01 1Tokyo Chemical Industry
01 1DICHLOROACETIC ACID SODIUM SALT
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7557
Submission : 1988-06-22
Status : Inactive
Type : II
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A DCA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DCA, including repackagers and relabelers. The FDA regulates DCA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DCA 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 DCA supplier is an individual or a company that provides DCA active pharmaceutical ingredient (API) or DCA finished formulations upon request. The DCA suppliers may include DCA API manufacturers, exporters, distributors and traders.
click here to find a list of DCA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A DCA DMF (Drug Master File) is a document detailing the whole manufacturing process of DCA active pharmaceutical ingredient (API) in detail. Different forms of DCA DMFs exist exist since differing nations have different regulations, such as DCA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DCA DMF submitted to regulatory agencies in the US is known as a USDMF. DCA USDMF includes data on DCA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DCA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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