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Suppliers and packagers for ceretec
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ceretec
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 | CERETEC | technetium tc-99m exametazime kit | INJECTABLE;INJECTION | 019829 | NDA | Medi-Physics Inc. dba GE Healthcare. | 17156-022-05 | 5 VIAL in 1 TRAY (17156-022-05) / 5 mL in 1 VIAL | 1988-12-30 |
| Ge Healthcare | CERETEC | technetium tc-99m exametazime kit | INJECTABLE;INJECTION | 019829 | NDA | Medi-Physics, Inc. dba GE Healthcare | 17156-025-05 | 1 KIT in 1 CARTON (17156-025-05) * 5 mL in 1 VIAL, GLASS (17156-022-05) * 2.5 mL in 1 VIAL, GLASS (17156-027-01) | 2018-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ceretec
Introduction
Ceretec, the trade name for Technetium Tc 99m exametazime, is a radiopharmaceutical primarily used in nuclear medicine imaging to assess cerebral blood flow. As a vital component of diagnostic imaging, Ceretec's supply chain is crucial for hospitals, diagnostic laboratories, and nuclear medicine centers worldwide. This article provides an in-depth analysis of the current suppliers, underlying manufacturing dynamics, regulatory considerations, and market implications for Ceretec.
Overview of Ceretec and Its Market
Ceretec is a radioactive diagnostic agent that contains technetium-99m, a widely used isotope in medical imaging due to its favorable physical properties and convenient half-life (6 hours). The agent’s primary application is in brain perfusion imaging, aiding in the diagnosis of stroke, epilepsy, dementia, and other neurological conditions.
The demand for Ceretec is closely tied to the global nuclear medicine market, which is projected to grow at a CAGR of approximately 6% through 2028. Factors influencing supply include the limited number of producers of technetium-99m, the aging infrastructure of nuclear reactors, and the regulatory environment governing radiopharmaceuticals.
Major Suppliers of Ceretec
1. NorthStar Medical Technologies
Overview: NorthStar Medical Technologies is a prominent player in the production of molybdenum-99 (Mo-99), the parent isotope for technetium-99m. They have developed an innovative reactor-free process to produce Mo-99, positioning themselves as a reliable supplier in a market historically dependent on aging research reactors.
Role in Ceretec Supply Chain: NorthStar supplies Mo-99 to radiopharmacies and radiopharmaceutical manufacturers via licensed distribution networks, which they then process into technetium-99m for various agents, including Ceretec.
Advantages: NorthStar's hold on the Mo-99 market is seen as a safeguard against shortages caused by reactor outages. They aim to supply high-specific-activity Mo-99, critical for producing high-quality radiopharmaceuticals.
2. Molymet (Part of CNNC Group)
Overview: China National Nuclear Corporation’s subsidiary Molymet has expanded its capabilities in the production of molybdenum and technetium radioisotopes.
Supply Chain Role: Molymet produces technetium-99m derived from local Mo-99 supply, marketing radiopharmaceuticals including Ceretec within China and internationally, especially in Asia.
Strengths: Low-cost production and government backing have facilitated Molymet’s growing influence in the global supply chain.
3. Nordion (A division of Sterigenics)
Overview: Nordion, based in Canada, has been a longstanding supplier of technetium-99m and other radiopharmaceuticals, with extensive distribution channels.
Supply Chain Role: They source Mo-99, primarily from reactors in Europe and North America, and convert it into technetium-99m for use in agents like Ceretec.
Operational Status: Despite some periods of supply disruption linked to reactor outages, Nordion remains a key supplier due to robust infrastructure and diversified sourcing.
4. Curium Pharma
Overview: Curium is a global radiopharmaceutical company with manufacturing facilities in Europe and the U.S., producing a broad portfolio, including technetium-99m generators.
Supply of Ceretec: Curium manufactures technetium-99m generators that contain sterile technetium-99m, supplied directly to hospitals, often used for multi-agent applications, including Ceretec.
Strengths: Their integrated manufacturing allows for reliable supply, especially within Europe and North America.
5. NTP Radioisotopes (South Africa)
Overview: NTP Radioisotopes specializes in the production of Mo-99 derived from its facility in South Africa, contributing significantly to the global supply of technetium-99m.
Relevance to Ceretec: While primarily supplying generators and bulk technetium-99m for local uses, NTP plays a role in stabilizing supply in Africa and neighboring regions.
Market Dynamics and Supply Chain Challenges
Dependence on Aging Nuclear Reactors
Over 80% of Mo-99 production historically relied on a handful of aging research reactors in Canada, the Netherlands, and Belgium. Reactor outages, such as the closure of NRU Reactor in Canada and HFR reactor in the Netherlands, disrupted global supply, prompting efforts to diversify sources.
Transition to Reactor-Free Production Methods
Innovations like NorthStar's reactor-free process and the development of accelerator-based production methods aim to reduce reliance on nuclear reactors, thus providing more stable, secure supplies.
Regulatory and Logistical Constraints
Radiopharmaceuticals face stringent regulations regarding production, transportation, and disposal. Export restrictions and regulatory approvals influence supplier markets, impacting global availability.
Market Concentration Risks
The limited number of producers means supply disruptions can significantly impact availability. Manufacturers are actively seeking diversification and backup suppliers to mitigate shortages.
Regulatory Considerations
Suppliers must adhere to international regulations, including those from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and respective national authorities. Good Manufacturing Practice (GMP) compliance and licensing are mandatory, affecting the production and distribution scope of suppliers.
Emerging Trends and Future Outlook
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Increased Capacity from New Reactors: Projects like Australia's OPAL reactor and Australia's potential Mo-99 export plans could bolster supply.
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Accelerator-Based Technetium-99m Production: Companies such as SHINE Medical Technologies and Best Cyclotron Systems are developing accelerator-based production methods, promising to disrupt traditional reactor-dependent supply chains.
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Global Initiatives to Reduce Shortages: Governments and organizations like the IAEA are actively supporting initiatives to bolster supplies, including establishing regional production hubs.
Key Takeaways
- The supply of Ceretex hinges on the availability of technetium-99m, primarily derived from Mo-99 produced by nuclear reactors or alternative methods.
- NorthStar Medical Technologies, Molymet, Nordion, Curium Pharma, and NTP Radioisotopes are dominant suppliers, with NorthStar leading in reactor-free Mo-99 production.
- Supply stability increasingly relies on diversification strategies and technological innovation to mitigate reactor outages and regulatory hurdles.
- Market participants should monitor regulatory changes, technological advances, and geopolitical developments affecting global radiopharmaceutical supply chains.
FAQs
1. Who are the primary global suppliers of Ceretec?
Major suppliers include NorthStar Medical Technologies, Nordion (Sterigenics), Curium Pharma, Molymet (CNNC Group), and NTP Radioisotopes, each offering different supply chain strengths.
2. How does NorthStar’s reactor-free production impact Ceretec supply?
NorthStar's reactor-free process contributes to a more resilient supply chain by reducing reliance on aging reactors, potentially mitigating shortages.
3. Are there regional differences in suppliers for Ceretec?
Yes. While NorthStar and Nordion are prominent in North America, Curium and Molymet mainly supply Europe and Asia, respectively, with local plants further diversifying regional supply.
4. What technological developments could influence Ceretec’s future supply?
Accelerator-based technetium-99m production and regional Mo-99 generators are poised to lower dependency on traditional reactors, improving supply stability.
5. What regulatory challenges affect Ceretec suppliers?
Strict GMP standards, licensing requirements, and international transport regulations for radioactive materials pose logistical and compliance challenges, influencing supplier operations.
References
- [1] International Atomic Energy Agency (IAEA). "Medical Radioisotope Supply and Demand." 2022.
- [2] NorthStar Medical Technologies. "Technetium-99m Production Overview." 2023.
- [3] Molymet Corporate Website. "Radiopharmaceuticals and Mo-99 Production." 2023.
- [4] Nordion (Sterigenics). "Technetium-99m Generator Portfolio." 2022.
- [5] Curium Pharma. "Global Radiopharmaceutical Manufacturing Capabilities." 2023.
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