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