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