01 1SIGMA TAU
01 1DL-3,4- DIHYDROXYPHENYLGLYCOL #D9753FD
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7370
Submission : 1988-03-01
Status : Inactive
Type : II
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A DHPG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DHPG, including repackagers and relabelers. The FDA regulates DHPG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DHPG API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A DHPG supplier is an individual or a company that provides DHPG active pharmaceutical ingredient (API) or DHPG finished formulations upon request. The DHPG suppliers may include DHPG API manufacturers, exporters, distributors and traders.
click here to find a list of DHPG suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A DHPG DMF (Drug Master File) is a document detailing the whole manufacturing process of DHPG active pharmaceutical ingredient (API) in detail. Different forms of DHPG DMFs exist exist since differing nations have different regulations, such as DHPG USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DHPG DMF submitted to regulatory agencies in the US is known as a USDMF. DHPG USDMF includes data on DHPG's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DHPG USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DHPG suppliers with USDMF on PharmaCompass.
