NorthStar Secures FDA Acceptance of Drug Master File for No-Carrier-Added Actinium-225

• FDA acceptance enables pharmaceutical development partners to directly reference NorthStar no-carrier-added (n.c.a.) Ac-225 DMF in IND and NDA submissions
• NorthStar’s regulatory and cGMP manufacturing readiness materially strengthens assured supply availability for targeted-alpha therapies at clinical and commercial scale

BELOIT, Wis.--(BUSINESS WIRE)--NorthStar Medical Radioisotopes, LLC (NorthStar), a leading radiopharmaceutical company, today announced that it received notice of the U.S. Food & Drug Administration’s (FDA) acceptance of its Type II Drug Master File (DMF) submission for the company’s no-carrier-added (n.c.a) Actinium-225 (Ac-225). This critical regulatory milestone formally establishes NorthStar’s n.c.a. Ac-225 for use in development of radiopharmaceutical medicines and allows pharmaceutical partners to directly leverage a fully-vetted, U.S.-recognized Ac‑225 supply—streamlining regulatory pathways for targeted alpha therapy development and cancer treatment.

“FDA acceptance of our n.c.a. Ac‑225 Drug Master File, together with our cGMP manufacturing capabilities, establishes NorthStar as a regulatory-ready and operationally proven supply partner for targeted alpha therapies,” said Dr. Frank Scholz, President and CEO of NorthStar. “This milestone reflects our heritage of disciplined execution across manufacturing, quality and regulatory functions and positions NorthStar to support partners as their programs progress from development to commercialization.”

The announcement marks a watershed event for NorthStar and the radiopharmaceutical industry. The FDA’s acceptance of NorthStar’s n.c.a. Ac-225 DMF affirms the company’s robust proprietary manufacturing processes, quality systems and regulatory controls. Importantly, the DMF provides pharmaceutical and biotech partners with high purity Ac-225 supply with greater confidence and reliability. Sponsors may now reference NorthStar’s Chemistry, Manufacturing, and Controls information in their Investigational New Drug (IND) and New Drug Application (NDA) future submissions.

In January 2026, NorthStar announced the successful production of commercial-scale Ac-225 using an indirect manufacturing approach that combines electron-accelerator irradiation of a Ra-226 target with purified Ra-225 sources that constantly in-grow n.c.a Ac-225. Produced at NorthStar’s Beloit, Wisconsin campus, this manufacturing platform delivers high radionuclidic purity, supply consistency and scalability required for both clinical development and future commercial demand. NorthStar has the international regulatory capabilities to support partners’ clinical trials across drug development, first-in-human studies, and late-stage clinical programs.

For more information, or to learn more about Ac-225, please visit us here.

About NorthStar Medical Radioisotopes, LLC (NorthStar)

NorthStar is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar produces copper-67 (Cu-67) and is the first commercial-scale producer of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron-accelerator technology. The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services. Visit: www.northstarnm.com