
Following MHRA approval, Alliance Medical’s Guildford and Dinnington radiopharmacy facilities can now commercially supply fully licensed Radelumin® across the UK, supporting dependable access to prostate cancer imaging.
Alliance Medical Group is pleased to announce a significant regulatory milestone for Alliance Medical Radiopharmacy (AMR) in the UK, following MHRA approval for the inclusion of its AMR Guildford and AMR Dinnington manufacturing facilities within the ABX Marketing Authorisation dossier for Radelumin® 2000 MBq/mL solution for injection ([18F]PSMA-1007). Radelumin® will now be supplied commercially from both sites in the North and South of England, supporting healthcare providers across the UK.
AMR has supplied [18F]PSMA-1007 to customers for several years under a Manufacturing Specials (MS) license. The move to fully Product Licensed (PL) commercial supply as Radelumin® marks the product's transition from MS supply to licensed commercial availability, providing clinicians with assurance of a fully authorised product whilst maintaining the service and reliability they already expect from AMR.
This achievement is the result of a huge amount of work across CMC, radiopharmacy, quality, regulatory, operational and support teams. It also reflects the close collaboration between colleagues across the UK and Northern Europe who have helped bring the product from development to licensed commercial availability.
The milestone reflects Alliance Medical Group's continued investment in specialist radiopharmaceutical manufacturing, quality systems and regulatory excellence, further reinforcing Alliance Medical Group's position as the UK's leading provider of molecular imaging and radiopharmacy services and helping to support dependable nationwide supply for prostate cancer imaging services.
Howard Marsh, Group Chief Financial Officer, Alliance Medical Group, said:
"This is an important achievement for our radiopharmacy team and for the healthcare providers we support. Customers who are already familiar with [18F]PSMA-1007 can continue to rely on the same expertise, service and supply infrastructure, further strengthened by fully licensed Radelumin® commercial supply. With AMR Dinnington and AMR Guildford supporting provision across the UK, we are well placed to continue meeting nationwide demand with confidence."
For more information about our radiotracer production and supply in the UK, please contact Leisl Anderson, Market Development Manager for Radiopharmacy: landerson@alliance.co.uk
