Sterling is an API manufacturer based in Italy. It holds 24 active US drug master files and 19 valid CEPs across a filed portfolio of 24 molecules. Its filings concentrate with INFARMED (PT), US FDA and INHRR (VE). Its GMP standing is certified by NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 1 December 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| CORCIANO, Italy | Not on file |
| Solomeo Di Corciano, Italy | Not on file |
| Corciano, Italy | Not on file |
| Italy, Italy | 3003042159 |
| Molecule | Regulators | Docs |
|---|---|---|
| Mometasone Furoate | EDQM, US FDA | 6 |
| Norgestimate | EDQM, US FDA | 4 |
| Budesonide | EDQM, US FDA | 3 |
| Finasteride | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Fulvestrant | EDQM, US FDA | 3 |
| Nomegestrol | EDQM, US FDA | 3 |
| Ciclesonide | EDQM, US FDA | 2 |
| Deflazacort | SFDA (Saudi Arabia), US FDA | 2 |
| Dienogest | EDQM, US FDA | 2 |
| Drospirenone | EDQM, US FDA | 2 |
| Etonogestrel | SFDA (Saudi Arabia), US FDA | 2 |
| Exemestane | SFDA (Saudi Arabia), US FDA | 2 |
| Fluticasone Propionate | EDQM, US FDA | 2 |
| Abiraterone | US FDA | 1 |
| Desoxycorticosterone Pivalate | US FDA | 1 |
| Dutasteride | US FDA | 1 |
| Flumetasone Pivalate | EDQM | 1 |
| Flunisolide | US FDA | 1 |
| Fluticasone Furoate | US FDA | 1 |
| Halobetasol Propionate | US FDA | 1 |
| Medroxyprogesterone Acetate | EDQM | 1 |
| Norelgestromin | US FDA | 1 |
| Norgestrel | US FDA | 1 |
| Trilostane | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| INFARMED (PT) | 28 | None |
| US FDA | 1 | None |
| INHRR (VE) | 1 | None |
| NAFDAC (NG) | None | 2 |
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