Inke S.A: APIs manufacturing plant.

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01 1Inke S.A
02 1Dr. Reddy's Laboratories
03 1Octavius Pharma Pvt. Ltd
04 1TAPI Technology & API Services
05 1Zeal MediPharma
06 1Venkar Chemicals
07 1Willow Birch Pharma
08 1Anugraha Chemicals
09 1Cadila Pharmaceuticals
10 1Cipla
11 1Darou Pakhsh Pharma Chem
12 1Dhanuka Laboratories Ltd
13 1GSK
14 1Gokulendu Life Science
15 1Guangzhou Tosun Pharmaceutical
16 1HELM Portugal
17 2Hikal
18 1Hikma Pharmaceuticals
19 1Hoventa Pharma
20 1Ipca Laboratories
21 1LAXAI Life Sciences
22 1Nishchem International Pvt. Ltd
23 1Qilu Pharmaceutical
24 1Sakar Healthcare
25 1ScinoPharm Taiwan Ltd
26 1Shodhana Laboratories
27 1Sun Pharmaceutical Industries Limited
28 2Teva Pharmaceutical Industries
29 1Therapiva
30 1Blank
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01 2China
02 19India
03 1Iran
04 3Israel
05 1Portugal
06 1Spain
07 1Taiwan
08 1U.S.A
09 2United Kingdom
10 1Blank
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01 6Active
02 2Inactive
03 24Blank
01 32Blank
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01 32Blank
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01 1WC-0026
02 1WC-0043
03 1WC-0091
04 1WC-0094
05 1WC-0094nA2A
06 1WC-0144
07 1WC-0168
08 1WC-0230
09 1WC-026n
10 23Blank
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01 120101230-47-B-303-15
02 120130510-47-B-349-18
03 120130510-47-B-349-18(2)
04 29Blank
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01 151846-1033
02 152482-019
03 155111-050
04 157451-1191
05 159115-807
06 162756-469
07 164567-0008
08 165129-2118
09 166651-904
10 184671-1033
11 22Blank
01 32Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16172
Submission : 2002-09-30
Status : Active
Type : II
NDC Package Code : 64567-0008
Start Marketing Date : 2009-08-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-02-25
Pay. Date : 2024-12-31
DMF Number : 16320
Submission : 2003-01-29
Status : Active
Type : II
Date of Issue : 2025-07-25
Valid Till : 2028-06-04
Written Confirmation Number : WC-0043
Address of the Firm :
NDC Package Code : 55111-050
Start Marketing Date : 2010-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16644
Submission : 2003-06-11
Status : Active
Type : II
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17980
Submission : 2005-01-11
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
NDC Package Code : 62756-469
Start Marketing Date : 2025-03-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21027
Submission : 2007-10-29
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19762
Submission : 2006-09-13
Status : Inactive
Type : II

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