Company Profile
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 cassettes, 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 SPECT precursors
•Custom synthesis and manufacturing according to GMP for APIs
• Design, custom synthesis and production of peptides (GMP quality on request)
• NEW: HCl for 68Ga generators
•Performance of stability studies
•Hot Lab for R&D of new pharmaceutical kits and cassettes and co-operation with pharmaceutical companies
•Development of radiotracers and labelling as well as purification strategies
• ROVER - ABX PET evaluation software
•Distributor of 18O-Water FDG grade and GMP grade
•190 professionals (among them 25 with PhD)
•Clean room production and filling under pharmaceutical conditions
•audited and accepted as GMP API manufacturer by
- German pharmaceutical authorities
- FDA ( US Food and Drug Administration )
•ISO 13485 certified
