the
M/s Mirza. anticancer
Genepharma Oestrogen Receptor facility for
S.A, 18th Km, Positive Early the
Marathonosave Breast Cancer manufactu
nue-15351, ring of the
Pallini-Greece. drug at the
time of
133 foreign
inspection.
177. M/s Umar Zymoplex 10mg Form 5A TGA. COPP Approved
Pharma Pvt tablet Cosudex issued as per
Ltd, C 5/6, Dy No. 1068 50mg by dated 25- Import
Auqaf Plaza Each tablet dated 20-08- M/s 06-2013. Policy for
Dabgari contains:- 2013 Astrazenec GMP Finished
Garden, Tamoxifen Citrate Rs.100,000/ a. compliant Drugs.
Peshwar. eq to as per Panel shall
Manufactured Tamoxifen…….10 As per SRO Local. COPP. confirm
by mg Calutide the
M/s by M/s AJ anticancer

Genepharma Oestrogen Receptor Mirza. facility for
S.A, 18th Km, Positive Early the
Marathonosave Breast Cancer manufactu
nue-15351, ring of the
132 time of
foreign
inspection.
178. M/s Umar Bicamide 50mg Form 5A MHRA. COPP Approved
Pharma Pvt tablet Soltamox issued as per
Ltd, C 5/6, Dy No. 1069 20mg tablet dated 25- Import
Auqaf Plaza Each film coated dated 20-08- by M/s 06-2013. Policy for
Dabgari tablet contains:- 2013 Aurobindo. GMP Finished
Garden, Bicalutamide…….5 Rs.100,000/ compliant Drugs.
Peshwar. 0mg Local. as per Panel shall
Manufactured As per SRO Arimidex COPP. confirm
by Adjuant to radial by M/s the
M/s prostectomy or ICI. anticancer
Genepharma radio-therapy in facility for
S.A, 18th Km, patients with locally the
Marathonosave advanced prostate manufactu
nue-15351, cancer ring of the
130 time of
foreign
inspection.
179. M/s A. Feroz & Star Haemopack Form 5A COPP Approved
Co, Medicine Single Blood Bag issued as per
Street No. 01, Dy No.1495 dated 03- Import
Marriot Road, Each 100ml of R&I dated 12- 02-2014 Policy For
Karachi. anticoagulant 03-2013 Rs. valid upto Finished
Manufactured solution CPDA-1 50,000 & Rs. 2 years. Drugs
by contains:- 50,000 dated GMP
M/s HLL Citric acid 05-11-2013 compliant
Lifecare (Anhydrous) dy No.303. as per
Limited ……….. COPP.
Akkulam, …..0.299gm As per Brand
Thiruvananthap Sodium Citrate leader/500ml
uran Kerala, (Dihydrate)
India. …..2.63gm
102 Monobasic Sodium
Phosphate
(Monohydrate)
………….0.222gm
Dextrose
(Anhydrous)

……………..2.90g
m
Adenine
(Anhydrous)
…..0.0275gm
WFI…….QS to
100ml
Anticoagulant
Solution
Manufacturer’s
Specifications
180. M/s A. Feroz & Star Haemopack Form 5A COPP Approved
Co, Medicine Double Blood Bag issued as per
Street No. 01, Dy No.1496 dated 03- Import
Marriot Road, Each 100ml of R&I dated 12- 02-2014 Policy For
Karachi. anticoagulant 03-2013 Rs. valid upto Finished
Manufactured solution CPDA-1 50,000& Rs. 2 years. Drugs
by contains:- 50,000 dated GMP
M/s HLL Citric acid 05-11-2013 compliant
Lifecare (Anhydrous) dy No.303. as per
Limited ……….. COPP.
Akkulam, …..0.299gm
Thiruvananthap Sodium Citrate As per Brand
uran Kerala, (Dihydrate) leader/500ml
India. …..2.63gm
Monobasic Sodium
103 Phosphate
(Monohydrate)
………….0.222gm
Dextrose
(Anhydrous)
……………..2.90g
m
Adenine
(Anhydrous)
…..0.0275gm
WFI…….QS to
100ml
Anticoagulant
Solution
Manufacturer’s
Specifications

181. M/s A.Feroz Star PGA Suture Form 5A Sizes. USP Free sale Deferred
& with needle 5-0~USP 3 certificate for
Co Medicine Diary No. With round is valid submission
Street PGA is a synthetic 174 R&I & reverse upto 21- of complete
details
no.1,Marriot absorbable surgical dated 22-06- cutting 02-2013.
regarding
road, Karachi, suture with needle. 2011 sizes and
Pakistan. Rs.15000& shapes of
Rs.85,000 sutures
Manufactured PGA dated 04-11-
by (Polyglycolicacid) 2013 dy No.
Shanghai Suture 208 R&I
Pudong .
Jinhuan Sutures
Medical As per SRO
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
182. M/s A.Feroz Star Nylon Suture Form 5A Sizes. USP Free sale Deferred
& with Needle 6-0~USP 1 certificate for
Street Nylon Suture is a 181 R&I cutting, upto 21- of complete
details
no.1,Marriot monofilament of dated 22-06- normal 02-2013.
regarding
road, Karachi, Polyamide Nylon & 2011 cutting & sizes and
Pakistan. the material is non- Rs.15000 & reverse shapes of
absorable. Rs.85,000 cutting sutures
Manufactured dated 04-11-
by Suture 2013 dy No.
Shanghai 208 R&I
Pudong .
Jinhuan
Medical As per SRO
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,

China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
183. M/s A.Feroz Star Chromic Form 5A Sizes. USP Free sale Deferred
& Catgut Suture with 4-0~USP 2 certificate for
Co Medicine needle. Diary No. With round is valid submission
Street 178 R&I & reverse upto 21- of complete
details
no.1,Marriot Chromic catgut is dated 22-06- cutting 02-2013.
regarding
road, Karachi, BSE Free & 2011 sizes and
Pakistan. produced from Rs.15000 & shapes of
intestinal serosa. Rs.85,000 sutures
by Suture. 2013 dy No.
Shanghai 208 R&I
Pudong .
Jinhuan
Medical As per SRO
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
184. M/s A.Feroz Star Polypropylene Form 5A Sizes. USP Free sale Deferred
& Suture with needle. 5-0~USP 2 certificate for
Co Medicine Diary No. With is valid submission
Street Polypropylene 180 R&I round, upto 21- of complete
details
no.1,Marriot Suture is a dated 22-06- round 02-2013.
regarding
road, Karachi, monofilament. 2011 double, sizes and
Pakistan. Rs.15000 & straight shapes of
Suture. Rs.85,000 cutting & sutures
Manufactured dated 04-11- reverse
by 2013 dy No. cutting
Shanghai 208 R&I
Pudong .
Jinhuan
Medical As per SRO

Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
185. M/s A.Feroz Star Polyester Form 5A Sizes. USP Free sale Deferred
& Suture with needle 6-0~USP 2 certificate for
Street 176 R&I & reverse upto 21- of complete
details
no.1,Marriot Braided polyester dated 22-06- cutting 02-2013.
regarding
road, Karachi, suture. 2011 sizes and
Pakistan. Rs.15000 & shapes of
Suture Rs.85,000 sutures
by 2013 dy No.
Shanghai 208 R&I
Pudong .
Jinhuan
Medical As per SRO
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
186. M/s A.Feroz Star PGA Suture Form 5A Sizes. USP Free sale Deferred
& with needle 5-0~USP 3 certificate for
Street PGLA-Poly 177 R&I & reverse upto 21- of complete
details
no.1,Marriot (glycolide-co dated 22-06- cutting 02-2013.
regarding
road, Karachi, lactide) (90/10) 2011 sizes and
Pakistan. braided, coated Rs.15000 & shapes of
synthetic Rs.85,000

Manufactured absorbable surgical dated 04-11- sutures
by suture. 2013 dy No.
Shanghai 208 R&I
Pudong Suture
Jinhuan As per SRO
Medical
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
187. M/s Samerians MASTER Suture Form 5A Shape Deferred
Enterprise, 4- Polyglycolic with Normal for
First Floor, H.J. Needles Diary No. cutting submission
centre Kuchi 233 R&I with sizes of complete
details
Gali No.2, Suture dated 10-10- 3/8, 1/2,,
regarding
Marriot Road, 2013 Reverse sizes and
Karachi. Rs.100000 Cutting shapes of
Manufacture with sutures
by As per SRO sizes3/8,
M/s Medico 1/2, and
(Huaian) Co. round
Ltd, No.09 with sizes
South Free sales
Guangzhou certificate
Road 223005, issued
Huaian, dated27-
Jiangsu, China 05-2013
164
Enterprise, 4- Chromic Catgut Normal for
First Floor, H.J. with Needles Diary No. 90 cutting submission
centre Kuchi R&I dated 24- with sizes of complete
details
Gali No.2, 1-2014 3/8, 1/2,,
regarding
Marriot Road, Suture Rs.100000 Reverse sizes and
Karachi. Cutting shapes of
Manufacture As per SRO with sutures
by sizes3/8,

M/s Medico 1/2, and
(Huaian) Co. round
South Free sales
Road 223005, issued
Huaian, dated27-
197
Enterprise, 4- Polypropylene with Normal for
First Floor, H.J. Needles Diary No. cutting submission
centre Kuchi 232 R&I with sizes of complete
details
Gali No.2, dated 10-10- 3/8, 1/2,,
regarding
Marriot Road, Suture 2013 Reverse sizes and
Karachi. Rs.100000 Cutting shapes of
Manufacture with sutures
by As per SRO sizes3/8,
M/s Medico 1/2, and
(Huaian) Co. round
South Free sales
Road 223005, issued
Huaian, dated27-
165
Enterprise, 4- Silk Braided with Normal for
First Floor, H.J. Needles Diary No. 91 cutting submission
centre Kuchi R&I dated 24- with sizes of complete
details
Gali No.2, 1-2014 3/8, 1/2,,
regarding
Marriot Road, Suture Rs.100000 Reverse sizes and
Karachi. Cutting shapes of
Manufacture As per SRO with sutures
by sizes3/8,
M/s Medico 1/2, and
(Huaian) Co. round
South Free sales
Road 223005, issued
Huaian, dated27-

196
191. M/s Novartis Sandimmun Neural Form 5A COPP Deferred
Pharma 50mg issued by for
Pakistan Ltd, Dy No. 235 TGA submissio
Karachi Each capsule dated 21-03- dated 13- n of CoPP
Manufactured contains:- 2014 11-2013. to confirm
By Cyclosporin…… Rs.10,000. GMP free sale
M/s Catalent 50mg compliant
Germany As per SRO as per
Eberbach Immunosuprassant COPP.
GmbH,
Gammelsbacher
Strasse 2
Eberbach D-
69412 Germany
Name and
address of
Applicant
M/s Novartis
Pharmaceutical
s Australia Pty
Ltd, 54
Waterloo Road,
North Ryde
NSW 2113,
Australia
221

Routine applications for local manufacturer.
S/N Name and Brand Name Type of Remarks on the Remarks Decision
address of (Proprietary name + Dosage Form formulation (if by
manufacturer / Form + Strength) any) including Evaluator/
Applicant Initial date, International Decision
Composition diary status in stringent
drug regulatory
Pharmacological Group Fee agencies /
including authorities
Finished product Specification differential
fee Me-too status
Demanded GMP status as

Price / Pack depicted in latest
size inspection report
(with date) by the
Evaluator
192. M/s Medicraft Irose Injection 5ml Form 5 MHRA. Venofer Approved
Pharmaceuticals by M/s Vifor
Pvt Ltd, Each ml contains:- 25-03-2013
Industrial Estate, Iron sucrose complex eq to vide diary Local. Venofer
Hayatabad, elemental iron………..……… 182 (R&I) by M/s RG
Peshawar 20mg Rs.20,000.
Haematinic GMP compliant
2201 USP Specifications As per SRO as per inspection
report dated 27-
05-2016.
193. M/s Safe Fayneec Capsule 50mg Form 5 Deflamat 50mg- Fee Approved.
Pharmaceuticals Kapseln by M/s Rs.8000 & Photocopy
Pvt Ltd, Karachi Each capsule contains:- Dy No. Nil Astellas Pharma Rs.12,000/- fee
Diclofenac Sodium as SR dated 17-02- GmbH Austria. are challanswill
Source of pellets………..………50mg 2010 photocopy. be verified
Pellets Rs.8000 Local. Mobikare by Budget &
M/s Vision Anti-Rheumatics (Photocopy) 50mg by M/s Accounts
Pharmaceuticals & 22-05- Barrett Hodgson Division and
Kahuta road, USP Specifications 2013 Chairman
Islamabad Rs.12000 GMP compliant Registration
(Photocopy) as per inspection Board will
15 report dated 09- permit
As per SRO 06-2015. issuance of
registration
letter.

194. M/s Rasco Pioglimp-DS tablet Form 5 FDA. Duetact Fee Approved.
Pharma, 5.5 Km 4mg/30mg by Rs.8000 is Photocopy
Raiwind road, Each tablet contains:- Dy No. nil M/s Takeda a fee
Lahore. Pioglitazone as HCl……….. dated 29-06- photocopy. challanswill
………30mg 2012 Local. Piotone be verified
(1784) Glimepiride………..4mg Rs.8000 4/30 by M/s by Budget &
(Photocopy) Atco. Accounts
Anti diabetic & Rs.12,000 Division and
dated 30-07- GMP compliant Chairman
Manufacturer’s Specifications 2013 dy no. as per inspection Registration
9349 R&I. date 09-09-2015. Board will
permit
As per SRO issuance of
registration
letter.
195. M/s Care Carnyl Syrup Form 5 MHRA. Bricanyl Fee Approved.
Pharmaceuticals, 0.3mg/ml Syrup Rs.8000 & Photocopy
8-Km Raiwind Each ml contains:- Dy No. nil by M/s 12000 are fee
road, Lahore. Terbutaline Sulphate……….. dated 24-05- AstraZeneca. photocopy. challanswill
………0.3mg 2011 be verified
(1004) Rs.8000 Local. Britanyl by Budget &
Bronchodialator (Photocopy) by M/s Barrett Accounts
& Rs.12,000 Hodgson Division and
Manufacturer’s Specifications dated 30-07- Chairman
2013 GMP compliant Registration
(Photocopy). as per inspection Board will
date 19-12-2014. permit
As per SRO issuance of
registration
letter.
196. -do- Hepacare Syrup Form 5 Fee Deferred for
(1069) Rs.8000 & the
Each 5ml contains:- Dy No. nil Local Hepa-Merz 12000 are confirmation
L-Ornithine L- dated 24-05- by M/s Brookes photocopy. of approval
Aspartate…………300mg 2011 Approval status by
Nicotinamide………..…24mg Rs.8000 GMP compliant status in regulatory
Riboflavin sodium (Photocopy) as per inspection reference authorities
phosphate….……….0.76mg & Rs.12,000 date 19-12-2014. countries is of reference
dated 30-07- not countries
Liver Supplement 2013 provided.
(Photocopy).
Manufacturer’s Specifications
As per SRO
197. M/s Amarant Tica 90mg tablet Form-5 FDA. Brilinta Approval Deferred for
Pharmaceuticals Each tablet contains:- 21-08-2013 90mg & 60mg by status in the

(Pvt) Ltd, 158, Ticagrelor………90mg vide diary M/s Astrazeneca Pakistan is confirmation
D. Tore, Gadap Anti-coagulant No. 1560 GMP compliant not of approval
Road, Super Manufacturer’s Specifications R&I as per inspection provided. status in
Highway, Rs.20,000. dated 04-11- Pakistan
Karachi. As per 2015.
(2513) SRO/30’s.
198. -do- Esonap Tablet 375/20mg Form-5 FDA. Vimovo Approval Deferred for
(2514) Each tablet contains:- 21-08-2013 delay release status in confirmation
Naproxen………….375mg vide diary tablet 20/375mg Pakistan is of approval
Esomeprazole Magnesium…. No. 1559 by M/s Horizon not status in
……..20mg R&I GMP compliant provided. Pakistan
Analgesic/PPI Rs.20,000. as per inspection
Manufacturer’s Specifications As per dated 04-11-
SRO/30’s. 2015.
199. -do- Mafinil 100mg tablets Form-5 MHRA.Modafinil Approved

(2515) Each tablet contains:- 21-08-2013 100mg by M/s
Modafinil……100mg vide diary Teva
Psychotic drug No. 1561 Local. V-Zac
USP Specifications R&I 100mg tablet by
Rs.20,000. M/s Wilshire
As per GMP compliant
SRO/20’s. as per inspection
dated 04-11-
2015.

Replies of Products deferred in 258th meeting of the Board.
200.M/s Sami Stein 175mg/5ml Form-5 Denmark. Deferred for It has been Approved.
Pharmaceuticals Suspension 4-08-2012 Erodin the Following verified Photocopy
Pvt Ltd, Each 5ml of vide 175mg/5ml by verification that the fee
Karachi. reconstituted diary No. M/s Orion of Fee. product is challanswill
suspension contains:- Nil Rs.8000. in free sale be verified
1892 Erdosteine Rs.8,000 Local. Erdos Approval in by Budget
MS……..175mg (Photocopy) suspension status Denmark & Accounts
(Mucolytic) & 175mg/5ml by inreference Division
Manufacturer’s 12,000 M/s Genome. Regulatory and
Specifications dated 29- authorities. Chairman
07-2013. Registration
Rs. Board will
178/100ml permit
issuance of
registration
letter
201.-do- Stein 150mg Capsule Form-5 Denmark. Deferred for It has been Approved.
Each Capsule 4-08-2012 Erdotin 150mg the verified Photocopy
1891 contains:- vide capsule by M/s Following that the fee
Erdosteine diary No. Orion pharma. verification product is challanswill
MS………..150mg Nil Local. Erdos of Fee. in free sale be verified
(Mucolytic) Rs.8,000 capsule 150mg Rs.8000. in by Budget
Manufacturer’s (Photocopy) by M/s Approval Denmark & Accounts
Specifications & Genome status Division
12,000 inreference and
dated 29- Regulatory Chairman
07-2013. authorities. Registration
Rs. 178/ 20 Board will
Capsules permit
issuance of
registration
letter
202.M/s Barett Mobikare Plus Form-5 Arthrotec Deferred in 255th Copy of Fee Deferred for
Hodgson Tablet Dy. No: 159 MHRA, FDA meeting for: Challan confirmation
Each tablet contains: dated. Original fee provided. of double
Karachi. Misoprostol……..200mcg 15-07-2010 Cytopan (Getz) Challan of Rs: Commitment punch/layer
Diclofenac Sodium …. Rs.8000/- 12000/-. provided machine from
94 75mg Rs.12,000/- Commitment as Me too area FID.
(Non-Steroidal 2x10’s / per 251st product, so
Antiinfammatory Rs.450/- meeting. stability not
with Synthetic Last inspection required.
Prostaglandin E1 analog) report. Inspection
Reply of letter report dated
no. 03.02.16
F.6- provided.

12/2013Reg-II Picture of
dated 01 machine
October along with
2013 not invoice
satisfactory but provided.
board decided to
submit stability
studies in
previous
meeting.
Proof of double
core
compression
machine
required. for
stability studies
was dispensing
10-09- 2010 and
Manufacturing
date 27-08-09.
Supportive data
Stability studies
as per RB
decision in 251st
meeting.
203. -do- Mobikare Plus Tablet Form-5 FDA Arthrotec Deferred for in Picture of Deferred for
Each tablet contains:- 15-06-2010 Tablet by M/s 254th meeting of machine confirmation
Diclofenac Sodium……... vide diary # Searle. RB along with of double
95 ….50mg 160 Rs.8000 Double invoice punch/layer
Misoprostol………200mcg R&I & 21-05- Arthrotec Tablet compression provided. machine from
NSAID+Prostaglandin 2013 diary # by M/s Pfizer. machine require Commitment area FID and
analogue ___ Rs.12000 to be verified. provided. fee challan.
Manufacturer’s Photocopy Commitment as Inspection
Specifications attached per the decision report dated
As per SRO of RB is not 03.02.16.
attached. Copy of fee
Fresh inspection Challan
report conducted provided.
within the
period of 1 year
is not attached.
Outline method
of manufacture
is not provided.
Photocopy of
fee Rs.12000
attached original
is required.
204. M/s Sami NovoTeph DR Sachet Form-5 Nexium Sachet Deferred for Approved
Pharma, 20mg Dy. No: of AstraZeneca rectification
Karachi. Each sachet contains: 8000/- dated USA of following:
Deferred in Enteric coated 31-12-10 Nexum Source of
250th meeting granules (22.5%) of 12000/- delayed relaese Esomeprazole

Esomeprazole dated 29-07- Sachet of granules,
744 magnesium Trihydrate 13 Getz(Approved their
eq to Esomeprazole… & Rs.80,000 in 227th composition,
20mg vide dy No. meeting of RB) certificate of
PPI 2791 R&I analysis,
Manufacturer dated 17-06- stability
2016 studies as per
Source Of Pellets. zone IV and
M/s RA Chem Pharma Rs. 450/- in case of
Ltd, Plot #A-19/C Pack of 14’s import of
Road No.18 IDA, pellets,
Nacharam Hydrabad, legalized
Andhrapradesh, India GMP
certificate of
the source
along with
the requisite
fee prescribed
under the
rules is not
submitted.
205.-do- NovoTeph DR Sachet Form-5 Nexium Sachet Deferred for Approved

Deferred in 40mg Dy. No: of AstraZeneca rectification
250th meeting Each sachet contains:8000/- dated USA of following:
Enteric coated 31-12-10 Nexum Source of
746 granules (22.5%) of 12000/- delayed relaese Esomeprazole
Esomeprazole dated 29-07- Sachet of granules,
magnesium Trihydrate 13 Getz(Approved their
eq. to Esomeprazole… Rs. 1800/-& in 227th composition,
40mg Rs.80,000 meeting of RB) certificate of
PPI vide dy No. analysis,
Manufacturer 2792 R&I stability
dated 17-06- studies as per
Source Of Pellets. 2016 zone IV and
M/s RA Chem Pharma Pack of in case of
Ltd, Plot #A-19/C 14’s import of
Road No.18 IDA, pellets,
Nacharam Hydrabad, legalized
Andhrapradesh, India GMP
certificate of
the source
along with
the requisite
fee prescribed
under the

rules is not
submitted.

Evaluator-IV Mr. Salateen Wasim Philip
Routine cases:-
S/N Name and Brand Name Type of Form International Remarks / Decisio
address of status in Observation
manufacturer / (Proprietary name + Initial date, diary stringent s
Dosage Form + regulatory
Applicant
Strength) Fee including agencies
differential fee
Composition Me-too status
Demanded Price /
Pharmacological Group Pack size GMP status as
depicted in
Finished product inspection
Specification report (dated)
206. M/s CCL Tablet Nitox 500mg Form 5 with fee Rs FDA approved Approv
Pharmaceuticals 20,000/- vide Dy. # Alinia- Romark Photoc
(Pvt.) Ltd, 62- Each film coated tablet nil dated 19-04- fee
Industrial contains:- 2013 Nitazide-Helix challan
Estate, Kot Nitazoxanide 500mg (Photocopy)
be ve
Lakhpat, Inspection
Lahore Antidiarreal / report dated
by B
antiprotozoal Pack size of SRO 11-03-2015 & Acc
Priority # 2263 Specifications:- Divisio
Manufacture and
Chairm
Registr
Board
permit
issuanc
registra
letter.
207. M/s CCL Tablet velamer 800mg Form 5 with fee Rs FDA approved Appro
Pharmaceuticals 20,000/- vide Dy. # Renagel-
(Pvt.) Ltd, 62- Each film coated tablet nil dated 19-04- Genzyme
Industrial contains:- 2013
Estate, Kot Sevelamer HCl 800mg Sevela-Hilton
Lakhpat,
Lahore Non absorbed phosphate Pack size of 30’s
binder
Priority # 2261 Specifications:-
Manufacture

208. M/s CCL Nitox powder for Form 5 with fee Rs FDA approved Appro
Pharmaceuticals Suspension 20,000/- vide Dy. # Alinia- Romark
(Pvt.) Ltd, 62- nil dated 19-04-
Industrial Each 5ml of reconstituted 2013 Nitazide-Helix
Estate, Kot suspension contains:-
Lakhpat, Nitazoxanide 100mg
Lahore Pack size of 30ml
Antidiarrheal /
Priority # 2264 antiprotozoal
Specifications:-
Manufacture
209. M/s Sami Cynfo 1g IV Injection 31-10-2011 Proof of Deferre

Pharmaceuticals Dy.No.283 approval confirm
(Pvt.) Ltd, F-95, Each combination pack Rs.8000/- Firm is GMP
Rs.l2,000/-
status of n
Off. Hub River contains: compliant as same approv
31-07-2013
Road, S.I.T.E, Sterile powder of per inspection
(Photocopy) dosage form status
Karachi fosfomycin sodium eq. to dated 03-11- in reference referen
Fosfomycin..1g 2015 countries regulat
Priority # 1467 Water for injection …10
Rs. 110/- per vial and authori
Swapped ml
Pakistan not and
(Anti biotic) provided. Pakista
and
challan
210. M/s Sami Capsule Colcin 8mg 21-03-2012 The Deferre
Pharmaceuticals Dy.No.644 proposed confirm
(Pvt.) Ltd, F-95, Each capsule contains Form 5 Firm is GMP
Rs.8000/-
dosage form n
Off. Hub River Thiocolchicoside IP 8mg compliant as doesn’t approv
Rs.l2,000/-
Road, S.I.T.E, per inspection
31-07-2013 exist in status
Karachi Muscle relaxant dated 03-11-
(Photocopy) Pakistan referen
Manufacture
Pack size of 2015 and regulat
Priority # 1486 Specification
10’s  Rs. 300/- reference authori
Swapped
20s  Rs. 600/- countries. and
Pakista
and
challan
211. M/s Sami Capsule Colcin 4mg 21-03-2012 Muscoril – Approv
Pharmaceuticals Dy.No.647 Sanofi, France Photoc
(Pvt.) Ltd, F-95, Each capsule contains Form 5
Rs.8000/-
fee
Off. Hub River Thiocolchicoside IP 4mg Muscoril challan
Rs.l2,000/-
Road, S.I.T.E, -Searle
31-07-2013 be veri
Karachi Muscle relaxant
(Photocopy) by Bud
Manufacture Firm is GMP
Priority # 1487 Specification & Acc
Pack size & priec compliant as
Swapped Divisio
as per SRO per inspection
and
dated 03-11-
Chairm
2015
Registr

Board
permit
issuanc
registra
letter
212. M/s Sami Injection Colcin 4mg/2ml 21-03-2012 Muscoril – Deferre
Pharmaceuticals Dy.No.654 Sanofi, France clarific
(Pvt.) Ltd, F-95, Each 2ml ampoule Form 5
Rs.8000/-
of m
Off. Hub River contains Muscoril formul
Rs.l2,000/-
Road, S.I.T.E, Thiocolchicoside IP 4mg -Searle
31-07-2013 and ro
Karachi Sodium chloride 16.8mg
(Photocopy) sodium
Priority # 1489 Muscle relaxant Firm is GMP chlorid
Pack size of either
Swapped Manufacture compliant as
ampoule & price as or in
Specification per inspection
per SRO ingredi
dated 03-11-
2015 and
challan
213. M/s Sami Colcin 0.25% Ointment 06-04-2012 The Deferre
Pharmaceuticals Dy.No.676 proposed confirm
(Pvt.) Ltd, F-95, Each gram contains Form 5 Firm is GMP
Rs.8000/-
dosage form n
Off. Hub River Thiocolchicoside IP compliant as doesn’t approv
Rs.l2,000/-
Road, S.I.T.E, 2.5mg per inspection
31-07-2013 exist in status
Karachi dated 03-11-
(Photocopy) Pakistan referen
Muscle relaxant 2015 and regulat
Priority # 1488 Manufacture
Pack size of 30gm reference authori
Swapped Specification
tube  Rs. 280/- countries. and
Pakista
and
challen
214. M/s Sami Tablet Esylate 500mg 29-08-2011 Dicynene Approv
Pharmaceuticals Dy # 1127 Form 5 500mg – Photoc
(Pvt.) Ltd, F-95, Each tablet contains Rs. 8000/- Sanofi France
Rs.12,000/- 31-07-
fee
Off. Hub River Etamsylate BP 500mg challan
Road, S.I.T.E, 2013 (Photocopy) Cytoplex – be veri
Karachi Hemostatic agent AGP Reg#
by Bud
Manufacture 061420
Priority # 1806 Specification Pack size & price & Acc
swapped as per PRC Divisio
Firm is GMP and
compliant as Chairm
per inspection Registr
dated 03-11- Board
2015 permit
issuanc
registra
letter

215. M/s Sami Injection Esylate 13-06-2012 Proof of Deferre
Pharmaceuticals 125mg/ml Dy # 1671, Form 5 approval confirm
(Pvt.) Ltd, F-95, Rs.20,000/-
status of n
Off. Hub River Each ml contains (Photocopy) Firm is GMP same approv
Road, S.I.T.E, Etamsylate BP 125mg compliant as dosage form status
Karachi per inspection
Pack size of in reference referen
Hemostatic agent dated 03-11-
Priority # 1524 Manufacture 6s  Rs. 120/- countries regulat
2015 not authori
swapped Specification
provided. and
Pakista
and
challan
216. M/s Sami Injection Esylate 13-06-2012 A product of Approv
Pharmaceuticals 250mg/2ml Dy # 1126, Form 5 OM Pharma - Photoc
(Pvt.) Ltd, F-95, Rs.8,000/- Switzerland
Rs. 12000/-
fee
Off. Hub River Each 2ml contains challan
31-07-2013
Road, S.I.T.E, Etamsylate BP 250mg Cytoplex –
(Photocopy) be veri
Karachi AGP Reg #
by Bud
Hemostatic agent 061419
Priority # 1521 Manufacture & Acc
Pack size & price Divisio
swapped Specification Firm is GMP
as per SRO and
compliant as
per inspection Chairm
dated 03-11- Registr
2015 Board
permit
issuanc
registra
letter
217. M/s Sami Tablet Viptin-Met 50/500 18-071-2012 TGA approved Approv
Pharmaceuticals Dy.No.1329 Form 5 Galvumet – Photoc
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/- Novartis
Rs.l2,000/-
fee
Off. Hub River contains challan
31-07-2013
Road, S.I.T.E, Vildagliptin MS 50mg Galvusmet -
(Photocopy) be veri
Karachi Metformin HCl BP Novartis
by Bud
500mg
Priority # 836 Pack size & price
Firm is GMP & Acc
as per SRO Divisio
swapped Anti-diabetic compliant as
Manufacture per inspection and
Specification dated 03-11- Chairm
2015 Registr
Board
permit
issuanc
registra
letter

218. M/s Sami Tablet Neo-Moor 50mg 03-10-2011 TGA approved Approv
Pharmaceuticals Dy.No.235 Form 5 Pristiq – Pfizer. Photoc
(Pvt.) Ltd, F-95, Each extended release Rs.8000/-
Rs.l2,000/-
fee
Off. Hub River film coated tablet Lafaxine - challan
31-07-2013
Road, S.I.T.E, contains Genix
(Photocopy) be veri
Karachi Desvenlafaxine (as
by Bud
succinate monohydrate) Firm is GMP
Priority # 1421 50mg Pack size & price & Acc
as per SRO compliant as
swapped Divisio
per inspection
Anti-depressant and
dated 03-11-
Manufacture Chairm
2015
Specification Registr
Board
permit
issuanc
registra
letter
219. M/s Sami Tablet Neo-Moor 100mg 03-10-2011 FDA approved Approv
Pharmaceuticals Dy.No.234 Form 5 Pristiq – Wyeth Photoc
(Pvt.) Ltd, F-95, Each extended release Rs.8000/-
Rs.l2,000/-
fee
Off. Hub River film coated tablet Lafaxine - challan
31-07-2013
Road, S.I.T.E, contains Genix
(Photocopy) be veri
Karachi Desvenlafaxine (as
by Bud
succinate monohydrate) Firm is GMP
Priority # 1469 100mg Pack size & price & Acc
as per SRO compliant as
swapped Divisio
per inspection
Anti-depressant and
dated 03-11-
Manufacture Chairm
2015
Specification Registr
Board
permit
issuanc
registra
letter
220. M/s Sami Tablet ULIP 30mg 23-09-2011 MHRA Approv
Pharmaceuticals Dy.No.196 Form 5 approved Photoc
(Pvt.) Ltd, F-95, Each tablet contains Rs.8000/- ellaOne-HRA
Rs.l2,000/-
fee
Off. Hub River Ulipristal Acetate 30mg challan
31-07-2013
Road, S.I.T.E, Elcat – Genix
(Photocopy) be veri
Karachi Synthetic Progesterone –
by Bud
Contraceptive Hormonal
Priority # 1422 Manufacture Pack size & Acc
5s  Rs. 500/- section of the
swapped Specification Divisio
firm is GMP
and
compliant as
Chairm
per inspection
Registr
dated 03-11-
Board
2015
permit
issuanc

registra
letter
221. M/s Sami Tablet Eriva 0.5 mg 23-09-2011 MHRA Approv
Pharmaceuticals Dy.No.196 Form 5 approved Photoc
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/- Baraclude –
Rs.l2,000/-
fee
Off. Hub River contains Bristol challan
31-07-2013
Road, S.I.T.E, Entecavir monohydrate
(Photocopy) be veri
Karachi eq to entecavir 0.5 mg BVIR-Bosch
by Bud
Priority # 1595 Anti-viral Pack size
Firm is GMP & Acc
5s  Rs. 500/- Divisio
swapped Manufacture compliant as
Specification per inspection and
dated 03-11- Chairm
2015 Registr
Board
permit
issuanc
registra
letter
222. M/s Sami Tablet Viptin 50mg 18-07-2012 MHRA Approv
Pharmaceuticals Dy # 1331 Form 5 approved Photoc
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/- Galvus – fee
Off. Hub River contains Rs.12,000/- Novartis challan
Road, S.I.T.E, Vildagliptin MS 50mg 31-07-2013 be veri
Karachi (Photocopy) Galvus
by Bud
Anti-Diabetic
Priority # 802 Manufacture Pack size  as per Firm is GMP & Acc
swapped Specification SRO compliant as Divisio
per inspection and
dated 03-11- Chairm
2015 Registr
Board
permit
issuanc
registra
letter
223. M/s Sami Mofest infusion 400mg 25-01-2011 Moxibar – Proof of In pro
Pharmaceuticals /100ml Dy.No.380 Form 5 B&H approval of strengt
(Pvt.) Ltd, F-95, Rs.8000/-
Rs.l2,000/-
same moxifl
Off. Hub River Each 100ml contains Firm is GMP strength in n
31-07-2013
Road, S.I.T.E, Moxifloxacin 400mg compliant as
(Photocopy) reference 400mg
Karachi per inspection countries. ml, it
Antibiotics dated 03-11-
Priority # 1805 Manufacture Pack size 100ml as been
per SRO 2015 observ
Specification
that
crystal
on o
and pr

is not s
The B
directe
firm
follow
innova
brand’s
formul
i.e.
Moxifl
n
400mg
ml
submit
revised
Form 5
224. M/s Sami Novoteph Insta Sachet 31-12-2010 Proof of Deferre
Pharmaceuticals 40/1680 Dy.No.2275 approval confirm
(Pvt.) Ltd, F-95, Rs.8000/- Firm is GMP
Rs.l2,000/-
status of n
Off. Hub River Each sachet contains compliant as same approv
31-07-2013
Road, S.I.T.E, Esomeprazole per inspection
Karachi Magnesium Trihydrate dated 03-11- in reference referen
USP eq to Esomeprazole
Pack size 14s  2015 countries regulat
Priority # 746 40mg
Rs. 1825/- not authori
Sodium carbonate BP
1680mg provided. and
Pakista
PPI-anti ulcer and
Manufacture challan
Specification
225. M/s Sami Tablet Mefloq-plus 25-03-2013 The Deferre
Pharmaceuticals 220/100 Dy.No.181 proposed confirm
(Pvt.) Ltd, F-95, Rs.20,000/- Firm is GMP formulation n
Off. Hub River Each tablet contains compliant as doesn’t approv
Road, S.I.T.E, Mefloquine HCl eq to Pack size
3s  Rs. 360/- per inspection exist in status
Karachi Mefloquine BP 220mg dated 03-11-
6s  Rs. 720/- reference referen
Artesunate MS 100mg 2015 countries regulat
Priority # 1791
Anti malarial and authori
Manufacture Pakistan. WHO
Specification Pakista

226. M/s Sami Tablet GPRIDE-M 1/500 20-01-2012 Proof of Deferre
Pharmaceuticals Dy.No.474 Form 5 approval confirm
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/-
Rs.l2,000/-
status of n
Off. Hub River contains Firm is GMP same approv
31-07-2013
Road, S.I.T.E, Glimepiride USP 1mg compliant as
Karachi Metformin HCl BP per inspection
Pack size & price in reference referen
500mg dated 03-11-
Priority # 1040 as per SRO countries regulat
2015 not authori
swapped Anti-diabetic
Manufacture provided. and
and
challan
227. M/s Sami Tablet GPRIDE-M 2/500 20-01-2012 Proof of Deferre
Pharmaceuticals Dy.No.475 Form 5 approval confirm
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/- Hipride –
Rs.l2,000/-
status of n
Off. Hub River contains Hilton same approv
31-07-2013
Road, S.I.T.E, Glimepiride USP 2mg
Karachi Metformin HCl BP Firm is GMP
500mg compliant as
Priority # 1041 as per SRO countries regulat
per inspection not authori
swapped Anti-diabetic dated 03-11-
Manufacture provided. and
2015 challan
Specification
228. M/s Sami Tablet GPRIDE-M 20-01-2012 Proof of Deferre
Pharmaceuticals 2/1000 Dy.No.475 Form 5 approval confirm
(Pvt.) Ltd, F-95, Rs.8000/- Hipride –
Rs.l2,000/-
status of n
Off. Hub River Each film coated tablet Hilton same approv
31-07-2013
Road, S.I.T.E, contains
Karachi Glimepiride USP 2mg Firm is GMP
Metformin HCl BP compliant as
Priority # 1084 1000mg 10’s  Rs. 300/- countries regulat
20s  Rs. 600/- per inspection not authori
swapped dated 03-11-
Anti-diabetic provided. and
2015 challan
Manufacture
Specification
229. M/s Sami Atpro Pedriatric 22-10-2012 Proof of Deferre
Pharmaceuticals Suspension Dy # 1669 Form 5 approval confirm
(Pvt.) Ltd, F-95, Rs.20,000/-
status of n
Off. Hub River Each 5ml of reconstituted (Photocopy) Firm is GMP same approv
Road, S.I.T.E, suspension contains compliant as dosage form status
Karachi Atovaquone USP 125mg per inspection
Proguanil HCl BP 50mg dated 03-11-
Priority # 1793 30ml  Rs. 1200/- countries & regulat
2015 Pakistan not authori
swapped Anti-Malarial
Manufacture provided. WHO
and
challan

230. M/s Sami Atpro Pedriatric tablet 29-08-2011 Proof of Deferre
Pharmaceuticals Dy # 95 Form 5 approval confirm
(Pvt.) Ltd, F-95, Each tablet contains Rs.8,000/-
Rs. 12000/-
status of n
Off. Hub River Atovaquone USP 125mg Firm is GMP same approv
31-07-2013
Road, S.I.T.E, Proguanil HCl BP 50mg compliant as
Karachi per inspection in reference referen
Anti-Malarial dated 03-11-
Priority # 1793 Manufacture countries & regulat
Pack size of 2015 Pakistan not authori
6s, 12s & 30s as provided. WHO
per SRO Pakista
and
challan
231. M/s Sami Atpro Pedriatric Tablet 29-08-2011 Proof of Deferre
(Pvt.) Ltd, F-95, Each tablet contains Rs. 8000/-
Rs.12,000/- 31-07-
status of n
Off. Hub River Atovaquone USP 187mg Firm is GMP same approv
Road, S.I.T.E, Proguanil HCl BP 75mg 2013 (Photocopy)
compliant as dosage form status
Karachi per inspection in reference referen
Anti-Malarial dated 03-11-
Priority # 1806 Manufacture Pack size of countries & regulat
6s, 12s & 30s 2015 Pakistan not authori
Per tablet  Rs. provided. WHO
522.50/- Pakista
and
challan
232. M/s Sami Atpro DS Pedriatric 22-10-2012 Proof of Deferre
Pharmaceuticals Suspension Dy # 1671, Form 5 approval confirm
(Pvt.) Ltd, F-95, Rs.20,000/-
status of n
Off. Hub River Each 5ml of reconstituted (Photocopy) Firm is GMP same approv
Road, S.I.T.E, suspension contains compliant as dosage form status
Karachi Atovaquone USP 250mg per inspection
Proguanil HCl BP 100mg dated 03-11-
Priority # 1792 30ml  Rs. 2000/- countries & regulat
2015 Pakistan not authori
swapped Anti-Malarial
Manufacture provided. WHO
and
challan
233. M/s Sami Tablet Dofyl 400 mg 26-12-2012 Proof of Deferre
(Pvt.) Ltd, F-95, Each tablet contains Rs. 20000 Firm is GMP status of n
Off. Hub River Doxofylline MS 400 mg (Photocopy) compliant as same approv
Road, S.I.T.E, per inspection formulation status
Karachi Bronchodilator dated 03-11-
Pack size & price in proposed referen
Manufacture
as per PRC 2015 strength in regulat
swapped reference authori
regulatory WHO
authorities Pakista

not and
provided. challan
234. M/s Sami Dofyl 100mg/5ml Syrup 26-12-2012 Broxane - Opal Proof of Deferre
Pharmaceuticals Dy # 1812, Form 5 approval confirm
(Pvt.) Ltd, F-95, Each 5ml contains Rs.20,000/-
status of n
Off. Hub River Doxofylline MS 100mg (Photocopy) Firm is GMP same approv
Road, S.I.T.E, compliant as formulation status
Karachi Bronchodilator per inspection
Pack size & price in proposed referen
Manufacture dated 03-11-
Priority # 1728 Specification as per SRO strength in regulat
2015 reference authori
swapped
regulatory and
authorities challan
not
provided.
235. M/s PharmEvo Tablet IRMAX 100/10 25-04-2013 Aimix – Stability Deferre
(Private) Dy.No.1656 Form 5- Dainnpon data proof
Limited, A-29, Each film coated tablet D Sumitomo
Rs.50,000/-
required as approv
North Western contains Pharma, Japan per status
Industrial Zone, Ibresartan 100mg
Pack size guidelines same
Port Qasim, Amlodipine Besylate Firm is GMP
10s  Rs. 445/- provided in formul
Karachi 13.87mg eq to compliant as
Amlodipine 10mg 14s  Rs. 623/- 251st RB in refe
28S  Rs. 1246/- per inspection meeting. countri
Priority # 2539 dated 03-11-
Anti-hypertensive and
2015 Pakista
Manufacture
Specification
236. M/s PharmEvo Tablet IRMAX 150/5 25-04-2013 Proof of Deferre

(Private) Dy.No.1656 Form 5- Firm is GMP approval confirm
Limited, A-29, Each film coated tablet D
compliant as status of n
North Western contains Rs.50,000/-
per inspection same approv
Industrial Zone, Ibresartan 100mg dated 03-11- formulation status
Port Qasim, Amlodipine Besylate 6.93 Pack size
10s  Rs. 490/- 2015 in proposed referen
Karachi mg eq to Amlodipine
5mg 14s  Rs. 686/- strength in regulat
Priority # 2535 28S  Rs. 1372/- reference authori
Anti-hypertensive regulatory and
Manufacture authorities Pakista
Specification not
provided.
Industrial Zone, Ibresartan 150mg dated 03-11-
Pack size formulation status
Port Qasim, Amlodipine Besylate
Karachi 13.87 mg eq to
Amlodipine 10mg 14s  Rs. 714/- strength in regulat

Specification not
provided.
Industrial Zone, Ibresartan 300mg dated 03-11- formulation status
Port Qasim, Amlodipine Besylate 6.93 Pack size
Karachi mg eq to Amlodipine
5mg 14s  Rs. 1120/- strength in regulat
Specification not
provided.
Industrial Zone, Ibresartan 300mg dated 03-11-
Pack size formulation status
Port Qasim, Amlodipine Besylate
Karachi 13.87 mg eq to
Amlodipine 10mg 14s  Rs. 1148/- strength in regulat
Specification not
provided.
240. M/s PharmEvo Tablet Inosita plus 50/850 25-04-2013 TGA approved Appro
(Private) Dy.No.266 Form 5 Janumet –
Limited, A-29, Each film coated tablet Rs.20,000/- Merck
North Western contains Australia
Industrial Zone, Sitagliptin (as phosphate Pack size 10s 
Port Qasim, monohydrate)50mg Rs. 1100/- Janumet -MSD
Karachi Metformin HCl 850mg
Firm is GMP
Priority # 2266 PPI-anti ulcer compliant as
Manufacture per inspection
Specification dated 03-11-
2015

241. M/s PharmEvo Tablet Infixa 2.5mg 29-08-2013 MHRA Proof of Deferre
(Private) Dy.No.1659 Form 5- approved approval provisi
Limited, A-29, Each film coated tablet D Xarelto –
Rs.50,000/-
status of stabilit
North Western contains Bayer same data a
Industrial Zone, Rivaroxiban 2.5mg (Photocopy)
dosage form guideli
Port Qasim, Firm is GMP
Factor Xa Inhibitor Pack size in Pakistan provide
Karachi compliant as
Manufacture 7s  Rs. 1050/- not the B
10s  Rs. 1550/- per inspection provided. IN
14s  Rs. 2100/- dated 03-11- meetin
2015 fee cha
242. M/s PharmEvo Tablet Infixa 5mg 29-08-2013 Proof of Deferre
(Private) Dy.No.832 Form 5-D Firm is GMP approval confirm
Limited, A-29, Each film coated tablet Rs.50,000/-
North Western contains (Photocopy)
Industrial Zone, Rivaroxiban 5mg dated 03-11-
Pack size dosage form status
Port Qasim,
Factor Xa Inhibitor 7s  Rs. 2100/- 2015 in reference referen
Karachi
Manufacture 10s  Rs. 3000/- countries regulat
Priority # 2536 Specification 14s  Rs. 4200/- and authori
Pakistan. and
Pakista
and
challan
243. M/s PharmEvo Tablet IRMAX 100/5 25-04-2013 Aimix – Stability Deferre
(Private) Dy.No.1660 Form 5- Dainnpon data submis
Limited, A-29, Each film coated tablet D Sumitomo
Rs.50,000/-
required as of sta
North Western contains Pharma, Japan per data
Industrial Zone, Ibresartan 100mg
Pack size guidelines require
Port Qasim, Amlodipine Besylate Firm is GMP
10s  Rs. 425/- provided in per
Karachi 6.93mg eq to Amlodipine compliant as
5mg 14s  Rs. 595/- 251st RB guideli
28S  Rs. 1190/- per inspection meeting. provide
Priority # 2535 dated 03-11-
Anti-hypertensive 251st
2015 meetin
Manufacture
Specification
244. M/s Unison Tablet Cyclocam 20mg 04-10-2010 Marketing Approv
Chemical worls, Dy.No.266 Form 5 authorization to Photoc
15KM Raiwind Each tablet contains Rs.8,000/- Chiesi –UK
02-12-2013
fee
Road, Lahore Piroxicam beta dextrin and challan
Rs. 12000/-
191.2mg eq to Piroxicam manufactured
(Photocopy) be veri
Priority # 403 20mg by Chiesi Italy.
by Bud
NSAID Pack size 2 x 10  Brexin – Chiesi & Acc
as per SRO Divisio
USP Specification
Firm is GMP and
compliant as Chairm
per inspection Registr
report. Board
permit

issuanc
registra
letter
245. M/s Highnoon Tablet Niacol XR 04-03-2011 FDA approved Firm Appro
Laboratories 1000mg Dy.No.3189 Form 5- Niaspan – Kos previously
Limited, 17.5 D Pharmaceutical
Rs.15,000/-
applied on
km, Multan Each extended released s Form 5-D
Rs. 35000/-
Road, Lahore tablet contains
30-07-2013 but now
Niacin 1000mg Niaspan
Dy # nil dated 30-07- product is
Priority # 2299 2013 -Merck
swapped Anti-hyperlipidemia being
USP Specification Firm is GMP registered in
Pack size
compliant as Pakistan.
7s  Rs. 560/-
10s  Rs. 800/- per inspection
dated 09-03-
2015
246. M/s Highnoon Tablet Niacol XR 500mg 01-03-2011 FDA approved Firm Appro
Laboratories Dy.No.3189 Form 5- Niaspan – Kos previously
Limited, 17.5 Each extended released D Pharmaceutical
Rs.15,000/-
applied on
km, Multan tablet contains s Form 5-D
Rs.35000/-
Road, Lahore Niacin 500mg
30-07-2013 but now
Niaspan
Priority # 2300 Anti-hyperlipidemia
Dy # nil dated 30-07-
-Merck
product is
2013 being
swapped USP Specification
Firm is GMP registered in
Pack size
7s  PRC
10s  PRC per inspection
dated 09-03-
2015
247. M/s Highnoon Tablet Niacol XR 750mg 01-03-2011 FDA approved Firm Appro
Laboratories Dy.No.3189 Form 5- Niaspan – Kos previously
Limited, 17.5 Each extended released D Pharmaceutical
Rs.15,000/-
applied on
km, Multan tablet contains s Form 5-D
Rs.35000/-
Road, Lahore Niacin 750mg
30-07-2013 but now
Niaspan
Dy # nil dated 30-07- product is
Priority # 2300 Anti-hyperlipidemia 2013 -Merck
swapped USP Specification being
Firm is GMP registered in
Pack size
7s  PRC
10s  PRC per inspection
dated 09-03-
2015

248. M/s MBL Tablet Melidone 10mg 16-04-2012 MHRA Approv
Pharma, Plot # Dy.No.722 Form 5 approved with bl
B-77/A, Hub Each film coated tablet Rs.8000/- Motillium - box
Industrial contains (Photocopy) Zentiva warnin
Trading Estate Domperidone 10mg
Rs.12,000/- Photoc
Balauchistan. Domotin -
05-08-2013 fee
Dopamine blocking agent Benson
Priority # 1533 / antiemetic challan
Pack size 5 x 10  be veri
BP Specification Firm is GMP
as per SRO by Bud
compliant as
per inspection & Acc
report dated Divisio
02-05-2016 and
Chairm
Registr
Board
permit
issuanc
registra
letter
249. M/s MBL Tablet Astin 40/240 17-02-2011 WHO Approv
Pharma, Plot # Dy.No.492 Form 5 recommended Photoc
B-77/A, Hub Each tablet contains Rs.8000/- formulation fee
Industrial Artemether 40mg (Photocopy)
Rs.12,000/- challan
Trading Estate Lumefantrine 240mg Amalar -
05-08-2013 be veri
Balauchistan. Bloom
by Bud
Antimalarial
Priority # 871 Manufacture Pack size 8s & 16s
Firm is GMP & Acc
 as per SRO Divisio
Specification compliant as
per inspection and
report dated Chairm
02-05-2016 Registr
Board
permit
issuanc
registra
letter
250. M/s MBL Fasid Cream 15gm 27-04-2012 MHRA Approv
Pharma, Plot # Dy.No.753 approved with ch
B-77/A, Hub Each gram contains Rs.8000/- Fusidin - Leo
Photocopy
of bran
Industrial Fusidic Acid 20mg name.
Rs.12,000/-
Trading Estate Sidic - Epoch
05-08-2013 Photoc
Balauchistan. Antibiotics
fee
BP Specification Firm is GMP
Priority # 1569 challan
Pack size of 15gm compliant as
be veri
by Bud
report dated
& Acc
02-05-2016
Divisio

and
Chairm
Registr
Board
permit
issuanc
registra
letter
251. M/s MBL Mb Din suspension 60ml 19-02-2011 FDA approved Approv
Pharma, Plot # Dy.No.505-A brand Photoc
B-77/A, Hub Each 5ml of reconstituted Rs.8000/-
Photocopy
fee
Industrial suspension contains Velosef challan
Rs.12,000/-
Trading Estate Cephradine USP 250mg
05-08-2013 be veri
Balauchistan. Firm is GMP by Bud
Antibiotics Pack size of 60ml compliant as
Priority # 875 USP Specification & Acc
as per SRO per inspection Divisio
report dated and
02-05-2016 Chairm
Registr
Board
permit
issuanc
registra
letter
252. M/s MBL Viospan DS suspension 27-04-2012 FDA approved Approv
Pharma, Plot # 30ml Dy.No.750 brand Suprax Photoc
B-77/A, Hub Rs.8000/- -Lupin
Photocopy
fee
Industrial Each 5ml of reconstituted challan
Rs.12,000/-
Trading Estate suspension contains Caricef - Sami
05-08-2013 be veri
Balauchistan. Cefixime (as trihydrate)
by Bud
200mg Firm is GMP
Priority # 1549 & Acc
Pack size of 30ml compliant as
Antibiotics Divisio
USP Specification and
report dated
Chairm
02-05-2016
Registr
Board
permit
issuanc
registra
letter

253. M/s Pliva Tablet Diamet 17-02-2011 Proof of Deferre
Pakistan (Pvt.) Dy.No.487 approval confirm
Ltd, Plot # B-77, Each tablet contains Rs.8000/-
Photocopy
status of n
Hub Industrial Glucosamine Sulphate Firm is GMP same approv
Rs.12,000/-
Trading Estate, USP 500mg compliant as
19-9-2013 dosage form status
Balauchistan. Chondroitin Sulphate
per inspection in reference referen
USP 400mg
Priority # 862
Pack size report dated countries. regulat
2 x 10s  Rs. 02-05-2016 authori
Dietary supplement
320/- Pack of and
USP Specification
locally Pakista
registered and
brand. challan
254. M/s Pliva Tablet Meelas 5mg 17-02-2011 MHRA Approv
Pakistan (Pvt.) Dy.No.486 Form 5 approved Photoc
Ltd, Plot # B-77, Each chewable tablet Rs.8000/- Singlulair –
(Photocopy)
fee
Hub Industrial contains Merck,UK challan
Rs.12,000/-
Trading Estate, Montelukast Sodium USP
19-9-2013 be veri
Balauchistan. equivalent to Montelukast Amisped -
by Bud
5mg Sanofi
Pack size & Acc
Priority # 864
Bronchodilators Firm is GMP
14s  Rs. 240/- and
USP Specification compliant as
per inspection Chairm
report dated Registr
02-05-2016 Board
permit
issuanc
registra
letter
255. M/s Pliva Tablet Meelas 10mg 17-02-2011 MHRA Approv
Pakistan (Pvt.) Dy.No.485 approved branf Photoc
Ltd, Plot # B-77, Each film coated tablet Rs.8000/- of Accord
(Photocopy)
fee
Hub Industrial contains challan
Rs.12,000/-
Trading Estate, Montelukast Sodium USP Asfree-
19-9-2013 be veri
Balauchistan. equivalent to Montelukast Medisure
by Bud
10mg
Pack size & Acc
Priority # 863 Firm is GMP
Bronchodilators compliant as
14s  Rs. 310/- and
USP Specification per inspection
report dated Chairm
02-05-2016 Registr
Board
permit
issuanc
registra
letter

256. M/s MBL Fomatin Suspension 60ml 10-05-2012 i. Applicant Deferre
Pharma, Plot # Dy.No.859 Firm is GMP s shall per dec
B-77/A, Hub Each 5ml contains Rs.8000/- revise of 250th
compliant as
Industrial Famotidine 10mg Photocopy their meeting
Rs.12,000/- per inspection
Trading Estate report dated formulati under:-
05-08-2013
Balauchistan. Anti ulcer on as per i. Ap
02-05-2016
USP Specification innovator nts
Pack size as per
Priority # 1570 (new rev
SRO
registrati th
on fo
applicatio tio
n with pe
complete in
fee) or
within six reg
months if io
manufact ap
uring io
facility is co
approved ef
by CLB. wi
ii. For six
already m
registered if
drugs, m
same ctu
procedur fac
e as is
mentione ap
d above db
(at Sr. CL
No. i) ii. For
shall be alre
adopted. regi
Otherwis drug
e show sam
cause proc
notice as
shall be men
issued for d ab
de- (at S
registrati No.
on of shal
registered ado
drugs in Oth
this e sh
formulati caus
on. noti
iii. All such shal
applicatio issu
n shall be de-

processed regi
on on o
priority regi
basis. drug
this
form
on.
iii. All
app
n sh
proc
on
prio
basi
257. M/s MBL Vanax Suspension 60ml 10-05-2012 Dexib –Tabros Proof of Deferre
Pharma, Plot # Dy.No.857 approval confirm
B-77/A, Hub Each 5ml contains Rs.8000/- Firm is GMP
Photocopy
status of n
Industrial Dexibuprofen 100mg compliant as same approv
Rs.12,000/-
Trading Estate per inspection
05-08-2013 dosage form status
Balauchistan. NSAID report dated in reference referen
Manufacture
Pack size as per 02-05-2016 countries. regulat
SRO authori
and
challan
258. M/s MBL Kanz Dry Powder 27-04-2012 Novidat - Sami Proof of Deferre
Pharma, Plot # Suspension Dy.No.753 approval  Pro
B-77/A, Hub Rs.8000/- Firm is GMP
Photocopy
status of app
Industrial Each 5ml of reconstituted compliant as same stat
Rs.12,000/-
Trading Estate suspension contains per inspection
05-08-2013 dosage form sam
Balauchistan. Ciprofloxacin HCl.2H2O report dated in reference dos
eq to Ciprofloxacin 02-05-2016 countries. form
Priority # 1547 250mg Pack size of 60ml
refe
as per SRO
Antibiotics Product is e
Manufacture under cou
Specification review as .
innovator  Pro
brand is in is
base form revi
of active as
ingredient inno
while firm r
has applied is
as salt form. bas
form
acti
ingr

nt
firm
app
as
form
 Fee
cha
259. M/s Asian Artim Plus Suspension 21-05-2012 WHO Approv

Continental Dy.No.955 recommended with ch
(Pvt.) Ltd, D-32, Each 5ml of reconstituted Rs.8000/- formulation
Rs.12,000/-
of bran
S.I.T.E, Super suspension contains name.
05-09-2013
Highway, Artemether 15mg Artem -Hilton
(Photocopy) Photoc
Karachi. Lumefantrine 90mg
fee
Firm is GMP
Priority # 1630 Antimalarial challan
Pack size 30ml x compliant as
Manufacture be veri
60ml  as per per inspection
Specification by Bud
SRO report dated
& Acc
11-11-2015
Divisio
and
Chairm
Registr
Board
permit
issuanc
registra
letter
260. M/s Asian Injection Vitadol 5mg 17-05-2012 Vit D3 B.O.N, Approv
Continental Dy.No.884 France Photoc
(Pvt.) Ltd, D-32, Each 1ml ampoule Rs.8000/-
Rs.12,000/-
fee
S.I.T.E, Super contains Indrop-D , challan
05-09-2013
Highway, Cholecalciferol (Vit. D3) Neutro
(Photocopy) be veri
Karachi. 5mg
by Bud
Firm is GMP
Priority # 1593 Vitamin & Acc
Pack size 30ml x compliant as
USP Specification Divisio
60ml  as per per inspection
and
SRO report dated
Chairm
11-11-2015
Registr
Board
permit
issuanc
registra
letter

261. M/s Atco Afantrine DS Dry 16-02-2012 WHO Approv
Laboratories Suspension Dy.No.581 recommended Photoc
Limited, B-18, Rs.8000/- formulation
Photocopy
fee
S.I.T.E, Karachi Each 5ml of reconstituted challan
Rs.12,000/-
suspension contains Artem plus -
05-08-2013 be veri
Priority # 1502 Artemether MS 30mg Hilton
by Bud
Lumefantrine MS 180mg Pack size of 30ml
Firm is GMP & Acc
& 60ml as per SRO Divisio
Antimalarial compliant
Manufacture and
Specification Chairm
Registr
Board
permit
issuanc
registra
letter
262. M/s Atco Vorinaz Powder for Oral 19-11-2012 Vfend-MHRA Firm Approv
Laboratories suspension 1774 Form 5-D approved previously Photoc
Limited, B-18, Rs.50,000/-
applied on fee
S.I.T.E, Karachi Each 5ml of reconstituted (Photocopy) Hongos-CCL Form 5-D challan
suspension contains Reg#077021 but now be veri
Priority # 1990 Voriconazole 200mg
Pack size of 30ml product is by Bud
GMP
(Triazole Anti-fungal & 60ml as per SRO compliant locally & Acc
agent) section registered Divisio
Manufacture and firm has and
Specification submitted Chairm
application Registr
of Board
prescribed permit
Form 5. issuanc
registra
letter
263. M/s Atco Tablet Xecam-P 4/500 16-02-2012 The Deferre
Laboratories Dy.No.584 Form 5-D GMP proposed confirm
Limited, B-18, Each film coated tablet Rs.15000/- compliant
Rs.35,000/-
formulation n
S.I.T.E, Karachi contains section doesn’t approv
05-08-2013
Lornoxicam MS 4mg
(Photocopy) exist in status
Priority # 1500 Paracetamol BP 500mg
reference referen
(Muscle relaxant ) countries regulat
Pack size of 14s & and authori
Manufacture 28s as per SRO
Specification Pakistan. and
challan

264. M/s Atco Tablet Xecam-P 8/500 16-02-2012 The Deferre
Laboratories Dy.No.584 Form 5-D GMP proposed confirm
Limited, B-18, Each film coated tablet Rs.15000/- compliant
Rs.35,000/-
formulation n
S.I.T.E, Karachi contains section doesn’t approv
05-08-2013
Lornoxicam MS 8mg
(Photocopy) exist in status
Priority # 1501 Paracetamol BP 500mg
reference referen
(Muscle relaxant ) countries regulat
Pack size of 14s & and authori
Manufacture 28s as per SRO
Specification Pakistan. and
challan
265. M/s Atco Tablet Panel 10mg 29-03-2011 MHRA Stability Deferre
Laboratories Dy.No.490 Form 5-D approved data provisi
Limited, B-18, Each film coated tablet Rs.15000/- Fycompa -
Rs.35,000/-
required as stabilit
S.I.T.E, Karachi contains Eisai per data
05-08-2013
Perampanel 10mg guidelines require
Priority # 2164
provided in per
(Antiepileptic) Pack size of 7s, 14s GMP
Manufacture compliant 251st RB guideli
& 28s meeting. provide
Specification Per tablet  Rs. section
251st
375/-
meetin
266. M/s Atco Tablet Alodip-H 29-03-2011 USFDA Stability Deferre
Laboratories Dy.No.490 Form 5-D approved data provisi
Limited, B-18, Each film coated tablet Rs.15000/- Amturnide-
Rs.35,000/-
S.I.T.E, Karachi contains Novartis per data
05-08-2013
Aliskiren (as guidelines require
Priority # 2375 hemifumarate) MS 300
provided in per
mg Pack size of 14s & GMP
Amlodipine (as besylate) compliant 251st RB guideli
28s as per SRO meeting. provide
BP 5mg section
Hydrochlorthiazide BP 251st
12.5mg meetin
(Cardiovascular drug )
Manufacture
Specification
267. M/s Atco Tablet Aloglip-M 24-10-2013 USFDA Stability Deferre
Laboratories 12.5/1000 Dy.No.273 Form 5-D approved data provisi
Limited, B-18, Rs.15000/- Kazano
Rs.35,000/-
S.I.T.E, Karachi Each film coated tablet -Takeda per data
05-08-2013
contains
guidelines require
Priority # 2656 Alogliptin Benzoate MS
eq to Alogliptin 12.5mg GMP
provided in per
Pack size of 10s, 251st RB guideli
Metformin HCl BP 14s 20s & 30s as compliant
1000mg section meeting. provide
per SRO 251st
(Cardiovascular drug ) meetin
Manufacture
Specification

268. M/s Pacific Rifin Dispersible tablet 16-11-2012 WHO -UN  To Deferre
Pharmaceuticals Form 5 prequalified followi
deposit
Limited, 30th Each dispersible tablet 20,000 formulation
(Photocopy) remainin shortco
km, Multan contains g fee for s
Road, Lahore Rifampicin 60mg
Pack size of prescrib  To
Isoniazid 30mg GMP
Priority # 1981 28s  Rs. 335.40/- compliant ed Form dep
56s  Rs. 670.79/- 5-D. rem
(Antimycobacterial) section
Manufacture  Stability g fe
Specification studies pre
as per d
guidelin 5-D
es  Stab
provided stud
in 251st as
RB guid
meeting. es
pro
in
RB
mee
269. M/s Pacific Rifin Dispersible tablet 16-11-2012 WHO -UN  To Deferre
Pharmaceuticals Form 5 prequalified followi
deposit
Limited, 30th Each dispersible tablet 20,000 formulation
(Photocopy) remainin shortco
km, Multan contains g fee for s
Road, Lahore Rifampicin 60mg
Pack size of prescrib  To
Isoniazid 60mg GMP
Priority # 1982 28s  Rs. 337.93/- compliant ed Form dep
56s  Rs. 675.86/- 5-D. rem
(Antimycobacterial) section
Manufacture  Stability g fe
Specification studies pre
as per d
guidelin 5-D
es  Stab
provided stud
in 251st as
RB guid
meeting. es
pro
in
RB
mee

270. M/s NabiQasim Kenazol 2% Lotion 08-05-2013 To provide Deferre
Industries Dy.No.304 Form 5 Conaz - Atco proof of confirm
(Private) Each ml contains: Rs.20,000/- approval of n
Limited, 17/24, Ketoconazole… 20 mg (Photocopy) Firm is GMP same approv
Korangi compliant dosage form status
Industrial Area, (Antifungal agent)
Pack size of 30ml in reference referen
Korangi, Manufacture
Karachi Specification & 60ml as per SRO countries. regulat
authori
Priority # 2294 and
challan
271. M/s Surge Dexol 5% infusion 27-6-2011  To Deferre

Laboratories Dy # 1487 provide  Prim
(Private) Each 100 ml contains: 8000/- Form 5
12000/16-01-2014 primary pack
Limited, 10th, Dextrose Anhydrous USP packagin g de
KM Faisalabad 5gm (5% w/v)
Road, Bikhi
g details.  Proo
Pack size appr
District, (Carbohydrate)
100ml, 500 ml, statu
Sheikhupura. USP Specification
1000ml as per SRO same
Priority # 1545 dosa
swapped form
same
prim
pack
by
refer
regu
auth
s
Paki
272. M/s Surge Injection Alset 27-6-2011 MHRA  Me too Deferre

Laboratories Dy # 1487 approved status  Con
(Private) Each 5ml vial contains: 8000/- Form 5
12000/16-01-2014
Aloxi – needs atio
Limited, 10th, Palonosetron (as HCl) Chughai confirmat pac
KM Faisalabad 0.25mg
ion size
Road, Bikhi
Pack size Aloxetron – Provisi
District, (5HT3 receptor
100ml, 500 ml, Atco approv
Sheikhupura. antagonist)
1000ml as per SRO approved in status
Manufacture
Priority # 1351 Specification 228th meeting same
swapped for improt dosage
form
Pakist
referen
mentio

in Fo
is
correc
273. M/s Surge Preslin Injection 20mg 26-4-2012  Complete Deferre

Laboratories 8000/- Form 5 form 5 provisi
(Private) Each ml contains: 12000/16-01-2014
(Photocopy) required.  Com
Limited, 10th, Hydralazine HCl USP
 Original form
KM Faisalabad 20mg
Road, Bikhi challan  Orig
Pack size of 30ml receipt chal
District, (Antihypertensive)
& 60ml as per SRO required. rece
Sheikhupura. USP Specification
 Complete  Com
Priority # 1202 descriptio desc
swapped n of n
dosage dosa
form form
required.  Proo
 Commit appr
ment statu
required same
as per dosa
decision form
of 251st refer
RB coun
meeting. and
 Latest Paki
inspectio  Com
n report ent a
required. deci
of
RB
mee
Latest
inspec
report.
Fee ch
274. M/s Surge Water for injection 29-8-2012  Complete Deferre

Laboratories 8000/- Form 5 form 5 provisi
(Private) Water for injection 50ml 12000/16-01-2014
(Photocopy) required.  Com
Limited, 10th,
 Original form
KM Faisalabad (Diluent)
Road, Bikhi USP Specification challan  Orig
Pack size of 30ml receipt chal
District,
& 60ml as per SRO required. rece
Sheikhupura.
 Complete  Clin
Priority # 1853 descriptio Indic

n of  Proo
dosage avai
form y of
required. pack
 Commit in
ment refer
required coun
as per and
decision Paki
of 251st  Proo
RB appr
meeting. statu
 Latest same
inspectio dosa
n report form
required. refer
 Indicatio coun
n of and
dosage Paki
form.  Com
ent a
deci
of
RB
mee
 Late
insp
n rep
 Inten
use.
 Fee
chal
275. M/s Surge Sunvega 39 mg injection 29-8-2012 USFDA  Complete Deferre

Laboratories 8000/- Form 5 approved form 5-D  Com
(Private) Each 0.25ml pre filled 12000/16-01-2014 Invega
(Photocopy) required. form
Limited, 10th, syringe contains sustenna –
 Original  Orig
KM Faisalabad Paliperidone palmitate Janssen
Road, Bikhi 39mg challan chal
Pack size of 30ml receipt rece
District, (Prolonged released)
& 60ml as per SRO required.  Com
Sheikhupura.
(Dopamine antagonist)  Complete desc
Priority # 1204 USP Specification descriptio n
n of dosa
dosage form
form  Com
required. ent a

 Commit deci
ment of
required RB
as per mee
decision  Late
of 251st insp
RB n
meeting. requ
 Latest  man
inspectio uring
n report facil
required. pre-f
 Proof of syrin
manufact  Fee
uring chal
facility of
pre-filled
syringes.
276. M/s Surge Sunvega 39 mg injection 29-8-2012 USFDA  Complete Deferre

Laboratories 8000/- Form 5 approved form 5-D  Com
(Private) Each 0.25ml pre filled 12000/16-01-2014 Invega
(Photocopy) required. form
Limited, 10th, syringe contains sustenna –
 Original  Orig
KM Faisalabad Paliperidone palmitate Janssen
Road, Bikhi 39mg challan chal
Pack size of 30ml receipt rece
District, (Prolonged released)
& 60ml as per SRO required.  Com
Sheikhupura.
(Dopamine antagonist)  Complete desc
Priority # 1545 USP Specification descriptio n
n of dosa
dosage form
form  Com
required. ent a
 Commit deci
ment of
required RB
as per mee
decision  Late
of 251st insp
RB n rep
meeting.  man
 Latest uring
inspectio facil
n report pre-f
required. syrin
 Proof of  Fee
manufact chal

uring
facility of
pre-filled
syringes.
277. M/s Venus Viofer Injection 02-12-2010 Dy # FDA approved Approv

Pharma, 23km, 4534 Venofer – with ch
Multan Road, Each 5ml ampoule 8000/- Form 5 Lutipold
12000/05 -11-2013
of bran
Lahore contains name.
Iron sucrose eq to (Photocopy) Venofer – RG Photoc
Priority # 498 elemental iron 100mg (20
fee
mg / ml) GMP
Pack size of 30ml challan
compliant
& 60ml as per SRO be veri
(Hematinic) section vide
USP Specification inspection by Bud
report dated & Acc
Divisio
and
Chairm
Registr
Board
permit
issuanc
registra
letter
278. M/s Venus Viofer Infusion 100 ml 02-12-2010 Dy # FDA approved Deferre
Pharma, 23km, 4534 Venofer – confirm
Multan Road, Part I 8000/- Form 5 Lutipold
12000/05 -11-2013
n
Lahore Each 5ml ampoule approv
contains (Photocopy) Venofer – RG status
Priority # 668 Iron sucrose eq to
same
elemental iron 100mg (20 GMP
Pack size formul
mg / ml) compliant
100ml  Rs. Rs. by ref
Part II section vide
1000/- regulat
Sodium Chloride 0.9% inspection
report dated authori
(Hematinic) and
USP Specification Pakista
and
challan
279. M/s Venus Normal Saline 0.9% 02-12-2010 Dy # Proof of Deferre
Pharma, 23km, 4534 GMP approval confirm
Multan Road, Each ml contains 8000/- Form 5 compliant
12000/05 -11-2013
status of n
Lahore Sodium Chloride 9 mg section vide same approv
(Photocopy) inspection dosage form status
Priority # 669 (Electrolyte) report dated
in glass same
USP Specification
Pack size bottle as formul
100ml  Rs. 45/- primary in

container bottle
primar
contain
refrenc
regulat
authori
and
Pakista
and
challan
280. M/s Venus Tablet Apresolin - 10 02-11-2010 FDA approved The product Deferre
Pharma, 23km, Dy # 4207 Aspresolin – is not yet  App
Multan Road, Each tablet contains 8000/- Form 5 Novartis
12000/05 -11-2013
registered in on
Lahore Hydralazine HCl 10mg Pakistan in pres
(Photocopy) GMP proposed d Fo
Priority # 499 (Antihypertensive) compliant
strength D
USP Specification section vide
Pack size with
inspection
1 x 50  Rs. 103/- othe
report dated
lega
coda
form
s be
the
prop
form
on i
yet
regis
in
Paki
 Fee
chal
281. M/s Hilton Colt Drops 125mg / 5ml Form 5 with MHRA Approv
Pharma (Pvt.) prescribed fee of Rs approved brand with c
Ltd, 13, Sector Each 5ml after 20,000 vide Dy # of Sandoz
1168 dated 03-07-
of
15, Korangi reconstitution contains name
2013
Industrial Area, Clarithromycin 125mg Klaricid – becaus
Karachi (granules for oral Abbott
propos
suspension) Pack size as per
Priority # 2122 brand
PRC resemb
swapped (Antibiotics) GMP
USP Specification compliant with al
section vide registe
inspection brand n
report dated

282. M/s Hilton Tablet Maxit-Neuro Form 5 with Proof of Rejecte
Pharma (Pvt.) prescribed fee of Rs approval formul
Ltd, 13, Sector Each film coated tablet 20,000 vide Dy # GMP
1297 dated 11-07-
status of is
15, Korangi contains compliant same approv
2013
Industrial Area, Diclofenac Sodium 50mg section vide dosage form referen
Karachi Thiamine(Vitamin B1) inspection
in reference regulat
50mg Pack size as per report dated
Priority # 2120 Pyridoxine HCl (Vit B6) countries authori
PRC and and
swapped 50mg
Cyanocobalamin Pakistan. Pakista
(Vitamin B12) 250 mcg
(pain reliever)
Manufacture
Specification
283. M/s Hilton Hilto-D Sachet Form 5-D with Firm needs Deferre
Pharma (Pvt.) prescribed fee of Rs to provide confirm
Ltd, 13, Sector Each Sachet contains 50,000 vide Dy #
1408 dated 19-07-
following n
15, Korangi Vitamin D3 documents / approv
2013
Industrial Area, (Cholecalciferol) 600,000 information status
Karachi IU GMP
for same
Pack size compliant
Priority # 2117 (Vitamin) section vide completion formul
30s  Rs. 900/- of / d
swapped Manufacture inspection
Specification report dated application. form
 Proof of referen
approval regulat
status of authori
same
dosage
form in
referenc
e
countrie
s.
284. M/s Hilton Capsule toploss 7.5/46 Form 5-D with FDA approved Firm needs Deferre
Pharma (Pvt.) prescribed fee of Rs Qsymia , Vivus to provide  Com
Ltd, 13, Sector Each capsule contains 50,000 vide Dy # 699
dated 31-01-2013
following e
15, Korangi Phentermine 7.5 mg documents / des
Industrial Area, Topiramate 46 mg information on
Karachi GMP
Pack size for dos
(anti-epileptic) compliant
10s  Rs. 4300/- completion form
Priority # 2143 Manufacture section vide
20s  Rs. 8600/- of  For
swapped Specification inspection
30s  Rs. 12,900/- application.
report dated ion
 Complet deta
e per
descripti inno
on of

dosage r br
form.  Stab
 Formula data
tion per
details guid
as per es
innovato 251
r brand. mee
 Stability
data as
per
guidelin
es of
st
251 RB
meeting.
285. M/s Hilton Capsule toploss 11.25/69 Form 5-D with FDA approved Firm needs Deferre
dated 31-01-2013
following e
15, Korangi Phentermine 11.25 mg documents / des
Karachi GMP
Pack size for dos
20s  Rs. 10300/- of  For
report dated ion
 Complet deta
e per
descripti inno
on of r br
dosage  Stab
form. data
 Formula per
tion guid
details es
as per 251
innovato mee
r brand.
 Stability
data as
per
guidelin
es of
251st RB
meeting.

286. M/s Hilton Capsule toploss 15/92 Form 5-D with FDA approved Firm needs Deferre
dated 31-01-2013
following e
15, Korangi Phentermine 15 mg documents / des
Karachi GMP
Pack size for dos
20s  Rs. 11600/- of  For
report dated ion
 Complet deta
e per
descripti inno
on of r br
dosage  Stab
form. data
 Formula per
tion guid
details es
as per 251
innovato mee
r brand.
 Stability
data as
per
guidelin
es of
st
251 RB
meeting.
287. M/s Hilton Ariza Injection IM Form 5-D with FDA approved Proof of Deferre
Pharma (Pvt.) prescribed fee of Rs Abilify – segregated provisi
Ltd, 13, Sector Each 1.3ml vial contains 50,000 vide Dy # Otsuka
1302 dated 01-07-
manufacturi stabilit
15, Korangi Aripiprazole 9.75mg ng facility data a
2013
Industrial Area, for guideli
Karachi (psychotropic drug)
psychotropi provide
Manufacture Pack size GMP
Priority # 2387 Specification compliant c injection 251st
5s  Rs. 2254/- not meetin
10s  Rs. 4508/- section vide
inspection provided.
30s  Rs. 13,524/-
report dated

288. M/s Hilton Ariza oral solution Form 5-D with FDA approved Proof of Deferre
Pharma (Pvt.) prescribed fee of Rs Abilify – segregated provisi
Ltd, 13, Sector Each ml contains 50,000 vide Dy # Otsuka
1299 dated 01-07-
manufacturi stabilit
15, Korangi Aripiprazole 1mg ng facility data a
2013
Industrial Area, for guideli
Karachi (anti-psychotic)
psychotropi provide
Manufacture Pack size GMP
Priority # 2391 Specification compliant c oral 251st
60ml  Rs. 5880/- solution not meetin
120ml  Rs. section vide
inspection provided.
11170/-
240ml  Rs. report dated
20000/-
289. M/s Hilton Tablet Hilpru 600 mg Form 5 with Tablet Unidrox Me too Deferre
Pharma (Pvt.) prescribed fee of Rs - Aziende status needs confirm
Ltd, 13, Sector Each film coated tablet 50,000 vide Dy # 104 Chimiche
dated 23-01-2013
confirmatio n
15, Korangi contains Riunite n. approv
Industrial Area, Prulifloxacin 600mg Angelini status
Karachi Francesco -
Pack size & price Pakista
(Antibiotics) A.C.R.A.F.
as per PRC
Priority # 2346 Manufacture S.p.A. Viale
Specification Amelia 70 -
00181 Rome,
Italy
Pruking
600mg,
Wilshire
GMP
compliant
section vide
inspection
report dated
290. M/s Medisearch Gerd Cure Tablet 31-08-2012 Dy # Product Deferre

Pharmacal 8556 under produc
(Pvt.) Ltd, 5km, Each tablet contains 8000/- Form 5 Ganaton –
12000/05 -11-2013
review. under
Raiwind Manga Itopride HCl 50mg Abbott review
Road, Lahore latest
(prokinetic / antiemetic) GMP
Pack size inspect
Priority # 669 Manufacture compliant
3 x 10  Rs. 425/- report
Specification section vide
inspection firm
report dated conduc
within
year
decisio
CLB

recomm
ation
PQCB,
Punjab
291. M/s Medisearch Capsule Diclofast 50mg 31-08-2012 Dy # Complete Deferre
Pharmacal 8554 description  Com
(Pvt.) Ltd, 5km, Each capsule contains 8000/- Form 5 Phlogin -
12000/31 -07-2013
of dosage e
Raiwind Manga Diclofenac Sodium 50 brookes form not des
Road, Lahore mg provided. on
GMP
Pack size dos
Priority # 988 (NSAID) compliant
2 x 10  Rs. 180/- form
Manufacture section vide
Specification inspection  Pro
report dated app
stat
dos
form
refe
e
cou
.
 Lat
insp
n
of
firm
con
d w
one
and
dec
of
on
reco
end
of
PQC
Pun
292. M/s Medisearch Tablet Nexpro 550mg 31-08-2012 Dy # Complete Deferre
Pharmacal 8554 description  Com
(Pvt.) Ltd, 5km, Each tablet contains 8000/- Form 5 Anex –
12000/31 -07-2013
of dosage e
Raiwind Manga Naproxen sodium 550mg Pharmevo form not des
Road, Lahore eq to Naproxen 500mg provided. on
GMP
Pack size dos
Priority # 1078 (NSAID) compliant
3 x 10  Rs. 240/- form
USP Specification section vide
inspection  Pro
report dated app

stat
dos
form
refe
e
cou
.
 Lat
insp
n
of
firm
con
d w
one
and
dec
of
on
reco
end
of
PQC
Pun
293. M/s Pharmatec Tablet Morease SR 29-8-2012 Diclectin –  The Defere

Pakistan (Pvt.) 8000/- Form 5 Canada proposed  The
Ltd, D-86/A, Each film coated delayed 12000/16-01-2014
(Photocopy) formulati prop
S.I.T.E, released tablet contains Envepe- RG on is not form
Karachi. Doxylamine Succinate Pharmaceutica
as per on
10mg
Priority # 1204 Vitamin B6 10mg Pack size of 30’s as innovator does
per SRO brand and matc
Folic Acid 2.5mg
me too in with
(Antihistamine / ant Pakistan. alrea
allergy / anti nauseant )  Original regis
Manufacture challan bran
Specification receipt beca
required. prop
form
on
cont
folic
whic
not
form
on

alrea
regis
bran
 Orig
chal
rece
requ
 App
statu
refer
regu
auth
s.
 Fee
chal
294. M/s Pharmatec Tablet Lanthanate 500mg 29-8-2012 USFDA  Original Deferre
Pakistan (Pvt.) 8000/- Form 5 approved challan  Orig
Ltd, D-86/A, Each chewable tablet 12000/16-01-2014 Fosrenol –
(Photocopy) receipt chal
S.I.T.E, contains DSM required. rece
Karachi. Lanthanum (as carbonate Pharmaceutical
hydrate) 500mg s –Greenville  Complete  Com
Pack size of 30’s as descriptio desc
Priority # 1956 Blvd
per SRO n of n
(Phosphate Binder ) US Patent
Manufacture 5,968,976 dosage dosa
Specification form form
required.  Com
 Commit ent a
ment deci
required of
as per RB
decision mee
of 251 st
 Late
RB insp
meeting. n rep
 Latest  Proo
inspectio appr
n report statu
required. same
 Proof of form
approval on
status of dosa
same form
dosage Paki
form in  Fee

Pakistan. chal
295. M/s Genix Tablet Metvil 30-11-2010 MHRA Approv

Pharma (Pvt.) Dy No.2076 Form 5 approved Photoc
Ltd, 44,45-B, Each film coated tablet Rs.8000/- Eucreas –
Rs.12,000/-
fee
Korangi Creek contains Novartis challan
25-9-2013
Road, Karachi. Metformin HCl 1000mg
(Photocopy) be veri
Vildagliptin 50mg Galvusmet-
by Bud
Priority # 643 Novartis
(Anti-diabetic) & Acc
Pack size of 10’s & Divisio
Manufacture 30’s as per SRO GMP
Specification compliant and
section Chairm
Registr
Board
permit
issuanc
registra
letter
296. M/s Obsons Capsule Flucob 150mg 22-6-2011 MHRA Approv
Pharmaceuticals 8000/- Form 5 approved Photoc
, 209-S, Each capsule contains 12000/19-12-2013 Azocan-P , fee
Industrial Fluconazole 150mg (Photocopy) FDC challan
Estate. be veri
Kotlakhpat, (Anti-diabetic) Fluderm-
Pack size & price by Bud
Lahore Manufacture NabiQasim
Specification as per SRO & Acc
Priority # 1170 GMP Divisio
compliant and
section vide Chairm
inspection Registr
report dated Board
07-07-2015. permit
issuanc
registra
letter
297. M/s Obsons Tablet OBMOX 400 mg Dy # 2705 MHRA Approv
Pharmaceuticals 22-6-2011 approved Photoc
, 209-S, Each film coated tablet Rs. 8000/- Avelox fee
Industrial contains Form 5 challan
Estate. Moxifloxacin (as HCl) Dy # 1281 Moxiget - Getz be veri
Kotlakhpat, 400mg 19-12-2013
by Bud
Lahore Rs. 12000/- GMP
(Antibiotics) (Photocopy) compliant & Acc
Priority # 1171 Manufacture section vide Divisio
Specification inspection and
Pack size report dated Chairm
1 x 5s  Rs. 07-07-2015. Registr
692.95/- Board

permit
issuanc
registra
letter
298. M/s Obsons Tablet AZICOB 250mg Dy # 2705 MHRA Approv
Pharmaceuticals 22-6-2011 approved brand Photoc
, 209-S, Each film coated tablet Rs. 8000/- of actavis, UK fee
Industrial contains Form 5 challan
Estate. Azithromycin (as Dy # 1281 Azopik – Wise be veri
Kotlakhpat, dihydrate) 19-12-2013
by Bud
Lahore 250mg Rs. 12000/- GMP
(Photocopy) compliant & Acc
Priority # 1181 (Antibiotics) section vide Divisio
Manufacture inspection and
Specification Pack size report dated Chairm
6s  as per SRO 07-07-2015. Registr
Board
permit
issuanc
registra
letter
299. M/s Irza Zeesulf Suspension 18/10/2012 WHO  Product Deferre
Pharma (Pvt.) Fee Rs. 20,000/- recommended is under produc
Ltd, 10.2km, Each 5ml of suspension Form 5 formulation review under
Lahore contains (Photocopy)
and review
Sheikhupura Zinc Sulphate USP 20mg GMP
waiting sent
Road, Lahore compliant
Pack size & price for comme
(Antidiarrheal ) section vide
Priority # 1917 USP Specification as per SRO inspection commen of WH
report dated ts of
21-03-2016 WHO.
300. M/s Irza Tablet Vilvus 50mg 18/10/2012 MHRA Approv

Pharma (Pvt.) Dy # 211 dated 17- approved Photoc
Ltd, 10.2km, Each tablet contains 10-2012 Galvus-
Fee Rs. 20,000/-
fee
Lahore Vildagliptin 50mg Novartis challan
Form 5
Sheikhupura
(Photocopy) be veri
Road, Lahore (Anti-diabetic) Galvus –
Manufacture Novartis
by Bud
Priority # 1914 Specification & Acc
as per SRO GMP
compliant and
section vide Chairm
inspection Registr
report dated Board
21-03-2016 permit
issuanc
registra
letter

301. M/s Irza Injection I-Mide 18/10/2012 Metoclopramid Approv
Pharma (Pvt.) Dy # 211 dated 17- e Injection – Photoc
Ltd, 10.2km, Each 2ml contains 10-2012 Sandoz Canada
Fee Rs. 20,000/-
fee
Lahore Metoclopramide HCl challan
Form 5
Sheikhupura 10mg (5mg/ml) Maxolon-GSK
(Photocopy) be veri
Road, Lahore
by Bud
(Anti-dopaminergic) GMP
Priority # 1014 Manufacture compliant & Acc
Specification as per SRO section vide
inspection and
report dated Chairm
21-03-2016 Registr
Board
permit
issuanc
registra
letter
302. M/s Irza Tablet Gabatin 100mg 18/10/2012 Gabapen – Proof of Deferre
Pharma (Pvt.) Fee Rs. 20,000/- Batala approval confirm
Ltd, 10.2km, Each tablet contains Form 5
status of n
Lahore Gabapentin USP 100mg (Photocopy) GMP same approv
Sheikhupura compliant dosage form status
Road, Lahore (Anti-epileptic) section vide
Manufacture inspection
Priority # 1916 Specification as per SRO report dated countries regulat
21-03-2016 not authori
provided. and
challan
303. M/s Irza Tablet Gabatin 300mg 18/10/2012 Gabapen – Proof of Deferre
Pharma (Pvt.) Fee Rs. 20,000/- Batala approval confirm
Ltd, 10.2km, Each tablet contains Form 5
status of n
Lahore Gabapentin USP 300mg (Photocopy) GMP same approv
Sheikhupura compliant dosage form status
Road, Lahore (Anti-epileptic) section vide
Manufacture inspection
Priority # 1915 Specification as per SRO report dated countries regulat
21-03-2016 not authori
provided. and
challan
304. M/s Irza Neotral Sachet 02-07-2012 Approved in Firm Rejecte

Pharma (Pvt.) Rs. 8,000/- 247th RB doesn’t firm do
Ltd, 10.2km, Each sachet contains Form 5
17-05-2013 meeting being possess possess
Lahore Sodium Chloride 3.5gm Sachet Sachet
Rs. 12000/- high osmolar
Sheikhupura Potassium Chloride
(Photocopy) formulation (General) (Gener
Road, Lahore 1.5gm
Section Section
Sodium Citrate 2.9gm
Priority # 1785 Dextrose Anhydrous Peditral -Searle
Pack size & price
20gm as per SRO

GMP
(Electrolyte) compliant
Manufacture section vide
Specification inspection
report dated
21-03-2016
305. M/s Lahore Tablet ARTEMEF DS 05-09-2012 WHO Latest Approv

Chemical & Rs. 8,000/- recommended inspection with c
Pharmaceutical Each tablet contains Form 5
formulation report of
Works (Pvt.) Artemether 40mg (Photocopy)
Dy#1134 conducted name.
Ltd, 137- Lumefantrine 240mg
16-12-2013 Artem - Hilton within one has
Ferozpur Road,
Lahore (Antimalarial)
Rs. 12000/- year. provide
Manufacture requisi
Priority # 1867 Specification Commitmen docum
Pack size
t required as Photoc
8s  Rs. 280/-
per decision fee
of 251st RB challan
meeting. be ve
by B
& Acc
Divisio
and
Chairm
Registr
Board
permit
issuanc
registra
letter
306. M/s Lahore Tablet ARTEMEF DS 05-09-2012 WHO Latest Approv
Chemical & Rs. 8,000/- recommended inspection with c
Pharmaceutical Each tablet contains Form 5
formulation report of
Works (Pvt.) Artemether 80mg (Photocopy)
Dy#1131 conducted name.
Ltd, 137- Lumefantrine 480mg
16-12-2013 Artem - Hilton within one has
Ferozpur Road,
Lahore (Antimalarial)
Rs. 12000/- year. provide
Manufacture requisi
Priority # 1868 Specification Commitmen docum
Pack size
t required as Photoc
6s  Rs. 312/-
per decision fee
of 251st RB challan
meeting. be ve
by B
& Acc
Divisio

and
Chairm
Registr
Board
permit
issuanc
registra
letter
307. M/s Mass Tablet VIMC-D Dy# 10276 Deferre
Pharma (Pvt) 10-12-2012 Onsate – AGP verifica
Ltd, 17-km, Each film coated tablet Rs. 20,000/-
Form 5
of a
Ferozepur contains:- absorp
Road, Lahore Ossein Mineral complex (Photocopy)
spectro
83mg eq. to residual
ometer
Priority # 2038 mineral salts 24.8mg,
Pack size area
collagen 224mg, other
Per tablet  Rs. require
protenins 88.4mg, trace
10/- analyti
elements fl,mg, Zn, Fe,
Ni, Cu) corresponding to testing
approx 440mg the pr
hydroxyapatite. and
challan
308. M/s Sharex Pyodex Solution 10% Dy# 3539 MHRA Latest Deferre
Laboratories 16-03-2011 approved inspection Latest
(Pvt.) Ltd, KLP, Each 100ml contains:- Rs. 8,000/- Betadine
Form 5
report inspect
Road, Iodinated povidone 10gm required report
Dy #1084
Sadiqabad eq to iodine 1gm Poviderm
29-05-2014 conduc
-Bexter
within
Priority # 285 Antiseptic
USP specification year
Pack size section
Per tablet  Rs.
10/-
309. M/s Sharex Cynoplex Injection Dy# 3271 Murfy plex – Latest Deferre
Laboratories 08-03-2011 Murfy inspection  Lat
(Pvt.) Ltd, KLP, Each 2ml ampoule Rs. 8,000/-
Form 5
report insp
Road, contains:- required n
Dy #1087
Sadiqabad Vitamin B1 BP 10mg
29-05-2014 con
Vitamin B2 BP 2mg
Priority # 285 Vitamin B6 BP 5mg d w
Nicotinamide BP 75mg one
Pack size
Dexpanthanol BP 5mg 25s  Rs. 90/-
 Con
atio
Vitamin app
Manufacture specification stat
refe
e
regu
auth
es

Pak
310. M/s Basel Capsule Befol Vit Dy# 843 Fefol-vit, GSK Latest Deferre
Pharmaceuticals 21-11-2013 inspection  Lat
, 227-Phase II, Each capsule contains:- Rs. 20,000/-
Form 5
report insp
Multan Dried ferrous Sulphate required n
Industrial 150mg Commitmen requ
Estate, Multan Folic acid 0.5mg
Pack size t required  Com
Thiamine mononitrate
10s  Rs. 141/- Complete men
Priority # 285 2mg
Riboflavin 2mg manufacturi per
Pyridoxine HCl 1mg ng method dec
Nicotinamide 10mg required of
Ascorbic acid 50mg RB
mee
Vitamins  Com
Manufacture specification
e
man
turi
met
 Vita
poli
311. M/s Zafa ZipPain 25mg Capsule 28-11-2013 FDA approved Stability Deferre
Pharmaceutical Dy.No.2039 Zipsor - US data as per provisi
Laboratories Each softgel capsule Form 5-D Patents:
Rs.50,000/-
guidelines Stabilit
(Pvt.) Ltd, L- contains 6,365,180; provided in data a
1/B, Block 22, Diclofenac Potassium (Photocopy) 7,662,858; 251st RB guideli
Federal “B” 25mg 7,884,095;
meeting. provide
Industrial Area, 7,939,518;
Pack size & price 251st
Karachi (NSAID) 8,110,606;
as per SRO meetin
Manufacture 6,287,594;
Priority # 2742 Specification 8,623,920 fee cha
Distributed by:
Depomed, Inc.
Newark, CA
94560, USA
Issued: 5/2016
312. M/s Zafa Tablet Durata 30 mg 28-11-2013 MHRA The product Deferre
Pharmaceutical Form 5 approved in proposed provisi
Laboratories Each film coated tablet Rs.20,000/- Priligy strength is applica
(Pvt.) Ltd, L- contains (Photocopy)
not yet on
1/B, Block 22, Dapoxetine HCl eq to registered in prescri
Federal “B” Dapoxetine 30mg
Pack size & price Pakistan. Form
Industrial Area,
Karachi (SSRIs) as per SRO becaus
produc

Manufacture propos
Priority # 1989 Specification strengt
not
registe
Pakista
and
challan
313. M/s Highnoon Tablet Cidine XR 22-11-2012 Proof of Deferre
Laboratories Fee Rs. 20,000/- approval confirm
Ltd, 17.5km, Each extended released Form 5
status of n
Multan Road, tablet contains (Photocopy)
same approv
Lahore Cinitapride as acid formulation status
tartrate 3mg
Pack size & price in same same
Priority # 2381
(Prokinetic drugs) as per SRO strength in formul
Manufcature reference by refe
Specification countries & regulat
Pakistan. authori
and
Pakista
and
challan
314. M/s Highnoon Tablet Cidine XR 3-10-2011 Proof of Deferre
Laboratories Form 5-D approval confirm
Ltd, 17.5km, Each tablet contains 15000/-
35000/30-07-2013
status of n
Multan Road, Dexrabeprazole sodium same approv
Lahore 5mg (Photocopy)
formulation status
in same same
Priority # 2747 (Proton Pump Inhibitor)
Pack size strength in formul
Manufcature
10s  Rs. 150/- reference by refe
Specification
14s  Rs. 210/- countries & regulat
28s  Rs. 420/- Pakistan. authori
and
Pakista
and
challan
315. M/s Highnoon Capsule Tres-Orix forte 18-10-2012 Proof of Deferre
Laboratories Form 5 approval confirm
Ltd, 17.5km, Each capsule contains 20000/-
status of n
Multan Road, Carnitine Hydrochloride (Photocopy)
same approv
Lahore 150mg Lysine
Hydrochloride 150mg formulation status
Coenzyme B12 1mg Pack size in same same
Priority # 2380
swapped Cyproheptadine orotate 10s  Rs. 100/- strength in formul
1.5mg 14s  Rs. 200/- reference by refe
28s  Rs. 300/- countries & regulat
(Nutritional Supplement)
Pakistan. authori
and

Pakista
fee cha
316. M/s Highnoon Tablet Spasnol 80/80 18-10-2013 Spasfon – Deferre
Laboratories Form 5 France produc
Ltd, 17.5km, Each tablet contains 20000/-
formul
Multan Road, Phlorglucinol 80mg (Photocopy) Spasfon is
Lahore Trimethylphlorglucinol -Himont review
80mg
Pack size as per The B
Priority # 2748
swapped (Antispasmodic) SRO advised
Manufacture specification issue
remind
to ex
for
opinion
317. M/s Seatle Tablet Exlem 3mg 18-10-2013 TGA approved Proof of Rejecte
(Private) Form 5 Lexotan- manufacturi firm do
Limited, 45-km, Each tablet contains 20000/- Roche ng facility possess
Multan Road, Bromazepam 3mg (Photocopy)
of tablet segrega
Lahore Lexotanil psychotropi manufa
(Benzodiazepines) Roche
c ng fa
Priority # 2414 Manufacture specification Pack size as per
SRO of
psycho
c as
require
of C
Licens
Board.
318. M/s Merck Tablet Osteolock 05-11-2012 Gevolox – Deferre
(Private) Dy # 1728 Form 5 Hilton confirm
Limited, 7, Jail Each film coated tablet Rs.20,000/-
n
Road, Quetta contains (Photocopy) GMP approv
Glucosamine Sulphate compliant status
Priority # 1969 2KCl USP eq. to section vide
Pack size same
Glucosamine Sulphate inspection
500mg 20s  Rs. 320/- report dated formul
Chondroitin Sulphate 13-14 May by refe
USP 400mg 2016 regulat
authori
(Osteoarthritis) and
Manufacture challan
specification

319. M/s Merck Lumairia Dry Suspension 16-11-2011 WHO Approv
(Private) Dy.No.361 Form 5 recommended Photoc
Limited, 7, Jail Each 5ml of reconstituted Rs.8000/- formulation
Rs.12,000/-
fee
Road, Quetta suspension contains challan
05-09-2013
Artemether 15mg Artem – Hilton
(Photocopy) be veri
Priority # 1429 Lumefantrine 90mg
by Bud
GMP
(Antimalarial) compliant & Acc
Pack size Divisio
Manufacture 30ml  Rs. 90/- section
specification and
Chairm
Registr
Board
permit
issuanc
registra
letter
320. M/s Merck Lumairia Tablet 80/480 16-11-2011 WHO Approv
Limited, 7, Jail Each Tablet contains Rs.8000/- formulation
Rs.12,000/-
fee
Road, Quetta Artemether 80mg challan
05-09-2013
Lumefantrine 480mg Artem – Hilton
(Photocopy) be veri
Priority # 1424
by Bud
(Antimalarial) GMP
Manufacture compliant & Acc
Pack size Divisio
specification 30ml  Rs. 90/- section
and
Chairm
Registr
Board
permit
issuanc
registra
letter
Rs.12,000/-
fee
05-09-2013
(Photocopy) be veri
Priority # 1431
by Bud
(Antimalarial) GMP
Pack size Divisio
specification 10s  Rs. 264/- section
and
Chairm
Registr
Board
permit
issuanc

registra
letter
Rs.12,000/-
fee
05-09-2013
(Photocopy) be veri
Priority # 1428
by Bud
(Antimalarial) GMP
Pack size Divisio
specification 16s  Rs. 320/- section
and
Chairm
Registr
Board
permit
issuanc
registra
letter
323. M/s Merck Mercip Powder for 16-11-2011 Product Deferre
(Private) suspension 250mg/5ml Dy.No.361 Form 5 under produc
Limited, 7, Jail Rs.8000/- GMP
Rs.12,000/-
review. under
Road, Quetta Each 5ml of reconstituted compliant review
05-09-2013
suspension contains section
(Photocopy) The
Priority # 2049 Ciprofloxacin HCl.2H2O
innovator The
USP eq to Ciprofloxacin
250mg brand is in innova
Pack size base form brand
60ml  Rs. 160/- while it is in base
(Antibiotics)
USP specification salt form. while i
salt for
324. M/s Merck Mercip Powder for 13-12-2012 The Rejecte
(Private) suspension 125mg/5ml Dy.No.361 Form 5 proposed the
Limited, 7, Jail Rs. 20,000/- GMP dosage form propos
Road, Quetta Each 5ml of reconstituted (Photocopy) compliant doesn’t dosage
suspension contains section exist in this doesn’
Priority # 2048 Ciprofloxacin HCl.2H2O
Pack size strength in exist
USP eq to Ciprofloxacin
250mg 60ml  Rs. 90/- reference propos
countries. strengt
(Antibiotics) referen
USP specification countri

325. M/s Star Irosoft Injection 17-07-2013 TGA approved Approv
Laboratories Form 5 Venofer – with ch
(Pvt.) Ltd, 23- Each 5ml contains Rs. 20,000/- Aspen Pharma of bran
km, Multan Ferric sucrose complex (Photocopy) Australia name.
Road, Lahore eq to elemental iron Photoc
100mg Venofer-RG
Pack size of fee
Priority # 2400
swapped (Iron preparation) ampoule GMP challan
5ml x 5  Rs. be veri
USP specification compliant
1250/- by Bud
section
& Acc
Divisio
and
Chairm
Registr
Board
permit
issuanc
registra
letter
326. M/s Star Irosoft Syrup 17-07-2013 TGA approved Approv
Laboratories Form 5 Maltofer – with ch
(Pvt.) Ltd, 23- Each 5ml contains Rs. 20,000/- Aspen Pharma of bran
km, Multan Iron (III) hydroxide (Photocopy) Australia name.
Road, Lahore polymaltose complex eq. Photoc
to elemental iron 50mg Ferosoft-Hilton
Pack size of fee
Priority # 2636
swapped (Iron preparation) ampoule GMP challan
5ml x 5  Rs. be veri
USP specification compliant
1250/- by Bud
section
& Acc
Divisio
and
Chairm
Registr
Board
permit
issuanc
registra
letter
327. M/s Pharmix Tablet Pepzym 30-09-10 Plasil with Deferre
Laboratories Rs.8000/- Form 5 enzyme – confirm
(Private) Each coated tablet 30-7-2013 Pacific
Rs. 12000/-
n
Limited, 21-km, contains approv
Ferozepur Pancreatin USP 210 FIP (Photocopy) GMP status
Road, Lahore P.U compliant
referen
Metoclopramide section
Pack size of regulat
Priority # 402 (HCL.2H2O) 6mg
30s  Rs. 300/- authori
Bromelain 35000 P.U.

Polysiloxane 50mg and
Sodium Dehydrocholate challan
20mg
(Digestive Enzyme)
328. M/s Pharmix Tablet Vital 08-09-2010 Occulovit – Deferre

Laboratories Rs.8000/- Form 5 Ethical confirm
(Private) Each film coated tablet 30-7-2013 Laboratories
Rs. 12000/-
n
Limited, 21-km, contains approv
Ferozepur Vitamin A (Acetate) USP (Photocopy) GMP
status
Road, Lahore 5000 I.U compliant
Vitamin C (Ascorbic section
referen
Pack size of regulat
Priority # 400 Acid) BP 500mg
30s  Rs. 510/- authori
Vitamin E USP 200 I.U
Vitamin D vitamin
(Cholecalciferol D3) USP policy
100 I.U fee cha
Folic Acid BP 200 mcg
Vitamin B1 (Thiamine
mononitrate) USP 15mg
Vitamin B2 (Riboflavin)
USP 15mg
Zinc BP 40mg
Copper BP 2mg
Manganses BP 1.5mg
Selenium BP 40.5mcg
(Vitamins/ minerals)
329. M/s Pharmix Polyrol Syrup 21-12-2010 TGA approved Approv

Laboratories Rs.8000/- Form 5 Maltofer- Photoc
(Private) Each 5ml contains: 30-7-2013 Aspen Pharma,
Rs. 12000/-
fee
Limited, 21-km, Iron (III) Hydroxide Australia challan
Ferozepur Polymaltose Complex (Photocopy)
be veri
Road, Lahore Eq. to elemental Iron Ferosoft
by Bud
………50mg -Hilton
Pack size of & Acc
Priority # 688
30ml & 60ml as per Divisio
Iron preparation
SRO and
Manufacture GMP
specification compliant Chairm
section Registr
Board
permit
issuanc
registra
letter

330. M/s Pharmix Tablet Vitamax 30-9-2010 Once a Day – Deferre
Laboratories Rs.8000/- Form 5 CCL confirm
(Private) Each tablet contains 30-7-2013 n
Limited, 21-km, Vitamin A (Acetate) USP Rs. 12000/- GMP approv
Ferozepur 10mg (Photocopy) compliant status
Road, Lahore Vitamin C (Ascorbic section
referen
acid) USP 60mg
Priority # 401 Vitamin E USP 30mg Pack size of regulat
Vitamin D 30s  Rs. 390/- authori
(Cholecalciferol D3) USP vitamin
10 mcg policy
Folic Acid USP 0.400mg fee cha
Vitamin B1 (Thiamine
mononitrate) USP
1.50mg
Vitamin B2 (Riboflavin)
USP 1.70mg
Vitamin B6 (Pyridoxine)
USP 2 mg
Vitamin B12
(Cyanocobalamin) USP 6
mcg
Niacin USP 20mg
Pantothenic acid USP
10mg
D-Biotin USP 30 mcg
Calcium USP 130mg
Phosphorus USP 100mg
Iodine USP 150 mcg
Iron USP 18 mg
Magnesium USP 100mg
Copper USP 2mg
Zinc USP 15mg
Potassium USP 37.50mg
Maganese USP 2.50mg
Chromium USP 10 mcg
Molybdenum USP 10
mcg
Selenium USP 10 mcg
Chloride USP 34 mg
(Digestive Enzyme)

331. M/s Renacon Renacit Hemodialysis 19-11-2012 Renasol –  The Deferre
Pharma (Pvt.) Concentrate Dry (RCTD) Rs.20000/- Form 5 Minntech re-
internatio
Ltd, 18-km, (Photocopy) evaluat
nal
Ferozpur Road, After mixing and dilution License availabilit and
Opp Nishtar of Part A & Part B by the renewed on 21-
Pack size of y compa
Colony, Lahore Haemodialysis machine, 09-2015.
30s  Rs. 300/- provided of
the resultant concentrate:-
Priority # 1991 Sodium 140 mmol/L GMP is formul
Potassium 2.0 mmol/L compliant different approv
Calcium 1.5 mmol/L section in regulat
Magnesium 0.75 mmol/L compositi authori
Chloride 109.25 mmol/L on from of refe
Citrate 0.8 mmol/L proposed countir
Bicarbonate 35.0 mmol/L formulati and
Glucose 5.5 mmol/L on. challan
Part A:-
Sodium 105.0 mmol/L
Potassium 2.0 mmol/L
Calcium 1.5 mmol/L
Magnesium 0.75 mmol/L
Chloride 109.25 mmol/L
Citrate 0.8 mmol/L
Glucose 5.5 mmol/L
Part B:-
Sodium 35 mmol/L
Bicarbonate 35 mmol/L
(Concentrate for
Bicarbonate
Hemodialysis)
Manufacture
specification
332. M/s Pharmacare Pharxime DS Suspension 27-12-2011 FDA Approved Approv

Labs (Pvt.) Ltd, Rs.8000/- Form 5 brand suprax Photoc
129/1 Industrial Each 5ml of reconstituted 30-7-2013
Rs. 12000/-
fee
Estate, Kot suspension contains:- Caricef-sami challan
Lakhpat, Cefixime trihydrate eq to (Photocopy)
be veri
Lahore cefixime 200mg GMP
by Bud
compliant
Pack size & price & Acc
Priority # 1463 (Cephalosporin) section vide
as per leader brand Divisio
USP specification inspection
report dated and
29-07-2015 Chairm
Registr
Board
permit
issuanc
registra

letter
333. M/s Pharmacare Tablet Malout 27-12-2011 WHO Approv
Labs (Pvt.) Ltd, Rs.8000/- Form 5 recommended Photoc
129/1 Industrial Each tablet contains:- 30-7-2013 formulation
Rs. 12000/-
fee
Estate, Kot Artemether 80mg challan
Lakhpat, Lumefantrine 480mg (Photocopy) Artem - Hilton be veri
Lahore
by Bud
(Antimalarial)
Priority # 1461 Manufacture GMP
specification compliant
section vide and
inspection Chairm
29-07-2015 Board
permit
issuanc
registra
letter
334. M/s Friends Injection Frendic 75mg 28-5-2011 FDA approved Approv
Pharma (Pvt.) Rs.8000/- Form 5 Dycloject – Photoc
Ltd, 31-km, Each 3ml ampoule 14-5-2013 Javelin pharms
Rs.12000/-
fee
Ferozpur Road, contains:- challan
Lahore Diclofenac sodium 75mg (Photocopy) Deborn-L be veri
(Wellborne)
by Bud
Priority # 1093 (NSAID)
GMP
compliant and
section 16-02- Chairm
2016 Registr
Board
permit
issuanc
registra
letter
335. M/s Friends Fledonil Injection 28-5-2011 FDA approved Approv
Pharma (Pvt.) Rs.8000/- Cyclokapron – Photoc
Ltd, 31-km, Each ampoule of 5ml 14-5-2013 Pfizer
Rs.12000/-
fee
Ferozpur Road, contains:- challan
Lahore Tranexamic acid 500mg (Photocopy) Brino -Sami be veri
by Bud
Priority # 1093 Anti fibrinolytic
Manufacture specification GMP
compliant
section and
Chairm
Registr
Board
permit

issuanc
registra
letter
336. M/s Friends Xylodent Injection 31-12-2012 FDA approved Appro
Pharma (Pvt.) Form 5 - Rs. 20000/- product
Ltd, 31-km, Each ml contains:- Dy # 10383 dated
Ferozpur Road, Lidocaine HCl 20mg 31-12-2012 A product of
Lahore Epinephrine (as tartrate) Harmaann,
10 ug lahore
Priority # 2091 Pack size
(Anesthetic agent) 2ml ampoule as per
USP specification leader brand GMP
compliant
section
337. M/s Friends Phenate Injection 28-5-2011 Avil-Sanofi, Approv

Pharma (Pvt.) Rs.8000/- Form 5 Germany Photoc
Ltd, 31-km, Each 2ml contains:- 14-5-2013
Rs.12000/-
fee
Ferozpur Road, Phenireamine maleate AVil-sanofi challan
Lahore 45.5mg (Photocopy)
be veri
Pack size by Bud
Priority # 1096 (Antihistamine) GMP
JP specification 2ml ampoule as per compliant & Acc
leader brand section Divisio
and
Chairm
Registr
Board
permit
issuanc
registra
letter
338. M/s Friends Norobion Injection 28-5-2011 Neurobion Approv
Pharma (Pvt.) Rs.8000/- Form 5 -France with ch
Ltd, 31-km, Each 3 ml ampoule 14-5-2013
Rs.12000/-
of bran
Ferozpur Road, contains:- Neurobion - name.
Lahore Vitamin B1 100mg Merck
Pack size & price
Vitamin B6 100mg
as per leader brand
Priority # 1088 Vitamin B12 1000mcg
GMP
(Vitamin) compliant
Manufacture specification section

339. M/s Pakistan Tablet Vastec 20mg 23-04-2011 MHRA Approv
Pharmaceutical Dy.No.986 Form 5 approved Photoc
Products (Pvt.) Each film coated tablet Rs.8000/- crestor -
(Photocopy)
fee
Ltd, D-122, contains:- Astrazeneca challan
Rs.12,000/-
S.I.T.E, Karachi Rosuvastatin (As
31-07-2013 be veri
calcium) 20mg Amro-
by Bud
Priority # 1002 Amarant
(Lipid regulating drug) & Acc
Manufacture specification as per leader brand
GMP and
compliant Chairm
section vide Registr
inspection Board
report dated permit
31-12-2015 issuanc
registra
letter
340. M/s Pakistan Tablet Candia 32mg 23-04-2011 MHRA Approv
Products (Pvt.) Each tablet contains:- Rs.8000/- Amias –
(Photocopy)
fee
Ltd, D-122, Candesartan Cilexetil Takeda challan
Rs.12,000/-
S.I.T.E, Karachi 32mg
31-07-2013 be veri
Carac -
by Bud
Priority # 1021 (Anti hypertensive ) Wilshire
Manufacture specification Pack size & price & Acc
Divisio
as per leader brand
GMP and
compliant Chairm
inspection Board
report dated permit
31-12-2015 issuanc
registra
letter
341. M/s Pakistan Tablet Candia 4mg 30-04-2011 MHRA Approv
Products (Pvt.) Each tablet contains:- Rs.8000/- Amias –
(Photocopy)
fee
Ltd, D-122, Candesartan Cilexetil Takeda challan
Rs.12,000/-
S.I.T.E, Karachi 4mg
31-07-2013 be veri
Carac -
by Bud
Priority # 1018 (Anti hypertensive ) Wilshire
Manufacture specification Pack size & price & Acc
Divisio
as per leader brand
GMP and
compliant Chairm
inspection Board
report dated permit
31-12-2015

issuanc
registra
letter
342. M/s Pakistan Tablet Zolot 75 mg 30-04-2011 MHRA Approv
Pharmaceutical Dy.No.1061 Form 5 approved brand Photoc
Products (Pvt.) Each film coated tablet Rs.8000/- of Accord
(Photocopy)
fee
Ltd, D-122, contains:- challan
Rs.12,000/-
S.I.T.E, Karachi Clopidogrel (as Hydrogen Lowplat
31-07-2013 be veri
Sulphate) 75mg -Pharmevo
by Bud
Priority # 1020
(Antiplatelet) & Acc
USP specification as per leader brand GMP
compliant and
section vide Chairm
inspection Registr
report dated Board
31-12-2015 permit
issuanc
registra
letter
343. M/s Pakistan Tablet Alfa-one 30-04-2011 Alfa-D Approv
Pharmaceutical Dy.No.1056 form 5 (Platinum) Photoc
Products (Pvt.) Each tablet contains:- Rs.8000/-
(Photocopy)
fee
Ltd, D-122, Alfacalcidol 0.5 ug GMP challan
Rs.12,000/-
S.I.T.E, Karachi compliant
31-07-2013 be veri
(Vitamin D analogue) section vide
by Bud
Priority # 1019 USP specification inspection
report dated & Acc
as per leader brand 31-12-2015
and
Chairm
Registr
Board
permit
issuanc
registra
letter
344. M/s Pakistan Zinkid 20mg / 5ml Syrup 30-04-2011 WHO Product Deferre
Pharmaceutical Dy.No.1056 form 5 recommended under produc
Products (Pvt.) Each 5ml contains: Rs.8000/- formulation
(Photocopy)
review as under
Ltd, D-122, Elemental Zinc as zinc waiting for review
Rs.12,000/-
S.I.T.E, Karachi sulphate monohydratre.. Kilin -Linear
31-07-2013 reply of sent
……20 mg GMP
WHO. views
Priority # 1530 compliant
(Mineral Supplement) section vide WHO.
Pack size & price
USP specification as per leader brand inspection
report dated
31-12-2015

345. M/s Highnoon Tablet Ivahi 7.5mg 04-11-2013 MHRA Stability Deferre
Laboratories form 5-D approved data proviso
Ltd, 17.5 km , Each film coated tablet Rs.50000/- Procoralan –
(Photocopy)
Multan Road, contains: Servier per data a
Lahore Ivabradine HCl eq to
Pack size guidelines guideli
Ivabradine 7.5mg GMP
10s  Rs. 2500/- provided in provide
Priority # 2629 compliant
(Anti angina ) 20s  Rs. 5000/- section vide 251st RB 251st
USP specification inspection meeting. meetin
report dated fee cha
09-03-2015
346. M/s Highnoon Tablet Ivahi 5mg 04-11-2013 Stability Deferre
Laboratories form 5-D GMP data provisi
Ltd, 17.5 km , Each film coated tablet Rs.50000/- compliant
(Photocopy)
Multan Road, contains: section vide per data
Lahore Ivabradine HCl eq to inspection
Pack size guidelines require
Ivabradine 5mg report dated
Priority # 2628 10s  Rs. 1500/- 09-03-2015
provided in per
(Anti angina ) 20s  Rs. 3000/- 251st RB guideli
USP specification meeting. provide
251st
meetin
fee cha
347. M/s Life Caliz Dry suspension 20-11-2012 Form 5 MHRA Approv
Pharmaceutical 20000/- (Photocopy) approved brand Photoc
company, 24-III Each 5ml of reconstituted of Sandoz fee
Industrial Estate suspension contains: Pack size
15ml  Rs. 300/- challan
Multan Azithromycin Dihydrate Azomax –
25 ml  Rs. 480/- be veri
eq to Azithromycin Novartis
Priority # 1992 200mg
by Bud
GMP & Acc
(Antibiotics ) compliant Divisio
USP specification section and
Chairm
Registr
Board
permit
issuanc
registra
letter
348. M/s Swiss Tablet Desotin 5mg 11-01-2011 MHRA Approv
Pharmaceuticals Dy.No.90 Form 5 approved brand Photoc
(Pvt.) Ltd, Each film coated tablet Rs.12,000/- of Consilient
05-02-2013
fee
A/159, S.I.T.E, contains: challan
(Photocopy)
Super Highway, Desloratadine 5mg Alenor –
be veri
Karachi Macter
(Antihistamine)
Pack size by Bud
10s  as per PRC & Acc
Priority # 810 Manufacture specification GMP
compliant Divisio
section vide and

inspection Chairm
31-08-2015 Board
permit
issuanc
registra
letter
349. M/s Swiss Tablet Alfadol 1mcg 11-01-2011 Approv
Pharmaceuticals Dy.No.87 Form 5 Adela - getz Photoc
(Pvt.) Ltd, Each tablet contains: Rs.8000/-
Rs.12,000/-
fee
A/159, S.I.T.E, Alfacalcidol 1.0 mcg GMP challan
05-02-2013
Super Highway, compliant
(Photocopy) be veri
Karachi (Vitamin D Analogue) section vide
by Bud
Pack size inspection
Priority # 803 report dated & Acc
10s  as per PRC Divisio
31-08-2015
and
Chairm
Registr
Board
permit
issuanc
registra
letter
350. M/s Swiss Spasno 40mg Injection 11-01-2011 Spasfon – Product Deferre
Pharmaceuticals Dy.No.87 Form 5 France under produc
(Pvt.) Ltd, Each 4ml contains:- Rs.8000/-
Hydrated Rs.12,000/-
review. under
A/159, S.I.T.E, Spasfon – review
Phloroglucinol.40mg 05-02-2013
Super Highway, Himont
Trimethylphloroglucinol (Photocopy) fee cha
Karachi 0.04mg
Pack size GMP
Priority # 1060 (Anti Spasmodic) 10s  as per PRC compliant
Manufacture Specification section vide
inspection
report dated
31-08-2015
351. M/s Swiss Laxolac 3.35gm Syrup 11-01-2011 MHRA. Source of Deferre
Pharmaceuticals Dy.No.117 Form 5 Duphalac Lactulose Source
(Pvt.) Ltd, Each 5ml contains:- Rs.8000/- 3.35g/5ml By
Lactulose USP 3.35gm Rs.12,000/-
required lactulo
A/159, S.I.T.E, M/s BGP along with fee,
05-02-2013
Super Highway,
(osmotic lexative) (Photocopy) fee and stabilit
Karachi Local.
USP Specification documents. data,
Pack size & price Duphalac
Priority # 806 3.35g/5ml by challan
as per SRO
M/s Highnoon
GMP
compliant
section vide

inspection
report dated
31-08-2015
352. M/s Swiss Tablet Lufid 20mg 12-04-2011 MHRA.Arava- Approv
Pharmaceuticals Dy # 883 Form 5 Sanofi Photoc
(Pvt.) Ltd, Each film coated tablet Rs.8000/-
contains:- Rs.12,000/-
fee
A/159, S.I.T.E, Adira - challan
Leflunomide 20mg 05-02-2013
Super Highway, Wilshire
(Photocopy) be veri
Karachi (Anti rheumatic)
GMP
by Bud
USP Specification Pack size of 30s  & Acc
Priority # 975 as per SRO compliant
section vide Divisio
inspection and
report dated Chairm
31-08-2015 Registr
Board
permit
issuanc
registra
letter
353. ] M/s Swiss Ironate 800mg/15ml Syrup 12-04-2011 Approv
Pharmaceuticals Dy # 883 Form 5 EMICO-NOA Photoc
(Pvt.) Ltd, Each 15ml contains:- Rs.8000/- HEMIS
Iron Protein Succinylate Rs.12,000/-
fee
A/159, S.I.T.E, challan
800mg eq to elemental iron 05-02-2013
Super Highway, GMP
40mg (Photocopy) be veri
Karachi compliant
section vide
by Bud
(Anti anemic) Pack size of 30s  & Acc
Priority # 1030 USP Specification as per SRO inspection
report dated Divisio
31-08-2015 and
Chairm
Registr
Board
permit
issuanc
registra
letter
354. M/s Swiss Tablet CartiPLUS 31-5-2011 Me too Deferre
Pharmaceuticals Dy.No.1435 Form 5 Cartigen plus – needs confirm
(Pvt.) Ltd, Each film coated tablet Rs.8000/- Getz
confirmatio n
A/159, S.I.T.E, n approv
Glucosamine Sulphate 05-02-2013
Super Highway, GMP
750mg (Photocopy) status
Karachi compliant
Chondroitin Sulphate
section vide
referen
600mg Pack size of 30s  regulat
Priority # 1101 as per SRO inspection
(Musculo-skeletal product) report dated authori
Manufacture Specification 31-08-2015 and
Pakista
and
challan

355. M/s Swiss Injection Cefot 2gm 11-01-2011 Approv
Pharmaceuticals Dy.No.89 Form 5 Cebac -Bosch Photoc
(Pvt.) Ltd, Each vial contains:- Rs.12,000/-
Cefoperazone Sodium USP 05-02-2013
fee
A/159, S.I.T.E, GMP challan
eq to Cefoperazone 1gm (Photocopy)
Super Highway, compliant
Salbactam sodium eq to be veri
Karachi section vide
salbactam 1 gm Pack size of 1s  by Bud
inspection
as per SRO & Acc
Priority # 217 (Antibiotics) report dated
Manufacture Specification 31-08-2015 Divisio
and
Chairm
Registr
Board
permit
issuanc
registra
letter
356. M/s Swiss Tablet Rapral 10mg 12-04-2011 MHRA Approv
Pharmaceuticals Dy.No.885 Form 5 approved Pariet Photoc
(Pvt.) Ltd, Each enteric coated tablet Rs.8000/- – Eisai
fee
Rabeprazole (as sodium) 05-02-2013
Super Highway, Rabecid
10mg (Photocopy) be veri
Karachi -Highnoon
by Bud
(Proton Pump Inhibitor) Pack size of 10s  & Acc
Priority # 968 Manufacture Specification as per SRO GMP
compliant Divisio
section vide and
inspection Chairm
31-08-2015 Board
permit
issuanc
registra
letter
357. M/s Swiss Tablet Swiss Mether 40/240 30-7-2010 WHO Approv
Pharmaceuticals Dy.No.1512 Form 5 recommended Photoc
(Pvt.) Ltd, Each tablet contains:- Rs.8000/- formulation
Artemether 40mg Rs.12,000/-
fee
Lumefantrine 240mg 05-09-2013
Super Highway, Artem -Hilton
(Photocopy) be veri
Karachi (antimalarial) by Bud
Manufacture Specification Pack size of 1 x 16s GMP
Priority # 805 compliant & Acc
 as per SRO Divisio
swapped section vide
inspection and
report dated Chairm
31-08-2015 Registr
Board
permit
issuanc

registra
letter
358. M/s Swiss Tablet Swiss Mether 30-7-2010 WHO Approv
Pharmaceuticals 80/480 Dy.No.1511 Form recommended Photoc
(Pvt.) Ltd, 5 formulation fee
A/159, S.I.T.E, Each tablet contains:- Rs.8000/- challan
Super Highway, Artemether 80mg Rs.12,000/- Artem -Hilton be veri
Karachi Lumefantrine 480mg 05-09-2013
by Bud
(Photocopy) GMP
Priority # 809 (antimalarial) compliant & Acc
swapped Manufacture Pack size of 1 x 6s section vide Divisio
Specification  as per SRO inspection and
report dated Chairm
31-08-2015 Registr
Board
permit
issuanc
registra
letter
359. M/s Amarant Amate 7.5mg Tablet 19-10-2012 Tablet L-  Firm Deferre
Pharmaceuticals Dy.No.1305 Form 5- Methylfolate needs to  Rem
(Pct.) Ltd, 158- Each film coated tablet D 7.5mg – Virtus
Rs.20,000/- submit ng
D, Tora Gadap contains: Pharmaceutical remainin for
(Photocopy)
Road, Super Calcium 1-5- s, USA
g fee for pre
Highway, methyltetrahydrofolate
Pack size of 10s & prescrib d
Karachi eq. to 1- GMP
30s  as per SRO ed Form 5-D
methylfolate….7.5 mg compliant
Priority # 1926 section vide 5-D.  Stab
(Adjunctive use in major inspection  Firm data
depressive and report dated needs to per
schizophrenia) 31-08-2015 submit guid
stability es
data as pro
per in
guidelin RB
es mee
provided  Fee
in 251st cha
RB
meeting.
360. M/s Amarant Amate 15mg Tablet 19-10-2012 Tablet L-  Firm Deferre
Pharmaceuticals Dy.No.1306 Form 5- Methylfolate needs to  Rem
(Pct.) Ltd, 158- Each film coated tablet D 15mg – Virtus
Rs.20,000/- submit ng
D, Tora Gadap contains: Pharmaceutical remainin for
(Photocopy)
Road, Super Calcium 1-5- s, USA
g fee for pre
Highway, methyltetrahydrofolate
Pack size of 10s & prescrib d
Karachi eq. to 1- GMP
30s  as per SRO ed Form 5-D
methylfolate….15 mg compliant
Priority # 1927 section vide 5-D.  Stab

(Adjunctive use in major inspection  Firm data
depressive and report dated needs to per
schizophrenia) 31-08-2015 submit guid
stability es
data as pro
per in
guidelin RB
es mee
provided  Fee
in 251st cha
RB
meeting.
361. M/s Linear Tablet Betalin 16mg 17-12-2013 MHRA Appro
Pharma, Plot # Rs. 12000/- approved brand
18, Street S-4, Each tablet contains: Dy.No.846 of Aurobindo.
National Betahistine 16mg Form 5
02-11-2010
Industrial Zone, Serc-Abbott
Rs.12,000/-
Rawat. Antihistamine
Manufacture
Priority # 485 Specification Pack size & price Inspection
as per SRO report dated
19-01-2016
362. M/s Linear Tablet Betalin 8mg 17-12-2013 MHRA Appro
18, Street S-4, Each tablet contains: Dy.No.8140 of Aurobindo.
National Betahistine 8mg Form 5
02-11-2010
Industrial Zone, Serc-Abbott
Rs.12,000/-
Rawat. Antihistamine
Manufacture GMP
Priority # 484 Specification Pack size & price compliant
as per SRO section
363. M/s Linear Tablet Linakast 10mg 17-12-2013 MHRA Appro

18, Street S-4, Each film coated tablet Dy.No.8133 of Accord
National contains: Form 5
02-11-2010
Industrial Zone, Montelukast (as sodium) Serc-Abbott
Rs.12,000/-
Rawat. 10mg
Priority # 513 Antihistamine Pack size & price

Manufacture as per SRO
Specification
364. M/s Linear Tablet Heam 500 mcg 17-12-2013 Methycobal – Appro
Pharma, Plot # Rs. 12000/- Eisai, Japan
18, Street S-4, Each sugar coated tablet Dy.No.8147
06-10-2010
Industrial Zone, Mecobalamin 500 mcg Anemovit -
Rs.12,000/-
Rawat. Pharmacare
Vitamin

Specification Pack size & price
as per SRO
365. M/s Linear Tablet Melix 15mg 17-12-2013 USFDA Appro
Pharma, Plot # Rs. 12000/- MOBIC -
18, Street S-4, Each uncoated tablet Dy.No.8136 Boehringer
Industrial Zone, Meloxicam USP 15mg 06-10-2010 ALOXI -
Rawat. Rs.12,000/- ALSON
NSAID
as per SRO
366. M/s Linear Tablet Melix 17-12-2013 USFDA Appro
Pharma, Plot # Rs. 12000/- MOBIC -
18, Street S-4, Each uncoated tablet Dy.No.8138 Boehringer
Industrial Zone, Meloxicam USP 7.5mg 06-10-2010 ALOXI -
Rawat. Rs.12,000/- ALSON
NSAID
as per SRO
367. M/s Linear Tablet Liprazole 15mg 17-12-2013 MHRA Proof of Appro
Pharma, Plot # Rs. 12000/- approved segregated
18, Street S-4, Each oro-dispersible Dy.No.8138 Abilify –
Form 5
facility for
National tablet contains: Otsuka psychotropi
06-10-2010
Industrial Zone, Aripiprazole 15mg
Rs.12,000/- c
Rawat.
manufacturi
Dopamine Partial agonist Zedan -Surge
Priority # 483 Psychotic drug ng not
Pack size & price provided.
Manufacture as per SRO
Specification
368. M/s Reko Epafen Ophthalmic 30-12-2013 MHRA Appro

Pharmacal Solution Rs. 20,000/- approved
(Pvt.) Ltd, 13th Dy.No. 1424 Nevanac-
km, Multan Each ml contains: Form 5 Alcon
Road, Lahore Nepafenac 1mg
Pack size
Priority # 2850 Anti inflammatory Fenap –Valor
5ml  Rs. 315/-
Manufacture
Specification GMP
Compliant
section vide
inspection
report dated
30-03-2016

369. M/s Reko Olopine Ophthalmic 30-12-2013 FDA approved Appro
Pharmacal Drops Rs. 20,000/- Pataday- Alcon
(Pvt.) Ltd, 13th Dy.No. 1423
km, Multan Each ml contains: Form 5
Road, Lahore Olopatadine (as HCl) Aptadine
USP 2mg -Barrett
Pack size
Priority # 2849
5ml  Rs. 306/-
Anti inflammatory
Manufacture
Specification
370. M/s Genome Ranast 112.5mg Capsules 31-05-2013 Proof of Deferre
Pharmaceuticals Rs. 20,000/- approval confirm
(Pvt.) Ltd, 16/1, Dy.No. 471
Form 5
status of n
Phase IV, Each capsule contains:- same approv
Industrial Pranlukast (as dosage form status
Estate, Hattar, hemihydrate) 112.5mg
Haripur
as per pRC countries regulat
(cysteinyl leukotriene
Priority # 2343 receptor-1 antagonist) and authori
Manufacture specification Pakistan not and
provided. Pakista
371. M/s Apex Apdinir Suspension 10-06-2010 Following Deferre
Pharmaceuticals 50mg/5ml Dy # 1158 Form 5 documents  Lat
(Pvt.) Ltd, D-21, Rs.8000/- Zaply-
Rs.12,000/-
not found in insp
A/1, S.I.T.E, Each 5ml of reconstituted Wislhire application n
28-03-2014
Super Highway, suspension contains:-
Photocopy  Latest con
Karachi Cefdinir 50mg
inspectio d w
Pack size of 60ml n report one
Priority # 42 (Antibiotics)
Manufacture specification & price as per pRC conducte  con
d within tion
one app
year. stat
 Proof of refe
approval e
status of reg
same y
dosage auth
form in es
referenc Pak
e .
countrie  Com
s and men
PAKIST per
AN. dec
 Commit of
ment as RB
per mee
decision  Fee

of 251st cha
RB
meeting.
372. M/s Apex Danvar capsule 10-06-2010 MHRA Following Deferre
Pharmaceuticals Dy # 1162 Form 5 approved documents  Lat
(Pvt.) Ltd, D-21, Each capsule contains:- Rs.8000/- Distaclor
Rs.12,000/-
not found in insp
A/1, S.I.T.E, Cefaclor (as -Flynn application n
28-03-2014
Super Highway, monohydrate) USP
Karachi 500mg Ceclor -AGP
inspectio d w
Priority # 39 (Antibiotics) n report one
Pack size 12s  as conducte  Com
USP specification per PRC
d within men
one per
year. dec
 Commit of
ment as RB
per mee
decision  Fee
of 251st cha
RB
meeting.
373. M/s Apex Apedroxile capsule 10-06-2010 MHRA Following Deferre
Pharmaceuticals Dy # 1162 Form 5 approved brand documents  Lat
(Pvt.) Ltd, D-21, Each capsule contains:- Rs.8000/- of Sandoz
Rs.12,000/-
not found in insp
A/1, S.I.T.E, Cefadroxil (as application n
28-03-2014
Super Highway, monohydrate) USP Neucef - Sami
Karachi 500mg
inspectio d w
Priority # 33 (Antibiotics) n report one
Pack size 12s  as conducte  Com
USP specification per PRC
d within men
one per
year. dec
 Commit of
ment as RB
per mee
decision  Fee
of 251st cha
RB
meeting.

374. M/s Davis Tricold plus Sachet 30-07-2011 Following Deferre
Pharmaceuticals Form 5 Flu Eze - documents  Lat
Laboratories, Each Sachet Contains Rs.8000/- Werrick
Rs.12,000/-
not found in insp
121, Industrial Paracetamol 500mg application n
30-07-2013
Triangle Area, Mepyramine Maleate
 Latest con
Kahuta Road, 13mg
Islamabad. Pheniramine maleate inspectio d w
Pack size 12s  as n report one
13mg per PRC
Priority # 1228 Pseudoephedrine HCl conducte  Pro
30mg d within app
one stat
Analgesic / Anti allergic year. sam
Manufacture  Commit dos
Specification ment as form
per refe
decision e
st
of 251 cou
RB and
meeting. PAK
 Proof of AN
approval  Com
status of men
same per
dosage dec
form in of
referenc RB
e mee
countrie
s.
375. M/s Davis Tricold plus Sachet 30-07-2011 Following Deferre
Pharmaceuticals Form 5 Flu Eze - documents  Lat
Laboratories, Each Sachet Contains Rs.8000/- Werrick
Rs.12,000/-
not found in insp
121, Industrial Paracetamol 500mg application n
30-07-2013
Triangle Area, Mepyramine Maleate
 Latest con
Kahuta Road, 13mg
Islamabad. Pheniramine maleate inspectio d w
Pack size 12s  as n report one
13mg per PRC
Priority # 1228 Pseudoephedrine HCl conducte  Con
30mg d within atio
one app
Analgesic / Anti allergic year. stat
Manufacture  Commit refe
Specification ment as e
per reg
decision y
of 251st auth
RB es
meeting. Pak

 Proof of .
approval  Com
status of men
same per
dosage dec
form in of
referenc RB
e mee
countrie
s.
376. M/s Getz Daxin 30mg Tablet 30-07-2011 Approval Deferre
Pharma (Pvt.) Form 5 priligy status of applica
Ltd, 29-30, Each film coated tablet Rs.8000/-
Rs.12,000/-
dosage form on Fo
Sector 27, contains: in Pakistan as it i
30-07-2013
Korangi Dapoxetine not registe
Industrial Area, Hydrochloride eq. to
provided. Pakista
Karachi Dapoxetine…………..30 Pack size 12s  as
mg per PRC
Priority # 1102
(SSRI)
377. M/s Allmed Pvt. Calso 28-07-2010 Phoslo by M/s Appro
Ltd. Tablet Form 5 Nabi-
(Formerly, Each tablet contains: Rs.8000/- BioPharmaceut
EverGreen Calcium Acetate B.P Rs.12,000/- ical USA
Pharmaceuticals, ….667mg eq.to 30-07-2013
Pvt. Ltd. Elemental Calcium Lophos by M/s
Plot.No.590, 169mg Pack size 10x10’s Getz Pharma
Sundar Industrial Calcium Supplement  as per PRC
Estate Lahore. (Manfacturer’s Specs)
Priorty # 196
378. M/s Allmed Pvt. Everpol 28-07-2010 Appro
Ltd. Infusion Form 5 Perfalgan by
(Formerly, Each 100ml contains: Rs.8000/- M/s B-Braun
EverGreen Paracetamol B.P…..1g Rs.12,000/- Germany
Pharmaceuticals, Analgesic / Antipytic 30-07-2013
Pvt. Ltd. (Manfacturer’s Specs) Falgan by M/s
Plot.No.590, Pack size Bosch Pharma
Sundar Industrial 1’sx100ml  as
Estate Lahore. per PRC
Priorty # 195
379. M/s Indus Parazol 25-06-2011 Appro
Pharma Karachi. Tablet Form 5 Paracetamol by
Priorty # 1197 Each tablet contains: Rs.8000/- M/s Johnsan &
Paracetamol…..500mg Rs.12,000/- Johnsan
Analgesic / Antipytic 06-06-2013 Canada
Pack size 20’s  Panadol by M/s

Rs.200/- GSK

Veterinary Routine cases :-
S/ Name and Brand Name Type of Form International Remarks / Decision

N address of status in Observation
manufacture (Proprietary name + Initial date, diary stringent s
regulatory
r / Applicant Dosage Form +
differential fee
Demanded Price /
Pharmacological Group Pack size GMP status as
depicted in
Finished product inspection
Specification report (dated)
380. M/s Star Toltrastar Oral Solution 18-06-2013 Emicide - nawal Appro
Laboratories Dy.No.708
, 23-km, Each ml contains Form 5 Firm is GMP
Multan Toltrazuril (I.H.S) 25 mg Rs.20.000/-
compliant as
Road, per inspection
Pack size of
Ghung, Antibiotics dated 21-09-
100ml, 150ml, 500ml
Lahore Manufacture
& 1000ml  2015
Specification
decontrolled
Priority #
371
381. M/s Star Tilmisin Oral Solution 18-06-2013 Motil - Breeze Appro
Laboratories Dy.No.705
Multan Tilmicosin (as phosphate) Rs.20.000/-
compliant as
Road, USP 250mg per inspection
Pack size of
Ghung, dated 21-09-
100ml, 150ml, 500ml
Lahore Antibiotics
& 1000ml  2015
Manufacture
decontrolled
Priority # Specification
372

382. M/s Star Closan 500mg Bolus 19-04-2013 Flukinil - Appro
Laboratories Dy.No.334 Selmore
, 23-km, Each bolus contains Form 5
Multan Clonastel (as Sodium) Rs.20.000/-
Firm is GMP
Road, 500mg compliant as
Pack size of
Ghung, per inspection
Glass bottle 
Lahore Anthelmintic dated 21-09-
decontrolled
Manufacture
2015
372
383. M/s Star Cipvet-200 injection 31-01-2014 Floxacin - Leads To follow Rejected
Laboratories Dy.No.101 policy
Rs.20.000/-
decision on The B
Multan Ciprofloxacin BP 200mg compliant as this also ad
Road, per inspection
Pack size of veterinary to
Ghung, Antibiotics dated 21-09-
Lahore Manufacture Glass bottle 50m  formulation. show c
decontrolled 2015 to
Specification
Priority # compan
372 with
registere
ciproflo
n.
384. M/s Star Leva 20% Oral Powder 04-07-2013 Levabak - Appro
Laboratories Dy.No.792 Attabak
, 23-km, Each gram contains Form 5
Multan Levamisole HCl BP Rs.20.000/-
Firm is GMP
Road, 200mg compliant as
Pack size of
Ghung, per inspection
100gm, 500gm,
Lahore Anthelmentics dated 21-09-
1000gm & 2.5kg
Manufacture 2015
378
385. M/s Star Florfenic Oral Solution 18-06-2013 Florobak - Firm applied Appro
Laboratories Dy.No.210 Attabak on Form 5-
, 23-km, Each ml contains Form 5-D
Rs.50.000/-
D but now
Multan Florfenicol 100mg Firm is GMP product is
Road, compliant as
Pack size of me too and
Ghung, Antibiotics
100ml, 150ml, 250ml, per inspection accordingly
Lahore Manufacture dated 21-09-
Specification 450ml, 1 litre firm has
2015 submitted
Priority #
369 Form 5.

386. M/s Star Tablet Carpropain 08-06-2013 FDA approved Stability Deferred
Laboratories Dy.No.706 Rimadyl studies provisio
, 23-km, Each chewable tablet Form 5-D chewable tablet –
Rs.50.000/-
required as stability
Multan contains Zoetis USA it is a new studies
Road, Carprofen USP 50mg
Pack size  molecule to per
Ghung, Firm is GMP
decontrolled be registered guidelin
Lahore NSAID compliant as
USP Specification in Pakistan. approve
per inspection 251st
Priority # dated 21-09-
367 meeting
2015
387. M/s Star Tablet Prazistar 18-06-2013 Cazitel 230/20 Stability Deferred
Laboratories Dy.No.706 falvoured film studies provisio
, 23-km, Each film coated tablet Form 5-D coated tablet –
Rs.50.000/-
Multan contains Chanelle it is a new studies
Road, Pyraziquantel BP 20mg Pharmaceuticals,
Ghung, Pyrantel Pamoate BP Ireland
Lahore 230mg
Drontal –Bayer- in Pakistan. approve
Priority # Anthemintic UK 251st
369 Manufacture meeting
Specification Firm is GMP
compliant as
per inspection
dated 21-09-
2015
388. M/s Star Tablet Prazistar plus 18-06-2013 Well plus Stability Deferred
Laboratories Dy.No.711 flavoured tablet – studies provisio
, 23-km, Each film coated tablet Form 5-D Divasa Spain
Rs.50.000/-
Multan contains it is a new studies
Road, Pyraziquantel BP 50mg Drontal plus
Ghung, Pyrantel Pamoate BP flavoured tablet –
Lahore 144mg decontrolled Bayer-UK
be registered guidelin
Febantel BP 150mg in Pakistan. approve
Priority # Firm is GMP 251st
366 Anthemintic compliant as meeting
Manufacture per inspection
Specification dated 21-09-
2015
389. M/s Star Diclavet Oral Solution 18-06-2013 Product in Deferred

Laboratories Dy.No.711 Firm is GMP proposed confirm
, 23-km, Each 100 ml contains Form 5-D
compliant as strength of app
Multan Diclazuril BP 1gm Rs.50.000/-
per inspection doesn’t exist status
Road, dated 21-09-
Pack size  in Pakistan same
Ghung, Anthemintic
decontrolled 2015 and formula
Lahore Manufacture
Specification reference by refer

Priority # countries. regulato
370 authorit
and
Pakistan
390. M/s Star Bamberstar Powder 18-06-2013 Flavomycin – Stability Deferred
Laboratories Dy.No.801 Intervet-USA studies provion
, 23-km, Each 100 gm contains Form 5-D
Rs.50.000/-
Multan Bambermycin 4gm Firm is GMP it is a new studies
Road, compliant as
Ghung, Antbiotics per inspection
Lahore Manufacture dated 21-09-
Specification in Pakistan. provided
2015 251st
Priority #
380 meeting
391. M/s Star Wormflash Deworming 18-06-2013 Product in Deferred

Laboratories Capsules Dy.No.800 proposed confirm
, 23-km, Form 5-D Firm is GMP
Rs.50.000/-
strength of app
Multan Each capsule contains compliant as doesn’t exist status
Road, Piperazine Citrate BP per inspection
Pack size  in Pakistan same
Ghung, 390mg dated 21-09-
decontrolled and formula
Lahore 2015 reference by refer
Anthelmintic
Priority # Manufacture countries. regulato
379 Specification authorit
and
Pakistan
392. M/s Star Micostar medicated 18-06-2013 Malaseb – Bayer Stability Deferred
Laboratories shampoo Dy.No.802 -UK studies provion
, 23-km, Form 5-D
Rs.50.000/-
Multan Each 100ml contains Firm is GMP it is a new studies
Road, Miconazole Nitrate BP compliant as
Ghung, 2gm per inspection
Lahore Chlorhexidine Gluconate dated 21-09-
BP 2gm in Pakistan. provided
2015 251st
Priority #
381 Antimicrobial meeting
Manufacture
Specification
393. M/s Star Doxygenta Powder 18-06-2013 Gentadox 10/5, Stability Deferred
Laboratories Dy.No.803 Agrar Holland, studies provion
, 23-km, Each gram contains Form 5-D The Netherland
Rs.50.000/-
Multan Doxycycline Hyclate BP it is a new studies
Road, 100mg Firm is GMP
Pack size  formulation per
Ghung, Gentamicin Sulphate compliant as
decontrolled to be guidelin
Lahore USP 50mg per inspection registered in provided
dated 21-09- Pakistan. . 251st
Priority # Antibacterial 2015 meeting
381 Manufacture

Specification
394. M/s Inshall Hepasoul Liquid 10-07-2013 Heptic Solution Approve

Pharmaceuti Each 100ml contains Dy.No.4234 by M/s Evergreen
cal L.Cartinine……5% Form-5 Pharma Lahore
Industries, Magnesium Sulphate. Rs.20,000/- Reg#072689
Plot # 2, USP…….1%
Pack size
Street SS2, Sorbitol…………20% Firm is GMP
100ml,150ml,250ml,5
RCCI Choline Chloride compliant as
00ml,1Liter,2.5Liter
Industrial BP….10% per inspection
decontrolled
area, Rawat Betain……….2% dated 04-12-
Islamabad. Inositol BP………..0.7%
2015
Hepatoprotective,
Priority # (Multivitamins. Immune
384 booster )
395. M/s Inshall Coolant Powder 10-07-2013 Acelyte water Approve

Pharmaceuti Each 1000 g contains Dy.No.4235 Soluble Powder
cal Vitamin C…………… Form-5 by M/s Decent
Industries, 200g Rs.20,000/- Pharma Rawat
Plot # 2, Acetyl Salicylic Reg#079821
Pack size
Street SS2, Acid….67g
30g,50g,100g,250g,
RCCI Calcium Firm is GMP
500g,1kg,5kg,10kg,
Industrial Carbonate…...50g compliant as
25kg
area, Rawat Sodium Chloride……40g per inspection
decontrolled
Islamabad. Magnesium dated 04-12-
Sulphate….40g
2015
Priority # Sodium citrate……0.7g
384 (NSAID)

Deferred cases :-
S.No Name and Brand Name Type of Form Decision of Remarks Decision
. address of (Proprietary Initial date, diary meeting of
manufactu name + Dosage Fee including Registration
rer / Form + differential fee Board
Applicant Strength) Demanded Price /
Composition Pack size
Pharmacological
Group Approval status
Finished product international /
Specification national
396. M/s Nocid 40mg/5ml Form 5 Registration Firm has Approved
Novartis Rs. 20,000/- vide Board in its 257th submitted the
Pharma Each 5 ml of Dy. No. 2629 meeting deferred prescribed fee Rs.
(Pakistan) reconstituted dated 11-12-2015 for evaluation as 20,000/- on 14-
06-2016, for form
Limited, suspension per decision of
5.
Petaro contains 250th Registration
Road, Famotidine BP Pack size of 60ml Board meeting.
Jomshoro. 40mg amber color glass
bottle
Histamine H2
receptor Famotidine
antagonist 40mg/5ml –FDA
(Manufacture Zepsin (Cirin)

Specification)
397. M/s CCL Sita-Met XR Tab Form-5-D Deferred 257th for Firm has Registratio
Pharmace 50/500 Dy. No: Not clarification of submitted Board
utical Tablet mentioned NCE as per Stability Studies referred
Lahore. Each tablet contains: Dated.08-04-2013 DRAP’s Policy conducted as per on s
Sitagliptin Rs.50,000/-
phosphate As per SRO Board decision decision of 251st verificatio
monohydrate eq. 10’s,14’s,30’s meeting of the of stabi
to USFDA Approved. Board. data by pa
Sitagliptin…......... JANUMET XR comprising
........50mg By MERCK of Direc
Metformin SHARP DOHME DTL,
HCI………..500
Peshawar,
mg
(Anti Diabetic) Lahore a
area F
DRAP.
Priority 2252

Lahore Each tablet contains: Dated.08-04-2013 DRAP’s Policy conducted as per on s
monohydrate eq. 10’s,14’s meeting of the of stabi
HCI……..
Peshawar,
…..1000mg
area F
Priority 2251 DRAP.
Lahore Each tablet contains: Dated.08-04-2013
DRAP’s Policy conducted as per on s
monohydrate eq. 10’s,14’s meeting of the of stabi
HCI……..
Peshawar,
…..1000mg
area F
Priority 2253 DRAP.
400. M/s CCL Urocon + Tablets Form-5-D Deferred 257th for Registratio
Pharmace Tablet Dy. No: Not clarification of Board
utical Each tablet mentioned NCE as per referred
Lahore contains: Dated.03-12-2013 DRAP’s Policy on s
Solifenacin Rs.50,000/-
succinate As per SRO Board decision verificatio
……….6mg 30’s of stabi
Tamsulosin HCl Vesomni (UK), data by pa
(as SR pellets) MHRA comprising
…..0.4mg of Direc
(Alpha-1 DTL,

adrenoceptor Peshawar,
antagonists) Lahore a
Priority 2745 area F
DRAP.
401. M/s Elko Carbo Vet Form 5-D vide Dy. Registration Firm has now Deferred
Organizati Injection # 2670 dated Board in 258th RB submitted provision
on 24-05-2013 meeting deferred application on following
(Private) Each ml the case and prescribed Form informatio
contains:- 5-D in which documents
Limited, advised to apply
Carbetocin……… Pack size –10ml, following  Stabilit
27 & 28, ..0.07mg/ml 50ml, 100ml, -
on prescribed shortcomings data
Sector Decontrolled Form 5-D along needs to be the
12/B, Oxytocic, antihem with required rectified :- produc
North orrhagic and utero documents  Stability data as
Karachi, tonic because same of the product guideli
Industrial drug formulation is not as per s
Area, BP Spec’s yet registered in guidelines provide
Karachi Pakistan. provided in in 25
251st RB RB
Priority # meeting. meetin
359  Prescribed fee  Prescri
of Form 5-D. d fee
Form
D.
402. M/s Elko Gamocin Injection Form 5-D vide Dy. Registration Firm has now Deferred
Organizati # 2669 dated 24- Board in 258th RB submitted provision
on Each ml 05-2013 meeting deferred application on following
(Private) contains:- the case and prescribed Form informatio
Gamithromycin… 5-D in which documents
Limited, advised to apply
……..150mg/ml Pack size –10ml, following  Stabilit
27 & 28, 50ml, 100ml,
on prescribed shortcomings data
Sector (Antibioric). 250ml, 500ml, Form 5-D along needs to be the
12/B, 1000ml vials with required rectified :- produc
North Decontrolled documents  Stability data as
Karachi, because same of the product guideli
Industrial formulation is not as per s
Area, yet registered in guidelines provide
Karachi Pakistan. provided in in 25
251st RB RB
Priority # meeting. meetin
361  Prescribed fee  Prescri
of Form 5-D. d fee
Form
D.
403. M/s UDL TENZOLID Form 5 Registration Photocopies of Approved.

Pharmaceut 100mg/5ml 20,000/- Board COA , GMP Firm w
icals, Plot # granules Dy. No. 4278 deferred the certificate. provide
E-44& E- for oral (07/07/2015) case in 258th legalized

45, North suspension meeting of RB for GMP, Co
Western Pellet fee Rs. provision of stability d
Industrial Each 5ml of 80,000/- vide Dy Source of of Zone IV
Zone, Port reconstituted # nil dated 24-05- coated taste and
Qasim Chairman,
suspension 2016 masked
Authority, RB w
contains: linezolid
Karachi. permit
Linezolid BP Pack of pellets along issunce
100 mg 10’s and 30’s as with GMP registration
per SRO certificate of letter.
(Antibiotics) the source,
USP FDA approved Stability data
Specification Avodart (GSK) and required
fee if source
Source of Avodart (GSK) is outside of
pellets:- Pakistan.
Benovo Labs
private limited,
Plot # 97 & 98,
Kolhar
Industrial Area,
Bidar, Karnatka,
India
404. M/s Saniplast Aqua Form-5 Deferred in 257th Reply of the firm Approved
Uniferoz Bandage First Aid Dy. No: 1442 RB meeting mentioned below
PVT. Ltd. Bandage Dated. 21.06.2012 for clarification for
32/8 Sector Rs.8,000/- registration of the
15, Korangi Each Bandage Dated.05.09.2013 same strength /
Industrial contains: Rs.12000/- composition.
Area, Polyurethane (PU) Rs.41/10’s
Karachi. Tape (25x72mm),
(1840) Bezalkonium 40.50/10’s
Chloride Pad (38x38mm)
………………..0. 40.57/10’s,
5%w/w. (5’s x25x72mm &
5’sx38x38mm)
(First Aid 40.57/20’s,
Bandage) (10’s x25x72mm &
(Mfg. specs) 10’s x38x38mm)
BAND-AID
(Johnson &
Johnson) made in
Brazile, distributed
in canada.
Nexcare Clear by
3M consumer
Health Care USA.
Saniplast Ultra first
aid Bandage (with

Poluethylene Base)
by M/sUniferoz.
 It is water proof bandage, thus the wound area is protected from getting wet. 
 It completely seals the applied area on the skin and help protect the small wound from dust and germs.
 The consumer will appreciate availability of this new improved variant once it is available in Pakistan,
as this is available abroad, and they do purchase this vairiant abroad.
 Introduction of this variant will help in introducing this new improved first aid bandages for domestic
and export markets, improve utilization of our capacity and adapt modern technology.
They further explained that Board has already granted export registration of saniplast aqua bandage. However
when we apply for registration abroad they require free sale certificate in the country of manufacturer, which
they couldn’t provide to importing country due to non-registration in Pakistan.
405. -do- Dermapore Non Form 5 Deferred for the Reply of
Woven Fabric 10 cmx10m confirmation of firm
Surgical Tape for 5 cm x 10m approval status in mentioned
(Surgical 2.5 cm x10 reference countries. below
Dressing & Demanded price
Bandage) has not been
mentioned
Rs.8000/-
(27/07/2010)
Rs.12,000/-
(23/07/2013)
Fee challans are
duplicate
Total
Rs.20,000/-
Dy. No. not
available /
Duplicate
dossier
GMP
inspection
report dated
15-07-2014.
Overall GMP
compliance
level rated as
good.
 We already manufacture Dermapore Non Woven Paper Surgical Tapes for domestic and export Registratio
markets and has registration from DRAP. Non-Woven fabric surgical tapes would be manufactured Board
by using the same manufacturing capacity to introduce a new varient. referred
 Dermapore Non Woven Fabric Surgical tapes export registration was granted by board earlier, now proposed
we are seeking registration to sell the same product in domestic market for utilization of capacity and product
modern technology. comments
 For export registrations in foreign countries we required free sale certificate which can only be ECMD.
applied when we have local registration.
 Non registered similar tapes are already being used in local hospitals. We on the other hand are

seeking registration to manufacture a better product locally by utilizing our hand are seeking
registration to manufacture a better product locally by utilizing our ideal capacity, and meeting the
demand of the market.
406. Importer Gentadox Water Form 5 with fee Rs The Board deferred Registratio
M/s. Soluble powder 100,000/- vide Dy. the case for Board
UM # 411 dated 13-05- provision of rejected
Enterpri Each gm contains:- 2013 approval status of proposed
ses, Gentamycin Sulphate same formulation formulatio
Karachi, 160mg equivalent to in Pakistan and being
18-C, 3rd Gentamycin 100mg Pack size of reference rational.
floor, Doxycycline HCl 100gm, 500gm, regulatory
Dolmen 100mg 1kg & 5kg  authorities.
Estate decontrolled
Building Antibiotic
, Block Specifications:- Zygosis-Nigeria
7-8, Manufacturer Jovet-Jordan
Shaheed
-e-
Millat Not yet registered
Road, in Pakistan
Karachi
Manufa
cturer:
M/s.
Arab
Veternia
ry
Industri
es CO,
(AVICO
), P.O
Box
150906
Amman,
11115,
Jordan
407. Importer Diclacox Liquid Form 5 with fee Rs The Board deferred Registratio
M/s. 100,000/- vide Dy. the case for Board
UM Each ml contains:- # 380 dated 08-05- provision of deferred
Enterpri Diclazuril 10mg 2013 approval status of case
ses, same dosage form provision
Karachi, Anticoccidal in reference following
18-C, 3rd Specifications:- Pack size of 100ml, regulatory documents
floor, Manufacturer 500ml, 1L & 5L  authorities and in formation:
Dolmen decontrolled Pakistan.  Product
Estate Develop
Building ent data
, Block however in powder liquid

7-8, from available. dosage
Shaheed Reg # 021258 form.
-e-  Stability
Millat data
Road, real ti
Karachi studies
and
Manufa accelera
cturer: d ti
M/s. studies.
Arab  Comple
Veternia master
ry formula
Industri n alo
es CO, with
(AVICO active a
), P.O inactive
Box ingrdien
150906
Amman,
11115,
Jordan
Deferred cases of new licensed manufacturers
408. M/s Ospra capsule 20mg Form 5 Deferred in 249th Firm has now Approved
Linta 17-04-2015 RB meeting for change the source
Pharmac Each Capsule (977) submission of of pellets and
euticals Contains: Rs.1,00,000/- legalized GMP submitted new
(Pvt.) Omeprazole As per SRO/ certificate of source documents
Ltd, Plot (enteric coated pellets) 2 x 7’s pellet’s as under:-
# 3, eq. to Omeprazole... manufacturer, COA Source of
Street # 20mg BNF: Losec and stability studies Omeprazole
S-5, (AstraZeneca) data of pellets. ECP pellets
National (Proton Pump 22.5%:-
Industri Inhibitor) RISEK 20mg M/s Vision
al Zone, (USP Spec.s) Capsule Pharmaceuticals,
Rawat Getz Pharma (Pvt.) Plot # 22-23,
Ltd Industrial
{Source of pellets: M/s Triangle, Kahuta
. Lee Pharma Ltd., Sy. Grant For Road, Islamabad.
No. 199, Plot No. 3 & registration of
4, D.No. 5-9-265/1 & drugs of new
2, Rajeevgandhinagar, license dated 02-
Prasanthinagar I.E, 04-2015
Kukatpally, Ranga
Reddy District,
Telangana State, India}

409. -do- Ospra capsule 40mg Form 5 Deferred in 249th Firm has now Approve
17-04-2015 RB meeting for change the source
Each Capsule (978) submission of of pellets and
Contains: Omeprazole Rs.1,00,000/- legalized GMP submitted new
(enteric coated pellets) As per SRO/ certificate of source documents
eq. to Omeprazole... 2 x 7’s pellet’s as under:-
40mg manufacturer, COA Source of
BNF: Losec and stability studies Omeprazole
(Proton Pump (AstraZeneca) data of pellets. ECP pellets
Inhibitor) 22.5%:-
(USP Spec.s) RISEK 40mg M/s Vision
Capsule Pharmaceuticals,
{Source of pellets: M/s Getz Pharma (Pvt.) Plot # 22-23,
. Lee Pharma Ltd., Sy. Ltd Industrial
No. 199, Plot No. 3 & Triangle, Kahuta
4, D.No. 5-9-265/1 & Grant For Road, Islamabad.
2, Rajeevgandhinagar, registration of
Prasanthinagar I.E, drugs of new
Kukatpally, Ranga license dated 02-
Reddy District, 04-2015
410. -do- Rush capsule 20mg Form 5 Deferred in 249th Firm has now Approved
17-04-2015 RB meeting for change the source with chan
Each Capsule (984) submission of of pellets and of bra
Contains:- Rs.1,00,000/- legalized GMP submitted new name.
Esomeprazole( as As per SRO/ certificate of source documents
Esomeprazole 2 x 7’s pellet’s as under:-
magnesium trihydrate manufacturer, COA Source of
enteric NEXIUM Capsule and stability studies Esomeprazole
coated pellets) (USP) (AstraZeneca) data of pellets as Mg ECP pellets
…20 mg per Zone IVA. 22.5%:-
E-CAP 40mg M/s Vision
(Proton Pump Capsules Pharmaceuticals,
Inhibitor) ((Brookes Plot # 22-23,
(USP Spec.s) Pharmaceuticals Industrial
(Pvt) Limited)) Triangle, Kahuta
{Source of pellets: M/s Road, Islamabad.
. Lee Pharma Ltd., Sy.
No. 199, Plot No. 3 & Grant For
4, D.No. 5-9-265/1 & registration of
2, Rajeevgandhinagar, drugs of new
Prasanthinagar I.E, license dated 02-
Kukatpally, Ranga 04-2015
Reddy District,

411. -do- Rush capsule 40mg Form 5 Deferred in 249th Firm has now Approved
17-04-2015 RB meeting for change the source with chang
Each Capsule (985) submission of of pellets and of brand
contains Rs.1,00,000/- legalized GMP submitted new name.
Esomeprazole( as As per SRO/ certificate of source documents
Esomeprazole 2 x 7’s pellet’s as under:-
magnesium trihydrate manufacturer, COA Source of
enteric NEXIUM Capsule and stability studies Esomeprazole
coated pellets) eq. to (AstraZeneca) data of pellets as Mg ECP pellets
Esomeprazole…40 mg per Zone IVA. 22.5%:-
E-CAP 40mg M/s Vision
(Proton Pump Capsules Pharmaceuticals,
Inhibitor) (Brookes Plot # 22-23,
(USP Spec.s) Pharmaceuticals Industrial
(Pvt) Limited) Triangle, Kahuta
{Source of pellets: M/s Road, Islamabad.
. Lee Pharma Ltd., Sy.
No. 199, Plot No. 3 & Grant For
4, D.No. 5-9-265/1 & registration of
2, Rajeevgandhinagar, drugs of new
Prasanthinagar I.E, license dated 02-
Kukatpally, Ranga 04-2015
Reddy District,
412. -do- Votsa capsule 30mg Form 5 Deferred in 249th Firm has now Approved
17-04-2015 RB meeting for change the source
Each Capsule (986) submission of of pellets and
Contains: Lansoprazole Rs.1,00,000/- legalized GMP submitted new
(enteric coated pellets) As per SRO/ certificate of source documents
eq. to Lansoprazole 2 x 7’s pellet’s as under:-
(USP) ... 30mg manufacturer, COA Source of
FDA: Prevacid and stability studies Lansoprazole
(Proton Pump (Novartis data of pellets. ECP pellets
Inhibitor) Pharmaceuticals) 22.5%:-
(USP Spec.s) M/s Vision
{Source of pellets: M/s Inhibitol 30mg Pharmaceuticals,
. Lee Pharma Ltd., Sy. Capsule Plot # 22-23,
No. 199, Plot No. 3 & (Highnoon Industrial
4, D.No. 5-9-265/1 & Laboratories Triangle, Kahuta
2, Rajeevgandhinagar, Limited) Road, Islamabad.
Prasanthinagar I.E,
Kukatpally, Ranga Grant For
Reddy District, registration of
Telangana State, India} drugs of new
license dated 02-
04-2015
413. M/s Montilak 4mg sachet Form-5 Deferred in 244th All shortcomings Approved
Hamaz 18-2-2014 RB meeting for rectified.
Pharmac Each sachet contains:- Dy # 619 R&I clarification of

euticals granules of Rs.20,000/- manufacturing
(Pvt.) Montilukast (as process for
Ltd, 13- sodium) 4mg Rs.225.00/14‟s granules.
km, sachet
Bosan Leukotriene receptor
Road, antagonist MHRA approved
Luftaba Manufacture
d, Specification
Multan
Deferred cases of pendency list
414. M/s Deproset Capsule Form 5 with fee Rs. The Board deferred Firm has Approve
Himont 20mg 20,000/- vide Dy. the case in 258th RB submitted source
Pharmac # 592 dated 06-09- meeting, for of pellets as
euticals Each capsule contains:- 2013 provision source of under:-
(Pvt.) Duloxetine HCl enteric pellets along with Source of
Ltd, 17- coated pellets eq. to Pack size relevant documents Duloxetine HCl
km, Duloxetine 20 mg 14’s  Rs.447/- ECP 19.0%
Ferozpu M/s Vision
r Road, SSRI Cymbalta-Eli Lilly- Pharmaceuticals,
Lahore Manufactures FDA Plot # 22,
specification Industrial
Priority Llario-Wilshire Trinagle, Kahuta
# 2655 Source of pellets:- Road, Islamabad.
415. M/s Deproset Capsule Form 5 with fee Rs. The Board deferred Firm has Approved
Himont 30mg 20,000/- vide Dy. the case for submitted source
Pharmac # 591 dated 21-10- provision source of of pellets as
euticals Each capsule contains:- 2013 pellets along with under:-
(Pvt.) Duloxetine HCl enteric relevant Source of
Ltd, 17- coated pellets eq. to documents. Duloxetine HCl
km, Duloxetine 30 mg Pack size ECP 19.0%
Ferozpu 10’s  Rs.415/- M/s Vision
r Road, SSRI Pharmaceuticals,
Lahore Manufactures Cymbalta-Eli Lilly- Plot # 22,
specification FDA Industrial
Priority Trinagle, Kahuta
# 2654 Source of pellets:- Llario-Wilshire Road, Islamabad.
416. M/s Deproset Capsule Form 5 with fee Rs. The Board deferred Firm has Approve
Himont 60mg 20,000/- vide Dy. the case for submitted source
Pharmac # 591 dated 21-10- provision source of of pellets as
euticals Each capsule contains:- 2013 pellets along with under:-
(Pvt.) Duloxetine HCl enteric relevant Source of
Ltd, 17- coated pellets eq. to documents. Duloxetine HCl
km, Duloxetine 60 mg Pack size ECP 19.0%
Ferozpu 10’s  Rs.415/- M/s Vision
r Road, SSRI Pharmaceuticals,
Lahore Manufactures Cymbalta-Eli Lilly- Plot # 22,
specification FDA Industrial
Priority Trinagle, Kahuta
# 2654 Source of pellets:- Llario-Wilshire Road, Islamabad.

417. M/s Lyta 40mg Capsule Form-5-D Deferred for Firm has rectified Approve
Getz Dy. No: 114 Balance fee of form all shortcomings.
Pharma, Each capsule contains: dated. 19.02.2011 5 D,  Product is
29- Enteric coated pellets Rs.15,000/- Legalized already
30/27, of Duloxetine HCl eq 19.09.2013 documents of the registered in
Korangi to Duloxetine………. Rs.5,000/- source and Pakistan.
Industri 40mg Rs. 645/14’s, Fee for source.  Firm
al Area, 925/20’s Stability studies as submitted
Karachi (Selective serotonin per 251st meeting of fresh Form 5.
Norepinephrine Duloxetine 20mg & RB.  Firm has
2053 reuptake inhibitor) 40mg gastric submitted
(Mfg. Specification) resistant capsules legalized
Duloxetine is indicated (Consilient Health documents of
for women for the Ltd) MHRA GMP and free
treatment of moderate sale certificate
to severe stress urinary Dulan –Hilton of Source of
incontinence. Reg# 067169 Duloxetine
Delayed
released
pellets
17.65% w/w:-
M/s Alphamed
Formulations Pvt
Ltd, Sy. No. 225,
Sampanhole
Village,
Shameerpet
Mandal, Ranga
Reddy District
500 078,
Telangana state,
India
418. M/s Lexxel Tablet Form 5 Deferred 254th RB All shortcomings Approve
Pharmac Dy No.1166 for rectified.
are Labs Each film coated tablet Rs.8000 dated 28-  Raw material and
(Pvt) contains:- 12-2011 & Rs. finished product
Ltd, Escitalopram Oxalate 12,000 dated 31- specifications
129/1, USP eq.to 07-2013. need to be
Industri Escitalopram 20mg As per SRO submitted.
al  Outline of
Estate, Anti-depressant MHRA Cipralex manufacturing
Kotlakh USP Specification 20mg f/c tablet method needs to
pat, Cipralex 20mg by be provided.
Lahore. M/s Lundbeck  Description of
1462 the dosage form
is not provided.
 Fresh inspection
require to be
submitted.

419. M/s Reevo .Form5 Deferred 244th for Deferred
Allmed Injection 2.Routine confirmation of correct
Pvt. Each ml contains: 3.Rs.5mlx10‟s/ As pharmacological pharmacol
Ltd. Levocarnitine…… per SRO group as applied by ical gro
(Former ……..200 mg 4.23-08-2010 firm. and
ly, 4.Anti infective Rs.8000/- submission
EverGre systematic 11-10-2012 of stabi
en Rs.12,000/- data as
Pharmac 251st
euticals, FDA: Carnitor meeting
Pvt. Ltd. Kefei Injection by
Plot.No. M/s RG Pharma
590,
Sundar
Industri
al
Estate
Lahore.
420. -do- Metoril 1.Form5 Deferred 244th for Registratio
Tablet 2.Routine confirmation of Board
Each tablet contains: 3.100‟s/As per international deferred
Nitrogen SRO availability and case
Contents…36mg 4.06-08-2010 facilty provision
Calcium .0.5gm Rs.8000/- for processing of complete
Aminoacids 11-10-2012 nitrogen master
Rs.12,000/ preparations formulatio
and
Ketosteril by M/s
confirmati
Fresenius Kabi
of appro
Pharma Germany.
status
Ketosteril by M/s Pakistan
Medipak Pharma
DDC PEC-I Dr. Hafsa Karam Ellahi
Sr. No Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + formulation (if any) Evaluator
manufacturer Dosage Form + Initial date, including /Decision
/ Applicant Strength) diary International status in
Composition stringent drug
Pharmacological Fee including regulatory agencies /
Group differential fee authorities
Finished product Demanded Me-too status
Specification Price / Pack size GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator

421. M/s Irza Dephan Syrup Form 5 International Deferred in 255th Deferred
Pharma (Pvt) Each 5ml contains: Dairy No. 705 availability not meeting of DRB for
Ltd. 10.2 K.M Dextromethorphan dated 04.10.11 confirmed  for latest confirmatio
Lahore – HBr ….13.5mg Rs.8,000/- De xtromethrphan n of
Sheikhupura (Antitussive) dated 29.07.2013 HBr 13.5 mg of cGMP
approval
Road, P.O.Kot Protocol Applied: Rs.12,000/- Neutropharma inspection
Abdul Malik, USP As per SRO Last GMP inspection
status by
report. reference
Distt: 120ml was conducted on 28-
Sheikhupura. 04-2014 regulatory
1378  availability authorities
in SRA is
not
confirmed.
Now the firm has

submitted latest
cGMP report
dated 21-03-
2016.
422. M/s Irza Dephan Syrup Form 5 International Deferred in 255th Deferred
Pharma (Pvt) Each 5ml contains: Dairy No. 706 availability not meeting of DRB for
Ltd. 10.2 K.M Dextromethorphan dated 04.10.11 confirmed  for latest confirmatio
Lahore – HBr …..10mg Rs:8,000/- n of
Sheikhupura Chlorpheniramine dated 29.07.2013 BUCKLEYS JACK & cGMP
approval
Road, P.O.Kot Maleate……2mg Rs.12,000/- JILL (Pacific inspection
Abdul Malik, (Antitussive / As per SRO Phararmaceutical
status by
report. reference
Distt: Antihistamine) 120ml
Sheikhupura. Protocol Applied: Last GMP inspection regulatory
1379 USP was conducted on 28-  availability authorities
04-2014 in SRA is
not
confirmed.
Now the firm has

submitted latest
cGMP report
dated 21-03-
2016.
423. M/s Irza R-Din Injection Form 5 International Deferred in 255th Approved
Pharma (Pvt) Each 2ml contains: Dairy No. 4831 availability meeting of DRB
Ltd. 10.2 K.M Ranitidine HCl dated 28.04.11 FDA approved Zantac  for latest
Lahore – equivalent to Rs.8,000/- Eq to 25MG
Sheikhupura Ranitidine……… dated 29.07.2013 Ranitidine Base/Ml cGMP
Road, P.O.Kot 50mg Rs.12,000/- Concordia Pharms Inc inspection
Abdul Malik, (H 2 Blocker) As per SRO report.
Distt: 5’s
Sheikhupura. Now the firm has
1010 submitted latest
cGMP report
dated 21-03-
2016.

424. M/s Irza Irzaline Injection Form 5 International Deferred in 255th Approved
Pharma (Pvt) Each 1ml contains: Dairy No. 4829 availability FDA: meeting of DRB
Ltd. 10.2 K.M Lincomycin dated 28.04.11 Lincocin Lincomycin  for latest
Lahore – Hydrochloride Rs.8,000/- HCl Eq. 300mg base
Sheikhupura equivalent to dated 29.07.2013 per ml cGMP
Road, P.O.Kot Lincomycin……… Rs.12,000/- (Pharmacia and inspection
Abdul Malik, 300mg As per SRO Upjohn) report.
Distt: (Lincosamide) 12’s
Sheikhupura. Lincocin (pfizer Now the firm has
1008 laboratories submitted latest
ltd. (Lincomycin HCl), cGMP report
equivalent to dated 21-03-
Lincomycin……..300m 2016.
g
Last GMP inspection
was conducted on 28-
04-2014
425. M/s Irza Irzaline Injection Form 5 International Deferred in 255th Approved
Pharma (Pvt) Each 2ml contains: Dairy No. 4827 availability FDA: meeting of DRB
Ltd. 10.2 K.M Lincomycin dated 28.04.11 Lincocin Lincomycin  for latest
Lahore – Hydrochloride Rs.8,000/- HCl Eq. 300mg base
Sheikhupura equivalent to dated 29.07.2013 per ml cGMP
Road, P.O.Kot Lincomycin…. 600mg Rs.12,000/- (Pharmacia and inspection
Abdul Malik, (Lincosamide) As per SRO Upjohn) report.
Distt: 12’s Lincocin (pfizer
Sheikhupura. laboratories Now the firm has
1011 ltd. (Lincomycin HCl), submitted latest
equivalent to cGMP report
Lincomycin……… dated 21-03-
600mg/2ml 2016.
Last GMP inspection
04-2014
426. M/s Irza Asmolin Injection Form 5 Aminophylline Deferred in 255th Approved
Pharma (Pvt) Each ml contains: Dairy No. 618 25mg/ml meeting of DRB with
Ltd. 10.2 K.M Aminophylline……..2 dated 28.05.11 Mercury pharma UK  for latest change of
Lahore – 5mg Rs.8,000/- Aminophylline Hydrate
Sheikhupura (Antiasthmatic) dated 29.07.2013 25mg/ml Sol for Inj of cGMP brand
Road, P.O.Kot Rs.12,000/- USFDA inspection name
Abdul Malik, As per SRO Aminophylline report.
Distt: 5’s 25mg/ml
Sheikhupura. GD SEARLE LLC
1099 (Discontinued)  Change of
Aminophylline name
25mg/ml of LCPW
Last GMP inspection Now the firm has
was conducted on 28- submitted latest
04-2014 cGMP report
dated 21-03-
2016.

427. M/s Irza Jantolin Injection Form 5 International Deferred in 255th Approved
Pharma (Pvt) Each 1ml contains: Dairy No. 4828 availability meeting of DRB with
Ltd. 10.2 K.M Salbutamol Sulphate dated 28.04.11 Ventolin Injection  for latest change of
Lahore – equivalent to Rs.8,000/- (0.5mg) in 1ml
Sheikhupura Salbutamol…. 0.5mg dated 29.07.2013 Glaxo Wellcome UK cGMP brand
Road, P.O.Kot (Selective Beta 2 Rs.12,000/- Ltd inspection name
Abdul Malik, Agonist) As per SRO Me too : ventral report.
Distt: 5’s Akson
Sheikhupura.
1007  Change of
Last GMP inspection mame
04-2014 Now the firm has
submitted latest
cGMP report
dated 21-03-
2016.
428. M/s Irza I-Menate Injection Form 5 DIMENHYDRINATE Deferred in 255th Approved
Pharma (Pvt) Each 1ml contains: Dairy No. 4825 50MG/ML meeting of DRB
Ltd. 10.2 K.M Dimenhydrinate……. dated 28.04.11 INJECTION OF  for latest
Lahore – 50mg Rs.8,000/- FRESENIUS KABI
Sheikhupura (Antihistamine) dated 29.07.2013 USFDA cGMP
Road, P.O.Kot Rs.12,000/- inspection
Abdul Malik, As per SRO Gravinate injection report.
Distt: 25’s Searl pharma
Sheikhupura. Last GMP inspection Now the firm has
1012 was conducted on 28- submitted latest
04-2014 cGMP report
dated 21-03-
2016.
429. M/s Irza I-Cobal Injection Form 5 Methycobal amine of Deferred in 255th Approved
Pharma (Pvt) Each 1ml contains: Dairy No. 4824 Eisai Co. Ltd. Japan meeting of DRB with
Ltd. 10.2 K.M Mecobalamin…….50 dated 28.04.11 Mabil Injection (Sami  for latest change of
Lahore – 0mcg Rs.8,000/- Pharma, Karachi).
Sheikhupura (Coenzyme type dated 29.07.2013 Last GMP inspection cGMP brand
Road, P.O.Kot vitamin B12) Rs.12,000/- was conducted on 28- inspection name
Abdul Malik, As per SRO 04-2014 report.
Distt: 10’s
Sheikhupura.
1013  Change of
name
Now the firm has

submitted latest
cGMP report
dated 21-03-
2016.
Import Case of M/s Atco Pharma was deferred in 255th meeting of RB.

Sr. No Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + formulation (if Evaluator
manufacture Dosage Form + Initial date, any) including /Decision
r / Applicant Strength) diary International
Composition status in
Pharmacological Fee including stringent drug
Group differential fee regulatory
Finished product Demanded agencies /
Specification Price / Pack size authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
430. Atco Micopirox, Nail Form 5-A Penlac,8% Deferred in 255th Approved as per
pharma Lacquer Rs. 15000 dt 19- Topical solution meeting for the Import Policy for
Cyclopirox 8mg/100g 04-2011 of following reasons; Finished Drugs
Internation
al
BP Specification Rs. 85000 dt 04- (Valeant  CPP issued on
06-2013 Bermuda)
(PVT.)LT Rs. 600 USFDA Feb 2011 and
D B-18, is valid for 12
S.I.T.E, months.
Karachi-
75700  Last GMP
Name and certificate was
address of issued on Nov
Manufactur 2010 and is in
er;
local
Laboratori
o Pablo language.
Cassar’a Latest
S.R.L legalized
Carhue Certificate
1096. with English
(C.P.1408)
translation
City:
Buenos required.
Aires
 Sole
Country:
Argentina agreement of
Laboratory
52 Pablo Cassara
with Atco is
valid till
December
2015.
Extension in
the agreement

is required.

Routine Cases.
S. No Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + formulation (if Evaluator
manufacture Dosage Form + Initial date, any) including /Decision
r / Applicant Strength) diary International
Composition status in
Pharmacological Fee including stringent drug
Group differential fee regulatory
Finished product Demanded Price agencies /
Specification / Pack size authorities
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
M/s. Friends Bactriol Form 5 Avelox I.V by Approved
431. Pharma (Pvt) infusion Dy.No.561 M/s. Bayer Inc.
Limited, Each 250ml contains: 28-05-2011 US FDA
31Km Moxifloxacin…… Rs:8,000/- Avilox Infusion
Ferozpure 400mg 14.05.2013 by M/s. Baeyer
Road, Lahore Rs.. 12000/- (Pvt) Limited,
1092 (Anti-biotic) As per SRO Karachi
432. M/s. Friends Cipfen Form 5 Ciprofloxacin Approved

Pharma (Pvt) infusion Dy.No.522 2mg / ml by
Limited, Each 100ml contains: 03-05-2011 Pharmathen
31Km Ciprofloxacin …200mg Rs:8,000/- MHRA
Ferozpure 14.05.2013
Road, Lahore (Anti-biotic) Rs.. 12000/- cipesta
1091 As per SRO Infusion by M/s.
Getz Pharma
433. M/s Zylofixim Capsule Form 5 Applied Applied Deferred for

Remington Oral Capsules Dy.No.3898 formulation is formulation is confirmation
Pharma Each Capsule contains: 28-03-2011 not available in not available in of approval
Lahore Cefixime Trihydrate Rs:8,000/- reference reference status by
846 U.S.P equivalent to Dy. No. 9276 SRA’s. SRA’s.
reference
Cefixime…..200mg 30.07.2013 Cefim by M/s The firm also
(Antibiotic). Rs.. 12000/- Getz Pakistan fails to provide
regulatory
Manufacturer’s Leader Price the same. authorities
Specification

434. M/s Nilol 10mg Form 5 Bystolic Tablet Approved
Remington Tablet Dy.No.136 of Forest Labs
Pharma Each tablet contains: 23-2-2016 US FDA
Lahore Nebivolol Hcl eq to Rs:20,000/-
1544 Nebivolol……10mg As per PRC ByscardTablet
Beta Blocker As per PRC Searle Pakistan
Manufacturer’s
Specification
435. M/s Malfan 80/480 Form 5 Applied Applied Deferred for

Remington Dispersible Dy.No.1500 formulation is formulation is confirmation
Pharma Oral dispersible Tablet 04-8-2011 not available in not available in of approval
Lahore Each dispersible tablet Rs:8,000/- reference reference status by
853 contains: Dy. No. 9296 SRA’s. SRA’s.
reference
Artemether……80mg 30.07.2013 Alar once The firm also
Lumefantrine…… Rs12000/- Dispersible by fails to provide
regulatory
480mg Leader Price M/s Searle the same. authorities /
(Anti Malarial) Pharma WHO
Manufacturer’s
Specification
436. M/s Malfan 40/240 Form 5 Applied Applied Deferred for

Remington Dispersible Dy.No.1501 formulation is formulation is confirmation
Pharma Oral Tablet 04-8-2011 not available in not available in of approval
Lahore Each tablet contains: Rs:8,000/- reference reference status by
852 Artemether……40mg Dy. No. 9289 SRA’s. SRA’s.
reference
Lumefantrine…… 30.07.2013 Alar once The firm also
240mg Rs12000/- Dispersible by fails to provide
regulatory
Leader Price M/s Searle the same. authorities /
(Anti Malarial) Pharma WHO
Manufacturer’s
Specification
437. M/s Nebra-D Form 5 Applied Applied Rejected

Remington Ophthalmic suspension Dy.No.1500 formulation is formulation is being
Pharma Each ml contains: 04-8-2011 not available in not available in
Lahore Tobramycin U.S.P…… Rs:8,000/- reference reference
irrational
945 3.0 mg Dy. No. 9296 SRA’s. SRA’s. formulation
Dexamethasone 30.07.2013 Me too status is The firm also and not
U.S.P……1.0mg Rs12000/- not confirmed fails to provide approved
Boric Acid B.P….5mg Leader Price the same. by ant
Manufacturer’s
Specification
reference
(antibacterial, regulatory
corticosteroid) authoritity
Manufacturer’s
Specification

438. M/s Remflox 750 Form 5 Levaquin Shelf life Approved
Remington Oral Tablet Dy.No. Tablet of provided by the
Pharma Each film coated tablet 21-05-2012 Janssen Pharms firm is three
Lahore contains: Rs:8,000/- US FDA years whereas 2
1818 Levofloxacin Dy. No. Leflox by M/s years are allowed
Hemihydrates eq. to 30.07.2013 Getz Pharma by the Board.
Levofloxacin U.S.P Rs12000/-
(Antibiotic, quinolones) Leader Price
Manufacturer’s
Specification
439. M/s Zincure Form 5 Applied Deferred for Deferred

Remington Oral Syrup Dy.No. 5853 formulation is opinion/commen for
Pharma Each 5ml contains: 29-06-2012 not available in ts of opinion/com
Lahore Zinc Sulphate Rs:8,000/- reference WHO as per ments of
842 Monohydrate U.S.P 30.07.2013 SRA’s. decision of the
WHO as per
equivalent to Elemetal Rs12000/- board in 250th
Zinc………20mg Leader Price meeting. Dosage
decision of
recommendation the board in
(Zinc Supplement) (UNICEF/ 250th
Manufacturer’s WHO): Tablets meeting.
Specification may contain
either 10 or 20
mg of zinc and
the concentration
of zinc in oral
solutions may be
10mg/5mL.
Decisions about
the best strength
to be used should
depend on better
adherence to
treatment by
patient, taking
into
consideration
other issues as
well, such as
price, medicine
delivery, and
duration of
treatment (10- or
14-day
treatment).
Preferably, in any
given country,
only one strength
of tablets or oral
solution should
be available to
avoid dosing
errors. If 10-mg
zinc tablets are
chosen, it will

mean that older
children will
have to take two
tablets each day;
if 20mg zinc
tablets are
chosen, it will
mean that for
younger infants
only half a tablet
will be given
each day and
therefore tablets
will have to be
scored to
facilitate this.
With oral
solutions,
because it is
difficult to
accurately
measure half a
teaspoon of
solution, it is
recommended
that oral solution
of zinc contain
10mg of
elemental zinc
per 5 mL, that is
to say per one
teaspoon. It
means that
infants below 6
months of age
will receive one
teaspoon, while
older children
will need 2
teaspoons of oral
solution per day.
(Ref: UNICEF/
WHO)
440. M/s Remisole-P Syrup Form 5D Applied Applied Deferred for
Remington Each 5ml contains: Dy.No. 5852 formulation is formulation is confirmation
Pharma Ammonium Chloride 29-06-2012 not available in not available in of approval
Lahore B.P….100mg Rs:15,000/- reference reference status by
841 Sodium Citrate 30.07.2013 SRA’s. SRA’s.
reference
B.P….60mg Rs35000/- The firm also
Chlorpheniramine Rs. 45/60ml fails to provide
regulatory
Maleate B.P……2mg Rs. 65/120ml the same. authorities
Phenylephrine HCl Rs. 200/450ml and Pakistan
B.P…..5mg
Menthol B.P…..1.0mg
(Expectorant)

Manufacturer’s
Specification
441. M/s Moxidex Form 5 Applied Applied Deferred for

Remington Each ml contains: Dy.No. 1465 formulation is formulation is confirmation
Pharma Moxifloxacin 23-04-2012 not available in not available in of approval
Lahore Hydrochloride B.p Rs:8,000/- reference reference status by
840 Equivalent to 30.07.2013 SRA’s. SRA’s.
reference
Moxifloxacin…..5mg Rs 12,000/- Oxcin-D by The firm also
Dexamethasone Sodium Leader Price M/s Atco fails to provide
regulatory
Phosphate U.S.P eq. to Pharma the same. authorities
Dexamethasone
Phosphate…..1mg
(Antibiotic &
Corticosteroid)
Manufacturer’s
Specification
442. M/s Moxear-Pain otic drops Form 5 Applied Applied Deferred for
Remington Each ml contains: Dy.No. 1465 formulation is formulation is confirmation
Pharma Moxifloxacin HCL B.P 23-04-2012 not available in not available in of approval
Lahore Equivalent to Rs:8,000/- reference reference status by
791 Moxifloxacin…..5mg 30.07.2013 SRA’s. SRA’s.
reference
Lignocaine HCL B.P Rs 12,000/- Me too status is The firm also
equivalent to Leader Price not confirmed fails to provide
regulatory
Lignocaine base …… the same. authorities
50mg and pakistan
(Antibiotic and local
Anaesthetic)
Manufacturer’s
Specification
443. M/s Valpin-H 5/160/25 Duplicate Dossier Exforge HCT Approved

Remington Oral Tablet Form 5 Novartis US
Pharma Each film coated tablet 02-02-2011 FDA
Lahore contains: Rs:8,000/- Valam-H
1772 Amlodipine (as 30.07.2013 5/160/25by M/s.
Besylate) B.P…..5mg Rs 12,000/- CCL Pharma
Valsartan Leader Price
U.S.P…..160mg
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
Blocker, Angiotensin-II
Receptor Antagonist &
Thiazide Diuretic )
Manufacturer’s
Specification

444. M/s Valpin 10/80 Duplicate Dossier Applied Applied Deferred for
Remington Oral Tablet Form 5 formulation is formulation is confirmation
Pharma Each film coated tablet 02-02-2011 not available in not available in of approval
Lahore contains: Rs:8,000/- reference reference status by
1777 Amlodipine (as 30.07.2013 SRA’s. SRA’s.
reference
Besylate) B.P…..10mg Rs 12,000/- Valam The firm also
Valsartan Leader Price 10/80 by M/s. fails to provide
regulatory
U.S.P…..80mg CCL Pharma the same. authorities
(Calcium Channel
Blocker, Angiotensin-
UII Receptor
Antagonist & Thiazide
Diuretic )
Manufacturer’s
Specification

Lahore contains: Rs:8,000/-
1773 Amlodipine (as 30.07.2013 Valam-H
Besylate) B.P…..10mg Rs 12,000/- 10/160/25by
Valsartan Leader Price M/s. CCL
U.S.P…..160mg Pharma
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
UII Receptor
Diuretic )
Manufacturer’s
Specification

Lahore contains: Rs:8,000/-
1774 Amlodipine (as 30.07.2013 Valam-H
Besylate) B.P…..10mg Rs 12,000/- 10/320/25by
Valsartan Leader Price M/s. CCL
U.S.P…..320mg Pharma
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
UII Receptor
Diuretic )
Manufacturer’s
Specification

Following products of M/s. Friends Pharma (Pvt.) ltd were deferred in 257th meeting of Drug registration board
for approval status of same formulation in reference regulatory authorities and for finished product
specification. Now the firm has submitted the evidence of same formulation in reference regulatory
authorities and for finished product specification. Submitted for consideration of Board.
S/N Name Brand Name Type of Form Remarks on the Remarks by Decision
and (Proprietary name + Initial date, formulation (if Evaluator
address Dosage Form + diary any) including
of Strength) Fee including International
manufact Composition differential fee status in
urer / Pharmacological Demanded stringent drug
Applican Group Price / Pack regulatory
t Finished product size agencies /
Specification authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by
the Evaluator
447. M/s. Ferifend Form-5 International International Deferred
Friends Injection Dy. No: 547 availability is not availability is not for
Pharma Each ml contains: dated. 28-05- confirmed confirmed confirmatio
(Pvt) Piroxicam……….20mg 2011 Rs.8000/- pcam By n of
Limited, Rs.12,000/- M/sMerck
approval
31Km (Analgesic) As per SRO Laboratories.
Ferozpure
status by
Road, reference
Lahore regulatory
1095 authorities
448. M/s. Nootrofil Injection Form-5 Dy. No: Availability in Piracetam is a Deferred
Friends Injection 553 dated. 28- SRA is not cyclic derivative for
Pharma Each ml contains: 05-2011 confirmed of GABA. In the confirmatio
(Pvt) Piracetam……..200mg Rs.8000/- United States, it is n of
Limited, Rs.12,000/- As not approved by approval
31Km (Nootropic Drug) per the US Food and
Ferozpure SRO/200mg/ml Nootropil
status by
Drug reference
Road, injection by Administration for
Lahore Glaxosmithkline, regulatory
any medical use and authorities
1089 Pakistan 1G/ 5ml
it is not permitted to
be sold as a dietary
supplement. In the
UK, piracetam is
prescribed mainly
for myoclonus, but
is used off-label for
other conditions.
Evidence to support
its use for many
conditions is
unclear.

DDC PEC-II Muhammad Amin.
Sofosbuvir Cases.
S/N Name and Brand Name Type of Form Remarks on Remarks by Decision
address of (Proprietary name + Dosage Initial date, diary the Evaluator
manufacturer / Form + Strength) Fee including formulation
Applicant Composition differential fee (if any)
Pharmacological Group Demanded Price / including
Finished product Pack size International
Specification status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
449. M/s NovaMed Ledinil Tablet Form 5-D Harvoni, FDA.  Stability Deferred for
Pharmaceuticals Tablet Dairy No. 1928 rectification
studies not
(Pvt) Ltd, Each tablet contains:- dated 20-04-2014 Harvoni, of mentioned
Lahore. Sofosbuvir……400mg Rs.50,000/- Ferozsons, submitted. deficiencies
Ledipasvir……90mg 14’s, 28’s Pakistan.  Last and
(Manufacturer’s Specs) Rs.630,000/- Inspection submission of
Rs.11,97,000/- report stability data
required. \
 Undertakin
g as per
new format.
450. M/s Barrett Hepgard Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Hodgson Tablet Dairy No. 5335 rectification
studies not
Pakistan (Pvt) Each film coated tablet dated 21-08-2015 Harvoni, of mentioned
Ltd. Karachi. contains:- Rs.50,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg 7’s,10’s,14’s,20’s, Pakistan.  Last and
Ledipasvir……90mg 28’s,30’s Inspection submission of
(Direct-acting antiviral agent Rs.24,500/- report stability data
against the hepatitis C virus) Rs.35,000/-
(Mnf Specs) Rs.49,000/-
required.
Rs.70,000/-  Undertakin
Rs.1,05,000/- g as per
new format
451. M/s Barrett Hepgard Form 5 Sovaldi, USA.  Stability Deferred for
Hodgson Tablet Dairy No. 5336 rectification
studies not
Pakistan (Pvt) Each film coated tablet dated 24-08-2015 Sovaldi, of mentioned
Ltd. Karachi. contains:- Rs.20,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg 7’s,10’s,14’s,20’s, Pakistan  Last and
(Direct-acting antiviral agent 28’s,30’s Inspection submission of
against the hepatitis C virus) Rs.17,500/- report stability data
(Mfg Specs) Rs.25,000/-

Rs.35,000/- required.
Rs.50,000/-  Undertakin
Rs.70,000/-
Rs.75,000/- g as per
new format
452. M/s Indus Indovir 400mg Form 5-D Sovaldi, USA.  Stability Deferred for
Pharma (Pvt.) Tablet Dairy No. 264 rectification
studies not
Ltd., Each film coated tablet dated 17-09-2014 Sovaldi, of mentioned
contains:- Rs.20,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg As per SRO] Pakistan  Last and
(Anti-Viral) As per SRO Inspection submission of
report stability data
required.
 Undertakin
g as per
new format
not
submitted.
453. M/s Nawan Virosof Form 5 Sovaldi, USA.  Stability Deferred for
Laboratories Tablet Dairy No. 402 rectification
Pvt Ltd. Each film coated tablet dated 22-03-2016 Sovaldi, studies not of mentioned
Karachi. contains:- Rs.20,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg As per SRO Pakistan and
 Last
(Antihepatitis ATC Code: As per SRO submission of
JO5AB) Inspection stability data
(Manufacturer’s Specs) report
required.
 Undertakin
g as per
new format
not
submitted.
454. M/s Helix Sofoled 90mg/400mg Form 5-D Harvoni, FDA.  Stability Deferred for
Pharma (Pvt) Tablet Dairy No. 512 rectification
Ltd Karachi. Each film coated tablet dated 11-04-2016 Harvoni, studies not of mentioned
Ledipasvir……90mg As per SRO Pakistan.  Undertakin and
Sofosbuvir……400mg As per SRO submission of
(Direct Acting Antiviral) g as per stability data
new format
455. M/s Paramount Savior Form 5 Sovaldi, USA.  Stability Deferred for
Pharmaceutical Tablet Dairy No. 1201 rectification
Islamabad. Each tablet contains:- dated 09-10-2015 Sovaldi, studies not of mentioned
Sofosbuvir……400mg Rs.20,000/- Ferozsons, submitted. deficiencies
(Anti-infective, Antiviral) As per SRO Pakistan and
 Last
submission of
Inspection stability data
report

required.
 Undertakin
g as per
new format
456. M/s Rotex Sonata Form 5 Harvoni, FDA.  Stability Deferred for
Pharma Tablet Dairy No. 78 rectification
Islamabad. Each film coated tablet dated 11-01-2016 Harvoni, studies not of mentioned
Ledipasvir…….90mg 28’s Pakistan. and
 Undertakin
(Nucleotide Analog NSB g as per stability data
Polymerase Inhibitor & new format.
Nucleotide NS5B Inhibitor
Anti viral)  Inspection
report states
that firm
has limited
capacity of
production.
457. M/s Pharmix Alvir Form 5-D Harvoni, FDA.  Stability Deferred for
Laboratories Tablet Dairy No.1452 studies not rectification
Pvt Ltd, Lahore Each film coated tablet dated 13-11-2015 Harvoni, submitted. of mentioned
contains:- Rs.50,000/- Ferozsons, deficiencies
 Last
Sofosbuvir……400mg Rs.100,000/- Inspection submission of
(Antiviral Agent) report stability data
required.
 Undertaking
as per new
format
458. M/s Nexus Sofonex Form 5-D Sovaldi, USA.  Stability Deferred for
Pharma Tablet Dairy No.2299 rectification
Karachi. Each film coated tablet dated 25-11-2015 Sovaldi, studies not of mentioned
Sofosbuvir……400mg As per SRO Pakistan  Last and
(Hepatitis C virus (HCV) submission of
Nucleotide analog Inspection stability data
report
required.
 Undertakin
g as per
new format

459. M/s Bosch Lesovir Form 5 Sovaldi, USA.  Stability Deferred for
Pharmaceutical Tablet Dairy No.87 rectification
Karachi. Each film coated tablet dated 20-01-2016 Sovaldi, studies not of mentioned
Ledipasvir……90mg 28’s Pakistan  Undertakin and
(Hepatitis C virus (HCV) g as per stability data
nucleotide analog NSB new format
polymerase inhibitor)
not
submitted.
460. M/s Siam Sifos Plus Form 5-D Sovaldi, USA.  Stability Deferred for
Pharmaceuticals Tablet Dairy No.1272 rectification
Islamabad. Each film coated tablet dated 03-03-2016 Sovaldi, studies not of mentioned
Ledipasvir……90mg As per SRO Pakistan and
 Last
Sofosbuvir……400mg submission of
(Antiviral) Inspection stability data
report
required..
 Undertakin
g as per
new format
not
submitted.
461. M/s Crystolite Hepled Form 5-D Harvoni, FDA.  Stability Deferred for
, Islamabad. Each film coated tablet dated 30-12-2015 Harvoni, studies not of mentioned
Ledipasvir……90mg As per SRO Pakistan. and
Sofosbuvir……400mg submission of
(Antiviral against Hepaptis C) stability data
(Manufacturer’s Specs)
462. M/s Medisave Sobovir Form 5 Sovaldi, USA.  Stability Deferred for
studies not
Lahore. Each film coated tablet dated 12-10-2015 Sovaldi, of mentioned
Sofosbuvir……400mg As per SRO Pakistan  Last and
(Antivirals for systemic use) Inspection submission of
report stability data
required.
 Undertakin
g as per
new format
not
submitted.

463. M/s Global Cure-C Plus Form 5-D Harvoni, FDA.  Stability Deferred for
studies not
Pvt. Ltd Each film coated tablet dated 18-02-2016 Harvoni, of mentioned
Islamabad. contains:- Rs.50,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg As per SRO Pakistan.  Undertakin and
Ledipasvir…..90mg g as per submission of
(Anti-viral agent) new format stability data
Manufacturer’s Specs
not
submitted.
464. M/s Jenner Sobovir Form 5 Sovaldi, USA.  Stability Deferred for
Pvt. Ltd. Each film coated tablet dated 20-10-2015 Sovaldi, studies not of mentioned
Sofosbuvir……400mg 28’s Pakistan and
(Direct-acting antiviral) As per SRO submission of
Manufacturer’s Specs stability data
465. M/s Martin Osvir Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Dow Karachi. Film coated Tablet Dairy No.795 rectification
Each film coated tablet dated 04-11-2015 Harvoni, studies not of mentioned
Sofosbuvir……400mg 7’s,14’s,28’s Pakistan.  Undertakin and
Ledipasvir…….90mg Rs.21,000/- submission of
(Antiviral) Rs.42,000/- g as per stability data
Manufacturer’s Specs Rs.84,000/- new format
not
submitted.
466. M/s Wilshire Ziqar Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Laboratories Tablet Dairy No.795 studies not rectification
(Pvt) Ltd. Each film coated tablet dated 04-11-2015 Harvoni, submitted. of mentioned
Lahore. contains:- Rs.50,000/- Ferozsons, deficiencies
 Last
Sofosbuvir……400mg 1’s,5’s,10’s,30’s, Pakistan. and
Ledipasvir…….90mg 50’s Inspection submission of
(Antiviral) As per SRO report stability data
required.
 Undertaking
as per new
format
467. M/s Saffron Viraldi Form 5-D Harvoni, FDA.  Stability Deferred for
Faisalabad. Each tablet contains:- dated 07-12-2015 Harvoni, studies not of mentioned
Sofosbuvir……400mg Rs.50,000/- Ferozsons, submitted. deficiencies
(HCV NS5A Inhibitor and Rs.60,000/- submission of
Nucleotide analog inhibitor of stability data
Hcv NS5B Polymerase.)

468. M/s Seatle Pvt Isuvir Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Limited, Tablet Dairy No.1361 rectification
Lahore. Each film coated tablet dated 04-11-2015 Harvoni, studies not of mentioned
Sofosbuvir……400mg 7’s,14’s,28’s Pakistan.  Undertakin and
Ledipasvir…….90mg Rs.21,000/- submission of
(Antiviral.) Rs.42,000/- g as per stability data
Rs.84,000/- new format
not
submitted.
469. M/s OBS Viratron-Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Pakistan, Film coated Tablet Dairy No.214 rectification
studies not
Karachi. Each film coated tablet dated 03-06-2015 Harvoni, of mentioned
Sofosbuvir……400mg 28’s Pakistan.  Last and
Ledipasvir…….90mg Rs.364,000/- Inspection submission of
(Antiviral.) report stability data
required.
 Undertakin
g as per
new format
not
submitted.
470. M/s Hilton Sofoled Form 5-D Harvoni, FDA.  Stability Deferred for
Pharma, Film coated Tablet Dairy No.273 rectification
studies not
Karachi Each film coated tablet dated 06-03-2015 Harvoni, of mentioned
contains:- As per DPC Ferozsons, submitted. deficiencies
Sofosbuvir……400mg Rs.364,000/- Pakistan.  Last and
Ledipasvir…….90mg Inspection submission of
(Antiviral.) report stability data
required.
471. M/s Tabros Concerta 400/90 mg Tablets Form 5-D Harvoni, FDA.  Stability Deferred for
Pharma, Each Film coated tablets Dairy No.273 rectification
studies not
Karachi contain: dated 06-03-2015 Harvoni, of mentioned
Sofosbuvir….400 mg As per DPC Ferozsons, submitted. deficiencies
Ledipasvir…….90 mg Rs.3392.85 per Pakistan.  Last and
tablet. Inspection submission of
Pack 2 × 14: Rs report stability data
95000/-
required.
 Undertakin
g as per
new format
not
submitted.

472. M/s Sami, Daclavir 30 mg tablets Form 5-D Deklinza of Stability data of Deferred for
Karachi Each film coated tablet Dy no: 1241 dated: M/s BMS, UK. 06 months rectification
contains: 14.6.2016 accelerated and of mentioned
Daclatasvir (as Rs: 50,000 New Molecule real time is deficiencies
dihydrochloride) 30 mg Price: 6500/ 28 required and
Mfg Specs Tablets submission of
stability data
473. M/s Sami, Daclavir 60 mg tablets Form 5-D Deklinza of -do- Deferred for
Karachi Each film coated tablet Dy no: 1240 dated: M/s BMS, UK. rectification
contains: 14.6.2016 of mentioned
Daclatasvir (as Rs: 50,000 New Molecule deficiencies
dihydrochloride) 60 mg Price: 13000/ 28 and
Mfg Specs Tablets submission of
stability data
474. M/s Hilton Clavir tablets 30 mg Form 5-D Deklinza of Stability data of Deferred for
Pharma, Each film coated Tablet : Dy. No. 403 M/s BMS, UK. 06 months rectification
Karachi Daclatasvir …………30mg dated: 14.09.2015 accelerated and of mentioned
(equivalent to 33mg Rs: 50,000 New Molecule real time is deficiencies
daclatasvir dihydrochloride) As Per DPC required and
submission of
stability data
475. M/s Hilton Clavir tablets 60 mg Form 5-D Deklinza of -do- Deferred for
Pharma, Each film coated Tablet : Dy. No 402 M/s BMS, UK. rectification
Karachi Daclatasvir ………… dated: 14.09.2015 of mentioned
60mg(equivalent to 66mg Rs: 50,000 New Molecule deficiencies
daclatasvir dihydrochloride) As Per DPC and
submission of
stability data

Deferred Cases:
Following cases of M/s Selmore Pharmaceutical Lahore were deferred in M-258th due to me too
status now the firm has submitted the deficiencies.
S/N Name and Brand Name Type of Form Remarks on Decision

address of (Proprietary name + Dosage Initial date, diary the
manufacturer Form + Strength) Fee including formulation
/ Applicant Composition differential fee (if any)
Pharmacological Group Demanded Price / including
Finished product Specification Pack size International
status in
stringent
drug
regulatory
agencies /
authorities
Me-too
status
GMP status
as depicted
in latest
inspection
report (with
date) by the
Evaluator
476. M/s. Selmore Novacin intra-Mammary Form-5 Me-too not Rejected
Pharmaceutical Suspension Liquid Injectable Dy. No.138 available on the
s (Pvt) Limited, Each 5ml contains:- Dated.28-01-2016 grounds
36 Km, Multan Penicillin G Rs.20,000/- that me-too
Road, Lahore. Sodium…………..200,000IU Decontrolled
of the drug
Novobiocin Sodium eq. to 10ml,10ml x 12’s
Novobiocin 10mlx24’s
is not
………………….400mg available
(2 years)
477. M/s. Selmore Speclimox Oral Dry Powder Form-5 Me-too not Rejected
Pharmaceutical Oral Dry Powder Dy. No.133 available on the
s (Pvt) Limited, Each Kg powder contains:- Dated.28-01-2016 grounds
36 Km, Multan Amoxicillin Trihydrate (BP) eq. to Rs.20,000/- that me-too
Road, Lahore. Amoxicillin…………….......200mg Decontrolled
of the drug
Lincomycin HCI (BP) eq. to 100gm,250gm
Lincomycin…..88mg 500gm,1Kg
is not
Spectinomycin Sulphate (BP available
VET). eq. to
Spectinomycin……........88mg
(Board Spectrum Antibiotics
(Penicillin/ Aminoglycosides)
02 years

Grant of Registration to New Drug Manufacturing Licenses
DDC-PEC-I Dr.Hafsa Karam Ellahi
S/N Name and address of Brand Name Type of Form International Remarks Decision
manufacturer / Applicant (Proprietary Initial date, status in
name + Dosage diary reference drug
Form + Fee including agencies /
Strength) differential fee authorities
Composition Demanded Me-too status
Pharmacological Price / Pack GMP status as
Group size depicted in
Finished product latest
Specification inspection
report (with
date) by the
Evaluator
Tablet (General)
478. Scilife Pharma Leflo Tablet 250 mg Form 5 FDA approved Approved
(Private) Each film coated Rs. 20,000/- Tablet Levaquin
Limited tablet contains: Dy. No.1156 250 mg
Plot # FD- Levofloxacin 250 mg 08-06-2016 manufactured by
57/58-A2, (as hemihydrates) 10’s,30’s Janssen Pharms
Korangi Creek (Scilife Spec) As Per SRO
Industrial Quinolone Tablet
park (KCIP) Antibiotics Dynaquin 250
Karachi mg by Barrett
Hodgson
Tablet
(General)
approved in
247st meeting
of Central
Licensing
Board held on
29-04-2016.
479. -do- Leflo Tablet 500 mg Form 5 FDA approved Approved
Each film coated Rs. 20,000/- Tablet Levaquin
tablet contains: Dy. No.1155 500 mg
Levofloxacin 500 mg 08-06-2016 manufactured by
(as hemihydrates) 10’s,30’s Janssen Pharms
(Scilife Spec) As Per SRO
Quinolone Tablet
Antibiotics Dynaquin 500
mg by Barrett
Hodgson
480. -do- Leflo Tablet 750 mg Form 5 FDA approved Approved

Each film coated Rs. 20,000/- Tablet Levaquin
tablet contains: Dy. No. 1154 750 mg
Levofloxacin 750 mg 08-06-2016 manufactured by
(as hemihydrates) 10’s,30’s Janssen Pharms

(Scilife Spec) As Per SRO
Quinolone Leflox by M/s
Antibiotics Getz Pharma
481. -do- Amstan Tablet 5/80 Form 5 FDA approved Approved
mg Dy. No. 1206 Tablet
Each film coated Dated.08-06-2016 Exforge 5/80 mg
tablet contains: Rs. 20,000/- manufactured by
Amlodipine: 5 mg (as Pack of 14’s,28’s /as Novartis
Amlodipine Besylate) per SRO
Valsartan: 80 mg Tablet
(Scilife Spec) Avsar 5/80 mg
Anti-Hypertensive manufactured by
Pharmevo
482. -do- Amstan Tablet 5/160 Form 5 FDA approved Approved

mg Rs. 20,000/- Tablet
Each film coated Dy. No.1207 Exforge 5/160
tablet contains: Dated.08-06-2016 mg
Amlodipine: 5 mg (as 14’s,28’s manufactured by
Amlodipine Besylate) As Per SRO Novartis
Valsartan: 160 mg
(Scilife Spec) Tablet
Anti-Hypertensive Avsar 5/160 mg
manufactured by
Pharmevo
483. -do- Amstan Tablet Form 5 FDA approved Approved

10/160 mg Rs. 20,000/- Tablet
Each film coated Dy. No.1208 Exforge 10/160
tablet contains: Dated.08-06-2016 mg
Amlodipine: 10 mg 14’s,28’s manufactured by
(as Amlodipine As Per SRO Novartis
Besylate)
Valsartan: 160 mg Tablet
(Scilife Spec) Avsar 10/160
Anti-Hypertensive mg
manufactured by
Pharmevo
484. -do- Co-Amstan Tablet Form 5 FDA approved Approved

5/160/12.5 mg Rs. 20,000/- Tablet
Each film coated Dy. No. 1209 Exforge HCT
tablet contains: 08-06-2016 5/160/12.5 mg
Valsartan: 160 mg
Hydrochlorothiazide Tri-Valsan by
USP: 12.5 mg M/s Hilton
(Scilife Spec) Pharma
Anti-Hypertensive
10/160/12.5 mg Rs. 20,000/- Tablet
Each film coated Dy. No.1173 Exforge HCT
tablet contains: 08-06-2016 10/160/12.5 mg

Besylate)
Valsartan: 160 mg Tri-valsan by
Hydrochlorothiazide Hilton Pharma
USP: 12.5 mg
(Scilife Spec)
Anti-Hypertensive
5/160/25 mg Rs. 20,000/- Tablet
tablet contains: 08-06-2016 5/160/25 mg
Valsartan: 160 mg
Hydrochlorothiazide Tri-Valsan by
USP: 25 mg M/s Hilton
(Scilife Spec) Pharma
Anti-Hypertensive
10/160/25 mg Rs. 20,000/- Tablet
tablet contains: 08-06-2016 10/160/25 mg
(as Amlodipine Novartis
Besylate)
Valsartan: 160 mg Tri-Valsan by
Hydrochlorothiazide M/s Hilton
USP: 25 mg Pharma
(Scilife Spec)
Anti-Hypertensive
10/320/25 mg Rs. 20,000/- Tablet
Each film coated Dy. No.1157 Exforge HCT
tablet contains: 08-06-2016) 10/320/25 mg
Besylate)
Valsartan: 320 mg Tri-Valsan by
Hydrochlorothiazide M/s Hilton
USP: 25 mg Pharma
(Scilife Spec)
Anti-Hypertensive
489. -do- Cowaldi Tablet 400 Form 5 FDA approved Stability Deferred
mg Rs. 20,000/- Tablet Sovaldi data is for
Each film coated Dy. No. 1186 400 mg required.
tablet contains: 08-06-2016 manufactured by
submissio
Sofosbuvir 400 mg 30’s As Per SRO Gilead science n of
(Scilife Spec) stability
Anti-Hepatitis C Tablet Sofos data as per
400 mg by guidelines
Genix Pharma
approved
by
registratio
n Board in

251st
meeting
490. -do- Arixa Tablet 10 mg Form 5 FDA approved Approved

Each film coated Rs. 20,000/- Tablet Xarelto
Rivaroxaban 10 mg 08-06-2016 manufactured by
(Scilife Spec) 14’s,28’s Janssen Pharms
Anti-Coagulant As Per SRO
Tablet
Xarelto 10 mg
manufactured by
Bayer

Anti-Coagulant As Per SRO
Tablet
Xarelto 15 mg
manufactured by
Bayer

Anti-Coagulant
Tablet
Xarelto 20 mg
manufactured by
Bayer
493. -do- Wilda-M Tablet Form 5 TGA & EMA Approved
50/500 mg Rs. 20,000/- approved Tablet
Each film coated Dy. No.1192 Eucreas 50/500
tablet contains: 08-06-2016 mg
Vildagliptin 14’s,28’s manufactured by
50 mg As Per SRO Novartis
Metformin HCl 500
mg Tablet
(Scilife Spec) Galvus Met
Anti-Diabetic 50/500 mg
manufactured by
Novartis

Vildagliptin manufactured by
50 mg 14’s,28’s Novartis

Metformin HCl 850 As Per SRO Tablet
mg Galvus Met
(Scilife Spec) 50/850 mg
Anti-Diabetic manufactured by
Novartis
Vildagliptin Pack of 14’s/as per manufactured by
50 mg DPC Novartis
Metformin HCl 1000 28’s / as per DPC
mg Tablet
(Scilife Spec) Galvus Met
Anti-Diabetic 50/1000 mg
manufactured by
Novartis
496. -do- Dolobid-P Tablet Form 5 FDA approved Approved

325/37.5 mg Rs. 20,000/- Tablet Ultracet with
Each film coated Dy. No.1190/- 325/37.5 mg
change of
Paracetamol 10’s,30’s Janssen Pharm brand
325 mg As Per SRO name
Tramadol HCL 37.5
mg Tablet
(Scilife Spec) Tramal Plus
Analgesic 325/37.5 mg
manufactured by
Searle Pharma
497. -do- Omitax Tablet 10/10 Form 5 FDA approved Approved

mg Rs. 20,000/- Tablet Diclegis
Each enteric coated Dy. No. 1185 10/10 mg
tablet contains 08-06-2016 manufactured by
Doxylamine 10’s,30’s Duche Snay
Succinate 10 mg
Pyridoxine Tablet
Hydrochloride 10 mg Envepe 10/10
(Scilife Spec) mg
Anti-emetic manufactured by
RG Pharma
498. -do- Romilast Tablet 500 Form 5-D FDA approved Stability Deferred
mcg Rs. 50,000/- Tablet data is for
Each tablet contains: Dy. No. Daliresp 500 required.
Roflumilast 08-06-2016 mcg
submissio
500 mcg 10’s,20’s,30’s manufactured by n of
(Scilife Spec) As Per SRO Astrazeneca stability
Phosphodiesterase Pharms data as per
Inhibitor guidelines
approved
by
registratio

n Board in
251st
meeting
499. -do- Scimox Tablet 400 Form 5 FDA approved Approved

mg Rs. 20,000/- Tablet Avelox
Each Film coated Dy. No. 1191 400 mg
Moxifloxacin…400 5’s/ As Per SRO Bayer Health
mg (as care
Hydrochloride)
(Scilife Spec) Tablet
Quinolones Moxiget 400
Antibiotic mg
manufactured by
Getz Pharma
Capsule (General)
500. Scilife Pharma Dolobid Capsule Form 5 TGA Approved Approved
(Private) Limited 50mg Rs. 20,000/- Zydol by M/s with
Plot # FD-57/58-A2, Dy. No.1183 Arrow Pharma
Korangi Creek Each capsule 08-06-2016
change of
Industrial park (KCIP) contains 10’s,30’s Tamadol 50 mg brand
Karachi Tramadol HCl 50mg As Per SRO (Highnoon name
Pharma)
Capsule (General) Analgesic (Scilife
approved in 247st Spec)
meeting of Central
Licensing Board held
on 29-04-2016.
501. -do- Duloxa Capsule Form 5 FDA approved Approved
20mg Rs. 20,000/- capsule
Each capsule Dy. No.1182 Cymbalta 20 mg
contains 08-06-2016 manufactured by
Duloxetine HCL 14’s,28’s Lilly
17.65% enteric
coated pellets Dulan 20 mg
equivalent to 20 mg (Hilton Pharma)
Duloxetine
Serotonin/Nor
epinephrine Re-
uptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
laboratories Private
Limited,
Sheikhupura

Duloxetine HCL Lilly
17.65% enteric 14’s,28’s
coated pellets As Per SRO Dulan 30 mg
equivalent to 30 mg (Hilton Pharma)
Duloxetine
Serotonin/Nor
epinephrine Re-
uptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
Limited,
Sheikhupura
Duloxetine HCL 14’s, 28’s As Lilly
17.65% enteric Per SRO Dulan 60 mg
coated pellets (Hilton Pharma)
equivalent to 60 mg
Duloxetine
Serotonin/Nor
epinephrine Re-
uptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
Limited,
Sheikhupura
504. -do- Timsol Capsule 0.4 Form 5 FDA approved Approved
mg Rs. 20,000/- capsule Flomax
Dy. No.1178 0.4 mg
Each capsule 08-06-2016 manufactured by
contains 20’s,30’s Boehringer
Tamsulosin HCl As Per SRO Ingelheim
0.2% Pellets
equivalent to 0.4 mg Tamsolin 0.4 mg
Tamsulosin (Getz Pharma)
Peripherally acting
anti-adrenergic
(Scilife Spec)
Source of pellets
M/s Vision
Pharmaceuticals,
Islamabad
505. -do- Ozon Capsule 20 Form 5 FDA approved Approved
mg Rs. 20,000/- capsule Prilosec
Each capsule Rs.80000/- Dy. 20 mg
contains No.1177 08- manufactured by

Omeprazole 12.5% 06-2016 Astrazeneca
Enteric coated Pharma
Pellets equivalent to 14’s,28’s
20 mg Omeprazole Risek 20 mg
(Getz Pharma)
Proton Pump
Inhibitor
(Scilife Spec)
Source of pellets
M/s Spansules
Formulation, India
506. -do- Ozon Capsule 40 Form 5 FDA approved Approved

mg Rs. 20,000/- capsule Prilosec
Rs.80000/- Dy. 40 mg
Each capsule No.1176 08- manufactured by
contains 06-2016 Astrazeneca
Omeprazole 12.5% Pharma
Enteric coated Pack of
Pellets equivalent to 14’s / as per Risek 40 mg
40 mg Omeprazole DPC (Getz Pharma)
28’s / as per
Proton Pump DPC
Inhibitor
(Scilife Spec)
Source of pellets
M/s Spansules
Formulation, India
507. -do- Mebrin MR Capsule Form 5 MHRA Approved
200 mg Rs. 20,000/- approved
Rs.80,000/- capsule Colofac
Each capsule Dy. No.1179 MR
Mebeverine HCl 10’s,20’s As Abbott
MR 80% Pellets 200 Per SRO
mg Mebever MR
200 mg
Anti-Spasmodic (Getz Pharma)
(Scilife Spec)
Source of pellets
M/s Spansules
Formulation, India
508. -do- Dexlanz Capsule 30 Form 5 USFDA Me too Deferred
mg Rs. 20,000/- approved needs to for
Rs.80,000 capsule
Each gastro resistant Dy. No.1205 Dexilant 30 mg
be submissio
Capsule contains: 08-06-2016 manufactured by verified. n of
Dexlansoprazole 14’s / As Per Takeda Pharma application
22.5% Enteric SRO on Form
Coated Pellets…… 5D,
30 mg
requisite
fee and

Proton pump stability
Inhibitor data as per
(Scilife Spec)
guidelines
Source of pellets approved
M/s Spansules by
Formulation, India registratio
n Board in
251st
meeting
509. -do- Dexlanz Capsule 60 Form 5 USFDA Me too Deferred
mg Rs. 20,000/- approved needs to for
Each gastro resistant Rs.80,000/-Dy. capsule
Capsule contains: No.1204 Dexilant 60 mg
be submissio
Dexlansoprazole 08-06-2016 manufactured by verified. n of
22.5% Enteric 14’s As Per Takeda Pharma Invalid application
Coated Pellets….60 SRO GMP on Form
mg Me too needs to certificat 5D,
Proton pump be verified.
Inhibitor
e requisite
(Scilife Spec) attached. fee and
Source of pellets stability
M/s Spansules data as per
Formulation, India guidelines
approved
by
registratio
n Board in
251st
meeting
Sachet (General)
510. Scilife Pharma (Private) Asthiven 4mg Form 5 FDA Approved Approved
Limited Sachet Rs. 20,000/- Singular
Plot # FD-57/58-A2, Each Sachet Dy. No.1203 Merck (FDA)
Korangi Creek contains 08-06-2016 Solo Powder 4
Industrial park (KCIP) Montelukast 14’s,28’s mg
Karachi Sodium eq. to As Per SRO manufactured by
Montelukast 4 mg (Atco)
Sachet (General) Leukotriene
approved in 247st receptor antagonist
meeting of Central (Scilife Spec)
Licensing Board held
on 29-04-2016.
511. -do- Ozon Insta Powder Form 5 FDA Approved In Deferred
20 mg Sachet Rs. 20,000/- Zegerid review in as
Dy. No.1196 Santarus INC
Each Sachet 08-06-2016
250th formulatio
contains 10’s,30’s Risek Insta meeting n is under
Omeprazole As Per SRO Powder 20 mg
20 mg manufactured by
Sodium (Getz Pharma)
Bicarbonate 1680

mg (as buffer)
Proton Pump
Inhibitor
(Scilife Spec)
512. -do- Ozon Insta Powder Form 5 FDA Approved Internati Deferred
40 mg Sachet Rs. 20,000/- Zegerid onal as
Each Sachet Dy. No.1195 Santarus INC
contains 03-06-2016 Risek Insta
availabili formulatio
Omeprazole 10’s,30’s Powder 40 mg ty n is under.
40 mg As Per SRO manufactured by discontin Also
Sodium (Getz Pharma) ue from confirmati
Bicarbonate 1680 market. on
mg (as buffer)
Proton Pump
In regarding
Inhibitor review in approval
(Scilife Spec) 250th status by
meeting reference
regulatory
authorities
513. -do- Forlax Sachet Form 5 TGA & MHRA Approved
Each Sachet Rs. 20,000/- Approved
contains Dy. No.1201 Movicol Sachet
PEG 3350 08-06-2016
Norgine Limited
…..13.125 g
Sodium Chloride…. 10’s,20’s
Movcol
0.3507 g As Per SRO
manufactured by
Sodium
(Genix Pharma)
bicarbonate….
0.1785 g
Potassium
chloride…
0.0466 g
Somatically acting
laxatives (Scilife
Spec)
514. -do- Forlax Junior Form 5 TGA & MHRA Composi Deferred
Sachet Rs. 20,000/- Approved tion API for
Each Sachet Dy. No.1200 Movicol Junior
contains 08-06-2016) Sachet
in me confirmati
PEG 3350 too is on of
Norgine Limited different compositio
…..6.563 g 10’s,20’s
Sodium Chloride…. As Per SRO
Movcol from the n as per
0.1754 g
manufactured by product me too
Sodium
bicarbonate….
(Genix Pharma) applied
0.0893 g for
Potassium
chloride… Sodium
0.0251 g Chloride…
.
Somatically acting 350.7mg
laxatives (Scilife Sodium
Spec) bicarbonat

e….
178.5mg
Potassium
chloride…
46.6mg
515. -do- Hydro Sachet Form 5 Non- Composi Approved

Each Sachet Rs. 20,000/- Proprietary Oral tion API
contains Dy. No.1199 Rehydration
Anhydrous Glucose 08-06-2016 Salt BP
in me
13.50 g too is
WHO different
Tri sodium citrate 20’s,30’s As
Recommended
Dihydrate 2.90 g Per SRO
Formulation from the
Sodium Chloride product
2.60 g Cellchem
Potassium Chloride
applied
Pharmaceutical
1.50 g Incorporation, for
Canada
Electrolyte Solution Anhydrous
(Anti-diarrheal) Glucose 20
Peditral Sachet
g
by M/s Searl
(Scilife Spec) sodium
Pharma
citrate
2.90g
Sodium
Chloride
3.5g
516. -do- One soda Sachet Form 5 TGA Approved Composi Deferred
Rs. 20,000/- Ural sachet tion of for
Each Sachet Dy. No.1197 Aspen Pharma
contains 08-06-2016
API in confirmati
Sodium Bicarbonate 20’s Citro soda ural on of
1.716 g As Per SRO manufactured by sachet is compositio
Sodium citrate (Abbott) different n as per
0.613g from the me too
Citric acid
0.702 g
product
Tartaric acid 0.858 applied
g for
Urinary and gastric Sodium

alkaliniser Bicarbonat
(Scilife Spec) e 1.76 g
Sodium
citrate
0.63g
Citric acid
0.72 g
Tartaric
acid 0.89 g
517. -do- Mehvisk Sachet Form 5 MHRA Approved Approved

Rs. 20,000/- Dy. Fybogel
Each Sachet contains No.1198 08-06- Mebeverine

Mebeverine HCl 135 2016 Forum Health
mg 10’s,20’s Product Limited
Isaphagul husk 3.5 g As Per SRO
Musk-MSachet
Antispasmodic, Anti manufactured by
Constipative Genix Pharma )
(Scilife Spec)
Evaluator-I Muhammad Ansar

Additional Sections.
Additional section Veterinary
S/N Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + formulation (if Evaluator/
manufacture Dosage Form + Strength) Initial date, diary any) including Decision
r / Applicant International
Composition Fee including status in
differential fee stringent drug
Pharmacological Group regulatory
Demanded Price / agencies /
Finished product Pack size authorities
Specification
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
518. M/s Sanna ATC-Forte Oral water Form 5 Approved
Laboratories, Soluble Powder
1019-B, Dy No.442 dated 20- Local. Amox-C
PSIE, Each 100gm contains:- 05-2016 Rs.20,000. Maarson by
Sargodha Amoxicillin Decontrolled/100gm, Attabak.
Road, Trihydrate……50gm 300gm, 500gm, 1kg,
Faisalabad. Colistin 5kg, 10kg & 25kg.
Sulphate…….50MIU
Antibacterial
Manufacturer’s
Specifications
519. -do- Himox-50 Oral water Form 5 Approved
Soluble Powder
Dy No.446 dated 20- Local. Amoxi-50
Each 1000gm contains:- 05-2016 Rs.20,000. by M/s Symans.
Amoxicillin Trihydrate eq
to Amoxicillin……500gm Decontrolled/100gm,
300gm, 500gm, 1kg,
Antibacterial 5kg, 10kg & 25kg.

520. -do- Lincosac-200 Oral water Form 5 Approved
Soluble Powder
Dy No.440 dated 20- Local. Amoxy
Each 1000gm contains:- 05-2016 Rs.20,000. L.S by M/s
Amoxicillin Trihydrate Inshall.
……20gm Decontrolled/100gm,
Lincomycin 300gm, 500gm, 1kg,
HCl……….8.8gm 5kg, 10kg & 25kg.
Spectinomycin
2HCl…….8.8gm
Antibacterial
Manufacturer’s
Specifications
521. -do- Clavmox-Forte Oral water Form 5 Approved
Soluble Powder
Dy No.445 dated 20- Local.
Each 100gm contains:- 05-2016 Rs.20,000. Wealmox-Plus
Amoxicillin as by M/s Prix.
Amoxicillin Trihydrate Decontrolled/100gm,
……16gm 300gm, 500gm, 1kg,
Clavulanic Acid as 5kg, 10kg & 25kg.
Potassium
Clavulanate……4gm
Bromhexine
HCl…………….0.5gm
Antibacterial
Manufacturer’s
Specifications
522. -do- Clavmox-200 Oral water Form 5 Approved
Soluble Powder
Dy No.441 dated 20- Local. Primox-
Each 100gm contains:- 05-2016 Rs.20,000. Plus by M/s Prix.
Amoxicillin as
Amoxicillin Trihydrate Decontrolled/100gm,
……16gm 300gm, 500gm, 1kg,
Clavulanic Acid as 5kg, 10kg & 25kg.
Potassium
Clavulanate……4gm
Antibacterial
523. -do- Himox-70 Oral water Form 5 Approved

Soluble Powder
Dy No.443 dated 20- Local. Primox
Each 100gm contains:- 05-2016 Rs.20,000. 70% by M/s
Amoxicillin Trihydrate Prix.
80gm eq to Amoxicillin Decontrolled/100gm,
……70gm 300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Antibacterial

524. -do- GP-80 Oral water Soluble Form 5 Approved
Powder
Dy No.444 dated 20- Local. PSB-100
Each 1000gm contains:- 05-2016 Rs.20,000. by M/s Epla.
Zinc Bacitracin ……52gm
Procaine Penicillin Decontrolled/100gm,
……..12gm 300gm, 500gm, 1kg,
Streptomycin 5kg, 10kg & 25kg.
Sulphate……36gm
Antibacterial
M/s Vision Pharma Human Additional section
S/N Name and Brand Name Type of Remarks on the Remarks by Decision
address of (Proprietary name + Dosage Form formulation (if Evaluator/
manufacturer / Form + Strength) any) including Decision
Applicant Initial date, International
Composition diary status in stringent
drug regulatory
Pharmacological Group Fee including agencies /
differential authorities
Finished product Specification fee
Me-too status
Demanded
Price / Pack GMP status as
size depicted in latest
inspection report
(with date) by the
Evaluator
525. M/s Vision Linzy 600mg Infusion Form 5 MHRA. Linzolid Approved
Pharmaceuticals 2mg/ml by M/s
, Plot No. 22 & Each vial of 300ml contains:- Dy No. 2713 Pfizer
23, Industrial Linezolid……….…..600mg dated 16-06-
Triangle Kahuta 2016 Local. Lezol
Road, Antibiotic Rs.20,000. 600mg by M/s
Islamabad. Bosch.
“Liquid Vial Manufacturer’s Specifications As per
General SRO/1’s
approved in
247th meeting of
CLB.”
526. -do- Linzy 400mg Infusion Form 5 MHRA. Linzolid Approved
2mg/ml by M/s
Each vial of 200ml contains:- Dy No. 2715 Pfizer
Linezolid……….…..400mg dated 16-06-
2016 Local. Lezol
Antibiotic Rs.20,000. 400mg by M/s
Bosch.
Manufacturer’s Specifications As per
SRO/1’s
527. -do- Linzy 200mg Infusion Form 5 MHRA. Linzolid Approved
2mg/ml by M/s
Linzolid……….…..200mg dated 16-06-
2016 Local. Zolrest

Antibiotic Rs.20,000. 200mg by M/s
Bosch.
SRO/1’s
528. -do- Katafast 500mg Injection Form 5 MHRA. Ketalar Approved
50mg/ml by M/s
Ketamine hydrochloride dated 16-06-
equivalent to ketamine………. 2016 Local. Ketarol
…..500mg Rs.20,000. 500mg by M/s
Global
Anesthetic As per Pharmaceuticals
SRO/1’s
USP Specifications
529. -do- Odimox 400mg Infusion Form 5 MHRA. Avelox by Approval Advised to
M/s Bayer status in apply Form 5
Each vial of 100ml contains:- Dy No. 2706 400mg/250ml reference with 250ml
Moxifloxacin hydrochloride dated 16-06- countries not
equivalent to 2016 Local. Barimox provided.
Moxifloxacin……….…..400mg Rs.20,000. 400mg by M/s
Barrett Hodgson.
Antibiotic As per
SRO/1’s
530. M/s Vision Artip 40mg Injection Form 5 Approved
Pharmaceuticals Local. Artem
, Plot No. 22 & Each ampoule contains:- Dy No. 2703 40mg by M/s
23, Industrial Artemether……….…..40mg dated 16-06- Holton Pharma
Triangle Kahuta 2016 (PVT) Limited
Road, Antimalarial Rs.20,000.
Islamabad.
“Liquid Manufacturer’s Specifications As per
Ampoule SRO/1x5’s &
General 1x10’s
approved in
247th meeting of
CLB.”
531. -do- Artip 80mg Injection Form 5 WHO approved Approved
Each ampoule of 1 ml contains:- Dy No. 2702 Local. Artem

Artemether……….…..80mg dated 16-06- 80mg by M/s
2016 Holton Pharma
Antimalarial Rs.20,000. (PVT) Limited

SRO/1x5’s &
1x10’s
532. -do- Feldex 20mg Injection Form 5 Approval Deferred for
status in confirmation
Each ampoule contains:- Dy No. 2705 Local. Pcam 20mg reference of approval
Piroxicam……….…..20mg dated 16-06- by M/s Merck countries is not status by
2016 (Pvt) Limited provided. reference
NSAID Rs.20,000. regulatory
authorities.

SRO/1x5’s &
1x10’s
533. -do- Doston 4mg Injection Form 5 MHRA. Zofran by Approved
M/s GSK
Each ampoule of 2ml contains:-
Dy No. 2771
Ondansetron hydrochloride
dated 20-06-
equivalent to Ondansetron…….
2016 Local. Ondiemetic
…..4mg
Rs.20,000. 4mg by M/s Zafa
As per Pharmaceuticals
5-HT3 Receptor Antagonist
SRO/1x5’s &
1x10’s
USP Specifications
534. -do- Doston 8mg Injection Form 5 MHRA. Zofran by Approved
M/s GSK
Each ampoule 0f 4ml contains:- Dy No. 2770
Ondansetron hydrochloride dated 20-06- Local. Ondiemetic
equivalent to Ondansetron……. 2016 8mg by M/s Zafa
…..8mg Rs.20,000. Pharmaceuticals
5-HT3 Receptor Antagonist As per

SRO/1x5’s &
USP Specifications 1x10’s
535. -do- Tramax 50mg Injection Form 5 MHRA. Tramadol Approved
by M/s Beacon
Each ampoule of 1ml contains:- Dy No. 2710
Tramadol hydrochloride dated 16-06- Local. Tramal
equivalent to Tramadol……. 2016 50mg by M/s
…..50mg Rs.20,000. Searle Pakistan
(Pvt) Limited.
Opioid analgesic As per
SRO/1x5’s &
536. -do- Spasmax Plus Injection Form 5 The product is Deferred as
under review. product is
Each ampoule contains:- Dy No. 2774 Local. Spadix by under review.
Phloroglucinol dehydrate dated 20-06- M/s Tabros
equivalent to 2016 Pharma.
Phloroglucinol…….40mg Rs.20,000.
Trimethylphloroglucinol….0.04m
g As per
SRO/1x5’s &
Antispasmodic 1x10’s
537. -do- Zytec 25mg Injection Form 5 MHRA. Ranitidine Approved
25mg/ml by M/s
Each ampoule of 1ml contains:- Dy No. 2702 Amdipharm
Ranitidine hydrochloride dated 16-06-
equivalent to 2016 Local. Ranitidine
Ranitidine…….25mg Rs.20,000. injection 25mg by
M/s
Histamine H2 receptor blocker As per Glaxosmithkline
SRO/1x5’s &
538. -do- Pyritec 150mg Injection Form 5 Deferred for
confirmation

Each ampoule 1ml contains:- Dy No. 2712 Local. Pravos of approval
Paracetamol………….150mg dated 16-06- 150mg injection by status by
2016 M/s Sami reference
Analgesic & antipyretic Rs.20,000. Pharmaceuticals regulatory
(Pvt) Limited. authorities.
SRO/1x5’s &
1x10’s
539. -do- Etorac 10mg Injection Form 5 MHRA Deferred for
confirmation
Each ampoule of ml contains:- Dy No. 2049 Local. Toradol of approval
Ketorolac tromethamine dated 26-05- 10mg injection by status by
equivalent to 2016 M/s Roche reference
Ketorolac………….10mg Rs.20,000. Pakistan Limited. regulatory
authorities.
NSAID As per
SRO/1x5’s &
540. -do- Etorac 30mg Injection Form 5 MHRA. Ketoralac Approved
30mg/ml by M/s
Each ampoule of 1ml contains:- Dy No. 2048 Beacon
Ketorolac tromethamine dated 26-05-
equivalent to 2016 Local. Toradol
Ketorolac………….30mg Rs.20,000. 30mg injection by
M/s Roche
NSAID As per Pakistan Limited.
SRO/1x5’s &
541. -do- Drotin 40mg Injection Form 5 Approved
Each ampoule of 2ml contains:- Dy No. 2709 Local. NO-SPA

Drotaverine hydrochloride dated 16-06- 40mg injection by
equivalent to Drotaverine. 2016 M/s Sanofi Aventis
……….40mg Rs.20,000. (Pakistan) Limited.
Antispasmodic As per
SRO/1x5’s &
Manufacturer’s Specifications 1x10’s
542. -do- Osteo-D 5mg Injection Form 5 Approved
Each ampoule of 1ml contains:- Dy No. 2047 Local. Calciferol

Cholecalciferol….……….5mg dated 26-05- 5mg injection by
2016 M/s Global
Vitamin Rs.20,000. Pharmaceuticals.
BP Specifications As per
SRO/1x5’s &
1x10’s
543. M/s Vision Indocin 1mg Injection Form 5 FDA approved Deferred as
Pharmaceuticals product is
, Plot No. 22 & Each vial contains:- Dy No. 2711 Local. Liometacen more than 10.
23, Industrial Indomethacin sodium ready to fill dated 16-06- Injection by M/s
Triangle Kahuta powder equivalent to 2016 Chiesi
Road, Indomethacin….……….1mg Rs.20,000. Pharmaceuticals
Islamabad. (Pvt) Limited.

“Sterile Dry NSAID As per
Powder SRO/1’s
Inectable Vials USP Specifications
General
approved in
240th meeting of
CLB.”
544. -do- Viscortin 100mg Injection Form 5 FDA approved Approved
Each vial contains:- Dy No. 2050 Local. Hy-

Hydrocortisone sodium succinate dated 26-05- cortisone 100mg
ready to fill powder equivalent to 2016 Injection by M/s
Hydrocortisone ….……….100mg Rs.20,000. Cirin
Pharmaceuticals
Glucocorticoid As per (Pvt) Limited.
SRO/1’s
USP Specifications

Pharmaceuticals
SRO/1’s
USP Specifications

Pharmaceuticals
SRO/1’s
USP Specifications
547. -do- Vanacin 500mg Injection Form 5 MHRA. Approved
Vancomycin
Each vial contains:- Dy No. 2056 500mg by M/s
Vancomycin hydrochloride ready dated 26-05- Actavis
to fill powder equivalent to 2016
Vancomycin….. …. Rs.20,000.
……….500mg Local. Vinjec
As per 500mg Injection
Antibiotic SRO/1’s by M/s Bosch
Pharmaceuticals
USP Specifications (Pvt) Limited.
548. -do- Vanacin 1g Injection Form 5 MHRA. Approved
Vancomycin 1g by
Each vial contains:- Dy No. 2055 M/s Actavis
Vancomycin hydrochloride ready dated 26-05-
to fill powder equivalent to 2016 Local. Vinjec 1g
Vancomycin….. ….……….1g Rs.20,000. Injection by M/s
Bosch

Antibiotic As per Pharmaceuticals
SRO/1’s (Pvt) Limited.
USP Specifications
549. -do- Methlone 500mg Injection Form 5 MHRA. Approved
Methylprednisolon
Each vial contains:- Dy No. 2053 e Powder for
Methylprednisolone sodium dated 26-05- injection by M/s
succinate ready to fill powder 2016 Beacon.
equivalent to Methylprednisolone Rs.20,000.
….……….500mg Local. Methylpred
As per 500mg Injection
Glucocorticoid
SRO/1’s by M/s Haji
medicine co.
USP Specifications
550. -do- Methlone 1g Injection Form 5 MHRA. Approved
Methylprednisolon
Each vial contains:- Dy No. 2054 e Powder for
Methylprednisolone sodium dated 26-05- injection by M/s
succinate ready to fill powder 2016 Beacon.
equivalent to Methylprednisolone Rs.20,000.
….……….1g Local. Methylpred
As per 1g Injection by
Glucocorticoid SRO/1’s M/s Haji medicine
co.
USP Specifications
551. -do- Tigelin 50mg Injection Form 5 MHRA. Tygacil Approved
50mg Powder for
Each vial contains:- Dy No. 2708 infusion by M/s
Tigecycline ready to fill powder dated 16-06- Pfizer
equivalent to Tigecycline……. 2016
……….50g Rs.20,000. Local. Tigecycline
50mg Injection by
Antibiotic As per M/s Wyeth
SRO/1’s Pakistan Limited.
552. M/s Vision Galmet 50mg/500mg Tablet Form 5 TGA. Sobrea by Approved
Pharmaceuticals M/s Novartis
, Plot No. 22 & Each film coated tablet contains:- Dy No. 2714
23, Industrial Vildagliptin….………...50mg dated 16-06- Local. Galvusmet
Triangle Kahuta Metformin hydrochloride 2016 50mg/500mg
Road, equivalent to Metformin……….. Rs.20,000. Tablet by M/s
Islamabad. …500mg Novartis Pharma
“Tablet General As per (Pak) Limited.
approved in Antidiabetic SRO/2x7’s
240th meeting of
CLB.” Manufacturer’s Specifications
553. -do- Galmet 50mg/850mg Tablet Form 5 MHRA. Eucrease Approved
by M/s Novartis
Each film coated tablet contains:- Dy No. 2717
Vildagliptin….………...50mg dated 16-06- Local. Galvusmet
Metformin hydrochloride 2016 50mg/500mg
equivalent to Metformin……….. Rs.20,000. Tablet by M/s
…850mg Novartis Pharma
As per (Pak) Limited.
Antidiabetic SRO/2x7’s

554. -do- Galmet 50mg/1000mg Tablet Form 5 MHRA. Eucrase Approved
by M/s Novartis
Vildagliptin….………...50mg dated 16-06- Local. Galvusmet
Metformin hydrochloride 2016 50mg/1000mg
equivalent to Metformin……….. Rs.20,000. Tablet by M/s
…1000mg Novartis Pharma
As per (Pak) Limited.
Antidiabetic SRO/2x7’s
555. -do- Valent-H 80mg/12.5mg Tablet Form 5 MHRA. Co- Approved
Diovan by M/s
Each film coated tablet contains:- Dy No. 2773 Novartis.
Valsartan….………...80mg dated 20-06-
hydrochlorothiazide…….… 2016 Local. Co-Diavan
12.5mg Rs.20,000. 80mg/12.5mg
Tablet by M/s
Calcium Channel Blocker + As per Novartis Pharma
Diuretic SRO/2x7’s (Pak) Limited.
USP Specifications
556. -do- Valent-H 160mg/12.5mg Tablet Form 5 MHRA. Co- Approved
Diovan by M/s
Each film coated tablet contains:- Dy No. 2772 Novartis
hydrochlorothiazide…….… 2016 Local. Co-Diavan
12.5mg Rs.20,000. 160mg/12.5mg
Tablet by M/s
Calcium Channel Blocker + As per Novartis Pharma
Diuretic SRO/2x7’s (Pak) Limited.
USP Specifications
557. -do- Valent-H 160mg/25mg Tablet Form 5 MHRA. Co- Approved
Diovan by M/s
Each film coated tablet contains:- Dy No. 2775 Novartis
Hydrochlorothiazide…….…25mg 2016 Local. Co Valtec
Rs.20,000. 160mg/25mg
Calcium Channel Blocker + Tablet by M/s
Diuretic As per Tabros Pharma.
SRO/2x7’s
USP Specifications
558. -do- Co-Valzaar 5mg/80mg Tablet Form 5 MHRA. Exforge Approved
by M/s Novartis
Amlodipine….………...5mg dated 20-06- Local. Amstan
Valsartan………….…80mg 2016 5mg/80mg Tablet
Rs.20,000. by M/s Getz
Angiotensin Receptor Blocker + Pharma (Pvt)
Calcium Channel Blocker As per Limited.
SRO/2x7’s
USP Specifications

by M/s Novartis
Valsartan………….…160mg 2016 5mg/160mg Tablet
Rs.20,000. by M/s Getz
SRO/2x7’s
USP Specifications
560. -do- Co-Valzaar 5mg/320mg Tablet Form 5 Deferred for
confirmation
Each film coated tablet contains:- Dy No. 2767 Local. Amstan of approval
Amlodipine….………...5mg dated 20-06- 5mg/320mg Tablet status by
Valsartan………….…320mg 2016 by M/s Getz reference
Rs.20,000. Pharma (Pvt) regulatory
Angiotensin Receptor Blocker + Limited. authorities
Calcium Channel Blocker As per
SRO/2x7’s
USP Specifications
by M/s Novartis
Valsartan………….…160mg 2016 10mg/160mg
Rs.20,000. Tablet by M/s Getz
SRO/2x7’s
USP Specifications
562. -do- Co-Valzaar 10mg/320mg Tablet Form 5 Deferred for
confirmation
Each film coated tablet contains:- Dy No. 2765 Local. Amstan of approval
Amlodipine….………...10mg dated 20-06- 10mg/320mg status by
Valsartan………….…320mg 2016 Tablet by M/s Getz reference
Rs.20,000. Pharma (Pvt) regulatory
Angiotensin Receptor Blocker + Limited. authorities
Calcium Channel Blocker As per
SRO/2x7’s
USP Specifications
563. -do- Spasmax 40mg Injection Form 5 The product is Deferred as
under review the product is
Each ampoule of 4ml contains:- Dy No. 2848 Local. Spasfon by under review
Phloroglucinol dehydrate dated 23-06- M/s Hilton Pharma
equivalent to 2016 (Pvt) Limited.
Phloroglucinol…….40mg Rs.20,000.
Antispasmodic As per
SRO/1x5’s &
Manufacturer’s Specifications 1x10’s
564. -do- Nalfy Injection 20mg Form 5 FDA Nubail by Approved
M/s Endo
Each 01ml ampoule contains: Dy No. 2849
Nalbuphine Hydrochloride eq. to dated 23-06- Local. Nalbin
Nalbuphine………20mg 2016 20mg by M/s
Rs.20,000. Global

Pharmaceuticals.
Opioid
As per
SRO/1x5’s &
(Manufacturer’s Specifications )
1x10’s
565. -do- Form 5 FDA Nubail by Approved
Nalfy Injection 10mg
M/s Endo
Dy No. 2850
Each 01ml ampoule contains:
dated 23-06- Local. Nalbin
Nalbuphine Hydrochloride eq. to
2016 10mg by M/s
Nalbuphine………10mg
Rs.20,000. Global
Pharmaceuticals.
Opioid
As per
SRO/1x5’s &
(Manufacturer’s Specifications )
1x10’s
Remaining applications of M/s Sami Pharma, Karachi
566. M/s SAMI ROSERA 5mg Tablets Form 5 EMA: Crestor Fee Rs Approved. Fee
Pharmaceutical (AstraZeneca) 20,000 is a will be verified
s (Pvt.) Each film coated tablet contains: Rs. 20,000/- FDA: Crestor photocopy. by Budget and
Limited, F-95, Rosuvastatin Calcium MS (06-01-2014) (AstraZeneca) Accounts,
Off. Hub River equivalent to DRAP &
Road, S.I.T.E., Rosuvastatin As per SRO Rovista Regn. Chairman
Karachi-75730 ………………………..5mg No. 044043 Registration
(M/s Getz) Board will
(Tablet HMG Reductase Inhibitor permit
General) issuance of
Manufacturer’s Specs. registration
letter.
Pharmaceutical Rs. 20,000/- (AstraZeneca) 20,000 is a will be verified
s (Pvt.) Each film coated tablet contains: (06-01-2014) FDA: Crestor photocopy. by Budget and
Limited, F-95, Rosuvastatin Calcium MS (AstraZeneca) Accounts,
Off. Hub River equivalent to As per SRO DRAP &
Road, S.I.T.E., Rosuvastatin Rovista Regn. Chairman
letter.
Pharmaceutical Rs. 20,000/- (AstraZeneca) 20,000 is a will be verified
s (Pvt.) Each film coated tablet contains: (06-01-2014) FDA: Crestor photocopy. by Budget and
Limited, F-95, Rosuvastatin Calcium MS (AstraZeneca) Accounts,
Off. Hub River equivalent to As per SRO DRAP &
Road, S.I.T.E., Rosuvastatin Rovista Regn. Chairman
letter.
569. M/s SAMI Lenor 8mg Injection Form 5 Approval Deferred for

Pharmaceutical Each combination pack contain: Acabel Reg. status in confirmation
s (Pvt.) Vial: Dy No.206 No. 061605 reference of approval
Limited, F-95, Lornoxicam MS……….…8mg dated 01-06- (M/s countries is status by
Off. Hub River 2015 Rs. Continental not reference
Road, S.I.T.E., Ampoule: 20,000/- Pharma) provided. regulatory
Karachi-75730 Water for Injection authorities.
USP……….2ml
(Freeze Dried As per SRO
Products HMG Reductase Inhibitor
General)
Manufacturer’s Specs.

Evaluator-IV Salateen Waseem Philp
New License & New Sections Cases.
New License
S/N Name and Brand Name Type of Form International Remarks / Decis
address of (Proprietary name + Initial date, diary status in Observations
manufactur Dosage Form + Fee including stringent
er / Strength) differential fee regulatory
Applicant Composition Demanded Price / agencies
Pharmacological Pack size
Group Me-too status
Finished product
Specification GMP status
570. SURGILIN Silk Braided Form 5 with fee Rs Mersilk – Source of Raw Defe
E 20,000/- vide Dy. # Ethicon, UK braided silk for
A business Silk Braided sterile non 580 dated 16-06- Pearsalls Limited,follo
division of absorbable surgical 2016 Ethicon London clarif
the licensed suture (all sizes with all mersilk-
n:
unit types of needles as per Johnson & Source of needles :-
M/s Vikor USP) Pack size of 12 Johnson Enova® 300 needles,  D
Healthcare pieces  (import) a brand of Suturex & en
(Pvt.) Ltd, Sutures, Non absorbable RenodexSurgical re
Plot # C-126 silk DML # 000834 Needles, France o
to C-135, USP Specification Silk Suture re
LIEDA, Hub Section Sterilization :- ce
District, By Gamma so
Lasbella, irradiations o
Balouchistan b
si
an
n
 M
d
g
ra
n
ag
en
 S
y
te
fa
Demanded Price & Pack size
# Siz Length Curvature Length Point Unit Pack size Pric

e/ price pe
Ga pac
uge
s
1) 2 76 cm ½ circle 40 mm Round bodies heavy 191.59 12 2299
2) 1 76 cm ½ circle 35 mm Taper point 181.82 12 2181
3) 1 76 cm Curved 60 mm Curved cutting 181.82 12 2181
4) 1 76 cm ½ circle 30 mm Round bodies heavy 181.82 12 2181
5) 1 76 cm Straight 60 mm Cutting 181.82 12 2181
7) 0 76 cm ½ circle 50 mm Cutting 175.95 12 2111
8) 0 76 cm Straight 60 mm Cutting 175.95 12 2111
9) 0 1m Straight 75 mm Cutting 175.95 12 2111
10) 0 76 cm Curved 45 mm Reverse cutting 175.95 12 2111
11) 2/0 45 cm Curved 26 mm Reverse cutting 166.18 12 1994
12) 2/0 76 cm ½ circle 26 mm Taper point 166.18 12 1994
14) 2/0 76 cm Curved 16 mm Curved cutting 166.18 12 1994
15) 2/0 45 cm ½ circle 22 mm cutting 166.18 12 1994
18) 2/0 1m Straight 75 mm Cutting 166.18 12 1994
20) 2/0 45 cm Curved 26 mm Precision cutting 166.18 12 1994
22) 2/0 45 cm ½ circle 25 mm taper point 166.18 12 1994
25) 3/0 45 cm Curved 25 mm Slim blade 150.54 12 1806
26) 3/0 45 cm 3/8 circle 26 mm Conventional cutting 150.54 12 1806
30) 3/0 76 cm 5/8 circle 25 mm Cutting 150.54 12 1806
31) 3/0 45 cm ½ circle 22 mm Cutting 150.54 12 1806
34) 3/0 76 cm Curved 20 mm Taper point 150.54 12 1806
36) 3/0 76 cm Straight 60 mm Straight cutting 150.54 12 1806

48) 4/0 45 cm ½ circle 15 mm Slim blade 150.54 12 1806
58) 4/0 45 cm curved 26 mm Precision cutting 150.54 12 1806
571. SURGILINE Surgigut plain Form 5 with fee Rs Softcat plain Source of Catgut Defe
A business 20,000/- vide Dy. # BBRAUN plain string for
division of the Plain sterile 559 dated 16-06- USA Locally manufactured follo
licensed unit absorbable surgical 2016 at Vikor Healthcare clarif
M/s Vikor sutures (all sizes) Catgut – (Pvt.) Ltd under
n:
Healthcare (Pvt.) Ethicon license of basic
Ltd, Plot # C-126 Catgut plain sterile Pack size of 12 (Import) manufacturing DML  D
to C-135, absorbable surgical pieces  # 000835. en
LIEDA, Hub sutures DML # 000834 re
District, Lasbella, USP Specification Catgut sutures Source of needles :- o
Balouchistan (absorbable) Enova® 300 needles, re
Section a brand of Suturex & ce
RenodexSurgical so
Needles, France o
n
Sterilization :-
 M
By Gamma
d
irradiations
g
ra
n
ag
en
 S
y
te
fa
.
 S
o
ca
m
l

# Size / Length Curvature Length Point Unit price Pack size Pric
Gauges pa
1) 1 76 cm ½ circle 40 mm Reverse Cutting 211.14 12 253
6) 0 76 cm Curved 26 mm Curved cutting 191.59 12 229
13) 2/0 76 cm Straight 38 mm Straight cutting 181.82 12 218
14) 2/0 76 cm ½ circle 30 mm cutting 181.82 12 218
15) 3/0 76 cm ½ circle 20 mm Taper Point 168.13 12 201
18) 3/0 76 cm ½ circle 16 mm Cutting 168.13 12 201
19) 3/0 76 cm Curved 26 mm Curved Cutting 168.13 12 201
572. SURGILI Surgigut Chromic Form 5 with fee Rs Softcan Chrom Source of Catgut Defe
NE 20,000/- vide Dy. # – BBRAUN, plain string for
A business Catgut chromic sterile 558 dated 16-06- USA Locally manufactured follo
division of absorbable surgical 2016 at Vikor Healthcare clarif
the suture (all sizes) Catgut – (Pvt.) Ltd under n:
licensed Ethicon license of basic
unit Catgut sterile absorbable Pack size of 12 (Import) manufacturing DML  D
M/s Vikor surgical sutures pieces  # 000835. en
Healthcare USP Specification DML # 000834 Source of needles :- re
(Pvt.) Ltd, Catgut sutures Enova® 300 needles, o
Plot # C- (absorbable) a brand of Suturex & re
126 to C- Section RenodexSurgical ce
135, Needles, France so
LIEDA, Sterilization :- o
Hub By Gamma n
District, irradiations  M
Lasbella,
Balouchista d
n g
ra
n
ag
en

 S
y
te
fa
.
 S
o
ca
m
l

# Size / Length Curvature Length Point Unit Pack size Pric
Gauges price pa
1) 2 76 cm ½ circle Heavy 35 mm Taper cut 232.65 12 279
3) 2 76 cm ½ circle Heavy 40 mm Taper point 232.65 12 279
6) 2 76 cm ½ circle 40 mm Reverse cutting 232.65 12 279
9) 2 76 cm ½ circle Heavy 40 mm Trocar point 232.65 12 279
12) 1 76 cm Curved 45 mm Taper point 220.92 12 265
15) 1 76 cm Curved 63 mm Blunt pint round bodied 220.92 12 265
16) 1 76 cm Curved 85 mm Blunt pint round bodied 220.92 12 265
19) 1 76 cm ½ circle 40 mm Taper cut 220.92 12 265
33) 0 76 cm Straight 40 mm Taper point 211.14 12 253
42) 0 76 cm 5/8 circle 35 mm Taper point 211.14 12 253
47) 0 76 cm ½ circle 45 mm Cutting 211.14 12 253
48) 0 260 Meeting
Minutes for th
76 cm Registration
HookBoard
needle 35 mm Round bodied 211.14
312 12 253
49) 2/0 76 cm Straight 40 mm Taper point 191.59 12 229
50) 2/0 76 cm Straight 50 mm Taper point 191.59 12 229
56) 2/0 76 cm ½ circle 25 mm Taper cut 191.59 12 229
59)
573. M/s2/0 76 cm
Medisol NS IV ½ circle 25
FORM 5 mm Taper point
Sodium 191.59 12 229
Defer
60) 2/0
MEDIPAK 76 cm
Infusion- B.P-½ circle 45 mm
Rs 20,000/- Taper point 0.9%
Chloride 191.59 12 for229
61) 2/0
LIMITED, 76 cm ½ circle 50 mm
24.05.16 Taper
IV point
infusion BP 191.59 12 229
provi
62) 2/0
554, Sundar 76 cm ½ circle
Each 100ml contains. 60 mm Taper pointHealth
(Baxter 191.59 12 of229
ap
63) 2/0
Industrial 76 cm 5/8 circle
Sodium Chloride….. 60 mm Taper
carepoint
Limited 191.59 12 229
status
64) 2/0
Estate, 76 cm
0.9g ½ circle Pack35size
mm100ml Taper (UK)point 191.59 12 229
formu
65) Lahore.
2/0 Water for Injection
76 cm ½ circleq.s plus35Eurocap
mm price Taper cut 191.59 12 in229
66) 2/0 100ml
76 cm ½ circle heavy with45single
mm & double Sterifluid
Taper cut NS 191.59 12 pack
229
67) (Intravenous
2/0 76 cm ½ circle injection
30 mm ports (FDL
Taper cutLimited) 191.59 12 by229
68) infusion)
2/0 Electrolytes
76 cm ½ circle heavy 25As
Price mm per SRO Taper cut 191.59 12 refere
229
69) approved
2/0 in 76 cm (B.P Specification)
½ circle heavy 50 mm DML
Taper point 191.59 12 regul
229
th
70) 2473/0 meeting 76 cm ½ circle 26mm Inspection
Reverse cutting 172.04 12 autho
206
71) of CLB
3/0 held 76 cm Straight 50mm dated
Taper 16.03.16
point 172.04 12 206
72) on 29.04.16
3/0 76 cm Curved 45mm Taper point 172.04 12 206
574.
73) 3/0 -do- Medisol
76 cm NS IV
½ circle FORM20mm 5 Sodium
Taper point 172.04 12 Defer
206
74) 3/0 Infusion- B.P-
76 cm ½ circle Rs 20,000/-
25mm Chloride
Taper point 0.9% 172.04 12 for206
75) 3/0 76 cm 5/8 circle 24.05.16
25mm , Taperinfusion
IV cut BP 172.04 12 provi
206
76) 3/0 Each 100ml contains.
76 cm ½ circle 30mm (Baxter
Taper cutting Health 172.04 12 of206
ap
Sodium Chloride...... Pack size 250ml care Limited status
77) 3/0 76 cm ½ circle 30mm Taper point 172.04 12 206
0.9g (UK) formu
78) 3/0 76 cm Hook needle 25mm Round bodied 172.04 12 206
Water for Injection q.s Price =As per SRO in
79) 4/0 76 cm ½ circle 20mm Taper point 168.13 12 201
100ml plus Eurocap price Sterifluid NS pack
80) 4/0 76 cm Curved with16mm
single & doubleTaper point 168.13 12
(FDL Limited) by201
Electrolytes injection ports refere
DML regul
(B.P Specs) Inspection autho
dated 16.03.16
575. -do- Medisol NS IV FORM 5 Sodium App
Infusion- B.P- Rs 20,000/- Chloride 0.9%
24.05.16 , IV infusion BP
Each 100ml contains. (Baxter Health
Sodium Pack size 500ml care Limited
Chloride.......0.9g (UK)
Water for Injection q.s Price =As per SRO
100ml plus Eurocap price Sterifluid NS
with single & double (FDL Limited)
Electrolytes injection ports
DML
(B.P Specs) Inspection
dated 16.03.16
576. -do- Medisol NS IV FORM 5 Sodium App
Infusion- B.P- Rs 20,000/- Chloride 0.9%
24.05.16 , IV infusion BP
Each 100ml contains. (Baxter Health
Sodium Pack size 1000ml care Limited
Chloride......0.9g (UK)
Water for Injection q.s Price =As per SRO
100ml plus Eurocap price Sterifluid NS
with single & double (FDL Limited)
Electrolytes injection ports
DML

(B.P Specs) Inspection
dated 16.03.16
577. -do- Ciprofena IV Infusion FORM 5 Ciprofloxacin App
B.P Rs 20,000/- solution for
24.05.16 , Infusion
Each 100ml contains. (MHRA)
Ciprofloxacin as Pack size 100ml
lactate....200mg Ciproxin IV
Price =As per SRO Infusion (Bayer
Antibiotic plus Eurocap price Healthcare)
(B.P Specs) with single & double
injection ports DML
Inspection
dated 16.03.16
578. -do- Ciprofena IV Infusion FORM 5 Ciprofloxacin Defer
B.P Rs 20,000/- solution for for
24.05.16 , Infusion provi
Each 100ml contains. (MHRA) of ap
Ciprofloxacin as status
lactate....200mg Pack size 250ml Ciproxin IV formu
Water for Injection plus Eurocap price Infusion (Bayer in
q.s ....100ml with single & double Healthcare) pack
injection ports by
Antibiotic Price =As per SRO DML refere
(B.P Specs) Inspection regul
dated 16.03.16 autho
and
Pakis
579. Aquasteril -water for FORM 5 Water for Defer
injection)BP- Rs 20,000/- Injection for
24.05.16 , Antigen provi
International of ap
Each 100ml contains. Pack size 100ml Ltd Auckland- status
Water for Injection New Zeeland formu
100ml Price =As per SRO (MHRA) in
Diluent for Admixing plus Eurocap price pack
with single & double Water for by
(BP Specs) injection ports injection refere
(Otsuka Pvt regul
Limited) autho
and
Pakis
and
inten
use i
pack
580. Aquasteril -water for FORM 5 Water for Defer
Each 100ml contains. International of ap

Water for Injection Pack size 250ml Ltd Auckland- status
100ml New Zeeland formu
Price =As per SRO (MHRA) in
(Otsuka Pvt regul
Limited) autho
and
Pakis
and
inten
use i
pack
581. Aquasteril (water for FORM 5 Water for Defer
(Otsuka Pvt regul
Limited) autho
and
Pakis
and
inten
use i
pack
582. Aquasteril (water for FORM 5 Water for Defer
injection ports injection refere
(BP Specs) (Otsuka Pvt regul
Limited) autho
and
Pakis
and
inten
use i
pack

583. Medisol 5% IV Infusion FORM 5 Dextrose IV Defer
—B.P Rs 20,000/- Infusion for
24.05.16 , (B. Braun) provi
Each 100ml contains. of ap
Dextrose Pack size 100ml status
Anhydrous....5g Sterifluid -5 formu
Water for Injection Price =As per SRO (FDL Limited) in
q.s ....100ml plus Eurocap price DML pack
with single & double Inspection by
Carbohydrates injection ports dated 16.03.16 refere
regul
(B.P Specs) autho
and
Pakis
584. Medisol 5% IV Infusion FORM 5 Dextrose IV Defer
—B.P Rs 20,000/- Infusion for
24.05.16 , (B. Braun) provi
Each 100ml contains. of ap
Dextrose Pack size 250ml status
Anhydrous....5g Sterifluid -5 formu
Water for Injection Price =As per SRO (FDL Limited) in
q.s ....100ml plus Eurocap price pack
with single & double by
Carbohydrates injection ports refere
(B.P Specs) regul
autho
and
Pakis
585. Medisol 5% IV Infusion FORM 5 Dextrose IV App
—B.P Rs 20,000/- Infusion
24.05.16 , (B. Braun)
Each 100ml contains.
Dextrose Pack size 500ml
Anhydrous....5g Sterifluid -5
Water for Injection Price =As per SRO (FDL Limited)
q.s ....100ml plus Eurocap price
with single & double DML
Carbohydrates injection ports Inspection
dated 16.03.16
(B.P Specs)
586. Medisol 5% IV Infusion FORM 5 Dextrose IV App
—B.P Rs 20,000/- Infusion
24.05.16 , (B. Braun)
Each 100ml contains.
Dextrose
Pack size 1000ml
Anhydrous....5g
Sterifluid -5
Water for Injection
Price =As per SRO (FDL Limited)
q.s ....100ml
plus Eurocap price
Carbohydrates with single & double DML
injection ports Inspection
(B.P Specs) dated 16.03.16

587. Medigyl Injection B.P – FORM 5 Metronidazole App
Rs 20,000/- Infusion
Each 100ml contains. 24.05.16 , AFT Pharma
Metronidazole....0.5g New Zeeland
Water for Injection Pack size 100ml
q.s ....100ml
Price =As per SRO Flagyl
Anti amoebic plus Eurocap price Injection
with single & double (Sanofi)
(B.P Specs) injection ports
DML
Inspection
dated 16.03.16
588. Medigyl Injection B.P – FORM 5 Metronidazole Defer
Rs 20,000/- Infusion for
Each 100ml contains. 24.05.16 , AFT Pharma provi
Metronidazole....0.5g New Zeeland of ap
Water for Injection Pack size 250ml status
q.s ....100ml formu
Price =As per SRO Flagyl in
Anti amoebic plus Eurocap price Injection pack
with single & double (Sanofi) by
(B.P Specs) injection ports refere
DML regul
Inspection autho
dated 16.03.16 and
Pakis
589. Medisol-S IV Infusion FORM 5 Sterifluid 0.9% Defer
—B.P Rs 20,000/- Glucose 5% for
24.05.16 , Baxter provi
Each 100ml contains. Healthcare Ltd- of ap
1. Sodium Pack size 100ml UK) status
Chloride...0.9g formu
2. Dextrose Price =As per SRO Sterifluid DS in
Anhydrous...5g plus Eurocap price (FDL) pack
3. Water for Injection with single & double by
Q.S. injection ports DML refere
Inspection regul
Electrolytes + dated 16.03.16 autho
carbohydrates and
Pakis
B.P specs
590. Medisol-S IV Infusion FORM 5 Sterifluid 0.9% Defer
—B.P Rs 20,000/- Glucose 5% for
24.05.16 , Baxter provi
Each 100ml contains. Healthcare Ltd- of ap
1. Sodium Pack size 250ml UK) status
2. Dextrose Price =As per SRO Sterifluid DS in
Anhydrous...5g plus Eurocap price (FDL) pack
3. Water for Injection with single & double by

Q.S. injection ports DML refere
Inspection regul
Electrolytes + dated 16.03.16 autho
carbohydrates and
Pakis
B.P specs
591. Medisol-S IV Infusion FORM 5 Sterifluid 0.9% App
—B.P Rs 20,000/- Glucose 5%
24.05.16 Baxter
Each 100ml contains. Healthcare Ltd-
1. Sodium Pack size 500ml UK)
Chloride...0.9g
2. Dextrose Price =As per SRO Sterifluid DS
Anhydrous...5g plus Eurocap price (FDL)
3. Water for Injection with single & double
Q.S. injection ports DML
Inspection
Electrolytes + dated 16.03.16
carbohydrates
B.P specs
592. Medisol-S IV Infusion FORM 5 Sterifluid 0.9% App
—B.P Rs 20,000/- Glucose 5%
24.05.16 , Baxter
Each 100ml contains. Healthcare Ltd-
1. Sodium Pack size 1000ml UK)
Chloride...0.9g
2. Dextrose Price =As per SRO Sterifluid DS
Anhydrous...5g plus Eurocap price (FDL)
3. Water for Injection with single & double
Q.S. injection ports DML
Inspection
Electrolytes + dated 16.03.16
carbohydrates
B.P specs
593. Medisol Hartmann’s FORM 5 Compound Defer
(Compound Sodium Rs 20,000/- Sodium Lactate for
Lactate) 24.05.16 , solution for provi
IV Infusion—B.P Infusion of ap
Pack size 100ml (Baxter status
Each 100ml contains. Healthcare Ltd- formu
1. Sodium Chloride... Price =As per SRO UK) in
0.6g plus Eurocap price pack
2. Potassium Chloride... with single & double Sterifluid –RL by
0.04g injection ports (FDL Limited) refere
3. Calcium Chloride. DML regul
2H2O.. 0.027g Inspection autho
4. Sodium Lactate (50% dated 16.03.16 and
solution).. 0.64g Pakis
5. Water for Injection and

Q.S..100ml clarif
n for
Electrolytes of s
lactat
(B.P Specs) 50%
soluti
form
3. Calcium Chloride. regul
2H2O.. 0.027g DML autho
4. Sodium Lactate (50% Inspection and
solution).. 0.64g dated 16.03.16 Pakis
Q.S..100ml clarif
Electrolytes n for
of s
(B.P Specs) lactat
50%
soluti
form
3. Calcium Chloride. regul
2H2O.. 0.027g DML autho
4. Sodium Lactate (50% Inspection and
solution).. 0.64g dated 16.03.16 Pakis
Q.S..100ml clarif
n for
Electrolytes of s
(B.P Specs) lactat
50%
soluti
form

Each 100ml contains. Pack size 1000ml (Baxter status
Healthcare Ltd- formu
Each 100ml contains. Price =As per SRO UK) in
1. Sodium Chloride... plus Eurocap price pack
0.6g with single & double Sterifluid –RL by
2. Potassium Chloride... injection ports (FDL Limited) refere
0.04g regul
3. Calcium Chloride. DML autho
2H2O.. 0.027g Inspection and
4. Sodium Lactate (50% dated 16.03.16 Pakis
solution).. 0.64g and
5. Water for Injection clarif
Q.S..100ml n for
of s
Electrolytes lactat
50%
(B.P Specs) soluti
form
597. Medisol Paeds IV FORM 5 0.18% sodium Defer
Infusion B.P Rs 20,000/- chloride , for
24.05.16 , 4% glucose provi
Each 100ml contains. B Braun of ap
1. Sodium Pack size 100ml Germany. status
2. Dextrose Price =As per SRO Sterifluid in
Anhydrous...4.3g plus Eurocap price Paeds (FDL pack
3. Water for Injection with single & double Limited) by
Q.S...100ml injection ports refere
DML regul
Electrolytes + Inspection autho
carbohydrates dated 16.03.16 and
Pakis
B.P Specs
598. Medisol Paeds IV FORM 5 0.18% sodium Defer
Infusion B.P Rs 20,000/- chloride , for
Each 100ml contains. 24.05.16 , 4% glucose provi
1. Sodium B Braun of ap
Chloride...0.18g Pack size 250ml Germany. status
2. Dextrose formu
Anhydrous...4.3g Price =As per SRO Sterifluid in
3. Water for Injection plus Eurocap price Paeds (FDL pack
Q.S...100ml with single & double Limited) by
injection ports refere
Electrolytes + DML regul
carbohydrates Inspection autho
dated 16.03.16 and
B.P Specs Pakis

599. Medisol Paeds IV FORM 5 0.18% sodium App
Infusion B.P Rs 20,000/- chloride ,
24.05.16 , 4% glucose
Each 100ml contains. B Braun
1. Sodium Pack size 500ml Germany.
Chloride...0.18g
2. Dextrose Price =As per SRO Sterifluid
Anhydrous...4.3g plus Eurocap price Paeds (FDL
3. Water for Injection with single & double Limited)
Q.S...100ml injection ports
DML
Electrolytes + Inspection
carbohydrates dated 16.03.16
B.P Specs
600. Medisol Paeds IV FORM 5 0.18% sodium App
Infusion B.P Rs 20,000/- chloride ,
24.05.16 , 4% glucose
Each 100ml contains. B Braun
1. Sodium Pack size 1000ml Germany.
Chloride...0.18g
2. Dextrose Price =As per SRO Sterifluid
Anhydrous...4.3g plus Eurocap price Paeds (FDL
3. Water for Injection with single & double Limited)
Q.S...100ml injection ports
DML
Electrolytes + Inspection
carbohydrates dated 16.03.16
B.P Specs
601. Medisol ½ NS (Sodium FORM 5 Sodium Defer
Chloride 0.45%) Rs 20,000/- Chloride for
Injection USP 24.05.16 , Injection provi
0.45% (Hospira of ap
Each 100ml contains. Pack size 100ml USA) status
Sodium Chloride............ formu
0.45g Price =As per SRO Nisf Normal in
Water for Injection plus Eurocap price Saline pack
q.s ....100ml with single & double (Otsuka by
injection ports Limited) refere
Electrolytes regul
DML autho
Inspection and
(USP Specs) dated 16.03.16 Pakis
602. Medisol ½ NS (Sodium FORM 5 Sodium Defer
Chloride 0.45%) Rs 20,000/- Chloride for
Injection USP 24.05.16 , Injection provi
0.45% (Hospira of ap
Each 100ml contains. Pack size 250ml USA) status
Sodium Chloride............ formu
0.45g Price =As per SRO Nisf Normal in

Water for Injection plus Eurocap price Saline pack
q.s ....100ml with single & double (Otsuka by
injection ports Limited) refere
Electrolytes regul
DML autho
(USP Specs) Inspection and
dated 16.03.16 Pakis
603. Medisol ½ NS (Sodium FORM 5 Sodium App
Chloride 0.45%) Rs 20,000/- Chloride
Injection USP 24.05.16 , Injection
0.45% (Hospira
Each 100ml contains. Pack size 500ml USA)
Sodium Chloride............
0.45g Price =As per SRO Nisf Normal
Water for Injection plus Eurocap price Saline
q.s ....100ml with single & double (Otsuka
injection ports Limited)
Electrolytes
DML
(USP Specs) Inspection
dated 16.03.16
604. Medisol ½ NS (Sodium FORM 5 Sodium App
Chloride 0.45%) Rs 20,000/- Chloride
Injection USP 24.05.16 , Injection
0.45% (Hospira
Each 100ml contains. Pack size 1000ml USA)
Sodium Chloride............
0.45g Price =As per SRO Nisf Normal
Water for Injection plus Eurocap price Saline
q.s ....100ml with single & double (Otsuka
injection ports Limited)
Electrolytes
DML
(USP Specs) Inspection
dated 16.03.16
605. Medilact-D Solution for FORM 5 Lactated Defer
Injection-USP Rs 20,000/- Ringer & for
24.05.16 , Dextrose provi
Each 100ml contains. Injection of ap
1. Sodium Chloride... Pack size 100ml Baxter status
0.6g Healthcare formu
2. Potassium Chloride ... Price =As per SRO Corporation- in
0.03g plus Eurocap price USA pack
3. Calcium Chloride. with single & double by
2H2O... 0.02g injection ports Sterifluid RLD refere
4. Sodium Lactate (50% (FDL Limited) regul
solution)... 0.620g autho
5. Dextrose DML and
Monohydrate... 5.0g Inspection Pakis
6. Water for Injection dated 16.03.16 and
Q.S...100ml clarif

n for
Electrolytes + of s
carbohydrates lactat
50%
USP Specs soluti
form
1. Sodium Chloride... Pack size 250ml Baxter status
5. Dextrose DML and
Q.S...100ml clarif
n for
Electrolytes + of s
50%
USP Specs soluti
form
1. Sodium Chloride... Pack size 500ml Baxter status
5. Dextrose DML and
Q.S...100ml clarif
n for
Electrolytes + of s
50%
USP Specs soluti
form

Sodium Chloride 0Each Injection of ap
100ml contains. Pack size 1000ml Baxter status
1. Sodium Chloride... Healthcare formu
0.6g Price =As per SRO Corporation- in
2. Potassium Chloride ... plus Eurocap price USA pack
0.03g with single & double by
3. Calcium Chloride. injection ports Sterifluid RLD refere
2H2O... 0.02g (FDL Limited) regul
4. Sodium Lactate (50% autho
solution)... 0.620g DML and
5. Dextrose Inspection Pakis
Monohydrate... 5.0g dated 16.03.16 and
6. Water for Injection clarif
Q.S...100ml n for
of s
lactat
50%
Electrolytes + soluti
carbohydrates form
USP Specs
Tablet (General)
609. M/s Jupiter Tablet Anatrin Form 5 MHRA App
Pharma Rs. 20000/- approved
Plot # 25, St# Each tablet contains (13-06-2016) Aratoin – Dr.
S6 RCCI Nitrofurantoin 100 mg Dy.No 2653 Reddy, UK
Rawat (BP).
Rawalpindi. Furadin
Antibacterial Pack of 10 x 10’s (Ferozsons)
Tablet BP Specification  as per DPC
(General)
Approved in
247th meeting
of central
licensing
board held on
29-04-2016
610. -do- Tablet Jucip 250 Form 5 MHRA App
Rs. 20000/- approved brand
Each film coated tablet (13-06-2016) of Dr. Reddy,
contains Dy.No 2652 UK
Ciprofloxacin (as
HCl.2H2O) 250mg. Pack of 1x 10’s  Novidat - Sami
as per DPC
Antibiotics
(USP Specification)

611. -do- Tablet Jucip 500 Form 5 MHRA App
Each film coated tablet (13-06-2016) of Dr. Reddy,
contains Dy.No 2650 UK
Ciprofloxacin (as
HCl.2H2O) 500mg Pack of 1x 10’s Novidat - Sami
 as per DPC
Antibiotics
(USP Specification)
612. -do- Tablet Julin 250 Form 5 MHRA App

Rs. 20000/- approved
Each film coated tablet (13-06-2016) Evoxil –
contains Dy.No 2649 Beacon
Levofloxacin (as
hemihydrate ) 250mg Pack of 1x 10’s Leflox-Getz
 as per DPC
Quinolones
(Jupiter’s Specs)
613. -do- Tablet Julin -500 Form 5 MHRA App

Each film coated tablet (13-06-2016) Evoxil –
contains Dy.No 2651 Beacon
Levofloxacin (as
hemihydrate) 500mg Leflox-Getz
Pack of 1x 10’s
Quinolones  as per DPC
(Jupiter’s Specs)
614. -do- Tablet Jukast 5 Form 5 MHRA App

Each chewable tablet (13-06-2016) of Aurobindo
contains Dy.No 2647
Montelukast (as sodium) Montika-Sami
5mg Pack of 2x 7’s
 as per DPC
Anti-asthmatic
(Jupiter’s Specs)
615. -do- Tablet Jukast -10 Form 5 MHRA App

Each film coated tablet (13-06-2016) Singulair –
contains Dy.No 2648 Merck
Montelukast (as
sodium) 10mg Pack of 2x 7’s Singulair -
 as per DPC OBS
(Jupiter’s Specs)
Anti-asthmatic
616. -do- Tablet Mozter 400mg Form 5 MHRA App

Each film coated tablet (13-06-2016) Avelox
contains Dy.No 2642
Moxifloxacin HCl USP Moxiget -Getz
eq. to Moxifloxacin 400 Pack of 1x 5’s
mg  as per DPC
quinolone antibiotic
(Manufacture Specs)
617. -do- Tablet Resjun-1 Form 5 MHRA App

Each film coated tablet (13-06-2016) Risperdal –
contains Dy.No 2643 Janssen
Risperidone 1mg
Benzisox
Benzisoxazole Pack of 2x 10’s -Highnoon
derivatives  as per DPC
(USP Specs)
618. -do- Tablet Resjun -2 Form 5 MHRA App

Riperidone 2mg
Pack of 2x 10’s Benzisox
Benzisoxazole  as per DPC -Highnoon
derivatives (USP Specs)
619. -do- Tablet Resjun -3 Form 5 MHRA App

Riperidone 3mg
620. -do- Tablet Resjun-4 Form 5 MHRA App

Riperidone 4mg

621. -do- Tablet Pirujin Form 5 Tablet Brexine App
Rs. 20000/- 20mg –Chiesi –
Each tablet Contains (13-06-2016) France
Piroxicam B Dy.No 2665
cyclodextrin 191.2mg eq Brexin -Chiesi
to Piroxicam 20mg Pack of 2x 10’s
 as per DPC
Analgesics, antipyretics
(Jupiter’s specs)
622. -do- Tablet Marlin Form 5 WHO App

Rs. 20000/- recommended
Each tablet contains (13-06-2016) formulation
Artemether ..20mg Dy.No 2636
Lumefentrine 120mg Artem -Hilton
(Jupiter’s specs) Pack of 2x 8’s

Antimalarial  as per DPC
623. -do- Tablet Marlin Fort Form 5 WHO App

Pack of 1x 8’s
(Jupiter’s specs)  as per DPC
Antimalarial
624. -do- Tablet Marlin DS Form 5 WHO App

Pack of 1x 6’s
(Jupiter’s specs)  as per DPC
Antimalarial
625. -do- Tablet J-Rox CR 12.5 Form 5 USFDA App

Rs. 20000/- Paxil SR-GSK
Each enteric film coated (13-06-2016)
controlled released Dy.No 2654 Seroxat CR-
tablet contains GSK
Paroxetin as HCl
12.5mg Pack of 1x 10’s
 as per DPC
(Jupiter’s specs)
SSRIs

626. -do- Tablet J-Rox CR 25 Form 5 USFDA App
Rs. 20000/- Paxil SR-GSK
Each enteric film coated (13-06-2016)
controlled released Dy.No 2663 Seroxat CR-
tablet contains GSK
Paroxetin as HCl 25mg Pack of 1x 10’s
 as per DPC
(Jupiter’s specs)
SSRI
627. -do- Tablet Amlodine 5/80 Form 5 MHRA App

Each film coated tablet (13-06-2016) Exforge-
contains Amlodipine (as Dy.No 2659 Novartis
besylate) 5mg
Valsartan 80mg Pack of 14’s Exforge –
 as per DPC Novartis
(Jupiter’s specs)
Calcium channel
blocker.
Angiotensis II (AT1)
receptor antagonist

contains Dy.No 2660 Novartis
Amlodipine (as besylate)
5mg Exforge –
Valsartan 160mg Pack of 14’s Novartis
 as per DPC
(Jupiter’s specs)
Calcium channel
blocker.
receptor antagonist.
contains Dy.No 2657 Novartis
Amlodipine (as besylate)
10mg Exforge –
Valsartan 160mg Pack of 14’s Novartis
 as per DPC
(Jupiter’s specs)
Calcium channel
blocker.
receptor antagonist.

630. -do- Tablet Judol Form 5 Adela - getz Defer
Rs. 20000/- 10
Each tablet contains (13-06-2016) mole
Alfacalcidol 0.5mcg Dy.No 2650 per s
has a
(Jupiter’s specs) Pack of 1 x 10’s been
Vitamin –D Analogue  as per DPC appro
631. -do- Mides Form 5 MHRA Defer

Rs. 20000/- approved brand 10
Each film coated tablet (13-06-2016) of Consilient mole
contains Dy.No 2655 per s
Desloratadine 5mg Alenor – has a
Pack of 1 x 10’s Macter been
( Jupiter’s specs).  as per DPC appro
Antihistamine
632. -do- Tablet Jubal Form 5 Methycobal – Defer

Rs. 20000/- Eisai, Japan 10
Each sugar coated tablet (13-06-2016) mole
contains Dy.No 2658 per s
Mecobalamin 500 mcg Anemovit - has a
Pharmacare been
Vitamin B-12 Pack of 3x 10’s appro
Manufacture  as per DPC
Specification
Capsule (General)
633. M/s Jupiter Capsule Jutrazole Form 5 MHRA App
Pharma Rs. 20000/- approved
Plot # 25, St# Each capsule contains (13-06-2016) Azocan-P,
S6 RCCI Fluconazole 150mg Dy.No 2641 FDC
Rawat
Rawalpindi. Synthetic Axicon - Axis
azole/Systemic Pack of 1x 1’s
Capsule antifungal agent  as per DPC
(General) (Jupiter’s Specs)
Approved in
247th meeting
of central
licensing
board held on

29-04-2016
634. -do- Capsule J-Baline-50 Form 5 US FDA App
Rs. 20000/- LYRICA
Each capsule contains (13-06-2016) Capsules (25,
Pregabalin 50mg Dy.No 2621 50, 75, 100,
150,200, 225
(Jupiter’s specs) and 300mg)
anti-epileptic drug, also Pack of 3x 10’s
called an anticonvulsant  as per DPC ZEEGAP
agent. Capsules (25,
50, 75, 100 and
150mg)
Hilton
635. -do- Capsule J-Baline -75 Form 5 US FDA App

Rs. 20000/- LYRICA
Pregabaline 75mg Dy.No 2622 50, 75, 100,
150,200, 225
(Jupiter’s specs) Pack of 3x 10’s and 300mg)
anti-epileptic drug, also  as per DPC
called an anticonvulsant ZEEGAP
50, 75, 100 and
150mg)
Hilton
636. -do- Capsule J-Baline-100 Form 5 US FDA App

Rs. 20000/- LYRICA
Pregabaline 100mg Dy.No 2629 50, 75, 100,
150,200, 225
(Jupiter’s specs) and 300mg)
anti-epileptic drug, also Pack of 3x 10’s
called an anticonvulsant  as per DPC ZEEGAP
50, 75, 100 and
150mg)
Hilton
637. -do- Capsule Tamsel 400mcg Form 5 MHRA App
Rs. 20000+30000= approved
Each capsule contains 50000 Tabphyn-
Tamsulosin HCl (as (13-06-2016) Genus
modified released (17-06-2016)
pellets 0.2 %) eq to Dy.No 2630 Alfamax
Tamsulosine 0.4mg -Platinum
(Jupiter’s Specs) Pack of 1x 10’s

α1-Adrenergic blocking  as per DPC
agent with selectivity for

α1A-adrenergic receptors
Source of pellets:-
M/s Vision
Pharmaceuticals, Kahuta
road, Islamabad.
638. -do- Capsule Azoter Form 5 MHRA App

Each capsule contains (13-06-2016) Zithromax –
Azithromycin (as Dy.No 2631 Pfizer
dehydrate) 250mg
Azelide-Hygeia
(USP Specs) Pack of 1x 10’s
Macrolide Antibiotic  as per DPC
agent.
639. -do- Capsule Mebal Form 5 Innovit Proof of approval Defer

Rs. 20000/- -Werrick status of same dosage for
Each capsule contains (13-06-2016) form in reference appro
Mecobalamine 500mcg Dy.No 2637 countries not given. status
same
(Jupiter’s specs) dosag
Antianemic agent Pack of 2x 10’s form
 as per DPC refere
count
640. -do- Capsule Jucam Form 5 MHRA App

Each capsule contains (13-06-2016) feldene-Pfizer
Piroxicam 20mg Dy.No 2633
Feldene -Pfizer
(USP Specs)
NSAID Pack of 2x 10’s
 as per DPC
641. -do- Capsule Judep Plus Form 5 USFDA App

Rs. 20000/- SYMBAX
Each capsule contains (13-06-2016)
Fluoxetine (as HCl) 25 Dy.No 2623 Co-Depricap,
mg Olanzopine 6mg NabiQasim
(USP specs) Pack of 2x 10’s

Antidepressent  as per DPC
642. -do- Capsule Lansjup 30mg Form 5 MHRA App

Each capsule contains (13-06-2016) of Consilient
Lansoprazole (as enteric Dy.No 2624

coated pellets 8.5% ) eq Doudcer-nil -
to Lansoprazole 30mg Global
Pack of 14’s
(USP Specs)  as per DPC
Proton Pump Inhibitor
Source of pellets:-
M/s Vision
Road, Islamabad.
643. -do- Capsulr Esojup-20 Form 5 MHRA App

Each capsule contains (13-06-2016) Emozul-
Esomeprazol(as Dy.No 2628 Consilient
Megnesium trihydrate
enteric coated pellet ESSO-Shaigan
22.5% ) eq to Pack of 14’s
Esomeprazole 20mg  per DPC
(Jupiter’s Specs)
Source of pellets:-
M/s Vision
Road, Islamabad.
644. -do- Capsule Esojup- 40 Form 5 MHRA App

Each capsule contains (13-06-2016) Emozul-
Esomeprazole (as Dy.No 2625 Consilient
Megnesium trihydrate
enteric coated pellet ESSO-Shaigan
22.5% ) eq to Pack of 14’s
Esomeprazole 40mg  as per DPC Source of
pellets:-
(Jupiter’s Specs) M/s Vision
Proton Pump Inhibitor Pharmaceutical
s, Kahuta
Road,
Islamabad.
645. -do- Capsule Jumep -20 Form 5 MHRA App
Each capsule contains (13-06-2016) Losec –
omeprazol(enteric Dy.No 2627 AstraZeneca
coated pellet 8.5 ) eq to
omeprazole 20mg Risek-Getz
Pack of
(USP Specs) 14’s  as per DPC

Source of pellets:-
M/s Vision
Road, Islamabad.
646. -do- Capsule Jumep- 40 Form 5 MHRA App

Each capsule contains (13-06-2016) Losec –
omeprazole (enteric Dy.No 2626 AstraZeneca
coated pellet 8.5) eq to
omeprazole 40mg Risek-Getz
Pack of 14’s
(USP Specs)  per DPC
Source of pellets:-
M/s Vision
Road, Islamabad.
Oral Dry Powder Suspension

647. M/s Jupiter Azoter Dry Powder for Form 5 MHRA App
Pharma Suspension Rs. 20000/- approved brand
Plot # 25, St# (13-06-2016) of Sandoz
S6 RCCI Each 5ml of Dy.No 2634
Rawat reconstituted suspension Azomax
Rawalpindi. contains Azithromycin -Novartis
(as dehydrate) 200mg Pack of 15ml
 as per DPC
Dry Powder ( USP Specs)
Suspension Macrolide Antibiotic
(General) agent.
Approved in
247th meeting
of central
licensing
board held on
29-04-2016
648. -do- Marlin Suspension Form 5 WHO App
15/90 Rs. 20000/- recommended
(13-06-2016) formulation
Each 5ml of Dy.No 2661

reconstituted suspension Artem - Hilton
contains Artemether
15mg Lumefentrine Pack of 60ml  as
90mg per DPC
(jupiter’s specs)
Anti malarial
649. -do- Marlin DS Suspension Form 5 WHO App
30/180 Rs. 20000/- recommended
(13-06-2016) formulation
Each 5ml of Dy.No
reconstituted suspension Artem - Hilton
contains Artemether
30mg Lumefentrine Pack of 60ml
180mg  as per DPC
(jupiter’s specs)
Anti malarial
650. -do- Clariter Oral Drops Form 5 MHRA App
Each 5ml of (13-06-2016) of Sandoz
reconstituted suspension Dy.No 2637
contains Klaricid –
Clarithromycin 125mg Abbott
Granules for suspension Pack of 60ml
 as per DPC
Macrolide Antibiotic
agent.
(USP Specs)
651. -do- J-Linz Suspension Form 5 USFDA Zyvox App
Rs. 20000/- –Pharmacia
Each 5ml reconstituted (13-06-2016) upjouhn
suspension contains Dy.No 2638
Linezolid 100 mg Nezocin -
Powder for suspension brookes
Pack of 60ml
(Jupiter’s Specs)  as per DPC
synthetic antibiotic, the
first of the
oxazolidinone class
652. -do- Jutrazole Dry Form 5 MHRA App

Suspension Rs. 20000/- Diflucan –
(13-06-2016) Pfizer
Each 5ml reconstituted Dy.No 2639
suspension contains Diflucan
Fluconazole 50 mg -Pfizer
Pack of 35ml
(USP Specs)  as per DPC
Synthetic
azole/Systemic

antifungal agent.
653. -do- Zincter Suspension Form 5 WHO Product under review Defer
Rs. 20000/- recommended as waiting for reply Produ
Each 5ml reconstituted (13-06-2016) formulation from WHO. under
suspension contains Dy.No 2640 revie
Zinc sulphate Zincat sent
monohydrate eq to comm
Elemental Zinc 20 mg Pack of 60ml of W
 as per DPC
(Jupiter’s Specs)
Zinc supplement

New License of M/s Regal Pharmaceuticals, Plot # 2-A, Street # S-5 National industrial
zone Rawat-Islamabad
S/N Name and Brand Name Type of Form International Remarks Decision
address of (Proprietary name + Initial date, status in reference
manufacturer / Dosage Form + diary drug agencies /
Applicant Strength) Fee including authorities
Composition differential fee Me-too status
Pharmacological Demanded GMP status as
Group Price / Pack size depicted in latest
Finished product inspection report
Specification (with date) by the
Evaluator
Tablet (General)
654. M/s Regal Regcam Tablet 4 mg Form 5 EMA approved Approved
Pharmaceuticals, Rs. 20,000/- Brand Xefo
Plot # 2-A, Street Each film coated 08-06-2016
# S-5 National tablet contains: Dy. No. 2460 Loricam - Saffron
industrial zone Lornoxicam 4 mg
Rawat-
Islamabad (Regal Spec) Pack of
NSAID. 10’s/as per DPC
DML of firm 20’s / as per DPC
approved in 247st 30’s / as per DPC
meeting of
Central
Licensing Board
held on 29-04-
2016.
655. -do- Regcam Tablet 8 mg Form 5 EMA approved Approved

Rs. 20,000/- Brand Xefo
Each film coated 08-06-2016
tablet contains: Dy. No. 2462 Loricam - Saffron
Lornoxicam 8 mg
(Regal Spec) Pack of 10’s/as

NSAID. per DPC

20’s / as per DPC
30’s / as per DPC
656. -do- Regoxin CR Tablet Form 5 FDA approved Approved

12.5 mg Rs. 20,000/- Paxil CR - GSK
08-06-2016
Each enteric coated Dy. No. 2457 Tablet Deroxat
controlled release 12.5 mg by
tablet contains: Gobal pharma
Paroxetine Hcl eq to Pack of 10’s/as
Paroxetine 12.5mg per DPC
20’s / as per DPC
(USP Spec) 30’s / as per DPC
SSRI
657. -do- Regoxin CR Tablet Form 5 FDA approved Approved

25 mg Rs. 20,000/- Paxil CR- GSK
08-06-2016
Each enteric coated Dy. No. 2461
controlled release Tablet Deroxat
tablet contains: Pack of 10’s/as 12.5 mg by
Paroxetine Hcl eq to per DPC Gobal pharma
Paroxetine 25mg 20’s / as per DPC
30’s / as per DPC
(USP Spec)
SSRI
658. -do- Dinac Tablet 50 mg Form 5 FDA approved Proof of Double Deferred for
Rs. 20,000/- Arthrotec – health punch  Confirmat
Each Delayed release 08-06-2016 care UK. compression by FID
tablet contains: Dy. No. 2458 machine. double p
Diclofenac sodium Erwin –Sami compressi
50mg + Complete machine.
Misoprostol 200mcg Pack of 10’s/as description of  Complete
per DPC dosage form descriptio
(Regal Spec) 20’s / as per DPC required. dosage
Pain reliever required.
Firm needs to  Firm need
follow innovator follow
brand innovator
formulation. brand
formulatio
Complete  Complete
manufacturing manufactu
method method
including including
procedure of procedure
outer core of outer cor
misoprostol, on misoprost
diclofenac on diclo
sodium tablet sodium t
before enteric before en
coating. coating.

659. -do- Dinec Tablet 75 mg Form 5 FDA approved Proof of Double Deferred for
Rs. 20,000/- Arthrotec – health punch  Confirmat
Each delayed release 08-06-2016) care UK. compression by FID
tablet contains: Dy. No. 2455 machine. Double p
Diclofenac sodium Erwin –Sami compressi
50mg Pack of Complete machine.
Misoprostol 200mcg 10’s/as per DPC description of  Complete
20’s / as per DPC dosage form descriptio
(Regal Spec) required. dosage
Pain reliever required.
Firm needs to  Firm need
follow innovator follow
brand innovator
formulation. brand
formulatio
Complete  Complete
manufacturing manufactu
method method
including including
procedure of procedure
outer core of outer cor
misoprostol, on misoprost
diclofenac on diclo
sodium tablet sodium t
before enteric before en
coating. coating.
660. -do- Pesom Tablet 50 mg Form 5 Myonal – Eisai Approved

Rs. 20,000/-
Each sugar coated 08-06-2016) Qulax – Myonal
tablet contains: Dy. No. 2449
Eperisone Hcl 50mg
Pack of
(Regal Spec) 10’s/as per DPC
Anticholinergic 20’s / as per DPC
30’s / as per DPC
661. -do- Epiwell CR Tablet Form 5 USFDA Depakote Deferred as m

250 Rs. 20,000/- than 10 molec
08-06-2016 Local
Each Controlled Dy. No. 2473 Tablet Leptil at
release tablet 250 mg by
contains: Pack of 10’s/as Donvalley
Divalproex sodium per DPC pharmaceuticals
250mg 30’s / as per DPC
100’s / as per
(USP Spec) DPC
Antiepileptic
662. Regal Epiwell CR Tablet Form 5 USFDA Depakote Deferred as m

Pharmaceuticals, 500 Rs. 20,000/- than 10 molec
Plot # 2-A, Street 08-06-2016 Local

# S-5 National Each Controlled Dy. No. 2465 Tablet Leptil at
industrial zone release tablet 250 mg by
Rawat- contains: Pack of 10’s/as Donvalley
Islamabad Divalproex sodium per DPC pharmaceuticals
DML of firm 100’s / as per
approved in 247st (USP Spec) DPC
meeting of Antiepileptic
Central
Licensing Board
held on 29-04-
2016.
663. -do- Radol-P Tablet Form 5 MHRA Approved
325/37.5 mg Rs. 20,000/- Tablet Tramacet
Each Film coated 08-06-2016 325/37.5mg
tablet contains: Dy. No. 2453 manufactured by
Paracetamol Grunenthal
325mg Pack of 10’s/as
Tramadol 37.5mg per DPC Local
(Regal Spec) 20’s / as per DPC Tablet Tronoflex P
Opiod analgesic 100’s / as per 325/37.5 mg
DPC by
Sami pharma
664. -do- Zolid Tablet 600 mg Form 5 MHRA Approved

Rs. 20,000/- Tablet Zyvox
Each Film coated 08-06-2016 600mg
tablet contains: Dy. No. 2450 manufactured by
Linezolid 600mg 338fizer
(Regal Spec) Pack of Local

Oxazolidone 10’s/as per DPC Tablet Nezolide
Antibiotic 20’s / as per DPC 600 mg
100’s / as per by
DPC Searl pharma
665. -do- Solfine Tablet 5 mg Form 5 MHRA Approved

Rs. 20,000/- Vesicare –Astellas
Each Film coated 08-06-2016 UK
Solifenacin succinate Fenaso – Highnoon
5mg Pack of
10’s/as per DPC
(Regal Spec) 20’s / as per DPC
Antimuscarinic
666. -do- Solfine Tablet Form 5 MHRA Approved

10 mg Rs. 20,000/- Vesicare Astellas
Each Film coated 08-06-2016
tablet contains: Dy. No. 2469 Tablet Vezitic
Solofinacin succinate 5mg
5mg Pack of 10’s/as By CCL
per DPC
(Regal Spec) 20’s / as per DPC

Antimuscarinic
667. Regal Qupixan Tablet 25 Form 5 MHRA Approved
Pharmaceuticals, mg Rs. 20,000/- Quetapine –
Plot # 2-A, Street 08-06-2016 Sandoze UK
# S-5 National Each Film coated Dy. No. 2457
industrial zone tablet contains:
Rawat- Quetapine 25mg Pack of Q-Par – Helix
Islamabad as Quetapine 10’s/as per DPC
Fumarate 20’s / as per DPC
approved in 247st (USP Spec)
meeting of Dibenzothiazepine
Central
Licensing Board
held on 29-04-
2016.
668. -do- Qupixan Tablet 50 Form 5 MHRA Approved
mg Rs. 20,000/- Quetapine –
08-06-2016) Sandoze UK
Each Film coated Dy. No. 2472
tablet contains:
Quetapine 50mg as Pack of 10’s/as Q-Par – Helix
Quetapine Fumarate per DPC
20’s / as per DPC
Dibenzothiazepine
669. -do- Qupixan Tablet 100 Form 5 MHRA Approved
mg Rs. 20,000/- Quetapine –
08-06-2016 Sandoze UK
tablet contains:
Quetapine 100mg as Pack of 10’s/as Q-Par – Helix
Quetapine Fumarate per DPC
20’s / as per DPC
Dibenzothiazepine
670. -do- Brudex Tablet 400 Form 5 Seractil (Genus Deferred as m
mg Rs. 20,000/- Pharmaceuticals than 10 molec
08-06-2016 UK) BNF-67
tablet contains: Dexib –Tabros
Dexibuprofen Pack of 10’s/as
400mg per DPC
50’s / as per DPC
(Manufacture Spec)
Propionic acid
671. Regal Re-SPA Tablet Form 5 NO-SPA FORTE Deferred as m

Pharmaceuticals, 80 mg Rs. 20,000/- than 10 molec
Plot # 2-A, Street 08-06-2016 Himont
# S-5 National Each Film coated Dy. No. 2468
industrial zone tablet contains:
Rawat- Drotaverine 80mg Pack of 10’s/as
Islamabad as Drotaverine Hcl per DPC

50’s / as per DPC
DML of firm (Regal Spec)
approved in 247st
meeting of Anti-Spasmodic
Central
Licensing Board
held on 29-04-
2016.
672. -do- Repram Tablet 10 mg Form 5 MHRA Approved
Rs. 20,000/- Cipralex
Each Film coated 08-06-2016 Lundback
Escitalopram 10mg Product of
as Escitalopram Pack of 10’s/as NabiQasim pharma
Oxalate per DPC
14’s / as per DPC
Anti depressant
673. Repram Tablet 20 mg Form 5 MHRA Approved
Rs. 20,000/- Cipralex
Each Film coated 08-06-2016 Lundback
Escitalopram 20mg Product of
as Escitalopram Pack of 10’s/as NabiQasim pharma
Oxalate per DPC
14’s / as per DPC
Anti depressant
674. -do- O-Mox Tablet 400 Form 5 MHRA Avelox Deferred as m

mg Rs. 20,000/- Bayer than 10 molec
08-06-2016)
Each Film coated Dy. No. 2463 Moxiget – Getz
tablet contains:
Moxifloxacin 400mg Pack of 5’s/as per
as Moxifloxacin Hcl DPC
(Regal Spec)
FlouroQuinolone
Antibiotic
675. M/s Regal Mograll Fort Tablet Form 5 Approved status in Deferred as m
Pharmaceuticals, Rs. 20,000/- Pakistan reference than 10 molec
Plot # 2-A, Street Each Film coated 08-06-2016 countries not
# S-5 National tablet contains: Dy. No. 2471 approved
industrial zone Orphenadrine Citrate
Rawat- 50mg + Paracetamol Pack of 30’s/as Local
Islamabad 450mg+ Caffeine per DPC Tablet Medigesic
30mg 50’s/as per DPC Fort
DML of firm By
approved in 247th (Regal Spec) 100’s/as per DPC Wilshire pharma
meeting of
Central Analgesic / Central

Licensing Board anti cholinergic /
held on 29-04- Xanthine
2016.
676. -do- Rostin Tablet 5mg Form 5 MHRA Approved
Rs. 20,000/- Crestor 5mg
Each Film coated 08-06-2016 Astrazeneca UK
Rosuvastatin 5mg Local
as Rosuvastatin Pack of Tablet Loster
Calcium 10’s/as per DPC By
20’s/as per DPC Helix pharma
(Regal Spec)
Lipid regulating
agent
677. Rostin Tablet 10mg Form 5 MHRA Approved
Rs. 20,000/- Crestor
Each Film coated 08-06-2016 Astrazeneca UK
Rosuvastatin 10mg Local
as Rosuvastatin Pack of 10’s/as Tablet Loster
Calcium per DPC By
Helix pharma
(Regal Spec) 20’s/as per DPC
Lipid regulating
agent
CAPSULE (GENERAL)
678. Regal Resold Capsule Form 5 MHRA approved Approved
Pharmaceuticals, 20mg Rs. 50,000/- Emozul
Plot # 2-A, Street 08-06-2016
# S-5 National Each Capsule Dy. No. 2493 Esso – Shaigan
industrial zone contains:
Rawat- Enteric coated pallets Pack of
Islamabad of Esomeprazole 10’s/as per DPC
20mg 14’s/as per DPC
DML of firm as Esomeprazole
approved in 247st magnesium
meeting of 341olymalto
Central
Licensing Board (USP Spec)
held on 29-04- Proton Pump
2016. Inhibitor
Source of
Esomeprazole Mg
ECP pellets 22.5%:-
M/s Vision
Pharmaceuticals, Plot
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
679. M/s Regal Resold Capsule Form 5 MHRA Approved

Pharmaceuticals, 40mg Rs. 50,000/- Emozul
Plot # 2-A, Street 08-06-2016
# S-5 National Each Capsule Dy. No. 2496 Esso – Shaigan

Rawat- Enteric coated pallets Pack of 10’s/as
Islamabad of Esomeprazole per DPC
40mg
DML of firm as Esomeprazole
approved in 247st magnesium dehydrate
meeting of
Central (USP Spec)
Licensing Board Protin pump Inhibitor
held on 29-04-
2016. Source of
Esomeprazole Mg
ECP pellets 22.5%:-
M/s Vision
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
680. Thicosid 4mg Form 5 Muscoril – Sanofi, Approved

Capsule Rs. 20,000/- France
08-06-2016
Each Capsule Dy. No. 2491 Muscoril –Searle
contains:
Thiocolchicoside Pack of
14’s/as per DPC
(Regal Spec)
Skeletal muscle
relaxant
681. Regastat 120mg Form 5 FDA approved Approved
Capsule Rs. 50,000/- Xenical
08-06-2016)
Each Capsule Dy. No. 2513 Alli 120mg
contains immediate GSK consumer
release pallets of Pack of 20’s / health care USA
Olrlistat 120mg as per DPC
Local
(USP Spec) Capsule Febical
Lipase inhibitor By
Highnoon
Source of Orlistat Laboratories
IR pellets 50%:-
M/s Vision
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
682. -do- Regalin 50mg Form 5 FDA approved Approved

Capsule Rs. 20,000/- Lyrica Pfizer
08-06-2016
Each Capsule Dy. No. 2506 Gabalin - CCL
contains:
Pregabalin 50mg Pack of 14’s /

as per DPC
(Regal Spec)
GABA Analogue

08-06-2016)
contains:
as per DPC
(Regal Spec)
GABA Analogue

08-06-2016
contains:
as per DPC
(Regal Spec)
GABA Analogue
685. -do- Olanzin – F 3/25mg Form 5 USFDA SYMBAX Approved

Capsule Rs. 20,000/-
08-06-2016) Co-Depricap,
Each Capsule Dy. No. 2497 NabiQasim
contains:
Olanzapine 3mg Pack of
Fluoxetine 25mg 14’s / as per DPC
30’s / as per DPC
(USP Spec)
Thienobenzodiazepin
e /SSRI
686. -do- Capsule Olanzin – F Form 5 USFDA SYMBAX Approved

6/25 Rs. 20,000/-
08-06-2016 Co-Depricap,
contains:
Olanzapine 6mg Pack of 14’s /
Fluoxetine 25mg as per DPC
(USP Spec)
Thienobenzodiazepin
e /SSRI
687. Olanzin – F 12/25mg Form 5 USFDA SYMBAX Me too needs Approved
Capsule Rs. 20,000/- confirmation
08-06-2016 Co-Depricap,
contains:
Olanzapine 12mg Pack of 14’s /
Fluoxetine 25mg as per DPC

(USP Spec)
Thienobenzodiazepin
e /SSRI
688. M/s Regal Recoxib 200mg Form 5 MHRA approved Approved

Pharmaceuticals, Capsule Rs. 20,000/- Celebrex – Pfizer
Plot # 2-A, Street 08-06-2016
# S-5 National Dy. No. 2502 Artiflex –
industrial zone Each Capsule Standpharm
Rawat- contains: Pack of 10’s /
Islamabad Celecoxib 200mg as per DPC
20’s / as per DPC
approved in 247st (Regal Spec)
meeting of COX -2 Inhibitor
Central
Licensing Board
held on 29-04-
2016.
689. Regal Tamsuger 0.4mg Form 5 FDA approved Approved

Pharmaceuticals, Capsule Rs. 50,000/- Contiflo XL
Plot # 2-A, Street 08-06-2016 E.Lilly and
# S-5 National Each Capsule Dy. No. 2494 company
Rawat- Tamsulosin HCl SR Pack of 10’s / Local
Islamabad pellets 0.2% eq to as per DPC Capsule Proset
Tamsulosin 0.4mg 20’s / as per DPC By
Synchro pharma
(USP Spec)
Slective alpha-1
blocker
Source of pellets :-
M/s Vision
Pharmaceutcals ,
Kahuta rOad,
Islamabad.
690. -do- Venflax XR 37.5mg Form 5 Proof of Deferred
Capsule Rs. 50,000/- approval status confirmation
Each Capsule 08-06-2016 of same dosage approval statu
contains: Dy. No. 2595 form in formulation
Extended release reference reference regul
pallets of Pack of 10’s / countires and authorities
Vanlafaxine 37.5mg as per DPC Pkaistan not Pakistan.
as Vanlafaxine Hcl provided.
14’s / as per DPC
(USP Spec)
Serotonin &
noradrenaline
reuptake inhibitor
Source of Venlafaxine
HCl SR pellets 33% :-

M/s Vision
Pharmaceuticals, Plot #
22-23, Industrial
Triangle, Kahuta Road,
Islamabad.
691. -do- Venflax XR 75mg Form 5 FDA approved Approved

Capsule Rs. 50,000/- Efexor XL
08-06-2016) Pfizer Ltd
Each Capsule Dy. No. 2492 USA
contains:
Extended release Pack of 10’s /
pallets of as per DPC Venalax – Stand
Vanlafaxine 75mg as pharm
Vanlafaxine Hcl 14’s / as per DPC
(USP Spec)
Serotonin &
noradrenaline
reuptake inhibitor
Source of Venlafaxine
HCl SR pellets 33% :-
M/s Vision
Pharmaceuticals, Plot #
22-23, Industrial
Triangle, Kahuta Road,
Islamabad.
692. M/s Regal Erox 60mg Capsule Form 5 The proposed Rejected
Pharmaceuticals, Rs. 20,000/- formulation is in proposed
Plot # 2-A, Street Each Capsule 08-06-2016 tablet form in formulation
# S-5 National contains: Dy. No. 2499 reference approved in t
industrial zone Etroricoxib 60mg countries and dosage form
Rawat- Pack of 10’s / not in capsule reference regul
Islamabad (Regal Spec) as per DPC form. authorities
Cyclooxygenase
inhibitor 20’s / as per DPC
693. -do- Rethro 250mg Form 5 FDA approved Approved

Capsule Rs. 20,000/- Azisara 250mg
08-06-2016 Piramal healthcare
Each Capsule Dy. No. 2487
contains: Local
Azithoromycin Pack of 6’s / Capsule Bactizith
250mg as as per DPC 250mg
Azithromycin By
dehydrate 10’s / as per DPC Woodwards
(USP Spec)
Macrolide antibiotic
694. -do- Mervin- MR 200mg Form 5 MHRA Innovator brand Deferred
Capsule Rs. 50,000/- Clofac MR contains confirmation

(21-06-2016) BGP Ltd modified release whether granul
Each Capsule Dy. No. 2464 UK granules. M/s Vision Ph
contains: are modified re
Mebeverine HCl SR Pack of 10’s / Local or otherwise
pellets 50% eq to as per DPC Capsule
Mebeverine Hcl 20’s / as per DPC Mebeverine MR
200mg 30’s / as per DPC By
Getz pharma
(Regal Spec)
Antispasmodic
Source of pellets:-
M/s Vision
Pharmaceuticals,
Kahuta Road,
Ilsambad.
ORAL DRY POWDER (GENERAL)
695. M/s Regal Rethrocin 125mg Form 5 FDA approved The innovator Approved
Pharmaceuticals, /5ml Rs. 20,000/- Claricid brand is in
Plot # 2-A, Street oral drops 08-06-2016) 125mg/5ml granules
# S-5 National Dy. No. 2528 Abbott laboratories formulation.
industrial zone Each 5ml of
Rawat- reconstituted Pack of 60ml / Local
Islamabad suspension contains: as per DPC Claritek
Clarithromycin 125mg/5ml
27.5% EC Taste By
Masked pellets eq to Getz pharma
Clarithromycin
125mg
(USP Spec)
M/s Vision
Pharmaceuticals,
Kahuta rOad,
Islamabad.
696. Regal Rethrocin 250mg Form 5 FDA approved The innovator Approved
Pharmaceuticals, /5ml Rs. 20,000/- Claricid brand is in
Plot # 2-A, Street oral suspension 08-06-2016 250mg/5ml granules
# S-5 National Dy. No. 2530 Abbott laboratories formulation.
industrial zone Each 5ml of
Rawat- reconstituted Pack of 60ml / Local
Islamabad suspension contains: as per DPC Claritek
Clarithromycin 250mg/5ml
DML of firm 27.5% EC Taste By
approved in 247st Masked pellets eq to Getz pharma
meeting of Clarithromycin
Central 250mg
Licensing Board
held on 29-04- (USP Spec)

2016. Macrolide antibiotic
M/s Vision
Pharmaceuticals,
Kahuta rOad,
Islamabad.
697. -do- Azocine 200mg /5ml Form 5 MHRA approved Approved

oral Dry Suspension Rs. 20,000/- brand of 347andoz
08-06-2016)
Each 5ml Dy. No. 2524 Local
(reconstituted) Zithrosan
contains: Pack of 30ml / 200mg/5ml
Azithromycin as per DPC By
200mg Sante pharma
15ml /
(USP Spec) as per DPC
698. -do- Remal 15/90mg /5ml Form 5 WHO Approved
oral Dry suspension Rs. 20,000/- recommended
08-06-2016) formulation
Each 5ml Dy. No. 2525
(reconstituted) Artem – Hilton
contains: Pack of 30ml /
Artimether 15mg as per DPC
Lumefantrine 90mg.
60ml /
(Manufacture Spec) as per DPC
Anti-malarial
699. -do- Remal 20/120mg Form 5 Proof provided Rejected
/5ml Rs. 20,000/- by firm for proposed
oral D/S 08-06-2016) proposed formulation
Dy. No. 2531 Local formulation neither approve
Each 5ml Arceva availability in reference regul
(reconstituted) Pack of 30ml / 20/120mg/5ml reference authorities
contains: as per DPC By countires and recommended
Artimether 20mg Sami Pakistan is not WHO.
Lumefantrine 60ml / pharmaceuticals correct.
120mg. as per DPC
(Manufacture Spec)
Anti-malarial
700. Regal Zolid 100mg /5ml Form 5 FDA approved Approved

Pharmaceuticals, oral D/S Rs. 20,000/- 100mg/5ml change of b
Plot # 2-A, Street 08-06-2016 name.
# S-5 National Each 5ml Dy. No. 2490 Local
industrial zone (reconstituted) Nezilide
Rawat- contains: Pack of 60ml / 100mg/5ml
Islamabad Linzolide 100mg as per DPC By
Powder for Searle

DML of firm suspension pharmaceuticals
approved in 247st
meeting of (Regal Spec)
Central Antibiotic
Licensing Board
held on 29-04-
2016.
701. -do- Zincal 10mg /5ml Form 5 The proposed Deferred
oral D/S Rs. 20,000/- formulation in confirmation
08-06-2016) Local dry powder approval statu
Each 5ml contains: Dy. No. 2527 Rite-Zinc forms while reference regul
Zinc Sulphate 10mg. 10mg/5ml WHO authorities or W
Pack of 60ml / By recommended in dry po
(Regal Spec) as per DPC Fynk formulation is suspension.
Zinc Supplement pharmaceuticals oral solution.
702. R – Flucon 50mg Form 5 MHRA Approved

/5ml Rs. 20,000/- DiFlucan one change of b
oral D/S 08-06-2016) 50mg/5ml name
Dy. No. 2526 Jhonson & Jhonson
Each 5ml contains: Newsland
Fluconazole 50mg Pack of 35ml /
as per DPC Local
(Regal Spec) Zolanix
By
Anti-Fungal GSK
pharmaceuticals
703. -do- Re – Dos 175mg Form 5 The product is Deferred
/5ml Rs. 20,000/- Local not available in confirmation
oral Dry suspension 08-06-2016) Dostin the proposed approval statu
Dy. No. 2785 By formulation in formulation
Each 5ml of Brooks reference reference regul
reconstituted Pack of 35ml / pharmaceuticals countires. authorities
suspension contains: as per DPC Pakistan.
Erdosterine 175mg
(Regal Spec)
Mucolytic agent
704. Regal Resar 100mcg /5ml Form 5 MHRA Firm doesn’t Deferred
Pharmaceuticals, oral D/S Rs. 20,000/- Foradil possess confirmation
Plot # 2-A, Street 08-06-2016 Novartis Uk Ltd segregated approval statu
# S-5 National Each 5ml contains: Dy. No. 2787 UK licensed formulation
industrial zone Formoterol fumarate manufacturing reference regul
Rawat- 100mcg Pack of 60ml / Local facility for authorities
Islamabad as per DPC Easair Capsule Pakistan in
(Regal Spec) By (Steroid) powder suspen
DML of firm Platinum Moreover statu
approved in 247st Mucolytic pharmaceuticals product will al
meeting of verified as st
Central or otherwise
Licensing Board
held on 29-04-

2016.
705. -do- Re-Zox 100mg /5ml Form 5 FDA approved Approved
oral D/S Rs. 20,000/- Alinia
08-06-2016 Lupin pharma
Each 5ml contains: Dy. No. 2786 USA
Nitazoxanide 100mg
Pack of 60ml / Local
(Regal Spec) as per DPC Izato
By
Nitrothiazolyl- Sami
salicylamide prodrug pharmaceuticals
706. -do- Regsan Form 5 Reference Deferred
500mg /30ml Rs. 20,000/- Liviat –Siza countries confirmation
oral D/S 08-06-2016 approval status approval statu
Dy. No. 2783 required formulation
Each dose of 30ml reference regul
contains: Pack of 30ml / authorities
Secnidazole 500mg as per DPC Pakistan.
(Regal Spec)
Nitoimidazole
707. -do- Regsan 750mg /30ml Form 5 Eknit – Hilton Reference Deferred
oral Dry suspension Rs. 20,000/- countries confirmation
08-06-2016 approval status approval statu
Each dose of 30ml Dy. No. 2784 required. formulation
contains: reference regul
Secnidazole 750mg Pack of 30ml / authorities
as per DPC Pakistan.
(Regal Spec)
Nitoimidazole
ORAL LIQUID SYRUP/SUSPENSION (GENERAL)

708. Regal Metrozole Plus Oral Form 5 The product not Deferred
Pharmaceuticals, suspension Rs. 20,000/- Metrodil –Sharex dound in confirmation
Plot # 2-A, Street 08-06-2016) reference approval statu
# S-5 National Each 5ml contains: Dy. No. 2518 countires. formulation
industrial zone Metronidazole as reference regul
Rawat- Benzoate 200mg Pack of 90ml / authorities
Islamabad Diloxanide furoate as per DPC Pakistan.
250mg
DML of firm
approved in 247st (Regal Spec)
meeting of Nitoimidazole ,
Central Amoebicide
Licensing Board
held on 29-04-
2016.
709. -do- Metrozole Oral Form 5 MHRA Approved
Liquid suspension Rs. 20,000/- Flygl, Sanofi-
08-06-2016 Aventis UK
Each 5ml contains: Dy. No. 2522
Metronidazole (as
Benzoate) 200mg Pack of Flgyl Sanofi-

60ml /as per DPC Aventis
(BP Spec) 120ml /as per
Nitoimidazole DPC
450ml / as per
DPC
710. -do- Dom – V Oral Liquid Form 5 MHRA-UK Approved

suspension Rs. 20,000/- Approved product
08-06-2016)
Domperidone Motillium – J & J
Maleate 5mg Pack of
60ml / as per DPC
(Regal Spec) 120ml / as per DPC
Anti-dopaminergic
711. -do- Sucralate Oral Liquid Form 5 MHRA Approved

suspension Rs. 20,000/- Antepsin 1gm
08-06-2016) Merk Barcelona
Each 5ml contains: Dy. No. 2519 spain
Sucralfate 1gm
Pack of
(Regal Spec) 60ml / as per DPC Ulsonic –
Anti-ulcerant/ 120ml /as per DPC Highnoon
mucoprotactant
712. M/s Regal Brofenac Oral liquid Form 5 MHRA approved Approved
Pharmaceuticals, suspension Rs. 20,000/- brand UK
Plot # 2-A, Street 08-06-2016)
# S-5 National Each 5ml contains: Dy. No. 2521
industrial zone Ibuprofen 100mg Brufen – Abbott
Rawat- Pack of 90ml /
Islamabad (USP Spec) as per DPC
Analgesic /
DML of firm Antipyretic
approved in 247st
meeting of
Central
Licensing Board
held on 29-04-
2016.
713. -do- Brofenac DS Form 5 MHRA approved Approved
Oral liquid Rs. 20,000/- brand UK
suspension 08-06-2016
Ibuprofen 200mg Brufen – Abbott
Pack of 90ml /
Analgesic /
Antipyretic
714. -do- Levocine oral Form 5 FDA approved Approved
solution Rs. 20,000/- Xyzal oral solution
08-06-2016 UCB pharma
Each 5ml contains: Dy. No. 2477 USA

Levocetirizine as di-
hydro chloride 2.5mg Pack of 60ml / Local
as per DPC Ocitra
(Regal Spec) By
Searle laboratories
Anti-Histamine
715. -do- Epiwell 250mg Form 5 Reference Deferred

Oral Liquid syrup’ Rs. 20,000/- countires and confirmation
08-06-2016) Pakistan approval statu
Each 5ml contains: approval status formulation
Sodium valproate Dy. No. 2516 not given. reference regul
250mg authorities
Pack of 60ml / Pakistan.
Anti-Epileptic
716. -do- Epiwell 500mg Form 5 Reference Deferred

Oral Liquid syrup Rs. 20,000/- countires and confirmation
08-06-2016 Pakistan approval statu
Each 5ml contains: Dy. No. 2512 approval status formulation
Divalproex 500mg not given. reference regul
(USP Spec) Pack of 60ml / authorities
Anti-Epileptic as per DPC Pakistan.
717. -do- Regadryl Oral Liquid Form 5 Approved status in Deferred
syrup Rs. 20,000/- Pakistan, reference confirmation
08-06-2016) from other approval statu
Each 5ml contains: Dy. No. 2523 counteriesd not formulation
Amiophylline 32mg available reference regul
Diphanhydramin Pack of 120ml / authorities.
8mg. as per DPC
Ammonium chloride Local
30mg Hydralline
Menthol 0.98mg By
Searle pharma
(Regal Spec)
Anti-
Histamine/Xanthine/
Expectorant.
718. -do- Regtus Oral Liquid Form 5 Approved status in Deferred
suspension Rs. 20,000/- Pakistan, reference confirmation
08-06-20162478 from other approval statu
Each 5ml contains: Dy. No. counteries not formulation
Paracetamol 80mg available reference regul
Pseudoephiderine Hcl Pack of 120ml / authorities.
15mg. as per DPC
Chlorphenaramine Local
maleate 1mg
Reltus CF
By
(Regal Spec) Pharmatec
Anti-Tussive /
Antipyretic
719. M/s Regal Regofer – F Oral Form 5 Approved status in Approved
Pharmaceuticals, Liquid Rs. 20,000/- Pakistan, reference
Plot # 2-A, Street 08-06-2016 from other

# S-5 National Dy. No. 2511 counteries not
industrial zone Each 5ml contains: available
Rawat- Pack of 120ml /
Islamabad Iron Ш hydroxide as per DPC
352olymaltose Local
DML of firm complex eq. To Approved vide
approved in 247st elemental Iron 50mg registration
meeting of No.055272
Central Folic Acid 0.35mg Rubifer-F- AGP
Licensing Board
held on 29-04- (Regal Spec)
2016. Haematinic .
720. -do- Regacal Oral Liquid Form 5 MHRA Approved

suspension Rs. 20,000/- Almus Paracetamol
08-06-2016) BCM. Nottingham
Each 5ml oral Dy. No. 2520 UK
suspension contains:
Paracetamol 120mg Pack of 120ml / Local
as per DPC Calpol
(BP Spec) By
Anti-pyretic GSK
LIQUID VIAL INJECTION (GENERAL)

721. -do- Ciprocin Infusion Form 5 FDA approved Approved
Rs. 20,000/- Cipro
Each 100ml contains: 08-06-2016 Bayer corporation
Ciprofloxacin as Dy. No. 2474 pharmaceutical
lactate 200mg division USA
Pack of 100ml /
(USP Spec) as per DPC Local
Novidate
Quinolone Antibiotic By
Sami
pharmaceutical
722. -do- Ciprocin Form 5 Qilox –Bosch Reference Deferred

Liquid vial injection Rs. 20,000/- countires confirmation
(Infusion) 08-06-2016 approval status approval statu
Dy. No. 2475 required for formulation
Each 100ml contains: proposed dosage reference regul
Ciprofloxacin as Pack of 100ml / form. authorities.
lactate 400mg as per DPC
(USP Spec)
Quinolone Antibiotic
723. -do- Metrozole Infusion Form 5 MHRA approved Approved

Rs. 20,000/- brand of Baxter
Each 100ml contains: 08-06-2016
Metronidazole Dy. No. 2481 Flagyl –Sanofi
500mg
Pack of 100ml /

Nitroimidazole / Anti
protozoal
724. -do- O – Mox Infusion Form 5 FDA approved Approved

Rs. 20,000/- Avelox –Bayer \
Each 250ml contains: 08-06-2016)
Moxifloxacin (as Dy. No. 2484 Moxiget – Getz
HCl) 400 mg
Pack of 250ml /
(Regal Spec) as per DPC
Quinolone Antibiotic
725. -do- WEFLOX Infusion Form 5 MHRA Evoxil – Approved

Rs. 20,000/- Beacon
Each 100 ml 08-06-2016
contains: Dy. No. 2476
Levofloxacin 500 mg Leflox – Getzs
(5mg/ml) Pack of 100ml /
as per DPC
(Regal Spec)
Floro Quinolone
Antibiotic
726. -do- Zolid Infusion 200mg Form 5 FDA approved Approved
Rs. 20,000/- Zyvox change of b
Each 100ml contains: 08-06-2016 Pharmacia Upjohn name
Linzolid 200mg Dy. No. 2479 pharmaceutical
Newyork
(Regal Spec) Pack of 1200ml / USA
as per DPC
Oxazolidinone Local
Antibacterial Ecasil
By
Sami

Newyork
as per DPC
Oxazolidinone Local
By
Sami

Newyork
as per DPC

Oxazolidinone Local
By
Sami
729. -do- PARAMOL Infusion Form 5 MHRA approved Approved

Rs. 20,000/- product of Actavis change of b
Each 100ml contains: 08-06-2016 name
Paracetamol 1gm Dy. No. 2480 Provas - Sami
(USP Spec) Pack of 300ml /

Antipyretic as per DPC
730. -do- Amikan Liquid Form 5 FDA amikasin- Proof of Deferred for
injection Rs. 20,000/- Teva 250mg/ml approval of of approval of
08-06-2016) same dosage formulation
Each 2ml vial Dy. No. 2505 Srasil – Sami form in strength (250mg/2ml)
contains: 250mg/2ml in reference regul
Amikacin (as Pack of 2ml / reference authorities.
Sulphate) 250mg as per DPC countires is not
correct.
(BP Spec)
Aminoglycoside
Antibacterial
731. -do- Amikan injection Form 5 FDA approved Approved

500mg Rs. 20,000/- Amikasin Teva change of b
08-06-2016) name
Amikacin (as Srasil
Sulphate) 500mg Pack of 2ml / By
as per DPC Sami
(BP Spec)
Aminoglycoside
Antibacterial
LIQUID AMPOULE INJECTABLE (GENERAL)
732. -do- V-REN Liquid Form 5 FDA approved Approved

injection Rs. 20,000/- Dyloject –
08-06-2016) Hospira
Each 3ml ampoule Dy. No. 2508
Contains: Dyclo – Indus
Diclofenac sodium Pack of 3ml /
75mg as per DPC
(Regal Spec)
NSAID
733. -do- Ondis injection Form 5 MHRA Approved
Rs. 20,000/- Ondansteron
Each 4ml Ampoule 08-06-2016 USA
Contains: Dy. No. 2510
Ondansetron 8mg Local
Pack of 5 x 4ml / Onset injection
(USP Spec) as per DPC By

Anti-emetic (5HT3 Pharmedic
antagonist) laboratories
734. -do- Ibro injection 3ml Form 5 FDA approved Approved

Rs. 20,000/- Ibandronate
Each 3ml ampoule 08-06-2016 Sodium Injection
contains Dy. No. 2504 vial - Sun
Ibandronate Pharmaceutical
monosodium Pack of 3ml / India
monohydrate salt BP as per DPC
eq to ibandronic acid Bonviva – Roche
3mg
Biophosphonate
Specification:-
Manufacture
735. -do- Calcirol injection Form 5 FDA approved Approved

Rs. 20,000/- Calitriol
Each 1ml Ampoule 08-06-2016) Americal Regent
Contains: Dy. No. 2500 pharmaceutical
Calcitriol 1mcg USA
Pack of 10 x 1ml /
(USP Spec) as per DPC Local
Vitamin D Analogue Calciwins injection
By
Winsfield pharma
736. -do- Calcvit injection Form 5 Vit D3 B.O.N, Approved

Rs. 20,000/- France
Each 1ml Ampoule 08-06-2016
Cholicalciferol 5mg Indrop D – Neutro
Pack of 1X1ml /
Vitamin D Analogue
737. Re-lac injection Form 5 USFDA Toradol – Approved

Rs. 20,000/- Roche
08-06-2016
Each 1ml Ampoule Dy. No. 2485
Contains: Molac – Linear
Ketorolac Pack of 5 x 1ml /
Trometamol 30mg as per DPC
(USP Spec)
NSAID
738. -do- Iron-C injection Form 5 FDA approved Approved

Rs. 20,000/- Venofer
Each 5ml Ampoule 08-06-2016) 100mg/5ml
Contains: Dy. No. 2503 Ampoule
Iron sucrose complex
equivalent to Pack of 5X5ml / Local

elemental iron 100mg as per DPC Bislery-S injection
By
(USP Spec) Sami pharma
Hematinic
739. -do- Regamin injection Form 5 Methycobal – Approved
Rs. 20,000/- Eisai, Japan
Each 1ml amber glass 08-06-2016
ampoule Contains: Dy. No. 2507 Mabil – Sami
Mecobalamin
500mcg Pack of 10 x 1ml /
as per DPC
(Regal Spec)
Vitamin B12 co-
enzyme
740. -do- Regadol injection Form 5 MHRA Tramol – Approved
Rs. 20,000/- CSL
Each 2ml Ampoule 08-06-2016)
Tramadol Hcl 100mg Lamadol – Brooks
Pack of10X1ml / pharma
Opiate Analogue
741. -do- Remol injection Form 5 Proof of Deferred

Rs. 20,000/- Paygone approval status confirmation
Each 2ml Ampoule 08-06-2016 injection of same dosage approval statu
Contains: Dy. No. 2501 By form in formulation
Paracetamol 300mg Fynk reference reference regul
Lidocain Hcl 20mg Pack of10X1ml / pharmaceuticals countires not authorities.
as per DPC provided.
(Regal Spec)
NSAID / Local
anesthetic
742. -do- AQUA-R Form 5 FDA approved Approved

Liquid Ampoule Rs. 20,000/- Sterile water for
injection 08-06-2016 injection
5ml Ampolue Dy. No. 2788 Americal Regent
pharmaceutical
Each 5ml Ampoule Pack of USA
Contains: 100 X5ml / as per
Sterile water for DPC Local
injection Aqua -P injection
By
(BP Spec) Ipram pharma
Vehicle/solvent/Dilue
nt for parental
administration

New Veterinary Licensed Unit M/s Vantage Pharmaceutical, 54/ R.B SARHALI, 6-KM SANGLA HILL ROAD
SHAHKOT, FAISALABAD.
S/N Name and Brand Name Type of Form International Remarks Decision
address of (Proprietary name + Initial date, diary status in
manufacture Dosage Form + Strength) Fee including reference drug
r / Applicant Composition differential fee agencies /
Pharmacological Group Demanded Price / authorities
Finished product Pack size Me-too status
Specification GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Veterinary Oral Liquid (General)
743. M/s Vantage Bromodil oral Liquid Form 5 Doctyl Super Approved
Pharmaceuti Rs. 20,000/- Solution –
cal, 54/R.B Each 100 ml contains: 21-06-2016 Alina
Sarhali, 6- Tylosin Tartrate 10gm Dy. No. 254
km Sangla Doxycycline HCl 20gm DML of firm
Hill Road, Bromhexine 1gm approved in
Shahkot, Pack size 100ml, 247st meeting
Faisalabad. (Manufcature Specification) 500ml & one litre of Central
Antibiotics Licensing
Price decontrolled Board held on
29-04-2016.
744. -do- Micotil 250 oral liquid Form 5 Tilcosin 25% - Approved
Rs. 20,000/- Nawan
Each ml contains: 21-06-2016
Tilmicosin 250mg Dy. No. 258
(Manufcature Specification) Pack size 100ml,

Antibiotics 250ml, 500ml, one
litre & 5 litre
Price decontrolled
745. -do- ENROX TAGE 20% oral Form 5 ENROCK -IPL Approved
liquid Rs. 20,000/-
21-06-2016
Each ml contains: Dy. No. 259
Enrofloxacin 200 mg
Pack size 100ml,
(Manufcature Specification) 250ml, 500ml, one
Antibiotics litre & 5 litre
Price decontrolled
746. -do- FOXIN TAGE oral liquid Form 5 FLORICOL – Approved

Rs. 20,000/- DECENT
Each ml contains: 21-06-2016
Florfenicol 230mg Dy. No. 256
Colistin Sulphate 50 MIU
Pack size 100ml,

Price decontrolled
747. -do- TAGE TRIL 10% oral Form 5 FLORICOL – Approved

liquid Rs. 20,000/- DECENT
21-06-2016
Each 100 ml contains: Dy. No. 257
Enrofloxacin 10gm
(100 mg/ml) Pack size 100ml,
250ml, 500ml, one
(Manufcature Specification) litre & 5 litre
Antibiotics Price decontrolled
748. -do- SULFATRIN TAGE oral Form 5 TRISTAR - Approved
liquid Rs. 20,000/- BIOGEN
21-06-2016
Each ml contains: Dy. No. 262
Sulphadiazine 400mg
Trimethoprim 80 mg Pack size 100ml,
250ml, 500ml, one
(Manufcature Specification) litre & 5 litre
749. -do- TIVERDOX oral liquid Form 5 MEDIDOX - Approved
Rs. 20,000/- MEDIVET
Doxycyclin HCl 20gm Dy. No. 250
Tylosin Tartrate 10gm
Pack size 100ml,
Price decontrolled
750. -do- FLORFEN 23 oral liquid Form 5 BAFLOR 23 - Approved
Rs. 20,000/- BAARIQ
Florfenicol 23gm Dy. No. 251
(Manufcature Specification) Pack size 100ml,

Antibiotics 250ml, 500ml, one
litre & 5 litre
Price decontrolled
751. -do- MICROMUTIN oral liquid Form 5 Tylo biotech – Approved
Rs. 20,000/- grand
Tylosin Tartrate 10gm Dy. No. 251
Doxycycline HCl 20gm
Colistin Sulphate 50000 IU Pack size 100ml,
Bromhexine 0.5gm 250ml, 500ml, one
litre & 5 litre
(Manufcature Specification) Price decontrolled
Antibiotics
752. -do- EAFLEXIN TAGE oral Form 5 ENROCOL Approved
liquid Rs. 20,000/- 10% - LEADS
21-06-2016
Enrofloxacin 10gm

Colistin Sulphate Pack size 100ml,
50,000,000 IU 250ml, 500ml, one
litre & 5 litre
Antibiotics
Veterinary Oral Powder
753. M/s Vantage Vantage ESB 30% Oral Form 5 E-COX ORAL Approved
Pharmaceuti Powder Rs. 20,000/- POWDER -
cal, 54/R.B 21-06-2016 BIOGEN
Sarhali, 6- Each 100 gm contains: Dy. No. 266
km Sangla Sulphaclozine sodium DML of firm
Hill Road, monohydrate 30gm approved in
Shahkot, Pack size 100gm, 247st meeting
Faisalabad. (Manufcature Specification) 250gm, 500gm, of Central
Antibiotics 1kg & 5kg Licensing
Price decontrolled Board held on
29-04-2016.
754. -do- DOXY TAGE Oral Powder Form 5 DOXYTYL Approved

Rs. 20,000/- ORAL
Each 100 gm contains: 21-06-2016 POWDER -
Tylosin tartrate 10gm Dy. No. 261 NAWAL
Pack size 100gm,
(Manufcature Specification) 250gm, 500gm,
Antibiotics 1kg & 5kg
Price decontrolled
755. -do- COLI TAGE 48 Oral Form 5 Deferred

Powder Rs. 20,000/- confirmation
21-06-2016 approval status
Each gm contains: Dy. No. 260 same formulation
Colistin Sulphate 48000000 Pakistan.
IU Pack size 100gm,
250gm, 500gm,
(Manufcature Specification) 1kg & 5kg
756. -do- TYL-D600 Oral Powder Form 5 REOCIN TD - Approved

Rs. 20,000/- DELUX
Each 100 gm contains: 21-06-2016
Tylosin tartrate 20gm Dy. No. 263
Pack size 100gm,
(Manufcature Specification) 250gm, 500gm,
Antibiotics 1kg & 5kg
Price decontrolled
757. -do- OXYTAGE Oral Powder Form 5 NEOCHLOR - Approved

Rs. 20,000/- ALINA
Each 100 gm contains: 21-06-2016
Oxytetracycline HCl 25gm Dy. No. 263
Neomycin Sulphate 25gm
Colistin Sulphate 30 MIU Pack size 100gm,
250gm, 500gm,

758. -do- VANTAGE ASPER-C Oral Form 5 Approved

Powder Rs. 20,000/- SB – ASPER-
21-06-2016 SB PHARMA
Each 100 gm contains: Dy. No. 264
Vitamin C 20gm
Acetylsalicylic acid 6.7gm Pack size 100gm,
250gm, 500gm,
Vitamin / antipyretic / anti Price decontrolled
inflammatory
759. -do- SPECLIN TAGE Oral Form 5 The product in Deferred

Powder Rs. 20,000/- proposed submission
21-06-2016 strength is not registration
Each gm contains: Dy. No. 265 yet registered in application
Lincomycin HCl 222mg Pakistan. prescribed Form
Spectinomycin HCl 444 mg Pack size 100gm, D as product
250gm, 500gm, proposed strengt
(Manufcature Specification) 1kg & 5kg not yet registered
Antibiotics Price decontrolled Pakistan.
760. -do- TYLOSTIN Oral Powder Form 5 Bronchodil – The local Deferred for
Rs. 20,000/- Attabak availability is in submission of
Each 1000 gm contains: 21-06-2016 liquid form registration
Tylosin Tartrate 100gm Dy. No. 268 while firm has application on
Doxycyclin HCl 200gm applied for fwy prescribed Form
Colistin Sulphate 480 MIU Pack size 100gm, powder. D as product in
Bromhexine HCl 3 gm 250gm, 500gm, proposed strength
1kg & 5kg not yet registered
(Manufcature Specification) Price decontrolled Pakistan.
Antibiotics Deferred
confirmation
approval status
same formulation
Pakistan
reference regulat
authorities
already appro
formulation are
liquid form wh
firm has applied
dry powder.
761. -do- CHLOR NEC Oral Powder Form 5 Approved
Rs. 20,000/- STRIKER -
Each 1000 gm contains: 21-06-2016 WIMITS
Chlortetracyclin 80gm Dy. No. 269
Neomycin Sulphate 70gm
Colistin Sulphate 4 gm Pack size 100gm,
250gm, 500gm,

762. -do- SPECLINX Oral Powder Form 5 Spiralin –B Approved
Rs. 20,000/- (Attabak)
Each 100 gm contains: 21-06-2016 import 249th
Lincomycin HCl 5gm Dy. No. 267 meeting and
Spectinomycin HCl 7.5gm 254th meeting
Spiramycin adipose 2.5gm Pack size 100gm,
Bromhexine HCl 0.5 gm 250gm, 500gm,
1kg & 5kg
Antibiotics

New Section:-
S/N Name and Brand Name Type of Form International Remarks / Decisio
address of status in Observation
manufacturer (Proprietary name + Initial date, diary stringent s
Dosage Form + regulatory
/ Applicant
differential fee
Demanded Price /
Pharmacological Pack size GMP status as
Group depicted in
inspection report
Finished product (dated)
Specification
Following cases of Azilsartan containing formulations were deferred in 259 th meeting of the
board:
Decision (259th meeting): Registration Board noticed that significant changes in the assay of the
API have been occurred in Azilsartan formulations applied by different applicants.
Therefore, all cases of azilsartan preparations were deferred for further deliberation in
next board meeting.
1. Azil tablets (Azilsartan Medoxomil 20mg,40mg, 80mg), M/s Helix Pharma Karachi.
Drug Azil tablets (Azilsartan Medoxomil 20mg,40mg, 80mg)

Source Jiangxi Synergy Pharmaceutical CO., Ltd. China
Storage Condition Real Time: 30°C and 65% RH
Accelerated: 40°C and 75% RH
Time Period Real Time: 6 months

Accelerated: 6 months
Frequency 0, 3, 6 months
Batch Size 400 Tablets, 400 Tablets, 400 Tablets,
No. of Batches 03
Sample Size 25 tablets
Meeting  Deferred 245th meeting of Registration
Board for stability data as per WHO
guidelines.
 Deferred in 255th meeting of registration
board for evaluation by committee.
Remarks  Significant change noticed in assay.
Documents / Data provided by the applicant (M/s Helix Pharma Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of Yes (Photocopy

origin or GMP certificate of API manufacturer issued by provided)
regulatory authority of country of origin.
3. Protocols followed for conduction of stability study and Yes
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. Yes (By courier only)
6. All provided documents will be attested (name, sign and Partially attested
stamp) for ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till Yes
assigned shelf life of the product.
Decision: Registeration Board deliberated on the matter of significant changes in the assay of
the API and decided to call technical team of firm for presentation on
aforementioned point before the Board.
2. Azil tablets 80 mg, Co-Azil 40/25 mg, M/s OBS Karachi.
Drug 1. Azil tablets 80 mg, (Azilsartan Kamedoximil)

2. Co-Azil 40/25 mg (Azilsartan Kamedoximi +
Chlorothalidone)
Source 1.Jiangxi Synergy Pharma Co. Ltd, China

2.Trichem Life Sciences India.

Frequency 0, 3, 6 months
Batch Size 2000 Tablets/ batch
No. of Batches 03
Sample Size 50 tablets
parameters Appearance, weight, dissolution, microbiology, assay,
Meeting Deferred 245th meeting of Registration Board for

stability as per WHO guidelines.
Remarks Firm has submitted a request for grant of registration of
Azil 40mg tablets and Co-Azil 40/12.5 mg based upon
above data.
Storage conditions not as per ICH Zone IV-A.
Significant change noticed in assay.
Documents / Data provided by the applicant
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP Yes (Photocopies

certificate of API manufacturer issued by regulatory authority of provided)
country of origin.
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents Yes

like chromatograms, laboratory reports, data sheets etc.
5. Documents confirming import of API etc. Yes (photocopy invoice
submitted)
6. All provided documents will be attested (name, sign and stamp) for Yes
ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till assigned shelf life Yes
of the product.
Decision: Registeration Board deliberated on the matter of significant changes in the assay of
the API and decided to call technical team of firm for presentation on
aforementioned point before the Board
3. M/s Genix Pharma Pvt Ltd.
Drug Lalap Syrup 10mg/per m l (Lacosamide)

Source Nutra Specialties pvt Ltd 69, chandrapadiya

village vinjamur mandal Nellore DT-524228
Indraspardash, India
Storage Condition Accelerated: 40°C±2°C/ 75% ±5% RH
Long Term: 30°C±2°C/ 65% ±5% RH
Time Period Accelerated: 06 months
Long Term: 24 months
Frequency 1,3,6,9,12,18,24months
Batch Size 5Liters / batch
No. of Batches 03
Sample Size 18 Packs
Meeting Deferred in 252nd meeting of registration board
for stability data
Documents / Data provided by the applicants (M/s Genix Pharma Pvt Ltd, Karachi.)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or
GMP certificate of API manufacturer issued by regulatory Yes
authority of country of origin.
3. Protocols followed for conduction of stability study and details Yes
of tests.
4. Data of 03 batches will be supported by attested respective Yes
documents like chromatograms, laboratory reports, data sheets
etc.
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign and stamp) Yes
for ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till assigned Yes
shelf life of the product.
Decision: Registration Board decided to constituted following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents,
import of API, quality, specification, test analysis, facilities etc.
 Director DTL Quetta (Chairman),

 Director DTL, Karachi;
 Area FID, DRAP (Member/Convener).

M/s CCL Labs, Lahore
4 M/s CCL Labs, Diyacon Tablets Form-5-D

Lahore Each tablet Duplicate New
contains: file Molecule
Dapagliflozin Rs.50,000/
5mg -
As per
SRO
5 M/s CCL Labs, Diyacon Tablets Form-5-D

Lahore Each tablet Duplicate New
contains: file Molecule
Dapagliflozin 10 Rs.50,000/
mg -
As per
SRO
Drug Diyacon Tablets

Dapagliflozin 5mg
Diyacon Tablets
Dapagliflozin 10 mg
Source Beijing Huikang boyuan chemical company ltd, China
Frequency 0,3,6
Batch Size 3,000 Tablets per batch
No. of Batches 3
Sample Size 50 tablets per batch
Documents / Data provided by the applicants

(M/s CCL Pharma Pvt Ltd, Lahore.)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin
or GMP certificate of API manufacturer issued by regulatory Yes
authority of country of origin. (Photocopy)
details of tests.

documents like chromatograms, laboratory reports, data
sheets etc.
(Commercial invoice not
attested)
6. All provided documents will be attested (name, sign and Yes
Decision: Registration Board decided to constituted following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents,
import of API, quality, specification, test analysis, facilities etc.
 Director DTL Peshawar (Chairman),

 Director DTL, Lahore;
 Area FID, DRAP (Member/Convener).
6 M/s CCL Labs, Dacvir Form-5-D

Lahore Tablets Duplicate New
Each film coated tablet file Molecul
contains: Rs.50,000/- e
Daclatasvir Dihydrochloride As per SRO
equivalent to Daclatasvir ……
30mg
Mfg Specs
7 M/s CCL Labs, Dacvir Form-5-D

Lahore Tablets Duplicate New
Each film coated tablet file Molecul
contains: Rs.50,000/- e
Daclatasvir Dihydrochloride As per SRO
equivalent to Daclatasvir ……
60mg
Mfg Specs
Drug Dacvir
Tablets
Daclatasvir Dihydrochloride equivalent to Daclatasvir
……30mg
Mfg Specs
Dacvir
Tablets
Daclatasvir Dihydrochloride equivalent to Daclatasvir
……60mg

Mfg Specs
Source Ruyuan HEC pharam Ruyuan county guangdond China

Frequency 0,3,6
Batch Size 1000 Tablets
No. of Batches 3
Sample Size 50 Tablets

(M/s CCL Pharma Pvt Ltd, Lahore .)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin The GMP certificate
or GMP certificate of API manufacturer issued by regulatory provided by the firm
authority of country of origin. shows scope of
inspection for bulk drug
is (Azithromycin,
Sofosbuvir, Ledipasvir)
details of tests.
sheets etc.
(Performa invoice not
attested)
6. All provided documents will be attessted (name, sign and Yes
Decision: Registration Board decided to constitute the following panel for onsite
investigation to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis,
facilities etc.
o Brig. (R) M.H. Najmi, Member Registration Board.

o Dr. Obaidullah, DDG (Reg-I), DRAP, Islamabad.
o Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.

M/s Pharmevo, Karachi
8 M/s PharmEvo, Dakvir tablet Form 5-D

Karachi Each film coated tablet Duplicate New
contains: file Molecul
Daclatasvir (as Rs: 50,000 e
dihydrochloride) 60 mg As per PRC
Mfg Specs
Drug Dakvir tablet

Daclatasvir (as dihydrochloride) 60 mg
Mfg Specs
Source Virupaksha organics India

Frequency 0,3,6
Batch Size 2500 Tablets
No. of Batches 3

(M/s Pharm Evo Pvt Ltd, Karachi .)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin Yes
or GMP certificate of API manufacturer issued by regulatory (However the proof of
authority of country of origin. approval of API not
attached )
3. Protocols followed for conduction of stability study and details No
of tests.
etc.
6. All provided documents will be attessted (name, sign and Yes


Decision: Registration Board decided to constitute the following panel for onsite
investigation to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis,
facilities etc.
o Brig. (R) M.H. Najmi, Member Registration Board.

o Dr. Obaidullah, DDG (Reg-I), DRAP, Islamabad.
o Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.
M/s English Pharma Pvt Ltd, Lahore.
Drug Esovir 400mg Tablet (Sofosbuvir)

Source M/s Pharmagen, Lahore
Frequency 0,1,3,6
Batch Size Not provided
No. of Batches 3
Sample Size Not provided

(M/s English Pharma Pvt Ltd, Lahore.)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or Yes
GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
3. Protocols followed for conduction of stability study and details No
of tests.
4. Data of 03 batches will be supported by attested respective Not Attested
etc.
5. Documents confirming import of API etc. Not Appied
6. All provided documents will be attessted (name, sign and No

7. Commitment to continue real time stability study till assigned No

Decision: Registration Board deferred case for completion of documents as recorded above.
M/s Getz Pharma, Karachi
9 M/s Getz Pharma, Verna tablets 30 mg Form 5-D

Karachi Each film coated Tablet : Dy no: 365 New
Daclatasvir dated: Molecul
dihydrochloride 08..09.201 e
equivalent to 5
Daclatasvir………… Rs: 50,000
30mg Price:
30000/ 28
Tablets
Price;
1071.42/pe
r tablet
10 M/s Getz Pharma, Verna tablets 60 mg Form 5-D
Karachi Each film coated Tablet : Dy no: 364 New
Daclatasvir………… dated: Molecul
60mg 08..09.201 e
5
Rs: 50,000
Price:
50000/ 28
Tablets
Price;
1785.42/pe
r tablet
Drug Verna tablets 30 mg

Each film coated Tablet :
Daclatasvir dihydrochloride equivalent to
Daclatasvir…………30mg
Verna tablets 60 mg
Each film coated Tablet :
Daclatasvir…………60mg
Source Zhejiang apeloa kangyu Pharmaceutical company limited
Zhejiang, China
Frequency 0,1,2,3,6
Batch Size Not available
No. of Batches 3
Sample Size Not available
Remarks The firm has informed that they have developed

daclatasvir 60mg tablet from shanghai forefront pharma
company Ltd China (contract development China- R&D
company) and through technology transfer they have
reproduced the same product at their facility. Further,
Getz phama has manufacturer 03batches of the drug using
same technology and 03months stability data has been
completed.

(M/s Getz Pharma Pvt Ltd, Karachi .)
1. COA of API Yes

or GMP certificate of API manufacturer issued by regulatory The GMP certificate
authority of country of origin. provided by the firm
shows scope of
inspection for bulk drug
(Ofloxacin, levofloxacin,
rimantadine, Ubenimex)
details of tests.
sheets etc.
5. Documents confirming import of API etc. NO

Decision: Registration Board deferred the case for scientifically rationale lab scale stability
data for six months as per recommendatons of the Board.
M/s CCL Pharma, Lahore
11 Lebriva Tablet Form 5-D

Each Tablet contains: Dy no: 705 dated:
Ledipasvir……..90mg 08.02.2016
Sofosbuvir………400mg Rs: 50,000
Mfg Specs Not applicable
Drug Lebriva Tablet

Each Tablet contains:
Ledipasvir……..90mg
Sofosbuvir………400mg
Mfg Specs
Source Ruyuan HEC pharam Ruyuan county guangdond China

Jiangxi Synergy Pharmaceutical Company limited China
Frequency 0,3,6
Batch Size 1000 tablets
No. of Batches 3

(M/s CCL Pharma Pvt Ltd, Lahore .)
1. COA of API Yes

(The firm has provided
COA of two different
companies )
or GMP certificate of API manufacturer issued by regulatory Yes
authority of country of origin. (Photocopy Provided)
details of tests.
etc.
(not clear from the
invoice that from which
source the firm has
imported the API)
Decision: Registeration Board deferred the case for clarification regarding source of
API used for conducting stability studies.

Registration of Aprovasc Range (Irbesartan + Amlodipine).
Following case of M/s Sanofi Aventis, Karachi was discussed in 257 th meeting and decided as
follows:
Registration Board in its 245th meeting discussed following products of M/s Sanofi Aventis,
Karachi and advised the firm to provide status about availability of products in SRAs and provide safety
and efficacy data of the drugs along with complete clinical trial data of these formulations.
S. No Name of drug(s) & Composition
I. Aprovasc 300/10mg Tablet

Irbesartan……….300 mg
Amlodipine besylate.14 mg eq. to amlodipine…10 mg
(Antihypertensive, angiotensin II receptor antagonist)
II. Aprovasc 150/10mg Tablet
Amlodipine besylate.14 mg eq. to amlodipine…10 mg
III. Aprovasc 150/5mg Tablet
Amlodipine besylate.7 mg eq. to amlodipine……5 mg
IV. Aprovasc 300/5mg Tablet
Amlodipine besylate.7 mg eq. to amlodipine……5 mg
In response, the firm had submitted that the fixed dose combination of Irbesartan + Amlodipine
(in the strength of Irbesartan 100mg /Amlodipine 5mg and Irbesartan 100mg /Amlodipine 10 mg) is
registered with PMDA Japan by the name of AIMIX by Daipinppon Suitomo Pharma. They have
submitted that as the dosing in Japan is considerably lower than the USA or Europe therefore the fixed
dose combinations are of lower strength.
They have informed that that three Bioequivalence studies have been conducted for Aprovasc and
the results of these had been submitted to DRAP for review and these studies show that the combination
of Irbesartan + Amlodipine versus free individual molecule is safe and well tolerated. Apart from these 2

randomized, open-label, multicenter, phase III trials were conducted and published in peer reviewed
index Journal, Clinical therapeutics (2012) and no untoward side effects were observed with this
combination other than those already reported for the individual drugs.
Registration Board in its 249th meeting discussed the case in view of the submission made by the firm and
following decision was taken:
“Registration Board referred the clinical data to Pharmacy Services Division for evaluation.”
 Division of Pharmacy Services has now submitted evaluation report as under:
“The clinical study data attached by the company have been studied. The pharmacokinetic,
Pharmacovigilance, safety, efficacy data provided by the company was evaluated. The representatives of
the company who are involved in clinical research were asked to explain the need of combination
medicines and their beneficial effects on hypertension patients.
The research articles, studies carried out on the above combination medicine provided by the company
and the discussion made with the expert reveals that the products could be approved for registration. Such
combination products with Amlodipine and valsartan are already available in the market. The products
may be considered by the Registration Board after completing other required codal formalities”
Decision (257th meeting): Registration Board deferred the case for detailed deliberation in the
light of report of Pharmacy Services Division.
Decision: Registeration Board deferred the case for further deliberation.

Item No.III: Biological Drugs Division.
Case No.01: Cases of imported human biological drugs from non reference countries.
”In 255th meeting of Registration Board it was apprised that registration

applications for finished imported products are submitted with Certificate of Pharmaceutical Products
(CoPP) and in some cases, CoPP is without any expiry date. The Board decided to consider such CoPP
valid for 05 years from date of issuance. Moreover, Registration Board also decided to consider
registration applications of those imported products whose CoPPs was valid at time of submission of
application and later on expired during processing of the application. In such cases, application will be
considered by Registration Board and firm will be advised to provide valid CoPP. Registration letter will
be issued after submission of legalized CoPP after approval of chairman, RB. Accordingly the following
cases require consideration by the Registration Board”
S.#. Name of Brand Name & Type of Form Document Remarks Decision
Importer & Composition Dy No & Date of details (CoPP)
Manufacturer application Me too
Fee submitted status/New
Pack size/ molecule
Demanded Price
1. M/s Medibid KXING-GCSF Form 5-A COPP No. Valid and Deferred for
First floor, 300ug/ml PFS WHO-CPP- legalized COPP/ expert opinion
Shafi Court Dy No. 2232 R&I CERT-JN- FSC along with of following
Merewether Recombinant dated 15-4-2013 131211 dated GMP Certificate and valid
Road, Civil human 17-2-2013 need to be
Fee deposited Rs. legalized
Lines, Karachi. granulocyte from Republic submitted as per
15000/- dated 19-4- COPP/FSC &
colony- of China above decision of
stimulating 2012 + Rs. 35000/- 255th meeting. GMP:
Shandong factor injection dated 13-11-2013 + Product
Rs. 50000/- dated a. Brig. Tariq
Kexing License No. Condition of Satti,
Bioproducts Strength of 12-1-2015 GYZZ inspection abroad AFBMTC,
Co., Ltd. active Shelf life: 24 S20103004 as per import Islamabad.
Mingshui ingredients: months dated 29-4- policy. b. Brig.
development 300ug/ml/Pre 2010 Qamar-un-
Zone, Filled Syringe Pack size: 300ug/ml Nisa,
Zhangqiu, Pre filled Free Sale AFBMTC,
Shandong, syringe/small Certificate No. Islamabad
China. carton, 10 2013-023 c. Dr Shamsi,
syringes/middle dated 17-2- Karachi
carton, 320 2013 valid for
syringes/big carton two years

Demanded Price.
Rs.4500/- per vial.
2. M/s Medinet FILATIL Dy. No. 1798 (R&I) GMP Valid and Deferred for
Pharmaceutical Prefilled Syringe DRAP (TF) Certificate No. legalized COPP/ expert opinion
s, Rawalpindi 300MCG/1ML Dated 21-11-2014 113300IT0114 FSC along with of following
(Filgrastim) 73 dated 05-7- GMP Certificate and valid
Fee deposited: Rs. 2011 need to be
legalized
Probiomed S.A Active 50000/- dated 17- submitted as per
COPP/FSC &
de C.V. ingredient: 11-2014 + Product above decision of
San Esteban Filgrastim…… Rs.50000/- dated Registration 255th meeting. GMP:
No.88, Col. 300MCG/1ML 15-3-2016 No.
a. Brig. Tariq
Santo Tomas, 101M2001S.S. Condition of Satti,
C.P. 02020, Antineoplastic A. inspection abroad AFBMTC,
Deleg, as per import Islamabad.
Azcapotzalco, Shelf life : 24 Free sale policy. b. Brig.
D.F., Mexico. months certificate No. Qamar-un-
113300516B1 Nisa,
305 dated 23- AFBMTC,
8-2011 valid Islamabad.
until 24 c. Dr Shamsi,
months Karachi
Sanitary
License No. 09
002 02 0001
Date of expiry
30-1-2009
Date of
translation 27
July, 2011
3. M/s Medinet BIOYETIN Dy No. 1164 (R&I) GMP Valid and Deferred for
Pharmaceutical Multi dose DRAP (TF) dated Certificate No. legalized COPP/ expert opinion
s, Rawalpindi 10,000IU 26-2-2015 113300IT0114 FSC along with of following
(Recombinant 73 dated 05-7- GMP Certificate and valid
Human Fee deposited: Rs. 2011 need to be
legalized
Probiomed S.A Erythropoietin) 50000/- dated 26-2- submitted as per
COPP/FSC &
de C.V. 2015 + Rs.50000/- Free sale above decision of
San Esteban dated 15-3-2016 certificate No. 255th meeting. GMP:
No.88, Col. Each 2ml vial 093300516B1
a. Dr. Ghias
Santo Tomas, contains: As per DRAP policy 213 dated 02- Condition of But, PIMS,
C.P. 02020, Recombinant 5-2009 valid inspection abroad Islamabad.
Deleg, Human until 24months as per import
Azcapotzalco, Erythropoietin--- from the policy.

D.F., Mexico. --10,000IU country of b. Maj. Gen.
origin. Sohail
: Product Sabir, MH,
Anti anemic Registration Rawalpindi.
agent No. 306M98
Hematopoietic S.S.A. c. Dr.Sami
Growth Factor siraj, KMU,
Sanitary Peshawar.
License No. 09
002 02 0001
Date of expiry
30-1-2009
Date of
translation 27
July, 2011
Pharmaceutical PFS 4000IU DRAP (TF) dated Certificate No. legalized COPP/ expert opinion
s, Rawalpindi (Recombinant 26-2-2015 113300IT0114 FSC along with of following
Human 73 dated 05-7- GMP Certificate and valid
Erythropoietin) Fee deposited: 2011 need to be
legalized
Probiomed S.A Rs. 50000/- dated submitted as per
COPP/FSC &
de C.V. Strength & 26-2-2015 + Free sale above decision of
San Esteban Active Rs.50000/- dated certificate 255th meeting. GMP:
No.88, Col. ingredients: 15-3-2011. letter
Santo Tomas, One pack of No.093300516 Condition of
C.P. 02020, Bioyetin 4000IU B1213 dated inspection abroad a. Dr. Ghias
Deleg, PFS Contains: 02-5-2009 as per import But, PIMS,
Azcapotzalco, Pre Filled valid until 24 policy. Islamabad.
D.F., Mexico. Syringes of months from
0.30ML Each. the country of
origin. b. Maj. Gen.
Recombinant Sohail, MH,
Human Product Rawalpindi.
Erythropoietin… Registration
…4000IU No. 306M98
Pharmacological S.S.A.
c. Dr.Sami
group: siraj, KMU,
Antianemic Sanitary Peshawar.
agent License No. 09
Hematopoietic 002 02 0001
Growth Factor Date of expiry
30-1-2009
Date of

translation 27
July, 2011
Pharmaceutical PFS 2000IU DRAP (TF) Certificate No. legalized COPP/ expert opinion
s, Rawalpindi (Recombinant Dated 26-2-2015 113300IT0114 FSC along with of following
Human 73 dated 05-7- GMP Certificate and valid
Erythropoietin) Fee deposited: Rs. 2011 need to be
legalized
Probiomed S.A 50000/- dated 26-2- submitted as per
COPP/FSC &
de C.V. Strength & 2015 + Rs. 50000/- Free sale above decision of
San Esteban Active dated 15-3-2016. certificate 255th meeting. GMP:
No.88, Col. ingredients: letter
a. Dr.
Santo Tomas, One pack of No.093300516 Condition of GhiasBut,
C.P. 02020, Bioyetin 2000IU B1213 dated inspection abroad PIMS,
Deleg, PFS Contains: 02-5-2009 as per import Islamabad.
Azcapotzalco, Pre Filled valid until 24 policy. b. Maj Gen.
D.F., Mexico. Syringes of months from Sohail, MH,
0.30ML Each. the country of Rawalpindi.
origin.
Recombinant c. Dr.Sami
Human Product siraj,, KMU,
Erythropoietin… Registration Peshawar
…2000IU No. 306M98
Pharmacological S.S.A.
group:
Antianemic Sanitary
agent License No. 09
Hematopoietic 002 02 0001
Growth Factor Date of expiry
30-1-2009
Date of
translation 27
July, 2011
6. M/s La-Vie Hecolin ® Dy. No. 2224 (R&I) New molecule The new Deferred for
(Pvt) Ltd., 0.5ml/dose PFS DRAP (TF) molecule for confirmation of
Lahore Each 0.5ml dose Dated 12-5-2016 GMP treatment of approval status
contains:- Certificate No. hepatitis E by reference
Manufacturer 30 ug of purified Fee deposited: Rs. CN20120056 require expert
regulatory
M/s xiamen recombinant 50000/- dated dated 09-7- evaluation from
authorities and
Innovax Hepatitis E virus 10.5.2016 2012 valid hepatalogists.
Biotech Co., antigen upto 08-7- expert opinion
Ltd., 2017 Condition of of following
130.Xinyuan Shelf life : 36 inspection abroad pertaining to
Road, Haicang months Free Sale as per import requirement of
District, Certificate No. policy will Hepatitis E

Exiamen, 2016002 dated prevail. virus vaccine in
Fujian 8.1.2016 country,
Province, PR keeping in view
China. its
prevelance,epid
emiology,
domestic
requirement etc.
a. Dr. Huma
Qureshi,
PHRC,
Islamabad
b. Prof, Dr.
Umar, Holy
Family
Hospital,
Islamabad
7. M/s La-Vie Hirax Injection Dy. No.886 (R&I) New molecule Evidence of Deferred for
(Pvt) Ltd., Each 0.5 ml DRAP (TF) availability in confirmation of
Lahore (vial) contains:- Dated 15-2-2016 CoPP No. reference drug approval status
2014-F1-0121 agencies is by reference
Manufacturer Hyaluronidase… Fee deposited: Rs. dated required.
regulatory
M/s BMI Korea …. 750 IU 50000/- dated 24.4.2014
authorities
Co., Ltd., 11,7 08.2.2016. (validity not
Gill, Chedanro, Enzyme mentioned) including
Jeju-si, Jeju-do, indications.
690,140 Korea. (Enhance GMP
permeation of Certificate No.
Subcutanious or 2014-F1-0172
Intramuscular dated 07-7-
Injections, local 2014
anesthetics and Free Sale
subcutaneous Certificate No.
infusions.) 2014-F1-0120
dated
24.4.2014
8. M/s La-Vie Hirax Injection Dy. No.4666 (R&I) New molecule Product is Deferred for
(Pvt) Ltd., Each 1ml (vial) DRAP (TF) available confirmation of
Lahore contains:- Dated 28-7-2015 CoPP No. internatioally in approval status
Hyaluronidase… 2014-F1-0121 reference by reference
Manufacturer …. 1500 IU Fee deposited: Rs. dated agencies under
regulatory
M/s BMI Korea 50000/- dated 24.4.2014 the name of
authorities
Co., Ltd., 11,7 (Enhance 09.7.2015 GMP HYLASE of
including

Gill, Chedanro, permeation of Certificate No. Wockhardt UK as indications.
Jeju-si, Jeju-do, Subcutanious or 2014-F1-0172 freeze dried
690,140 Korea. Intramuscular dated 07-7- formulation
Injections, local 2014 (powder) in
anesthetics and Free Sale ampoule,
subcutaneous Certificate No. however tha
infusions.) 2014-F1-0120 applied product is
dated solution in vial.
24.4.2014 The lyphollized
formulation is
included in BP.
9. Venture RHOCLONE Form-5A Legalized The product was Deferred for
Pharmaceutical 300 MCG Valid COPP discussed in the
s (Pvt) Ltd, Dy. No. 1218 (R&I) No. 257th meeting and a. Confirmation
Karachi. Anti Rho-D DRAP dated 25-2- COPP/CERT/ deferred for of approval
Immuno 2016 KD/42264/201 submission of status by
Bharat Serums globulin 6/11/14803/73 vaild legalized reference
and Vaccines Injection Fee Deposited: 243 valid up to CoPP. Now the regulatory
Limited (Monoclonal) Rs.100000/- dated 01-10-2016 Firm has authorities.
Plot No. K-27, (Liquid 03-2-2016 submitted Valid
Anand Nagar, Injection) Product legalized CoPP b. References
Additional vial License No. valid upto 01-10- pharmacopias
M.I.D.C. Each ml KD5 in Form 2016.
Ambernath contains: 28E c. Importability
(East), India Anti Rho-D Dated 07-2- Evidence of as per import
Immunoglobulin 2011 availability in policy order
….300mcg/ reference drug from India
1500 IU Legalized agencies is
GMP required as the d. Safety
Water for Certificate No. Pharmacopieal profile, clinical
Injection NEW-WHO- preparation (BP) efficacy, and
U.S.P…q.s GMP/CERT/K contains specific clarification as
D/12788/2014/ antibodies against
the
Immune Sera 11/6320 dated erythrocyte D-
Pharmacopieal
and 04-4-2014 antigen and may
Immunoglobulin also contain small
preparation
Anti-D (Rh) quantities of (BP) contains
Immunoglobulin other blood-group specific
ATC code: J06B antibodies. antibodies
B01 However the against
applied erythrocyte D-
Shelf life: 24 formulation antigen and
months contains only IgG may also
antibodies. contain small

Condition of quantities of
inspection abroad other blood-
as per import group
policy. antibodies.
However the
applied
formulation
contains only
IgG antibodies.
10. M/s Opulent ALBUREL Form-5A Legalized As per COPP, the Deferred for
International (Human Normal CoPP/CERT/ product is
clarification
Karachi. Albumin IP Dy. No 1120 dated KD/42047/201 licensed to be about non
20%) 28-05-2014 6/11/14718/72 placed in the abailability of
M/s Reliance 804 dated 30- market for use in
product in the
Life Sciences, Each 100 ml vial Rs.100000 dated 28- 4-2016 valid the exporting
country of
of Dhirubhai contains: 06-2013 upto 31-12- country; however
Ambani Life Total 2017 product is not origin and valid
Sciences Center protein….200g/ 60USD / vial available in the reason thereof
(DALC),Plant L market in the by the
No. 4B, Plot Sodium country of origin.regulatory body
No. R-282, Caprylate…..6.6 and
TTC Area of 5g/ L Condition of confirmation of
MIDC, Rabale Na+ not more inspection abroad availability of
Thane Belapur than…160mM/L as per import similar products
Road Navi K+ not more policy. in country.
Mumbai India. than…..2mM/ L
Aluminum…..≤
200µg/ L
Human Albumin
–Plasma protein
Shelf life : 36
months
11. M/s Opulent ALBUREL Form-5A Legalized As per COPP, the Deferred for
International (Human Normal CoPP/CERT/ product is clarification
Karachi. Albumin IP Dy. No 1119 dated KD/42047/201 licensed to be about non
20%) 28-05-2014 6/11/14718/72 placed in the abailability of
M/s Reliance 804 dated 30- market for use in
product in the
Life Sciences, Each 50 ml vial Rs. 100000 dated 4-2016 valid the exporting
country of
of Dhirubhai contains: 28-06-2013 upto 31-12- country; however
Ambani Life Total 2017 product is not origin and valid
Sciences Center protein….200g/ 30USD / vial available in the reason thereof

(DALC),Plant L market in the by the
No. 4B, Plot Sodium country of origin. regulatory body
No. R-282, Caprylate…..6.6 and
TTC Area of 5g/ L Condition of confirmation of
MIDC, Rabale Na+ not more inspection abroad
availability of
Thane Belapur than…160mM/L as per import
similar products
Road Navi K+ not more policy.
Mumbai India. than…..2mM/ L in country.
Aluminum…..≤
200µg/ L
Human Albumin
–Plasma protein
Shelf life : 36
months
12. M/s Opulent IMMUNOREL Form-5A Legalized As per COPP, the Deferred for
International (Human Normal CoPP product is
clarification
Karachi. Immunoglobulin Dy. No 11198 dated /CERT/MD/26 licensed to be about non
for Intravenous 28-05-2014 507/2015/11/1 placed in the abailability of
M/s Reliance Administration) 0485/48262 market for use in
product in the
Life Sciences, 100000 dated 28-06- dated 28-4- the exporting
country of
Pvt Limited, Each 50ml 2013 2015 valid country; however
Plant-1 Sandhra contains: upto 09-3- product is not origin and valid
Textile Mills 98 USD / vial 2017 available in the reason thereof
Compound, Protein…..50g/ market in the by the
Ground and L country of origin.regulatory body
First Floor C.S. IgG…..2.5g and
No. 1621 Plot Stabilizer Condition of confirmation of
No. 3 Plan 1 Maltose…..100g inspection abroad availability of
Pandurang /L as per import similar products
Budhkar, Marg IgA content≤ policy. in country.
Worli Mumbai. 80mg/L
IgG
subclases……
Normal
distribution
Immunoglobulin
s
Shelf life: 36
months

13. M/s Hakim HuCoG- 5000 Form-5A Legalized Valid andDeferred for
sons (Impex) HP CoPP No: legalized COPP/ submission of
Pvt Limited, Dy No. 279 R&I CoPP/ CERT/ FSC along with valid legalized
Hakim sons Each vial dated 15-01-16 KD/ 16870/ GMP Certificate COPP,
Building, 19 contains: 2014/ 11/ need to be
confirmation of
West Warf Chorionic Fee Rs.100000/- 6610/ 292156/ submitted as per
availability of
Road, Karachi Gonadotropin dated 12-01-2016 valid up to 01- above decision of
Pakistan BP……5000 I.U 04-2016 255th meeting. similar products
in country and
M/s Bharat Gonadotropins Legalized Condition of expert opinion
Serum and GMP No: inspection abroad of following:
Vaccines Indications: New-WHO- as per import
Limited, Plot An ovulatory GMP/ CERT/ policy. a. Brig.
No K-27 Anaa Fertility, KD/ 12788/ Muzamil
Hussain
nd Nagar, Hypogonadism 2014/ 11/ 6320
Najmi,
Additional and valid up to 01-
Member
MIDC Cryptorchidism 04-2016
Registration
Ambernath
Board
(East) India. Shelf life: 24 b. Brig, Aamir
months Ikram,
AFIP,
Rawalpindi.
c. Dr. Masud-
ur-Rehman,
DDG,
DRAP
14. M/s Hakim BSV HUMOG Form-5A Legalized Valid and Deferred for
sons (Impex) 75 HP CoPP No: legalized COPP/ submission of
Pvt Limited, Dy No. 280 R&I CoPP/ CERT/ FSC along with valid legalized
Hakim sons Each vial dated 14-01-16 KD/ 26812/ GMP Certificate COPP,
Building, 19 contains: 2015/ 11/ need to be
confirmation of
West Warf Menotropin BP Fee Rs.100000/- 10547/ 48878/ submitted as per
availability of
Road, Karachi equivalent to dated 12-01-2016 valid up to 01- above decision of
Pakistan activity of 04-2016 255th meeting. similar products
Follicle in country and
M/s Bharat Stimulating Legalized Condition of expert opinion
Serum and Hormone……75 GMP No: inspection abroad of following:
Vaccines IU New-WHO- as per import
Limited, Plot Luteinizing GMP/ CERT/ policy. a. Brig.
No K-27 Anaa Hormone…… KD/ 12788/ Muzamil
Hussain
nd Nagar, 75IU 2014/ 11/ 6320
Najmi,
Additional valid up to 01-
Member
MIDC Hormone 04-2016
Registration
Ambernath
Board

(East) India. Shelf Life: 36 b. Brig, Aamir
months Ikram,
AFIP,
Rawalpindi.
c. Dr. Masud-
ur-Rehman,
DDG,
DRAP
15. Hospital EPOREL-10,000 Form 5A Legalized Free Valid and Deferred for
Services & I.U PFS Sale legalized COPP/ submission of
Sales 13-C 10-10-2014 Certificate No. FSC along with valid legalized
Annexe, Block Each 1.0ml D&C/841/201 GMP Certificate COPP and
6, P.E.C.H.S, contains: Fee Rs.100000/- 110/-00525-4 need to be
expert opinion
Shahrah-e- Erythropoietin dated 10-10-2014 Dated 09-11- submitted as per
of following:
Faisal, Karach concentrated 2011 above decision of
75400. (rhEPO) Ph Eur Rs. 6086/- pack of 255th meeting. a. Dr. Toqeer
……10,000 1’s Legalized Raza,
Manufacturer: CoPP Condition of NUST,
M/s. Reliance Blood Forming provided, valid inspection abroad Islamabad
Life Sciences, Agent up to 19-03- as per import b. Dr. Huma
Limited 2014 policy. Qureshi,
Dhirubhai Shelf life: 24 PMRC,
Ambani Life months Product Islamabd
Sciences Center License No. c. Dr. Sami J
(DALC), KD/7 Khan
R-282, TTC Dated 28-04-
Industrial Area, 2014
Thane Belapur
Road, Rabale, Legalized
Navi Mumbai, GMP
Maharashtra, provided, valid
India up to 19-03-
2014.
16. Hospital EPOREL-2000 Form 5A Legalized Free Valid and Deferred for
Annexe, Block Each 0.5ml D&C/841/201 GMP Certificate COPP and
expert opinion
of following:
……2000 1’s Legalized Raza,

(DALC), KD/7 Khan
R-282, TTC Dated 28-04-
Thane Belapur
Navi Mumbai, GMP
India up to 19-03-
2014.
17. Hospital EPOREL-4000 Form 5A Legalized Free Valid and Deferredfor
Annexe, Block Each 0.4 ml D&C/841/201 GMP Certificate COPP and
expert opinion
of following:
……4000 1’s Legalized Raza,
(DALC), KD/7 Khan
R-282, TTC Dated 28-04-
Thane Belapur
Navi Mumbai, GMP
India up to 19-03-
2014.
18. Hospital APIGRAST Form-5A Legalized Free Valid and Defered for
Services & 300µg PFS Sale legalized COPP/ expert opinion
Sales 13-C 02-09-2014 Certificate No. FSC along with of following
Annexe, Block Each 0.5ml D&C/841/201 GMP Certificate and valid
legalized
Shahrah-e- Filgrastim dated 02-09-2014 Dated 09-11- submitted as per
COPP/FSC &

Faisal, Karach concentrated 2011 above decision of GMP:
75400. solution Ph. Rs.4910/- Pack of 255th meeting.
Eur… 300µg 1’s Legalized a. Brig. Tariq
Manufacturer: CoPP Condition of Satti,
M/s. Reliance Antineoplastic provided, valid inspection abroad AFBMTC,
Life Sciences, and up to 19-03- as per import Islamabad.
Pvt Limited Immunomodulat 2014 policy. b. Brig.
Dhirubhai or
Qamar-un-
Nisa,
Ambani Life Product
AFBMTC,
Sciences Center Shelf life: 24 License No.
Islamabad.
(DALC), months KD/7
c. Dr Samsi
R-282, TTC Dated 28-04- Karachi
Thane Belapur
Navi Mumbai, GMP
India up to 19-03-
2014
19. Hospital CARDIRAL Form 5A Legalized Free Valid and
Deferred for
Services & 18mg/ 10Units Sale legalized COPP/ confirmation of
Sales 13-C Per Vial (Sterile 100000 dated 02-09- Certificate No. FSC along with approval status
Annexe, Block lyophilized 2014 D&C/841/201 GMP Certificate by reference
6, P.E.C.H.S, powder for 110/-00525-4 need to be
regulatory
Shahrah-e- injection) Dated 09-11- submitted as per
authorities,
Faisal, Karach 47188/- pack of 2 2011 above decision of
75400. Each vial single use vials, 2 255th meeting. local
contains: ampoules of 10ml Legalized availability of
Manufacturer: Reteplase sterile water of CoPP Condition of similar products
M/s. Reliance (Recombinant injection, 2 single provided, valid inspection abroad and provision of
life sciences Tissue use 10 ml syringes, up to 19-03- as per import valid legalized
Pvt. Ltd., Plasminogen 4 sterile needles. 2014 policy. COPP/FSC &
Dhirubhai Activator) ……. Product GMP.
Ambani Life …. 18mg License No.
Sciences Center Tranexamic KD/7 Tranexamic acid
(DALC), acid... 8.32mg. Dated 28-04- is used as
R-282, TTC excipient in
2014
formulation
Industrial Area, Antithrombotic
which require
Thane Belapur Legalized clarification from
Road, Rabale, Shelf life: 24 GMP the firm.
Navi Mumbai, months provided, valid
Maharashtra, up to 19-03-
INDIA. 2014
20. Hospital APFERON Form 5A Legalized Free Valid and Deferred for

Services & 5MIU vial Sale legalized COPP/ submission of
Sales 13-C 100000 dated 02-09- Certificate No. FSC along with valid legalized
Annexe, Block Each 0.5ml 2014 D&C/841/201 GMP Certificate COPP and
6, P.E.C.H.S, contains: 110/-00525-4 need to be expert opinion
Shahrah-e- rH Interferon Rs. 1936/- Pack of Dated 09-11- submitted as per
of following:
Faisal, Karachi alfa 2b Ph. Eur. 1’s 2011 above decision of
75400. …………..… 5 255th meeting. a. Prof. Dr.
MIU Legalized Muhammad
Manufacturer: CoPP Condition of Umar, Holy
M/s. Reliance Cytokines and provided, valid inspection abroad Family
life sciences Immunomodulat up to 19-03- as per import Hospital,
pvt. Ltd., or 2014 policy. Islamabad.
Dhirubhai b. Dr. Huma
Ambani Life Shelf life : Product Qureshi,
Sciences Center 2years License No. PMRC,
(DALC), KD/7 Islamabad.
R-282, TTC Dated 28-04- c. Dr. Nasir
Industrial Area, 2014 Jalal,
Thane Belapur NUST,
Islamabad.
Navi Mumbai, GMP
INDIA. up to 19-03-
2014
21. Hospital APFERON Form 5A Legalized Free Valid and Defered for
Services & 3MIU vial Sale legalized COPP/ submission of
Sales 13-C 100000 dated 02-09- Certificate No. FSC along with valid legalized
Annexe, Block Each 0.5ml 2014 D&C/841/201 GMP Certificate COPP and
6, P.E.C.H.S, contains: 110/-00525-4 need to be
expert opinion
Shahrah-e- rH Interferon Rs. 1134/- Pack of Dated 09-11- submitted as per
of following:
Faisal, Karachi alfa 2b Ph. Eur. 1’s 2011 above decision of
75400. …………..… 3 255th meeting. a. Prof. Dr.
MIU Legalized Muhammad
Manufacturer: CoPP Condition of Umar, Holy
M/s. Reliance Cytokines and provided, valid inspection abroad Family
life sciences Immunomodulat up to 19-03- as per import Hospital,
pvt. Ltd., or 2014 policy. Islamabad.
Dhirubhai b. Dr. Huma
Ambani Life Shelf life : Product Qureshi,
Sciences Center 2years License No. PMRC,
Thane Belapur NUST,
Islamabad.

Navi Mumbai, GMP
INDIA. up to 19-03-
2014
22. Hospital RELIBETA Form-5A Legalized Free Valid and Defered for
Services & 30µg – 0.5ML Sale legalized COPP/ submission of
Sales 13-C PFS ( 10-10-2014 Certificate No. FSC along with valid legalized
Annexe, Block D&C/841/201 GMP Certificate COPP and
6, P.E.C.H.S, Each 0.5ml in Deposited fee 110/-00525-4 need to be
expert opinion
Shahrah-e- PFS contains: 100000 Dated 09-11- submitted as per
of following:
Faisal, Karach Recombinant 2011 above decision of
75400. Interferon beta 30430/- Pack of 1’s 255th meeting. a. Prof. Dr.
1a …………… Legalized Muhammad
Manufacturer: 30µg CoPP Condition of Umar, Holy
M/s. Reliance provided, valid inspection abroad Family
life sciences Cytokines up to 19-03- as per import Hospital,
pvt. Ltd., 2014 policy. Islamabad.
Dhirubhai Shelf life: 2 b. Dr. Huma
Ambani Life years Product Qureshi,
Sciences Center License No. PMRC,
Thane Belapur NUST,
Road, Rabale, Legalized Islamabad.
Navi Mumbai, GMP
INDIA. up to 19-03-
2014
23. The Searle TUXIMAB 09 -6-2015 CoPP letter No Valid and Deferred for
Company Ltd Injection .20132019 legalized COPP/ submission
First floor 100mg/10ml Fee Deposited 000140 dated FSC along with valid legalized
NICL Building 17-4-2015 GMP Certificate COPP and
Abbasi Each vial Rs.100000/- vide valid for need to be
expert opinion
Shaheed Road , contain challan No. twelve months. submitted as per
of following:
Karachi 75530 100mg/10ml of 0233078 dated 18-5- above decision of
Rituximab 2015 Prod Reg No. 255th meeting.
Product 57.279 date of
License Holder Indication: Balance fee issuance 16th Condition of a. Gen.
Address October, 2013. inspection abroad Iftikhar,
Non-Hodgkin’s Nil Issued by as per import CMH,
Laboratorio Lymphoma anmat policy. Rawalpindi.
ELEA Chronic Argentina.

S.A.C.I.F.y.A.. Lymphocytic b. Dr. Humera
Sanabria No Leukemia Pharm ADN Mehmood,
2353 Rhematoid GMP Consultant
C1417AZE Arthritis Certificate No. of
Ciudad Granulomatosis 20132014 Oncolologis
Autonoma de with Polyangitis 000791 14 t NORI,
Buenos Aires, (previously dated 09-6- Islamabad.
Republica termed wegner’s 2014
argentina Granulomatosis) c. Dr. Saleem
and microscopic SINERGIUM Siddique,
Shifa
API polyangitis. BIOITECH
Internationa
Manufacturing S.A.
l,
Site: GMP
Islamabad.
Pharm ADN Certificate No.
Carlos Villate 20132014
5148, Buenos 001894 14
aires, Argentina dated 14-2-
2015
Finished Documents
Manufacturing Legalized and
& Packaging notarized.
site:
SINERGIUM
BIOITECH
S.A.
Ruta 9km 38.7
– Grain – Prov.
De, Buenos
Aires,
Republica
argentina
24. The Searle TUXIMAB 09 -6-2015 COPP letter Valid and Deferred for
Company Ltd Injection No. legalized COPP/ submission
First floor 500mg/50ml Fee Deposited 20132019 FSC along with valid legalized
NICL Building 000142 15 GMP Certificate COPP and
Abbasi Each vial Rs.100000/- vide dated 17-4- need to be
expert opinion
Shaheed Road , contain challan No. 2015 submitted as per
of following:
Karachi 75530 500mg/50ml of 0233077 dated 18-5- above decision of
Rituximab 2015 Prod Reg No. 255th meeting.
Product 57. 279 dated
License Holder Balance fee 16-10-2013 Condition of a. Gen.
Address Indication: Issued by inspection abroad Iftikhar,
Nil anmat as per import CMH,

Laboratorio Non-Hodgkin’s Argentina. policy. Rawalpindi.
ELEA Lymphoma
S.A.C.I.F.y.A.. Chronic
Sanabria No Lymphocytic b. Dr. Humera
2353 Leukemia Pharm ADN Mehmood,
C1417AZE Rhematoid GMP Consultant
Ciudad Arthritis Certificate No. of
Autonoma de Granulomatosis 20132014
Oncolologis
t NORI,
Buenos Aires, with Polyangitis 000791 14
Islamabad.
Republica (previously dated 09-6-
argentina termed wegner’s 2014
c. Dr. Saleem
Granulomatosis) Siddique,
API and microscopic SINERGIUM Shifa
Manufacturing polyangitis. BIOITECH Internationa
Site: S.A. l,
Pharm ADN GMP Islamabad.
Carlos Villate Certificate No.
5148, Buenos 20132014
aires, argentina 001894 14
dated 14-2-
2015
Finished
Manufacturing Documents
& Packaging Legalized and
site: notarized.
SINERGIUM
BIOITECH
S.A.
Ruta 9km 38.7
– Grain – Prov.
De, Buenos
Aires,
Republica
argentina
25. M/s Hakimsons Sterilezed water Form 5-A Legalized Valid and Approved as
(Impex) Pt Ltd for Injection for COPP NO. legalized COPP/ diluent for
Karachi VaxiRab-N Dy No. 768 Dir DD- FSC along with exclusive use of
(Purified Chick (BD) dated 24-12-2- 449/1/D/2011 GMP Certificate VaxiRab-N
M/s Embryo Cell 13 valid upto 29- need to be
vaccine and as
SOVEREIGN Culture Rabies 11-2013 submitted as per
per Import
PHARMA Vaccine. Fee deposited submitted above decision of
PVT.LTD, S Rs.50000/- dated 255th meeting. Policy for
urvey no.46/1- Each 1ml Vial 29-10-2013 + finished drugs.
4, Kadaiya water for Inj 50000/- dt 12-12- Condition of

Village nanai 2014 inspection abroad The firm will
Daman-396210 Diulent as per import provide valid
India Unit price: Free of policy. legalized COPP
Shelf life 05year Cost and Chairman
Registration
Board will
allow the
issuance of
registration
letter.
Case No. 02: Cases of imported veterinary biological drugs from non reference countries
Sr. Name of Brand Name & Type of Form Document Remarks Decision
No Importer & Composition details (CoPP)
Manufacturer Dy No & Date of
application Me too
status/New
Fee submitted
molecule
Pack size/ Price
1. M/s Al-Asar MYVAC IBD Form-5A Legalized Free Condition of Approved as per
Enterprise, V877 Sale certificate inspection Import Policy for
Multan (Infectious Bursal Dy. No. 1916 dated dated 23-12- abroad as per finished drugs
Disease V877 24-05-16 2015 import policy. and valid
Malaysian vaccine) legalized COPP.
Vaccines and Fee Rs. 100000/- Legalized GMP
Pharmaceutica Each dose dated 24-05-16 dated 27-09-
ls, Lot 11182, contains: 2020
Batu 20 Jalan Infectious Decontrolled/ 1000
Puchong, bronchitis virus doses per vial, 10 vials Me too
Kajang, Pulau strain V877 per pack
2.5
Meranti, Off ……..10 EID 50
Cyberjaya Active
47100 immunization of
Puchong chickens against
Selangor, IBD
Malaysia.
Shelf life: 2 years
Route of Adm:
oral via drinking
water, Intraocular
and Intranasal

2. M/s Al-Asar MyVAC NDV Form-5A Legalized Free Condition of Approved as per
Enterprise, 4HR Sale certificate inspection Import Policy for
Multan (New Castle Dy. No. 2583 dated dated 23-12- abroad as per finished drugs
Disease Vaccine) 13-06-16 2015 import policy. and valid
Malaysian legalized COPP.
Vaccines and Each dose Fee Rs.100000/- Legalized GMP
Pharmaceutica contains: dated 13-06-2016 dated 27-09-
ls, Lot 11182, New castle 2020
Batu 20 Jalan disease V4 Heat Decontrolled/ 1000
Puchong, resistant virus doses per vial, 10 vials Me too
Kajang, Pulau strain………106.0 per pack
Meranti, Off EID 50
Cyberjaya
47100 Active
Puchong immunization of
Selangor, chickens anew
Malaysia. castle disease
virus
Shelf life: 2 years

Route of Adm:
oral via drinking
water, Intraocular
and Intranasal
3. M/s Al-Asar MyVAC Fowl Form-5A Legalized Free Condition of Approved as per
Enterprise, Pox Sale certificate inspection Import Policy for
Multan (Beaudette strain Dy. No. 2582 dated dated 23-12- abroad as per finished drugs
vaccine) 13-06-16 2015 import policy. and valid
Malaysian Each dose legalized COPP.
Vaccines and contains: Rs.100000/- Legalized GMP
Pharmaceutica Fowl Pox live dated 13-06-2016 dated 27-09-
ls, Lot 11182, virus Beaudette 2020
Batu 20 Jalan Strain………102.6 Decontrolled/ 1000
Puchong, EID 50 doses per vial, 10 vials Me too
Kajang, Pulau per pack
Meranti, Off Active
Cyberjaya immunization of
47100 chickens against
Puchong fowl pox
Selangor, Shelf life: 2 years
Malaysia. Route of Adm:
wing web,
intraocular,
Intramuscular

4. M/s Al-Asar IBD UPM93 Form-5A Legalized Free Condition of Approved as per
Enterprise, (Infectious Bursal Sale certificate inspection Import Policy for
Multan Disease Vaccine) Dy. No. 2581 dated dated 23-12- abroad as per finished drugs
13-06-16 2015 import policy. and valid
Malaysian Each dose legalized COPP.
Vaccines and contains: Fee Rs.100000/- Legalized GMP
Pharmaceutica IBD Live virus dated 13-06-2016 dated 27-09-
ls, Lot 11182, strain UPM 93 2020
Batu 20 Jalan ………102.5 EID Decontrolled/ 1000
Puchong, 50 doses per vial, 10 vials Me too
Kajang, Pulau per pack
Meranti, Off Active
Cyberjaya immunization
47100 against IBD in
Puchong broilers and layer
Selangor, chickens
Malaysia.
Route of Adm:
Drinking water,
eye drop route
Shelf life: two
years
5. M/s Al-Asar MYVAC ND Form-5A Legalized Free Condition of Approved as per
Enterprise, EMULSION Sale certificate inspection Import Policy for
Multan Dy. No. 1915 dated dated 23-12- abroad as per finished drugs
(Inactivated oil
24-05-16 2015 import policy. and valid
adjuvant
Malaysian legalized COPP.
Newcastle
Vaccines and Fee Rs.100000/- Legalized GMP
disease vaccine
Pharmaceutica dated 13-06-2016 dated 27-09-
B1 Type LaSota)
ls, Lot 11182, 2020
Batu 20 Jalan Each dose Decontrolled/ 1000
Puchong, contains: doses per vial, 10 vials Me too
Kajang, Pulau New castle per pack
Meranti, Off disease virus
Cyberjaya LaSota strain ≥
47100 108.5 EID 50
Puchong Active
Selangor, immunization
Malaysia. against new
castle disease
Shelf life: 2 years

Route of Adm:
SC/ IM

6. M/s Al-Asar MYVAC 102 Form-5A Legalized Free Condition of Approved as per
Enterprise, Sale certificate inspection Import Policy for
Multan (New castle Dy. No. 1917 dated dated 23-12- abroad as per finished drugs
disease B1 type 24-05-16 2015 import policy. and valid
Malaysian LaSota Strain) legalized COPP.
Vaccines and Fee Rs.100000/- Legalized GMP
Pharmaceutica Each dose dated 13-06-2016 dated 27-09-
ls, Lot 11182, contains: 2020
Batu 20 Jalan New castle Decontrolled/ 1000
Puchong, disease virus doses per vial, 10 vials Me too
Kajang, Pulau LaSota strain: per pack
Meranti, Off …… 105.5 EID 50
Cyberjaya
47100 Active
Puchong immunization
Selangor, against new
Malaysia. castle disease
Shelf life: 2 years
Route of Adm:
oral route,
intraocular route
and intranasal
7. M/s Al-Asar MYVAC 202 Form-5A Legalized Free Condition of Approved as per
Enterprise, (Combined New Sale certificate inspection Import Policy for
Multan castle disease & Dy. No. 1917 dated dated 23-12- abroad as per finished drugs
Infectious 24-05-16 2015 import policy. and valid
Malaysian bronchitis legalized COPP.
Vaccines and vaccine) Fee Rs.100000/- Legalized GMP
Pharmaceutica dated 13-06-2016 dated 27-09-
ls, Lot 11182, Each dose 2020
Batu 20 Jalan contains: Decontrolled/ 1000
Puchong, doses per vial, 10 vials Me too
Kajang, Pulau New castle per pack
Meranti, Off disease virus B1
Cyberjaya Type, LaSota
47100 strain… 105.5 EID
Puchong 50
Selangor, Infectious
Malaysia. bronchitis virus
Massachusetts
type H120
strain…. 103.1
EID 50

Active
immunization
against ND and
IBD
Shelf life: 2 years

Route of Adm:
oral route,
intraocular route
and intranasal
8. Hospital QYH-ND IB 22-Dec-10 Legalized Free Condition of Deferred for
Services & EDS Sale Certificate inspection confirmation of
Sales 13-C (Newcastle Deposited fee No. (2011) abroad as per local availability/
Annexe, Block Disease, 100000/- 160132129 import policy. approval of
6, P.E.C.H.S, Infectious Dated 01-06- similar vaccine.
Shahrah-e- Bronchitis & Egg Balance Fee 2013
Faisal, Karachi Drop Syndrome Nil
75400. Vaccine, Legalized
Inactivated) CoPP No. 3
Parent Pack Sizes: Dated 10-12-
Company/Lic. Each one dose (250mL / Bottle) 2015
Holder: contains:-
QYH Biotech Inactivated Product
Company Newcastle License No.
Ltd., Disease virus La (2010) 01008
Building. No. Sota strain (the Dated 09-03-
20, Part 11, virus titer is ≥ 2010
ABP, No. 188, 3x108.0EID50/
Southwest 4th 0.1ml before Legalized GMP
Ring Road, Certificate No.
inactivation),
Fengtai (2014) 220
District, inactivated Dated 16-10-
Beijing, China.Infectious 2014
Bronchitis
Manufacturin virus M41
g Site:
strain (the
Zhengzhou
Bio- virus titer is ≥
6.0
Pharmaceutic 3x10 EID50/
al Factory of 0.1ml before
QYH Biotech inactivation)
Co. Ltd., and inactivated
Shibalihe,
Egg Drop
South Surburb,
Syndrome
virus AV127
Zhengzhou strain (the HA
City, Henan
titer of the
Provice, P. R.
China. virus is ≥
1:30720 before
inactivation),
(For Veterinary
Use)
9. Tarobina Bovishot® Form-5(A) Legalized FSC Condition of Deferred for
Corporatin , Ephemer dated 26-6- inspection expert opinion
New Garden (Bovine Dy No. 4913 (R&I) 2015. abroad as per pertaining to
Town, Lahore ephemeral fever DRAP dated 05-8- import policy. prevelance,
virus live 2015 Legalized GMP epidemiology,
vaccine) Certificate domestic
Choong Ang Fee deposited dated 22-5- requirement etc.
Vaccine Composition per Rs. 100000/- dated 2015
Laboratories dose (2.0ml/dose) 03-8-2015 from following:
co., Ltd. 1476- Bovine a. Dr. Qurban
37 Yuseong- ephemeral fever Dosage: Ali, NVL,
daero, virus….≥ 3doses/bottle Islambad
Yuseong-gu, 103.0TCID50/dose b. Dr. Masood
daejeon, Korea Stablizer…50% Maximum Retail Rabbani,
305-348 Price: Rs. 2115/- UVAS,
Lahore.
Uses: For control
c. Dr. Arif
and preventin of Awan,
bovine ephemeral CASVAB
fever caused by Quetta.
BEFV in cows.
Shelf life:
Twelve(12)
months
Route:
Subcutanously
Injection
(For Veterinary
Use)
10. M/s Vetline ITA ND + IB Form 5-A Copy of GMP Legalized As the firm has
International , (Inactivated Certificate No. valid Free sale provided valid
Lahore, Injectable Dy No. 1497 R&I CG- certificate legalized FSC
Pakistan emulsion Vaccine DRAP dated 05-5- HU/09V/2014 along with ((02.2/3442-2/

for active 2016. GMP/ CoPP is 2016 dated 10-
CEVA- Immunization of DML No. MA- required. 06-2016) and
PHYLAXIA chickens against Fee deposited Rs. HU/04V/2009/ GMP certificate
Veterinary Newcastle 100000/- dated 02-5- M1. Dated 04- (02.2/3442-5/
Biologicals disease (ND) and 2016 11-2014 2016 dated 10-
Co. Ltd., infectious Hungary. 06-2016) and
Horog u. 32- Bronchitis (IB). Registration
34. 1107 Board considerd
Budapaest -50 pd50 of the documents
HUNGARY Inactivated and approved the
Newcastle product as per
disease Virus, Import Policy for
strain LaSota. finised drugs.
-induced min . 6
log2 HI, of
Inactivated
Infectious
bronchitis virus,
strain
Pharmacologial
group: Avian
inactivated
vaccine
Route
administratin:
Subcutaneously
or
Intramuscularly
Uses: Vaccine is
recommended for
the vaccination of
breeder and lying
type chikens
flocks, previously
immunization
against
Newcastle
disease and
infectious
bronchitis with
attenuated live
virus vaccine.

11. M/s Vetline ITA CORYZA Form 5-A GMP Legalized As the firm has
International , ABC Gel Certificate No. valid Free sale provided valid
Lahore, (Inactivated Dy No. 1495 R&I CG- certificate legalized FSC
Pakistan Aluminium DRAP dated 05-5- HU/09V/2014 along with ((02.2/3442-3/
Hydrooxide 2016 GMP/ CoPP is 2016 dated 10-
CEVA- suspension DML No. MA- required. 06-2016) and
PHYLAXIA Vaccine for the Fee deposited: HU/04V/2009/ GMP certificate
Veterinary immunization of Rs.100000/- dated 02- M1. Dated 04- (02.2/3442-5/
Biologicals chickens against 5-2016 11-2014 2016 dated 10-
Co. Ltd., infectious Hungary 06-2016) and
Horog u. 32- Coryza. Packs: One dose of Registration
34. 1107 0.5ml Board considerd
Budapaest Composition: the documents
HUNGARY Active and approved the
substances: product as per
Inactivated Import Policy for
antigens: finised drugs.
Avibacterium
paragallinarum
serotypeA……
min. 7 log 10
CFU* before
inactivation
Avibacterium
paragallinarum
serotype B……
min. 7 log 10
CFU* before
inactivation
Avibacterium
paragallinarum
serotype C……
min. 7 log 10
CFU* before
inactivation.
*CFU – colony
forming unit
Pharmacological
group:
Biologicals –
Avian inactivate

vaccine.
Route of
administration:
one dose of 0.5ml
injected
subcutaneously
or
intramuscularly
Uses: ITA
CORYZA ABC
Gel is
recommended for
vaccinatin f
breeder and
laying type of
chicken flocks
against infectious
Coryza caused by
Avibacterium
paragallinarum
infection in order
to reduce the
clinical signs and
lesions of
diseases.
12. M/s Marush CEVAC Form 5-A Legalized FSC Approved as per
Limited, Transmune No.02.2/729- Import Policy for
Lahore Dy No. 271 R&I 21/2016 dated finished drugs
(Live freeze dried DRAP dated 13.5.16 08-2-2016 and as per valid
CEVA complex vaccine, legalized COPP.
PHYLAXIA, (winterfield 2512 Fee deposited: Legalized GMP
Veterinary G-61 strain IBD Rs.100000/- dated 11- No.02.2/729-
Biological, Co. antibidoes) 5-2016 21/2016 dated
Ltd 110 7 08-2-2016.
budapest Each dose Packs: 2000. 4000,
Szallas u 5 contains: 8000 doses.
Hungary. Avian infectious
bursal disease
virus strain
winterfield 2512,
G-61……min 0.1
CID 50

Immunization of
healthy chicjens
against IBD
Route of adm: SC
Shelf life: 24
months
Case No.03: Cases of Veterinary Biological Vaccines / Drugs for Local Manufacturing.
S.#. Company Brand name Date of International Remarks Decision

name and /Drug application/ availability
name of Composition Fee status/ / Me too status
manufacturer packs
1. M/s Grand GPVAC ND (A) Form-5 Local Deferred for
Pharma (Pvt) Injection manufacturing of products
Ltd, Rawat, Newcastle Disease Dy No. 567 veterinary specification
inspection
Islamabad Vaccine ADC(BD) vaccine. In the
by following
(Local Each dose of 0.30 dated 23-5- 254th RB Meeting experts:
Manufacturer) ml contains: 2016 on the similar
Inactivated case the Board a. Dr.
Newcastle Disease Fee deposited decided for Muham
Virus….Inducing≥ Rs.20000/- product specific mad
4.5 log2 HI uits dated 20-5- inspection by Arshad,
Member
2016 experts focusing
Registrat
Uses: on processs, ion
For the precention Price : strain status, Board
of Newcastle Decontrolled safety and
Disease in poultry potency data. b. DDG
for facster Packs 250ml, Biologic
production of 300ml,500ml al),
DRAP
antibodies ,600ml
c. Area
Shelflife: one year FID,
DRAP
2. M/s Grand GPVAC H-9 Form-5 Local Deferred for

Pharma (Pvt) Shield Injection manufacturing of products
Ltd, Rawat, Dy No.562 veterinary specification
inspection by
Islamabad Avian Influenza ADC (BD) vaccine. In the
following
(Local H9 cloned vaccine dated 23-5- 254th RB Meeting experts:

Manufacturer) Each ml (1000 2016 on the similar
doses0 contains; case the Board a. Dr.
Live rHVT-H9 Fee deposited decided for Muham
mad
virus…..3x106 Rs. 20000/- product specific
Arshad,
plaque-forming dated 20-5- inspection by Member
units (pfu) 2016 experts focusing Registrat
Dosage: 3x103 fpu on processs, ion
per bird Price: strain status, Board
Decontrolled safety and b. DDG
Shelf life: Two potency data. Biologic
al)
years Packs,
c. Area
1000,2000,40 FID,
Uses: For the 00,5000 DRAP
prevention against doses
avian influenza
virus serotype H9
and Marek’s
disease virus
serotype-3 in
broilers.
3. M/s Grand GPVAC Form-5 Local Deferred for
Pharma (Pvt) ND+IB+H9 manufacturing of products
Ltd, Rawat, Injection Dy No. 563 veterinary specification
inspection by
Islamabad Combined ADC (BD) vaccine. In the
following
(Local Newcastle disease, dated 23-5- 254th RB Meeting experts:
Manufacturer) Infectious 2016 on the similar
bronchitis and case the Board a. Dr.
avian influenza H9 decided for Muham
vaccine Fee deposited product specific mad
Each dose of Rs. 20000/- inspection by Arshad,
Member
0.30ml contains: dated 20-5- experts focusing
Registrat
Inactivated 2016 on processs, ion
Newcastle disease strain status, Board
virus….inducing Price : safety and b. DDG
5 log2 HI Decontrolled potency data. Biologic
units/dose al)
Packs 250ml, c. Area
FID,
Infectious 300ml,500ml
DRAP
bronchitis virus , 600ml
(Mass strain)
….inducing5
log2 HI units/dose
Inactivated Avian

Influenza virus
H9….inducing5
log2 HI units/dose.
Shelf life: Two

years
4. M/s Grand GPVAC ND- Form – 5 Local Deferred for

Pharma (Pvt) Kaseef Injection Dy No. 564 manufacturing of products
Ltd, Rawat, New castle ADC (BD) veterinary specification
inspection by
Islamabad Disease Vaccine dated 23-5- vaccine. In the
following
(Local Each dose of 2016 254th RB Meeting experts:
Manufacturer) 0.20ml contains: on the similar
Inactivated Fee deposited case the Board a. Dr.
Newcastle Disease Rs. 20000/- decided for Muham
Virus… dated 20-5- product specific mad
Inducing4.5 log2 2016 inspection by Arshad,
Member
HI units experts focusing
Registrat
Price: on processs, ion
Shelf life: Two Decontrolled strain status, Board
years safety and b. DDG
Packs 250ml, potency data. Biologic
300ml,500ml al)
,600ml c. Area
FID,
DRAP
5. M/s Grand GPVAC POLY- Form – 5 Local Deferred for
Pharma (Pvt) FLU Injection manufacturing of products
Ltd, Rawat, Avian Influenza Dy No. 565 veterinary specification
inspection by
Islamabad polyvalent vaccine ADC (BD) vaccine. In the
th following
(Local Each dose of dated 23-5- 254 RB Meeting experts:
Manufacturer) 0.30ml contains: 2016 on the similar
case the Board a. Dr.
Inactivated Avian decided for Muham
Influenza type Fee deposited product specific mad
H5….Inducing5 Rs. 20000/- inspection by Arshad,
Member
log2 HI units/dose dated 20-5- experts focusing
Registrat
2016 on processs, ion
Inactivated Avian strain status, Board
Influenza type Price: safety and b. DDG
H7….inducing5 Decontrolled potency data. Biologic
log2 HI units/dose al)
FID,
Inactivated Avian 300ml,500ml
DRAP
Influenza virus ,600ml

H9….inducing5
log2 HI units/dose.
Shelf Life: Two

years
6. M/s Grand GPVAC Hydro- Form – 5 Local Deferred for

Pharma (Pvt) TC Plus Injection manufacturing of products
Ltd, Rawat, Bivalent HPS-IBH Dy No. 561 veterinary specification
inspection by
Islamabad vaccine ADC (BD) vaccine. In the
following
(Local Each 0.30 ml dose dated 23-5- 254th RB Meeting experts:
Manufacturer) contains: 2016 on the similar
case the Board a. Dr.
Inactivated Avian decided for Muham
Adenovirus Fee deposited product specific mad
serotype-4….7 Rs. 20000/- inspection by Arshad,
Member
log10 EID50/dose dated 20-5- experts focusing
Registrat
2016 on processs, ion
Inactivated Avian strain status, Board
Adenovirus Price: safety and b. DDG
serotype-8….7 Decontrolled potency data. Biologic
log10 EID50/dose. al)
FID,
Shelf life: Two 300ml,500ml
DRAP
years ,600ml
7. M/s Grand GPVAC MG- Form – 5 Local Deferred for
Pharma (Pvt) Bacterin Injection manufacturing of products
Ltd, Rawat, Mycoplasma Dy No. 566 veterinary specification
inspection by
Islamabad gallisepticum ADC (BD) vaccine. In the
following
(Local vaccine dated 23-5- 254th RB Meeting experts:
Manufacturer) Each ml contains: 2016 on the similar
Mycoplasma case the Board a. Dr.
gallisepticum…… decided for Muham
5 x 107 CFU/ml Fee deposited product specific mad
Rs. 20000/- inspection by Arshad,
Member
Shelf life: Two dated 20-5- experts focusing
Registrat
years 2016 on processs, ion
strain status, Board
Uses: For the Price: safety and b. DDG
prevention of Decontrolled potency data. Biologic
mycoplasma al)
gallisepticmum in Packs 250ml, c. Area
FID,
poultry. 300ml,500ml
DRAP
,600ml

8. M/s Grand GPVAC FLU 7+9 Form – 5 Local Deferred for
Pharma (Pvt) (A) Injection manufacturing of products
Ltd, Rawat, Avian Influenza Dy No. 568 veterinary specification
inspection by
Islamabad virus H7+N9 ADC (BD) vaccine. In the
following
(Local Aqueous vaccine dated 23-5- 254th RB Meeting experts:
Manufacturer) Each dose of 2016 on the similar
0.30ml contains: case the Board a. Dr.
Inactivated Avian Fee deposited decided for Muham
Inafluenza virus Rs. 20000/- product specific mad
H7…Inducing4.5 dated 20-5- inspection by Arshad,
Member
log2 HI units 2016 experts focusing
Registrat
on processs, ion
Inactivated Avian Price: strain status, Board
Inafluenza virus Decontrolled safety and b. DDG
H9…Inducing4.5 potency data. Biologic
log2 HI units Packs 250ml, al)
300ml,500ml c. Area
FID,
Shelf life: One ,600ml
DRAP
year
9. M/s SANNA NIAB (H.S. Form – 5 PSI is required by Deferred for
Laboratories, VACCINE) the panel of products
Faisalabad Injectable Dy No. 655 experts. specification
inspection by
(Local Formaline R&I DRAP
following
Manufacturer) inactivated dated 29-1- experts:
Pasturella 2015
muoltocida oil a. Dr.
adjuvanted Fee deposited Muham
vaccine Rs. 20000/- mad
Each dose dated 23-12- Arshad,
Member
contains: 2014
Registrat
….Inactivated oil ion
emulsified Price: Board
Pasturella Decontrolled b. DDG
multocida Biologic
Packs 30ml, al)
Proposed route: 90ml,300ml, c. Area
FID,
Subcutanous 900ml
DRAP
Injection
Uses: For animals

to protect against
Heamorrhagic
Septicemia

Shelf life: 02 years
10. M/s SANNA PROMAS Form -5 PSI is required by Deferred for
Laboratories, Injectable the panel of products
Faisalabad Fee deposited experts. specification
inspection by
(Local Each ml contains Rs. 60000/-
following
Manufacturer an minimum of 6 dated 20-6- experts:
x 109 m.o of: 2013
Staphylococcus a. Dr.
aureus, Dosage: 5ml Muham
Streptococcus mad
agalactiae, Price - Arshad,
Member
Escherichia coli Decontrolled
Registrat
and ion
Arcanobacterium Board
pyogenes oil b. DDG
adjuvancted Biologic
vaccine. al)
c. Area
FID,
Uses: For
DRAP
prevention of
mastitis in cattle
buffalo, sheep,
goat and camel.
Shelf life: One

year
11. M/s SANNA ENTOMIAVAC Form -5 Deferred for

Laboratories, (Enterotoxemia products
Faisalabad Vaccine) Dy No. 472 specification
inspection by
(Local R&I, DRAP
following
Manufacturer Formaline dated 22-3- experts:
inactivated 2016
clostridium a. Dr.
perfringeens oil Fee deposited Muham
adjuvanted Rs. 20000/- mad
vaccine dated 22-3- Arshad,
Member
2016
Registrat
Each dose ion
contains: Dosage: 2ml Board
Inactivated Oil b. DDG
Emulsified Price – Biologic
Clostridium Decontrolled al)
perfringens… 1 x c. Area
FID,

109 Packs: 15ml, DRAP
30ml ,
Shelf Life: One 300ml,
(01) Year 600ml.
Uses: For Sheep/

Goat to protect
atainst
Enterotixemia
12. M/s SANNA BQ-VAC (Black Form -5 Deferred for
Laboratories, Quarter Vaccine) products
Faisalabad Dy No. 476 specification
inspection by
(Local Formaline R&I, DRAP
following
Manufacturer Inactivated dated 22-3- experts:
Clastridium 2016
chavoei oil a. Dr.
adjuvanted Fee deposited Muham
Vaccine Rs. 20000/- mad
dated 22-3- Arshad,
Member
Each dose 2016
Registrat
contains: ion
Inactivated Oil Board
Emulsified Price – b. DDG
Clostridium Decontrolled Biologic
Chavoei.. 1 x 109 al)
Packs: 30ml, c. Area
FID,
90ml ,
DRAP
Shelf Life: One 300ml,
Year 600ml.
Uses: For large

animals to protect
against Black
Quarter
13. M/s SANNA APTHOVAC Form -5 Deferred for

Laboratories, (Foot and Mouth products
Faisalabad disease Vaccine) Dy No. 475 specification
inspection by
(Local R&I, DRAP
following
inactivate 2016
Aphthovirus oil a. Dr.

adjvanted Vaccine Fee deposited Muham
Rs. 20000/- mad
Each dose dated 22-3- Arshad,
Member
contains: 2016
Registrat
Inactivated Oil ion
Emulsified Board
Aphthovirus Price – b. DDG
Decontrolled Biologic
Shelf life: One al)
year Packs: 25ml, c. Area
FID,
50ml ,
DRAP
100ml,
200ml.
14. M/s SANNA SANTHRAX Form -5 Deferred for
Laboratories, (Anthrax Disease products
Faisalabad Vaccine) Dy No. 473 specification
inspection by
(Local R&I, DRAP
following
inactivated 2016
bacillus anthracis a. Dr.
oil adjuvanted Fee deposited Muham
Vaccine Rs. 20000/- mad
dated 22-3- Arshad,
Member
Each dose 2016
Registrat
contains: ion
Inactivated Oil Board
Emulsified Price – b. DDG
Bacillus anthracis Decontrolled Biologic
5 x109 al)
Packs: 25ml, c. Area
FID,
Shelf life: One 1250ml ,
DRAP
year 300ml,
900ml.
Uses: For large
animal to protect
against anthrax
15. M/s SANNA GALLIPRO Form -5 Deferred for

Laboratories, ND+H9 (ND & products
Faisalabad A1 H9 Disease Dy No. 474 specification
inspection by
(Local Vaccine) R&I, DRAP
following
Manufacturer dated 22-3- experts:
Formaline 2016
inactivated New a. Dr.

castle disease Fee deposited Muham
virus lasota & Rs. 20000/- mad
Influenza A Virus dated 22-3- Arshad,
Member
subtype H9 oil 2016
Registrat
ion
Each dose Board.
contains: Price –
Inactivated Oil Decontrolled b. DDG
Emulsified New Biologic
castle disease Packs: al).
virus lasota 150ml, ,
Influenza A Virus 300ml, c. Area
FID,
subtype H9 600ml.
DRAP
Shelf life: One

year
Uses: For Poultry

Birds to protect
against New castle
disease and sub
strain H9 of Avian
Influenza disease
Case No.04: Local Manfacturing Of (Biological Drugs) M/S Macter International, Karachi
a. Clariclot (Recombinant streptokinase) 1.5MIU Vial of M/S Macter International

Karachi
S.No. Documents and data Documents and data submitted Remarks

required as per 246th by M/s Macter International
meeting Karachi
1. Legalized GMP certificate of Firm has submitted the legalized Valid legalized GMP
biological drug as an GMP certificate NO. is required.
evidence that the 3753/M3b/2013 dated 20-5-2013
manufacturer is an valid upto 2years from date of
authorized manufacturer of issuance of Manufactured by M/s
that particular biological Shasun Pharmaceuticals Limited
drug in its country of origin. 33&34, Shasun Road,
Periyakalapet, Puducherry –
605014, Mfg at Vijayapuri North
Nagarjunasagar Nalagonda District

India
2. Legalized COPP No. 1919-

AB(M3A) TS / 2014 valid upto 19-
5-2015 for LIFOKINASE 1.5MIU
(STREPTOKINASE INJECTION
IP)
Manufactured by M/s Shasun
Pharmaceuticals Limited 33&34,
Shasun Road, Periyakalapet,
Puducherry – 605014, Mfg at
Vijayapuri North Nagarjunasagar
Nalagonda District India
3. Structural similarity of Not provided Structural similarity
subject biological drug data is required
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological product
(innovator)
4. Manufacturer to manufacture Not provided

the finished biological
product for trial studies
5. Bio-comparability studies Not provided Bio-comparability
including identity testing to study data is required.
parent molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing data, gel
electrophoresis, Western-
Blot and other analytical
techniques) and stability
studies of finished biological
product
6. Others Specification of streptokinase No local data

bulk solution provided as under: available. Directions
 Description from RB is solicited.
 Particular Matter
 Identification test
 PH
 Bacterial endotoxin
 Assay (Activated by bioassay

 Sterility
Stability Study report
streptokinase bulk solution
provided
Finished product specifications
submitted by M/s Macter
International, Karahci are as
under:
Description, Identification, PH,

Steptodoranse, Streptolysin, Loss
on drying, Bacterial Endotoxin,
Assay (Acitivity by Bioassay),
Sterility, Clarity of solution,
Particulate Matter, Extractable
volume and Uniformity of weight.
Finished product stability

submitted by M/s Shasun
Pharmaceuticals India.
The submitted data needs to be evaluated in the light of 246 th meeting of RB by panel of experts
for geniuness and accuracy.
b. Redimab (Rituximab) 100mg/10ml Vial of M/s Macter International, Karachi
Sr. Documents and data Documents and data submitted by Remarks

No required as per 246th M/s Macter International Karachi
meeting
1 Legalized GMP certificate of Legalized GMP Certificate No.

biological drug as an CN20110019 DATED 09-10-2011
evidence that the valid until 08-10-2016 M/s
manufacturer is an Shanghai CP Guojian
authorized manufacturer of Pharmaceutical co., Ltd. China.
that particular biological
drug in its country of origin.
2 Structural similarity of Charactrization of Primanry and

subject biological drug secrondary structure of redimab and
product (concentrate/ ready its comparability analysis with

to fill bulk for further innovator retuximab sold under
processing) with reference brand name of Rituxan by M/s
biological product Shanghai CP Guojian
(innovator) Pharmaceutical co., Ltd. China
following methods:
 N-terminal amino acid

sequenced analysis,
 C-terminal Lys truncation by
mass peptide maping by
sequence coverage.
 Molecule weight by reducing
SDS PAGE.
 MALDI-TOF Mass spectrum
performed the test results
demonstrate that the main
components of basically
identical, and the molecular
weight of relative to each other
 Peptide Mapping by RP-HPLC
which demosntrates that our
products are homogeneioujs and
stable.
 Comparison of Methionine
Oxidation for Anti-CD20
innovator.
 Biological Charatarization was
done by biocactivity
determination and affinity
comparison by
immumofluorescence method.
 Inpurities by SEC-HPLC, SDS-
PAGE

3 Manufacturer to manufacture
4 Bio-comparability studies Comparitive analysis of finished

including identity testing to drug (Redimab) with Ristova of
parent molecule, purity Roche:
testing, in vitro biological Identity by SDS Page
activity, potency and toxicity Purity:
with support of iso-electro SDS Page (Silver staining)
focusing data, gel Gel Filteration HPLC
electrophoresis, Western- Protein content by UV (280nm)
Blot and other analytical Biological activity

techniques) and stability General safety tests :
studies of finished biological BET and sterlity
product
5 Others Certificateof analyisis of Rituximab

bulk is submitted.
Stability data of finished product
(accelerated and real time ) is
provided.
Clinical Data has also been
submitted.
c. Redimab (Rituximab) 500mg/50ml Vial of M/s Macter International, Karachi

meeting
1 Legalized GMP certificate of Copy of GMP Certificate No.
biological drug as an CN20110019 DATED 09-10-2011
evidence that the valid until 08-10-2016 sumbitted.
manufacturer is an
authorized manufacturer of
subject biological drug secrondary structure of redimab and
product (concentrate/ ready its comparability analysis with
to fill bulk for further innovator retuximab sold under
processing) with reference brand name of Rituxan by M/s
biological product Shanghai CP Guojian
(innovator) Pharmaceutical co., Ltd. China
following methods:
 N-terminal amino acid
sequenced analysis,
 C-terminal Lys truncation by
mass peptide maping by
sequence coverage.
 Molecule weight by reducing
SDS PAGE.

weight of relative to each other
stable.
 Comparison of Methionine
Oxidation for Anti-CD20
innovator.
comparison by
PAGE
4 Bio-comparability studies Comparitive analysis of finished
including identity testing to drug (Redimab) with Ristova of
parent molecule, purity Roche:
testing, in vitro biological Identity by SDS Page
activity, potency and toxicity Purity:
with support of iso-electro SDS Page (Silver staining)
focusing data, gel Gel Filteration HPLC
electrophoresis, Western- Protein content by UV (280nm)
Blot and other analytical Biological activity
techniques) and stability General safety tests :
studies of finished biological BET and sterlity
product
5 Others Certificateof analyisis of Rituximab
bulk is submitted.
(accelerated and real time) is
provided.
Clinical Data has also been
submitted.
d. EPOCAN Injection (Epoetin alpha 2000IU/ml., 4000IU/ml and 10000IU/ml) Vial of M/s Macter
International, Karachi

meeting
1 Legalized GMP certificate of Legalized GMP Certificate No. GMP submitted
biological drug as an CN20140140 date of issuance 17-3- reflects that
evidence that the 2014 valid upto 16-03-2019 M/s manufacturer is
manufacturer is an Shandong Kexing Bio – Products authorize to
authorized manufacturer of co., Ltd. Tangwangshan Road, manufacturer
that particular biological Mingshui Development Zone, Recombinant Human
drug in its country of origin. Zhangqiu, Shandong, China Erythropoietin
submitted. injection.
2 Legalized Free Sale Certificate No.
2015-157 date of issuance 16-11-
2015 valid for two year for date of
issuance for Erythropoietin injection
submitted.
Legalized COPP No. WHO. CPP-
CERT-ZQ-151116 date of issuance
16-11-2015
3 Structural similarity of Not provided Only comparative
subject biological drug studies conducted
product (concentrate/ ready locally is submitted
to fill bulk for further
biological product
(innovator)
5 Bio-comparability studies Comparative analysis of
including identity testing to Recombinant Human
parent molecule, purity Erythropoietin Vs RMP
testing, in vitro biological Recormon Roche is submitted
activity, potency and toxicity and following test are carried out
with support of iso-electro by M/s Macter International,
focusing data, gel Karachi
electrophoresis, Western-  SDS-PAGE (Silver staining)
Blot and other analytical  Isoelectric focusing
techniques) and stability  Purity( By Gel filtration
studies of finished biological chromatography)
product  Sialic Acid (by Resorcinol
Method)
 Protein content (By ELISA)
Comparitive analysis of Finished

product VS BRP Erythropoetin

Alfa EDQM is also submitted
and following test are carried out:
Identity by ELISA, Potency by

Elisa, Total Protein content (By
Lowry Assay), General Safety Test
(By Bacterial endotixin test by gel
Clot Method (LAL Test), Sterility
Test by membrane filtration
method.
6 Others Specification of ready to filled
bulk of M/s Shandong Kexing
bioproducts Co., Ltd, China
Identification test, Physical tests
(Appearance Visible particles),
Chemical tests (pH, Content of
sodium ion content of citrate ion
content of protein Osmolality,
Activity tests (Activity in vitro ,
Activity in vivo), Sterility and
BET , Abnormal toxicity test.
Finished products specification of

M/s Macter International Karachi
as under:
Physical Appearance,
ParticulateMater, Extractable
volume, pH, Osmaolality, Immuno-
identification, Potency, Content of
Protein, BET, Sterility, Abnormal
Toxicity.
The firm has also submitted

accelerated and real time stability
studies
e. T-Mab (Trastuzumab) 150mg Vial of M/s Macter International, Karachi

meeting

1 Legalized GMP certificate of Legalized GMP Certificate No.
biological drug as an CN20110019 dated 09-10-2011
evidence that the valid until 08-10-2016 M/s
manufacturer is an Shanghai CP Guojian
authorized manufacturer of Pharmaceutical co., Ltd. China.
subject biological drug secondary structure of anti-HER2
product (concentrate/ ready rh.MAb and its comparability
to fill bulk for further analysis with innovator Herceptin
processing) with reference by M/s Shanghai CP Guojian
biological product Pharmaceutical co., Ltd. China
(innovator) following methods:
 The pimary structure of anti-
HER2 rhMAb. Similarity in
secondary sturucture by circular
dichroism (CD) and Spectra.
 Similarity in IEF profile.
 Similarity in molecular weight
by reducing SDS-PAGE.
weight of relative to each other.
stable.
 N-Glycosylation Analtysis.
 Similarity in Biological
Activities and Immunological
Properties

comparison by
PAGE
4 Bio-comparability studies Biocomparability of finished drug

including identity testing to the firm has submitted following
parent molecule, purity data are as under:
activity, potency and toxicity Comparative Analysis of Locally
with support of iso-electro Manufactured Drug Product of T-
focusing data, gel Mab 150 mg with Reference
electrophoresis, Western- Medicinal Product Harceptin,
Blot and other analytical Materials, Indentificatin (BySDS-
techniques) and stability PAGE), Purity (By SDS-PAGE),
studies of finished biological Reiative Potency (By ELISA),
product General Safety Tests (By Bacterial
Endotoxin Test) (By Sterility Test)
(By Abnormal Toxicity Test) (By
Abnormal Toxicity Test).
Stability Studies of Locally
Manufactured Drug Product of T-
Mab 15mg with Reference
Medicinal Product Harceptin.
Real Time stability studies,
Accelerated stability studies
5 Others Animal Toxicology study The firm
submitted data are as under:
1. Pharmacology
(Primary pharmacology, Secondary
Pharmacology, Safety
Pharmacology, Pharmacodynamic
drug interactions).
2. Pharmacokinatics
(Absorption, distribution,
Metabolism, Excretion,
Pharmacokinetics Drug Interaction)
3. Single-Dose Toxicity
(Acute Single-Dose toxicity for
intravenous injection anti-HER2 rh
MAB of CPGJ into mice)
4. Repeat-Dose toxicity
(Repeat-Dose toxicity for
MAB of CPGJ into rhesus)
5. Genotoxicity
(Genotoxicity of –HER2 rh MAB of
CPGJ)
6. Hepolytic Study
(Hemolytic Study of –HER2 rh

MAB of CPGJ)
f. T-Mab (Trastuzumab) 440mg Vial of M/s Macter International, Karachi

meeting
1 Legalized GMP certificate of Legalized GMP Certificate No. The application of the
biological drug as an CN20110019 dated 09-10-2011 firm is consider in
evidence that the valid until 08-10-2016 M/s 257th meeting of RB
manufacturer is an Shanghai CP Guojian wherein it was
authorized manufacturer of Pharmaceutical co., Ltd. China deferred for
that particular biological evaluation by the
drug in its country of origin. division.
subject biological drug secondary structure of anti-HER2
product (concentrate/ ready rh.MAb and its comparability
to fill bulk for further analysis with innovator Herceptin
processing) with reference by M/s Shanghai CP Guojian
biological product Pharmaceutical co., Ltd. China
(innovator) following methods:
 The pimary structure of anti-
HER2 rhMAb. Similarity in
secondary sturucture by circular
dichroism (CD) and Spectra.
 Similarity in IEF profile.
 Similarity in molecular weight
by reducing SDS-PAGE.
weight of relative to each other.
stable.
 N-Glycosylation Analtysis.
 Similarity in Biological
Activities and Immunological
Properties

comparison by
PAGE
4 Bio-comparability studies Biocomparability of finished drug

including identity testing to the firm has submitted following
parent molecule, purity data are as under:
activity, potency and toxicity Comparative Analysis of Locally
with support of iso-electro Manufactured Drug Product of T-
focusing data, gel Mab 15mg WITH Reference
electrophoresis, Western- Medicinal Product Harceptin,
Blot and other analytical Materials, Indentificatin (BySDS-
techniques) and stability PAGE), Purity (By SDS-PAGE),
studies of finished biological Reiative Potency (By ELISA),
product General Safety Tests (By Bacterial
Endotoxin Test) (By Sterility Test)
(By Abnormal Toxicity Test) (By
Abnormal Toxicity Test).
Stability Studies of Locally

Manufactured Drug Product of T-
Mab 15mg with Reference
Medicinal Product Harceptin.
Real Time stability studies,
Accelerated stability studies
5 Others Animal Toxicology study The firm

submitted data are as under:
1. Pharmacology
(Primary pharmacology, Secondary
Pharmacology, Safety
Pharmacology, Pharmacodynamic
drug interactions).
2. Pharmacokinatics
(Absorption, distribution,
Metabolism, Excretion,
Pharmacokinetics Drug Interaction)

3. Single-Dose Toxicity
(Acute Single-Dose toxicity for
MAB of CPGJ into mice)
4. Repeat-Dose toxicity
(Repeat-Dose toxicity for
MAB of CPGJ into rhesus)
5. Genotoxicity
(Genotoxicity of –HER2 rh MAB of
CPGJ)
6. Hepolytic Study
(Hemolytic Study of –HER2 rh
MAB of CPGJ)
g. Macgrastim (Filgrastim (rhGCSF) 300mcg/ 1.2 ml) vial.

meeting
1 Legalized GMP certificate of Legalized CoPP No: CN20130269
biological drug as an dated 30.09.2013 valid upto
evidence that the 29.09.2018 of M/s Hangzhou
manufacturer is an Jiuyuan Gene Engeineering Co.,
authorized manufacturer of Ltd, China indication that the
that particular biological manufacturer has approval to
drug in its country of origin. manufacture the rhGCSF injection
2 Structural similarity of Physicichemical and biosililarity

subject biological drug analysis of rhGSCF with Filgratim
product (concentrate/ ready produced by Kirin Brewery Co.,
to fill bulk for further Japan:
processing) with reference rhGSCF Formula/ chemical
biological product structure.
(innovator)  Molecular weight:
SDS reducing Page
HPLC
 Purity:
Gel electrophoresis
Isoelecric focusing

RP HPLC
SEC HPLC
Capillary electrophoresis
 Assay for chemical structure:
Sequencung of rDNA
UV spectrum
Composition of amino acids
Pepetide mapping
N- terminal sequencing
 Immunology:
Identification by wetstern
blot
ELISA
 Bilogical activity.
4 Bio-comparability studies
Comparative Analysis of Locally
including identity testing to
parent molecule, purity Manufactured Product
testing, in vitro biological Macgrastim Liquid Solution for
activity, potency and toxicity Injection (300 mcg/ 1.2 ml ) VS
with support of iso-electro Neupogen (Innovator):
focusing data, gel  Immunoidentification by
electrophoresis, Western- western blot
Blot and other analytical  Purity by SDS Page
techniques) and stability  Purity by gel filteration
studies of finished biological  Potency protein by
product Bradford assay
 Bilogical activity by cell
proliferation assay
 General safety tests : BET
and sterlity
5 Others Certificate of analysis of bulk
material to be supplied is sunmitted.
(accelerated and real time is
provided)
Clincal data submitted.
Local manfacturing of (biological drugs) M/s Sami Pharmaceuticals (Pvt) Limited, Karachi.

h. PEGINTOR-2a Recombinant Human Peginterfereon Alfa-2a, (180mcg) 0.5ml Pre-filled
syringe of M/s SAMI Pharmaceutical s(Pvt Limited Karachi.

No required as per 246th M/s SAMI Pharmaceutical s(Pvt
meeting Limited Karachi
1 Legalized GMP certificate of Legalized GMP Certificate No. Firm will import the
biological drug as an 20132014-001810-14 dated 30-1- bulk interferon alfa 2a
evidence that the 2015 of M/s LABORATORIO and pegylation will be
manufacturer is an PABLO CASSARA S.R.L done at
authorized manufacturer of Republica Argentina. manufacturing facilty
that particular biological of M/s Sami Pharma
drug in its country of origin. Karachi
2 Structural similarity of Following details are provided for
subject biological drug the bulk concentrate against the
product (concentrate/ ready standard by the M/s
to fill bulk for further LABORATORIO PABLO
processing) with reference CASSARA S.R.L Republica
biological product Argentina.
(innovator)  Appearance
 PH
 Identification:
a. Assay: Protein content,
biological activity
b. Isoelectic focusing
c. Test for impurities fo
molecular masses
differing from that of
interferon alfa 2 (SDS
Page reducing
condition)
d. Peptide mapping
e. impurities fo molecular
masses differing from
that of interferon alfa 2
(SDS Page reducing
and non reducing
condition)
f. related proteins by
HPLC
g. BET
4 Bio-comparability studies Accelerated stability data 6 months
including identity testing to of 3 batches submitted and
parent molecule, purity biocomparibility studies witb

testing, in vitro biological pepgasys are provided with
activity, potency and toxicity fillowing parameters:
with support of iso-electro  Appearance
focusing data, gel  Identification by SDS Page
electrophoresis, Western-  Proetein content by optical
Blot and other analytical density
techniques) and stability  Impurities
studies of finished biological  BET
 Sterility
product
5 Others Clinical data provided.
Product specific inspectin for the facility is required. The submitted data needs to be evaluated in
the light of 246th meeting of RB by panel of experts for geniuness and accuracy.
Local Manfacturing of (Biological Drugs) M/S BF Biosciences, Lahore
i. Noxane (Prefilled syringe) (Enoxaprin sodium 20mg/0.2ml, 40mg/0.4ml,

60mg/0.6ml and 80mg/0.8ml) of M/S BF biosciences, Lahre

required as per 246th
meeting
1. Legalized GMP certificate Firm has submitted the Copy of The Director
of biological drug as an GMP Certificate No. SD 20140225 Technical has inform
evidence that the
vlidupto 26-5-2019 of M/s that the bulk will be
manufacturer is an
Dongying Tiandong Phamraceutical imported from the
authorized manufacturer of Co., Ltd No. 1236, Noner Road, Uroguay. The API in
that particular biological dongying City China, for the said bulk will be
drug in its country of origin.Enoxaparin Sodium used from
2. Legalized COPP No. 156026 dated manufacturer at
09-4-2014 for Noxprin Sodium China.
manufacurerd by Laboratorios
Clausen S.a.- Bulevar Artigas 3896
– Montevideo, Uruguay.
3. Structural similarity of Eludication of structure Following
subject biological drug details are provided by M/s
product (concentrate/ ready Dongying Tiandong Phamraceutical
to fill bulk for further Co., Ltd China.
biological product  Absorption
(innovator) Spectrophotometry , The
infrared spectra of sample is
consitent with that of the CRS
 Absorption Spectrophotometry,
UV spectra is consitent with

that of the CRS
 NMR Spectrophotometry ( 1H
–NMR spectrum and 13C-
NMR cpectrum of thesample is
consistent with those of the
CRS
 Imputities
(Potential Imopurities
Originating from the route of
synthesis), (Potential Impurities
Orininating from the raw
material s and from the
impurities in the raw materials),
(Protein and nucleotide),
Dermatan sulfate) (Heavy
metals) (Bacterial endotoxins),
(Limit of Impurities and
Analytical Methods applied by
the API’s manufacturer),
Protein and nucleotide heavy
metals and bacterial
endotoxins), Dermatan
sulphate), (The Potential
Toxicity of Impurities),
(Residual solvents)
4. Manufacturer to Not provided
manufacture the finished
biological product for trial
studies
5. Bio-comparability studies Not provided
focusing data, gel
product
6. Others

j. Eritrogen (Erythropoetin) 2000IU, 4000IU and 10000IU PreFilled Syringe of M/S BF

Biosciences, Lahre

required as per 246th
meeting
1. Legalized GMP certificate Firm has submitted the Legialized
of biological drug as an GMP certificate No. 20132021-000
evidence that the 033-15 dated 08-6-2015 of M/s
manufacturer is an ZELLTEK S.A, Ruta Nacional No
authorized manufacturer of 168 S/N, Pasaje “EI Pozo’, Parque
that particular biological Tecologico Litoral , of the Province
drug in its country of origin. of Santa Fe, of the Argentine
Republic.
2. Structural similarity of Under Eludication of structure of

subject biological drug API, comparative analysis with
product (concentrate/ ready EPO Standard BPR is provided by
to fill bulk for further M/s ZELLTEK S.A, Argentine
processing) with reference Republic.
biological product
(innovator)

Glycoform analysis

Primary Structure

Secondary Structure

Tertiary structure

Disulfide bridges

N-terminal sequence

Sialic Acid Content

Native N-glycans profile

Neutra N-glycans profile

O-glyscosilatin site occupation

Content of dimmers and
related substances of high
molecular weight
 Invivo biological activity.
3. Manufacturer to Not provided
manufacture the finished
biological product for trial

studies
4. Bio-comparability studies Not provided
focusing data, gel
product
5. Others
Decision: Regiatration Board deliberated and deferred these applications that manufacturing
and quality control of biological products require specialized facilities and approval
from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing
units have already been granted registrations of various biological products for local
manufacturing (mostly therapeutic proteins). As theses firms have applied for
registration for local manufacturing of various biological products including rDNA
products, Theraputic protein, Monocronial antibodies, Vaccines (Live, Attentuated,
rDNA vaccines, so the Board decided to have opinion of licensing division DRAP
regarding approved manufacturing facilities (categories of biological products) of
these firms and status of already registerd biological drugs from these firms.
Case No.05: As per decision of 258th meeting of RB. All the cases of import of Heparin are placed
below for a joint collective decision as per recommendation of WHO.
a. Deferred case of M/s Ghazali Brothers Karachi in 258 th meeting of Registration Board
Following product of M/s Ghazali brothers Karachi are deferred by the Registration
Board 254th meeting for completion of applications, remaining fee, CoPP status, information regarding
availability in country of origin and deliberations regarding requirement for bio-similarity of products.
Sr. Name of Brand Name & Type of Document Remarks

No Importer & Composition Form details
Manufacturer (CoPP)
Dy No &

Date of Me too
application status/New
molecule
Fee
submitted
Pack size/
Demanded
Price
1. Ghazali Brothers, VAXCELL Form-5A Legalized Product is
Karachi. Heparin CoPPCertific available in
Sodium Injection Dy No. 43 ate No. 0346/ country of origin
KotraPharma(M) 5000 IU/ml dated 03-03- 2015 dated and full fee as
SdnBhd, Jalan 2011 10-03-2015 required is
TTC 12 Each 5ml submitted. Firm
ChengIndustrial contains:- 15000/- dated Me too has submitted the
Estate,Melaka, Heparin 03-03-2011 clinical data/
Malaysia. Sodium…..25000I 3500/- dated biosimilarity data
U 09-10-2012
50000/- dated
Anticoagulant 16-06-2015
Shelf life: three

years Rs.540/ 5ml
Decision: Registration board deliberated that WHO exempts Heparins and Enoxaprin from
the condition of biosimilarity. Keeping in view this position, the Board approved the
above products for registration as per Import Policy for Finished Drugs.
b. Deferred case of M/s Shamco Traders (Pvt) Limited, Lahore in 258 th meeting of
Registration Board.
S.#. Company Name Brand Name Date of Document Remarks

and Name of and application/Fe ary details
Manufacturer Composition e status
13. M/s Shamco POLIPARIN Form-5A CoPP No
Traders (Pvt) 25000 IU/ 5ml 2014/ 335
Limited, Lahore IV/ SC Dy No. 1241 dated 22-
Injectable vial dated 12-10-15 07-2014
License Holder:
PolifarmaIlacSanayi Each 5ml vial Rs 100000 Copy of
VeTicaretAS contains: dated 12-10-15 GMP dated
TozkoparanMah. Heparin 15-08-2013

HaldunTaner&SkAl sodium…… 625/ vial valid up to
parsalanMerkezi 25000IU 12-2015
Istanbul
Manufacturer:
MefarIlac San AS
RamazanogluMah.
Ensar Cad. No: 20
34906
KurtkoyPendik
Istanbul.
Decision: Registration board deliberated that WHO exempts Heparins and Enoxaprin from
c. Registration of Import Product Namely Medirin Heparin Sodium 5000IU/ml &

25000IU/ml M/s Medi Mark Pharmaceutical Lahore and Hepacin Injection 25000
iu/5ml, Bajwal Sons, Lahore
M/s Medi Mark Lahore had applied for registration of Medirin Injection (Heparin) 25000
IU/5ML and Medirin Injection (Heparin) 5000IU/ml and M/s Bajwa sons, Lahore had applied for
registration of Hepacin Injection 25000 iu/5ml. Both companies have same manufacturer abroad. The
case is being placed 254th meeting before the Registration Board. The decision of 254 th Registration Board
meeting as follows:
“Registration Board deferred the case. M/s Medi Mark and Bajwa sons has same source. Firm will be
advised to provide latest Whole Sale Agency Certificate from manufacturer. Complete information for
CoPP is also required”.
Later on the M/s Medi Mark has provided copy of sole agency agreement with its Chinese
manufacturer. The document is not on the company letter head nor has been notarized. The Medi Mark
provided also copy of CoPP. The case was placed on agenda of 256 th meeting of Registration Board.
Documentary details as below:
S.#. Company Name and Name of Product Date of Remarks

Name of / Composition application / Fee
Manufacturer status

1. Medi Mark Pharma, MEDIRIN INJECTION Date of Me too
Lahore. 5000IU/ML Application
23-05-2013
Furen Pharmaceutical Composition
Group Co., Ltd, Fee deposited
Address: 1 (Heparin Sodium Rs.100000/-
Xuan Wu Economic Injection 5000 IU/ml )
Developing -area, Balance fee
Luyi Country, Henan Anti Coagulant Nil
China.
Address 2:
No.1 Tongyuan road,
Industrial centralized
area, LuYi County,
Henan Province
China
2. Medi Mark Pharma, MEDIRIN INJECTION Date of Me too

Lahore. 25000 IU/5ML Application
23-05-2013
Furen Pharmaceutical Composition
Group Co., Ltd, (Heparin Sodium Fee deposited
Address: 1 25000IU/5ml) Rs.100000/-
Xuan Wu Economic
Developing -area, Anti Coagulant Balance fee
Luyi Country, Henan Nil
China.
Address 2:
No.1 Tongyuan road,
Industrial centralized
area, LuYi County,
Henan Province
China
Registration Board decided as follows:
“Registration board considered above applications of Medi Mark Pharma, Lahore and
advised to provide legalized CoPPs and notarized sole agency agreement.”
M/s Medi Mark has now provided the legalized CoPP (original) and notarized sole agency
agreement as per directions of the Registration Board.

Decision: Registration Board considered the request of M/s Medi Mark Lahore and referred the
applications for expert opinion of the following:
i. Brig. (R) Muzamil Hussain Najmi, Member Registration Board.

ii. Brig. Abid Azhar, AFIP, Rawalpindi.
iii. Dr. Masud-ur-Rehman, DDG DRAP, Islamabad.
“M/s Medi Mark is advised to provide the notarized sole agency agreement from country of
origin. As two manufacturing sites are mentioned on CoPP submitted by M/s Medi Mark
Lahore, therefore clarification will be obtained from firm about manufacturing site. The
application of M/s Bajwa Sons Lahore will be considered after aforementioned
clarification”.
M/s Medi Mark has submitted Legalized and Notarized Sole Agency Agreement and Notarized
cancellation letter from Furen Pharmaceutical Group Co., Ltd. China as per directions of the Registration
Board in 257th meeting mentioned above.
Decision: Registration Board deliberated that WHO exempts Heparins and Enoxaprin from

d. Grant of Registration Human Imported product Enclex 40 (Enoxaparin Sodium Injection
IP 40MG/0.4ml) M/s AJ Mirza Pharma (Pvt) Ltd, Karachi.
M/s AJ Mirza Pharma (Pvt) Ltd Karachi has applied for grant of registration
HumanImported product Enclex 40 (Enoxaparin Sodium Injection IP 40MG/0.4ml). Product details is as
under:
1. M/s AJ Mirza Enclex 40 Form 5-A Legalized COPP Valid and

Pharma (Pvt) No. legalized
Ltd, Karachi (Enoxaparin 831/MFG/WHO- COPP/ FSC
sodium Injection GMP/DFDA/201 along with
IP 40mg/0.4ml Dy. No. 29 R&I
2/1742 valid up GMP
DRAP dated 10-
to 14-6-2014 Certificate need
Cipla Ltd 289, Each prefilled 10-2014
from India to be submitted
Bellasis Road, syringe contains:
as per above
Mumbai
Enoxaparin decision of
Central, Fee deposited: th
Mumbai 400 Sodium Product License 255 meeting.
IP…….40mg. Rs. 100000/-
008 India No. 704 dated
dated 10-10-2014
08-4-2005
Equivalent to 4000
Condition of
IU anti-Xa
inspection
activity. Packs: 0.4ml PFS abroad as per
Water for Injection import policy.
Ip…….q.s. DML No.
831/MFG/CERT/
DFDA/12/5863
dated 06-2-2012
Pharmacological
group:
Antithrombotic
agent, low
molecular weight
Heparin.
Route of
Adminstration:
Intara Venous &
Sub cutaneous
2. M/s AJ Mirza Enclex 60 Form 5-A Legalized COPP Valid and

Pharma (Pvt) No. legalized
Ltd, Karachi (Enoxaparin 831/MFG/WHO COPP/ FSC
sodium Injection GMP/DFDA/201 along with
IP 60mg/0.6ml Dy. No. 28 R&I

Each prefilled DRAP dated 10- 2/1734 valid up GMP
syringe contains: 10-2014 to 14-6-2014 Certificate need
Cipla Ltd 289, from India to be submitted
Bellasis Road, Enoxaparin as per above
Mumbai Sodium decision of
Central, IP…….60mg. Fee deposited:
255th meeting.
Mumbai 400 Rs. 100000/- Product License
008 India Equivalent to 6000 dated 10-10- No. 704 dated
IU anti-Xa 2014. 08-4-2005
activity. Condition of
inspection
Water for Injection
Ip…….q.s. Packs: 0.6ml PFS DML No. abroad as per
831/MFG/CERT/ import policy.
Pharmacological DFDA/12/5863
group: dated 06-2-2012
Antithrombotic
agent, low
molecular weight
Heparin.
Route of
Adminstration:
Intara Venous &
Sub cutaneous.
e. Grant of Registration Human Imported product Heparodic 5000 (Heparin sodium)

M/s AA Pharma, Karachi.
M/s AA Pharma, Karachi has applied for grant of registration Human Imported product
Heparodic 5000 (Heparin sodium) Product details is as under:
S. Name of Importer Brand Name & Dy No & Date of Document Remarks

No & Manufacturer Composition application/ Fee details (CoPP)
status/ Pack size/
demanded Price Me too status
1 M/s AA Pharma, HEPARODIC 5000 Form 5-A Legalized Me too

Karachi (Heparin sodium COPP available
5000U/ml Dy No. 958 R& I from Islamic
Caspian tamin IV, Deep SC DRAP dated 17-3- Republic of
PhamaceuticalCo. Injection 2014 Iran
First Entrance, Rasht IV infusion
Industrial Zone, P.O. Each 1ml ampule Fee deposited: Rs. Product
Box: 43375-1116, (injectable 50000/- dated 07- License No.
Rasht-Iran solution) contains: 11-2012 + Rs. IRC
Heparin sodium 50000/- dated 31- 1228049750
USP……5000IU 12-2014 dated 04-7-
Benzyl alcohol 2011
B.P……9.45 MG Balance fee: Nil
Sodium chloride Legalized Free
B.P…….. 9 mg Sale Certificate
Water for injection available from
USP……..q.s the country of
origin
f. Cases of Imported Human Biological Drugs ENOXAPRIN M/s Allmed

Laboratories, Karachi
S.No. Name of Brand Name & Dy No & Document Decision in

Importer & Composition Date of details 257th RB
Manufacturer application/ (CoPP)/ Meeting
Fee Status/ International
Pack size/ availability/
Price Me too status
1. M/s Allmed ENOXA 2000 IU Dy No. 1140 Market Deferred for
Laboratories, A- anti Xa 20mg R&I dated authorization expert opinion
21/3 KDA Solution Injectable 2 23-5-2014 no. 9233494 of following:
Scheme No. 1 Syringes / 0.2 ml until valid 05- a. Dr. Abid
Ext Karachi 15000 dated 2017 Azhar,
Pakistan One prefilled 02-1-2012 Sole agency A.Q.Khan
Institute of
syringe of 0.2 ml 85000/- dated agreement
Biotechnol
Les contains: 11-10-2012 dated 23-11- ogy,
Laboratories Enoxaparin Sodium 2015 University
Medis Route De ……20mg As per PRC/ of Karachi.
Nabeul Km Pack of 2’s Clexane b. Dr.
78000 Nabeul Antithrombotic syringes prefilled Zeeshan
Tunise syringes Danish,
University
(MHRA)
of the

Punjab.
Clexane PFS c. Prof. Dr
of Sanofi Ghias Butt,
PIMS
Karachi
Islamabad.
2. M/s Allmed ENOXA 4000 IU Dy No. nil Market Deferred for
21/3 KDA Solution Injectable 2 26/5/2014 no. 9233494 of following:
Institute of
Biotechnol
University
(MHRA)
of the
Punjab.
Karachi PIMS
Islamabad.
Institute of
Biotechnol
University
(MHRA)
of the
Punjab.
Karachi PIMS
Islamabad.

Institute of
syringe of 0.8 ml 85000 dated agreement
Biotechnol
University
(MHRA)
of the
Punjab.
Karachi PIMS
Islamabad.
The expert opinion of above products have no been received yet.
g: Cases of Imported Human Biological Drugs Heparin sodium 25000IU M/s Genome Phamra,
Rawalpindi
S.No. Name of Brand Name & Dy No & Date Document

Importer & Composition of application/ details
Manufacturer Fee Status/ (CoPP)/
Pack size/ International
Price availability/
Me too status
1. Genome NEFRIN Form 5-A Legalized valid
Phamra, Injection COPP is required
Rawalpindi Dy No. 119 As the firm has
Each 5 ml R&I DRAP submitted copy of
contains: dated 11-1- COPP issued on
Belmedpreparat Heparin sodium 2016 dated 07-8-2014.
y RUE 25000IU
Republic of Fee deposited Copy of sole agency
Belarus Pharmacological Rs.100000/- agreement is
group: Anti dated 30-12- submitted.
cogualant 2015
Orignal legalized

Shelf life : Price: Not documents are
03years provided. required.
Decision: Registration Board approved NEFRIN Injection as per Import Policy for Finished
Drugs. The firm will provide the original legalized CoPP and sole agency agreement
and Chairman RB will allow further processing of the case as per Import Policy for
Finished Drugs.
Deferred/ Miscellenous Cases
Case No.06: Following product of M/s BroMed animal Health, Lahore are deferred in the 258 th meetin
of RB due to non submission of original legalized GMP Certrificate. The firm has now provided the
legalized GMP certificate. The case is placed before the board for consideration please.
Sr. Name of Brand Name & Type of Form Document Remarks Decision
No Importer & Composition details
Manufacturer Dy No & Date of (CoPP)
application
Me too
Fee submitted status/New
molecule
Pack size/
Demanded Price
1. BroMed animal TRI- Dy No. 2841 Product Reg The Firm has Approved As
Health, Lahore APHTHOVAC (R&I) DRAP No 614 submitted GMP Per Valid
dated 21-12-2015 Dated certificate Legalized
Inactivated Foot 19/02/2014 legalized COPP And
Middle East for & mouth Tri- Fee deposited: Legalized through Import Policy
Vaccines (ME vlent Vaccine Rs.100000/- dated Free sale Embassy of For Finished
VAC) Strain A Iran05, 18-12-2015. dated 17-09- Pakistan Drugs
Industrial area 2 O Pan Asia 2, 2015
Piece 22-24, Asia 2, Asia 1 20/50/100/300 ml Condition of
New Salhia, el Shamir vial inspection
Sharkia Head abroad as per
Office : 20 Each ldose (2ml) import policy.
Jospeh teto el contains:
nozha el gededa, Inactivated FMD
Cairo, Egypt. Virus Serotype A
Iran 05……≥ 108
TCID50 per dose.
(4 ug of viral
protein / Dose
which is

equivalent to 6
PD50/ dose).
Inactivated FMD
Virus Serotype O
Panasia 2……≥
108 TCID50 per
dose. (4 ug of
viral protein /
Dose which is
equivalent to 6
PD50/ dose).
Inactivated FMD
Virus Serotype
Asia 1
Shamir…..……≥
108 TCID50 per
dose. (4 ug of
viral protein /
Dose which is
equivalent to 6
PD50/ dose).
Montanide Isa
50…….1ml
Inactivant
BEI……….3mM
Bulk
saline…………..
Q.S. to2ml
Total ……….2
ml
Protection of
cattle dairy sheep
goat from FMD
Shelf life: 24
months
Route : SC
2. BroMed animal ME FLUVAC Dy No. 2842 Product Reg The Firm has Approved As
Health, Lahore H9+ND 0.3% (R&I) DRAP No 653 submitted GMP Per Valid
Inactivated dated 21-12-2015 Legalized certificate Legalized
Bivalent Virus Free sale legalized COPP And
Middle East for Vaccine against Fee deposited ; dated 17-09- through Import Policy
Vaccines (ME Avian influenza Rs.100000/- dated 2015 Embassy of For Finished

VAC) H9N2 and 16-12-2015 vide Pakistan Drugs
Industrial area 2 Newcastle challan no.
Piece 22-24, disease. 0131605 Condition of
New Salhia, el inspection
Composition:
Sharkia Head 300 ml vial abroad as per
Inactivated
Office : 20 import policy.
Avian Influenza
Jospeh teto el
A /Chicken
nozha el gededa,
/Egypt/114940v/
Cairo, Egypt.
NLQP /2011
(H9N2)……
≥108EID50/dose
before
inactivation.
Inactivated
Newcastle
Disease
NDV/Chicken/E
gypt/11478AF/2
011 (ND)……
≥108EID50/dose
before
inactivation.
Mantonied Isa
71VG…021 ml
BNE
……..0.0005 G
Bulk saline ……
Q.S.to 0.3ml
Total ….. 0.3ml
Protection
against AI, and
ND
Shelf life 24
months
Route: IM/SC
3. BroMed animal MEVAC IB+ND Dy.No. 2844 Product Reg The Firm has Approved As
Health, Lahore Inactivated (R&I) DRAP No 630 submitted GMP Per Valid
trivalent Virus dated 21-12-2015 Legalized certificate Legalized
Vaccine of Original free legalized COPP And
Middle East for Infectious Fee deposited; sale certificate through Import Policy
Veterinary Bronchitis Rs.100000/- dated dated 20-06- embassy of For Finished

Vaccines (ME Disease. 16-12-2015 vide 2015 Pakistan. Drugs
VAC) challan
Egypt. Each (0.5ml) ml no.0131609. Condition of
contains: inspection
500 & 300 ml vial abroad as per
Inactivated Virus import policy.
Vaccine of
Infectious
Bronchitis
Disease of IB
Classical
(Eg/11539F)&
IB Variant type 2
(Eg/1212B)……
≥107EID50/dose
at release.
Inactivated
Newcastle
Disease
NDV/Chicken/E
gypt/11478AF/2
011 (ND)……
≥108EID50/dose
at release
(>128PD50).
Mantonied Isa
70V……0.35 ml
Formaldehyde
solution
…..0.0045ml
Bulk saline ……
Q.S.to 0.5ml
Total …. 0.5ml
Immunization
against IB and
ND
Shelf life: 24
months
Route : IM/ SC

4. BroMed animal ME FLUVAC Dy No. 2845 Legalized The Firm has Approved As
Health, Lahore H9 0.3% (R&I) DRAP Original free submitted GMP Per Valid
(Inactivated virus dated 21-12-2015 sale certificate certificate Legalized
Vaccine against dated 20-06- legalized COPP And
Middle East for Avian influenza Fee deposited: Rs. 2015 through Import Policy
Vaccines (ME H9N2) 100000/- dated 16- Embassy of For Finished
VAC) 12-2015. vide Pakistan Drugs
Industrial area 2 Each (0.3ml) challan no.
Piece 22-24, dose contains: 0131604.
New Salhia, el Condition of
Sharkia Head Inactivated Packs: 300 ml vial inspection
Office : 20 Avian Influenza abroad as per
Jospeh teto el A /Chicken import policy.
nozha el gededa, /Egypt/114940v/
Cairo, Egypt. NLQP
/2011(H9N2)
……
≥108EID50/dose
before
inactivation.
Protection
against influenza
Shelf life: 24
months
Route : IM/ SC
5. BroMed animal ME VAC ND Dy No. 2843 Legalized The Firm has Approved As
Health, Lahore Broiler (R&I) DRAP Original free submitted GMP Per Valid
Inactivated Virus dated 21-12-15 sale certificate certificate Legalized
Vaccine against dated 20-06- legalized COPP And
Middle East for Newcastle Fee deposited: Rs. 2015 through Import Policy
Vaccines (ME disease 100000/- dated 16- Product reg Embassy of For Finished
VAC) 12-2015 vide no 651 dt Pakistan Drugs
Industrial area 2 Each 0.3 ml dose challan no. 8/5/2014
Piece 22-24, contains: 0131607. Condition of
New Salhia, el inspection
Sharkia Head Inactivated 300 ml vial abroad as per
Office : 20 Newcastle import policy.
Jospeh teto el Disease
nozha el gededa, NDV/Chicken/E
Cairo, Egypt. gypt/11478AF/2
011 (ND)……
≥108EID50/dose

before
inactivation.
Protection
against ND
Shelf life: 24
months
Route : IM/ SC
Case No.07: Cases of Imported Products of Veterinary Biological Drugs M/s SNAM
Pharma, Lahore
M/s Snam Pharma, Lahore applied the new registration of following Veterinary Biological
Products. The Registration Board considers the request in 256 th Registration Board meeting. The decision
of 256th RB meeting is below:
Decision of 256thRB: Approved as per import Policy for Finished Drugs.
The firm is provided registration certificates of three (03) Eastern Europe Countries as per
Import Policy. Product details as under:
Name of Manufacturer Name of Drug Date of Document Remarks

Sr #. Indenter/ (s)/ Composition applica ary Details
Manufactur & Therapeutic tion /
er Group Fee
status
1. M/s SNAM BIOVETA, Biofel PCH Date of CoPP No. Me too
Pharma a. s. emulsion for applicat 047/2014
61-G Komenskeho injection for cats ion dated 01-4- 1. Marketing
Defense 212, 683 23 25-11- 2014 Country: Romania
Housing Ivanovice na Active Substance 2014
Authority , Hane, Czech Prod Market
Lahore Republic, Virus Fee License No. authorization No.
panleucopeniae deposite 97/004/06- 130217dated 22-
contagiosae felis d C dated 01- 11-2013.
inactivatum, 06-2006
satrain FPV-Bio Rs.1000 2. Marketing
7 00/- Free Sale Country: Republic
vide Certificate of Poland
Calicivirus felis Challan No.
inactivatum, No 048/2014 Authorization No.
strain FCV F 9- 022788 dated 01-4- 2398/14 dated 18-

Bio 8 0 dated 2014 12-2014
27-11-
Herpesvirus felis 2014 GMP 3. Marketing
inactivatum, Certificate Country: Hungary
strain FHV-1-Bio Balance No.
9 fee 178/2012/C Marketing
Nil GMP dated Authorization
03-9-2012 No.3612/1/14
NEBIH ATI
(1dose) dated 1-
12-2014
2. M/s SNAM BIOVETA, Biocan Puppy Date of CoPP No. Me too
Pharma 61- a. s. lyophilisate for applicat 057/2014
G Defense Komenskeho the preparation of ion dated 01-4- 1. Marketing
Housing 212, 683 23 injection 25-11- 2014 Country: Romania
Authority , Ivanovice na suspension with 2014
Lahore Hane, diluent Prod Market
Czech Republic, Fee License No. authorization No.
Composition- 1 deposite 97/011/04- 120087 dated 21-
ml (1 dose): d C dated 04- 3-2012.
a) Component D 02-2004
(freeze-dried) Rs.1000 2. Marketing
Virus febris 00/- Free Sale Country: Slovak
contagiosae canis vide Certificate Republic
min. 10 4.2 TCID50 Challan No.
– MAX. 10 5,0 No 058/2014 Market
TCID50 022787 dated 01-4- authorization No.
9 dated 2014 97/115/99-S dated
b) Component P 27-11- 12-12-2012
(fluid) 2014 GMP
Parvovirus Certificate 3. Marketing
enteritidis canis Balance No. Country: Republic
inact. Min. 1024 fee 178/2012/C of Bulgaria
HAU- max. 4096 Nil GMP dated
HAU 03-9-2012 Marketing
Authorization of
Veterinary
product No,
0022-1461 dated
14-7-2015
3. M/s SNAM BIOVETA, Biocan DHPPi+L Date of CoPP No. Me too
Pharma 61- a. s. lyophilisate for applicat 209/2014
G Defense Komenskeho the preparation of ion dated 03-7- 1. Marketing
Housing 212, 683 23 injection 25-11- 2014 Country: Hellenic

Authority , Ivanovice na suspension with 2014 Republic (Greece)
Lahore Hane, diluent Prod
Czech Republic, Fee License No. Marketing
Composition- 1 deposite 97/046/02- authorization No.
ml: d C dated 06- 81940 dated 22-9-
06-2002 2014.
Freeze-dried Rs.1000
Component 00/- Free Sale 2. Marketing
Virus febris vide Certificate Country: Republic
contagiosae canis Challan No. of Poland
min. 10 3.0 TCID50 No 210/2014
– max. 10 4.5 022787 dated 03-7- Authorization No.
TCID50 8 dated 2014 2010/10 dated 21-
Virus 27-11- 10-2010
laryngotracheitidi 2014 GMP
s contagiosae Certificate 3. Marketing
canis min. 10 3.5 Balance No. Country: Hungary
TCID50 – max. 10 fee 178/2012/C
4.5
TCID50 Nil GMP dated Marketing
03-9-2012 Authorization
Parvovirus No, 250/1/09
enteritidis canis MgSzH ATI
min. 10 4.5 TCID50 (1dose) dated 21-
– max. 10 5.5 4-2015
TCID50
Virus
parainfluensis
canis min. 10 3.0
TCID50 – max. 10
4.2
TCID50
b) Liquid
component
Leptospira
icterohaemorrhag
iae inact.
Min.titre 32
defined by
MAT*)
Leptospira
canicola inact.

Min.titre 32
defined by
MAT*)
Leptospira
grippotyphosa
inact. Min.titre
32 defined by
MAT*)
*) geometrical
mean of titres of
specific
antibodies
defined by
microagglutinatio
n test
3. Two Veterinary Biological Products namely Biocan Puppy (lyophilisate for the preparation of
injection) and Biocan DHPPi+L (lyophilisate for the preparation of injection ) of M/s Snam Phamra,
Lahore deferred in 256th Registration Board meeting for expert opinion of confirmation of need vis-à-vis
compatibility with local immunogenic requirement safety profile product.
Pannel of experts are as under:
a. Dr. Qurban Ali Animal Husbandary Commissioner, Ministry of National Food Security,
Islamabad.
b. Prof. Dr. Khushi Muhammad, UVAS, Lahore
c. Prof.Akram Munir, Ripha University, Lahore
1. The opinion of Prof. Dr. Khushi Muhamad against Biocan DHPPi and Biocan Puppy Vaccine
are as under:
Comments: Based on the “quality control data, results of the experimental trails and composition of the
Vaccines”, it can be stated that vaccines against the said canine disease in Pakistan seem to be safe and
effective.
It is therefore recommended that the said vaccines may be registered in Pakistan in the best interest of
canine lovers.
2. The opinion of Prof. Dr. Muhamad Akram Muneer, Riphah International University,
Lahore against Biocan DHPPi and Biocan Puppy lyophilisate Vaccine are as under:
Comments against Biocan Puppy lyophilisate:The technical data provided in the dossier supports the
efficacy of this vaccine product against CD Aand CPV. In view of supporting documents I recommend
that the registration of this vaccine may be considered by the Registration Board.

Comments against Biocan DHPPi+L lyophilisate: The technical data support the efficacy of this
multivalent vaccine against canine distemper (CDV), infectious canine hepatitis (CAV-1), infectious
laryngotracheitis (CAV-2), parvovirus infection (CPV), parainfluenza (CPIV-2) vivid and leptospirosis in
dogs. I recommend consideration of this multivalent preparation by the registration board.
3. The Opinion of Dr. Qurban Ali, DG, NVL, Islamabad against Biocan Puppy
lyophilisate and Biocan DHPPi+L lyophilisate are as under:
Biocan Puppy lyophilized is a two component vaccine for active immunization of dogs against canise
distemper and parvovirus. The subject vaccine is a veterinary requirement especially for the pet dogs in
the country. The dossier has merits of clear description of technical contents. The product is registered in
the country of origin, multiple European and developed and developing countries. The product is
recommended.
Biocan DHPPi+L is a multicomponent veterinary caccine containing veterinary vaccine containing

freeze dried and liquid components having biological entities. The vaccine is required for pet dogs for
immunization against multiple diseases for the age of eight weks and above. The technical application has
scientific contents with clear description of technical details. The product is registered in country of
origin, multiple developed and developing countries. The product is recommended.
Decision: Registration Board approved avove Product as per Import Policy for Finished
Drugs. The firm shall provide legalized and Notarized COPP from three regulatory
bodies of Eastern European countries, where the drug is registered for purpose of
the waiver of inspection aborad as required as per Import Policy for Finished
Drugs.
Case No.08: Deferred cases Registration of Products of M/s Mustafa Brothers, Faisalabad
Following veterinary vaccine products of M/s Mustafa Brothers Faisalabad are deferred for
submission of valid legalized documents i.e. CoPP or Free sale certificate with GMP, issued by the
regulatory agency of country of origin with certified English translation in 257 th meeting of Registration
Board. The firm has submitted the documents. The evaluation is detailed below for consideration of
Registration Baord please.
S. Name of Brand Name & Dy No & Date Document Remarks

No Importer & Composition of application/ details (CoPP)
Manufacturer Fee status/
Pack size/ Me too status
demanded
Price
1. Mustafa Virus Vaccine Dy. No.600 State Registration Firm has
Brothers against infectious (R&I) dated No. submitted valid
Faisalabad. bursal disease from 12-6-2012 1047796296437 lealized
BG strain “ARRIAH dated 11-8-2011 documents i.e.
Manufacturer GUMBORO VAC” Free sale

Contains:- Fee Rs.15000/- certificate with
Federal Infectivity of the virus dated 12-6- DML No.00-11- GMP issued by
Governmental vaccine shall be at 2012 + 85000/- 1-001221 dated the regulatory
Budgetary least 104.5EID50/cm3 dated 01-2- 11-8-2011 agency of
Institution One dose of the 2016 country of origin
“Federal Centre vaccine shall contain GMP Registration with English
for Animal 103 EId50 Balance Fee N 4-4060 translation
Health” (FGBI (Vaccine). Nil enclosed
“ARRIAH”, Pharmacological Condition of
Vladimir, group: inspection
Russia. Vaccine. abroad as per
import policy.
2. Mustafa Vaccine against Dy No. 599 Product .Firm has

Brothers chicken infectious (R&I) dated Registration No. submitted valid
Faisalabad. bronchitis from strain 12-6-2012 1023/301283720 lealized
“H-120” strain live Fee Rs. Dated 26-7-2011 documents i.e.
Manufacturer dry Contains:- 15000/- dated Free sale
12-6-2012 + State Registration certificate with
Federal One immunizing 85000/- dated No. GMP issued by
Governmental vaccine dose contains 01-2-2016 1047796296437 the regulatory
Budgetary not less than 104 EID50 Dated 26-12- agency of
Institution of the chicken Balance fee 2011 country of origin
“Federal Centre infectious bronchitis Nil with English
for Animal virus (‘H-120” strain, Legalized Free translation
Health” (FGBI serotype sale Certificate
“ARRIAH”, Massachusetts). Registration N 1- Condition of
Vladimir, 2347 enclosed inspection
Russia. Pharmacological abroad as per
group: GMP Registration import policy.
Vaccine N 4-4060
encosed.
3. Mustafa Associated Vaccine Date of DML No. 00-11- Firm has

Brothers Against Newcastle application 1-001220 Dated submitted valid
Faisalabad. Disease 12-Jun-2012 11-8-2011 lealized
Infectious Chicken enclosed. documents i.e.
Manufacturer Bronchitis and egg Fee Rs.15000/- Free sale
drop syndrome-76 dated 12-6- Legalized Free certificate with
Federal inactivated emulsion 2012+ 85000/- Sale Certificate GMP issued by
Governmental dated 01-2- No. N 1-2346 the regulatory
Budgetary Pharmacological 2016 encosed. agency of
Institution group: Balance Fee country of origin
“Federal Centre Vaccine for prevention NIL GMP Certificate with English

for Animal of Newcastle Disease No. N 4-4060 translation
Health” (FGBI Infectious Chicken Packing of 400 copy enclosed.
“ARRIAH”, Bronchitis and egg doses in a Condition of
Vladimir, drop syndrome-76 in bottle. inspection
Russia. breeding and abroad as per
marketable pultry import policy.
farms and farms of
other categories that
have poultry.
4. Mustafa Virus vaccine against Dy No. 596 Prod Reg No. Firm has
Brothers Bursal disease from (R&I) dated 1023301283720 submitted valid
Faisalabad. Winterfield Disease 12-6-2012 Dated 26-7-2011 lealized
2512 strain documents i.e.
Manufacturer Fee Rs. GMP No. 0011-1- Free sale
One Immunizing dose 15000/- dated 001221 certificate with
Federal of vaccine shall 12-6-2012 26-12-2011 GMP issued by
Governmental contain: the regulatory
Budgetary 4,0 lg EID50 of 85000/- dated Free Sale agency of
Institution attenuated virus of 01-2-2016 Certificate No. 4- country of origin
“Federal Centre infectious bursal 4078 with English
for Animal disease of Winter field Balance Fee translation
Health” (FGBI strain 2512 Nil
“ARRIAH”, Condition of
Vladimir, Composition: inspection
Russia. abroad as per
Active substances: import policy.
Virus of infectious
bursal disease (IBDV)
(strain Winterfield-
2512), titer of
infectivity at lease 6.0
lg EID50/cm3.
Pharmacological
group:
The vaccine is used
for prophylactic
immunization of
chickens and chicks
against infectious
bursal disease.
5. Mustafa Virus Vaccine Dy. No.600 State Registration Firm has

Brothers against infectious (R&I) dated No. submitted valid

Faisalabad. bursal disease from 12-6-2012 1047796296437 lealized
BG strain “ARRIAH dated 11-8-2011 documents i.e.
Manufacturer GUMBORO VAC” Free sale
Contains:- Fee Rs.15000/- certificate with
Federal Infectivity of the virus dated 12-6- DML No.00-11- GMP issued by
Governmental vaccine shall be at 2012 + 85000/- 1-001221 dated the regulatory
Budgetary least 104.5EID50/cm3 dated 01-2- 11-8-2011 agency of
Institution One dose of the 2016 country of origin
“Federal Centre vaccine shall contain GMP Registration with English
for Animal 103 EId50 Balance Fee N 4-4060 translation
Health” (FGBI (Vaccine). Nil enclosed
“ARRIAH”, Pharmacological Condition of
Vladimir, group: inspection
Russia. Vaccine. abroad as per
import policy.
Decision: Registration Board approved above five products as per Import Policy for Finished
Drugs and valid legalized COPP
Case No.09: Change in Name of company and address already registered and unregistered
products of M/s Sanofi-Aventis Pakistan Ltd.
M/s Sanofi-Aventis Paksitan has applied for the change in name of company and address
for the following products:
i. Shanvac B 1ml (Reg.No. 0456371) already registerd product.
ii. Shanvac B 0.5ml (Approved in 240th RB meeting and under process in Pricing)
iii. Shanvac B 5ml MD (Approved in 240th RB meeting and under process in
Pricing)
iv. Shan TT 0.5ml single vial (Approved in 240th meeting of RB and 12th DPC.
v. Shan TT 0.5ml SD (35x0.5ml) (Approved in 240th meeting of RB and 12th
DPC.
vi. Shan TT 5ml MD (30x5ml) (Approved in 240th meeting of RB and 12th
DPC.
M/s Sanofi-Aventis Pakistan Ltd has requested that the state of Andhra Pradesh by virtue of the
Andhra Pradesh Reorganization Act 2014 has been split in to two states Andhra Pradesh and Telangtana
fro mid of 2014.
As a result of Reorganization Act the manufacturing unit located in erstwhile Andhra Pradesh are
now came into existence in the reorganized Telangana and as per fresh certificate of incorporation
consequent upon conversion from public company to private company issued by ministry of corporate
affairs, w.e.f. 19-11-2014. The change of name and address details are as under:

Old Name of Company and Address New Name of Company and address
Shantha biotechnics Limited Shantha biotechnics Private Limited
Survey No. 274, Athvelli village, Medchal Survey No. 274, Athvelli village, Medchal
Mandal – 501401, Ranga Reddy district, Mandal – 501401, Ranga Reddy district,
Andhra Pradesh, India Telangana, India
Firm has submitted fee against each product Rs. 5000/- , Legalized COPP and other legal documents.
Decision: Keeping in view the approval of change of name and address by the regulatory body
of exporting country (valid legalized CoPP), the Registration Board approved the
change of name and address of manufacturer from Shantha biotechnics Limited
Survey No. 274, Athvelli village, Medchal Mandal – 501401, Ranga Reddy district,
Andhra Pradesh, India to Shantha biotechnics Private Limited Survey No. 274,
Athvelli village, Medchal Mandal – 501401, Ranga Reddy district, Telangana, India.
Case No.10: Deferred Case of 256th RB, Request for additional pack size by M/s. Snam Pharma,
Lahore.
M/s Snam Pharma Lahore may be advised to submit the separate application / dossier
alongwith COPP and case may be taken up in the next Registration Board meeting. However the opinion
of Secretary, Registration Board may also be taken on the instant case for further clarification.
Product Biocan R injection is registered Veterinary Product in multiple dose vial (Reg.No.
057167). The firm requested additional volume/ pack in single dose form as per COPP issued by
regulatory body of Czech Republic. The Registration Board acceded to the request of firm in 256 th RB
meeting. Now the clarification is needed wether the firm shall follows the policy of submitting separate
application dossier along with full fee as per policy adopted on human drugs.
The firm has submitted the balance fee of 95000/- other formalities are complete. Case is submitted
before board please.
Decision: Registration Board deferred the request of additional pack volume 1ml x 20 doses of
Biocan R bearing Registration No. 057167 and advised to submit application on
Form-5A with requisite details.
Case No.11: Transition of Formulation from Lyophilized To Liquid Form of WinRho SDF
Injection (025216) M/s Eastern Trade and Distribution Co. Pvt Limited Karachi

M/s Eastern Trade and Distribution Co. Pvt Limited Karachi have informed that their
principal M/s Cangene Corporation, Canada is transitioning the formulation of their registered product
WinRho SDF Injection from lyophilized to Liquid formulation. The existing formulation was supplied as
freeze dried powder I vial along with single ampoule of sterile water for injection, while the new
formulation is liquid injection will contain a convenient formulation ready to use 3ml single dose vial of
1500IU (300mcg) of Anti Rho (D) in glass vial
The liquid formulation is approved by Health Canada, detailed below:
Existing WinRho SDF Lyophilized New approved SDF Liquid formulation

formulation composition
Each vial contains: Each vial contains:

Human Anti-D Immunoglobulin (in house) Human Anti-D Immunoglobulin (in house)
………300 mcg ………300 mcg
Glycine Ph. Eur/ USP……22.5 mg Maltose USP………………..0.135g

Saodium chloride Ph. Eur/ USP…..7 mg Ploysorbate 80 Ph. Eur/ USP…..0.39mg
Ploysorbate 80 Ph. Eur/ USP…..0.3mg Water for Injection Ph. Eur/ USP……QS *
Water for Injection Ph. Eur/ USP……QS *
* Removed by lyophilization.
The firm has submitted the following documents:
a. 5000 fee in respect of above application

b. Copy of registration letter along with renewal evidence.
c. USFDA Approval and CoPP issued by Health Canada for liquid formulation.
d. Specifications of new excipients.
e. Data of long term (36 months) and accelerated (6months) stability studies.
If approved by the board, we may direct the firm to apply afresh, as it is new dosage design. The case
is submitted for consideration of Board please.
Decision: Registration board did not acceed to the request of the firm for change of
formulation from lyophilized to liquid form of Winrho SDF injection (025216) as
present formulation is also approved by regulatory authority of Canada. However
firm was advised to apply fresh application with prescribed fee for new formulation/
dosage design.
Case No:12 Reditux TM Injection applied by M/s Macter International Limited
S. Name of Brand Name /Drug Dy No & Document Decision of RB

No Importer composition Date of details

& application/ (CoPP)
Manufactu Fee status/
rer Pack size/ Me too status
demanded Remarks
Price
1. Macter Reditux TM Injection Date of The reference Deferred for expert
Internationa 100mg Each 10ml application product is opinion of following
l (Pvt) vial 2.02.2011 Ristova by a. Brig (Retd),
Limited, contains :- Roche. Muzamil Hasain
Karachi. Rituximab (r-DNA Fee deposided The case was Najmi, foundation
origin)…............. 15000 (02-2- recommended Medical College,
Dr. Reddy’s 100mg 2011)+ in 48th ECBD Rawalpindi
Laboratorie (Antineoplastic 85000 (09-10- + b. Brig. Amir Ikram,
s Ltd., Monoclonal 2011) Biosimilarity AFIP, Rawalpindi.
Ranga Antibody). +PICS c. Dr. Masud-ur-
Reddy (For Human Use) Total. 100000 Copies of Rehman DDG,
District, COPP DRAP, Islamabad.
Hyderabad, Original Notarized Balance fee provided,
India. and Legalized GMP Nil valid up to 18-
certificate no. 12-2015.
259//M3B/2014 Structural
issued by Drug similarity of Bioequivalenc
Control subject e and efficacy
Administration, biological Clinical trials
Andhra Pradesh. Date product is data is
Of Issue 13/02/2014 available in submitted
and valid up to provided Safety
18/12/2015. COPP DMF by Studies
no. 2821/M3B/2014 manufacturer. Four years
for finished drug of Protein post marketing
strength 100 mg sequence is surveillance
issued by Drug compared data of 818
Control with WHO patients.
Administration, Govt. sequence.
of Andhra Pradesh. Animal
Original notarized toxicity
and Legalized. Valid studies are
up to 18/12/2015. available in
provided DMF
Indications: by
Non Hodgkin manufacturer
Lymphoma
Antineoplastic
Monoclonal

Antibody
2. Macter Reditux TM Injection Date of The reference Deferred for expert

Internationa 500mg Each 50ml application product is opinion of following
l (Pvt) vial 02.02.2011 Ristova by a. Brig (Retd),
Limited, contains :- Roche. Muzamil Hasain
Karachi. Rituximab (r-DNA Fee deposited The case was Najmi, foundation
origin)…...........… 15000+85000 recommended Medical College,
Dr. Reddy’s 500mg in 48th ECBD Rawalpindi
Laboratorie (Antineoplastic + b. Brig. Amir Ikram,
s Ltd., Monoclonal Balance fee Biosimilarity AFIP, Rawalpindi.
Ranga Antibody). Nil +PICS c. Dr. Masud-ur-
Reddy (For Human Use) Copies of Rehman DDG,
District, COPP DRAP, Islamabad.
Hyderabad, COPP no. provided,
India 2381/M3B/2014 valid up to 18-
issued by Drug 12-2015.
Control
Administration, Govt. Animal Bioequivalenc
of Andhra Pradesh. toxicity e and efficacy
Date Of Issue studies Clinical trials
22/03/2014. Valid up are available data is
to 18/12/2015. in provided submitted
Original notarized DMF by Safety
and Legalized manufacturer Studies:
Four years
post marketing
surveillance
Indications: data of 818
Non Hodgkin patients.
Lymphoma
Antineoplastic
Monoclonal
Antibody
1. EXPERT OPINIONS
BY BRIG. (Retd) PROF MUZAMIL HASAN NAJMI, ON PRODUCTS
(BIOLOGICAL) OF M/S MACTER INTERNATIONAL, KARACHI.
Rituximab is a chimeric monoclonal antibody produced by recombinant DNA technique.

It reacts with the CD20 protein present on the surface of B lymphocytes which are thus
destroyed. Reduction in the number of B lymphocytes results in decreased antibody production
by these cells.

The drug is approved for treatment of certain leukemias and lymphomas including non-
Hodgkin’s lymphoma. It is also used in some of the autoimmune diseases. It is a disease
modifying drug for rheumatoid arthritis, particularly refractory to other treatments.
The drug can cause several adverse effects which include severe reaction after administration as
infusion, cardiotoxicity, lung toxicity, tumor lysis syndrome and reactivation of viral infections
including hepatitis B. However, keeping in view the nature of diseases in which it is used, the
benefit/risk ratio is favorable.
M/S Macter International, Karachi has applied for registration of the brand of Rituximab
which is of Indian origin. The manufacturer, Dr. Reddy’s Lab has provided details of
manufacturing method and biosimilarity studies of their product, Reditux TM injection 100 and
500 mg. The Company has obtained cGMP compliance certificates from USFDA and MHRA of
UK. Having reviewed the data provided, I am of the opinion that both strengths of Reditux TM
injection may be approved so that a cost-effective alternative brand of this drug may become
available for the patients.
2. EXPERT OPINION BY DR. MASUD UR REHMAN, DDG, DRAP ON

BIOLOGICAL PRODUCT OF M/S MACTER INTERNATIONAL, KARACHI
Introduction:
Rituximab a long chain monoclonal antibody is produced by recombinant DNA
technique. Having site of action on CD20 protein present on the surface of B lymphocytes. It
binds there and destroys B Lymphocytes cancerous cell. Reduction in the number of B
lymphocytes results in decreased antibody production by these cells. The drug is approved for
treatment of leukemias, lymphomas including non-Hodgkin’s lymphoma. It is also used in some
of the autoimmune diseases. It is a disease modifying drug for rheumatoid arthritis, particularly
refractory to other treatments.
Evaluation of Dossier:
Product dossier carries scientific data of structural characterization & comparability with
innovator product (Mabthera / Rituxan) in peptide mapping, intact protein mass, UV circular dichorism,
Disulphide bonding pattern by LC-MS. There is comparability / similarity of structure in high order
structure by fluorescence spectroscopy, thermal stability by scanning calorimetric method, glycosialation
analysis by Reagent Array Analysis (RAAM), Charge isomers by IEF, SDS PAGE, SEC HPLC. Potency
is determined by CDC & ADCC. Specific binding of FCγR1, FCγRIIa, FCγRIIB, FCγRIIIa and FCγRn
regions by ELISA, SPR & FACS has also been done.
Pharmacokinetic studies:
Pharmacokinetic and extensive animal toxicology studies data is provided. Clinical efficacy trial
on Non Hodgkin Lymphoma (NHL) of stage II, III and IV patients has shown overall response of 93.8%.
Toxicity data is also provided which is in acceptable range. Four years post marketing safety data of 808
patients is also submitted.
Manufacturers Profile:

Manufacturer of Rituximab is Dr. Reddy’s Laboratories, India. Its a GMP certified manufacturer
by many international regulatory agencies such as Brazil, Peru, QP EU, GCC and Iran. The Company has
also obtained cGMP compliance certificates from USFDA and MHRA of UK.
Recommendations:
M/S Macter International, Karachi has applied for registration of the generic brand of Rituximab.
Reditux generic biosimiler injection may be approved so that a cost-effective alternative brand of this
drug may become available for the patients. Based on aforementioned evaluated specifications by M/S
Macter International, Karachi, the product registration is recommended.
3. Reply of Brig. Amir Ikram, AFIP, Rawalpindi
Thanks for referring the case of Reditux TM Injection 100mg and 500mg strength. Comments are as
below:
1. Product Safety: The provided literature shows that the preparation s are safe. Trials have
been conducted in the country f origin with satisfactory outcome. The manufacturer is following GMPs.
2. Efficacy; The clinical trials conducted in the contry of origin indicate that the
preparations are efficacious, however further evaliuation if requisite may be done.
3. The provided material indicates that the preparations are comparable to

published literature for innovator rituximab. The preparations are required and if probably not incorrect
not much of preparations are easily available within the country. Its transportation under requisite
parameters especially temperature has to be guaranteed by the company at all levels.
The three experts have recommended the products for registration. The case is submitted is before the
board for consideration as per import policy.
Decision: Registration Board considered the expert opinions and approved the registration of
Reditux Injection 500mg manufactured by Dr. Reddy’s Laboratories Ltd., Ranga
Reddy District, Hyderabad, India as per Import Policy for Finished Drugs and valid
legalized CoPP
Case No.13: Hepatitis B Vaccine applied by M/s Macter International Limited.
Following products of M/s Macter International Limited Karachi for local manufacturing were
deferred in the 257th meeting of Registration Board for confirmation of manufacturing facility.
S.#. Name of Brand Date of Documentary Remarks

Importer/Man Name application/Fee details
ufactruer /Composition status/price
1. Macter Biovac HB Out Dy No. 184 Me too a. Firm has

International dated 10.3.2014 submitted the
(Recombinant

Ltd. 216, SITE, Hepatitis B CoPP FSC
Karachi, Vaccine) and GMP of
Pakistan (Local 20000/- dated 21- Legalized bulk material
Manufacturer) 20 µg/ml 8-2013 CoPP No. 2- issued from
13-A1-1023 regulatory
Republic of body of
Korea Korea.
Bulk material Price. As per PRC
b. Under
source: finished
LG Life Product product
Sciences Korea. License No. specifications
213 dated 29- firm has
12-1994 provided, tests
of Physical
appearance,
aluminum
Legalized Free content,
sale certificate Potency by
No. 2013-A1- Elisa,
1022 dated 08- identification
5-2013 and purity by
SDS-Page,
endotoxin
bioburden and
Legalized GMP
sterility tests.
Dated 15-3-
2013 enclosed.
2. Macter Biovac HB Dy No.40 DDC Me too a. Firm has

International (BD) Dated 17-3- submitted the
Ltd. 216, SITE, (Recombinant 2014 CoPP FSC
Karachi, Hepatitis B and GMP of
Pakistan (Local Vaccine) Legalized bulk material
Manufacturer) CoPP No. issued from
10 µg/0.5ml Fee Rs. 20000/- 2015-A1-0917 regulatory
Dated 16-7- body of
Dated 21-8-2013 2015 Korea.
Bulk material b. Under
source: finished
LG Life Price: As per PRC Product product
Sciences Korea. License No. specifications
213 dated 29- firm has
12-1994 provided, tests
of Physical
appearance,
aluminum
Legalized GMP content,
No. 2015-F1- Potency by
0102 dated 09- Elisa,
4-2015 identification
and purity by

SDS-Page,
endotoxin
bioburden and
sterility tests.
The firm has submitted that:
Macter’s Biotech manufacturing license covers the formulation, filling and packing of
recombinant DNA technology products. Hepatitis B vaccine is also recombinant DNA technology protein
which is relevant to the license. Recombinant human hepatitis B antigen (rHBsAg) is a polypeptide
protein of 226 amino acid with molecular weight of 24 KDa produced by incorporating genes that code
for important antigens (HBV envelope proteins) into common baker’s yeast (Saccharomyces cerevisiae).
This polypeptide is similar in nature to any other biopharmaceutical products like Interferon alpha which
is 19Kda polypeptide.
This vaccine is entirely different to other categories of vaccines which contain live attenuated or
killed pathogenic organisms (fully or partially). Ready to fill bulk vaccine will be imported from LG South
Korea which is WHO qualified manufacturer for this vaccine (WHO letter for qualification is submitted.
Weblink of WHO site of prequalified manufacturers of rHBsAG is given. Formulated bulk will be
imported and Firm will do filling in vials with online sterile filtration. Details of availability of QC
equipments is attached. Firm has submitted quality & stability data of three batches manufactured
locally. ADC signed invoice of import of ready to fill bulk is provided. Firm’s Biotech manufacturing
license covers the formulation, filling and packing of recombinant DNA technology products. Hepatitis B
vaccine is also recombinant DNA technology protein which is relevant to the license.
Sr. Documents/ data as per Documents / data submitted by Remarks

no. requirement of DRB 246 Macter
1. Legalized GMP certificate Legalized GMP certificate by KFDA Notarized and legalized (by
of biological drug as issued on March 15, 2013. Pakistan embassy Soule, South
evidence that manufacturer Korea) GMP certificate Issued by
is an authorized Korea Food & Drug
manufacturer of that Administration
particular biological drug on March 15, 2013 is submitted.
in its country of origin
WHO pre-qualification letter
Issued by Coordinator quality,
safety and standard is submitted.
WHO prequalification certificate This product & manufacturer are
and Web link of WHO website included in the list of prequalified
link vaccines & manufacturer at WHO
https://extranet.who.int/gavi/PQ_W web link

eb/  https://extranet.who.int/gavi/PQ_W
for WHO prequalified vaccine eb/.
manufacturers included in GAVI
program is provided. Notarized and legalized (by
Pakistan embassy Soule, South
Legalized COPP certificate no. 2013- Korea) COPP certificate no. 2013-
A1-1023 issued on May 08, 2013 is A1-1023 issued on May 08, 2013
provided. is provided.
2. Structural similarity of Product characterization is performed Studies are performed by LG life
subject biological drug for comparability with WHO Sciences South Korea are
product (ready to fill bulk) reference standard of NIBSC Hep B available in provided CTD
with reference biological antigen & innovators product Engerix dossier.
product (innovator). B of GSK by SDS PAGE (mol. Wt.),
UV spectrophotometry
(identification), Circular Dichorism
(secondary structure), electron
microscopy (particle morphology),
gradient centrifugation (density),
gradient Centrifugation
(homogeneity), Tryptic digestion &
SDS Page, N Terminal sequence
(identity), C terminal sequencing
(identity), Amino acid composition,
thin layer chromatography
(phospholipid composition),
Antigenicity by ELISA (efficacy),
Size Exclusion Charmatography and
SDS page for purity,
3. Bio comparability studies Comparative analysis of locally Comparative studies of local
including identity testing to produced drug product with batches with innovators product
parent molecule, purity Reference medicinal product (Engerix Engerix B of GSK are provided.
testing, in vitro biological B).
activity / potency testing
and toxicity with support Identity: SDS PAGE
of IEF data, gel Purity: SDS PAGE
electrophoresis, western Potency: ELISA
blot and other analytical General safety tests
methods and stability Bacterial Endotoxin test, Sterility test
studies of finished drug. and abnormal toxicity test.
Real time stability studies for one
year and accelerated stability studies
for 6 months.
4. Others Animal toxicity studies and clinical Pharmacokinetics and toxicological
trial studies are submitted studies are provided.
Section 5.2 requires that dedicated nd self contained facilities for production of particular drug
shall be provided in addition to general facilities sch as highly sensitizing materials ( pencillins or biologicals

preperation, live microorganisams or cytotoxix substances or radio pharamaceuticals or veterinaray
immunological preparation or sterile products or for that matter such hihky active pharmaceutical products,
antibiotics, hormones, as may be identified by the CLB at any stage in order to minimize the risk of serious
medical hazards due to cross contamination, veterinary products contaioning ingrdients similar to those used for
human health and of the sane quality which can be manufactured in the same premises used for manfacture of
pharamacetical products.
It is also described under the above sub rule in exceptional cases of emergency, the prociple of campaign
working in the same facilities may be allowed provided that the specific precautions are taken nd necessary
validations are made.
It is submitted that a discussion was carried out with Licensing Division to discuss the manufacturing
facility for vaccines and other biological products should be separate or can be manufacutered in the same
biotech facility. The Licensing Divisin has desired to make a comprehensive and well thoughtfull delimitation
of manufacturing process being careied out, so the Biological Division and Licensing Division may come up
with comprehensive proposal in the light of existing legislation and international practices being adopted. It is
proposed that the board may allow adaptation of WHO guideline in this regard. (Annex-I)
The case is submitted before the Board for a discussion/delibration/direction on the subject issue by the
Registration Board.
Decision: Regiatration Board deliberated and deferred these applications that manufacturing and
quality control of biological products require specialized facilities and approval from the
Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have
already been granted registrations of various biological products for local manufacturing
(mostly therapeutic proteins). As theses firms have applied for registration for local
manufacturing of various biological products including rDNA products, Theraputic
protein, Monocronial antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the
Board decided to have opinion of licensing division DRAP regarding approved
manufacturing facilities (categories of biological products) of these firms and status of
already registerd biological drugs from these firms.
Case No.14: Cases of Import Veterinary Product Medivac ND G7B Emulsion and Medivac
Coryza T Suspension M/s Hilton Pharma, Karachi.
S.No Name of Brand Name & Dy No & Date Document Remarks Decision
. Importer & Composition of application details (CoPP)
Manufactur
er Fee submitted Me too status

Pack size
1. Hilton Medivac ND G7B Dy No. 196 Legalized Firm has Approved as per
Pharma (Pvt) Emulsion R&I dated 12- Certificate of submitted Import Policy
Ltd. 3-2014 Free Sale No. Legalized Free for Finished
13, Sector 15, Each dose (0.5ml) 10004/PL500/F/0 Sale Certificate, Drugs and valid
Korangi of vaccine contains 100000/- dated 2/2016 valid until GMP legalized CoPP.
Industrial inactivated 18-9-2013 January, 2021 Certificate,
Area, Newcastle disease Letter of
Karachi, virus MD15 strain Product authorization
Pakistan at least 50 PD 50 Pack Size Registration and Product
Kementan RI No. Stability Data.
Manufacturer Inactivated vaccine 500 ml D-13034471
: for poultry VTC
Name:
PT.MEDION
Legalized GMP
JI.Raya Certificate No.
Batujajar 29 086/MFJ/HK.340
cimareme, /F.5/08/11 Dated
Kabupaten 23-8-2011 until
Bandung- valid 23-8-2016
Indonesia
Authorization
Adress: Ji. Letter No.
Babakan RD/IJ/III/2016/C
ciparay No. 141 dated30-3-
282 Bandung 2016 from
40223 - Medion
Indoneshia Bandung-
Indonesia.
2. Hilton Medivac Coryza T Dy No. 543 Legalized Firm has Approved as per
Pharma (Pvt) Suspension R&I dated 04- Certificate of submitted Import Policy
Ltd. 6-2014 Free Sale No. Legalized Free for Finished
13, Sector 15, Strrength / 10004/PL500/F/0 Sale Certificate, Drugs and valid
Korangi Formulation 100000/- dated 2/2016 GMP legalized CoPP.
Industrial 04-6-2014 Certificate,
Area, Each 0.5ml dose Product Letter of
Karachi, contains: Registration authorization
Pakistan -Haemophillus Pack Size Kementan RI No. and Product
paragallinarum W D-14022729 Stability Data.
Manufacturer strain before 500 ml VTC.1
: inactivation
Name: ≥2x108.0 CFU/ml Legalized GMP
PT.MEDION -Haemophillus Certificate No.

paragallinarum 086/MFJ/HK.340
JI.Raya Spross strain before /F.5/08/11 Dated
Batujajar 29 inactivation 23-8-2011 until
cimareme, ≥2x108.0 CFU/ml valid 23-8-2016
Kabupaten -Haemophillus
Bandung- paragallinarum Authorization
Indonesia Modesto strain Letter No.
before inactivation RD/IJ/III/2016/C
Address: Ji. ≥2x108.0 CFU/ml 141 dated30-3-
Babakan 2016 from
ciparay No. Inactivated Medion
282 Bandung Suspension Bandung-
40223 - Vaccine Indonesia.
Indoneshia against
infectious
coryza
Case No.15: Deferred Cases of 257th Meetong of Registration Board of M/s Amson Vaccines
Pharma (Pvt) Ltd Rawalpindi (WHO Prequalified)
S.No Name of Brand Name / Date of Dicision of 257RB Documents Decision

Importer/Man Composition application/fe Meeting submitted by M/s
ufacturer e status/ Amson Vaccine
Price/pacsk Phamra, Islamabad
1. M/s Amson ComBE Five Dy No. 1216 Deferred for Legalized COPP No. Registration Board
Vaccines & (Suspension for R&I DRAP submission of COPP/RLA/DI/MDL/ approved the
Pharma (Pvt) Injection). dated 25-2- following documents HYD/2016 valid upto product as per
Ltd. Rawalpindi 2016 : 03-9-2017 import policy,
Pakistan
a. Sole agency Legalized GMP Import policy order
Diphtheria, agreement. Certificate No. (Ministry of
Tetanus, Fee Rs. b. Valid legalized Dis.No. Commerce) and as
Manufacturer Pertussis 100000/- CoPP. 10694/E(V)/TS/2015 per valid legalized
(Whole cell), dated 25-2- dated 04/9/2015 valid CoPP.
Hepatitis B 2016 for two years from the
(rDNA) and date of issue
M/s. Biiological WHO
Haemophilus
E Limited Type b prequalification
Conjugate Pack size: status shall be
Vaccine Legalized Sole verified at the time
1ml – Two Agency Agreement
18 / 1 7 3, (Adsorbed) dose of issuance of
Azamabad, dated 6thApril, 2016
registration letter.
Hyderabad, Each dose of submitted.
India-500 020. 0.5 ml contains:
Shelf life: 24

Diphtheria months, when
Toxoid : 25 Lf stored at 2-
(≥30IU) 8oC.
Tetanus toxooid
: 5.5 Lf
(≥60IU).
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal
BP : 0.01%
w/v
Pharmacologica
l group:
Vaccine
Vaccines & (Suspension for R&I DRAP submission of DI/BPN/Sec(Mfg)/CO approved the
Pharma (Pvt) Injection). dated 03-2- following PP /18.03.16-02 valid product as per
Ltd. Rawalpindi 2016. documents: up to 25-7-2016
Diphtheria, import policy,
Pakistan Submitted
Tetanus, a. Sole agency Import policy order
Pertussis agreement. (Ministry of
(Whole cell), Fee Rs. b. Valid legalized Commerce) and as
Manufacturer Hepatitis B 100000/- CoPP. Legalized GMP
per valid legalized
(rDNA) and dated 03-2- Certificate No. Dis
2016 No. 1610/M3B/2014 CoPP.
Haemophilus
Type b dated 26-7-2014 valid
M/s. Biiological WHO
Conjugate for two years from the
E Limited

Vaccine Shelf life: 24 date of issue. prequalification
(Adsorbed) months when Submitted status shall be
18 / 1 7 3, stored at 2- verified at the time
Azamabad, Each dose of 8oC.
Hyderabad, 0.5 ml contains: of issuance of
India-500 020. Legalized Sole registration letter.
Diphtheria Agency Agreement
Toxoid : 25 Lf Pack Size: 2.5 dated 7th April, 2016
(≥30IU) ml Five dose) submitted.
Tetanus toxooid
: 5.5 Lf
(≥60IU).
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal
BP : 0.01%
w/v
Pharmacologica
l group:
Vaccine
Vaccines & (Suspension for R&I DRAP submission of COPP/RLA/DI/MDL/ approved the
Pharma (Pvt) Injection). dated 10-3- following HYD/2016 valid upto product as per
Ltd. Rawalpindi 2016 documents: 03-9-2017 submitted
Diphtheria, import policy,
Pakistan
Tetanus, a. Sole agency Import policy order
Pertussis agreement. (Ministry of
Fee Rs. Legalized Sole

Manufacturer (Whole cell), 100000/- b. Valid legalized Agency Agreement Commerce) and as
Hepatitis B dated 10-3- CoPP. dated 6th April , 2016 per valid legalized
(rDNA) and 2016 submitted CoPP.
Haemophilus
M/s. Biiological Type b
E Limited WHO
Conjugate prequalification
Vaccine Pack size: Legalized GMP
Certificate No. Dis status shall be
(Adsorbed) 5ml – Ten No. verified at the time
18 / 1 7 3, dose 10694/E(V)/TS/2015 of issuance of
Azamabad, Each dose of
0.5 ml contains: dated 04-9-2015 valid registration letter.
Hyderabad, for two years from the
India-500 020. Diphtheria date of issue.
Shelf life: 24
Toxoid : 25 Lf months, when submitted
(≥30IU) stored at 2-
Tetanus toxooid 8oC.
: 5.5 Lf
(≥60IU).
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal
BP : 0.01%
w/v
Pharmacologica
l group:
Vaccine
4. Amson BEtt Dy No. 707 Deferred for Legalized COPP no. Registration Board

Vaccines & (R&I) DRAP submission of COPP approved the
Pharma (Pvt) Dated 03-2- following /RLA/DI/MDL/HYD/ product as per
Ltd. Rawalpindi (Adsorbed 2016 documents: 2016 valid upto 20- import policy,
Pakistan Tetanus 10-2016 from Govt of
Vaccine a. Sole agency Import policy order
Telangana submitted.
[Tetanus agreement. (Ministry of
Toxoid Fee Rs. b. Legalized valid Commerce) and as
Manufacturer Vaccine] 100000/- CoPP or Free per valid legalized
Sale Certficate Legalized GMP
Dated 03-2- CoPP.
Each 0.5 mL of and GMP Certificate NO. L.Dis
vaccine 2016 certificate. No.
M/s Biological WHO
contains: 8010/AB/(M3)/TS/20
E Limited prequalification
14 dated 21-10-2014
Tetanus valid for two years the status shall be
Toxoid……..≥4 Ten dose vial
date of issuance verified at the time
0 IU of 5ml
18/1&3, of issuance of
Azamabad, registration letter.
Adsorbed on
Hyderabad – Aluminium Legalized Sole
INDIA, 500 020 Phosphate Agency Agreement
(AIPO4)……. dated 07-4-2016
≥1.5 mg submitted
Preservative:
Thiomersal
BP…….0.01%
w/v
Pharmacolgical
group:
Vaccine
Indications:
For active
immunization
against tetanus
in adults,
children and
infants.
5. Amson BEtt Dy No. Deferred for Legalized COPP No. Registration Board
Vaccines & 1215(R&I) submission of COPP/RLA/DI/MDL/ approved the
Pharma (Pvt) (Adsorbed DRAP Dated following HYD/2016 valid upto product as per
Ltd. Rawalpindi Tetanus 25-2-2016 documents: 20-1—2016 submitted
Vaccine import policy,
Pakistan
[Tetanus a. Sole agency Import policy order
Toxoid agreement. (Ministry of
Vaccine] Fee Rs. b. Legalized valid Legalized Sole Commerce) and as
Manufacturer 100000/- CoPP or Free Agency Agreement
th per valid legalized
Each 0.5 mL of Sale Certficate a dated 7 April, 2016 CoPP.
vaccine Dated 27-01- and GMP

M/s Biological contains: 2016 certificate. submitted. WHO
E Limited prequalification
Tetanus
status shall be
Toxoid……..≥4
0 IU Single dose Legalized GMP verified at the time
18/1&3, vial of 0.5ml Certificate No. Di. of issuance of
Azamabad, Adsorbed on No, registration letter.
Hyderabad – Aluminium 8010/AB/(M3)/TS/20
INDIA, 500 020 Phosphate 14 dated 21-10-2014
(AIPO4)……. valid for two years
≥1.5 mg from the date of issue.
Submitted
Preservative:
Thiomersal
BP…….0.01%
w/v
Pharmacolgical
group:
Vaccine
Indications:
For active
immunization
against tetanus
in adults,
children and
infants.
Case No. 16. Deferred case of 256 Meeting of Registration Board for expert opinion
M/s Marush (Pvt) Limited, Lahore
M/s Marush (Pvt) Limited, Lahore has applied for the registration of following biological products
which were considered in the 256 th meeting of Registration board. The board deferred the request of
the firm for expert opinion.
Name of Manufacturer Name of product & composition
Vaxxinova GmbH Anton- Cevac new Flu H9 K

Flettner-Str. 6 27472 Each dose contains:-

Cuxhaven, Germany Atleast 109.0 EID50 of inactivated Newcastle disease Virus (strain
Distributed by: CEVA SANTE LaSota) and atleast 108.0 EID50 Avian Influenza Virus (strain
ANIMALE 10 avenue de la H9N2), suspended in the amnio-allantoic fluid from embryonated
Ballastiere Libourne, 33500 SPF hen’s eggs.
France
Laboratories Hipra S.A.Avda. Hipraviar SHS
La Selva Amer (Girona) Spain. Each dose contains:
Live Turkey Rhinotracheitis Virus, strain 1062---------≥102.4
TCID50
Excipiants q.s……….0.03 ml
-do-. Hipraviar B1/H120

1 dose contains:
Live Newcastle disease (ND) Virus, strain B1………….105.5
EID50
Live infectious bronchitis (IB) Virus, strain H120…………..
………….103 EID50
The Reply of experts is as under:
Reply of Dr. Iftikhar Hussain
Based on the data provided in the respective dossiers, the products seem to contain the
required antigenic masses of the respective viral strain present in the product for effective amount of
antibody productions, the above mentioned products may be considered for registration.
Reply of Dr. Muhamad Khalil
In the light of current local epidemiology Newcastle (ND), infectious bronchitis (IB) are
the mostprevalent diseases in local commercial layer, broiler & breeder farms, whereaa swollen head
syndrome (SHS) is common disease problem of commercial layer & breeding flocks. All types of
chickens in Paksitan are being vaccinated regularly against these diseases through similar combinations as
of the subject vaccines. It is also cited in the literature that similar vaccines are also carried out in
Pakistan and world wide where commercial poultry is grown.
Keeping in view the local epidemiology, data presented and review of the literature. I feel
the subject veterinary biologics are suitable for prevention of above cited diseases.
Therefore, I recommend to register these vaccines in Pakistan.
Reply of Dr. Masood Rabbani, UVAS, Lahore is still awaited
The case is submitted before the board for consideration please.
Decision: Registration Board considered the expert opinions and approved the registration of
Cevac new Flu H9 K, Hipraviar SHS, Hipraviar B1/H120 vaccine
Case No.17. Deferred Cases of 257th Me too of Registration Board of Sanofi-Aventis Pakistan
Limited, Karachi

Name of Brand Name / Date of Dicision of Documents Decision
Importer/ Composition application/fee 257RB Meeting submitted by
Manufactu status/ Price/pacsk Sanofi-Aventis
rer Pakistan Limited,
Karachi
Sanofi- THYROGEN Application submit Deferred for The firm has The Product is
Aventis (R&I) Section dated submission of submitted USFDA approved,
Pakistan (Thyrotropin following: Legalized so Registration
Limited, alfa, 09-6-2014 Board approved
Karachi thyrotropin a. Legalized COPP No. 04- the registration of
alfa for CoPP/ GMP 0013-2014-02-PK product as per
Product injection) & Free Sale Dated 29/4/2014
Fee Rs. 100000/- Certifcate. import policy and
License valid legalized
b. Orignal sole
holder (also Dated 09-6-2014 agency CoPP.
packager, agreement.
Each vial Product License
labeler & c. Stability data
contain 1.1mg Holder No. 20-898
batch of finished
thyrotropin To be submitted at dated 30-11-1998
release): product.
alfa (Each 1 time of price fixation/
Genzyme ml contains box of 2vials.
Corporatio 0.9 mg/ml of GMP Certificate
n, 11Forbes thyrotropin No. UK GMP
Road, alfa when 24655 Insp GMP
Northborou reconstituted 22907/37128-0005
gh, MA with 1.2 ml [H] dated 31-12-
USA water for 2012.
injection)
Manufactur
er:
The stability data
Hospira Pharmacologic has also been
Inc. 1776 al group: submitted.
North Pituitary and
Centennial Hypothalamic
Drive Hormones and
McPherson, Analogues,
KS
67460USA Shelf life:
three years.
Case No.18: Deferred Cases of M/s Acumen Pharmaceuticals Rawalpindi in the 258 th meeting of
Registration Board

Following product of M/s Acumen Pharmaceuticals Rawalpindi, are deferred in the 258 th
meeting of registration board for submission of valid legalized CoPP from country of origin and if not
available in the country of origin, then valid reason thereof.
Sr. No Name of Brand Name Type of Form Document Remarks Decision of

Importer & & details 258th RB
Manufacturer Composition Dy No & Date (CoPP)
of application/
Fee status/ International
Avalaibality
Pack size/
demanded Me too
Price status
1. Acumen DICLAIR Dy No. 258 Legalized Legalized Deferred for
Pharmaceutical HP-HCG dated 13-1-15 /original CoPP of submission of
s, For Injection COPP NO Belgium valid legalized
Rawalpindi Rs. 100000/- 109-07-14 submitted CoPP from
Each vial dated 13-1- dated 19-7- Product is country of origin
BBT Biotech contains: 2015 2014 of not and if not
GmbH Arnold Human Federal available available in the
Sommerfeldrin Chorionic Price 1500/vial Agency 97 in the country of origin,
g Gonadotopin Medicine and country of then valid reason
28 ………….50 health origin . thereof.
52499Baeswile 00IU Belgium. ( declared
r for
Germany. Treatment of Me too export).
an ovulatory Molecule
infertility is me too.
Shelf life 36
months
2. Acumen DICLAIR Form 5A COPP No. Legalized Deferred for
Pharmaceutical HP-FSH 209-07-14 CoPP of submission of
s, Each vial Dy No. 260 dated 19-7- Belgium valid legalized
Rawalpindi contains: dated 13-1- 2014 (Copy submitted CoPP from
2015 submitted) Product is country of origin
BBT Biotech Folical Federal not and if not
GmbHArnoldS stimulating Rs. 100000/- Agency 97 available available in the
ommerfeldring Hormone dated 131-15 Medicine and in the country of origin,
28 75IU health country of then valid reason
52499Baeswile Beljium. origin. thereof.
r Induction of Price 1500/vial (declared
Germany. ovulation for
export).

Shelf life: 36 Molecule
months is me too.
3. Acumen DICLAIR Dy No. 259 Legalized Legalized Deferred for
Pharmaceutical HP-HMG dated 13-1-15 /original CoPP of submission of
s, Each vial COPP NO Belgium valid legalized
Rawalpindi contains: Rs. 100000/- 1023-12-14 submitted CoPP from
Folical dated 131-15 dated 23-12- Product is country of origin
BBT Biotech stimulating 2014 of not and if not
GmbHArnoldS Hormone Federal available available in the
ommerfeldring 75IU Price 1500/vial Agency 97 in the country of origin,
28 Medicine and country of then valid reason
52499Baeswile Luteinizing health origin . thereof.
r hormone Beljium ( declared
Germany. 75IU for
export).
Shelf life: 36 Molecule
months is me too.
The firm has submitted a letter from BBT Bio Tech GmbH Germany that the above products are
not marketed in European markets yet, as there was no economical interest for that.
All registration s made in our home market, are only of interest in case the product can have a
status of reimbursement. The social security of western European countries were not reimbursing the
human gonadotrophin until recently.
As European authorities do change the rules of re-imbursment, giving our products

(gonadotrophin) an economical reason to be registered, we can inform that we are now starting MRP
registration process. This process will take some time as we will then cover all countries of the ECC.
Therefore we can conclude that BBT-Biotech GmbH is starting now registration procedures for,
consecutively, HMG, HCG and FSH, throughpartners and /or in direct form.
Our manufacturing sites/facilities are fully GMP/WHO approved. All necessary authorizations are
available including the CPP format declaring that sales on export are allowed by our Ministry of Health.
Decision: Registraion Board considered the request of the firm. The reason submitted by the firm
for non registration of products in country of origin was from the manufacturer and not
from the regulatory body. The board is of the view that the reason is not sufficient for
granting registration. The board deferred the products till registration in the country of
origin as per policy
Case No. 19 Deferred case of 258th Meeting of RB M/s LDS (Pvt) Ltd Rawalpindi.
Sr. Name of Brand Name & Type of Form Document Decision of Decision
No Importer & Composition details (CoPP)/ 258th Meeting
Manufacturer of RB /

Dy No & Date of International Remarks
application/ Avalaibality/ Me
too status
Fee status/
Pack size/
demanded Price
1. M/s LDS (Pvt) PEDA TYPH Dy No. 502 dated Legalized COPP Defered in Deferred for
th
Ltd Vaccine single 22-1-15 NO. 258 RB submission of valid
Rawalpindi. dose vial Drug/837/403 meeting for legalized CoPP/
valid upto 23-1- confirmation FSC and GMP,
2016 from India of formulation evidence of
Rs. 50000/- dated
in reference approval of product
M/s BioMed Each dose vial 22-1-2015
drug agencies in reference
Pvt Ltd C-96 0.5ml contains:
Single dose vial and agencies and WHO
site No.1
5ug of Vi Rs.495/- submission of prequalification
Bulandshar
polysaccharide valid legalized status as per import
Road Industrial
of Salmonella CoPP. policy order for
Areal
typhi conjugated importibilty from
Ghaziabad UP The firm has India
India. to 5ug Tetanus
submitted only
toxoid protein in
legalized free
isotonic saline
sale certificate.
0.5ml.
Confirmation
Immunization
of fee is
against
required
salmonella in
infants of age ≥
6 months
children and Approval of
adults product in
reference
Shelf Life agencies is
36months required.
2. M/s LDS (Pvt) Bio Typh Form 5-(A) Legalized COPP The firm has Deferred for
Ltd No. submitted only submission of
Rawalpindi. Drug/837/403 legalized free following
dated 23-1-2016 sale certificate.
(Tphoid vaccine) Date of application a. Valid legalized
from India.
CoPP/ FSC and
Single dose 53 DDC (BD) dated GMP,

M/s BioMed vial , Multi (5) 22-1-16 b. WHO
Pvt Ltd C-96 dose vial prequalification
site No.1 Product License Confirmation status as per
Each dose of No. 05/LVP/Sera of fee is import policy
Bulandshar
(0.5 ml) Fee deposited; & Vaccines/2004 required orders for
Road Industrial importibilty from
contains: Vi Rs.50000/- dated dated 20-5-2004
Areal India.
polysaccharide 20-1-2016
Ghaziabad UP c. Clarification
India. of Salmonella from the firm for
MHRA
typhi (strain selection of pack
Free sale approved
ty2)-25mcg Demande price; size.
certificate No.
Isotonic saline single dose vial Drug/837/37
I.P. q.s.- 0.5ml Rs.160/- and Multi dated 16-1-2015
dose vial Rs. 525/- from the country
Proposed dosage
of origin
a. For adults :
0.5 ml Pack size:
b. Children by Letter of
1. Single dose vial
age group : 0.5 authorization No.
ml (after 2 years 2. Multi (5) dose BM/PK/LDS/BT/
of age) vial 071015 dated 07-
10-2015 from the
c. Infants & country of origin.
special groups :
Not
recommended
Pharmacological
group: Vaccine
Route of
administration :
Intramuscular or
subcutaneous
Clinical use:
Recommended
for prevention of
typhoid fever.
Case No.20 Case of M/s. Graton Pharma, Karachi for registration of Interferon Alfa 2B
3000IU /Vial (Lipheron from Beijing Shanglu, China) along with diluent.
The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration of
Interferon Alfa 2b 300MIU injections 22.6. 2011. The request consider in 256 th Registratin Board meeting
and deferred for expert opinion. The product details is as under;

S.No Company Name of Name of Date of Documentary
Name Manufacturer Products application / Details
Fee status
1. M/s Graton Beijing SL Recombinant Date of CoPP No.

Pharma office # Pharmaceutical Human application 20150204 dated
102, First Co., Ltd. Interferon alfa 2b 10-2-2015
Floor, The for injection
Plaza, Block-9 No.9.
Clifton, Zhongyuan Strength: 3M
Road, Badachu IU/vial Prod License No.
Karachi. Fee Deposited
High Tech. S20100501 dated
Park, 18-9-2010.
Rs.15000/-
Shijingshan dated 22-6-2011
District, + 35000/- dated
Beijing, 09-10-2012+ GMP Certificate
P.R.China 50000/- dated No. CN
11-6-2015 20130327
DATED 31-10-
2013
Free Sale
Certificate No.
2015-14 dated
02-1-2015
validity 02 years.
The firm has now submitted the legalized CoPP No . 20150204 dated 10-2-2015 Prod License No.
H20100501 dated 18-09-2010. Submitted for consideration of Registration Board please.
Decision: Registration Board considered the case and referred the above application of the firm for
expert opinion by following experts:
a. Brig (R), Muzamil Hussain Najmi, Member Registration Board.

b. Brig. Amir Ikram, AFIP Rawalpindi.
c. Dr. Masud-ur-Rehman, DDG, DRAP, Islamabad.
Inspection of the manufacturer abroad can be conducted after the expert opinion.
Expert Opinions are as under:
1. EXPERT OPINION OF BRIG. AAMER IKRAM, AFIP,

RAWALPINDI

Thanks for referring the case; comments are as below:
1. Product Safety:
The Preparation seems to be safe. The original manufactures is following GMPs. Toxicological
reports after testing are also attached and are satisfactory. Post market surveillance is also satisfactory.
2. Efficiency:
The provided literature shows that the preparation is efficacious. The trials have been conducted
in the country of origin. Further trials may be done here if required.
3. Themolecular descriptin seems satisfactory. The preparation is required; however its

transportation under requisite parameters especially temperature has to be ensured by the company at all
levels.
2. EXPERT OPINION OF DR. MASUD UR REHMAN, ADDITIONAL DIRECTOR

(BIOLOGICAL DIVISION) DRAP, FOR (LIPHERON) INTERFERON ALPHA
2B 3000 IU OF M/S GRATON PHARMA, KARACHI, IS AS UNDER:
Introduction:
Human interferon-α 2a or 2b are well-known characterized proteins consisting of 165
amino acids. The non-glycosylated protein has a molecular weight of approx. 19,240 KD. It
contains two disulfide bonds, one between the cysteine residues 1 and 98, and the other between
the cysteine residues 29 and 138. The sequence contains potential O-glycosylation sites. Physico-
chemical and biological methods are available for characterisation of the proteins. Recombinant
IFN-α 2a or 2b is approved in a wide variety of conditions such as viral hepatitis B & C,
leukaemia, lymphoma, renal cell carcinoma and multiple myeloma. It is used alone or in
combination in oncology indications. Interferon-alpha may have several pharmacodynamic
effects. The sub-types Interferons alpha 2a and 2b have different clinical use. In general,
interferon-α 2a or 2b use in oncology indications has reduced considerably had been superseded
by other more effective specific treatments. Treatment with recombinant interferon alpha 2a or
2b is associated with a variety of adverse reactions such as flu-like illness, fatigue, and myalgia.
A variety of immunemediated disorders such as thyroid disease, rheumatoid arthritis, systemic
lupus erythematosus, neuropathies and vasculitis have been observed with r-IFN-α.
Pharmacology of Product:
The product Lipheron is produced by Beijing SL Pharmaceutical Company, it has provided general
pharmacological action studies at (P 50) which are line with documented action of product as mentioned
in intrduction. Interferon induce pleiotropic biologic responses which include antiviral, antiproliferative,
and immunomodulatory effects, regulation of cell surface major histocompatibility antigen (HLA class I
and class II) expression and regulation of cytokine expression. Company has provided antiviral activity
studies done in vivo using chi cell model (P 65).

Pharmacokinetics:
The pharmacokinetic properties of Interferons were evaluated in normal, healthy volunteer
subjects after subcutaneous injection of 1 mcg, 3 mcg, or 9 mcg Interferons. Plasma levels of
interferon after subcutaneous injection administration of any dose were too low to be detected by
either enzyme-linked immunosorbent assay (ELISA) and by inhibition of viral cytopathic effect.
Antiviral Activity in Cell Culture:

The antiviral activity of interferon against HCV or HCV-derived replicons in cell culture has
been studied and were upto mark.
In vitro studies:
In order to compare any alterations in reactivity between the similar and the reference
medicinal products, data from a number of comparative bioassays (e.g. receptor-binding studies,
antiviral effects in cell culture, antiproliferative effects on human tumour cell lines), is provided.
Standardised assays are used to measure activity and potency (p 65).
In vivo studies:
To support the comparability exercise for the sought clinical indications, the
pharmacodynamic activity of the similar biological medicinal and the reference medicinal
products quantitatively compared is provided:
An appropriate pharmacodynamic animal model (e.g. evaluating effects on

pharmacodynamic markers of serum 2´,5´-oligoadenylate synthetase activity) are provided.
Pharmacodynamic measurements are performed as part of repeat-dose toxicity studies. &
provided (P 64). Toxicological studies data from toxicity study in a relevant species is provided.
The study is performed in accordance with the requirements of the “Guideline on similar
biological medicinal products containing biotechnology-derived proteins as active substance. A
guidance for assessing systemic exposure in toxicological studies is provided. (P 62- 67)
• Data on local tolerance is also provided in accordance with the guidance on non
clinical local tolerance testing of medicinal products.
• Safety pharmacology, reproduction toxicology, mutagenicity and carcinogenicity
studies are also provided.
Clinical Studies:
Company provided phase II clinical trial to evaluate safety & tolerability in HCV patients
(page 41) conclusion was that it is well tolerated. Company has provided phase II clinical trial to

determine maximum tolerated dose in renal cell cancer patients (P 23). Company has provided
phase III clinical trial in patients suffering from HBV, results and are in line with innovators (P
1-22). Company provided Phase IV clinical trial in patients suffering from HCV results are in
line with innovators (P 33). Company provided post marketing surveillance data which is in line
with published results of innovator on (P 44).
Pharmacovigilance plan:
Company has provided a risk management programme / pharmacovigilance plan in
accordance with current WHO legislation and pharmacovigilance guidelines. Attention has been
paid to immunogenicity and potentially rare and/or delayed serious adverse events, especially in
patients undergoing chronic administration. Company also provided product recall system 74-
78).
1) Safety of Lipheron;
Company has provided following studies. Single dose toxicity data on mice. Repeat dose
toxicity data on rats. Repeat dose toxicity data on Dogs. Genotoxicity & mutagenicity
studies. Phase II human studies. Phase II human studies to determine maximum tolerated
dose.
2) Efficacy of Lipheron;
Company has provided following studies. Post marketing surveillance studies. Phase III
trail. Multi-center study to determine efficacy. Phase IV study to demonstrate efficacy &
safety, Phase II human studies. Phase II human studies to determine maximum tolerated
dose
Structural Comparative Studies with Innovator:
The company has done purity studies by Chromatogram of purity by HPLC. UV

Spectrum of Stack Spectra Image report. QC reort showing molecular weight, bands and
standered lines. Isoelectric focusing spectrum, Peptide mapping and host cell DNA test has been
done.
Administrative documents’ showing legalized GMP, evidence that manufacturer is

authorized manufacturer in country of origin. The provided credentials show that Graton Pharma
is their authorized agent. Provision of bio-comparability studies including identity testing to
parent molecule, purity testing, in vitro biological activity, clinical studies, stability studies of
product, and certificate of analysis of finished product.
After detailed evaluation it is found that product is safe & have efficacy in different
indications of (Recombinant Human Interferon Alpha 2 b) and shall be cost effective to poor
patients. Moreover result of Structure Comparison Studies is similar with Innovator Intron A.
The authenticity of data / documents / adapted protocols cannot be verified here. At the
time of inspection of the firm, the authenticity of all provided documents, their systems /

protocols of manufacturing / quality control / abnormal toxicity etc need to be evaluated on spot
through vigilant inspection. The CoPP and GMP certificates legalized and notarized however
confirm the availability of product in country of origin. Lipheron (interferon alpha 2 b 3000 IU)
is hereby recommended for consideration of registration based on provided documents.
3. THIR EXPERT OPINION OF BRIG (R), MUZAMIL HUSSAIN NAJMI,

MEMBER REGISTRATION BOARD, DRAP, IS STILL AWAITED.
Decision: Registration Board considered the expert opinions. The third expert Brig. Muzamil
Hssain Najmi, whose reply was still awaited, also agreed to recommendations of
other two experts. Based of the recommendations of all three experts, Registration
Board approved the registration of Lipheron Injection (Recombinant Human
Interferon alfa 2b for injection 3M IU vial) manufactured by M/s . Beijing SL
Pharmaceutical Co., Ltd. No.9. Zhongyuan Road, Badachu High Tech. Park,
Shijingshan District, Beijing, P.R.China as per import policy and valid legalized
CoPP. The firm shall also submit separate Form 5A, fee and CoPP for registration
of diluent.
Case No.21 DEFERRED CASE IN 257TH MEETING OF RB (DENGVAXIA, POWDER AND

SOLVENT FOR SUSPENSION FOR INJECTION (DENGUE TETRAVALENT
VACCINE (LIVE, ATTENUATED). M/S SANOFI-AVENTIS PAKISTAN
LIMITED, KARACHI
S. Name of Brand Dateof Documentary Decision of 257th

No Importer/Manfa Name/Composi application/Fee details RB Meeting
. cturer tion status/
Packs/Price
1. Sanofi-Aventis DENGVAXIA, Dy No. 940 (R&I) COPP NO. Deferred for

Pakistan Limited, powder and dated 16-2-2016 2016010813450 evaluation of
Karachi solvent for 4 Dated 25-1- clinical data by
suspension for 2016 FDA following experts:
Injection Republic of
Fee Rs. 200000/- a. Maj. Gen.
Philippines.
Manufacturer (Dengue dated 15-2-2016 Muhammad
tetravalent for powder and Aslam, Member
solvent Registration
vaccine (live,
Product License Board.
Sanofi Pasteur attenuated). b. Dr. Huma,
No. BR-1128
Parc Industrial PMRC,
Dated 22-12-
Incarville, 27100 MRP 9500/- per Islamabad.
2015 c. Represenrative
Val de Reuil One dose (0.5 dose
France. of malaria
ml) contains: control, WHO
Pakistan,
CYD dengue GMP Certificate
Pack size: Islamabad.
virus No.

Final release site: serotype1,2,3,4 HPF/FR/222/20
………….each 15 Dated 05-10-
4.5-6.0 log10 1. Powder (1 dose) 2015
CCID50/dose in vial + 0.5 ml of
Sanofi Pasteur solvent in pre- France
NVL 31-33 quai filled syringe with
Armand Barbes 2 separate needles
69250 Neuville- Pharmacologica (pack size of 1).
sur-Saone l group:
France.
ATC code:
J07BX 2. Powder (1 dose)
in vial + 0.5 ml of
J solvent in pre-
(ANTINEFECT filled syringe with
IVES FOR 2 separate needles
SYSTEMIC (pack size of 10).
USE) 07
(VACCINES) B
(VIRAL
VACCINES) X
(OTHER viral
vaccines)
2. Sanofi-Aventis DENGVAXIAT Dy No. 941 (R&I) COPP NO. Deferred for

Pakistan Limited, M
MD, powder dated 16-2-2016 2016010813450 evaluation of
Karachi and solvent for 1 Dated 25-1- clinical data by
suspension for 2016 FDA following experts:
Injection Republic of
Fee Rs. 200000/- a. Maj. Gen.
Philippines.
Manufacturer: (Dengue dated 15-2-2016 Muhammad
tetravalent for powder and Aslam, Member
solvent Registration
vaccine (live,
Product License Board.
Sanofi Pasteur attenuated). b. Dr. Huma,
No. BR-1129
NVL 31-33 quai PMRC,
Dated 22-12-
Armand Barbes MRP 9500/- per Islamabad.
2015 c. Represenrative
69250 Neuville- One dose (0.5 dose Pack size:
sur-Saone of malaria
ml) contains: control, WHO
France.
Pakistan,
CYD dengue GMP Certificate
1. Powder (5 Islamabad.
virus No.
doses) in vial +
serotype1,2,3,4 HPF/FR/222/20
2.5 ml of solvent
………….each 15 Dated 05-10-
in vial (pack size
4.5-6.0 log10 2015
of 5).
CCID50/dose
NVL SITE,

France.
Pharmacologica
l group:
ATC code:
J07BX
J
(ANTINEFECT
IVES FOR
SYSTEMIC
USE) 07
(VACCINES) B
(VIRAL
VACCINES) X
(OTHER viral
vaccines)
1. EXPERT OPINION OF DR. HUMA QURESHI, EXECUTIVE DIRECTOR,

PMRC, ISLAMABAD IS AS UNDER:
The 1st dengue vaccine is produced by Sanofi and is licensed and being used in Mexico. It is also
available on WHO website. Its phase 3 tgrials have been published in New England Journal of Medicine.
The vaccine is given in 3 doses at 0,6,12 month’s interval and has shown excellent protection in
various dengue serotypes. For serotype 4, protection was seen in 77% for serotype 3 it was 71%, for type
2 it was 43% and for type 1 it was 54%.
Pakistan has been facing outbreaks of dengue infection since many years and each outbreak
causes large morbidity, additional hospitalization cost and some ortality. Panic during outbreak causes
huge out of pocket spending for undergoing various tests and treatments.
Evidence shows tht exposure to dengue and its recovery does not protect the individual from
second exposure, in fact 2nd exposure makes the patient more vulnerable to complications like bleeding,
shock and death.
A national study done all over Pakistan by Pakistan Medical Research Council in 2013, showed
that 32% population who had no history of suffering from dengue fever had actually suffered from
dengue fever, as seen by the presence of IgG antibodies in their blood. It can be stipulated from this study
that a large population of Pakistan is vulnerable to dengue complications in every new outbreak.
It is therefore strongly recommended that dengue vaccine may be registered in Pakistanfor

future ude and protection of the population.
2. EXPERT OPINION OF SYED KHALID SAEED BUKHARI, COUNTRY

ADVISOR MEDICINE & HEALTH PRODUCTS, REPRESENTATIVE OF WHO
PAKISTAN IS AS UNDER:

As you are aware that Dengue is a major health burden all across the world, which can
affect anyone regardless of age, sex, underlying health, or socioeconomic status.
Pakistan is now considered Endemic for Dengue, and in order to limit Dengue, and
integrated approach is optimal for prevention and contro of Dengue. Vector-control efforts prove
to be unsustainable in preventing dengue disease; this gives rise to a need for the inclusion of a
safe and effective dengue vaccine in Countries endemic with Dengue disease.
During the Q & A session with WHO in 2014, WHO commente4d that a safe, effective
and affordable dengue vaccine would repreent amajor advance for the control of the disease and
could be an important tool for reaching the WHO goal of reducing Dengue morbidity by at least
25% and mortality by at least 50% by 2020.
In March 2016, WHO Strategic Advisory Group of Experts on Immunization (SAGE)

issued recommendations on Dengue vaccine that supports the use of the vaccine in endemic
countries. The SAGE recommendations provide important validation of the efficacy, sfety,
quality and potential public health value of the existing Dengue vaccine.
Based on the SAGE recommendations and the WHO initiative to control Dengue, it is
theefore essential that Dengue vaccine is introduced in Pakista in ordr tolimit the burden of
Dengue outbrteaks in the country.
The pricing of the Dengue vaccine should be as per the DRAP regulatory rules.
3. THIRD EXPERT OPINION OF MAJ. GEN. MUHAMMAD ASLAM, MEMBER

REGISTRATION BOARD, DRAP, IS STILL AWAITED.
Recommendations of WHO Strategic Advisory Group of experts (SAGE):
The World Health Organization (WHO) Strategic Advisory Group of Experts

(SAGE) on Immunization today issued recommendations on the use of the first licensed
dengue vaccine. SAGE recommends countries consider introduction of CYDTDV, also
known as Dengvaxia®, only in geographic settings (national or subnational) where
dengue is highly prevalent. SAGE recommends that vaccination should be considered as
an integrated strategy together with a communication strategy, well-executed and
sustained vector control, the best evidence-based clinical care for all patients with
dengue, and robust dengue surveillance.
Dengue, also known as “breakbone fever,” is the most common mosquito-borne
viral disease. Dengue causes about 390 million infections each year, putting at risk nearly
half of the world’s population. To date, no specific treatment for dengue exists.

Dengue vaccines have been under development since the 1940s. In late 2015 and
early 2016, the first dengue vaccine—Dengvaxia®, developed by Sanofi Pasteur—was
approved by Mexico, the Philippines, Brazil, El Salvador and Paraguay for use in
individuals 9-45 years old (9-60 years old in Paraguay) living in dengue-endemic areas.
The world’s first public dengue immunization program started this month in the
Philippines. Several other vaccine candidates are currently in clinical development, two
of which are in advanced stages.
The new recommendations resulted from the SAGE meeting held this week in
Geneva. SAGE consists of independent experts who advise the WHO on optimal use of
vaccines through an evidence-based review process. The age to target for vaccination to
maximize the reduction of dengue cases is projected to vary by transmission setting, but
it will likely fall between 9 and 14 years of age. Dengvaxia® is not recommended for use
in children under 9 years of age, consistent with the vaccine’s current labelling. These
and other SAGE recommendations can be found here.
As SAGE emphasized, introduction requires careful assessment by each country.
Such assessments should consider local priorities; national and subnational dengue
epidemiology; predicted impact and cost-effectiveness with country-specific
hospitalizations rates and costs; and affordability and budget impact.
If dengue vaccines are introduced, support for pharmacoviligance and post-
introduction studies will be essential to monitor and evaluate countries’ experiences.
Strategic communication will be critical for effective introduction and to inform partners
and stakeholders about lessons learned on the use of Dengvaxia®. DVI will continue
working to generate and disseminate evidence-based information that supports countries’
decisions on dengue vaccine introduction, as well as to raise the visibility of the
challenges and opportunities ahead in dengue prevention and control.
Decision: Registration Board considerd the expert opinions and basesd on their
recommendations and recommendations of WHO Strategic Advisory Group
of experts (SAGE) on 15th April 2016 approved the grant of registration of
DENGVAXIA, powder and solvent for suspension for Injection (Dengue
tetravalent vaccine (live, attenuated) manufactured by Sanofi Pasteur Parc
Industrial Incarville, 27100 Val de Reuil France and final release by M/s
Sanofi Pasteur NVL 31-33 quai Armand Barbes 69250 Neuville-sur-Saone
France, as per import policy. The firm shall provide the valid legalized CoPP
issued by the regulatory body of France. The Chairman Registration Board
shll allow the issuance of registration letter, if CoPP provided earlier than
the next meeting of Regiration Board.
Case No.22: MEASLES VACCINE BY NIH, ISLAMABAD
It is submitted that NIH, Islamabad has applied for registration of Measles Virus Vaccine live
attenuated (dried Injectable (Measles virus)

The Registratin Board Approved the request of Measles Virus Vaccine Live attenuated (dried
Injectable (Measles virus) in 256 th Meeting of Registration Board. The Registration Board decided as
follows:
Decision of 256th RB: “Keeping in view the above mentioned discussion, Registratin board
approved the request of NIH, Islamabad for bulk import of measles vaccine concentrate from M/s Beijing
Minhai biotechnology co-operative Ltd, No.1, S1 Miao road, bio-engineering & Pharmacetical Industrial
park, Daxing district, Beijing, China and its local packing and labeling at NIH licensed facility for
manufacturing of measle vaccine for supply to EPI. The NIH shall arranghe the test/ analysis of first
batch from manufacturer at China and submit the reports to DRAP.”
Registratin Board also deliberated about the capacity of NIH for its installed facility where the
NIH was once manufacturingits own vaccine from the measles virus seed. NIH representatives were also
called to explain to the Registratin Board the circumstances under which the previous manufacturing
could not be carried out. The NIH is of view that the seed culture is got out of stock and no one has
showed its interest to supply the seed culture to NIH. The only way is import the bulkconcentrate from
china its local repacking at NIH facility. NIH claimed that all the manufacturing of measles vaccine shall
be for supply to EPI and its lot relaease will be through NCLB. The responsibility of quality, efficacy, and
safety shall be of NIH. EPI shall report AEFI of the said vaccine.
It is to mention that FSC & GMP provided by the NIH of aforementioned manufacturer
fromwhere they import bulk concentrate of measles vaccine, is of Combined Measles and Rubella
Vaccine, Live Injection, However, the product applied for registration is Measles Virus Vaccine live
attenuated (dried) Injectable. Since the submitted legalized documents are not align with information
contained on Form-5 for issuance of market authjorization (Registration Certificate) as approved by the
Registration board., Therefore the NIH was advised to submit clarification for measles bulk concentrate
manufacturing authorization of the manufacturer abroad approved by SFDA.
In reply the NIH has submitted statement leter issued by M/s Minhai biotechnology co. Ltd China:-
“ we hereby certify that we are allowed to produce andexport vaccines mentined in the drug
Manufacturing License, containing DTap-Hib vaccine, Live Attenuated combined vaccine of Measles and
rubella,dtap vaccine, Hib conjugate vaccine,freeze-dried conjugate vaccine, 23-valent Pneumococcal
Polysaccharide Vaccine, freeze-dried rabies vaccine for human use, small volume injectin and freeze-
dried powder.
According to Chinese GMP regulation, there is no speprate license for the production of
concentrate and bulk of vaccine, only the drug Manufactguring License of finsished product is available,
which is also the license for all intermediate products.”
Decision: Registration Board deliberated on all the aspects of contentiotion of the Biological
Division in lieu of previous decision of Registration Board. Technical Personels of NIH
also assued that also neccessay precautions shall be adopted to import only measle
vaccine concentrate, as SFDA has granted approval to M/s Beijing Minhai biotechnology
co-operative Ltd, No.1, S1 Miao road, bio-engineering & Pharmacetical Industrial park,
Daxing district, Beijing, China for manufacturing of Rubella and measle vaccine. The

Board finally reconfirmed its previous decision taken in 256 th meeting and further
advised to take extra caution by NIH to confirm the import of only measles virus
concentrate and to avoid its mixing of rubella concentrate. The NIH shall also give
undertaking in this regard.

Item No.IV: Quality Assurance & Lab Testing Division.
Case No.01: Manufacture & Sale of Sub-Standard Drug-Metrozole Suspension Batch No.
09121508 By M/S Marvi Pharmaceuticals, Karachi. F. No. 3-01/2016-QC
The sample of Metrozole Suspension Batch No. 09121508 manufactured by

M/S Marvi Pharmaceuticals, Karachi drawn by FID Karachi from manufacturing premises on
21st December 2015 for test analysis. The sample was sent to the CDL Karachi, however the
sample was declared Substandard vide test report No.R.KQ.415/2015 dated 13 th January 2016.
The result of CDL on the basis of which sample under reference has been declared sub-standard
is under:-
pH. Determined:- 4.0
Limits:- 5.6 to 6.5 Does not comply BP 2014
The sample is of “Sub-Standard” quality under the Drug Act 1976.
On the explanation letter to the firm by the FID Karachi the firm challenged the CDL
Test report in Appellate Laboratory NIH Islamabad under Section 22(5) of the Drugs Act 1976.
Result of Appellate Laboratory
pH:- Determined: 4.2 Limit:-5.0-6.5 Does not comply
Assay: Stated Found Limit Percentage
Metronidazole as 200mg/5ml 170.92mg/5ml 95.105% 85.46%

Metronidazole benzoate Does not comply with BP-2013
U/s 42 of the Drugs Act 1976, rules framed there under and The DRAP Act 2012 show
cause notices was issued to the firm and accused persons, offering opportunity of personal
hearing before the Drug Registration Board.
They have been called for personal hearing.
Decision: Mr. Pahlwan Tanvir, Plant Manager of the firm was appeared before the
Registration Board on29-06-2016 and pleaded their case. He stated before
the Board that there is some mistake in calculation in the report of Appellate
Laboratory, which if corrected their sample would be passed in assay. The
Honorable members of the Board after going through the said report found
that there seems some mistake which may be typographical but needs to be
clarified from the Appellate Laboratory (NIH ,Islamabad). The Board after

detailed discussion, deliberation, considering the facts and legal provision
decided to defer the case to get the clarification from the Appellate
Laboratory NIH Islamabad regarding the result of assay as percentage of
contents was written as 190.31 while found 170.92 in 5ml.
Case No.02: Manufacture and Sale of Substandard “Regnum Syrup” Batch No. 7297 By
M/s Novamed (Pvt) Ltd Lahore for M/s ICI Pakistan Limited , Karachi
The FID Karachi visited at the premises of M/s ICI Pakistan Limited 5-West Wharf Road,
Karachi on 19-03-2015. The FID took the sample of Regnum Syrup Batch No. 7297
Manufactured by M/s Novamed pharmaceuticals (Pvt) Ltd 28-Km Ferozpur Road Lahore, for the
test analysis and sent the above said sample to, CDL’s Karachi. However the FGA, declared the
sample as substandard quality vide its test report No.KQ.107/2015 dated 11th June 2015
Determined stated
Assay for amount/10ml: amount/10ml: Percentage:
Vitamin B2 1.482mg 1.2mg 123.5%

Limits 90.0% to 150.0% complies
Nicotinamide 11.721 mg 10.0mg 117.21%
Limits 90.0% to 150.0% complies
Vitamin C 17.61mg 50.0mg 35.22%
Limits 90.0% to 200.0% Does not comply
On explanation letter issued by the FID, the firm challenged the CDL report and requested for
Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also
declared the sample as Substandard vide their test report 025-MNHRS/2015 dated 22nd October
2015.
Assay:- Stated Found Limit

Percentage
Vitamin B1 1.5mg/10ml 1.80mg/10ml 90-200% 120.04%
Vitamin A 0.90mg/10ml 1.34mg/10ml 90-200% 148.94%
Vitamin C 50mg/10ml 26.317mg/10ml 90-200% 52.635%
Nicotinamide 10mg/10ml 13.123mg/10ml 90-150% 131.23%
Does not comply with manufacturers specification.

U/s 42 of the Drugs Act 1976, rules framed there under and The DRAP Act 2012 show cause
notices was issued to the firm and accused persons, offering opportunity of personal hearing
before the Drug Registration Board.
They have been called for personal hearing.
Decision: Mr. Muhammad Shahid Khan, Production Manager of the firm and Mr.
Muhammad Jhangir, Quality Control Manger of the firm was appeared
before the Registration Board on 29-06-2016 and pleaded their case. The
representative of the firm stated that Regnum Syrup contains multiple
ingredients in the formulation. As the product is in-house the testing method
is also in –house. For the analysis of vitamin “C” they use iodometry titration
and use of startch indicator by using preservative which is very critical to
visualize the end point of the result. The firm representatives stated that as
the formulation is liquid Glucose base which is very thick containing caramel
colour, so it is very hard to watch the end point. So they developed and
validated in- house method for the estimation of vitamin C. They stated that
the Government Lab may have used the Redox titration for the analysis of
vitamin C. The Board after detailed discussion, deliberation, considering the
facts and legal provision decided to conduct the Product specific inspection of
firm for complete investigation of case and confirming aforementioned
statement of firm by performing complete analysis of Regnum Syrup before
them.
i. Chairman Quality Control DRAP, Islamabad,
ii. DTL Lahore.
iii. Area FID
Panel will submit its report in 30 days time for consideration by Registration Board.
Case No.03:
Test Reports declared by Federal Government Analyst that the fate of sample may kindly be
decided under the guidance of Division of PE&R.
The Division of Quality Assurance DRAP Islamabad is receiving many reports from FGA, CDL
Karachi like some of the following cases
Federal Government Analyst does not declare the sample of such ingredients which are used in
both allopathic or non allopathic (or food supplement) allopathic drugs.
S.No. Name of Product Test Report and Identification Remarks of the

and manufacturer dated CDL
1. Osteo Calcium + R. LHR.222/2016 1) Calcium 1) The label
Calcium Plus dated 12th May identified claims Nutritional
Tablets 2016 Supplement
manufactured by 2.) Vitamin D
Zonex Pharma not identified 2) Vitamin D was

(Pvt) Ltd Lahore not identified as
suspected by the
Federal Inspector
of Drugs
concerned.
However Calcium
was found
340.68mg/tab
3.) The RDA

(adults) for
Calcium range is
1000-1200mg/day
hence the assay
result of Calcium is
below the limits of
the respective RDA
4.) Since Calcium

is used in food
supplements as per
Pharmacopoeia
and also by the
allopathic
manufacturers as a
registered product
therefore the fate
of sample may
kindly be decided
under the guidance
of Directorate of
Registration DRAP
Islamabad
2. Nucal 600mg R.KQ.61/2016 1) Calcium The label claims

Tablets dated 27th April identified Natural Product
manufactured by 2016
M/s Pak 2.) Vitamin D 2) Assay result
Nutraceuticals not identified reveals that the
Karachi sample contains
calcium
400mg/tablet
3) Since Calcium
is used in food
supplements as per
pharmacopoeia
and also by the
allopathic
manufacturers as a
registered product
therefore the fate
of sample may

kindly be decided
under the guidance
of Directorate of
Registration DRAP
3. Juvederm Tablet R.IP.86/2015 Alphatacopheral The label claims
manufactured by Vitamin E Natural product
identified
2.) Since
Ascorbic Acid not Alphatocopheral
identified Vitamin E is used
in food
supplements as per
Pharmacopoeia
and also by the
allopathic
manufacturer as a
registered product
therefore the fate
of sample may be
decided under the
guidance of
Directorate of
Registration DRAP
Islamabad
Decision: Registration Board deliberated that Division of Health & OTC, DRAP is functional
and after the promulgation of DRAP Act 2012 Natural, Nutritional, Herbal and Homeo products
etc come in the domain of aforementioned Division. Products referred by Government Analyst
are not registered by Registration Board, hence such references will be sent to Health and OTC
Division for deciding the matter
Case No.04: Manufacture & Sale of Sub-Standard Drug- Regogent Eye/Ear Drops
Batch .No. E-058 Mfd. by M/s Amros Pharmaceutical Karachi. (F. No. 03-
39/2014-QC)
Background of the case
The Assistant Drugs Controller (ADC), Karachi, Ms Ume Laila vide her letter date 15-
07-2014 intimated that she took the sample of the drug under reference from the export
consignment for Nigeria on 20-01-2014. It was further submitted that the drug sample has been
declared as of substandard quality by FGA, Central Drug Laboratory (CDL), Karachi vide its test
report No.EXP.19/2014, dated 14th July 2014. Salient features of the CDL test report are
reproduced as under
Assay for Gentamycin:
Determined amount %w/v: 0.2535%
Calculated amount %w/v: 0.3%

Percentage: 84.5%
Limits: 90.0% to 135.0% Does not comply.
Remarks:- The sample is of “Substandard” quality under the Drugs Act, 1976.
As per examination of documents submitted, it was evident that the drug sample under
reference was drawn by the ADC on 20-01-2014. However the CDL test report reflected that the
sample was received in the Lab on 12-06-2014 meaning thereby the sample was sent to the Lab
almost after four months and 21 days after its seizure for test/analysis. As per record of this
office, it was also apprised that Board Portion of sample has not been received in the QC
Section.
The ADC concerned was asked for explaining the reasons for not sending the sample to
the CDL Karachi and disposing off the Board’s portion with in 07 days vide letter dated 16-09-
2014.
In response, the ADC informed that the sample was delivered to the CDL on 20-01-2014
and acknowledgment receipt of CDL was furnished in this regard. The Director CDL also
confirmed vide reply dated 23-10-2014 that the sample was sent to the Lab by ADC Karachi
with Form-4 on 20-01-2014. However the stance of ADC regarding sending Board’s portion was
not correct as neither the Board’s portions of the samples nor Memorandum bearing No.UL-01-
03/2014-ADC(K) Export dated 20-01-2014 was not received in the Directorate of QA since
January 2014 to 31-10-2014. As per communication made by the ADC, it is very clear that the
mandatory provision of Section 19(3) of the Drugs Act 1976, and rules framed there under was
not followed. So the ADC was asked again as why the Board’s portion was not forwarded as per
above stated mandatory provision of the law
The ADC in response to this office letter dated 17-10-2014 sent retaining sample of the
drug under reference and stated that beside all misunderstanding and minor error of lower staff, I
am again sending the retaining sample of aforesaid batch which was available in her custody.
The view point of the ADC Karachi regarding sending Boards portion is not correct as no sample
as per memorandum bearing No. UL 01-03/2014-ADC (K)-Export date 20-01-2014 has been
received in Directorate of QA/LT Islamabad. The retaining sample sent by the ADC afterwards
and received by QC Section on 31-10-2014 is without memorandum and can not be entertained
as the same has not been forwarded with in mandatory 07 days time period as prescribed under
Section 19(3)(ii) of Drugs Act 1976.
The Director CDL was asked to comment on the delayed analysis of the sample of the
drug under reference sent/delivered to the Lab on 20-01-2014 as same should have been
analysed/reported within 60 days of the receipt of sample as required under Section 22(2) of
Drugs Act 1976. No extension in the testing period was sought from the competent authority as
per record of Directorate of QA/LT. The test report of the samples was issued on 14-07-2014 i.e.

05 months and 25 days after the receipt of sample by the Lab. It has also been stated that samples
from export consignment are liable to be charged for testing fee by CDL for test analysis. It was
also submitted that the date of receipt of testing fee is considered as the date of receipt of sample
as per policy framed after repeated observations by audit and public accounts committee of
National Assembly on outstanding testing fee. In the instant case the relevant voucher of testing
fee for the sample was submitted to CDL on 12-06-2014 therefore the same was mentioned as
the date of receipt of sample. It has been further stated that CDL tested and reported the drugs
sample under reference with in only one weak after receiving the sample with complete legal
formalities.
The Director CDL Karachi has not adhered to the above stated mandatory provision of Section
22(2) of Drugs Act 1976.
In the instant case the Board portion has not been received as required under Section
19(3) (ii) of the Drugs Act 1976 and the CDL test report has been issued after the laps of
mandatory time period. In view of above, it was therefore, proposed to place the case before the
Registration Board for consideration, direction and decision as the firm has challenged the CDL
test report under Section 22(4) of the Drugs Act 1976. The Board may also inquire further from
Director CDL Karachi and ADC Karachi on the issue.
The worthy Chairman Registration Board directed to bring the case before the Board for
discussion.
The case was placed before Drug Registration Board in its 248 th meeting held on 19th
March 2015 but due to paucity of time the Board deferred the case till next meeting of the
Registration Board. The case was again submitted to the Board in its 249 th meeting held on 19-
05-2015 for consideration and further directions in the matter.
Decision of 249th meeting:
Due to paucity of time the Board deferred the case till next meeting of the Registration Board
Decision: Registration Board deliberated the matter and advised QA&LT Division to
investigate the case and take appropriate action and inform Registration
Board accordingly.

Item no.V: Additional cases.
Case No.01: Writ Petition No.758/2015 and 4174/2015, Islamabad High Court.
Registration Board in 259th meeting deliberated decision of Islamabad High Court,

Islamabad in Writ Petition No.758/2015 and 4174/2015. Members were of the view that matter is
required to be discussed in detail with representative of M/o Law and Justice (Member
Registration Board) for opinion regarding registration of drug. Accordingly, decision in subject
petitions was deliberated in presence of representative of M/o Law and Justice. Registration
Board) was of the view that both petitions No. 758/2015 and 4174/2015 filed by the petitioner
M/s Everest Pharmaceuticals, Islamabad were disposed of by Islamabad High Court, Islamabad
vide a single order. The petitioner sought relief on the following five points: -
i. Declare that the drug Everlong is validly registered.

ii. The withdrawal of the registration of tablet Everlong may be declared as illegal and
without lawful authority.
iii. That the inspection of the premises, sealing of the tablet section of the premises/factory
be declared as without lawful authority and of no legal effect.
iv. That registration of FIR No. 12/2015 be declared as without lawful authority and of no
legal effect.
v. The Federal Investigation Agency be directed not to harass the petitioner or its staff.
Vide para 10 of the order, the Islamabad High Court has quashed the F.I.R’s, whereas
regards the withdrawal of registration, the Islamabad High Court has declared this writ petition
as infructuous on the ground that the matter of illegal withdrawal of registration is pending
before Lahore High Court vide writ petition No. 3200/2015.
In other words, the Islamabad High Court has granted relief to the petitioner on clauses
(iv) & (v) of the prayer and has left the decision on clauses (i), (ii) & (iii) upon Lahore High
Court.
The Registration Board in 260th meeting has decided to convey the relevant
quarters of DRAP to vigorously persue the case in Lahore High Court.

Case No.02: Deferred Case in 258th RB Meeting ZINNIA F (Levonorgestrel and Ethinylestradiol
Tables with Ferrous Fumarate Tablets) of M/s Hakimsons (Impex) Private Limited, Karachi
Sr. Name of Brand Name & Type of Form Document Decision in 258th
No Importer & Composition details (CoPP) meeting
Manufacturer Dy No & Date
of application Me too
status/New
Fee submitted molecule
Pack size/
Demanded
Price
1. M/s Hakimsons ZINNIA F Dy No. 1114 Legalized Deferred for expert
(Impex) Private (Levonorgestrel (R&I) DRAP CoPP dated 23- opinion by following
Limited, Karachi and (TF) dated 29-9- 05-2014 experts and valid
Ethinylestradiol 2014 Legalized GMP legalized CoPP:
Tables with Certificate No.
M/s Famy Care Ferrous Fee deposited: 1403070 dated a. Brig ® Muzamil
Limited Plot No. Fumarate Rs. 100000/- 05-3-2014 Hussain Najmi
1606-1609, Tablets) dated 04-9-2014 Member
G.I.D.C vide challan no. Free Sale Registration Board
SARIGAM Strength of 0017217. Certificate No.
396155, Dist. active ACV/Certi/ b. Brig.Amir Ikram,
VALSAD, ingredient: For UNFPA/ Famy Care/ AFIP, Rawalpindi.
GUJRAT, INDIA. Label Claim: USAID 2592/14 dated
Each Sugar not for market. 21-4-2014 c. Dr, Masud-ur-
coated white Rehman, DDG,
tablet contains: Combi pack of DRAP
Levonorgestrel 21 tablets of
Ph. Levonorgestrel
Eur……..150m &
cg ethinylestradiol
Ethinylestradiol & 7 tablets of
Ph. Eur……..30 ferrous fumarate
mcg
Ferrous
Fumarate
Tablets
Each Sugar
coated Brown
tablet contains:
Ferrous
fumarate

BP………75
mcg
(Equivalent to
Ferrous iron…
24.375mg)
Pharmacologica
l group:
Hormonal
Contraceptives.
ATC
Classification:
G03AA07.
It is submitted that in the 258th meeting of Registration Board following of the experts of the decided by
the Board.
1. Prof Dr. Sayeda Batool, MCH, PIMS Islamabad.

2. Col.Dr. Abeera Ch. MH, Rawalpindi.
3. Prof Dr. Nasira , PIMS, Islamabad
The above experts were also mentioned in the final draft minutes of 258 th RB communicated to Secretary,
Registration Board. However they were in advertently replaced by the experts as mentioned in the last
column of the agenda item and also in the decision of the Board.
Decision: Registration Board approved following relevant experts :

a. Prof Dr. Sayeda Batool, MCH, PIMS Islamabad.
b. Col.Dr. Abeera Ch. MH, Rawalpindi.
c. Prof Dr. Nasira , PIMS, Islamabad
Registration Board deferred rest of agenda due to paucity of time.
Meeting ended with a vote of thanks to and from the chair.
End of Document
*************************************************************************

Minutes For 260th Meeting Registration Board

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Minutes for 260th Meeting Registration Board held on 28-29th June, 2016.

Item No. Detail of Item Page No(s)

Item No.I Confirmation for minutes of 259th Registration Board meeting 04

Item No.II Pharmaceutical Evaluation & Registration Division 05 - 375

Item No.III Biological Drugs Division 376 - 483

Item No.V Additional cases 491 - 493

Minutes for 260th Meeting Registration Board 1

1. Lt General (R) Karamat Ahmed Karamat. Member

2. Brig (R). Dr. Muzammil Hasan Najmi, Member

4. Sheikh Sarfraz Ahmad Member

Minutes for 260th Meeting Registration Board 2

Dr.Masud-ur-Rehman (DDG Biological), Zaheer-ud-Din M Babar (DDC R.I/R IV),

In addition to routine agenda, following was also discussed and decided:

Minutes for 260th Meeting Registration Board 3

 Dr.Amanullah Khan, Director DTL, Quetta:

It may be decided as per decision of Registration Board.

 Dr.Noor Muhammad Shah, Director Medical Device, DRAP:

Decision: Registration Board deliberated that points observed by Director Medical

Minutes for 260th Meeting Registration Board 4

Registration Board in 258th meeting considered following proposal of Dr.Muhammad

S.No Name of Drug & Composition No of applicants / manufacturers

In 259th meeting, Registration Board decided as follows:

Minutes for 260th Meeting Registration Board 5

 Punjab: Director DTL Lahore; Director DTL Peshawar and

Registration Board also approved above panels for confirmation genuineness/

 Sind and Balochistan: Director DTL Quetta (Chairman), Director DTL

Case No.02: Price fixation under the Drug Pricing Policy-2015.

Minutes for 260th Meeting Registration Board 6

It is not a new chemical entity. Reference price is neither available

 Imported by Pfizer Demanded price of Sayana Press Injection @ Rs.1078/- per

Minutes for 260th Meeting Registration Board 7

It is not a new chemical entity. Reference price is neither available

It is not a new chemical entity. Reference price is neither available

Minutes for 260th Meeting Registration Board 8

It is not a new chemical entity. Reference price is neither available

Minutes for 260th Meeting Registration Board 9

Case No.03: Renewal of registered drug and Post-registration variation approval.

Minutes for 260th Meeting Registration Board 10

a. M/s Prix Pharma Lahore.

S. Reg/No Products/Name Initial Date of Application receiving

Decision: Firm submitted renewal application within 60 days of expiry period of

S. Reg/No Products/Name Date of Application receiving date

Minutes for 260th Meeting Registration Board 11

S. Reg/No Products/Name Initial Date Application receiving date

Minutes for 260th Meeting Registration Board 12

S. Reg/No Products/Name Initial Date Application receiving

Minutes for 260th Meeting Registration Board 13

Minutes for 260th Meeting Registration Board 14

29 009353 Kotria tablet do Do

30 004328 Paracambind tablet do Do

31 010577 Clean Skin Solution do Do

Minutes for 260th Meeting Registration Board 15

Decision: Firm submitted renewal application within 60 days of expiry period of

S. Reg/No Products/Name Initial Date of Application receiving

Decision: Firm submitted renewal application within 60 days of expiry period of

Minutes for 260th Meeting Registration Board 16

Case No.05: Request for change of manufacturer of Kefei ® Injection (Reg.No.059054) by

M/s. RG Pharmaceutical (Pvt) Ltd., Karachi had applied for change of

Decision: Registration Board advised to provide evidence of approval of the drug