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), EMA and EAEU_EEC. Customs aggregates show $1K of exports covering 3 molecules to 1 destination in 2022.
| Site | FDA FEI |
|---|---|
| Spain, Nigeria | Not on file |
| Nijmegen, Netherlands | Not on file |
| Nijmegen, Netherlands | Not on file |
| 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 |
| 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
| 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 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2022 | Not reported | $1K | 1 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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