Northstar Medical Radioisotopes received notice of U.S. Food & Drug Administration (FDA) acceptance of its Type II Drug Master File (DMR) submission for the company’s no-carrier-added (n.c.a.) Actinium-225 (Ac-225), the company announced today.

The FDA acceptance enables pharmaceutical development partners to directly reference NorthStar n.c.a Ac-225 DMF in IND and NDA submissions.

“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,” NorthStar President and CEO Dr. Frank Scholz said in a statement. “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.”

According to a release, NorthStar’s regulatory and cGMP manufacturing readiness materially strengthens assured supply availability for targeted-alpha therapies in clinical and commercial scale. As previously reported, Ac-225 is being produced at its Beloit campus.