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