Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
01 1CHLORMEZANONE
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 : 4654
Submission : 1982-07-27
Status : Inactive
Type : II
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A Lobak manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lobak, including repackagers and relabelers. The FDA regulates Lobak manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lobak 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 Lobak supplier is an individual or a company that provides Lobak active pharmaceutical ingredient (API) or Lobak finished formulations upon request. The Lobak suppliers may include Lobak API manufacturers, exporters, distributors and traders.
click here to find a list of Lobak suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lobak DMF (Drug Master File) is a document detailing the whole manufacturing process of Lobak active pharmaceutical ingredient (API) in detail. Different forms of Lobak DMFs exist exist since differing nations have different regulations, such as Lobak USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lobak DMF submitted to regulatory agencies in the US is known as a USDMF. Lobak USDMF includes data on Lobak's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lobak USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lobak suppliers with USDMF on PharmaCompass.
