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Suppliers and packagers for generic pharmaceutical drug: flutemetamol f-18
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flutemetamol 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 |
|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137 | NDA | GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare) | 17156-067-30 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE | 2014-01-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Flutemetamol F-18
Introduction
Flutemetamol F-18 is a radiotracer used predominantly in positron emission tomography (PET) imaging to detect amyloid plaques associated with Alzheimer’s disease. The compound's utilization in neurodegenerative diagnostics has increased the demand for reliable and high-quality suppliers capable of producing pharmaceutical-grade Flutemetamol F-18 under stringent regulatory standards. This article examines the leading suppliers, their manufacturing capabilities, regulatory compliance, and strategic significance within the global pharmaceutical and nuclear medicine supply chain.
Understanding Flutemetamol F-18
Flutemetamol F-18, chemically known as N-[2-(1-Hydroxy-3,3-dimethyl-2,3-dihydro-1H-inden-5-yl)ethyl]-N-methyl-2-[(18)F]fluoroacetamide, is a fluorinated radiotracer developed by GE Healthcare. It functions by binding to amyloid plaques, enabling visualization of amyloid pathology in vivo (via PET scans). Its production requires specialized facilities capable of handling radioactive materials and complying with Good Manufacturing Practice (GMP) standards.
The radiotracer’s half-life of approximately 110 minutes necessitates rapid synthesis, quality control, and distribution, making suppliers' geographic proximity and logistical competence critical.
Leading Suppliers of Flutemetamol F-18
1. GE Healthcare
Overview: GE Healthcare, the original developer, remains the primary supplier globally. Their manufacturing facility in the United Kingdom produces Flutemetamol F-18 under rigorous GMP guidelines, ensuring regulatory compliance across markets such as the U.S., Europe, and Asia.
Capabilities: GE Healthcare’s radiopharmaceutical facility is equipped with advanced automation for synthesis and quality control, enabling high throughput and consistent product quality. They supply both pre-packaged doses and supplies for onsite synthesis.
Regulatory Status: Approved by the FDA for certain diagnostic indications and registered with the European Medicines Agency (EMA), GE's Flutemetamol F-18 holds a key position in accessible neuroimaging.
Distribution Network: Their global distribution network ensures rapid delivery within approximately 2 hours from production, maintaining the integrity of the radiotracer.
2. IBA Molecular (Part of IBA Group)
Overview: IBA Molecular specializes in radiopharmaceutical manufacturing and distribution, providing a range of PET tracers, including F-18 labeled compounds. Their facilities in the United States and Europe can produce Flutemetamol F-18, often under partnership agreements with GE or through licensing.
Capabilities: Their production units are equipped with automated synthesis modules and quality assurance protocols that comply with international standards. IBA emphasizes flexible logistics solutions to ensure timely delivery.
Regulatory Compliance: IBA adheres to GMP and ISO standards, with some facilities approved by the FDA and the EMA, facilitating multi-regional supply.
Strategic Advantage: As a third-party supplier, IBA offers scalable capacity and geographic flexibility, which is vital during peak demand or regional shortages.
3. Development of In-house Production by Major Hospitals and Research Centers
Overview: Several leading academic medical centers and hospitals have developed in-house synthesis capabilities for Flutemetamol F-18, often under research licenses. These centers serve as regional suppliers for local needs and contribute to clinical research.
Capabilities: In-house producers utilize cyclotrons and dedicated synthesis modules, enabling rapid and localized supply, essential where logistics constraints exist.
Limitations: Manufacturing in-house entails significant capital investments and regulatory hurdles; thus, these sources are generally not considered primary global suppliers but are pivotal in regional contexts.
4. Emerging Regional Suppliers and Contract Manufacturing Organizations (CMOs)
Overview: A growing number of regional suppliers and CMOs are entering the market through licensing agreements and technology transfers with initial developers like GE. Notably, companies in Asia and Europe are investing in cGMP facilities to produce Flutemetamol F-18.
Capabilities: These entities aim to expand supply stability, reduce lead times, and lower costs for regional markets.
Regulatory Status: While some are in the process of obtaining approvals, regulatory compliance remains a critical barrier for full market access.
Regulatory and Quality Considerations
The production of Flutemetamol F-18 involves complex synthesis involving radioactive fluorine-18, necessitating specialized facilities. Suppliers must adhere to multiple standards:
- GMP Certification: Ensures consistency, safety, and efficacy of radiotracers.
- FDA and EMA Approval: Necessary for market authorization, especially in North America and Europe.
- ISO Standards: For quality management systems and environmental safety.
Compliance with these standards ensures product reliability, particularly for primary suppliers like GE Healthcare and certified CMOs.
Strategic Implications for Stakeholders
Pharmaceutical Companies & Healthcare Providers: Access to a reliable supplier like GE Healthcare is critical due to the established regulatory approvals and distribution infrastructure. Regional suppliers and CMOs aid diversification, reducing supply chain risks.
Investors & Business Analysts: The market for Flutemetamol F-18 is expanding with increasing Alzheimer's diagnostic procedures. The presence of multiple certified suppliers hints at market stability but also emphasizes the need for capacity expansion.
Researchers & Clinicians: Availability from multiple suppliers enhances access, especially vital in clinical trial settings requiring large or rapid dispatches.
Supply Chain Challenges and Opportunities
- Supply Chain Disruptions: Regulatory hurdles, logistical constraints, and geopolitical issues can disrupt supply. Diversification through regional suppliers mitigates such risks.
- Technological Advances: Innovations in cyclotron technology and automated synthesis are improving yields and reducing costs for suppliers.
- Regulatory Landscape: Ongoing efforts for standardization and mutual recognition of approvals may streamline cross-border supply.
Key Takeaways
- Primary Supplier: GE Healthcare remains the dominant global provider, with extensive manufacturing and distribution infrastructure.
- Regional & Emerging Suppliers: IBA Molecular and regional entities are crucial for supply stability and regional access.
- In-house & CMOs: Academic centers and CMOs contribute to local fulfillment but typically have limited global reach.
- Regulatory Compliance: Maintaining GMP and regulatory approvals is essential for supplier credibility and market access.
- Strategic Diversification: Stakeholders should consider multiple sourcing options to mitigate supply chain risks and ensure continuous access.
Conclusion
The supply landscape for Flutemetamol F-18 centers around accredited, technologically advanced suppliers meeting rigorous regulatory standards. While GE Healthcare remains the mainstay, regional suppliers and CMOs diversify options and bolster supply resilience. The evolving global demand driven by Alzheimer's diagnostics underscores the importance of strategic supplier partnerships and continued technological innovation.
FAQs
1. Who is the primary manufacturer of Flutemetamol F-18 globally?
GE Healthcare is the primary and most prominent manufacturer, with established GMP-certified facilities supplying markets worldwide.
2. Are there regional suppliers of Flutemetamol F-18?
Yes, several regional and emerging suppliers, including licensed CMOs and academic centers, provide localized production, particularly in Europe and Asia.
3. What regulatory standards must suppliers meet to distribute Flutemetamol F-18?
Suppliers must comply with GMP standards, obtain approvals from regulatory agencies like the FDA and EMA, and adhere to ISO quality management standards.
4. How does the short half-life of F-18 affect the supply chain?
The 110-minute half-life necessitates rapid synthesis, quality control, and distribution, emphasizing the importance of proximity and efficient logistics for suppliers.
5. What are the opportunities for new entrants in the Flutemetamol F-18 supply market?
New entrants can capitalize on technological innovations, regional market needs, and regulatory approvals to establish manufacturing capabilities and diversify supply sources.
References
[1] GE Healthcare. "Flutemetamol F-18." Product Details, 2023.
[2] IBA Molecular. "Radiopharmaceutical Portfolio," 2023.
[3] European Medicines Agency. "Regulatory approval status for Flutemetamol," 2023.
[4] U.S. Food and Drug Administration. "FDA Approvals and Regulatory Information for PET Radiotracers," 2023.
[5] World Nuclear Association. "Radiopharmaceuticals Production," 2023.
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