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.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Zydus Lifesciences Limited 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
Zydus Lifesciences Limited holds 153 active (156 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.
- RESMETIROMActive2026-04-29
- EMPAGLIFLOZINActive2026-03-31
- SITAGLIPTIN HYDROCHLORIDEActive2026-03-31
- DONEPEZIL HYDROCHLORIDE USP (PROCESS-II)Active2025-12-30
- DEUCRAVACITINIBActive2025-12-30
- 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 PROPANEDIOL MONOHYDRATE USPActive2024-12-31
- GABAPENTIN ENACARBILActive2024-12-30
- SUVOREXANTActive2024-12-30
- LETROZOLE USPActive2024-11-18
Showing 15 of 156 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- warning_letter2026-06-02
FDA Warning Letter (drug product)
- 4832026-05-05
Floors, walls, ceiling surfaces
- 4832026-05-05
Computer control of master formula records
- 4832026-05-05
Validation lacking for sterile drug products
- 4832026-05-05
Procedures for sterile drug products
- 4832026-05-05
In-process materials characteristics testing
- 4832026-05-05
Absence of Written Procedures
- 4832026-05-05
Investigations of discrepancies, failures
- warning_letter2024-08-29
FDA Warning Letter (drug product)
- 4832024-04-23
Following/documenting laboratory controls
- 4832024-04-23
Validation lacking for sterile drug products
- 4832024-04-23
Cleaning SOPs/instructions
- 4832024-04-23
Absence of Written Procedures
- 4832024-04-23
Computer control of master formula records
- 4832024-04-23
Environmental Monitoring System
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