Newchem is an API manufacturer based in Italy. It holds 19 active US drug master files and 20 valid CEPs across a filed portfolio of 28 molecules. Its most recent recorded inspection, by US FDA, closed on 30 March 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| SAN MARTINO SICCOMARIO, Italy | Not on file |
| VERONA, Italy | Not on file |
| Milano, Italy | Not on file |
| Italy, Italy | 3005786129 |
| Italy, Italy | 3017845324 |
| Molecule | Regulators | Docs |
|---|---|---|
| Drospirenone | EDQM, US FDA | 4 |
| Budesonide | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Fluticasone Propionate | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Mometasone Furoate | EDQM, US FDA | 3 |
| Ciclesonide | EDQM, US FDA | 2 |
| Clobetasol Propionate | EDQM, US FDA | 2 |
| Dienogest | EDQM, US FDA | 2 |
| Hydrocortisone | EDQM | 2 |
| Latanoprost | EDQM, US FDA | 2 |
| Methylprednisolone | EDQM, US FDA | 2 |
| Ulipristal | SFDA (Saudi Arabia), US FDA | 2 |
| Alclometasone | US FDA | 1 |
| Bimatoprost | US FDA | 1 |
| Cyproterone | EDQM | 1 |
| Deflazacort | US FDA | 1 |
| Desogestrel | EDQM | 1 |
| Estetrol | US FDA | 1 |
| Fluticasone Furoate | US FDA | 1 |
| Gestodene | EDQM | 1 |
| Latanoprostene Bunod | US FDA | 1 |
| Methylprednisolone As Methylprednisolone Hemisuccinate | SFDA (Saudi Arabia) | 1 |
| Mometasone Furoate Monohydrate | EDQM | 1 |
| Nomegestrol | EDQM | 1 |
| Prednicarbate | EDQM | 1 |
| Prednisolone | SFDA (Saudi Arabia) | 1 |
| Tibolone | EDQM | 1 |
| Triamcinolone | US FDA | 1 |
| Triamcinolone Acetonide | EDQM | 1 |
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