ROTOP Radiopharmacy is located in the former PET center of the Helmholtz-Zentrum Dresden-Rossendorf, Germany, and was inaugurated in 2020. In the modernized building, there are three hot cells in which high activities of Iodine-123 can be processed and Ioflupane (123I) is manufactured under cGMP conditions. The proprietary API was developed and produced entirely in-house. This precursor is used for Ioflupane production and provided to third parties.
Ioflupane (123I) ROTOP is distributed in environmentally friendly Type-A packaging all over Europe and we hold marketing authorizations in more than ten European countries. In compliance with high radiation protection standards, we developed fully automated cGMP labeling and packaging software to package and deliver Ioflupane from Dresden, Germany.