Archimica is an API manufacturer based in Italy. It holds 11 active US drug master files across a filed portfolio of 10 molecules. Its GMP standing is certified by ANSM (FR), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 June 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| BON ENCONTRE, France | Not on file |
| TONNEINS, France | Not on file |
| LODI, Italy | Not on file |
| Lodi (LO), Italy | Not on file |
| Italy, Italy | 3002874947 |
| Molecule | Regulators | Docs |
|---|---|---|
| Hydroxyurea | SFDA (Saudi Arabia), US FDA | 3 |
| Pirenzepine | US FDA | 2 |
| Capecitabine | US FDA | 1 |
| Cytarabine | US FDA | 1 |
| Diacerein | US FDA | 1 |
| Disopyramide | US FDA | 1 |
| Hydralazine | US FDA | 1 |
| Oxcarbazepine | US FDA | 1 |
| Sucralfate | US FDA | 1 |
| Sulfapyridine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 1 | None |
| ANSM (FR) | None | 10 |
| EMA | None | 2 |
| US FDA | None | 1 |
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