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