Share This Page
Suppliers and packagers for vizamyl
✉ Email this page to a colleague
vizamyl
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: VIZAMYL
Introduction
VIZAMYL (flutemetamol F18 injection) is a radioactive diagnostic agent used in positron emission tomography (PET) imaging to detect amyloid plaques in the brains of patients with suspected Alzheimer’s disease. As an important tool in neurodegenerative disease diagnosis, VIZAMYL’s supply chain is critical for healthcare providers and pharmaceutical firms. This report provides a comprehensive overview of key suppliers involved in the manufacturing, distribution, and distribution of VIZAMYL, analyzing their roles, market positioning, and strategic significance.
Manufacturers of VIZAMYL
1. GE Healthcare (Subsidiary of General Electric)
GE Healthcare is the primary manufacturer of VIZAMYL, holding the patent rights and regulatory approvals for its production. The company developed VIZAMYL as part of its molecular imaging portfolio, leveraging advanced radiopharmaceutical manufacturing capabilities.
- Manufacturing Facilities: GE Healthcare operates specialized facilities compliant with Good Manufacturing Practices (GMP) to produce VIZAMYL, ensuring high purity and safety standards. These facilities are located in regions with sophisticated regulatory oversight, including the United States and Europe.
- Supply Capacity: GE’s manufacturing infrastructure is designed for limited but specialized production runs, given the short half-life of fluorine-18 (~110 minutes). This necessitates keeping supply chains tightly integrated and geographically optimized.
2. Contract Manufacturing Organizations (CMOs)
GE Healthcare collaborates with several CMOs to scale production and meet international demand. These partners facilitate local and regional supply, especially in markets where direct manufacturing is limited due to regulatory or logistical reasons.
- Examples: Collaborations with CMOs in Europe and Asia help expand regional distribution, minimize transportation challenges, and ensure rapid deployment to imaging centers.
Key Distributors and Regional Suppliers
VIZAMYL's distribution involves a network of authorized radiopharmacies and specialized logistics providers focusing on temperature-controlled, rapid delivery.
3. Radiopharmacies
These pharmacies are licensed, certified entities responsible for preparing, dispensing, and delivering VIZAMYL to clinical facilities.
- Major Players: Leading radiopharmacies such as Curium Pharma, Lantheus Medical Imaging, and others have secured distribution rights through licensing agreements with GE Healthcare.
- Distribution Network: They operate within strict regulatory frameworks, utilizing specialized containers and vehicles to preserve radiochemical integrity during transit.
4. Distributors and Logistics Providers
Given the short half-life of VIZAMYL, logistics providers are crucial in maintaining timely delivery.
- Key Players:
- Curium Pharma: Known for logistics in radiopharmaceuticals, with extensive regional distribution networks.
- Lantheus Medical Imaging: Offers supply chain solutions, including real-time tracking and temperature monitoring.
- Express Transport Services: Specialized courier services operating under strict regulations for radioactive materials.
Logistics providers coordinate with regional authorities and ensure compliance with international hazardous materials regulations (e.g., IATA, ADR).
Supply Chain Challenges and Strategic Suppliers
The supply chain for VIZAMYL faces unique challenges originating from the complex nature of radiopharmaceuticals, short half-life, and regulatory constraints.
5. Supply Chain Constraints
- Half-life Limitations: The rapid decay of fluorine-18 necessitates a highly responsive logistics network, often within radiochemistry facilities located near production sites.
- Regulatory Compliance: Suppliers must adhere to stringent safety standards, maintaining detailed documentation and quality assurance protocols for transportation and storage.
- Regional Variability: Regulatory approvals differ among jurisdictions, impacting the number and type of suppliers operating in each region.
6. Strategic Importance of Suppliers
Suppliers with established manufacturing capabilities and logistics infrastructures are vital for uninterrupted supply. The key players—GE Healthcare, radiopharmacies, and specialized logistics firms—are strategically positioned to manage these constraints effectively.
Emerging Trends and Alternatives
The limited number of suppliers for VIZAMYL underscores the importance of diversifying supply chains, especially in regions where GE Healthcare has limited distribution rights or manufacturing presence.
- Development of Alternative Imaging Agents: Companies such as Eli Lilly and Novartis are developing other amyloid imaging tracers, potentially impacting VIZAMYL's market and supply dynamics.
- Regional Production Initiatives: Governments and private firms explore regional manufacturing hubs to reduce dependence on centralized suppliers, fostering resilience in the supply chain.
Conclusion
The supply ecosystem for VIZAMYL heavily relies on GE Healthcare's manufacturing, supplemented by a network of licensed radiopharmacies and specialized logistics providers capable of maintaining the integrity of this short-lived radiopharmaceutical. As the demand for Alzheimer’s diagnostic imaging grows, securing reliable supply chains remains a priority for stakeholders.
Key Takeaways
- Primary Manufacturer: GE Healthcare retains the dominant role in VIZAMYL's production, leveraging specialized facilities and regulatory expertise.
- Regional Suppliers & Distributors: Licensed radiopharmacies and logistics firms are critical, with regional partners expanding access through licensing agreements.
- Supply Chain Complexity: Short half-life and regulatory hurdles demand tightly coordinated, rapid logistics and compliance.
- Market Dynamics: Emerging competitors and regional manufacturing initiatives could influence future supplier landscapes.
- Business Strategy: Stakeholders should monitor technological advancements in radiotracers and regional infrastructure developments to mitigate supply risks.
FAQs
1. Who are the main suppliers of VIZAMYL globally?
GE Healthcare is the primary manufacturer, with regional radiopharmacies and logistics providers facilitating distribution tailored to local regulatory needs.
2. What factors influence VIZAMYL supply chain stability?
The key factors include its short half-life, manufacturing capacity constraints, regulatory compliance, and logistical orchestration for timely delivery.
3. Are there alternative suppliers to GE Healthcare for VIZAMYL?
Currently, GE Healthcare maintains a monopoly on VIZAMYL production; however, alternative amyloid imaging agents are under development by other pharmaceutical companies.
4. How does logistics impact VIZAMYL supply?
Logistics are critical due to the radioactive decay of fluorine-18, requiring rapid, temperature-controlled transportation within a limited geographic radius.
5. What future developments could affect VIZAMYL suppliers?
Advances in radiotracer technology, regional manufacturing initiatives, and regulatory changes could diversify or disrupt existing supply chains.
Sources
- GE Healthcare Official Website. “VIZAMYL (flutemetamol F18).”
- U.S. Food and Drug Administration (FDA). “VIZAMYL Approval and Regulatory Details.”
- Society of Nuclear Medicine & Molecular Imaging. “Radiopharmaceutical Supply Chain Overview.”
- IATA Dangerous Goods Regulations. “Transport of Radioactive Materials.”
- Industry Reports on Radiopharmaceutical Market Trends.
More… ↓
