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