SpectronRx’s Indianapolis facility has cleared a major regulatory hurdle, completing a recent U.S. Food and Drug Administration (FDA) inspection without a single observation, the company announced Monday.

The Indiana-based firm, which specializes in radiopharmaceutical contract development, manufacturing, isotope production, and analytical testing, received a Section 704 inspection letter — a formal acknowledgment that regulators found no deficiencies during their review. Such clean outcomes are rare and are considered a strong indicator of a company’s commitment to rigorous compliance standards.

The inspection marks another step forward for SpectronRx as it works to expand its production capacity to meet rising global demand for radiopharmaceuticals used in cancer detection and treatment. It follows a similarly successful inspection at the company’s South Bend, Indiana facility, conducted previously by the FDA on behalf of the European Medicines Agency (EMA).

“This result reflects our commitment to regulatory compliance and maintaining the highest quality standards,” said Anwer Rizvi, President of SpectronRx. “We’re proud to reassure our partners that SpectronRx is a trusted choice for developing and manufacturing life-saving diagnostics and therapies.”

The company’s broader expansion efforts reflect these priorities. SpectronRx operates across five locations with more than 200 employees, serving clients in 29 countries. Its footprint includes facilities in Indiana, Connecticut, and Europe, totaling nearly 200,000 square feet of production space. Across its network, the company maintains dozens of cleanrooms and 40 advanced hot cells designed to handle complex and sensitive radiopharmaceutical processes. Its Nuclear Regulatory Commission materials license authorizes work with over 25 isotopes used for both medical and research applications, providing flexibility to support a wide range of diagnostic and therapeutic programs.

The FDA’s finding comes amid increased pressure on healthcare systems to secure reliable supplies of medical isotopes, which are essential for diagnostic imaging and targeted therapies. Demand for positron emission tomography (PET) tracers, targeted alpha therapies, and other advanced radiopharmaceuticals is expected to grow sharply over the next decade, driven by expanded use in oncology, neurology, and cardiology.

SpectronRx stated that its focus on regulatory excellence is part of a broader strategy to help improve patient access to life-saving diagnostics and treatments. The company has invested heavily in both infrastructure and workforce training, aiming to stay ahead of increasingly complex regulatory requirements while ensuring continuity of supply for critical isotopes and finished products.

The company’s recent regulatory milestones position it to play an expanded role in the evolving field of nuclear medicine, as demand for radiopharmaceutical innovation continues to grow. With global health systems pushing for faster, more accurate diagnostics and more targeted therapies, companies with proven manufacturing reliability are likely to become increasingly central to the healthcare ecosystem. SpectronRx’s expanding operations and regulatory track record suggest it is well-positioned to meet that demand.