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