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