-   Company and Quality


Manufacturing and development of chemicals for nuclear medicine

  • Worldwide leading supplier of PET precursors and FDG reagents kits
  • Production and development of PET and SPECT precursors and reference standards
  • Manufacturing of reagents kits and cassetes, particularly kits for FDG, F-DOPA, FLT, F-Choline, NaF, F-Miso, FES and FET production
  • US and European Drug Master File (DMF) for Mannose Triflate (FDG precursor)
  • Further DMFs and technical documents for reagent kits, PET and SPEC precursors
  • Custom synthesis and manufacturing according to GMP for APIs
  • Design, custom synthesis and production of peptides (GMP quality on request)
  • HCl for 68Ga generators
  • Performance of stability studies
  • Hot Lab for R&D of new pharmaceutical kits and cassettees and co-operation with pharmaceutical companies
  • Development of radiotracers and labeling as well as purification strategies
  • ROVER - ABX PET evaluation software
  • Distributor of 18O-Water FDG grade and GMP grade
  • 250 professionals (among them 25 with PhD)
  • Clean room productions and filling under pharmaceutical conditions
  • audited and accepted as GMP API manufacter by
    • German pharmaceutical authorities
    • FDA ( US Food and Drug Administration )
  • ISO 13485 certified