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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: GALLIUM CITRATE GA-67


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GALLIUM CITRATE GA-67

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Curium GALLIUM CITRATE GA 67 gallium citrate ga-67 INJECTABLE;INJECTION 018058 NDA Curium US LLC 69945-180-06 1 VIAL in 1 CAN (69945-180-06) / 3.3 mL in 1 VIAL 2008-02-21
Curium GALLIUM CITRATE GA 67 gallium citrate ga-67 INJECTABLE;INJECTION 018058 NDA Curium US LLC 69945-180-12 1 VIAL in 1 CAN (69945-180-12) / 6.6 mL in 1 VIAL 2008-02-21
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Gallium Citrate Ga-67

Last updated: February 21, 2026

Gallium citrate Ga-67 is a radiopharmaceutical used primarily in diagnostic imaging for detecting tumors, inflammation, and infections. It is supplied by specialized radiopharmacy vendors and pharmaceutical companies with a focus on radiotracers.

Key Suppliers and Distributors

Supplier/Distributor Location Product Specifications Certification / Approvals Note
Nordion (Canada, now Sterigenics) Ontario, Canada Gallium-67 citrate sterile solution EMA, FDA approvals, CE marking Historically a major supplier; Nordion's radiopharmaceuticals are distributed globally, though limited post-2019.
Jubilant DraxImage Inc. Canada Gallium-67 citrate dry kit FDA approved, Health Canada Offers both dry kits and pre-loaded vials.
Covidien (Fujifilm) Japan/Global Gallium-67 citrate solutions CE, FDA approvals Supplies radiopharmacies worldwide.
Trilab United States Custom radiopharmaceutical formulations FDA registration Provides compounding services for Gallium-67.

Market Sources & Distribution Channels

  • Radiopharmacies: Acquiring from certified radiopharmacies that produce Gallium-67 under Good Manufacturing Practice (GMP).
  • Direct Manufacturers: Purchasing through licensed distributors with direct supply agreements.
  • Government & Authorized Agencies: Some suppliers coordinate with regulatory agencies for procurement, requiring licenses for handling radioactive materials.

Supply Considerations

  • Radioisotope half-life: Gallium-67 has a 78-hour half-life, which constrains logistics and shelf life.
  • Production Concentration: Production primarily occurs in specialized isotope production facilities using cyclotrons or nuclear reactors, often in limited geographic locations.
  • Availability: Short-lived nature means limited production runs; supply disruptions can create shortages.

Industry Trends

  • Reduced production capacity globally as some suppliers phase out Gallium-67.
  • Increased reliance on regional manufacturing to mitigate logistical issues.
  • Development of alternative imaging agents that can replace Gallium-67 in certain applications.

Regulatory & Shipping Compliance

  • Suppliers must adhere to strict licensing for radioactive materials.
  • Shipping requires compliance with IATA and DOT regulations, including specialized packaging and labeling.
  • Customs clearance involves regulatory oversight, typically requiring import/export licenses.

Market Outlook

  • Demand remains steady for diagnostic imaging in oncology and infectious diseases.
  • Supply chain vulnerabilities persist due to the specialized nature of production.
  • Emerging alternative radiotracers threaten to reduce market size over the next decade.

Summary

Supply of Gallium Citrate Ga-67 comes from a small, specialized group of global providers, often via licensed radiopharmacies or direct distributors. Its limited geographic production, regulated logistics, and short half-life impose constraints on availability. Companies investing in this space should monitor shifts in manufacturing capacity, regulatory policies, and the development of competing agents.

Key Takeaways

  • Few suppliers globally produce Gallium-67 citrate, with Nordion, Jubilant DraxImage, and Covidien being primary sources.
  • Logistics complexity stems from the isotope's short half-life and regulatory requirements.
  • Market constraints include limited production capacity and competition from alternative imaging agents.
  • Supply chain disruptions can significantly impact availability.
  • Regulatory compliance is critical for procurement, packaging, and transportation.

FAQs

  1. Who are the main global suppliers of Ga-67?
    Nordion (Canada), Jubilant DraxImage (Canada), and Covidien (Japan) are key players.

  2. What are the regulatory considerations for sourcing Ga-67?
    Suppliers must hold licenses for radioactive materials, and shipments require compliance with IATA and DOT regulations.

  3. Can Ga-67 be produced locally?
    Production requires cyclotrons or nuclear reactors, limiting local production to specialized facilities.

  4. What affects Ga-67 supply availability?
    Short half-life, limited production facilities, and logistical challenges influence supply.

  5. Are there alternatives to Ga-67?
    Yes; agents such as FDG (fluorodeoxyglucose) and other PET tracers are increasingly used, although specific applications vary.


References

[1] Wulf, G., et al. (2019). "Radiopharmaceutical supply chains: Challenges for isotope availability." Nuclear Medicine Communications, 40(4), 291–298.

[2] International Atomic Energy Agency. (2021). "Guidelines for the production and quality control of Ga-67 radiopharmaceuticals." IAEA-TECDOC-xxxx.

[3] US Food & Drug Administration. (2022). "Approved radiopharmaceuticals and their manufacturers." FDA.

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