Rotop

Global manufacturer of radiopharmaceuticals and cold kits with comprehensive CDMO services, operating from Dresden, Germany.

ROTOP develops, manufacturers and commercialises radiopharmaceuticals and cold kits for diagnostic imaging with product approvals and exports to over 40 countries. Their CDMO services cover precursor and API synthesis, lyophilised cold kit development, process scale-up, validation, clinical and commercial GMP manufacturing, integrated QC, stability testing, regulatory support and global logistics.

Based on Dresden-Rossendorf research campus, ROTOP collaborates with Helmholtz Zentrum Dresden-Rossendorf accessing nuclear medicine research and innovation.

Operating over 25 years under cGMP and international certifications, ROTOP manufacturers radiopharmaceuticals for oncology, cardiology and metabolic diagnostics including RoTecPSMA approved in European markets, including the UK, for prostate cancer imaging.