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