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