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 1Anugraha Chemicals
08 1Cadila Pharmaceuticals
09 1Cipla
10 1Darou Pakhsh Pharma Chem
11 1GSK
12 1Gokulendu Life Science
13 1Guangzhou Tosun Pharmaceutical
14 1HELM Portugal
15 2Hikal
16 1Hikma Pharmaceuticals
17 1Hoventa Pharma
18 1Ipca Laboratories
19 1LAXAI Life Sciences
20 1Natco Pharma
21 1Nishchem International Pvt. Ltd
22 1Qilu Pharmaceutical
23 1Sakar Healthcare
24 1ScinoPharm Taiwan Ltd
25 1Shodhana Laboratories Pvt. Ltd
26 1Sun Pharmaceutical Industries Limited
27 2Teva Pharmaceutical Industries
28 1Therapiva
29 1Blank
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01 2China
02 19India
03 1Iran
04 3Israel
05 1Portugal
06 1Spain
07 1Taiwan
08 2United Kingdom
09 1Blank
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01 6Active
02 2Inactive
03 23Blank
01 31Blank
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01 31Blank
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01 1WC-0026
02 1WC-0043
03 1WC-0091n
04 1WC-0094n
05 1WC-0094nA2A
06 1WC-014
07 1WC-0144nA2
08 1WC-0168
09 1WC-0230
10 1WC-026n
11 21Blank
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01 120101230-47-B-303-15
02 120130510-47-B-349-18
03 120130510-47-B-349-18(2)
04 28Blank
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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 21Blank
01 31Blank
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 : 2022-05-27
Valid Till : 2025-06-04
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 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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-08-06
DMF Number : 23758
Submission : 2010-08-18
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091n
Address of the Firm :
NDC Package Code : 57451-1191
Start Marketing Date : 2010-08-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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