SpectronRx’s Actinium-225 Master File Approved for Reference in Canadian Radiopharmaceutical Submissions

SpectronRx, a leading radiopharmaceutical contract development and manufacturing organization CDMO/CMO and isotope producer, today announced that its Master File (MF) for Actinium-225 (Ac-225) Trinitrate has been reviewed by Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate. The file (MF #2025-132) is now available for reference in Canadian radiopharmaceutical clinical trial and drug submissions, paving the way for expanded access to this critical isotope for cancer therapy development.

This regulatory milestone allows Canadian researchers and pharmaceutical companies to reference SpectronRx's Chemistry and Manufacturing information in their applications by obtaining a Letter of Access (LoA) from SpectronRx. As a result, this simplifies the submission process for new radiopharmaceuticals that utilize SpectronRx’s cGMP-produced Actinium-225.

"Receiving this positive review from Health Canada is a significant achievement that reinforces our leadership in the radiopharmaceutical space," said John Zehner, CEO of SpectronRx. "It validates the quality and consistency of our manufacturing processes and enhances our ability to support our partners' efforts to bring groundbreaking cancer treatments to patients in Canada."

Actinium-225 is a highly sought-after alpha-emitting isotope showing immense promise in targeted cancer therapy. When attached to a targeting molecule, Ac-225-based radiopharmaceuticals can selectively deliver potent radiation to cancer cells, minimizing damage to surrounding healthy tissue.

"We are committed to increasing the global supply of high-purity Actinium-225 and enabling innovation in nuclear medicine," stated Anwer Rizvi, President of SpectronRx. "This development in Canada is another step forward in our mission to provide our partners with the critical isotopes they need to advance their clinical trials and develop life-saving therapies."

SpectronRx solidifies its position as a global leader in radiopharmaceutical development and manufacturing with an expansive footprint spanning over 250,000 square feet of production space. The company operates more than 50 cutting-edge hot cells and clean rooms, supported by a dedicated team of 220 highly skilled professionals across five strategic locations in the United States and Europe.

“As a trusted partner in radiolabeling and supply, SpectronRx plays a pivotal role in advancing nuclear medicine,” added John Zehner. We currently manufacture and deliver multiple Ac-225 radiolabeled drug products used in clinical trials, while closely collaborating with leading pharmaceutical and biotech companies.”

In addition to Ac-225, SpectronRx holds a U.S. Nuclear Regulatory Commission (NRC) materials license, enabling the company to handle a wide range of isotopes, including Lu-177, Pb-212, Th-232, Th-228, F-18, I-124, I-123, I-131, Tc-99, Y-90, Cu-64, Cu-67, Cu-61, Mo-99, Re-186, In-111, Zr-89, Ga-68 and Ge-68. This authorization supports diverse applications, such as the preparation and distribution of radioactive drugs, chemical synthesis and the redistribution of used and unused generators.

To learn more, visit SpectronRx.com.