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