Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1OLTA PHARMACEUTICALS CORP
01 1LINDANE
02 1LINDANE, USP
01 1France
02 1U.S.A
01 2Inactive
01 2Blank
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 : 8167
Submission : 1989-08-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22259
Submission : 2009-01-08
Status : Inactive
Type : II
A Gammexane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gammexane, including repackagers and relabelers. The FDA regulates Gammexane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gammexane 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 Gammexane supplier is an individual or a company that provides Gammexane active pharmaceutical ingredient (API) or Gammexane finished formulations upon request. The Gammexane suppliers may include Gammexane API manufacturers, exporters, distributors and traders.
click here to find a list of Gammexane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gammexane DMF (Drug Master File) is a document detailing the whole manufacturing process of Gammexane active pharmaceutical ingredient (API) in detail. Different forms of Gammexane DMFs exist exist since differing nations have different regulations, such as Gammexane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gammexane DMF submitted to regulatory agencies in the US is known as a USDMF. Gammexane USDMF includes data on Gammexane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gammexane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gammexane suppliers with USDMF on PharmaCompass.
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