Suppliers / Synthon

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), EMA and EAEU_EEC. Customs aggregates show $1K of exports covering 3 molecules to 1 destination in 2022.

16
active US DMFs
12
valid CEPs
3
registered plants
160
filings across 14 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
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

Show 26 more 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 We do not publish the identity of any buyer.

Questions about Synthon

Does Synthon hold a US DMF or a CEP?
Synthon holds 16 active US drug master files and 12 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does Synthon manufacture?
3 registered sites are on record, in Nigeria and Netherlands (Spain and Nijmegen among others). Every site is listed on this page with the register it came from.
What does Synthon make?
30 molecules are on record against Synthon, including Tamsulosin, Lenalidomide, Gefitinib and Letrozole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Synthon's GMP?
Current GMP certificates are on record from NAFDAC (NG), EMA and EEC (Eurasian Economic Union). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

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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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