- NorthStar Medical Radioisotopes has received FDA acceptance for its Type II Drug Master File for no-carrier-added Actinium-225 (Ac-225).
- The milestone enables pharmaceutical partners to reference NorthStar’s manufacturing data in IND and NDA submissions for radiopharmaceutical development.
NorthStar Medical Radioisotopes has announced that the U.S. Food and Drug Administration has accepted its Type II Drug Master File submission for no-carrier-added Actinium-225 (Ac-225). The milestone establishes the company’s Ac-225 supply for use in radiopharmaceutical development and supports regulatory pathways for targeted alpha therapies in oncology.
The FDA acceptance allows pharmaceutical and biotechnology companies to reference NorthStar’s Chemistry, Manufacturing, and Controls data in future Investigational New Drug and New Drug Application filings. The company stated that this provides partners with access to a validated and regulatory-recognized supply of Ac-225 for clinical and commercial programs.
NorthStar’s manufacturing platform, based at its Beloit, Wisconsin facility, produces Ac-225 using an indirect approach that combines electron-accelerator irradiation of a Ra-226 target with purified Ra-225 sources. The company indicated that this process delivers high radionuclidic purity, supply consistency, and scalability for clinical and commercial demand.
The development follows NorthStar’s earlier announcement in January 2026 regarding successful commercial-scale production of Ac-225. The company stated that its manufacturing capabilities are designed to support clinical trials across early and late-stage development.
“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.”
Dr. Frank Scholz, President and CEO of NorthStar
