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