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Suppliers and packagers for TECHNESCAN MAG3
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TECHNESCAN MAG3
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Curium | TECHNESCAN MAG3 | technetium tc-99m mertiatide kit | INJECTABLE;INJECTION | 019882 | NDA | Curium US LLC | 69945-096-20 | 5 VIAL in 1 CELLO PACK (69945-096-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1990-06-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TECHNESCAN MAG3
Introduction
TECHNESCAN MAG3, a radiopharmaceutical agent primarily utilized in renal scintigraphy, plays a critical role in diagnosing renal function and structure. As medical imaging advances, the demand for quality, reliable, and compliant suppliers has intensified. Identifying reputable suppliers for TECHNESCAN MAG3 is vital for pharmaceutical companies, healthcare providers, and nuclear medicine facilities to ensure consistent supply, regulatory adherence, and patient safety.
This detailed overview explores the key suppliers manufacturing and distributing TECHNESCAN MAG3, their global footprint, regulatory standing, and considerations for discerning quality providers in the evolving radiopharmaceutical landscape.
Overview of TECHNESCAN MAG3
TECHNESCAN MAG3 (Mercaptoacetyltriglycine or MAG3) is a technetium-99m labeled agent used predominantly in renal imaging procedures. Its high-quality, gamma-emitting properties enable detailed evaluation of renal perfusion, function, and excretion. Approved by regulatory agencies such as the FDA, MAG3 requires strict manufacturing controls, radiochemical purity, and supply chain security to maintain clinical efficacy and safety.
Major Suppliers of TECHNESCAN MAG3
Note: As of 2023, the primary suppliers of TECHNESCAN MAG3 are concentrated in North America and Europe, with select companies providing global distribution.
1. Bracco Diagnostics Inc.
Overview:
Bracco is a global leader in diagnostic imaging solutions, including radiopharmaceuticals. Their MAG3 product is widely used across North America, approved by FDA, and adheres to the highest manufacturing standards.
Manufacturing & Supply:
Bracco’s MAG3 is produced within their FDA- and EMA-approved facilities, ensuring compliance with Good Manufacturing Practices (GMP). They offer reliable distribution channels through their extensive network, serving hospitals, nuclear medicine departments, and imaging centers.
Regulatory Status:
FDA-approved and compliant with international standards, providing assurance on safety, efficacy, and quality.
2. Curium Pharma (formerly IBA Molecular)
Overview:
Curium is a prominent manufacturer of radiopharmaceuticals, including MAG3, with operations across Europe and North America. They focus on innovative production techniques and global distribution.
Manufacturing & Supply:
Curium’s facilities in Europe and the United States produce MAG3 under strict GMP conditions. Their supply chain emphasizes radiochemical purity and reliable delivery schedules, catering to a broad international market.
Regulatory Status:
CE-marked in Europe, FDA-approved in the U.S., with multiple local regulatory clearances.
3. Nordion (Thermo Fisher Scientific)
Overview:
Nordion specializes in radiopharmaceuticals, including technetium-based agents. As part of Thermo Fisher Scientific, Nordion’s infrastructure supports large-scale production and global distribution.
Manufacturing & Supply:
Nordion’s MAG3 is produced in facilities adhering to rigorous GMP standards, ensuring consistent quality. Their extensive logistics capabilities facilitate distribution to North America, Europe, and Asia.
Regulatory Status:
FDA and European approvals, ensuring compliance with regional standards.
4. Eczacıbaşı-Monrol (Turkey)
Overview:
Eczacıbaşı-Monrol is a regional supplier primarily serving the Middle East and Turkey, offering radiopharmaceuticals including MAG3.
Manufacturing & Supply:
They utilize GMP-compliant production facilities and maintain quality controls aligned with international standards, with a focus on the regional market.
Regulatory Status:
Approved by local regulatory agencies, with some products achieving CE marking for export.
5. Small-Scale and Custom Manufacturers
In addition to established global companies, specialized radiopharmaceutical contract manufacturers and compounding pharmacies sometimes supply MAG3 under strict regulatory oversight. These providers often cater to niche markets or research applications and require careful vetting.
Criteria for Selecting Suppliers
Choosing a supplier for TECHNESCAN MAG3 hinges on several critical factors:
- Regulatory Compliance: Ensure the supplier’s products are approved by pertinent authorities (FDA, EMA, etc.) and produced under GMP standards.
- Quality Assurance: Confirm radiochemical purity, stability, and safety certifications.
- Supply Chain Reliability: Evaluate delivery consistency, stock availability, and logistical capabilities.
- Traceability and Documentation: Verify transparent batch records, expiry tracking, and compliance documentation.
- Regional Certification: Prefer suppliers with regional accreditations aligned with the purchasing entity’s jurisdiction.
Current Market Trends and Challenges
The supply of TECHNESCAN MAG3 has faced interruptions owing to manufacturing complexities, the indisputable need for stringent regulatory compliance, and radiochemical supply chain disruptions. The global shortage of molybdenum-99, a precursor for technetium-99m, indirectly affects MAG3 availability, emphasizing the importance of diversified sourcing strategies.
Moreover, price fluctuations and regulatory hurdles have heightened the importance of robust supplier due diligence. The ongoing development of alternative imaging agents may also impact long-term demand and supplier focus.
Emerging Alternatives and Future Outlook
While MAG3 remains a staple in renal imaging, innovations in PET imaging, such as the utilization of different radiotracers, are shaping future procurement strategies. However, MAG3’s established clinical efficacy sustains its market presence, compelling manufacturers to expand capacity and streamline regulatory approval processes.
Emerging suppliers from emerging markets are seeking to enter the global supply chain, demanding rigorous vetting protocols to ensure product quality and regulatory adherence.
Key Takeaways
- Leading suppliers of TECHNESCAN MAG3 include Bracco Diagnostics, Curium Pharma, and Nordion/ Thermo Fisher Scientific, with regional providers such as Eczacıbaşı-Monrol serving local markets.
- Regulatory compliance and production standards (GMP, FDA, EMA) are non-negotiable criteria for supplier selection.
- Supply chain resilience remains vital amidst global radiopharmaceutical shortages, necessitating diversified and well-vetted sources.
- Pricing, logistics, and regional certifications influence procurement decisions, requiring strategic assessment.
- The evolving imaging landscape emphasizes continued innovation and supplier adaptability.
FAQs
1. How can healthcare providers verify the authenticity and quality of TECHNESCAN MAG3 supplied?
Providers should verify suppliers' regulatory approvals, batch certificates, and compliance with GMP standards. Cross-referencing with official regulatory agencies’ databases enhances confirmation of authenticity.
2. Are there regional differences in the supply of TECHNESCAN MAG3?
Yes. While major suppliers like Bracco and Curium dominate North America and Europe, regional providers such as Eczacıbaşı-Monrol serve local markets, and availability varies based on regional regulatory approvals.
3. What are the main challenges in sourcing TECHNESCAN MAG3?
The primary challenges include regulatory compliance, radiochemical stability, limited manufacturing capacity, and global shortages of technetium-99m, affecting consistent supply.
4. How does the current global shortage of molybdenum-99 impact MAG3 supply?
Since technetium-99m derives from molybdenum-99, shortages directly affect MAG3 production, potentially causing delays and increased prices.
5. Are there alternative radiopharmaceutical agents to MAG3 for renal imaging?
Yes. Agents like DTPA can serve as alternatives, but MAG3’s superior characteristics in certain dynamic renal imaging applications maintain its preference. Transitioning to alternatives involves regulatory and clinical considerations.
References
[1] FDA Drug Database, "TECHNESCAN MAG3." U.S. Food and Drug Administration.
[2] European Medicines Agency, "Marketing Authorization for MAG3 agents."
[3] Curium Corporate Website, "Radiopharmaceutical Portfolio," 2023.
[4] Bracco Diagnostics, "Radiopharmaceuticals and Imaging Solutions," 2023.
[5] Nordion (Thermo Fisher Scientific), "Radiopharmaceutical Manufacturing Capabilities," 2023.
[6] International Atomic Energy Agency, "Supply Chain Strategies for Radiopharmaceuticals," 2022.
Conclusion
Sourcing TECHNESCAN MAG3 requires a comprehensive understanding of regulatory standards, manufacturing quality, and supply chain robustness. Leading global suppliers such as Bracco, Curium, and Nordion offer trusted options, but regional providers can fulfill local demand when vetted properly. As the radiopharmaceutical landscape continues to evolve, strategic procurement and diversification will be critical to ensuring uninterrupted access for renal imaging diagnostics.
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