Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
01 1EMULPHOR EL - 620 & EL - 719
01 1France
01 1Inactive
01 1Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 365
Submission : 1960-03-03
Status : Inactive
Type : IV
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A Ethanol, 2-(9-octadecenyloxy)-, (Z)- manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethanol, 2-(9-octadecenyloxy)-, (Z)-, including repackagers and relabelers. The FDA regulates Ethanol, 2-(9-octadecenyloxy)-, (Z)- manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethanol, 2-(9-octadecenyloxy)-, (Z)- API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ethanol, 2-(9-octadecenyloxy)-, (Z)- DMF (Drug Master File) is a document detailing the whole manufacturing process of Ethanol, 2-(9-octadecenyloxy)-, (Z)- active pharmaceutical ingredient (API) in detail. Different forms of Ethanol, 2-(9-octadecenyloxy)-, (Z)- DMFs exist exist since differing nations have different regulations, such as Ethanol, 2-(9-octadecenyloxy)-, (Z)- USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ethanol, 2-(9-octadecenyloxy)-, (Z)- DMF submitted to regulatory agencies in the US is known as a USDMF. Ethanol, 2-(9-octadecenyloxy)-, (Z)- USDMF includes data on Ethanol, 2-(9-octadecenyloxy)-, (Z)-'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ethanol, 2-(9-octadecenyloxy)-, (Z)- USDMF is kept confidential to protect the manufacturer’s intellectual property.
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