Drug factory · FDA FEI 3004006229
Alivus Life Sciences Limited
Plot No. 3109, GIDC Industrial Estate, District Bharuch, Ankleshwar, India
Problems found, fixed voluntarily at FDA's last inspection, Jan 31, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amiodarone | Makes the active ingredient | AuroMedics Pharma LLC | 55150-180, 55150-181, 55150-182 |
| Aprepitant | Makes the active ingredient | Heron Therapeutics, Inc. | 47426-201, 47426-401 |
| Fluconazole | Makes the active ingredient and tests it | BluePoint Laboratories. | 68001-251, 68001-252, 68001-253 +1 |
| Levocetirizine | Makes the active ingredient | Ranbaxy Laboratories Inc. | 63304-433 |
| Tofacitinib | Makes the active ingredient | Hikma Pharmaceuticals USA Inc. | 0054-0821 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 31, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 5, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 27, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 15, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label.