SpectronRx, a leading radiopharmaceutical contract development and manufacturing organization (CDMO), announced today that the U.S. Nuclear Regulatory Commission (NRC) has issued a Materials License for its new Indianapolis, IN headquarters. The license also expands SpectronRx's roster of authorized nuclear pharmacists and authorized users. The news comes as SpectronRx continues to scale its early-stage development and commercialization services for leading pharmaceutical companies working to develop and deploy radiopharmaceutical compounds for the treatment and detection of certain cancers and other diseases.
"Securing Nuclear Regulatory Commission materials licensing for our new headquarters and additional staff is a significant milestone for the growth of SpectronRx," said John Zehner, CEO of SpectronRx. "We now have the necessary approvals to scale our newly opened 60,000 square foot Indianapolis facility. This is great news for both patients and the State of Indiana alike, as it means a bigger pipeline for life-saving therapies and more jobs for medical professionals specializing in radiopharmaceuticals."
SpectronRx now has two Indiana locations; a 6,300 Sq. Ft. facility located at 17490 Dugdale Dr. in South Bend, and a new 60,000 Sq. Ft. facility at 9550 Zionsville Rd. in Indianapolis. SpectronRx opened its South Bend facility in 2016, and has now relocated its headquarters to the new Indianapolis location. SpectronRx also has plans to expand into the European Union.
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"In response to increased demand for early phase therapeutic and diagnostic development services, SpectronRx has experienced significant growth as an early-stage contract developer for global and domestic life sciences companies," added Anwer Rizvi, President of SpectronRx. "The scope of our new location and materials license gives us the ability to operate as a large-scale developer, manufacturer and nuclear pharmacy."
The NRC materials license authorizes that SpectronRx can receive, acquire, possess and transfer byproduct, source, and special nuclear material in chemical and/or physical form. This includes any byproduct material with Atomic Numbers 1 through 83 with a half-life less than or equal to 120 days, with some exceptions. The license lists more than 25 different isotopes, ranging from Lutetium-177, Actinium-225, Iodine-131,and Iodine-123. Authorized uses include the preparation and distribution of radioactive drugs and radiochemicals for medical use to authorized recipients.
SpectronRx is a Contract Development Manufacturing Organization (CDMO) based in Indianapolis, Indiana focused on diagnostic and therapeutic solutions for the pharmaceutical industry (clinical and commercial pharmaceutical supply, with a special focus on radiopharmaceuticals), as well as nucleic acid testing of coronavirus.