Suppliers and packagers for generic pharmaceutical drug: gallium citrate ga-67

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

Suppliers for the Pharmaceutical Drug: Gallium Citrate Ga-67

Last updated: July 29, 2025

Introduction

Gallium citrate Ga-67 is a radiopharmaceutical primarily employed in nuclear medicine for diagnostic imaging, notably in detecting and monitoring various cancers, infections, and inflammatory diseases. The demand for Ga-67 stems from its unique ability to localize in malignant tissues, infectious sites, and inflammatory lesions, facilitating non-invasive diagnostics through scintigraphy. Securing reliable suppliers for Ga-67 is crucial for healthcare providers, pressing for an understanding of the manufacturing landscape, commercial availability, quality standards, and market dynamics.

Overview of Gallium-67 Radiopharmaceutical Production

Ga-67 is produced through cyclotron irradiation of enriched zinc-68 targets, generating gallium-67 via a (p,2n) reaction. This process requires sophisticated equipment, skilled operators, and adherence to strict radiopharmaceutical standards. The isotope's half-life of approximately 78 hours necessitates an efficient supply chain for timely distribution, emphasizing the importance of suppliers with robust production capacities and distribution networks.

Key Suppliers of Gallium-67

1. ITG Isotope Technologies Garching GmbH (ITG)

   ITG is a prominent supplier of radiopharmaceuticals and radioisotopes for clinical and research applications. Their portfolio includes Ga-67, which they produce using their tailored cyclotron facilities in Germany. ITG emphasizes quality assurance, compliance with Good Manufacturing Practices (GMP), and global distribution capabilities, making them a preferred vendor for institutions requiring reliable isotope supply [1].

2. Lantheus Medical Imaging

   Lantheus is a leading manufacturer and supplier of diagnostic imaging agents, including gallium-67 chloride. Their Ga-67 is documented for high radiochemical purity and consistent performance, employed in hospitals across North America and Europe. Lantheus supports a comprehensive supply chain and provides extensive customer support, reinforcing their role as a significant Ga-67 provider [2].

3. Nordic Nuclear Solutions

   Specializing in radioisotope supply, Nordic Nuclear Solutions sources or produces Ga-67 through collaborations with cyclotron facilities. Their offerings often include customized radiopharmaceutical services, ensuring adaptability to client needs, especially in European markets. Their emphasis on quality and regulatory compliance aligns with strict clinical standards [3].

4. COMARIS (AstraZeneca’s Radiopharmaceutical Division)

   Though primarily established in the field of theranostics and positron emission tomography (PET) isotopes, COMARIS collaborates with external cyclotron facilities for Ga-67 production, offering supply support for diagnostic imaging workflows. Their integrated approach leverages advanced manufacturing platforms to enhance isotope accessibility [4].

5. In-house Production by Major Hospitals and Research Institutions

   Some academic centers and hospitals operating cyclotrons may produce Ga-67 locally for their immediate clinical needs. While not traditional commercial suppliers, these entities play a crucial role in ensuring regional availability, especially in regions where commercial suppliers have limited presence.

Market Dynamics and Challenges

• Limited Commercial Suppliers: The complex production process, coupled with relatively low global demand compared to other isotopes, results in a limited number of commercial suppliers for Ga-67. This concentration can impact supply security, especially during increased clinical demand or supply chain disruptions [5].

• Regulatory and Compliance Considerations: Suppliers must meet rigorous standards set by regulatory agencies such as the FDA, EMA, and regional authorities, ensuring radiochemical purity, sterility, and proper labeling. Regulatory hurdles can prolong or complicate new entrants’ market participation.

• Supply Chain Constraints: The short half-life of Ga-67 necessitates efficient logistics, including rapid transportation and scheduling. Manufacturers with integrated production-to-distribution pathways tend to better serve clinical needs, reducing the risk of shortages.

• Emerging Alternatives: Advances in PET imaging and novel radiotracers are gradually influencing Ga-67 demand. Suppliers are adapting by broadening their isotope portfolios or investing in alternative diagnostics to diversify their offerings.

Regulatory and Quality Standards

Suppliers adhere to international standards such as GMP, ISO certifications, and regional pharmacopeia regulations (e.g., USP, EP). Quality assurance involves rigorous testing for radiochemical purity (usually >95%), sterility, endotoxin levels, and stability. Distribution channels must maintain cold chain integrity, considering Ga-67’s decay profile.

Future Outlook

The supply landscape for Ga-67 is poised for modest growth, driven by increasing adoption in oncology and infectious disease diagnostics. However, supply constraints due to manufacturing complexity and regulatory challenges are expected to persist. Emerging production methods, such as generator-based production or alternative isotopes with similar diagnostic capabilities, could influence market dynamics in the next decade.

Key Players Summary Table

Supplier	Production Location	Market Focus	Regulatory Compliance	Distribution Network
ITG Isotope Technologies Garching	Garching, Germany	Research & clinical isotopes	GMP, ISO	Global
Lantheus Medical Imaging	North America/Europe	Diagnostic radiopharmaceuticals	FDA, EMA	North America, Europe
Nordic Nuclear Solutions	Scandinavia	Custom radioisotope supply	GMP, regional standards	Europe
COMARIS	Europe (collaborative)	Advanced diagnostic radionuclides	Regulatory framework	Global (via partnerships)
University and hospital cyclotrons	Regional/local	On-demand Ga-67 production	Institutional standards	Local/regional

Conclusion

The supply chain of Ga-67 radiopharmaceuticals hinges on a handful of specialized producers, primarily located across Europe and North America. Their ability to meet quality, safety, and logistical demands influences clinical availability, impacting diagnostic workflows. As the nuclear medicine field evolves, suppliers will need to innovate and diversify to sustain demand, especially amid regulatory shifts and technological advancements.

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Key Takeaways

• The primary suppliers for Ga-67 are ITG, Lantheus, Nordic Nuclear Solutions, and collaborative units like COMARIS, with production concentrated mainly in Europe and North America.
• Supply security depends on the complex cyclotron production process, strict regulatory standards, and efficient cold chain logistics.
• Limited supplier diversity presents potential risks, emphasizing the importance of regional production capabilities, especially in areas with high clinical demand.
• Advances in alternative imaging agents and production methods could influence the long-term market for Ga-67, requiring suppliers to adapt quickly.
• Healthcare providers should establish reliable, compliant supply partnerships, considering logistical and quality assurance factors, to ensure continuous diagnostic capabilities.

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FAQs

1. How is Gallium-67 produced for pharmaceutical use?
Ga-67 is produced via cyclotron irradiation of zinc-68 targets in a (p,2n) nuclear reaction. The process requires precise irradiation, chemical separation, and purification steps to ensure radiochemical purity and safety.

2. Which regions have the most reliable suppliers for Gallium-67?
Europe and North America predominantly host reliable suppliers due to their advanced cyclotron and radiopharmaceutical manufacturing infrastructure, notably ITG and Lantheus.

3. Are there alternatives to Gallium-67 for infection or cancer imaging?
Yes. PET tracers like Gallium-68 (from generators) and newer agents, including FDG (fluorodeoxyglucose), are often used as alternatives, benefiting from better resolution and shorter half-lives.

4. What challenges do suppliers face in distributing Ga-67?
The primary challenges include the isotope’s short half-life, requiring rapid transportation; regulatory compliance; manufacturing complexities; and fluctuations in clinical demand.

5. How might the Ga-67 market evolve in the next decade?
Growth may be modest due to competition from PET imaging agents, but demand for specific diagnostic applications could sustain supplier viability. Innovation and regional production will be key to maintaining supply security.

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References

[1] ITG Isotope Technologies GmbH. (2023). Product Portfolio.
[2] Lantheus Medical Imaging. (2023). Gallium-67 Clinical Applications.
[3] Nordic Nuclear Solutions. (2022). Radiopharmaceutical Supply Services.
[4] COMARIS. (2023). Advanced Diagnostic Radioisotopes.
[5] International Atomic Energy Agency (IAEA). (2021). Nuclear Medicine Isotope Supply Chain.