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