A Biguanide, 1-phenethyl-, hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Biguanide, 1-phenethyl-, hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Biguanide, 1-phenethyl-, hydrochloride DMFs exist exist since differing nations have different regulations, such as Biguanide, 1-phenethyl-, hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Biguanide, 1-phenethyl-, hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Biguanide, 1-phenethyl-, hydrochloride USDMF includes data on Biguanide, 1-phenethyl-, hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biguanide, 1-phenethyl-, hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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