Drug factory · FDA FEI 3003952717
Sun Pharmaceutical Industries Limited
Plot No 24/2, 25, Phase IV, GIDC, Panoli, Bharuch, India
No problems found at FDA's last inspection, Jun 13, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Esomeprazole | Makes the active ingredient | Caraco Pharmaceutical Laboratories, Ltd. | 63304-734, 63304-735 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 13, 2025 | No problems found | Drug Quality Assurance | — |
| Nov 8, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 4, 2018 | No problems found | Drug Quality Assurance | — |
| Jul 31, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 14, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 26, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.