Zydus Lifesciences Limited
Overview
Zydus Lifesciences Limited, formerly known as Cadila Healthcare, is a leading Indian pharmaceutical company engaged in the discovery, development, and manufacture of a wide range of healthcare products. The company is known for its strong presence in the generics market and is committed to delivering affordable and innovative medicines globally.
Therapeutic areas
API / Drug Master Files
Zydus Lifesciences Limited holds 163 active (166 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.
- SITAGLIPTIN HYDROCHLORIDEActive2026-03-31
- EMPAGLIFLOZINActive2026-03-31
- DEUCRAVACITINIBActive2025-12-30
- DONEPEZIL HYDROCHLORIDE USP (PROCESS-II)Active2025-12-30
- BENZGALANTAMINE GLUCONATEActive2025-12-26
- IVACAFTORActive2025-12-19
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP (PROCESS-III)Active2025-12-17
- SAROGLITAZAR MAGNESIUMActive2025-10-02
- VISMODEGIBActive2025-07-02
- TOLVAPTANActive2025-06-27
- DAPAGLIFLOZIN PROPANEDIOLActive2025-04-18
- PAPAVERINE HYDROCHLORIDEActive2025-04-18
- IPRATROPIUM BROMIDE USPActive2025-01-23
- CARGLUMIC ACIDActive2025-01-22
- DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE USPActive2024-12-31
Showing 15 of 166 Drug Master Files.
FDA compliance signals
49 FDA enforcement records linked to this company.
- warning_letter2026-06-02
FDA Warning Letter (drug product)
- warning_letter2024-08-29
FDA Warning Letter (drug product)
- 4832024-04-23
Environmental Monitoring System
- 4832024-04-23
Computer control of master formula records
- 4832024-04-23
Validation lacking for sterile drug products
- 4832024-04-23
Absence of Written Procedures
- 4832024-04-23
Training , Education , Experience overall
- 4832024-04-23
Investigations of discrepancies, failures
- 4832024-04-23
Following/documenting laboratory controls
- 4832024-04-23
Procedures for sterile drug products
- 4832024-04-23
Cleaning SOPs/instructions
- 4832024-04-23
Cleaning / Sanitizing / Maintenance
- 4832024-03-27
Buildings not maintained in good state of repair
- 4832024-03-27
Cleaning / Sanitizing / Maintenance
- 4832024-03-27
Procedures for sterile drug products
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