Overview

Synthon is a pharmaceutical company headquartered in Nijmegen, Netherlands, founded in 1991, with 1,001-5,000 employees.

Core services & business areas

Pharmaceutical DevelopmentContract ManufacturingRegulatory AffairsQuality Assurance

Active pharmaceutical ingredients supplied

Substances Synthon is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

Synthon holds 16 active (22 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

  • NUSINERSEN SODIUMActive2026-03-17
  • SIPONIMOD ADIPIC ACIDActive2025-09-25
  • VISMODEGIBActive2025-07-17
  • IXAZOMIB CITRATEActive2025-01-30
  • TIVOZANIB HYDROCHLORIDE MONOHYDRATEActive2024-09-10
  • OZANIMOD HYDROCHLORIDEActive2023-11-23
  • AXITINIBActive2023-02-02
  • ENZALUTAMIDEActive2021-10-29
  • PALBOCICLIBActive2020-04-14
  • LENALIDOMIDEActive2020-03-27
  • SUGAMMADEX OCTASODIUMActive2019-07-10
  • VALSARTAN DISODIUMActive2019-03-07
  • MIRABEGRONActive2018-02-02
  • POMALIDOMIDEActive2016-08-02
  • GEFITINIBActive2015-11-17

Showing 15 of 22 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Synthon in our records. PharmaTek screens the full directory against live FDA enforcement data.

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