Innovare Labs is an API manufacturer based in Mexico. It holds 15 active US drug master files and 9 valid CEPs across a filed portfolio of 16 molecules. Its GMP standing is certified by COFEPRIS (MX), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 19 September 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Visakhapatnam, India | 3015709928 |
| Benito Juárez, Mexico | Not on file |
| Álvaro Obregón, Mexico | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Clopidogrel | EDQM, US FDA | 2 |
| Levetiracetam | EDQM, US FDA | 2 |
| Moxifloxacin | EDQM, US FDA | 2 |
| Oseltamivir | EDQM, US FDA | 2 |
| Pregabalin | EDQM, US FDA | 2 |
| Rivaroxaban | EDQM, US FDA | 2 |
| Rosuvastatin | EDQM, US FDA | 2 |
| Voriconazole | EDQM, US FDA | 2 |
| Cinacalcet | US FDA | 1 |
| Darunavir | US FDA | 1 |
| Metaxalone | US FDA | 1 |
| Oseltamivir Phosphate | EDQM | 1 |
| Ranolazine | US FDA | 1 |
| Tenofovir Disoproxil | US FDA | 1 |
| Ticagrelor | US FDA | 1 |
| Vildagliptin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 2 | None |
| COFEPRIS (MX) | None | 2 |
| US FDA | None | 1 |
| EMA | None | 1 |
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