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