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Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M BICISATE KIT
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TECHNETIUM TC-99M BICISATE KIT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lantheus Medcl | NEUROLITE | technetium tc-99m bicisate kit | INJECTABLE;INJECTION | 020256 | NDA | Lantheus Medical Imaging, Inc. | 11994-006-02 | 2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) | 1994-11-23 |
| Lantheus Medcl | NEUROLITE | technetium tc-99m bicisate kit | INJECTABLE;INJECTION | 020256 | NDA | Lantheus Medical Imaging, Inc. | 11994-006-05 | 5 KIT in 1 PACKAGE, COMBINATION (11994-006-05) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) | 1994-11-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TECHNETIUM TC-99M BICISATE KIT
Introduction
Technetium-99m (Tc-99m) Bicisate Kit, also known by its trade name Eovist or Neuraceq depending on regional branding, is a radiopharmaceutical agent used predominantly in neuro-oncology imaging. It leverages Tc-99m's ideal physical properties for diagnostic imaging, specifically SPECT (Single Photon Emission Computed Tomography), facilitating detailed visualization of brain tumors and cerebral pathologies. As a critical component in nuclear medicine, its supply chain involves specialized manufacturers and accredited distributors focused on radiopharmaceuticals.
This article provides a comprehensive analysis of the key suppliers responsible for manufacturing, distributing, and licensing Tc-99m Bicisate Kits globally, emphasizing their roles, geographic reach, regulatory compliance, and market influence.
1. Overview of Tc-99m Bicisate Kits
Tc-99m Bicisate Kits are radiopharmaceuticals that require on-site preparation using a Tc-99m generator. The kits contain pre-measured compounds that, upon labeling with Tc-99m, produce the diagnostic agent suitable for intravenous administration. Their production must meet stringent regulatory standards set by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities, emphasizing high purity, stability, and safety.
2. Leading Manufacturers of Tc-99m Bicisate Kits
2.1. GE Healthcare
GE Healthcare remains a leading global supplier of radiopharmaceuticals, including Tc-99m Bicisate Kits, under their Neuraceq brand. Originally developed for amyloid PET imaging, the company has expanded its portfolio within nuclear medicine.
- Market presence: North America, Europe, Asia-Pacific
- Regulatory approvals: Approved by FDA, EMA, and other regulatory entities for specific indications
- Distribution channels: Direct sales, licensed radiopharmacies, hospital radiology departments
- Key characteristic: Leveraging advanced manufacturing processes, comprehensive training, and global regulatory compliance
2.2. Curium (A Nordion/IBA Company)
Curium, a division of Nordion (focused on radiopharmaceuticals), supplies Tc-99m based diagnostic kits, including Bicisate formulations, through its global network.
- Market reach: North America, Europe, Asia, Australia
- Regulatory status: Registered with multiple authorities; products undergo rigorous quality assurance
- Unique offerings: Focus on high-quality, stable kits along with robust supply chain logistics
2.3. Jubilant Radiopharma
Based in India, Jubilant Radiopharma has become a significant regional supplier, especially within the Indian subcontinent and expanding exports.
- Product portfolio: Tc-99m Bicisate Kits, among others
- Regulatory compliance: DCGI approval in India, with efforts towards global certifications
- Distinct advantages: Cost-effective solutions, localized supply to meet regional demand
2.4. Local/National Suppliers
- Many countries operate their own radiopharmaceutical manufacturers licensed to produce Tc-99m kits, including national nuclear medicine centers and regional pharmaceutical entities.
- Examples include Alliance Medical (Europe), Mallinckrodt Pharmaceuticals (U.S.), and various hospital-based radiopharmacies with licensed production capabilities.
3. Distributors and Licensed Pharmacies
3.1. Licensed Radiopharmacies
In many regions, Tc-99m Bicisate Kits are supplied via licensed radiopharmacies that prepare and dispense the radiopharmaceuticals under strict regulatory compliance. These facilities often procure raw kits from manufacturers and supply to hospitals, clinics, and imaging centers.
3.2. International Distributors
Authorized distributors play crucial roles in bridging manufacturers and healthcare providers, especially in markets with limited manufacturing infrastructure. Distributors adhere to Good Distribution Practice (GDP) standards ensuring product integrity and safety.
4. Regulatory and Licensing Considerations
Manufacturers and distributors of Tc-99m Bicisate Kits operate within a complex regulatory landscape. Obtaining licenses involves demonstrating compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), along with adherence to national nuclear regulatory bodies, such as:
- U.S. FDA: Center for Drug Evaluation and Research (CDER)
- European Medicines Agency (EMA): Committee for Medicinal Products for Human Use (CHMP)
- India’s DCGI
- International Atomic Energy Agency (IAEA) guidelines**
Regulatory approval impacts supplier power and availability, emphasizing the importance of well-established, compliant suppliers.
5. Market Dynamics and Supply Chain Challenges
- Limited Number of Suppliers: The specialized nature of radiopharmaceutical manufacturing constrains the number of global producers, giving existing manufacturers significant market influence.
- Supply Chain Disruptions: Dependence on technetium-99m generators, often derived from aging nuclear reactors, impacts supply stability.
- Regulatory Barriers: Stringent manufacturing and licensing standards further limit entry for new suppliers.
6. Trends and Future Outlook
- Manufacturing Expansion: Efforts are underway to diversify supply sources through new reactor projects and alternative production methods (e.g., accelerator-based technetium-99m production).
- Regional Growth: Emerging markets are increasing local manufacturing capacity to reduce dependency on imports.
- Regulation & Innovation: Streamlined approval processes and technological advances will likely expand the supplier base and ensure more reliable supplies.
Key Takeaways
- The primary suppliers of Tc-99m Bicisate Kits include GE Healthcare and Curium, with regional players like Jubilant Radiopharma also contributing significantly.
- Distribution relies heavily on licensed radiopharmacies and authorized distributors ensuring regulatory compliance and product integrity.
- The supply chain's stability is influenced by nuclear reactor operations, regulatory frameworks, and advancements in technetium-99m production.
- Global trends point toward increased local manufacturing and alternative production methods to address supply constraints.
- Business professionals should monitor regulatory developments, supply chain logistics, and regional market players to optimize procurement strategies.
FAQs
Q1: What are the key factors to consider when selecting a Tc-99m Bicisate Kit supplier?
A1: Regulatory approval status, manufacturing quality standards (GMP compliance), supply stability, regional availability, and price competitiveness.
Q2: How does regulatory approval impact the availability of Tc-99m Bicisate Kits globally?
A2: Strict regulatory standards limit market entry, with only recognized manufacturers able to export and supply these kits within compliant markets, affecting overall availability.
Q3: Are there alternative agents to Tc-99m Bicisate Kits for cerebral imaging?
A3: Yes, alternatives include PET tracers like amino acid or glucose-based agents, but Tc-99m Bicisate remains prevalent due to its wide availability and compatibility with existing SPECT imaging systems.
Q4: How do supply chain issues affect the clinical use of Tc-99m Bicisate Kits?
A4: Disruptions in the technetium-99m generator supply or manufacturing delays can lead to shortages, impacting diagnostic workflows and patient care.
Q5: What is the impact of regional manufacturing on global supply?
A5: Regional manufacturers help diversify the supply chain, reduce dependency on a few global producers, and improve access in underserved markets.
References
- [1] "Radiopharmaceuticals in Nuclear Medicine," European Association of Nuclear Medicine.
- [2] U.S. Food and Drug Administration (FDA), Product approvals and package inserts.
- [3] International Atomic Energy Agency (IAEA), Guidelines on Production and Quality Control of Tc-99m Radiopharmaceuticals.
- [4] Market research reports, Global Radiopharmaceuticals Market Overview, 2022.
- [5] Company websites: GE Healthcare, Curium, Jubilant Radiopharma.
Conclusion
The supply landscape for Tc-99m Bicisate Kits is characterized by a few prominent global players supported by regional manufacturers and licensed radiopharmacies. Business decisions should involve a thorough understanding of regulatory compliance, supply chain stability, and regional market conditions. As technological advances and new production methods emerge, the availability and reliability of supply are poised to improve, ensuring continued efficacy of cerebral imaging diagnostics worldwide.
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