Baxter Oncology is an API and finished-dose manufacturer based in Germany. It holds one active US drug master file. Its filings concentrate with EDE (AE), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), NCELS (KZ) and MFDS (Korea).
| Site | FDA FEI |
|---|---|
| Halle/Westfalen, United Arab Emirates | Not on file |
| Halle (Westf), Germany | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Cyclophosphamide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EDE (AE) | 481 | None |
| ARCSA (EC) | 16 | None |
| INVIMA (CO) | 10 | None |
| DPM (TN) | 7 | None |
| EDA (EG) | 7 | None |
| ANPP (DZ) | 3 | None |
| ZLG (DE) | None | 4 |
| NCELS (KZ) | None | 2 |
| MFDS (Korea) | None | 2 |
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