SP
Sun Pharmaceutical Industries Ltd
Manufacturer · Mumbai, India
GMP
Open FDA warning letters: Halol, Gujarat site (issued 2022-12-15, amended 2023-10-16) and Dadra site (2024-06-18); no close-out letter found. See the FDA enforcement tracker
Overview
Sun Pharma is an Indian generics and specialty drug maker founded in 1983. It manufactures APIs, intermediates and finished dosage forms, including injectables, at a network of about 40 plants. On the FDA DMF list it holds active Type II DMFs for these peptide APIs: Bivalirudin, Cetrorelix, Eptifibatide, Exenatide, Ganirelix, Icatibant, Lanreotide, Leuprolide, Linaclotide, Liraglutide, Octreotide, Pramlintide, Semaglutide, Sincalide, Teriparatide. FDA has inspected several of its plants, and warning letters for the Halol and Dadra sites have no posted close-out letter.
Capabilities
- Peptide API manufacturing
- Complex injectables
- Lyophilized products
- Process chemistry R&D
- 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 |
Sources
- sunpharma.com/about-us/
- sunpharma.com/spain/
- fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs
- google.com/finance/quote/SUNPHARMA:NSE
- fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun
- fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun