Sanofi Winthrop Industrie
Overview
Sanofi Winthrop Industrie is a subsidiary of Sanofi, a global biopharmaceutical company based in France. It is involved in the manufacturing and distribution of pharmaceutical products, focusing on improving patient care through innovation.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Sanofi Winthrop Industrie is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
Sanofi Winthrop Industrie holds 7 active (9 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- CABAZITAXEL ACETONE SOLVATEActive2010-01-29
- RPR106721 - POMA (INTERMEDIATE)Active2009-12-15
- ZOLPIDEM TARTRATEActive2007-10-30
- DRONEDARONE HYDROCHLORIDEActive2005-06-08
- CLOPIDOGREL BISULFATE FORM IIActive2000-03-31
- PROMETHAZINE HCLActive1972-06-09
- CHLORPROMAZINE HYDROCHLORIDEActive1970-04-23
- CORDARONE (AMIODARONE HYDROCHLORIDE)Inactive1983-05-05
- MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN AMBARES, FRANCE.Inactive1983-04-25
FDA compliance signals
13 FDA enforcement records linked to this company.
- 4832024-01-26
Validation lacking for sterile drug products
- 4832024-01-26
Equipment Design, Size and Location
- 4832024-01-26
Procedures not in writing, fully followed
- 4832024-01-26
Buildings of Suitable Size, Construction, Location
- 4832018-06-15
Procedures not in writing, fully followed
- 4832016-10-31
Test methods
- 4832016-10-31
Changes to Procedures Not Reviewed, Approved
- 4832016-10-31
Training , Education , Experience overall
- 4832012-09-18
Cleaning / Sanitizing / Maintenance
- 4832012-09-18
Validation lacking for sterile drug products
- 4832012-09-18
Defined areas of adequate size for operations
- 4832012-09-18
Procedures for sterile drug products
- 4832012-09-18
Investigations of discrepancies, failures
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