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