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