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  • INDUSTRY COMMITMENT

    Ensuring a steady, uninterrupted supply of Technetium 99m for our customers and the patients they serve is our top priority. Mallinckrodt is continuously making investments to increase worldwide stability of Mo-99 by constantly evaluating all potential long-term global supply opportunities and solutions.

    Mallinckrodt’s Mo-99 LEU Conversion Efforts:

    Conversion from high enriched uranium or HEU to low enriched uranium or LEU for Mo-99 production:

    • Mallinckrodt received approval of low enriched uranium Mo-99 from the South African processor, NTP, for generator production in both the U.S. and Europe and anticipate approval of the ANSTO reactor in Australia. 
    • Development work for LEU conversion is ongoing at our Mo-99 processing facility in the Netherlands. 
    • Active in support of the American Medical Isotopes Production Act, a bill promoting the domestic production of Mo-99 utilizing low enriched uranium.

    Demand for reliable, large-scale U.S. manufacture of Mo-99 using low-enriched uranium (LEU) technology.

    • U.S. plant has already received approval from FDA and Health Canada to use LEU-based Mo-99 from the Safari reactor
    • Awaiting European Medicines Agency approval for use of Safari LEU-based Mo-99 in our Dutch plant
    • Awaiting FDA/HC approval for use of LEU-produced  Mo-99 from OPAL reactor
    • Continue to explore partnerships with other LEU-based Mo-99 producers

    Mallinckrodt’s Continued Investment in Manufacturing:

    Investments are being made to our U.S. manufacturing facilities and products to improve quality and reliability.

    • Development of a new, robust U.S. generator manufacturing line incorporating innovative automation and redundancy technologies.
    • Significant investment to our internal generator shielding that provides a lower radiation exposure alternative