Isotopia Molecular Imaging

Indianapolis,  IN 
United States
https://isotopia-global.com/
  • Booth: 1507


Isotopia is one of the major worldwide suppliers of 177Lu under GMP condition and Drug Master File, with new manufacturing sites in EU and USA.

✨Isotopia: Advancing Radiopharmaceutical Solutions with Reliable Lu-177 and Tb-161 Supply ✨ Isotopia USA, based in Westfield, Indiana, ensures a seamless, dependable supply of Lutetium-177 (Lu-177) for radiopharmaceutical therapies. With a strong focus on overcoming logistical challenges, we streamline isotope delivery by eliminating customs delays, mitigating flight cancellations, and providing real-time tracking—ensuring on-time delivery every time. Our state-of-the-art, GMP-compliant facility spans approximately 40,000 square feet and features aseptic manufacturing and sterility testing cleanrooms, advanced Quality Control (QC) and microbiology laboratories, and dedicated engineering spaces. Starting July 2025, Isotopia USA will begin commercial-scale production of GMP-grade Lu-177 n.c.a., supporting process validation and clinical trials. We are expanding to include Terbium-161 and other breakthrough isotopes, plus finished drug products for preclinical, clinical, and commercial use. In Europe, we offer Isoprotrace, an advanced PSMA-11 radiolabelling kit for prostate cancer imaging, enabling efficient preparation of Gallium (68Ga) Gozetotide for I.V. injection. *Isoprotrace is not yet FDA-approved in the USA. **Authorized in the Netherlands, Germany, Denmark, Sweden, Malta, and the UK, with more EU approvals pending. As a global nuclear medicine leader, Isotopia is committed to innovation, patient safety, and reliability, with long-term partnerships ensuring continuous isotope delivery worldwide.

Brands: Lu-177 n.c.a Lu-177 c.a Isoprotrace® - Kit for radiopharmaceutical preparation of Gallium (68Ga) Gozetotide


 Products

  • Lu-177 Targeted Molecular Radiotherapy

    Reliable, Global Lu-177 Supply

    Isotopia is the only company offering both no-carrier-added (n.c.a.) and carrier-added (c.a.) Lu-177, ensuring flexibility for diverse clinical needs.

    We provide:
    Global production and supply—any quantity, on demand
    Unmatched reliability—stable, on-time deliveries with expert support
    cGMP-compliant production—adhering to European Pharmacopoeia standards

    Strategic Worldwide Distribution

    With production sites in Israel, North America, and Austria (Seibersdorf Laboratories)—where we hold full marketing authorization—Isotopia ensures an uninterrupted weekly supply of Lu-177. Our upcoming expansion into Asia will further solidify our global reach.

    Advancing Nuclear Medicine

    Partnering with industry leaders and healthcare providers, Isotopia delivers innovative radiopharmaceutical solutions, setting new standards in patient care.

    ...

  • Isoprotrace®
    Kit for the preparation of Gallium (68Ga) Gozetotide
    An advanced PSMA-11 radiolabelling kit for prostate cancer imaging

    Isoprotrace® is indicated for PET imaging of PSMA-positive lesions in adult men with prostate cancer:
    • Primary staging of patients with high-risk prostate cancer prior to primary curative therapy.
    • Suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA)
    level, after primary curative therapy.

    Isoprotrace® offers unparalleled convenience with on-site preparation.
    The process is remarkably efficient:
    • Preparation time: Only 5 minutes (excluding elution)
    • Simplicity: 1 vial, 2 simple preparation steps



    *Isoprotrace® has not yet been approved by the FDA for marketing in the USA.
    **Isoprotrace® has received marketing authorization in the Netherlands, Germany, Denmark, Sweden, Malta, and the UK, and is pending approval in additional EU countries.
    ...