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