Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1Coral Drugs Private Limited
03 2Axplora
04 1Aspen API
05 1Aarti Pharmalabs
06 1Hubei Gedian Humanwell Pharmaceutical
07 2TAPI Technology & API Services
08 1Amphastar Pharmaceuticals
09 1Apotex Pharmachem
10 1AstraZeneca
11 2Breathgreen Pharmaceuticals
12 1Cipla
13 2Curia
14 1Henan Lihua Pharmaceutical
15 2Industriale Chimica
16 1NEWCHEM SPA
17 1Sterling Spa
18 1Sun Pharmaceutical Industries Limited
19 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-03
Pay. Date : 2017-02-10
DMF Number : 28441
Submission : 2014-06-20
Status :
Type : II
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30534
Submission : 2017-02-02
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-16
Pay. Date : 2013-05-03
DMF Number : 18910
Submission : 2005-10-26
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10493
Submission : 1993-09-23
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-03
Pay. Date : 2013-03-04
DMF Number : 20609
Submission : 2007-06-13
Status :
Type : II
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-03
Pay. Date : 2022-04-21
DMF Number : 34268
Submission : 2019-10-29
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-13
DMF Number : 10976
Submission : 1994-07-11
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25615
Submission : 2011-12-20
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 16932
Submission : 2003-10-28
Status :
Type : II
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