Novitium Pharma is a finished-dose manufacturer based in United States. It holds 24 active US drug master files across a filed portfolio of 12 molecules. Its filings concentrate with US FDA, DMP (NO) and EDE (AE). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 16 February 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| New Jersey, United Arab Emirates | Not on file |
| East Windsor, United States | 3012541241 |
| Molecule | Regulators | Docs |
|---|---|---|
| Betaine | US FDA | 2 |
| Carglumic Acid | US FDA | 2 |
| Dapsone | US FDA | 2 |
| Diazoxide | US FDA | 2 |
| Diclofenamide | US FDA | 2 |
| Fludrocortisone | US FDA | 2 |
| Levorphanol | US FDA | 2 |
| Methyltestosterone | US FDA | 2 |
| Nitisinone | US FDA | 2 |
| Oxandrolone | US FDA | 2 |
| Prazosin | US FDA | 2 |
| Thiothixene | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 70 | 1 |
| DMP (NO) | 4 | None |
| EDE (AE) | 1 | None |
| SFDA (Saudi Arabia) | 1 | None |
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