Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Siegfried AG
01 1LEVONORDEFRIN
02 1LEVONORDEFRIN MNFG AT RENSSELAER, NY FACILITIES
01 1France
02 1Switzerland
01 1Active
02 1Inactive
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 : 3723
Submission : 1980-02-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16699
Submission : 2003-07-11
Status : Active
Type : II
A Nordefrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nordefrin, including repackagers and relabelers. The FDA regulates Nordefrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nordefrin 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 Nordefrin supplier is an individual or a company that provides Nordefrin active pharmaceutical ingredient (API) or Nordefrin finished formulations upon request. The Nordefrin suppliers may include Nordefrin API manufacturers, exporters, distributors and traders.
click here to find a list of Nordefrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nordefrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nordefrin active pharmaceutical ingredient (API) in detail. Different forms of Nordefrin DMFs exist exist since differing nations have different regulations, such as Nordefrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nordefrin DMF submitted to regulatory agencies in the US is known as a USDMF. Nordefrin USDMF includes data on Nordefrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nordefrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nordefrin suppliers with USDMF on PharmaCompass.
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