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