ICE is an API manufacturer based in Italy. It holds 3 active US drug master files and 10 valid CEPs across a filed portfolio of 6 molecules. Its filings concentrate with AIFA (IT) and RCETH (BY). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 2 December 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Basaluzzo, Alessandria, Italy | Not on file |
| REGGIO NELL'EMILIA, Italy | Not on file |
| Reggio Emilia, Italy | Not on file |
| BASALUZZO, Italy | Not on file |
| Italy, Italy | 3003744137 |
| Ivrea, Italy | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Ursodeoxycholic Acid | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Chenodeoxycholic Acid | EDQM, US FDA | 2 |
| Cholic Acid | EDQM | 2 |
| Deoxycholic Acid | EDQM | 1 |
| Deoxycholic Acid And Its Derivatives | EDQM | 1 |
| Tauroursodeoxycholic Acid | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 197 | None |
| RCETH (BY) | 1 | None |
| EMA | None | 1 |
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