An emerging manufacturer of medical isotopes and radiopharmaceuticals

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Services

US Radiopharmaceuticals has the capabilities to work with research partners developing new products from bench to bedside.

Our sole business is the production of cGMP qualified radioisotopes and radiopharmaceuticals. The company is therefore well placed to offer unique services to organizations in the Nuclear Medicine Community to develop and produce new radioisotope and radiopharmaceutical products.

From research products, through clinical trials, to production, US Radiopharmaceuticals provides a cost effective solution to Universities or pharmaceutical organizations involved in radioactive drug development and production. US Radiopharmaceuticals offers a site with a broad scope Radioactive Materials License, accelerator production and radioactive material processing and sterile finishing capabilities, and full cGMP qualification, along with the associated expertise in radioactive drug production and radiation safety.

Facilities:

– 33 MeV, 6 target, pulsed proton LINAC
– Two additional high energy proton cyclotrons available
– 20,000 sq. ft. cGMP qualified manufacturing area
– Hot cells for bulk radioactive material handling and processing
– Sterile finishing areas to ISO 5 (Class 100)
– Engineering capability for target or custom equipment fabrication

Services:

– Isotope (radiochemical or API) development and production
– Radiopharmaceutical development and production
– cGMP (DMF, ANDA, etc.)
– Extensive in-house distribution network
– Health physics
– Radioactive facility validation and licensing
– Low level waste handling
– Full cGMP analytical capability for radioactive products –

  1. ICP-OES
  2. HPLC
  3. GC
  4. TLC
  5. pH
  6. UV-Vis
  7. Microbiology
  8. HPGe
  9. Gross Gamma