3 batches

propose No. of No. of API Qty Cost -

Ext. Units / Ext. Units / with 15%
I Sr No Name of the Product batch size batch / batch / (Kg) / 14.5L
year month extra API Qty
(Lac) year Month batch /Kg
(Kg)
1 Levothyroxine Tablets 25 mcg 67,035,000 5586250 24 0.060 0.069 0.069
Scale
2 Levothyroxine Tablets 150 mcg 22,638,784 1886565 10 0.150 0.173 0.173
up
3 Levothyroxine Tablets 300 mcg 1,391,892 115991 2.4 0.072 0.083 0.083

1 Levothyroxine Tablets 25 mcg 67,035,000 5586250 24 27 2 0.060 0.069 0.207

2 Levothyroxine Tablets 50 mcg 123,144,796 10262066 24 49 4 0.120 0.138 0.414
3 Levothyroxine Tablets 75 mcg 111,147,496 9262291 24 44 4 0.180 0.207 0.621
4 Levothyroxine Tablets 88 mcg 65,966,620 5497218 24 26 2 0.211 0.243 0.729
5 Levothyroxine Tablets 100 mcg 49,997,576 4166465 10 50 4 0.100 0.115 0.345
6 Levothyroxine Tablets 112 mcg 54,872,592 4572716 10 55 5 0.112 0.129 0.386
EB
7 Levothyroxine Tablets 125 mcg 28,029,868 2335822 10 28 2 0.125 0.144 0.431
8 Levothyroxine Tablets 137 mcg 37,028,496 3085708 10 37 3 0.137 0.158 0.473
9 Levothyroxine Tablets 150 mcg 22,638,784 1886565 10 23 2 0.150 0.173 0.518
10 Levothyroxine Tablets 175 mcg 86,104,084 7175340 24 34 3 0.438 0.503 1.509
11 Levothyroxine Tablets 200 mcg 16,567,216 1380601 2.4 69 6 0.048 0.055 0.166
12 Levothyroxine Tablets 300 mcg 1,391,892 115991 2.4 6 0.5 0.072 0.083 0.248
175 449 37 6.371 116.000
Total Tablets
560.8
(lac)
Note :- 1 Scale up batch to be taken for 25, 150 & 300mcg

3 batches
propose No. of No. of API Qty Cost -
Ext. Units / Ext. Units / with 15%
II Sr No Name of the Product batch size batch / batch / (Kg) / 14.5L
year month extra API Qty
(Lac) year Month batch /Kg
(Kg)
Scale 1 Levothyroxine Tablets 25 mcg 67,035,000 5586250 24 0.060 0.069 0.069
up 2 Levothyroxine Tablets 300 mcg 1,391,892 115991 2.4 0.072 0.083 0.083

1 Levothyroxine Tablets 25 mcg 67,035,000 5586250 24 28 2 0.060 0.0690 0.207

2 Levothyroxine Tablets 50 mcg 123,144,796 10262066 24 51 4 0.120 0.1380 0.414
3 Levothyroxine Tablets 75 mcg 111,147,496 9262291 24 46 4 0.180 0.2070 0.621
4 Levothyroxine Tablets 88 mcg 65,966,620 5497218 24 27 2 0.211 0.2429 0.729
5 Levothyroxine Tablets 100 mcg 49,997,576 4166465 24 21 2 0.240 0.2760 0.828
6 Levothyroxine Tablets 112 mcg 54,872,592 4572716 24 23 2 0.269 0.3091 0.927
EB
7 Levothyroxine Tablets 125 mcg 28,029,868 2335822 24 12 1 0.300 0.3450 1.035
8 Levothyroxine Tablets 137 mcg 37,028,496 3085708 24 15 1 0.329 0.3781 1.134
9 Levothyroxine Tablets 150 mcg 22,638,784 1886565 24 9 1 0.360 0.4140 1.242
10 Levothyroxine Tablets 175 mcg 86,104,084 7175340 24 36 3 0.420 0.4830 1.449
11 Levothyroxine Tablets 200 mcg 16,567,216 1380601 2.4 69 6 0.048 0.0552 0.166
12 Levothyroxine Tablets 300 mcg 1,391,892 115991 2.4 6 0.5 0.072 0.0828 0.248
245 344 29 9.152 145.000
Total Tablets
(lac) 760.8
Note :- 1 Scale up batch to be taken for 25 & 300mcg
 Levothyroxine Tablet _ USA _ New Development _ Costing

Packaging - Levothyroxine Tablets - USA

Req for 36 Cost / unit
Material Strengths Batch size No/ batch Total (Rs)
batches (Rs)
HDPE 40 CC 1.5 mm + 33 mm
all strengths (12) 0.15 L / batch 500 18000 9 162000
CR Closure - 30's count
Pharmakeep CD 2.15 g all strengths (12) 0.15 L / batch 500 18000 45 810000
HDPE 40 CC 1.5 mm + 33 mm
all strengths (12) 0.15 L / batch 250 9000 9 81000
CR Closure - 90's count
Pharmakeep CD 2.15 g all strengths (12) 0.15 L / batch 250 9000 45 405000
HDPE 225 CC 1.5 mm + 38 mm
all strengths (12) 1.25 L / batch 125 4500 25 112500
Cr closure - 1000's count
Pharmakeep CD 2.15 g all strengths (12) 1.25 L / batch 500 18000 45 810000
TLP Bags (650 x 100 mm) all strengths (12) 240 kg 40 1440 84 120960
Silica gel (56 gm) all strengths (12) 240 kg 200 7200 28 201600
TLP Sachet all strengths (12) 240 kg 60 2160 40 86400
2789460
Total Cost 0.28 Crore
 Strategy _ I (2.4 & 24 Lacs)
Total Tablets 76000000 31.666667
MCC Strategy
Qty in Kg / Total -
SAP Excipients mg/tab Cost / kg Total Cost
batch (24L) 7.6Cr
113417 Ceolus 711 40 96 3072 1522 4675584
110092 MCC 102 59 141.6 4531.2 720 3262464
111904 SSG 0.25 0.6 19.2 801 15379.2
113361 Lake blend 0.2 0.48 15.36 4161 63912.96
111040 SSF 0.88 2.112 67.584 16390 1107702
Total Cost in Lacs 9125042 91 lacs

Mannitol Strategy
Qty in Kg / Total -
SAP Excipients mg/tab Cost / kg Total Cost
batch (24L) 7.6Cr
110684 Mannitol (Pearlitol Sd 200) 54.03 132 4224 816 3446784
110295 Corn Starch (Uni-Pure FL) 7.65 18.36 587.52 416 244408.32
113417 Ceolus 711 (MCC) 20 48 1536 1522 2337792
110092 MCC 102 30 72 2304 720 1658880
110467 Gum Acacia (spray dried) 3.5 8.4 268.8 1703 457766.4
- Sodium Citrate 3.6 8.64 276.48 3000 829440
113361 Lake Blend Green LB-510016 0.2 0.48 15.36 4161 63912.96
113555 Magnesium Stearate 0.72 1.728 55.296 460 25436.16
Total Cost in Lacs 9064420 91 lacs

Strategy - II (2.4 , 10.0 & 24 Lacs)

Total Tablets 57000000 23.75
MCC Strategy
Qty in Kg /
SAP Excipients mg/tab Total Cost / kg Total Cost
batch (24L)
113417 Ceolus 711 40 96 2280 1522 3470160
110092 MCC 102 59 141.6 3363 720 2421360
111904 SSG 0.25 0.6 14.25 801 11414.25
113361 Lake blend 0.2 0.48 11.4 4161 47435.4
111040 SSF 0.88 2.112 50.16 16390 822122.4
Total Cost in Lacs 6772492 68 lacs

Mannitol Strategy
Qty in Kg /
SAP Excipients mg/tab Total - 5Cr Cost / kg Total Cost
batch (24L)
110684 Mannitol (Pearlitol Sd 200) 54.03 132 3135 816 2558160
110295 Corn Starch (Uni-Pure FL) 7.65 18.36 436.05 416 181396.8
113417 Ceolus 711 (MCC) 20 48 1140 1522 1735080
110092 MCC 102 30 72 1710 720 1231200
110467 Gum Acacia (spray dried) 3.5 8.4 199.5 1703 339748.5
- Sodium Citrate 3.6 8.64 205.2 3000 615600
113361 Lake Blend Green LB-510016 0.2 0.48 11.4 4161 47435.4
113555 Magnesium Stearate 0.72 1.728 41.04 460 18878.4
Total Cost in Lacs 6727499.1 68 lacs
 MCC Strategy

Levothyro Levothyr Levothyr Levothyr

Levothyrox
xine oxine oxine oxine
Name of the Product ine Tablets
Tablets 50 Tablets Tablets Tablets
25 mcg
mcg 75 mcg 88 mcg 100 mcg
Batch size in Lakhs 24 24 24 24 24
Quantity of API /batch in kg 0.060 0.120 0.180 0.211 0.240
API cost/ Kg in INR 637500
API cost / batch in kg 38250 76500 114750 134640 153000
API cost/ Tab 0.0159375 0.031875 0.047813 0.0561 0.06375
API cost/ 100 tab 1.59375 3.1875 4.78125 5.61 6.375
Ceolus 711 mg/ 100 tab 4000 4000 mg 4000 mg 4000 mg 4000 mg
Ceolus 711 kg/ 100 tab 0.004 0.004 0.004 0.004 0.004
Cost/kg 1522
price/100 tab in rs 6.088 6.088 6.088 6.088 6.088
MCC 102mg/100 Tab 5900
MCC 102 kg /100 Tab 0.0059
Cost/kg 720
cost/100 bottles 4.248 4.248 4.248 4.248 4.248
SSGmg/100 tab 25
SSG kg/100 tab 0.000025
Cost/kg 801
cost/100 tab 0.020025 0.020025 0.020025 0.020025 0.020025
Lake blend mg/100 tab 20
Lake blend kg/tab 0.00002
Cost/kg 4161
cost/100 tab 0.08322 0.08322 0.08322 0.08322 0.08322
SSF mg/100 tab 8.8
SSF kg/100 tab 0.0000088 0.0000088 8.8E-06 8.8E-06 8.8E-06
Cost/kg 16390
cost/100 tab 0.144232 0.144232 0.144232 0.144232 0.144232
Total Cost API+ Excipient 12.177227 13.770977 15.36473 16.19348 16.95848

PACKAGING
Material
HDPE 40 CC 1.5 mm + 33
mm CR Closure - 30's count/
price/bottle 9 9 9 9 9
Pharmakeep CD 2.15 g 45 45 45 45 45
TOTAL cost Tab/pack of 100
66.177227 67.770977 69.36473 70.19348 70.95848
Levothyr Levothyr Levothyr Levothyr Levothyr Levothyr Levothyr
oxine oxine oxine oxine oxine oxine oxine
Tablets Tablets Tablets Tablets Tablets Tablets Tablets
112 mcg 125 mcg 137 mcg 150 mcg 175 mcg 200 mcg 300 mcg
24 24 24 24 24 2.4 2.4
0.269 0.300 0.329 0.360 0.420 0.048 0.072

171360 191250 209610 229500 267750 30600 45900

0.0714 0.079688 0.087338 0.095625 0.111563 0.01275 0.019125
7.14 7.96875 8.73375 9.5625 11.15625 1.275 1.9125
4000 mg 4000 mg 4000 mg 4000 mg 4000 mg 4000 mg 4000 mg
0.004 0.004 0.004 0.004 0.004 0.004 0.004

6.088 6.088 6.088 6.088 6.088 6.088 6.088

4.248 4.248 4.248 4.248 4.248 4.248 4.248

0.020025 0.020025 0.020025 0.020025 0.020025 0.020025 0.020025

0.08322 0.08322 0.08322 0.08322 0.08322 0.08322 0.08322

8.8E-06 8.8E-06 8.8E-06 8.8E-06 8.8E-06 8.8E-06 8.8E-06

0.144232 0.144232 0.144232 0.144232 0.144232 0.144232 0.144232

17.72348 18.55223 19.31723 20.14598 21.73973 11.85848 12.49598

9 9 9 9 9 9 9
45 45 45 45 45 45 45

71.72348 72.55223 73.31723 74.14598 75.73973 65.85848 66.49598

Sr. No. Title SOP No.
1. Specimen signature FRD-010-01
2. Qualification of Equipments and Instruments FRD-011-04

3. Assigning of National Drug Code (NDC) FRD-014-01

4. Procedure for materials receipt and storage FRD-022-01

5. Cleaning operation and calibration of pH meter FRD-032-01

6. Operation and cleaning of Hot plate magnetic FRD-042-02

stirrer
7. Operation and cleaning of Mechanical stirrer FRD-043-02

8. Procedure for operation, cleaning and calibration of FRD-055-01

pH & Conductivity meter
9. Procedure for operation, cleaning and calibration of FRD-064-02
high shear laboratory mixer (Make: Silver son,
Model: L5M-A)
10. Procedure for operation and cleaning of high FRD-075-01
pressure homogenizer & Extruder (Model:
Emulsitlex® C-3; Make: Avastin Inc)

11. General Operation, cleaning and calibration of FRD-076-02

Weighing Balances
12. Calibration of Dissolution test apparatus FRD-099-02

13. Operation & calibration of Distek Dissolution FRD-110-00

system Model: 2100 C

14. Procedure for operation and Cleaning of Varian FRD-111-00

Dissolution tester Model: VK7010
15. Operation & cleaning of Electrolab dissolution FRD-113-01
tester (EDT 08LX with Dissolution Sampler &
Calibration of Autosampler
16. Procedure for calibration and temperature FRD-150-00
monitoring of Refrigerator

17. Receiving, storage, handling, issuance and disposal FRD-016-02

of controlled substance in the controlled substance
laboratory
18. Entry and exit procedure in controlled substance FRD-018-02
lab
19. Operation, cleaning and calibration of moisture FRD-049-00
analyser (Make: Sartorius, Model: MA 100 H)
20. Procedure for operation and cleaning of Vibratory FRD-050-02
sifter

21. Operation and calibration of Tapped Density FRD-100-00

Tester (Electrolab, Model ETD-1020)
22. Operation and cleaning of Quadro co mill FRD-134-00

23. Procedure for operation of tablet drilling machine FRD-135-00

(Make: Saeyang, Model: marathon 4)
24. Procedure for operation and cleaning of Fluid FRD-137-00
Bed Processor (Model: SAI-FBP 20)
25. Procedure for operation and cleaning of LIPEX™ FRD-139-00
Extruder.
26. Operation and cleaning of micro fluidizer FRD-143-00
(Make: Micro fluidics, Model:M110P)

27. Operation, cleaning and calibration of moisture FRD-145-00

analyser (Make: Sartorius, Model:MA-160-1)
28. Operation and cleaning of capsule filling machine FRD-147-00
(Make: ACG Pam; Model: AFT-lab)
29. Operation and cleaning of Ro-tap sieve shaker FRD-148-00
(Model: RX 29-10)
30. Operation and cleaning of data count JR Machine FRD-149-00
31. Procedure for Operation and cleaning of Double FRD-151-00
cone Blender (DCB20)
32. Procedure for operation and cleaning of mini FRD-153-00
roller compactor (KMRC120)
33. Procedure for operation of Induction sealing FRD-154-00
machine (BREZO-P)

34. Status Labeling in process development and FRD-155-00

scale up laboratory
35. Entry and exit procedure for process development FRD-157-00
and scale up laboratory

36. Operation and cleaning of Mini super Mill (Kevin FRD-158-00

KSM30).
37. Operation and cleaning of Quadro Co mill FRD-160-00

38. Operation and cleaning of Double cone Blender FRD-161-00

(TAP-DB-150)
39. Dispensing of Active Phannaceutical Ingredients FRD-162-00
and Excipients
40. Operation, cleaning and calibration of Tablet FRD-169-00
Modei:ED 2SAPO) Disintegration Tester (Make:
Electrolab,
41. Operation and cleaning of compression machine FRD-170-00
(Make: Cadmach, Model: CMD4: MT)
42. Line Clearance Procedure FRD-172-00
43. Procedure for movement of change parts and FRD-173-00
manufacturing aids
44. Procedure for Operation and cleaning of High FRD-178-00
shear mixer granulator
(Make: Tapasya Modei:HSMGR2T 100)
45. Cleaning of Containers, Utensils and Production FRD-185-01
aids
46. Handling and storage of Mobile Equipment FRD-186-01
instruments

47. In-process Quality Assurance Monitoring FRD-191-00

48. Procedure for handling of spillage in store FRD-192-00

49. Handling of materials in chemical room and FRD-195-00

Alcohol storage area

Allotment of rooms and miscellaneous sampling

50. FRD-197-00
locations identification number

Operation & cleaning of Bohle Laboratory Blender

51. FRD-202-00
LM 40-NIR

Operation and cleaning of Hot water generation

52. FRD-204-00
tank (60Litre)

Operation, cleaning and calibration / qualification

53. FRD-205-00
of reverse laminar air flow (RLAF)

54. Cleaning and sanitization of drain points FRD-206-00

Procedure for cleaning operation and performance

55. verification of Viscometer (Make: Schott, Model: FRD-040-02
AVS350)

56. Procedure for cleaning of glassware and utensils FRD-054-01

Procedure for operation and calibration of

57. FRD-104-01
Rheometer (Make: Brookfield, Model: DV-111)

Operation and cleaning of Jacketed Syrup

58. FRD-203-00
manufacturing vessel

Procedure for operation and calibration of

59. incubator shaker instrument (Make: Scigenics FRD-061-01
Biotech Pvt Ltd Model: Orbitek)

Entry and Exit procedure in to injection

60. FRD-077-01
manufacturing area

Procedure for Operation and cleaning of Master

61. FRD-095-00
flex dosing pump

Preparation, checking & approval of pre exhibit &

preclinical batch manufacturing record (PE/PC
62. BMR), sampling protocol and pre exhibit & FRD-136-01
Preclinical Batch report( injection and ophthalmic
products)
 Procedure to carry out cleaning, calibration and
63. FRD-138-00
operation of thermo Orion versa star meter.

Operation cleaning, and calibration of water

64. activity meter (Make : Aqualab, Model: Series FRD-180-00
4TE)
Implemen-tation Date Next Review Department Scientist Name
12/29/2016 Nov-19 Common Sachin
12/21/2018 Nov-21 Common sachin

12/29/2016 Nov-21 Common sachin/moiz

3/24/2017 Feb-20 Common himanshu

4/9/2014 Mar-19 Common asif

8/6/2015 Jul-20 Common shoeb

8/6/2015 Jul-20 Common shoeb

5/28/2015 Apr-20 Common asif

10/17/2018 Sep-21 Common shoeb

3/8/2016 Feb-21 Common shoeb

10/6/2015 Sep-20 Common himanshu

2/6/2015 Jan-20 Common NA

2410512014 Apr-18 Common NA

24105/2014 Apr-19 Common NA

11/4/2014 Oct-19 Common NA

2/18/2016 Jan-21 Common deepak wagh

9/29/2018 Aug-21 OSD shridhar

8/31/2018 Jul-21 OSD NA

3/26/2014 Feb-19 OSD shoeb

8/13/2015 Jul-20 OSD shridhar

5/24/2014 Apr-19 OSD shoeb

 1/13/2015 Dec-19 OSD shoeb

1/13/2015 Dec-19 OSD sachin

4/9/2015 Mar-20 OSD shridhar

6/8/2015 May-20 OSD himanshu

7/25/2015 Jun-20 OSD sachin

9/9/2015 Aug-20 OSD shoeb

11/4/2015 Oct-20 OSD shridhar

1/22/2016 Dec-20 OSD shoeb

8/16/2016 Jul-21 OSD na

8/9/2016 Jul-21 OSD shridhar

6/24/2016 May-21 OSD shridhar

8/9/2016 Jul-21 OSD shoeb

8/8/2016 Jul-19 OSD NA

8/9/2016 Jul-19 OSD NA

7/5/2016 Jun-21 OSD shoeb

7/5/2016 Jun-21 OSD shridhar

7/5/2016 Jun-21 OSD shridhar

7/8/2016 Jun-19 OSD shridhar

8/10/2016 Jul-19 OSD sachin

6/24/2016 May-21 OSD sachin

12/21/2016 Nov-19 OSD shridhar

8/10/2016 Jul-19 OSD riyaz

1/28/2017 Dec-21 OSD shoeb

 3/1/2017 Feb-20 OSD riyaz

3/1/2017 Feb-20 OSD riyaz

12/21/2016 Nov-19 OSD himanshu

12/21/2016 Nov-19 OSD riyaz

4/11/2017 Mar-20 OSD riyaz

sachin
4/7/2017 Mar-20 OSD

shoeb
28111/2017 Oct-20 OSD

riyaz
12/15/2017 Nov-20 OSD

riyaz
12/14/2018 Nov-21 OSD

riyaz
12/21/2018 Nov-21 OSD
sachin

6/25/2016 May-21 Liquid

3/30/2017 Feb-20 Liquid sambhaji and group

sambhaji and group

7/23/2015 Jun-20 Liquid

sambhaji and group

12/14/2017 Nov-20 Liquid

deepak wagh
9/30/2014 Aug-19 Injection

asif
2/28/2017 Jan-20 Injection

wagh
9/30/2014 Aug-19 Injection

asif

7/14/2017 Jun-20 Injection

 wagh
6/1/2015 May-20 Injection

asif

8/4/2016 Jul-21 Injection