GALLIUM DOTATATE GA-68: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aaa Usa Inc	NETSPOT	gallium dotatate ga-68	POWDER;INTRAVENOUS	208547	NDA	Advanced Accelerator Applications USA, Inc	69488-001-40	1 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2016-06-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Gallium Dotatate Ga-68 (Gallium-68 DOTA-TATE) has emerged as a pivotal radiopharmaceutical in the diagnosis of neuroendocrine tumors (NETs). Its proliferation in clinical settings is driven by its precision in imaging somatostatin receptor-positive tumors. As demand escalates, understanding the supply landscape becomes crucial for stakeholders across manufacturing, healthcare provisioning, and investment domains. This report delineates key suppliers of Gallium-68 Dotatate Ga-68, exploring manufacturing sources, regional suppliers, and market dynamics shaping availability.

Overview of Gallium-68 Dotatate Ga-68

Gallium-68 (Ga-68) is a positron-emitting radioisotope produced via a germanium-68/gallium-68 generator system. Its conjugation with DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) to form Dotatate creates a radiotracer that binds selectively to somatostatin receptors, making it invaluable for PET imaging in NETs.

The production pipeline involves sourcing Ga-68 generators, synthesizing the radiolabeled compound, and ensuring compliance with regulatory standards. Given the short half-life of Ga-68 (~68 minutes), supply chain logistics demand rapid, reliable delivery channels.

Major Suppliers of Gallium-68 for Pharmaceutical Use

1. Ga-68 Generators (Source of Radionuclide)

The foundational component for Gallium-68 Dotatate production is the Ga-68 generator. Several manufacturers worldwide produce these generators, which subsequently supply the radioactive isotope to radiopharmacies and contract manufacturers.

Eckert & Ziegler
A German-based company, Eckert & Ziegler manufactures the GalliAd TM generator, which is FDA-approved in the United States. They are among the pioneers in commercial Ga-68 generator manufacturing, offering reliable isotopic supplies for clinical and research purposes [1].
Click Chemistry Technologies, Inc.
This US-based company produces Gallium-68 generators with competitive pricing and high yield, catering primarily to North American markets. Their generators are compatible with standard radiopharmaceutical synthesis modules [2].
IRE Elit
An Israeli company, IRE Elit offers GalliPEARL generators, emphasizing high radionuclide purity and ease of elution, suitable for clinical demands [3].
Eckert & Ziegler's Variants
Several other regional variants and portable generators are available, including those from itrex, Hollywood Medical, and Medtronic, each catering to localized needs with differing elution capacities.

2. Radiopharmaceutical Manufacturers (Production of Gallium-68 Dotatate)

Once Ga-68 is eluted from generators, it is often processed by licensed manufacturers into the final radiopharmaceutical.

Advanced Accelerator Applications (AAA) (a Novartis company)
AAA produces NETSPOT (Gallium Ga-68 DOTATATE), which is FDA-approved in the U.S. and marketed globally. Their manufacturing facilities are FDA-licensed and equipped with high-capacity synthesis modules [4].
IBA Molecular
A leading global radioactive drug producer, IBA offers various radiopharmaceuticals and has partnered with local facilities for Ga-68 Dotatate production in Europe and North America.
Nuclear pharmacies and regional compounding facilities
Numerous regional or hospital-based radiopharmacies synthesize Ga-68 Dotatate using licensed kits or on-site synthesis modules, sourced from major manufacturers or regional suppliers.

Regional and Contract Manufacturing

Given the short half-life of Ga-68, the supply chain relies heavily on regional generators and on-site synthesis units. Major nuclear pharmacies and radiopharmacies across North America, Europe, and Asia maintain certified production facilities.

United States
The U.S. market predominantly sources Ga-68 from Eckert & Ziegler and IRE Elit generators. Several radiopharmacies, such as Covidien, Lantheus, and Curium, have established GMP-compliant production processes.
Europe
Major suppliers include IBA Molecular and the European pharmacies coordinated through licensing agreements with the European Medicines Agency (EMA).
Asia-Pacific
Countries like Japan and South Korea are developing local sources, often via collaborations with European manufacturers. Companies such as Korea Cancer Center Hospital (KCCH) and regional distributors serve growing demand.

Emerging Supply Chain Developments and Challenges

The supply landscape for Gallium-68 Dotatate faces challenges such as limited generator lifespan, logistical constraints, and regulatory hurdles. Innovations such as automated synthesis modules and longer-lived generators aim to improve supply reliability. Additionally, cyclotron-based Ga-68 production is under exploration, potentially increasing regional supply independence.

Collaborations between pharmaceutical firms, radiopharmacy networks, and regulatory authorities are vital to streamline distribution and ensure consistent availability.

Market Dynamics and Future Outlook

The global Gallium-68 therapeutic and diagnostic market is projected to grow at a CAGR of approximately 10-12% through 2027. Increasing adoption of PET/CT imaging for neuroendocrine tumors and expanding clinical indications are prime growth drivers. Key players are investing in scalable production technologies and regional manufacturing hubs to meet rising demand.

Furthermore, developments in generator technology and the potential for cyclotron-produced Ga-68 could reduce dependence on limited supply chains, expanding accessibility.

Key Takeaways

The primary suppliers of Gallium-68 for pharmaceutical use include Eckert & Ziegler, IRE Elit, and Click Chemistry Technologies.
Major pharmaceutical manufacturers such as AAA and IBA produce and market Ga-68 Dotatate formulations, notably NETSPOT, under regulatory licenses.
The supply chain relies heavily on regional generators and radiopharmacies, with logistical challenges due to Ga-68’s short half-life.
Innovations in generator technology and alternative production methods, such as cyclotron synthesis, are anticipated to improve supply consistency.
Growing global demand underscores the importance of expanding manufacturing capacity and streamlining distribution channels.

FAQs

1. What are the leading manufacturers of Ga-68 generators?
Eckert & Ziegler, IRE Elit, and Click Chemistry Technologies dominate the market, providing reliable generators for clinical use across various regions [1][2][3].

2. How does the short half-life of Ga-68 impact its supply chain?
With a half-life of approximately 68 minutes, Ga-68 requires rapid elution from generators and immediate utilization in synthesis, necessitating localized production facilities and efficient logistics.

3. Are there alternative methods to supply Ga-68 besides generators?
Yes, research is ongoing into cyclotron production of Ga-68, which could supplement generator-based supply and reduce logistical constraints.

4. Is Gallium-68 Dotatate commercially available globally?
Availability varies by region; in North America and Europe, FDA and EMA-approved products like NETSPOT are widely available, while in other markets, regional suppliers and hospitals perform on-site synthesis.

5. What factors influence the choice of supplier for Gallium-68 Dotatate?
Quality assurance, regulatory compliance, generator capacity, supply reliability, and logistical considerations are critical factors.

Sources

[1] Eckert & Ziegler. "GalliAd™ Gallium-68 Generator." Available at: [company website]
[2] Click Chemistry Technologies. "Gallium-68 Generators." Available at: [company website]
[3] IRE Elit. "GalliPEARL™ Gallium-68 Generator." Available at: [company website]
[4] Novartis. "NETSPOT (Gallium Ga-68 DOTATATE)." Regulatory and product information.

Suppliers and packagers for generic pharmaceutical drug: GALLIUM DOTATATE GA-68