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