Indena is a contract manufacturer based in Italy. It holds 12 active US drug master files and 19 valid CEPs across a filed portfolio of 17 molecules. Its GMP standing is certified by ANSM (FR) and EMA. Its most recent recorded inspection, by US FDA, closed on 26 November 2021 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| TOURS, France | Not on file |
| Tours, France | Not on file |
| Milan, Italy | Not on file |
| Milano, Italy | Not on file |
| Settala, Italy | Not on file |
| Italy, Italy | 1000280888 |
| Molecule | Regulators | Docs |
|---|---|---|
| Colchicine | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Paclitaxel | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Docetaxel | EDQM, US FDA | 4 |
| Thiocolchicoside Hydrate | EDQM | 3 |
| Cabazitaxel | US FDA | 2 |
| Cannabidiol | EDQM, US FDA | 2 |
| Thiocolchicoside Crystallised From Ethanol | EDQM | 2 |
| Thiotepa | SFDA (Saudi Arabia), US FDA | 2 |
| Fresh Bilberry Fruit Dry Extract | EDQM | 1 |
| Galantamine Hydrobromide | EDQM | 1 |
| Milk Thistle Dry Extract | EDQM | 1 |
| Reserpine | US FDA | 1 |
| Resiniferatoxin | US FDA | 1 |
| Saw Palmetto Extract | EDQM | 1 |
| St. John'S Wort Dry Extract | EDQM | 1 |
| Tirbanibulin | US FDA | 1 |
| Voclosporin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 3 | None |
| ANSM (FR) | None | 20 |
| EMA | None | 1 |
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