Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Dr. Reddy's Laboratories
03 1Octavius Pharma Pvt. Ltd
04 1Atman Pharmaceuticals
05 1Anugraha Chemicals
06 1Cadila Pharmaceuticals
07 1Cipla
08 1Darou Pakhsh Pharma Chem
09 1Gokulendu Life Science
10 1Guangzhou Tosun Pharmaceutical
11 1HELM Portugal
12 1Hikal
13 1Hoventa Pharma
14 1Ipca Laboratories
15 1Nishchem International Pvt. Ltd
16 1Qilu Pharmaceutical
17 1Sakar Healthcare
18 2Shodhana Laboratories Pvt. Ltd
19 1Sun Pharmaceutical Industries Limited
20 1Teva API
21 2Teva Pharmaceutical Industries
22 1Therapiva
01 2China
02 16India
03 1Iran
04 3Israel
05 1Portugal
06 1Spain
01 6Active
02 2Inactive
03 16Blank
01 24Blank
01 24Blank
01 1WC-0026
02 1WC-0043Amended
03 1WC-0074
04 1WC-0091
05 1WC-0094
06 1WC-0144
07 1WC-0230
08 1WC-0230A2
09 16Blank
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 : 2024-12-31
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 16320
Submission : 2003-01-29
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043Amended
Address of the Firm :
NDC Package Code : 55111-050
Start Marketing Date : 2010-01-01
End Marketing Date : 2024-12-31
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.
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-0091
Address of the Firm :
NDC Package Code : 57451-1191
Start Marketing Date : 2010-08-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-17
Pay. Date : 2021-08-12
DMF Number : 18829
Submission : 2005-09-03
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0094
Address of the Firm :
NDC Package Code : 66651-904
Start Marketing Date : 2015-01-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2020-06-19
Registration Number : 20130510-47-B-349-18(2)
Manufacturer Name : HIKAL Ltd.
Manufacturer Address : 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore-562105, Karnataka, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16644
Submission : 2003-06-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17980
Submission : 2005-01-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19762
Submission : 2006-09-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21027
Submission : 2007-10-29
Status : Inactive
Type : II
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074
Address of the Firm :
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