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