COSMA is an API manufacturer based in Italy. It holds 34 active US drug master files and 4 valid CEPs across a filed portfolio of 18 molecules. Its most recent recorded inspection, by US FDA, closed on 17 June 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Italy, Italy | 3002806754 |
| Ciserano, Italy | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Torasemide | EDQM, US FDA | 5 |
| Hydroxyzine | US FDA | 4 |
| Propranolol | SFDA (Saudi Arabia), US FDA | 4 |
| Amisulpride | EDQM, US FDA | 3 |
| Gliclazide | SFDA (Saudi Arabia), US FDA | 3 |
| Ketoprofen | EDQM, US FDA | 3 |
| Cetirizine | US FDA | 2 |
| Diclofenac | US FDA | 2 |
| Labetalol | US FDA | 2 |
| Levomilnacipran | US FDA | 2 |
| Metoclopramide | US FDA | 2 |
| Milnacipran | US FDA | 2 |
| Oxaprozin | US FDA | 2 |
| Pyrantel | US FDA | 2 |
| Ranolazine | US FDA | 2 |
| Cetirizine Dihydrochloride | SFDA (Saudi Arabia) | 1 |
| Hydroxyzine Dihydrochloride | SFDA (Saudi Arabia) | 1 |
| Rifaximin | EDQM | 1 |
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