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