Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 2Minakem
02 2Granules India Limited
03 2Metrochem API Private Limited
04 3Dr. Reddy's Laboratories
05 2Alkem Laboratories
06 2Aurobindo Pharma Limited
07 1Chromo Laboratories
08 2Cipla
09 1Everest Organics
10 3F.I.S. Fabbrica Italiana Sintetici
11 4Glenmark Life Sciences
12 1HEC Pharm
13 5Hetero Drugs
14 5Jubilant Generics
15 1LONZEAL PHARMACEUTICALS CO LTD
16 1Lee Pharma
17 1Lupin Ltd
18 3MSN Laboratories
19 2Macleods Pharmaceuticals Limited
20 1Murli Krishna Pharma
21 1Ningbo Menovo Pharmaceutical
22 1Perrigo API India Private Limited
23 1RANBAXY LABORATORIES LIMITED
24 2Raks Pharma
25 2Shouguang Fukang Pharmaceutical Co., Ltd
26 1Srini Pharmaceuticals
27 2Sun Pharmaceutical Industries Limited
28 2Torrent Pharmaceuticals Limited
29 1UQUIFA
30 1Vasudha Pharma Chem
31 3Viatris
32 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
33 1Zhejiang Yongtai Technology
34 2Zydus Lifesciences
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28462
Submission : 2014-07-08
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-26
Pay. Date : 2023-04-18
DMF Number : 36556
Submission : 2021-12-24
Status :
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 : 35400
Submission : 2020-11-28
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2013-01-16
DMF Number : 23994
Submission : 2010-07-26
Status :
Type : II
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-25
Pay. Date : 2019-10-16
DMF Number : 34026
Submission : 2019-10-04
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37233
Submission : 2022-07-01
Status :
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 : 35519
Submission : 2020-12-29
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-04-21
DMF Number : 28127
Submission : 2014-03-31
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-01-16
DMF Number : 25858
Submission : 2012-03-30
Status :
Type : II
A Esomeprazole Magnesium Trihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Magnesium Trihydrate, including repackagers and relabelers. The FDA regulates Esomeprazole Magnesium Trihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Magnesium Trihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Esomeprazole Magnesium Trihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esomeprazole Magnesium Trihydrate supplier is an individual or a company that provides Esomeprazole Magnesium Trihydrate active pharmaceutical ingredient (API) or Esomeprazole Magnesium Trihydrate finished formulations upon request. The Esomeprazole Magnesium Trihydrate suppliers may include Esomeprazole Magnesium Trihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Esomeprazole Magnesium Trihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esomeprazole Magnesium Trihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Esomeprazole Magnesium Trihydrate active pharmaceutical ingredient (API) in detail. Different forms of Esomeprazole Magnesium Trihydrate DMFs exist exist since differing nations have different regulations, such as Esomeprazole Magnesium Trihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esomeprazole Magnesium Trihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Esomeprazole Magnesium Trihydrate USDMF includes data on Esomeprazole Magnesium Trihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esomeprazole Magnesium Trihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esomeprazole Magnesium Trihydrate suppliers with USDMF on PharmaCompass.
We have 34 companies offering Esomeprazole Magnesium Trihydrate
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