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