Xellia Pharmaceuticals ApS is an API manufacturer based in Denmark. It holds 19 active US drug master files across a filed portfolio of 10 molecules. Its filings concentrate with MPA (SE), EMA and AIFA (IT). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 28 October 2021 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Kobenhavn S, United Arab Emirates | Not on file |
| China, China | 3007422723 |
| COPENHAGEN, Denmark | Not on file |
| Denmark, Denmark | 3002806860 |
| Copenhagen S, Denmark | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Vancomycin | SFDA (Saudi Arabia), US FDA | 7 |
| Amphotericin B | SFDA (Saudi Arabia), US FDA | 4 |
| Bacitracin | US FDA | 4 |
| Colistimethate | SFDA (Saudi Arabia), US FDA | 3 |
| Daptomycin | SFDA (Saudi Arabia), US FDA | 3 |
| Gramicidin D | SFDA (Saudi Arabia), US FDA | 3 |
| Polymyxin B | US FDA | 2 |
| Tobramycin | US FDA | 2 |
| Colistin | US FDA | 1 |
| Dalbavancin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MPA (SE) | 10 | None |
| EMA | 10 | 1 |
| AIFA (IT) | 8 | None |
| INFARMED (PT) | 5 | None |
| JFDA (JO) | 3 | None |
| AEMPS (ES) | 2 | None |
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