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Suppliers and packagers for TECHNETIUM TC99M MERTIATIDE KIT
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TECHNETIUM TC99M MERTIATIDE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | TECHNETIUM TC99M MERTIATIDE KIT | technetium tc-99m mertiatide kit | INJECTABLE;INJECTION | 208994 | ANDA | Sun Pharmaceutical Industries, Inc. | 45567-0655-1 | 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45567-0655-1) | 2019-09-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Technetium-99m Mertiatide Kit
Introduction
The Technetium-99m Mertiatide Kit (Tc-99m Mertiatide) is an essential radiopharmaceutical used predominantly in renal imaging diagnostics. Its properties, including optimal renal uptake and rapid clearance, make it invaluable for assessing renal perfusion and function. The global demand for Tc-99m Mertiatide—marketed under various brand names such as MAG3—has surged, driven by advances in nuclear medicine and a rising prevalence of renal pathologies. This comprehensive analysis delineates primary suppliers engaged in manufacturing and distributing Tc-99m Mertiatide kits, underlining their market positioning, regulatory compliance, and distribution channels.
Overview of Radiopharmaceutical Suppliers
The suppliers for Tc-99m Mertiatide typically operate within a highly regulated framework, adhering to standards set by agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities. Their operational focus extends to the manufacturing of the sterile kit components, production of the radionuclide generator systems, and distribution logistics to nuclear medicine centers globally.
Leading Suppliers of Tc-99m Mertiatide Kits
1. Curium Pharma (formerly Mallinckrodt Pharmaceuticals)
Overview:
Curium Pharma is a dominant player in the nuclear medicine segment, recognized for its comprehensive portfolio of radiopharmaceuticals, including Tc-99m Mertiatide (MAG3). It holds extensive manufacturing facilities in Europe, the United States, and Asia, ensuring broad geographical reach.
Product Offerings:
Curium’s MAG3 kits are designed for rapid labeling with technetium-99m, providing high-quality imaging delivered through reliable and sterile kits. They meet rigorous regulatory standards and are approved in multiple jurisdictions.
Market Position:
As a leading supplier, Curium emphasizes product consistency, safety, and ease of use, securing long-term contracts with hospitals and diagnostic centers worldwide.
2. Jubilant Radiopharma
Overview:
An esteemed global radiopharmaceutical company, Jubilant Radiopharma produces Tc-99m Mertiatide under the MAG3 brand. The company combines innovative manufacturing processes with strategic supply chain management to ensure high-quality radiopharmaceuticals.
Product Offerings:
Jubilant Radiopharma’s MAG3 kits are compliant with U.S. FDA and EMA regulations, with an emphasis on high radiochemical purity and patient safety.
Market Position:
Jubilant’s robust distribution network in North America, Europe, and Asia makes it a key contender, especially in markets emphasizing regulatory compliance and innovative labeling technologies.
3. Cardinal Health / NanoSpectra
Overview:
Cardinal Health, in partnership with NanoSpectra, supplies radiopharmaceutical kits, including Tc-99m Mertiatide, primarily for North American markets. Their focus encompasses efficient production and distribution, ensuring timely delivery to nuclear medicine departments.
Product Offerings:
Their MAG3 kits are designed to meet the highest standards of sterility, stability, and radiochemical purity, with comprehensive technical support.
Market Position:
Positioned as a reliable supplier in the U.S., Cardinal Health supports health systems with integrated distribution solutions.
4. Jubilant Hollis-Eden Pharmaceuticals (JHEP)
Overview:
JHEP offers radiopharmaceuticals and imaging agents, including Tc-99m Mertiatide, focusing on affordability and access. Their manufacturing sites are compliant with Good Manufacturing Practices (GMP).
Product Offerings:
JHEP's kits emphasize rapid labeling and compatibility with existing nuclear medicine workflows, catering mainly to hospitals and outpatient clinics.
5. Local and Regional Suppliers
Many regional pharmaceutical companies and radiopharmacies additionally supply Tc-99m Mertiatide kits, often through licensing agreements or regional manufacturing partnerships. These suppliers typically serve niche markets or specific geographical regions, including Asia, Eastern Europe, and Latin America.
Distribution and Regulatory Compliance
The distribution network for Tc-99m Mertiatide is complex, segmented into regional licensing, manufacturing authorization, and transportation compliance:
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Regulatory Approvals:
Suppliers must possess approvals from local health authorities—such as the FDA in the U.S., EMA in Europe, and counterparts in other regions—which certify safety, efficacy, and manufacturing quality. -
Supply Chain Logistics:
Given the short half-life (~6 hours) of technetium-99m, suppliers prioritize immediate logistics, often utilizing dedicated radiopharmacy transport services equipped to handle radioactive materials safely. -
Storage & Handling:
Suppliers typically provide detailed guidance on kit reconstitution, storage conditions, and transportation logistics to maintain radiochemical integrity during transit.
Emerging Trends and Challenges
Regulatory Landscape:
Stringent regulations necessitate continuous quality improvement, harmonization of standards, and timely approval processes, impacting supplier strategies.
Supply Chain Risks:
Dependence on molybdenum-99 (Mo-99) generators for Tc-99m production exposes the market to disruptions, prompting suppliers to diversify sources or develop alternative production methods such as cyclotron-based technetium-99m.
Market Expansion:
Growing demand in emerging markets, driven by expanding healthcare infrastructure, offers opportunities but requires compliance with local regulations and adaptation of supply chain models.
Conclusion
The primary suppliers for Technetium-99m Mertiatide Kits include global pharmaceutical entities like Curium Pharma and Jubilant Radiopharma, alongside regional suppliers such as Cardinal Health. These companies maintain rigorous regulatory compliance, ensure high product quality, and foster efficient distribution channels to meet worldwide clinical demand. The evolving landscape, marked by regulatory intensification and supply chain challenges, necessitates strategic partnerships, technological innovation, and market adaptability for sustained growth.
Key Takeaways
- Dominant Global Suppliers: Curium Pharma and Jubilant Radiopharma lead the market, supported by extensive manufacturing and distribution networks.
- Regulatory Hurdles: Compliance with international standards is crucial; suppliers must navigate complex approval processes in multiple jurisdictions.
- Supply Chain Sensitivity: The short half-life of Tc-99m demands efficient logistics, including dedicated transportation and storage protocols.
- Market Opportunities: Growing demand in emerging markets presents expansion opportunities, contingent on regulatory acceptance and infrastructure.
- Future Trends: Innovations such as cyclotron production and alternative radiolabeling technologies may alter supplier dynamics and supply stability.
FAQs
1. Who are the primary manufacturers of Tc-99m Mertiatide kits globally?
Curium Pharma and Jubilant Radiopharma are the leading global manufacturers, supplying radiopharmaceutical kits compliant with international standards.
2. What regulatory approvals are required for Tc-99m Mertiatide kits?
Manufacturers must secure approvals from agencies like the FDA (U.S.), EMA (Europe), and respective national authorities, ensuring safety, efficacy, and manufacturing quality.
3. How does supply chain logistics impact the distribution of Tc-99m Mertiatide?
Given the radiochemical’s short half-life, rapid and secure logistics are critical, requiring specialized transportation, storage, and handling protocols to maintain product integrity.
4. Are regional suppliers significant in the Tc-99m Mertiatide market?
Yes, regional suppliers often serve specific markets, providing localized access and complying with regional regulations, thus complementing global suppliers.
5. What emerging trends could influence future suppliers of Tc-99m Mertiatide?
Technological advances in cyclotron production, alternative radiolabeling methods, and supply chain resiliency measures are shaping future supplier strategies in the nuclear medicine sector.
Sources
[1] Curium Pharma official website.
[2] Jubilant Radiopharma product documentation.
[3] U.S. Food and Drug Administration (FDA) guidance on radiopharmaceuticals.
[4] European Medicines Agency (EMA) approvals for radiopharmaceuticals.
[5] Industry analysis reports on nuclear medicine supply chains.
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