Navinta is an API and finished-dose manufacturer based in United States. It holds 31 active US drug master files and one valid CEP across a filed portfolio of 27 molecules. Its filings concentrate with US FDA, SFDA (Saudi Arabia) and NMPA (CN). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 30 September 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Ewing, United States | 3004375014 |
| Molecule | Regulators | Docs |
|---|---|---|
| Ropivacaine | EDQM, US FDA | 3 |
| Cyclophosphamide | US FDA | 2 |
| Hydralazine | US FDA | 2 |
| Sevelamer | US FDA | 2 |
| Bendamustine | US FDA | 1 |
| Benzatropine | US FDA | 1 |
| Cisatracurium | US FDA | 1 |
| Colesevelam | US FDA | 1 |
| Crizotinib | US FDA | 1 |
| Diazepam | US FDA | 1 |
| Fomepizole | US FDA | 1 |
| Fosaprepitant | US FDA | 1 |
| Glycerol Phenylbutyrate | US FDA | 1 |
| Iron Sucrose | US FDA | 1 |
| Maraviroc | US FDA | 1 |
| Melphalan | US FDA | 1 |
| Miglustat | US FDA | 1 |
| Nicardipine | US FDA | 1 |
| Penicillamine | US FDA | 1 |
| Phenoxybenzamine | US FDA | 1 |
| Phylloquinone | US FDA | 1 |
| Remifentanil | US FDA | 1 |
| Sodium Ferric Gluconate Complex | US FDA | 1 |
| Tafamidis | US FDA | 1 |
| Taurolidine | US FDA | 1 |
| Triethylenetetramine | US FDA | 1 |
| Triheptanoin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 23 | 1 |
| SFDA (Saudi Arabia) | 7 | None |
| NMPA (CN) | 1 | None |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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