Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
02 2Metrochem API Private Limited
03 1Dr. Reddy's Laboratories
04 1Chunghwa Chemical Synthesis & Biotech
05 1Apotex Pharmachem
06 1Aurore Life Sciences
07 1Beijing Mesochem Technology
08 1Beijing Sjar Technology Development
09 1Changzhou Pharmaceutical Factory
10 1Glenmark Life Sciences
11 1HONOUR LAB LTD
12 1Hunan Warrant Chiral Pharmaceutical
13 1Intas Pharmaceuticals
14 1Lee Pharma
15 1MSN Laboratories
16 1Macleods Pharmaceuticals Limited
17 1Micro Labs Limited
18 1Olon S.p.A
19 1PharmaBlock Sciences
20 1Qilu Tianhe Pharmaceutical Co., Ltd.
21 1SINTENOVO, S.A. DE C.V.
22 1Sun Pharmaceutical Industries Limited
23 1Unichem Laboratories Limited
24 1Viatris
25 1Yabao Pharmaceutical Group Co. Ltd
26 1Zhejiang Ausun Pharmaceutical
27 1Zhejiang Huahai Pharmaceutical
28 1Zydus Lifesciences
01 26TOFACITINIB CITRATE
02 1TOFACITINIB CITRATE (NON-STERILE API)
03 1TOFACITINIB CITRATE (PAI)
04 1TOFACITINIB CITRATE [ROUTE CODE - TT"]
01 2Canada
02 9China
03 14India
04 1Italy
05 1Mexico
06 1Taiwan
07 1U.S.A
01 28Active
02 1Inactive
01 19Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33332
Submission : 2018-12-21
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35976
Submission : 2021-05-29
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-11-15
DMF Number : 37164
Submission : 2022-07-29
Status : Active
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37532
Submission : 2022-10-28
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-06
Pay. Date : 2024-01-31
DMF Number : 38994
Submission : 2023-12-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-08
Pay. Date : 2015-03-10
DMF Number : 29002
Submission : 2015-03-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-13
Pay. Date : 2015-09-23
DMF Number : 27721
Submission : 2013-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-06-22
DMF Number : 30578
Submission : 2016-06-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-28
Pay. Date : 2016-07-14
DMF Number : 30617
Submission : 2016-08-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-08
Pay. Date : 2016-05-13
DMF Number : 30531
Submission : 2016-06-04
Status : Active
Type : II
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