Drug factory · FDA FEI 3002806691
Cipla Limited
Virgonagar, Old Madras Road, Bengaluru, India
Problems found, fixed voluntarily at FDA's last inspection, Nov 13, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 0 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amlodipine | Makes the active ingredient and tests it | Cipla USA., Inc., Quallent Pharmaceuticals Health LLC | 69097-126, 69097-127, 69097-128 +3 |
| Esomeprazole | Makes the active ingredient and tests it | Cipla USA., Inc. | 69097-507, 69097-508, 69097-527 |
| Lenalidomide | Makes the active ingredient and tests it | Cipla USA., Inc. | 69097-381, 69097-382, 69097-383 +2 |
| Nintedanib | Makes the active ingredient and tests it | Cipla USA., Inc., Exelan Pharmaceuticals, Inc. | 69097-639, 69097-641, 76282-786 +1 |
| Pantoprazole | Makes the active ingredient and tests it | Cipla USA., Inc. | 69097-531 |
| Topiramate | Makes the active ingredient and tests it | Cipla USA., Inc. | 69097-122, 69097-123, 69097-124 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 13, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 31, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 19, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 5, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 25, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 28, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 9, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.