A Poloxamer-188 DMF (Drug Master File) is a document detailing the whole manufacturing process of Poloxamer-188 active pharmaceutical ingredient (API) in detail. Different forms of Poloxamer-188 DMFs exist exist since differing nations have different regulations, such as Poloxamer-188 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Poloxamer-188 DMF submitted to regulatory agencies in the US is known as a USDMF. Poloxamer-188 USDMF includes data on Poloxamer-188's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Poloxamer-188 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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