A 3-ingenol angelate DMF (Drug Master File) is a document detailing the whole manufacturing process of 3-ingenol angelate active pharmaceutical ingredient (API) in detail. Different forms of 3-ingenol angelate DMFs exist exist since differing nations have different regulations, such as 3-ingenol angelate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 3-ingenol angelate DMF submitted to regulatory agencies in the US is known as a USDMF. 3-ingenol angelate USDMF includes data on 3-ingenol angelate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 3-ingenol angelate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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