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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fidaresstat manufacturer or Fidaresstat supplier.
A Fidaresstat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fidaresstat, including repackagers and relabelers. The FDA regulates Fidaresstat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fidaresstat 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 Fidaresstat supplier is an individual or a company that provides Fidaresstat active pharmaceutical ingredient (API) or Fidaresstat finished formulations upon request. The Fidaresstat suppliers may include Fidaresstat API manufacturers, exporters, distributors and traders.
click here to find a list of Fidaresstat suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fidaresstat DMF (Drug Master File) is a document detailing the whole manufacturing process of Fidaresstat active pharmaceutical ingredient (API) in detail. Different forms of Fidaresstat DMFs exist exist since differing nations have different regulations, such as Fidaresstat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fidaresstat DMF submitted to regulatory agencies in the US is known as a USDMF. Fidaresstat USDMF includes data on Fidaresstat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fidaresstat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fidaresstat suppliers with USDMF on PharmaCompass.
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