Drug factory · FDA FEI 3003600340
Syngene International Limited
Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, India
No problems found at FDA's last inspection, Feb 20, 2025.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2013: 4 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Esmolol | Tests it | Baxter Healthcare Corporation | 10019-055, 10019-075, 10019-115 |
| Odevixibat | Makes the active ingredient and tests it | Ipsen Biopharmaceuticals, Inc. | 15054-3301, 15054-3302, 15054-3303 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 20, 2025 | No problems found | Drug Quality Assurance | — |
| Aug 21, 2019 | No problems found | Drug Quality Assurance | — |
| Jul 11, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 18, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.