A Calcium (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate tetrahydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate tetrahydrate active pharmaceutical ingredient (API) in detail. Different forms of Calcium (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate tetrahydrate DMFs exist exist since differing nations have different regulations, such as Calcium (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate tetrahydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate tetrahydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate tetrahydrate USDMF includes data on Calcium (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate tetrahydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate tetrahydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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