A 177Lu-Labeled PSMA-617 DMF (Drug Master File) is a document detailing the whole manufacturing process of 177Lu-Labeled PSMA-617 active pharmaceutical ingredient (API) in detail. Different forms of 177Lu-Labeled PSMA-617 DMFs exist exist since differing nations have different regulations, such as 177Lu-Labeled PSMA-617 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 177Lu-Labeled PSMA-617 DMF submitted to regulatory agencies in the US is known as a USDMF. 177Lu-Labeled PSMA-617 USDMF includes data on 177Lu-Labeled PSMA-617's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 177Lu-Labeled PSMA-617 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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