Drug factory · FDA FEI 3002806702
Cipla Limited
Plot D-7, D-22, D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune, India
Problems found, fixed voluntarily at FDA's last inspection, May 8, 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: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Abacavir | Makes the active ingredient |
Cipla USA., Inc. |
69097-514 |
| Arformoterol | Makes the active ingredient |
Cipla USA., Inc. |
69097-168 |
| Celecoxib | Makes it, makes the active ingredient and tests it |
Cipla USA., Inc., Northstar Rx LLC., Quallent Pharmaceuticals Health LLC |
69097-420, 69097-421, 69097-422 +7 |
| Darunavir | Makes the active ingredient |
Cipla USA., Inc., Exelan Pharmaceuticals, Inc. |
69097-244, 69097-248, 76282-737 +1 |
| Deferasirox | Makes it and makes the active ingredient |
Cipla USA., Inc. |
69097-550, 69097-560, 69097-570 |
| Emtricitabine | Makes the active ingredient and tests it |
Cipla USA., Inc. |
69097-642 |
| Emtricitabine and Tenofovir | Makes the active ingredient |
Cipla USA., Inc. |
69097-209, 69097-741 |
| Entecavir | Makes the active ingredient |
Cipla USA., Inc., Northstar Rx LLC. |
69097-425, 69097-426, 16714-717 +1 |
| Esomeprazole | Makes it, makes the active ingredient and tests it |
Cipla USA., Inc. |
69097-507, 69097-508, 69097-527 +2 |
| Fosfomycin | Makes it and tests it |
Cipla USA., Inc. |
69097-579 |
| Nintedanib | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-639, 69097-641 |
| Pantoprazole | Makes it and tests it |
Cipla USA., Inc. |
69097-531 |
| Pregabalin | Makes it |
Cipla USA., Inc. |
69097-677, 69097-678, 69097-679 +5 |
| Sertraline | Makes it, tests it, packages it and labels it |
Cipla USA., Inc., Quallent Pharmaceuticals Health LLC |
69097-833, 69097-834, 69097-835 +2 |
| Sevelamer | Makes it, tests it and packages it |
Cipla USA., Inc. |
69097-967 |
| Tenofovir | Makes it, makes the active ingredient, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-533 |
| Topiramate | Makes it |
Cipla USA., Inc. |
69097-122, 69097-123, 69097-124 +1 |
| Zonisamide | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-861 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| May 8, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 20, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 30, 2018 | No problems found | Drug Quality Assurance | — |
| Dec 9, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 23, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 1, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 26, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.