Suppliers and packagers for amyvid

amyvid

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008	NDA	Eli Lilly and Company	0002-1200-48	1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48) / 100 mL in 1 VIAL, MULTI-DOSE	2012-06-01
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008	NDA	Eli Lilly and Company	0002-1200-50	1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50) / 50 mL in 1 VIAL, MULTI-DOSE	2012-06-01

Suppliers for the Pharmaceutical Drug: Amyvid

Last updated: July 30, 2025

Introduction

Amyvid, also known by its generic name florbetapir F18, is a radiopharmaceutical agent used in positron emission tomography (PET) imaging to assess amyloid plaque density in the brain—a biomarker associated with Alzheimer’s disease (AD). Approved by the U.S. Food and Drug Administration (FDA) in 2012, Amyvid plays a vital role in the diagnostic process of AD, enabling clinicians to visualize amyloid deposits non-invasively (FDA, 2012). As with any high-demand radiopharmaceutical, establishing a reliable supply chain is critical for healthcare providers, imaging centers, and pharmaceutical companies engaged in AD diagnostics. This article provides an in-depth overview of current Amyvid suppliers, analyzing manufacturing sources, distribution networks, and strategic considerations crucial for stakeholders.

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Manufacturers of Amyvid

1. Eli Lilly and Company

Eli Lilly is the sole FDA-approved manufacturer of Amyvid, holding exclusive rights to produce and distribute florbetapir F18. The pharmaceutical giant announced approval in 2012, leveraging its extensive radiopharmaceutical manufacturing capabilities. Lilly's manufacturing facilities are strategically located to meet global demand, adhering to stringent Good Manufacturing Practices (GMP) and radiopharmaceutical standards set by regulatory authorities.

Lilly's investment in specialized cyclotron facilities enables the production of the F18 isotope, which has a short half-life (~110 minutes), necessitating proximity to imaging centers. Lilly’s distribution network uses regional nuclear pharmacies and licensed radiopharmacies to ensure timely delivery of Amyvid to imaging sites (Lilly, 2012).

2. Contract Manufacturing and Supply Partnerships

While Lilly remains the exclusive producer, some regional supply arrangements involve partnerships with radiopharmacy networks, including:

• Navidea Biopharmaceuticals: Though primarily known for Lymphoseek, Navidea’s expertise in radiopharmaceuticals offers potential supply solutions and partnerships.

• Isotope Suppliers: Lilly relies on isotope suppliers like Covidien (now part of Medtronic) and Novartis to ensure a steady F18 isotope supply; however, these are not direct Amyvid suppliers but critical components of the manufacturing process.

3. Production Limitations and Supply Challenges

The short half-life of F18 limits distribution to within approximately 300 miles of production facilities. This geographic constraint has led Lilly to establish multiple regional manufacturing hubs across the U.S. to improve availability. Nevertheless, supply shortages have occasionally been reported, especially during high demand periods, emphasizing the importance of the supply chain’s resilience.

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Distribution Channels for Amyvid

1. Radiopharmacies and Nuclear Pharmacies

Distribution of Amyvid hinges on specialized radiopharmacies that are licensed and equipped to handle radiopharmaceuticals. These facilities coordinate logistics to deliver the drug within its limited shelf life, often employing courier services optimized for rapid transit. Some of the leading radiopharmacies involved include:

• NorthStar Medical Radioisotopes
• Nuclear pharmacies affiliated with major hospital systems
• Third-party logistics providers specializing in radiopharmaceuticals

2. Hospital and Imaging Center Supply Chains

Amyvid is distributed directly to imaging centers, outpatient clinics, and hospitals with PET capabilities. Many imaging sites establish contractual relationships with regional radiopharmacies to maintain a steady supply, especially in high-volume centers focused on neurodegenerative disease diagnostics.

3. International Supply

Beyond the U.S., Lilly collaborates with international partners and distributors to supply Amyvid in select markets, subject to local regulatory approvals. Distribution in Europe, Asia, and other regions is facilitated through licensing agreements with regional pharmaceutical distributors, emphasizing regulatory compliance and cold chain integrity.

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Regulatory and Strategic Considerations

Lilly’s role as the exclusive producer grants a competitive advantage but also imposes dependence on manufacturing capacity and regulatory approvals. Supply constraints can impact clinical workflows and patient access, prompting Lilly to explore:

• Capacity Expansion: Investing in additional cyclotron facilities and manufacturing lines.
• Supply Agreements: Forming strategic alliances with radiopharmacies to ensure consistent availability.
• Alternative Diagnostic Agents: Monitoring development of other amyloid PET tracers or non-radioactive biomarkers to diversify diagnostic options.

Emerging Alternatives and Market Dynamics

While Lilly remains the sole supplier for Amyvid, the landscape of amyloid imaging agents is evolving. For example, drugs like Vizamyl (Glenmark) and Neuraceq (Bio-Techne/ACimmune) are FDA-approved or in clinical use, introducing potential competition. However, Amyvid’s established clinical utility and distribution networks position it as a primary agent for amyloid imaging in the near term.

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Conclusion

Amyvid's supply chain relies predominantly on Lilly's manufacturing capacity, supplemented by regional radiopharmacies and logistics providers capable of handling the drug's sensitive nature and short half-life. Strategic expansion of manufacturing facilities and robust distribution alliances are essential to meet increasing demand, particularly as Alzheimer's diagnosis becomes more prevalent.

Business stakeholders should monitor Lilly’s capacity expansion initiatives, regional distribution networks, and emerging competitors or alternatives to ensure optimal sourcing strategies for Amyvid.

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Key Takeaways

• Exclusive Production: Lilly is the sole FDA-approved manufacturer of Amyvid, highlighting the importance of their manufacturing and distribution network.
• Supply Constraints: The F18 isotope’s short half-life necessitates proximity between production sites and imaging centers, influencing supply logistics.
• Distribution Network: Specialized radiopharmacies and courier services play a critical role in delivering Amyvid within its limited shelf life.
• Market Dynamics: Emerging amyloid imaging agents may impact long-term supply and demand; strategic planning is essential.
• Strategic Expansion: Investing in capacity and regional hubs enhances supply resilience amid rising AD diagnostic needs.

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FAQs

1. Who manufactures Amyvid?
Eli Lilly and Company is the sole FDA-approved manufacturer of Amyvid, with no competing producers currently authorized.

2. What are the main challenges in supplying Amyvid?
The primary challenge is the isotope’s short half-life, requiring production facilities to be geographically close to imaging centers, which limits distribution range and complicates logistics.

3. How is Amyvid distributed to healthcare providers?
Typically through licensed radiopharmacies and nuclear pharmacies, which deliver the drug via courier services optimized for rapid transit within the isotope’s shelf life.

4. Are there alternative amyloid PET tracers available?
Yes. Brands like Vizamyl (Glenmark) and Neuraceq (Bio-Techne/ACimmune) are approved in various regions and may serve as alternatives, although Amyvid remains the most widely adopted in the U.S.

5. Is Lilly planning to increase Amyvid production capacity?
Lilly has shown interest in expanding manufacturing capabilities, including investing in additional cyclotron and radiopharmaceutical production facilities, to meet growing demand.

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References

[1] FDA. (2012). FDA approves florbetapir F 18 for PET diagnosis of Alzheimer’s disease. U.S. Food and Drug Administration.
[2] Lilly. (2012). Lilly Announces FDA Approval of Amyvid (Florbetapir F 18 Injection) for PET Imaging of Amyloid Plaques in Alzheimer’s Disease. Lilly Press Release.