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