Quimica Sintetica is an API manufacturer based in Switzerland. It holds 41 active US drug master files. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 9 November 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Switzerland, Switzerland | 3004058163 |
| MENDRISIO, Switzerland | Not on file |
| Couvet, Switzerland | Not on file |
| Spain, Spain | 3002807965 |
| Molecule | Regulators | Docs |
|---|---|---|
| Ciprofloxacin | SFDA (Saudi Arabia), US FDA | 3 |
| Ketorolac | SFDA (Saudi Arabia), US FDA | 3 |
| Apremilast | US FDA | 2 |
| Famotidine | SFDA (Saudi Arabia), US FDA | 2 |
| Indapamide | SFDA (Saudi Arabia), US FDA | 2 |
| Irbesartan | SFDA (Saudi Arabia) | 2 |
| Lansoprazole | US FDA | 2 |
| Levofloxacin | SFDA (Saudi Arabia), US FDA | 2 |
| Ofloxacin | SFDA (Saudi Arabia), US FDA | 2 |
| Acyclovir | US FDA | 1 |
| Benznidazole | US FDA | 1 |
| Captopril | US FDA | 1 |
| Chloramphenicol | US FDA | 1 |
| Droxidopa | US FDA | 1 |
| Edaravone | US FDA | 1 |
| Eltrombopag | US FDA | 1 |
| Fluconazole | US FDA | 1 |
| Fluoxetine | US FDA | 1 |
| Fosfomycin | US FDA | 1 |
| Guanfacine | US FDA | 1 |
| Isradipine | US FDA | 1 |
| Itraconazole | US FDA | 1 |
| Ketoconazole | US FDA | 1 |
| Levomilnacipran | US FDA | 1 |
| Loratadine | US FDA | 1 |
| Meloxicam | US FDA | 1 |
| Miconazole | US FDA | 1 |
| Omeprazole | US FDA | 1 |
| Pantoprazole | US FDA | 1 |
| Posaconazole | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 4 |
| US FDA | None | 1 |
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