Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
01 1ACESULFAME K (ACETOSULFAM-KGERMAN)
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 : 3593
Submission : 1979-06-15
Status : Inactive
Type : II
A Acesulfamo manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acesulfamo, including repackagers and relabelers. The FDA regulates Acesulfamo manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acesulfamo 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 Acesulfamo supplier is an individual or a company that provides Acesulfamo active pharmaceutical ingredient (API) or Acesulfamo finished formulations upon request. The Acesulfamo suppliers may include Acesulfamo API manufacturers, exporters, distributors and traders.
click here to find a list of Acesulfamo suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acesulfamo DMF (Drug Master File) is a document detailing the whole manufacturing process of Acesulfamo active pharmaceutical ingredient (API) in detail. Different forms of Acesulfamo DMFs exist exist since differing nations have different regulations, such as Acesulfamo USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acesulfamo DMF submitted to regulatory agencies in the US is known as a USDMF. Acesulfamo USDMF includes data on Acesulfamo's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acesulfamo USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acesulfamo suppliers with USDMF on PharmaCompass.
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