Drug factory · FDA FEI 3008861605
Amneal Pharmaceuticals, LLC
47 Colonial Dr Bldg B, Piscataway, NJ, United States
No problems found at FDA's last inspection, Apr 30, 2026.
No Action Indicated: inspectors found no objectionable conditions.
16 drug inspections on record since 2013: 7 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acyclovir | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-836 |
| Bexarotene | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-2088 |
| Clindamycin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-2031 |
| Clobetasol | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-1732 |
| Dapsone | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-1627 |
| Diclofenac and Misoprostol | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-436, 65162-438 |
| Doxepin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-1733 |
| Estradiol | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-2448, 69238-2449, 69238-2450 +2 |
| Lidocaine | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-918 |
| Mupirocin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-2029 |
| Penciclovir | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-1791 |
| Tretinoin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-2323 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 30, 2026 | No problems found | Drug Quality Assurance | — |
| Apr 30, 2026 | No problems found | Drug Quality Assurance | — |
| Mar 28, 2025 | No problems found | Bioresearch Monitoring | — |
| Mar 28, 2025 | No problems found | Bioresearch Monitoring | — |
| Nov 21, 2023 | No problems found | Drug Quality Assurance | — |
| Nov 21, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 10, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 19, 2018 | No problems found | Bioresearch Monitoring | — |
| Oct 19, 2018 | No problems found | Bioresearch Monitoring | — |
| Feb 19, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 19, 2016 | No problems found | Drug Quality Assurance | — |
| Oct 23, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 23, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 26, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 26, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.