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