Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
01 1PROPIONYL PROMAZINE (PROPIOPROMAZINE)
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 : 3363
Submission : 1978-08-10
Status : Inactive
Type : II
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A Combelen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Combelen, including repackagers and relabelers. The FDA regulates Combelen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Combelen 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 Combelen supplier is an individual or a company that provides Combelen active pharmaceutical ingredient (API) or Combelen finished formulations upon request. The Combelen suppliers may include Combelen API manufacturers, exporters, distributors and traders.
click here to find a list of Combelen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Combelen DMF (Drug Master File) is a document detailing the whole manufacturing process of Combelen active pharmaceutical ingredient (API) in detail. Different forms of Combelen DMFs exist exist since differing nations have different regulations, such as Combelen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Combelen DMF submitted to regulatory agencies in the US is known as a USDMF. Combelen USDMF includes data on Combelen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Combelen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Combelen suppliers with USDMF on PharmaCompass.
