Drug factory · FDA FEI 3003696998
Zydus Lifesciences Limited
291, G.I.D.C. ESTATE, Ankleshwar, India
No problems found at FDA's last inspection, Mar 14, 2025.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2011: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Duloxetine | Makes the active ingredient, tests it, packages it and labels it | Cipla USA., Inc. | 69097-297, 69097-298, 69097-299 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 14, 2025 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2019 | No problems found | Drug Quality Assurance | — |
| Jul 4, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 4, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.