Drug factory · FDA FEI 3004086396
Zentiva Private Limited
Plot No 3501 to 3515, 6301 to 6313 & 16 Meter Road/c, GIDC Estate, Ankleshwar, India
No problems found at FDA's last inspection, Feb 13, 2025.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Glyburide | Makes the active ingredient | Teva Pharmaceuticals USA, Inc. | 0093-9364, 0093-9433, 0093-9477 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 13, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 7, 2019 | No problems found | Drug Quality Assurance | — |
| Jul 1, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 19, 2012 | No problems found | Drug Quality Assurance | — |
| Sep 4, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.