GALLIUM CITRATE GA 67: Pharmaceutical manufacturers, suppliers, and wholesalers

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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

Last updated: August 4, 2025

Introduction

Gallium citrate Ga-67 is a radiopharmaceutical widely used in nuclear medicine for tumor imaging, inflammation detection, and infectious disease diagnosis. As a diagnostic agent, Ga-67's unique properties hinge on its ability to localize in malignant and infectious tissues, making its supply chain a strategic concern for healthcare providers, pharmaceutical companies, and radiopharmacies. This article explores the landscape of suppliers for Ga-67, emphasizing manufacturer capabilities, supply sources, regulatory considerations, and market dynamics.

Gallium-67: Overview and Market Demand

Gallium-67, a radioactive isotope with a half-life of approximately 78 hours, emanates gamma radiation signals used in Single Photon Emission Computed Tomography (SPECT). Its production primarily involves neutron irradiation of enriched zinc or germanium targets in nuclear reactors, followed by complex chemical separation processes. Reliable sourcing is critical given the isotope's relatively short half-life and the necessity for prompt distribution.

The clinical demand for Ga-67 remains substantial, especially in oncology and infectious disease diagnostics. However, the proliferation of other radiotracers and advances in PET imaging, such as Gallium-68, challenge Ga-67’s market share but do not diminish its essential role in nuclear medicine.

Manufacturers and Suppliers of Ga-67

1. Nuclear Reactor Operators and Radioisotope Suppliers

Most Ga-67 originates from nuclear reactors operating in specialized facilities worldwide. Key suppliers act as intermediaries, converting reactor-produced isotopes into pharmaceutical-grade radiopharmaceuticals.

Institute of Radiochemistry (Germany): Historically, German research reactors have played a center role in Ga-67 production. Some facilities like the Hahn-Meitner Institute/Wissenschaftlich-Technische Bundesanstalt (PTB) have contributed to neutron irradiation and isotope purification.
NTP Radioisotopes (South Africa): A leading global supplier, NTP specializes in the production of radioisotopes, including Ga-67, via neutron irradiation of enriched zinc targets in their South African research reactors. NTP’s facilities are equipped for high-volume production and supply internationally.
Mallinckrodt Pharmaceuticals: As a prominent radiopharmaceutical manufacturer, Mallinckrodt historically supplied Ga-67, particularly in the United States, although their focus has shifted toward emerging tracers.
Curium Pharma: Operating in Europe, Curium supplies Ga-67, leveraging European reactor infrastructure to produce and distribute radiotracers.

2. Contract Manufacturers and Distributors

Several companies act as intermediaries, procuring Ga-67 from reactor facilities and assembling pharmaceutical-grade products for clinical use.

GE Healthcare: Historically, GE has supplied Ga-67-based diagnostic kits and radiopharmaceuticals, often partnering with global nuclear reactors to ensure supply.
BBI Solutions: Specializes in radiopharmaceuticals and has historically supplied Ga-67, especially for clinical and research settings in Europe and North America.

3. Emerging and Alternative Suppliers

Although current supply chains are relatively concentrated, new entrants and collaborative manufacturing initiatives aim to enhance availability amid rising global demand.

Argentinian Nuclear Centers: Some South American facilities produce Ga-67 through locally operated reactors, though supply volume remains limited.
Academic and Governmental Institutions: Certain laboratories in the US, Canada, and Europe are developing small-scale or on-demand production techniques, addressing regional shortfalls.

Supply Chain Challenges

The supply of Ga-67 faces significant hurdles, including:

Dependence on Nuclear Reactors: As a reactor-irradiated isotope, Ga-67's availability relies on aging reactors, many of which face shutdown or capacity reductions.
Limited Production Capacity: High costs and infrastructural requirements restrict the number of facilities capable of producing Ga-67 at scale.
Regulatory Constraints: Stringent safety, transportation, and licensing standards influence the distribution networks, increasing lead times.
Emerging Alternatives: The advent of Gallium-68 generators and other imaging agents influence demand dynamics.

Regulatory and Quality Considerations

Suppliers must adhere to Good Manufacturing Practices (GMP) and obtain approvals from regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Traceability, purity standards, and radiation safety documentation are critical for market approval and clinical trust.

Market Dynamics and Trends

Supply Concentration: A handful of players dominate Ga-67 production, raising concerns over supply security.
Regional Variations: Availability varies globally, with Europe, North America, and South Africa as key suppliers.
Innovation and Alternatives: The development of Ga-68 and other PET tracers continues to challenge Ga-67’s market position, yet its unique diagnostic capabilities sustain sustained demand.
Geo-Political Factors: International sanctions and reactor maintenance schedules influence supply stability.

Key Players Summary

Company/Organization	Location	Role	Production Capacity	Remarks
NTP Radioisotopes	South Africa	Major Supplier	High	Stable, globally exporting
Curium Pharma	Europe	Distributor/Supplier	Moderate	Reliable European supplier
GE Healthcare	US/Global	Distributor	N/A	Packaging and distribution
Institute of Radiochemistry	Germany	Production	Limited	Niche supplier, research-driven
Academic Institutions and NRG	US, Canada	On-demand production	Small-scale	Emerging alternative

Conclusion

The supply landscape for Gallium citrate Ga-67 remains specialized and concentrated, heavily reliant on nuclear reactors in select regions. While key players like NTP Radioisotopes and Curium Pharma ensure continuity, industry stakeholders must navigate supply chain vulnerabilities, regulatory compliance, and technological alternatives. As global demand persists for Ga-67’s diagnostic applications, these dynamics will influence procurement strategies, inventory planning, and R&D investments.

Key Takeaways

Supply Chain Concentration: Ga-67 production hinges on a few reactor facilities, underscoring the importance of diversifying production sources to mitigate risks.
Global Key Players: NTP Radioisotopes is the predominant international supplier, with others like Curium Pharma contributing significantly.
Regulatory and Quality Assurance: Suppliers must maintain strict compliance with GMP and regulatory standards to ensure safe, effective use of Ga-67.
Market Challenges: Aging reactors and high production costs restrict capacity, highlighting the need for innovation and alternative imaging agents.
Future Outlook: Demand remains steady, but increasing competition from Ga-68 PET tracers and technological advancements necessitate strategic sourcing and R&D adaptability.

FAQs

1. What are the main regions producing Gallium-67?
Production is primarily concentrated in Europe (Germany, France), South Africa (NTP Radioisotopes), and North America (limited, academic, or government labs).

2. Why is Gallium-67 supply limited compared to other isotopes?
Its production relies on aging research reactors and complex chemical processes, leading to capacity constraints and supply vulnerabilities.

3. Are there any alternatives to Ga-67 for nuclear imaging?
Yes. Gallium-68 PET tracers, such as Gallium-68 DOTATATE, are gaining popularity, providing higher resolution imaging and easier availability via generator systems.

4. How can healthcare providers ensure reliable access to Ga-67?
By establishing relationships with multiple suppliers, maintaining inventory buffers, and staying informed about regulatory and supply chain developments.

5. What is the future for Ga-67 in nuclear medicine?
While competition from newer tracers rises, Ga-67 remains valuable for certain diagnostic applications, especially where SPECT imaging is preferred. Industry investments in production upgrades and novel nuclear reactor technologies could enhance supply security.

References

[1] IAEA Radioisotope Production and Application: Challenges and Opportunities. International Atomic Energy Agency, 2022.
[2] NTP Radioisotopes. Company website: https://ntp.co.za (accessed January 2023).
[3] European Association of Nuclear Medicine. "Gallium-67 in Clinical Practice," 2020.
[4] U.S. Food and Drug Administration. Radiopharmaceuticals standards and guidelines.
[5] World Nuclear Association. "Nuclear Technology Capacity," 2022.

Suppliers and packagers for GALLIUM CITRATE GA 67