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