A benfothiamine DMF (Drug Master File) is a document detailing the whole manufacturing process of benfothiamine active pharmaceutical ingredient (API) in detail. Different forms of benfothiamine DMFs exist exist since differing nations have different regulations, such as benfothiamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A benfothiamine DMF submitted to regulatory agencies in the US is known as a USDMF. benfothiamine USDMF includes data on benfothiamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The benfothiamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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