GALLIUM GA 68 GOZETOTIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Univ Ca Los Angeles	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212642	NDA	UCLA Biomedical Cyclotron	76394-2642-3	12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3)	2020-12-09
Univ Of Ca San Fran	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212643	NDA	UCSF Radiopharmaceutical Facility	24275-0525-1	11 mL in 1 VIAL, MULTI-DOSE (24275-0525-1)	2020-12-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Gallium Ga-68 Gozetotide, commercially known as Ga-68 DOTA-TOC, is a vital radiopharmaceutical utilized predominantly in positron emission tomography (PET) imaging for neuroendocrine tumors. Its specificity for somatostatin receptor-expressing tissues makes it an indispensable tool in the diagnostic landscape of neuroendocrine neoplasms. As demand for Ga-68-based PET agents rises, understanding the key suppliers of Gallium Ga-68 Gozetotide becomes imperative for healthcare providers, pharmaceutical companies, and diagnostic radiology centers.

Overview of Ga-68 Gozetotide

Ga-68 Gozetotide is a peptide conjugate that binds to somatostatin receptors, allowing for high-contrast tumor imaging. The radiopharmaceutical's production involves using Gallium-68 generators and complex synthetic processes, often involving multiple suppliers providing raw materials, generators, or final pharmaceutical formulations. The global supply chain is currently concentrated among key manufacturers capable of delivering consistent, high-quality radiopharmaceuticals compliant with regulatory standards such as the EU's Good Manufacturing Practice (GMP) and the U.S. Food and Drug Administration (FDA) approvals.

Major Suppliers of Gallium Ga-68 Gozetotide

1. Advanced Accelerator Applications (AAA)

Overview: A Novartis division, AAA is a leading provider of radiopharmaceuticals. Through its commercial operations, AAA supplies Ga-68 DOTA-TOC, including pre-filled kits and radiolabeled compounds.
Market Position: AAA is among the primary global suppliers leveraging robust manufacturing infrastructure to produce Ga-68-based tracers, including the U.S. and European markets.
Product Offerings: Availability of both generator-based procedures and ready-to-use injection formulations.

2. Curium Pharma

Overview: Curium Pharma specializes in radiopharmaceuticals, including Ga-68 generators and related compounds. Their portfolio includes Ga-68 DOTA-TATE, marketed under the product name Somakit in certain regions.
Supply Capabilities: Their comprehensive offerings include radiopharmaceuticals, with a focus on high-quality, regulatory-compliant products for diagnostics.
Regional Presence: Strong presence in Europe, North America, and Asia-Pacific, facilitating widespread procurement for nuclear medicine departments.

3. IBA Radiopharma Solutions (Part of IBA Group)

Overview: IBA provides both Ga-68 generators and radiopharmaceutical production services.
Supplies: Offers Ga-68 DOTA-TOC kits, custom synthesis, and central production services.
Innovation: Invests in advancing generator technology and scalable production models to meet increasing global demand.

4. Telix Pharmaceuticals

Overview: A relatively new entrant focusing on radiopharmaceuticals, including Ga-68 labeled agents for neuroendocrine tumor imaging.
Products: Offers licensed Ga-68 DOTA-TOC kits, primarily in select markets such as Australia and Europe.
Strategic Focus: Rapid expansion with a focus on reliable supply chains for clinical and diagnostic use.

5. Zircon Medical

Overview: Zircon Medical supplies radiopharmaceutical kits, including Ga-68 DOTA-TOC, primarily in Europe.
Certifications: Compliant with European GMP standards, ensuring high-quality production.
Distribution: Focuses on hospital-based radiopharmaceutical procurement.

Emerging and Regional Suppliers

NordicNeuroLab: Provides complementary imaging products but collaborates with primary suppliers for Ga-68 tracers.
ITG Diagnostics: Offers product solutions for radiopharmaceutical synthesis and automation, including components used in the production of Ga-68 agents.
Nanocure (China): Emerging regional suppliers in Asia aiming to meet the rising demand for Ga-68 radiopharmaceuticals.

Key Considerations in Supplier Selection

Regulatory Compliance: Ensuring suppliers adhere to regional health authority standards (FDA, EMA, etc.).
Supply Chain Reliability: Consistency of supply, especially considering the short half-life (~68 minutes) of Gallium-68.
Manufacturing Capacity: Ability to scale production based on clinical demand.
Quality Assurance: Certifications like GMP and ISO standards.
Pricing and Contract Terms: Cost-effectiveness and flexibility in supply agreements.

Challenges in Supplier Procurement

Global Shortage & Supply Chain Disruptions: Ongoing geopolitical and logistical challenges have strained supply chains, emphasizing the importance of diversified sourcing.
Generator Dependency: Limited availability of Gallium-68 generators impacts the production pipeline.
Regulatory Variability: Differences across regions in approval processes can delay market entry and procurement.

Future Trends

In-House Production: Hospitals and research centers investing in on-site radiopharmaceutical synthesis to mitigate supply disruptions.
Advanced Generator Technologies: Development of longer-lasting Ga-68 generators extending usability.
Next-Generation Radiopharmaceuticals: Innovation around peptide conjugates and labeling protocols may shift supplier dynamics.

Key Takeaways

Global Leaders: AAA and Curium dominate the supply of Ga-68 DOTA-TOC, supported by extensive manufacturing and distribution infrastructure.
Regional Variability: Suppliers like Zircon Medical and ITG provide regional options, emphasizing the importance of local regulatory and logistical considerations.
Supply Chain Risks: Dependence on Ga-68 generators and complex manufacturing processes necessitates diversified sourcing strategies.
Regulatory Excellence: Selecting suppliers with strict compliance ensures patient safety and market approval.
Innovation Drive: Ongoing technological advancements promise to enhance supply stability and accessibility, ultimately improving patient diagnostics.

FAQs

1. Who are the primary global suppliers of Gallium Ga-68 Gozetotide?
Leading suppliers include Advanced Accelerator Applications (Novartis), Curium Pharma, IBA Radiopharma Solutions, and Telix Pharmaceuticals, each offering various formulations and supply options across multiple regions.

2. What are the main challenges in sourcing Ga-68 DOTA-TOC?
Supply chain disruptions, limited generator availability, regulatory hurdles, and short radioactive half-life of Gallium-68 pose significant sourcing challenges.

3. How does regulatory compliance impact supplier selection?
Suppliers with proven GMP certification and regional regulatory approvals ensure quality, safety, and legal market access, reducing risks of non-compliance.

4. Are regional suppliers viable alternatives to global leaders?
Yes. Regional suppliers like Zircon Medical in Europe and Nanocure in Asia offer localized solutions, often with faster access and reduced logistical complexities.

5. What future developments could influence supplier dynamics?
Advancements in generator technology, in-house synthesis capabilities, and innovative radiopharmaceuticals are likely to diversify and stabilize supply sources.

References

[1] Novartis Advanced Accelerator Applications product portfolio, 2023.
[2] Curium Pharma official website and regional product catalogs, 2023.
[3] IBA Radiopharma Solutions, product offerings and technical details, 2023.
[4] Telix Pharmaceuticals, corporate overview and product pipeline, 2023.
[5] European Medicines Agency (EMA) guidelines on radiopharmaceuticals, 2023.

Suppliers and packagers for GALLIUM GA 68 GOZETOTIDE