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