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