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