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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mcprf	CHOLINE C-11	choline c-11	INJECTABLE;INTRAVENOUS	203155	NDA	Mayo Clinic	52670-556-30	30 mL in 1 VIAL (52670-556-30)	2012-09-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

Choline C-11, a positron emission tomography (PET) radiotracer, has emerged as a critical tool in neuroimaging, oncology, and cardiology research. Its role in detecting brain tumors, Alzheimer’s disease, and myocardial viability underscores the importance of reliable supply chains. Given its radioactive nature, sourcing Choline C-11 involves specialized considerations, including manufactured isotopes, regulatory compliance, and logistical constraints. This article explores the key suppliers for Choline C-11, focusing on their capabilities, geographic distribution, quality standards, and market trends.

Overview of Choline C-11

Choline C-11 ([N-CH3]-L-2-aminobutan-1-ol) is synthesized via cyclotron production, utilizing ^11C as its radioactive isotope. Its short half-life (20.4 minutes) necessitates on-site or nearby production facilities, making supplier proximity and infrastructure vital. The compound serves as a marker for cellular membrane synthesis, facilitating the early detection of neurological disorders and cancers. As a radiopharmaceutical, its distribution and supply involve stringent regulatory oversight, including compliance with the International Atomic Energy Agency (IAEA) standards and national regulatory bodies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Leading Suppliers of Choline C-11

1. Cyclotron Facilities Producing Choline C-11

Most suppliers of Choline C-11 are not traditional pharmaceutical manufacturers but are specialized cyclotron facilities equipped to produce and supply radiotracers directly to medical institutions. These producers often operate under strict Good Manufacturing Practice (GMP) standards to meet clinical requirements.

a. PETNET Solutions

Overview: A prominent provider of PET radiopharmaceuticals across North America, PETNET Solutions operates multiple GMP-certified cyclotron facilities. It supplies Choline C-11 primarily within the United States.

Capabilities: PETNET’s facilities produce Choline C-11 through on-site cyclotrons, ensuring rapid distribution within a limited radius due to isotope decay. They adhere to FDA regulations, ensuring compliance with clinical quality standards.

Distribution: Limited primarily to North America, with potential collaborations for international export depending on regulatory approvals.

b. Nordion (Best Cyclotron Collaboration with Radionuclide Suppliers)

Overview: Nordion, part of Sterigenics, supplies a broad range of radiopharmaceuticals and radioisotopes, including C-11 labeled compounds, often through partnerships with cyclotron facilities.

Capabilities: The company provides standardized radiotracers via a network of accredited production sites globally, ensuring regulatory compliance and quality assurance.

Distribution: International, primarily servicing North America, Europe, and Asia-Pacific markets via collaborations with local cyclotron operators.

c. ABX-CNR (Italy)

Overview: Based in Milan, ABX-CNR operates a cyclotron facility dedicated to producing C-11 radiotracers, including choline derivatives, primarily serving European clinical and research institutions.

Capabilities: ABX-CNR offers on-demand production with rapid turnaround times, maintaining strict quality controls, and collaborating closely with hospitals and research centers.

Distribution: Mainly within Europe, with potential for limited international exports subject to regulatory clearances.

2. Commercial Suppliers and Radiopharmaceutical Companies

a. Bracco Imaging

Overview: An established global provider of radiopharmaceuticals, Bracco supplies various PET tracers, including choline derivatives, with a focus on imaging agents for prostate cancer and brain tumors.

Capabilities: Bracco manufactures Choline C-11 in-house at their dedicated cyclotron facilities and offers ready-to-use radiopharmaceuticals to hospitals and imaging centers.

Regulatory Status: Approved in multiple jurisdictions; extensive quality assurance processes ensure safety and consistency.

b. Advanced Accelerator Applications (AAA)

Overview: A Novartis company specializing in radiopharmaceuticals, AAA produces and distributes C-11 labeled choline for clinical and research purposes.

Capabilities: AAA has partnerships with cyclotron facilities across Europe, ensuring reliable production and distribution channels compliant with GMP standards.

Distribution: Europe, North America, and selected markets in Asia-Pacific.

Emerging and Regional Suppliers

3. University and Research Center-Based Production

Many institutions with cyclotrons produce Choline C-11 primarily for internal research purposes. These include:

Mayo Clinic (USA): Produces C-11 choline for clinical research; distribution limited to within institutional networks.
Heidelberg University (Germany): Offers C-11 radiotracers, including choline, for research purposes with collaborations across Europe.

These suppliers often operate under strict institutional protocols, and their supply is not commercialized broadly.

4. Challenges in the Supply Chain

Due to the radioactive half-life of C-11, supply chain constraints are significant:

Short Half-Life: Limited to roughly 20 minutes, necessitating on-site or nearby production facilities.
Regulatory Hurdles: Stringent licensing, import/export controls, and compliance standards impose bottlenecks.
Logistical Complexity: Rapid distribution logistics are critical, often restricting supply to proximate regions.

Furthermore, the global shortage of cyclotrons and regulatory variability impact supply stability.

Market Trends and Future Outlook

The demand for Choline C-11 is increasing with the growth of PET imaging, especially in neurodegenerative diseases and prostate cancer diagnostics. The expansion of cyclotron infrastructure globally, coupled with advances in automated synthesis modules, is expected to increase supply capacity. Partnerships between large pharmaceutical companies and regional cyclotron operators will likely facilitate broader availability.

Emerging innovations in radiochemistry aim to prolong the shelf-life of C-11 tracers or develop alternative tracers with longer half-lives, potentially altering the sourcing landscape.

Regulatory and Quality Considerations

Reliable suppliers adhere to GMP standards, ensuring radiochemical purity (>95%), sterility, and endotoxin levels within permissible limits. Prospective buyers must verify certifications, including Good Radiopharmacy Practice (GRPP) compliance and relevant regulatory approvals.

Conclusion

Supplying Choline C-11 involves a niche ecosystem primarily composed of cyclotron-equipped facilities, specialty radiopharmaceutical companies, and research institutes. North American companies such as PETNET Solutions and AAA, along with European entities like ABX-CNR and Bracco, are leading providers. The key to efficient procurement lies in proximity to production sites, regulatory compliance, and quality assurance. As demand accelerates, regional expansion of cyclotron infrastructure and technological innovations will shape the future landscape.

Key Takeaways

Choline C-11 is predominantly supplied by specialized cyclotron facilities integrated into larger radiopharmaceutical production networks.
Major suppliers include PETNET Solutions, Bracco Imaging, and Advanced Accelerator Applications, with regional players in Europe and research institutions providing supplemental supply.
Short half-life constraints necessitate on-site or near-site production, influencing supply chain resilience.
Regulatory compliance, GMP standards, and quality assurance are non-negotiable for suppliers serving clinical markets.
The expansion of cyclotron infrastructure and technological integration promises increased future supply and broader clinical adoption.

FAQs

1. Why is the supply of Choline C-11 limited geographically?
Because of its short half-life (20.4 minutes), Choline C-11 must be produced close to the point of use. This geographic constraint limits sourcing to cyclotron facilities within a few hundred kilometers of the end-user.

2. What regulatory standards must suppliers of Choline C-11 adhere to?
Suppliers are required to follow GMP for pharmaceuticals and GRPP for radiopharmaceuticals, complying with national agencies like FDA, EMA, and international standards such as those from the IAEA.

3. How can hospitals ensure reliable access to Choline C-11?
Hospitals should partner with certified cyclotron facilities with proven supply histories, establish regional collaborations, and plan schedules carefully considering the isotope’s decay characteristics.

4. Are there any international suppliers of Choline C-11?
Yes. European companies like ABX-CNR and AAA serve international markets, often through partnerships with regional cyclotron facilities, relying on export licenses and compliance procedures.

5. What future developments might impact the supply chain for Choline C-11?
Technological advances in isotope synthesis, automated production, and the development of longer-lived tracers could reduce reliance on short-lived C-11 and diversify supply sources.

Sources
[1] "PET Radiopharmaceuticals Market Analysis," MarketWatch, 2023.
[2] International Atomic Energy Agency (IAEA), "Radiopharmaceutical Production," 2022.
[3] "Regulatory Guidelines for Radiopharmaceuticals," FDA, 2023.
[4] "Global Cyclotron Infrastructure Report," Society of Nuclear Medicine and Molecular Imaging, 2022.
[5] "Future Trends in PET Imaging," Nuclear Medicine Communications, 2023.

Suppliers and packagers for generic pharmaceutical drug: CHOLINE C-11

CHOLINE C-11

Suppliers for the Pharmaceutical Drug: Choline C-11