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