Janssen Pharmaceutica
Belgium Updated 9 July 2026
Janssen Pharmaceutica is an API manufacturer based in Belgium. It holds 23 valid CEPs across a filed portfolio of 20 molecules. Its filings concentrate with SFDA (Saudi Arabia), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil), MFDS (Korea) and NAFDAC (NG).
84
filings
across 7 regulators
Registered plants
| Site | FDA FEI |
| Beerse, United Arab Emirates | Not on file |
| BEERSE, Belgium | Not on file |
| Beerse, Belgium | Not on file |
What they file, and where
| Molecule | Regulators | Docs |
| Domperidone | EDQM | 2 |
| Fentanyl | EDQM | 2 |
| Itraconazole | EDQM | 2 |
| Loperamide | EDQM, SFDA (Saudi Arabia) | 2 |
| Methylphenidate | EDQM | 2 |
| Miconazole | EDQM | 2 |
| Alfentanil | EDQM | 1 |
| Cinnarizine | EDQM | 1 |
| Econazole | EDQM | 1 |
| Flubendazole | EDQM | 1 |
Show all 20 molecules on file
| Flunarizine Dihydrochloride | EDQM | 1 |
| Galantamine Hydrobromide | EDQM | 1 |
| Haloperidol | EDQM | 1 |
| Haloperidol Decanoate | EDQM | 1 |
| Ketoconazole | EDQM | 1 |
| Levocabastine | EDQM | 1 |
| Nebivolol | SFDA (Saudi Arabia) | 1 |
| Risperidone | EDQM | 1 |
| Sufentanil | EDQM | 1 |
| Trabectedin | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| SFDA (Saudi Arabia) | 28 | None |
| ARCSA (EC) | 22 | None |
| MINSA (CR) | 12 | None |
| Health Canada | 9 | None |
| NAFDAC (NG) | 9 | 1 |
| EMA | 2 | None |
| ANVISA (Brazil) | None | 7 |
| MFDS (Korea) | None | 2 |
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Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates