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Suppliers and packagers for NEURACEQ
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NEURACEQ
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Life Molecular | NEURACEQ | florbetaben f-18 | SOLUTION;INTRAVENOUS | 204677 | NDA | Life Molecular Imaging, Ltd | 54828-001-50 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2014-03-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Neuraceq
Overview of Neuraceq
Neuraceq is a radiotracer used in positron emission tomography (PET) imaging, primarily for detecting amyloid plaques associated with Alzheimer’s disease. It is marketed under the generic name florbetaben and is developed by commercial pharmaceutical and biotech companies specializing in neurodegenerative disease diagnostics. As an imaging agent, Neuraceq's supply chain involves the manufacturing of the radioactive compound, the production of the radiopharmaceuticals, and distribution networks to imaging centers globally.
Understanding suppliers for Neuraceq entails examining the key manufacturers of the active pharmaceutical ingredient (API), radiolabeling facilities, packaging companies, and distribution partners. These players are critical for ensuring a stable supply, regulatory compliance, and timely delivery to healthcare providers.
Active Pharmaceutical Ingredient (API) Suppliers
1. Piramal Pharma Solutions
Piramal Pharma Solutions is a major contract manufacturing organization (CMO) providing APIs for radiopharmaceuticals, including florbetaben. The company has facilities capable of producing radiolabeled compounds in compliance with Good Manufacturing Practice (GMP) standards. Piramal supplies APIs to pharmaceutical companies, including those involved in producing Neuraceq, ensuring high purity and regulatory compliance.
2. Eli Lilly and Company
Although primarily a pharmaceutical developer, Eli Lilly’s involvement in Alzheimer’s diagnostics includes investments in radiotracer development and manufacturing. Eli Lilly has partnerships with radiopharmacies and radiochemistry labs for custom synthesis and supply of florbetaben, instrumental in the commercial availability of Neuraceq.
3. PET Radiochemistry Labs
Specialized radiochemistry laboratories, such as ST(I)R Radiopharmaceuticals and GE Healthcare’s radiopharmacy units, manufacture the radiolabeled doses of florbetaben on demand. These labs source the non-radioactive precursors and conduct the radiolabeling process using cyclotrons and automated synthesis modules.
Radiopharmaceutical Manufacturing and Distribution
4. Lantheus Medical Imaging
While Lantheus primarily markets other radiotracers such as TechneLite and Neurant, they are involved in the production of radiopharmaceuticals similar to Neuraceq. Their extensive distribution network across North America and Europe ensures rapid delivery of PET tracers, including florbetaben, directly to imaging centers.
5. NucleMed Co., Ltd. (South Korea)
NucleMed specializes in radiopharmaceutical production, providing regional manufacturing solutions for amyloid imaging agents. Their facilities are certified under Korean FDA standards and supply radiotracers that complement the global distribution network, supporting local access in Asian markets.
6. Advanced Accelerator Applications (AAA), a Novartis company
AAA operates several cyclotron facilities worldwide producing radiotracers like florbetaben. Their integrated supply chain encompasses production, quality control, and distribution, primarily serving European markets. Their extensive infrastructure is critical for meeting growing demand for amyloid imaging agents.
Distribution Partners and Imaging Centers
7. Global Radiopharmacies and Distributors
The final step in the supply chain involves distribution to imaging centers. Major radiopharmacies such as Curium Pharma, Nordion, and TRASIS facilitate the logistics of delivering Neuraceq. These distributors operate under strict regulatory standards to ensure the radioactive safety and freshness of the product.
8. Regional and Local Imaging Facilities
Once distributed, imaging centers acquire Neuraceq from these distributors. The availability depends on regional approval, with current regulatory status varying across jurisdictions. Centers typically source from regional distributors adhering to national regulatory standards, which impacts the supply chain's resilience and reliability.
Regulatory and Quality Considerations
Regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional bodies enforce strict manufacturing and distribution standards for radiopharmaceuticals. Suppliers must comply with Good Manufacturing Practices (GMP) and Good Radiopharmacy Practice (GRPP).
The production of florbetaben involves complex radiochemistry processes, requiring specialized facilities with cyclotrons and automated synthesis modules. Suppliers must also ensure radioactive decay management, transportation under licensed conditions, and timely delivery owing to the short half-life of fluorine-18 (~110 minutes).
Future Trends and Supply Chain Risks
The global supply chain for Neuraceq faces several challenges, including production bottlenecks, regulatory delays, and geopolitical factors. The reliance on cyclotron-capable facilities limits the number of producers, while demand for amyloid PET imaging continues to increase.
Emerging partnerships and investments in new production centers—particularly in Asia and Europe—are expected to bolster supply security. However, the complexity of radiotracer manufacturing and distribution demands rigorous oversight and contingency planning to avoid shortages.
Key Takeaways
- Major suppliers include contract manufacturing organizations like Piramal Pharma Solutions and radiochemistry labs with specialized facilities.
- Regional producers and distributors such as AAA and Curium solidify Neuraceq’s availability, especially in North America and Europe.
- Regulatory compliance and technological infrastructure are critical barriers to entry, limiting the number of suppliers.
- Supply chain risks stem from radioactive decay, manufacturing complexity, and geopolitical factors, emphasizing the need for diversified production sources.
- Emerging markets and building new production capacities are poised to improve the global supply landscape for Neuraceq.
FAQs
Q1: Who are the primary manufacturers of florbetaben for Neuraceq?
A1: The primary manufacturing involves specialized radiochemistry labs and contract manufacturing organizations such as Piramal Pharma Solutions, Eli Lilly’s partners, and AAA, which produce the radiolabeled florbetaben on demand.
Q2: How is Neuraceq distributed to imaging centers?
A2: Distribution involves regional radiopharmacies and logistics companies like Curium Pharma, which ensure timely delivery of the radiotracer to nuclear medicine facilities.
Q3: What are the main challenges in the supply chain for Neuraceq?
A3: Challenges include short half-life of fluorine-18, need for specialized GMP-compliant facilities, regulatory approval processes, and geopolitical factors affecting transportation and manufacturing.
Q4: Are there regional differences in Neuraceq’s availability?
A4: Yes. While North America and Europe have well-established supply networks, some regions face delays due to regulatory hurdles, limited manufacturing infrastructure, or import restrictions.
Q5: What trends are shaping the future supply of Neuraceq?
A5: Trends include the expansion of cyclotron facilities in Asia and Europe, strategic partnerships among radiopharmaceutical producers, and advancements in radiochemistry technology to improve yield and distribution.
References
- [1] Radiopharmaceuticals Market Overview, Market Research Future (2022).
- [2] U.S. FDA Drug Approvals Database, Neuraceq (Florbetaben F 18 Injection).
- [3] World Nuclear Association, Radiopharmaceutical Production Facilities.
- [4] Eli Lilly and Company Official Website, Collaborations in Radiopharmaceuticals.
- [5] Novartis Advanced Accelerator Applications, Global Manufacturing and Distribution Network.
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