01 1Sumitomo Chemical
02 1Blank
01 2SNK-860
01 1Japan
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17411
Submission : 2004-05-24
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14327
Submission : 1999-08-02
Status : Inactive
Type : II
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PharmaCompass offers a list of Fidaresstat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Fidaresstat manufacturer or Fidaresstat supplier for your needs.
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A FID manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FID, including repackagers and relabelers. The FDA regulates FID manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FID 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 FID supplier is an individual or a company that provides FID active pharmaceutical ingredient (API) or FID finished formulations upon request. The FID suppliers may include FID API manufacturers, exporters, distributors and traders.
click here to find a list of FID suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A FID DMF (Drug Master File) is a document detailing the whole manufacturing process of FID active pharmaceutical ingredient (API) in detail. Different forms of FID DMFs exist exist since differing nations have different regulations, such as FID USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FID DMF submitted to regulatory agencies in the US is known as a USDMF. FID USDMF includes data on FID's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FID USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FID suppliers with USDMF on PharmaCompass.
