Radiopharma manufacturer SpectronRx’s Indiana facility gets positive FDA assessment

SpectronRx has received a Section 704 inspection letter from the U.S. Food and Drug Administration (FDA) for its Indianapolis, Indiana facility, with no observations noted, according to the company. 

The FDA’s inspection outcome indicates that the site met regulatory requirements during the assessment. SpectronRx provides contract development and manufacturing services, isotope production, and analytical testing for radiopharmaceuticals. The clean bill from the FDA with no findings aligns with SpectronRx’s broader strategy to ensure regulatory compliance as it scales production of radiopharmaceutical products.

The regulator’s findings follow a previous successful inspection at SpectronRx’s South Bend, Indiana facility conducted on behalf of the European Medicines Agency. Both assessments come as the company expands its operations to address rising global demand for radiopharmaceuticals used in cancer diagnostics and treatment.

CEO John Zehner in a statement said “global health leaders are increasingly concerned about the quality and availability of life-saving radiopharmaceuticals” and SpectronRx is “addressing these challenges by investing in world-class facilities, innovative equipment and highly skilled teams.”

SpectronRx operates five locations across Indiana, Connecticut, and Europe, employing over 200 staff. Its facilities in Indiana, Danbury, Connecticut and Europe house multiple cleanrooms and hot cells for isotope handling and drug manufacturing, with nearly 200,000 square feet of production capability. The company holds a broad U.S. Nuclear Regulatory Commission (NRC) materials license that covers over 25 isotopes for clinical and research use.

According to SpectronRx, it serves more than 30 clients across 29 countries and has extensive expertise across radiopharmaceutical contract development (rCDMO), radiopharmaceutical contract manufacturing (rCMO), isotope production and analytical testing.

CDMOs with capabilities in handling radiopharmaceuticals are seeing strong demand, reflecting strength in these therapeutic modalities, according to CPHI’s 2024 annual report. “Barriers to entry here are extremely high and could lead to a supply/demand imbalance in the near term as more radiopharmaceuticals make their way into the clinical pipelines,” according to CPHI.