Cambrex Profarmaco Milano is an API manufacturer based in Italy. It holds 94 active US drug master files and 18 valid CEPs. Its most recent recorded inspection, by US FDA, closed on 11 November 2022 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Italy, Italy | 3003723076 |
| Paullo, Italy | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Epinephrine | EDQM, SFDA (Saudi Arabia), US FDA | 8 |
| Midazolam | EDQM, SFDA (Saudi Arabia), US FDA | 8 |
| Norepinephrine | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Chlordiazepoxide | US FDA | 4 |
| Clozapine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Cysteamine | US FDA | 4 |
| Lacosamide | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Alprazolam | EDQM, US FDA | 3 |
| Amiodarone | EDQM, US FDA | 3 |
| Glyburide | SFDA (Saudi Arabia), US FDA | 3 |
| Hydrochlorothiazide | EDQM, US FDA | 3 |
| Lorazepam | EDQM, US FDA | 3 |
| Rifaximin | EDQM, US FDA | 3 |
| Sodium Picosulfate | EDQM, US FDA | 3 |
| Sotalol | SFDA (Saudi Arabia), US FDA | 3 |
| Zolpidem | EDQM, US FDA | 3 |
| Albuterol | US FDA | 2 |
| Bisacodyl | US FDA | 2 |
| Chlorothiazide | US FDA | 2 |
| Clobazam | US FDA | 2 |
| Clonazepam | US FDA | 2 |
| Clorazepic Acid | US FDA | 2 |
| Cromoglicic Acid | US FDA | 2 |
| Dapagliflozin | US FDA | 2 |
| Diazepam | US FDA | 2 |
| Diltiazem | US FDA | 2 |
| Eltrombopag | US FDA | 2 |
| Estazolam | US FDA | 2 |
| Flurazepam | US FDA | 2 |
| Glipizide | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 8 | None |
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