Synthon
Netherlands Updated 9 July 2026
Synthon is an API and finished-dose manufacturer based in Netherlands. It holds 16 active US drug master files and 12 valid CEPs. Its filings concentrate with EMA, INFARMED (PT) and MPA (SE). Its GMP standing is certified by NAFDAC (NG), EAEU_EEC and EMA. Customs aggregates show $1K of exports covering 3 molecules to 1 destination in 2022.
160
filings
across 14 regulators
These figures were checked against the regulators' own files on 25 July 2026
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Registered plants
| Site | FDA FEI |
| Spain, Nigeria | Not on file |
| Nijmegen, Netherlands | Not on file |
| Nijmegen, Netherlands | Not on file |
What they file, and where
| Molecule | Regulators | Docs |
| Tamsulosin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Lenalidomide | SFDA (Saudi Arabia), US FDA | 3 |
| Gefitinib | EDQM, US FDA | 2 |
| Letrozole | EDQM, SFDA (Saudi Arabia) | 2 |
| Anastrozole | EDQM | 1 |
| Aripiprazole | EDQM | 1 |
| Axitinib | US FDA | 1 |
| Bendamustine | SFDA (Saudi Arabia) | 1 |
| Bicalutamide | EDQM | 1 |
| Dasatinib | SFDA (Saudi Arabia) | 1 |
Show all 30 molecules on file
| Enzalutamide | US FDA | 1 |
| Everolimus | EDQM | 1 |
| Exemestane | EDQM | 1 |
| Fingolimod | EDQM | 1 |
| Flumazenil | EDQM | 1 |
| Glatiramer | SFDA (Saudi Arabia) | 1 |
| Ixazomib | US FDA | 1 |
| Mirabegron | US FDA | 1 |
| Nusinersen | US FDA | 1 |
| Ozanimod | US FDA | 1 |
| Palbociclib | US FDA | 1 |
| Pemetrexed Disodium 2.5-Hydrate | EDQM | 1 |
| Pomalidomide | US FDA | 1 |
| Pramipexole Dihydrochloride | EDQM | 1 |
| Siponimod | US FDA | 1 |
| Sugammadex | US FDA | 1 |
| Sugammadex Octasodium | SFDA (Saudi Arabia) | 1 |
| Tivozanib | US FDA | 1 |
| Valsartan | US FDA | 1 |
| Vismodegib | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| EMA | 51 | 1 |
| INFARMED (PT) | 41 | None |
| MPA (SE) | 20 | None |
| ANMAT (AR) | 10 | None |
| MINSA (CR) | 9 | None |
| JFDA (JO) | 7 | None |
| NAFDAC (NG) | None | 2 |
| EAEU_EEC | None | 1 |
Scale
| Year | Revenue | Exports | Destinations |
| 2022 | Not reported | $1K | 1 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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Open risk flags
- 4 active litigation matters are on record.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates
- Customs aggregates
- Export values, molecule and destination counts