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