01 1HUYA Bioscience International
01 1HBI-8000 DRUG SUBSTANCE
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29907
Submission : 2015-11-13
Status : Inactive
Type : II
A Chidamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chidamide, including repackagers and relabelers. The FDA regulates Chidamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chidamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Chidamide supplier is an individual or a company that provides Chidamide active pharmaceutical ingredient (API) or Chidamide finished formulations upon request. The Chidamide suppliers may include Chidamide API manufacturers, exporters, distributors and traders.
click here to find a list of Chidamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chidamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Chidamide active pharmaceutical ingredient (API) in detail. Different forms of Chidamide DMFs exist exist since differing nations have different regulations, such as Chidamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chidamide DMF submitted to regulatory agencies in the US is known as a USDMF. Chidamide USDMF includes data on Chidamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chidamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chidamide suppliers with USDMF on PharmaCompass.
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