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