A Uracil-2-13C DMF (Drug Master File) is a document detailing the whole manufacturing process of Uracil-2-13C active pharmaceutical ingredient (API) in detail. Different forms of Uracil-2-13C DMFs exist exist since differing nations have different regulations, such as Uracil-2-13C USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Uracil-2-13C DMF submitted to regulatory agencies in the US is known as a USDMF. Uracil-2-13C USDMF includes data on Uracil-2-13C's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Uracil-2-13C USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Uracil-2-13C suppliers with USDMF on PharmaCompass.