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