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