Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1Seqens
02 1LGM Pharma
03 1Dr. Reddy's Laboratories
04 1HRV Global Life Sciences
05 1Medichem S.A
06 1Shandong Loncom Pharmaceutical
07 1ALP Pharm
08 1Actavis Inc
09 1Amoli Organics
10 1Apotex Pharmachem
11 1Aurobindo Pharma Limited
12 1Centaur Pharmaceuticals
13 1Charioteer
14 1Darou Pakhsh Pharma Chem
15 1Dipharma
16 1Dishman Carbogen Amcis
17 1DongWha Pharm
18 2Enaltec Labs Private Limited
19 1Guangzhou Tosun Pharmaceutical
20 2Hetero Drugs
21 1Jubilant Generics
22 1Jubilant Pharmova
23 1Lee Pharma
24 1LifeFirst Pharma
25 1Lupin Ltd
26 1Macleods Pharmaceuticals Limited
27 1Maithri Drugs
28 1Nanjing Clasien Pharmaceutical & Chemical Co., Ltd
29 1Ningbo Zhenlei Chemical Co.,Ltd
30 1Piramal Pharma Solutions
31 1Prajna Generics
32 1SGMR Pharmaceuticals
33 1SKVen Technologies Pvt. Ltd
34 1Shilpa Medicare
35 1Shodhana Laboratories Pvt. Ltd
36 1Unichem Laboratories Limited
37 1Viatris
38 2Viwit Pharmaceuticals Limited
01 1Canada
02 8China
03 1France
04 23India
05 1Iran
06 1Ireland
07 1Italy
08 1South Korea
09 1Spain
10 3U.S.A
01 18Active
02 2Inactive
03 21Blank
01 41Blank
01 1303MF10142
02 40Blank
01 1WC-0015
02 1WC-0040
03 1WC-0040A3
04 1WC-0092
05 1WC-0186A4
06 1WC-0407a4
07 1WC-0424
08 1WC-0424A4
09 33Blank
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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 : 38693
Submission : 2023-08-30
Status : Active
Type : II
NDC Package Code : 71796-060
Start Marketing Date : 2023-08-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
NDC Package Code : 53296-0093
Start Marketing Date : 2009-12-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-16
Pay. Date : 2020-09-28
DMF Number : 34174
Submission : 2019-09-30
Status : Active
Type : II
Date of Issue : 2020-10-20
Valid Till : 2023-06-28
Written Confirmation Number : WC-0407a4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-20
Pay. Date : 2020-02-18
DMF Number : 34116
Submission : 2020-01-30
Status : Active
Type : II
NDC Package Code : 65085-0073
Start Marketing Date : 2021-02-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-31
Pay. Date : 2018-09-11
DMF Number : 32638
Submission : 2018-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30182
Submission : 2015-12-22
Status : Inactive
Type : II
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