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