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