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.
Therapeutic areas
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
Buildings of Suitable Size, Construction, Location
- 4832024-01-26
Procedures not in writing, fully followed
- 4832024-01-26
Validation lacking for sterile drug products
- 4832024-01-26
Equipment Design, Size and Location
- 4832018-06-15
Procedures not in writing, fully followed
- 4832016-10-31
Training , Education , Experience overall
- 4832016-10-31
Changes to Procedures Not Reviewed, Approved
- 4832016-10-31
Test methods
- 4832012-09-18
Procedures for sterile drug products
- 4832012-09-18
Investigations of discrepancies, failures
- 4832012-09-18
Defined areas of adequate size for operations
- 4832012-09-18
Cleaning / Sanitizing / Maintenance
- 4832012-09-18
Validation lacking for sterile drug products
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