Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
01 1TILUDRONATE DISODIUM DRUG SUBSTANCE
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 : 11821
Submission : 1996-01-23
Status : Inactive
Type : II
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A Cl-TMBP manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cl-TMBP, including repackagers and relabelers. The FDA regulates Cl-TMBP manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cl-TMBP 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 Cl-TMBP supplier is an individual or a company that provides Cl-TMBP active pharmaceutical ingredient (API) or Cl-TMBP finished formulations upon request. The Cl-TMBP suppliers may include Cl-TMBP API manufacturers, exporters, distributors and traders.
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A Cl-TMBP DMF (Drug Master File) is a document detailing the whole manufacturing process of Cl-TMBP active pharmaceutical ingredient (API) in detail. Different forms of Cl-TMBP DMFs exist exist since differing nations have different regulations, such as Cl-TMBP USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cl-TMBP DMF submitted to regulatory agencies in the US is known as a USDMF. Cl-TMBP USDMF includes data on Cl-TMBP's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cl-TMBP USDMF is kept confidential to protect the manufacturer’s intellectual property.
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