Drug factory · FDA FEI 3008957483
Zydus Lifesciences Limited
Plot No. 1 B, PHARMEZ Special Economic Zone, Sarkhej Bavla N.H.No. 8A, Matoda, Tal.: Sanand, Ahmedabad, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 19, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2013: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Rivastigmine | Makes it and tests it | Cadila Healthcare Limited, Northstar Rx LLC., Zydus Lifesciences Limited, Zydus Pharmaceuticals (USA) Inc. | 70771-1949, 70771-1950, 70771-1951 +9 |
| Scopolamine | Makes it and tests it | Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. | 70771-1787, 70710-1846 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 13, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 21, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.