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