Medicheck Completes Regulatory Submission for Flotufolastat F-18 (POSLUMA®) – Türkiye’s First F-18 PSMA PET Imaging Agent.

Medicheck has submitted a Marketing Authorization Application (MAA) to the Turkish Medicines and Medical Devices Agency (TMMDA) for flotufolastat F-18 (commercial name POSLUMA®), under its technology transfer and licensing agreement with Blue Earth Diagnostics.

Through this collaboration, the technology transfer and regulatory submission have been successfully completed within a short timeframe, thanks to the productive joint efforts of the Medicheck and Blue Earth Diagnostics teams.
With over 15 years of experience in technology transfer, licensing, and GMP operations, Medicheck continues to broaden diagnostic options for Türkiye’s advanced nuclear medicine community.

Upon approval, flotufolastat F-18 will be manufactured at Medicheck’s GMP-certified, state-of-the-art facility in Silivri, under license from Blue Earth Diagnostics.
The product, a ready-to-use solution for injection, is expected to expand access to PSMA-targeted PET imaging across the region by enabling wider distribution and higher patient throughput.