ORIL Industrie is an API manufacturer based in France. It holds one active US drug master file and 4 valid CEPs across a filed portfolio of 7 molecules. Its GMP standing is certified by ANSM (FR). Its most recent recorded inspection, by US FDA, closed on 6 April 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| BOLBEC, France | Not on file |
| BOLBEC, France | Not on file |
| France, France | 1000435915 |
| Bolbec, France | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Gliclazide | EDQM, SFDA (Saudi Arabia) | 2 |
| Indapamide | EDQM, SFDA (Saudi Arabia) | 2 |
| Ivabradine | SFDA (Saudi Arabia), US FDA | 2 |
| Perindopril | SFDA (Saudi Arabia) | 2 |
| Atorvastatin | SFDA (Saudi Arabia) | 1 |
| Perindopril Tert-Butylamine | EDQM | 1 |
| Rilmenidine Dihydrogen Phosphate | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ANSM (FR) | None | 50 |
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