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