Drug factory · FDA FEI 3005857289
Cipla Limited
285, 286, 287, KIADB, IV Phase, Industrial area Bommasandra-Jigani Link Road, Bengaluru, India
Problems found, fixed voluntarily at FDA's last inspection, May 30, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Esomeprazole | Makes the active ingredient | Cipla USA., Inc. | 69097-528, 69097-529 |
| Lenalidomide | Makes the active ingredient and tests it | Cipla USA., Inc., Exelan Pharmaceuticals, Inc. | 69097-604, 76282-696, 76282-697 +4 |
| Nilotinib | Makes the active ingredient | Cipla USA., Inc. | 69097-030, 69097-031, 69097-032 |
| Pomalidomide | Makes the active ingredient | Cipla USA., Inc. | 69097-036, 69097-037, 69097-038 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 30, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 24, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 12, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 17, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.