A 027, FK DMF (Drug Master File) is a document detailing the whole manufacturing process of 027, FK active pharmaceutical ingredient (API) in detail. Different forms of 027, FK DMFs exist exist since differing nations have different regulations, such as 027, FK USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 027, FK DMF submitted to regulatory agencies in the US is known as a USDMF. 027, FK USDMF includes data on 027, FK's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 027, FK USDMF is kept confidential to protect the manufacturer’s intellectual property.
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