Indiana-based radiopharmaceutical contract developer, manufacturer, isotope producer and analytical testing provider receives FDA Section 704 inspection letter with no observations
SpectronRx, a leader in radiopharmaceutical contract development, manufacturing, isotope production and analytical testing, today announced the successful completion of the U.S. Food and Drug Administration’s (FDA) assessment of its Indianapolis, Indiana, facility. The assessment resulted in a Section 704 inspection letter with no observations, reflecting SpectronRx's dedication to quality and compliance.
This milestone follows a previous successful inspection by the FDA on behalf of the European Medicines Agency (EMA) at SpectronRx’s South Bend, Indiana, facility. These achievements come as the company rapidly scales operations to meet the rising global demand for radiopharmaceuticals used in detecting and treating cancers and other critical diseases.
“Global health leaders are increasingly concerned about the quality and availability of life-saving radiopharmaceuticals,” said John Zehner, CEO of SpectronRx. “At SpectronRx, we are addressing these challenges by investing in world-class facilities, innovative equipment and highly skilled teams. Receiving no observations from the FDA underscores our commitment to industry-leading standards and our role in advancing radiopharmaceutical science.”
With its extensive expertise across Radiopharmaceutical Contract Development (rCDMO), Radiopharmaceutical Contract Manufacturing (rCMO), Isotope Production and analytical testing, SpectronRx leverages cutting-edge technology and processes to ensure unmatched service and product quality. The FDA’s findings affirm the company's steadfast focus on operational excellence.
Anwer Rizvi, President of SpectronRx, added, “This result reflects our commitment to regulatory compliance and maintaining the highest quality standards. We’re proud to reassure our partners that SpectronRx is a trusted choice for developing and manufacturing life-saving diagnostics and therapies.”
SpectronRx’s strategic investments in technology and infrastructure are helping to improve the availability of essential radiopharmaceuticals for patients worldwide. To date, SpectronRx has over 200 employees working across five locations, serving more than 31 clients in 29 countries. Their facilities in Indiana, Danbury, Connecticut and Europe include dozens of state-of-the-art cleanrooms, 40 advanced hot cells and nearly 200,000 square feet of production capability. The company’s extensive NRC materials license authorizes it to handle over 25 isotopes used for medical and research purposes.
To learn more, visit SpectronRx.com.
SpectronRx, a leader in radiopharmaceutical contract development, manufacturing, isotope production and analytical testing, today announced the successful completion of the U.S. Food and Drug Administration’s (FDA) assessment of its Indianapolis, Indiana, facility. The assessment resulted in a Section 704 inspection letter with no observations, reflecting SpectronRx's dedication to quality and compliance.
This milestone follows a previous successful inspection by the FDA on behalf of the European Medicines Agency (EMA) at SpectronRx’s South Bend, Indiana, facility. These achievements come as the company rapidly scales operations to meet the rising global demand for radiopharmaceuticals used in detecting and treating cancers and other critical diseases.
“Global health leaders are increasingly concerned about the quality and availability of life-saving radiopharmaceuticals,” said John Zehner, CEO of SpectronRx. “At SpectronRx, we are addressing these challenges by investing in world-class facilities, innovative equipment and highly skilled teams. Receiving no observations from the FDA underscores our commitment to industry-leading standards and our role in advancing radiopharmaceutical science.”
With its extensive expertise across Radiopharmaceutical Contract Development (rCDMO), Radiopharmaceutical Contract Manufacturing (rCMO), Isotope Production and analytical testing, SpectronRx leverages cutting-edge technology and processes to ensure unmatched service and product quality. The FDA’s findings affirm the company's steadfast focus on operational excellence.
Anwer Rizvi, President of SpectronRx, added, “This result reflects our commitment to regulatory compliance and maintaining the highest quality standards. We’re proud to reassure our partners that SpectronRx is a trusted choice for developing and manufacturing life-saving diagnostics and therapies.”
SpectronRx’s strategic investments in technology and infrastructure are helping to improve the availability of essential radiopharmaceuticals for patients worldwide. To date, SpectronRx has over 200 employees working across five locations, serving more than 31 clients in 29 countries. Their facilities in Indiana, Danbury, Connecticut and Europe include dozens of state-of-the-art cleanrooms, 40 advanced hot cells and nearly 200,000 square feet of production capability. The company’s extensive NRC materials license authorizes it to handle over 25 isotopes used for medical and research purposes.
To learn more, visit SpectronRx.com.