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