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