FDA Accepts NorthStar Medical’s Drug Master File for Actinium-225 Production

Key Facts

1NorthStar Medical Radioisotopes received FDA acceptance for its Type II Drug Master File (DMF) for no-carrier-added Actinium-225.

2The regulatory milestone allows Ac-225 to be used in the development of radiopharmaceutical medicines by pharmaceutical partners.

NorthStar Medical Radioisotopes has achieved a significant regulatory milestone with the FDA's acceptance of its Type II Drug Master File (DMF) for no-carrier-added Actinium-225 (Ac-225). This acceptance allows pharmaceutical partners to reference NorthStar’s proprietary manufacturing processes in their own drug applications and clinical trials. Actinium-225 is a critical radioisotope used in the development of targeted radiopharmaceutical therapies, particularly in oncology. By securing this DMF, NorthStar provides a reliable and scalable supply chain for a sector often hampered by material shortages. The move validates the company's production technology and is expected to accelerate the development of next-generation cancer treatments. While NorthStar remains a private entity, this development serves as a bullish indicator for the broader radiopharmaceutical industry and its listed partners.