Arevipharma is an API manufacturer based in Germany. It holds 7 active US drug master files and 21 valid CEPs across a filed portfolio of 17 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 20 June 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Radebeul, Germany | Not on file |
| Germany, Germany | 1000505976 |
| Molecule | Regulators | Docs |
|---|---|---|
| Buprenorphine | EDQM, US FDA | 7 |
| Bisoprolol | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Esketamine | EDQM, US FDA | 2 |
| Fentanyl | EDQM | 2 |
| Ketamine | EDQM, US FDA | 2 |
| Torasemide | EDQM | 2 |
| Amiodarone | EDQM | 1 |
| Carbamazepine | EDQM | 1 |
| Cetirizine Dihydrochloride | EDQM | 1 |
| Dimethyl Fumarate | US FDA | 1 |
| Ebastine | EDQM | 1 |
| Hydromorphone | EDQM | 1 |
| Moxonidine | EDQM | 1 |
| Pyridostigmine | EDQM | 1 |
| Remifentanil | EDQM | 1 |
| Sotalol | EDQM | 1 |
| Tilidine | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 3 | None |
| ZLG (DE) | None | 4 |
| US FDA | None | 1 |
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