CL
Cipla Ltd
Manufacturer · Mumbai, India
GMP
Open FDA warning letter 320-24-11 dated 2023-11-17 (CGMP, Pithampur finished-dosage plant); no close-out letter found. See the FDA enforcement tracker
Overview
Cipla is a Mumbai-based pharmaceutical company incorporated in 1935 that makes APIs and finished medicines, with plants in India and US subsidiary sites such as InvaGen in New York. It holds active US Type II DMFs for Difelikefalin, Icatibant, Terlipressin. FDA inspects its sites regularly; the November 2023 warning letter for the Pithampur plant has no posted close-out letter.
Capabilities
- API manufacturing
- Respiratory and injectable products
- Finished dosage manufacturing
- Global regulatory filings
Quality signals
| GMP evidence | Yes |
|---|---|
| Certificates of analysis | Not found |
| Third-party testing | Not found |
| ISO certification | Not found |
| Makes own product | Yes, in-house production |