Share This Page
Suppliers and packagers for axumin
✉ Email this page to a colleague
axumin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054 | NDA | Blue Earth Diagnostics | 69932-001-30 | 30 mL in 1 VIAL, MULTI-DOSE (69932-001-30) | 2016-05-27 |
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054 | NDA | Blue Earth Diagnostics | 69932-001-50 | 50 mL in 1 VIAL, MULTI-DOSE (69932-001-50) | 2016-05-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AXUMIN
Introduction
AXUMIN (fluciclovine F-18) is a diagnostic radiotracer used in positron emission tomography (PET) imaging to detect recurrent prostate cancer. Approved by the FDA in 2016, AXUMIN has rapidly gained prominence within the nuclear medicine and oncology spheres, due to its specificity for prostate cancer cells that exhibit increased amino acid transport activity. As the demand for precise imaging escalates, understanding the supplier landscape for AXUMIN becomes vital for healthcare providers, pharmacy chains, and diagnostic labs aiming to optimize procurement strategies and ensure consistent access.
Manufacturing and Supply Chain Overview
A. Core Manufacturer
The primary manufacturer of AXUMIN is Blue Earth Diagnostics, a leading radiopharmaceutical company specializing in the development of nuclear imaging agents. Acquired by Lantheus Holdings, Inc. in 2021, Blue Earth retains exclusive rights for the formulation, production, and distribution of AXUMIN across multiple markets, including the United States and Europe. The company's proprietary manufacturing facilities ensure high-quality standards following Good Manufacturing Practice (GMP) guidelines (1).
B. Production Challenges and Logistics
Given the short half-life (~110 minutes) of F-18, which restricts the window for shipping, AXUMIN’s supply chain hinges on proximity to radiopharmacies equipped with cyclotrons or access to regional distribution centers. The rapid decay requires that suppliers operate sophisticated production and transportation networks, often limiting distribution to within regional or national borders (2).
Major Suppliers and Distributors
1. Blue Earth Diagnostics (Lantheus)
As the sole original producer, Blue Earth supplies AXUMIN through a combination of direct distribution and authorized radiopharmacies. Their global partnerships enable regional distribution, particularly in North America and parts of Europe.
2. Radiopharmacies and Nuclear Medicine Centers
Due to the half-life constraint, AXUMIN is predominantly supplied through specialized radiopharmacies. These facilities obtain the radiotracer from Blue Earth’s manufacturing sites and dispense directly to clinical settings. Notable US-based radiopharmacies include Bracco Diagnostics, NorthStar Medical Radioisotopes, and independent nuclear pharmacies accredited by the American College of Radiology (ACR).
3. Regional Distributors
Several regional and national distributors facilitate AXUMIN logistics, such as:
- Lantheus Distribution Network
- Localized radiopharmacy networks partnering with Blue Earth
4. International Suppliers and Importers
In Europe, Blue Earth’s European subsidiary, Blue Earth Diagnostics Ltd., manages distribution via authorized partners, including hospitals and nuclear medicine centers. In markets like Canada and Australia, licensed importers handle procurement due to regulatory nuances.
Regulatory and Market Access Factors
The supply landscape is heavily influenced by regulatory approvals and market access pathways. Reduced market entry barriers expedite licensing, but the specialized nature of the radiotracer and regulatory requirements for handling radioactive substances create logistical complexities. The regulatory authorities (e.g., FDA, EMA) require strict compliance in manufacturing, transportation, and quality control.
Regulatory constraints can limit the number of suppliers, creating high dependence on Blue Earth’s production capacity. Efforts to diversify supply chains are ongoing but remain constrained by the technical and safety requirements unique to radiopharmaceuticals.
Emerging Suppliers and Future Outlook
While current supply hinges predominantly on Blue Earth Diagnostics, ongoing investments in cyclotron infrastructure and radiopharmaceutical manufacturing are likely to foster new entrants. Companies such as Novartis and GE Healthcare are exploring radiotracer development platforms, potentially expanding future supply options. Additionally, regional nuclear medicine networks aim to establish local production capabilities, which could mitigate disruptions and foster competition.
Recent advancements in generator-based radiotracers and alternative imaging agents may influence future demand and supply dynamics, although AXUMIN’s specific F-18 chemistry remains unique.
Supply Chain Risks and Mitigation Strategies
Given AXUMIN’s reliance on short half-life isotopes and specialized manufacturing, current supply chain risks include:
- Production disruptions due to equipment failure or regulatory issues.
- Logistical delays related to transportation and customs.
- Limited geographical reach owing to the isotope’s decay properties.
Healthcare providers should assess local radiopharmacy capacities, establish relationships with multiple licensed suppliers, and consider regional distribution agreements to mitigate shortages.
Conclusion
The supply of AXUMIN remains concentrated primarily within the capabilities and distribution network of Blue Earth Diagnostics and associated regional radiopharmacies. While a high-quality, efficient supply chain exists in key markets, inherent challenges due to isotope half-life and regulatory strictures underscore the importance of strategic procurement planning. Anticipated industry investments and innovations in radiopharmaceutical manufacturing may diversify and strengthen the supply chain over the coming years.
Key Takeaways
- Blue Earth Diagnostics (now part of Lantheus) is the sole manufacturer of AXUMIN, with exclusive production rights.
- Supply is primarily facilitated through specialized radiopharmacies due to isotope’s short half-life, limiting physical distribution zones.
- Regional distributors and accredited radiopharmacies constitute the primary suppliers, especially in North America and Europe.
- Supply chain risks include manufacturing disruptions, logistical challenges, and regulatory hurdles; diversification remains limited but emerging.
- Healthcare providers should develop robust procurement strategies that include regional partnerships and contingency planning.
FAQs
1. Who is the primary supplier of AXUMIN?
Blue Earth Diagnostics, now part of Lantheus Holdings, Inc., is the exclusive manufacturer and primary supplier globally.
2. Why is AXUMIN supply limited compared to other pharmaceuticals?
Its reliance on F-18, with a half-life of approximately 110 minutes, requires on-site or nearby cyclotron production, constraining distribution and creating logistical complexities.
3. Are there alternative suppliers to Blue Earth for AXUMIN?
Currently, no; Blue Earth holds exclusive rights. Future market entries may evolve with new radiotracers and manufacturing investments.
4. How does transportation impact AXUMIN supply stability?
Rapid isotope decay necessitates rapid, secure logistics; delays can result in unusable products, impacting supply continuity.
5. What strategies can healthcare providers employ to ensure consistent AXUMIN access?
Establish relationships with multiple regional radiopharmacies, plan procurement well in advance, and consider regional production capabilities to mitigate supply disruptions.
References
- Blue Earth Diagnostics. Manufacturing and Quality Control. Available at: https://blueearthdiagnostics.com
- Kennedy, J. et al. “Logistics and challenges of radiotracer distribution.” Journal of Nuclear Medicine Technology, 2020.
- Lantheus Holdings. Corporate Overview and Strategic Initiatives. Available at: https://lantheus.com
More… ↓
