Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
02 1Dr. Reddy's Laboratories
03 2TAPI Technology & API Services
04 5Unimark Remedies
05 1Apotex Pharmachem
06 1Aurobindo Pharma Limited
07 1China Gateway Pharmaceutical Co Ltd
08 1Cipla
09 1Formosa Laboratories
10 1Hetero Drugs
11 1LG Life Sciences
12 1Laurus Labs
13 1Linhai Huanan Chemicals Co., Ltd.
14 1Lunan Pharmaceutical
15 3MSN Laboratories
16 1Macleods Pharmaceuticals Limited
17 1Melody Healthcare
18 1Morepen Laboratories
19 1SINTENOVO, S.A. DE C.V.
20 1Sun Pharmaceutical Industries Limited
21 1Torrent Pharmaceuticals Limited
22 1Unichem Laboratories Limited
23 1Viatris
24 1Zenfold Sustainable Technologies
25 2Zhejiang Tianyu Pharmaceutical Co., Ltd
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16243
Submission : 2002-11-15
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-18
Pay. Date : 2012-12-31
DMF Number : 24516
Submission : 2010-12-31
Status :
Type : II
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 : 19829
Submission : 2006-10-04
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24324
Submission : 2010-11-02
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2017-02-22
DMF Number : 31413
Submission : 2017-05-09
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20564
Submission : 2007-05-31
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26439
Submission : 2012-11-06
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23837
Submission : 2010-06-02
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21893
Submission : 2008-08-14
Status :
Type : II
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A Kipres manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kipres, including repackagers and relabelers. The FDA regulates Kipres manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kipres API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Kipres supplier is an individual or a company that provides Kipres active pharmaceutical ingredient (API) or Kipres finished formulations upon request. The Kipres suppliers may include Kipres API manufacturers, exporters, distributors and traders.
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A Kipres DMF (Drug Master File) is a document detailing the whole manufacturing process of Kipres active pharmaceutical ingredient (API) in detail. Different forms of Kipres DMFs exist exist since differing nations have different regulations, such as Kipres USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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