01 1PCAS
02 1Aurobindo Pharma Limited
03 2Emcure Pharmaceuticals
04 1Hainan Poly Pharm
05 1Hetero Drugs
06 2Jubilant Generics
07 1Lunan Pharmaceutical
08 1MSN Laboratories
09 1Sterile India Pvt. Ltd
10 1Sun Pharmaceutical Industries Limited
11 1Yangtze River Pharmaceutical Group
12 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.
13 1Zydus Lifesciences
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28375
Submission : 2014-06-09
Status :
Type : II
61
PharmaCompass offers a list of Esomeprazole Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Esomeprazole Sodium manufacturer or Esomeprazole Sodium supplier for your needs.
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PharmaCompass also assists you with knowing the Esomeprazole Sodium API Price utilized in the formulation of products. Esomeprazole Sodium API Price is not always fixed or binding as the Esomeprazole Sodium Price is obtained through a variety of data sources. The Esomeprazole Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Esomeprazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Sodium, including repackagers and relabelers. The FDA regulates Esomeprazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Sodium 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 Esomeprazole Sodium supplier is an individual or a company that provides Esomeprazole Sodium active pharmaceutical ingredient (API) or Esomeprazole Sodium finished formulations upon request. The Esomeprazole Sodium suppliers may include Esomeprazole Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Esomeprazole Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esomeprazole Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Esomeprazole Sodium active pharmaceutical ingredient (API) in detail. Different forms of Esomeprazole Sodium DMFs exist exist since differing nations have different regulations, such as Esomeprazole Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esomeprazole Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Esomeprazole Sodium USDMF includes data on Esomeprazole Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esomeprazole Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
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