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