Bulk Pharmaceutical API Sources for PIFLUFOLASTAT F-18

Bulk Pharmaceutical API Sources for PIFLUFOLASTAT F-18

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-5H05274
AKos Consulting & Solutions		AKOS040746739

Bulk Active Pharmaceutical Ingredient (API) Sources for Piflufluostat F-18

Last updated: July 29, 2025

Introduction

Piflufluostat F-18 is a radiopharmaceutical agent used primarily in positron emission tomography (PET) imaging for cancer diagnostics, notably in detecting tumors with high metabolic activity. As with all radiotracers, the supply chain for the active pharmaceutical ingredient (API) becomes critical in ensuring consistent, high-quality production and supply to meet clinical demand. This analysis explores the global sources of bulk API for Piflufluostat F-18, considering manufacturing landscapes, supplier profiles, regulatory considerations, and market dynamics.

Overview of Piflufluostat F-18 API

Piflufluostat F-18 is a fluorine-18 labeled analog designed for selective binding to specific cellular targets, facilitating precise imaging of tumor tissues. The API, F-18 fluorodeoxyglucose (FDG), is produced via cyclotron irradiation of enriched oxygen-18 water, followed by complex downstream processing.

Given the short half-life of fluorine-18 (~110 minutes), API sourcing requires proximity to cyclotron facilities or rapid transportation networks to ensure viability. The production process heavily depends on advanced cyclotron technology and specialized radiochemistry expertise.

Key Sources of F-18 API Globally

1. Cyclotron Facilities Producing F-18

The backbone of F-18 API supply hinges on the availability of dedicated cyclotron facilities capable of producing high-purity fluorine-18. These facilities are primarily concentrated in regions with robust nuclear medicine infrastructure, including North America, Europe, and parts of Asia.

North America

• Lantheus Medical Imaging (United States): Operates multiple cyclotrons in production centers, supplying FDG to hospitals and imaging centers across the U.S.

• Cardinal Health (United States): Maintains cyclotron facilities in various locations, providing API for clinical and research use.

• TriFoil Imaging (United States): Focused on producing FDG and other radiotracers for regional markets.

Europe

• IBA (Belgium): A leading manufacturer of cyclotrons and radiopharmaceuticals, producing F-18 for regional and export markets.

• GE Healthcare (UK): Operates cyclotron units for in-house production and supply.

• Eczacibasi-Monrol (Turkey): Provides F-18 API and radiopharmaceuticals catering to Eurasian regions.

Asia

• Sumitomo Heavy Industries (Japan): Key player in Cyclotron manufacturing, supporting domestic F-18 production.

• Bayer Asia: Produces radiopharmaceuticals through regional facilities linked to cyclotron sites.

• Indraprastha Apollo Hospitals (India): A growing nuclear medicine facility with cyclotron capability.

2. Contract Manufacturing Organizations (CMOs) and Radiopharmaceutical Suppliers

Some companies act as intermediaries, producing and supplying F-18 API under contractual arrangements:

• Nordion (Canada): Provides cyclotron services and radiochemicals, including F-18.

• Eckert & Ziegler (Germany): Offers cyclotron upgrades and radiopharmaceutical production, including supply of F-18.

• PETNET Solutions (United States, a Siemens Healthineers subsidiary): Produces and supplies radiopharmaceuticals, including F-18 FDG, sourced internally or via partnerships.

3. Regional and Specialty Manufacturers

Certain regional players with specialized facilities supply F-18 for research, clinical trials, or regional distribution:

• Royal Philips (Netherlands): Provides infrastructure and sometimes direct supply of radiotracers sourced from regional cyclotrons.

• Advanced Biochemical (India): Engages in developing radiopharmaceuticals and eventually supplies F-18 API to domestic markets.

4. Emerging Markets and New Entrants

As demand for PET imaging grows worldwide, especially in China, South Korea, and the Middle East, new cyclotron facilities are emerging. Noteworthy entrants include:

• Shanghai ChemPharm (China): Developing infrastructure to produce F-18 locally.

• Korea Institute of Radiological & Medical Sciences (KIRAMS): Building advanced cyclotron facilities for regional F-18 supply.

Regulatory Considerations in Sourcing F-18 API

The production and distribution of radiopharmaceuticals, including F-18, are highly regulated. Suppliers must comply with:

• Good Manufacturing Practice (GMP): Ensuring consistent quality and safety.

• Pharmacopoeial standards: For radiochemical purity, residual solvents, and radionuclidic purity.

• Licensing and procurement regulations: Varying by country and necessitating rigorous quality assurance and documentation.

Manufacturers often seek to align with approved source vendors to ensure regulatory compliance, especially when importing APIs across borders.

Market Trends and Supply Chain Dynamics

• Consolidation of Suppliers: Large pharmaceutical and radiopharmaceutical firms increasingly dominate supply, providing stability but reducing diversity in sourcing options.

• Geographical Constraints: The short half-life of F-18 limits long-distance transportation; proximity to cyclotrons remains crucial.

• Technological Advances: Innovations in cyclotron design and automation improve yield and reliability, impacting supplier capacity.

• Regional Expansion: Increasing investment in regional cyclotron facilities aims to mitigate supply disruptions and meet rising demand.

Challenges in Sourcing F-18 API

• Short Half-Life: Necessitates rapid logistics and supply chain synchronization.

• Regulatory Hurdles: Variability across jurisdictions complicates cross-border sourcing and licensing.

• Supply Disruptions: Unplanned outages at cyclotron facilities can lead to shortages.

• High Capital Costs: Setting up and maintaining cyclotron infrastructure involves substantial investment, influencing the number of suppliers.

Future Outlook

The global F-18 API supply landscape is poised for growth, driven by expanding PET imaging applications. Trends indicate:

• Regionalization: Countries emphasizing local production to enhance supply resilience.

• Innovation in Cyclotron Technology: Compact, more efficient cyclotrons expanding the number of potential producers.

• Strategic Partnerships: Collaborations between pharmaceutical companies and cyclotron manufacturers to secure supply.

• Regulatory Harmonization: Streamlining approval processes for radiopharmaceuticals facilitates broader sourcing options.

Key Takeaways

• The bulk API source for Piflufluostat F-18 predominantly originates from specialized cyclotron facilities in North America, Europe, and Asia.

• Availability hinges on proximity to cyclotron hubs due to the short half-life of F-18.

• Market players range from large pharmaceutical interventions to regional facilities and emerging market entrants.

• Supply chain stability depends on technological reliability, regulatory compliance, and infrastructure investments.

• Ongoing expansion of regional cyclotron networks aims to diversify sourcing options and mitigate logistical limitations.

FAQs

1. Why is proximity to cyclotron facilities critical for sourcing F-18 API?
Because fluorine-18 has a short half-life (~110 minutes), timely delivery from production to clinical sites is essential to ensure radiopharmaceutical efficacy. Longer transport distances can lead to decay and reduced activity, impacting diagnostic quality.

2. Which regions dominate the global production of F-18 API?
North America, Europe, and parts of Asia—particularly Japan and South Korea—are the primary regions with established cyclotron facilities producing F-18.

3. Are there any emerging markets for F-18 API sourcing?
Yes. Countries like China, India, and the Middle East are investing in new cyclotron infrastructure, aiming to localize production and meet growing regional demand.

4. What regulatory standards oversee the quality of F-18 API?
Production must comply with GMP, and the API must meet pharmacopeial standards such as pharmacopoeial specifications (USP, EP, etc.) for radiochemical purity, radionuclidic purity, and residual impurities.

5. How does technological innovation impact F-18 API supply?
Advances in cyclotron technology—smaller, more efficient, and automation-enabled—increase production capacity, improve reliability, and reduce costs, facilitating broader sourcing options.

References

1. [1] International Atomic Energy Agency (IAEA). "Cyclotron Production of Radionuclides." IAEA Radioisotopes & Radiopharmaceuticals.
2. [2] GE Healthcare. "F-18 Production for PET Imaging." Technical Specifications.
3. [3] EANM Practice Guidelines. "Production of PET Radionuclides." European Association of Nuclear Medicine.
4. [4] TriFoil Imaging. "Clinical and Research PET Radiotracer Production." Company Website.
5. [5] Philips. "Advances in Cyclotron Technology." Philips Healthcare Literature.