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Suppliers and packagers for generic pharmaceutical drug: FLORBETAPIR F-18
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FLORBETAPIR F-18
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Florbetapir F-18
Introduction
Florbetapir F-18 (brand name: Amyvid) is a radiotracer used in positron emission tomography (PET) imaging to detect amyloid plaques in the brain, aiding in the diagnosis of Alzheimer's disease. As a crucial diagnostic tool, the supply chain for Florbetapir F-18 involves various specialized pharmaceutical and radiopharmaceutical companies. This article provides a comprehensive overview of the primary suppliers, highlighting their roles, regulatory status, and market influence within the neuroimaging segment.
Manufacturers of Florbetapir F-18
1. Eli Lilly and Company
Eli Lilly developed Florbetapir F-18 and gained FDA approval for Amyvid in 2012, positioning itself as the principal supplier globally. The company controls the patent, manufacturing facilities, and distribution channels. Their integrated production process includes sourcing of precursor materials, synthesis of the radiotracer, and distribution logistics emphasizing rapid delivery to radiopharmacies and hospitals. Eli Lilly’s market leadership is reinforced by their broad manufacturing capacity and strategic partnerships with nuclear medicine centers worldwide.
2. Partnered Radiopharmacies and Contract Manufacturing Organizations (CMOs)
The nature of radiopharmaceuticals like Florbetapir F-18 necessitates collaboration with specialized CMOs and radiopharmacies. These entities perform synthesis, quality control, and distribution, often under Eli Lilly’s supervision or licensing agreements. For example, advanced radiochemistry facilities in the United States and Europe routinely produce the compound to meet local demand, ensuring supply stability amidst the short half-life (approximately 110 minutes) of F-18. Companies like Cardinal Health and Jubilant Radiopharma support regional distribution and synthesis, expanding access globally.
3. Regional and Local Suppliers
In certain territories, regional suppliers or licensed manufacturing partners distribute Florbetapir F-18 under Eli Lilly’s licensing arrangements. These include several U.S.-based radiopharmacies with FDA licenses to produce and dispense radiotracers for medical imaging. Regulatory compliance, including Good Manufacturing Practices (GMP), remains critical for these suppliers to ensure safe and effective delivery.
Supply Chain Challenges and Market Dynamics
The production and supply of Florbetapir F-18 are inherently complex due to its short half-life, requiring a highly synchronized logistics network. The demand for rapid delivery creates reliance on a limited pool of manufacturers capable of executing high-quality radiopharmaceutical synthesis under strict regulatory oversight. Supply disruptions can occur due to regulatory changes, manufacturing delays, or logistical issues, emphasizing the importance of diversified supply sources and regional production hubs.
Moreover, as the diagnostic use of amyloid imaging expands, the competitive landscape may evolve with alternative radiotracers and emerging synthetic pathways. Eli Lilly’s dominant role positions it as a key player with significant influence over the supply chain, but also as a potential single point of vulnerability during shortages.
Regulatory Considerations
Suppliers must adhere to rigorous regulations outlined by agencies such as the U.S. FDA, EMA (European Medicines Agency), and local health authorities. These regulations govern manufacturing practices, quality controls, and distribution procedures to maintain safety and efficacy. Continuous compliance and proactive engagement with regulatory updates are essential for sustained supply.
Emerging Trends and Future Outlook
The increasing prevalence of Alzheimer’s disease and the growing acceptance of amyloid PET imaging suggest rising demand for Florbetapir F-18. Advancements in radiochemistry, such as improved synthesis protocols or longer half-life isotopes, could influence future supplier landscapes. Additionally, biosimilar or generic versions may enter markets, contingent on patent landscapes and regulatory pathways, potentially diversifying supply sources over the next decade.
Furthermore, innovations in regional production facilities, including mobile radiotracer units or reactor-based synthesis, are poised to enhance supply resilience. Partnerships between pharmaceutical companies and academic institutions or government entities could also facilitate expanded manufacturing capacity.
Key Takeaways
- Major Supplier: Eli Lilly remains the primary global manufacturer and distributor of Florbetapir F-18, leveraging its patent and extensive production network.
- Supply Challenges: The radiotracer’s short half-life necessitates a tightly coordinated logistics network, making regional manufacturing partnerships critical.
- Regulatory Compliance: Suppliers must meet stringent regulatory standards, with ongoing oversight ensuring safety and quality.
- Market Expansion: Growing demand for amyloid PET imaging underscores potential for diversification of suppliers through regional facilities and new synthetic pathways.
- Strategic Implications: Healthcare providers should evaluate supply chain reliability, including regional production capabilities, to mitigate risks associated with shortages or delays.
FAQs
1. Who are the primary suppliers of Florbetapir F-18 globally?
Eli Lilly is the leading producer of Florbetapir F-18 (Amyvid), supported by regional radiopharmacies and contract manufacturing organizations that produce and distribute the radiotracer locally to meet demand.
2. What are the main challenges in the supply chain for Florbetapir F-18?
Its short half-life (110 minutes) imposes strict logistical constraints, requiring rapid synthesis, quality control, and distribution. Supply disruptions can occur due to manufacturing delays, regulatory issues, or logistical failures.
3. Are there any competitors or alternatives to Florbetapir F-18?
Yes. Other amyloid PET radiotracers like Flutemetamol (Vizamyl) and Florbetaben (Neuraceq) are available, but Florbetapir remains a dominant agent, with supply heavily reliant on Eli Lilly.
4. How do regulatory agencies influence Florbetapir F-18 supply?
Regulations enforce manufacturing standards, safety protocols, and distribution practices. Non-compliance can lead to manufacturing suspensions, affecting overall supply chains.
5. Is the supply of Florbetapir F-18 expected to grow?
Yes. The increasing prevalence of Alzheimer’s disease and rising adoption of amyloid PET imaging are expected to drive demand, encouraging expansion of manufacturing and regional supply capabilities.
References
[1] Eli Lilly and Company. (2012). FDA approves Amyvid for PET imaging of amyloid plaques.
[2] U.S. Food and Drug Administration. (2012). FDA approves first radioactive diagnostic agent for Alzheimer’s disease.
[3] European Medicines Agency. (2013). Summary of Product Characteristics for Amyvid.
[4] Radiopharmaceuticals Market Reports. (2022). Global production and supply chains for radiotracers.
[5] American Society of Nuclear Medicine. (2020). Practice guidelines for amyloid PET imaging.
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