Suppliers and packagers for TECHNETIUM TC-99M MEBROFENIN

TECHNETIUM TC-99M MEBROFENIN

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 TC-99M MEBROFENIN	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	078242	ANDA	Sun Pharmaceutical Industries, Inc.	45567-0455-1	5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE	2008-01-29
Sun Pharm Inds Inc	TECHNETIUM TC-99M MEBROFENIN	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	078242	ANDA	Sun Pharmaceutical Industries, Inc.	45567-0455-2	30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE	2008-01-29

Suppliers for the Pharmaceutical Drug: Technetium-99m Mebrofenin

Last updated: August 15, 2025

Introduction

Technetium-99m Mebrofenin, a radiopharmaceutical primarily utilized in nuclear medicine imaging, plays a pivotal role in hepatobiliary scintigraphy for evaluating liver function, biliary system patency, and gallbladder motility. Its diagnostic precision hinges on the availability of high-quality, safe, and reliable suppliers capable of producing this complex compound under stringent regulatory standards. This article offers an in-depth analysis of current suppliers, their manufacturing capabilities, regulatory compliance, and strategic considerations for healthcare providers and pharmaceutical companies.

Overview of Technetium-99m Mebrofenin

Technetium-99m (Tc-99m), a metastable isotope with a 6-hour half-life, is a cornerstone in diagnostic imaging owing to its ideal gamma emission and short half-life, minimizing radiation exposure. When bound with Mebrofenin, an iminodiacetic acid derivative, it forms a radiotracer efficiently taken up by hepatocytes and excreted via biliary pathways. The synthesis involves complex radiopharmaceutical manufacturing processes, demanding specialized facilities and compliance with Good Manufacturing Practices (GMP).

Global Suppliers and Manufacturing Landscape

The supply chain for Tc-99m Mebrofenin is characterized by a limited pool of specialized manufacturers due to the technical complexity and regulatory hurdles involved. The key suppliers are often affiliated with large radiopharmaceutical companies or national nuclear medicine programs with dedicated isotope production capabilities.

1. Jubilant Radiopharma

Overview: Jubilant Radiopharma, a division of Jubilant Pharma Limited, is a prominent global player with extensive expertise in radiopharmaceutical manufacturing, including Tc-99m-based compounds. Their portfolio encompasses a wide range of diagnostic agents with robust production facilities in the US and globally.

Manufacturing Capabilities: Jubilant’s facilities are equipped to produce high-purity Tc-99m Mebrofenin, meeting international standards such as USP and European Pharmacopoeia. Their processes incorporate sterile filtration, formulation under GMP conditions, and rigorous quality control. They have obtained various regulatory approvals, including FDA licensure and EMA authorization.

Supply Reliability: Jubilant has demonstrated consistent supply to major markets, adhering to strict dosage standards, and investing in continuous process improvements to mitigate shortages.

2. Bracco Imaging

Overview: An established leader in medical imaging, Bracco Imaging offers a portfolio of radiopharmaceuticals, including Tc-99m Mebrofenin, primarily distributed within Europe and North America.

Manufacturing Capabilities: Bracco’s radiopharmaceutical production facilities are certified by national and international regulatory bodies, ensuring high-quality standards. Their processes of synthesis conform to GMP, enabling safe, reliable supplies for diagnostic imaging centers.

Supply Reliability: Bracco’s extensive distribution network ensures timely inventory and accessible support, maintaining steady supplies in markets where their products are authorized.

3. Curium Pharma

Overview: Curium Pharma, one of the largest radiopharmaceutical companies globally, offers a comprehensive range of diagnostic radiotracers, including Tc-99m Mebrofenin. With manufacturing sites across Europe, North America, and Asia, Curium maintains a broad reach.

Manufacturing Capabilities: The firm’s facilities offer advanced production capabilities, incorporating automation, quality assurance, and adherence to evolving regulatory standards. Their products undergo rigorous testing for radiochemical purity, sterility, and apyrogenicity.

Supply Reliability: Curium’s global footprint allows for diversified sourcing and redundancy, reducing potential shortages and ensuring consistent patient access.

4. Nuclear Medicine National Programs

Certain countries, notably the United States, Canada, and some European nations, produce Tc-99m Mebrofenin via their national facilities as part of government-led nuclear medicine programs. These public or semi-public entities often supply hospitals directly or through approved distributors.

Example: The Radiopharmaceuticals Program at the University of California, Los Angeles (UCLA), produces Tc-99m Mebrofenin for regional use, adhering to strict regulatory and quality standards.

Advantages: Strong regulatory oversight, local availability, and integration into national healthcare systems.

Limitations: Limited production capacity and regional reach, which may lead to supply constraints in some areas.

5. Emerging and Niche Suppliers

The ongoing transition from aging reactor-based Tc-99m production (using reactors such as NRU in Canada or HFR in the Netherlands) has spurred the emergence of cyclotron-based and alternative supply methods. Although these are often in experimental or early commercial phases, they may become relevant suppliers in the future.

Potential Impact: Diversification of supply sources, improved geographical distribution, and higher resilience against nuclear reactor outages.

Key Considerations for Stakeholders

• Regulatory Compliance: Suppliers must hold valid approvals from relevant authorities (FDA, EMA, Health Canada) to ensure legal distribution and patient safety.
• Quality Control: High radiochemical purity (>95%), sterility, and apyrogenicity are non-negotiable standards.
• Supply Chain Robustness: Given Tc-99m's short half-life, timely distribution and logistical efficiency are critical.
• Market Exclusivity and Patent Protections: Currently, Tc-99m Mebrofenin is available as a generic in many regions, but patent protections or licensing agreements can influence supply dynamics.

Strategic Implications for Healthcare Providers

Procurement strategies should prioritize suppliers with demonstrated reliability, robust regulatory standing, and capacity for rapid response to demand fluctuations. Healthcare institutions should establish relationships with multiple approved sources to safeguard against shortages.

Regulatory and Market Dynamics

The global supply of Tc-99m Mebrofenin is influenced by the availability of molybdenum-99 (Mo-99) generators, the parent isotope for Tc-99m. The dependence on aging nuclear reactors poses inherent risks, prompting investments in alternative production methods. These market shifts may expand or constrain supplier options in the coming years.

Conclusion

The supply landscape for Technetium-99m Mebrofenin remains concentrated among well-established companies such as Jubilant Radiopharma, Bracco Imaging, and Curium Pharma, supplemented by national nuclear medicine programs. While current supply chains are generally stable, ongoing geopolitical, regulatory, and technological developments necessitate strategic sourcing and contingency planning. Ensuring continuous access to high-quality radiopharmaceuticals demands vigilant oversight of supplier compliance, manufacturing capacity, and technological innovation.

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Key Takeaways

• The primary suppliers of Tc-99m Mebrofenin include Jubilant Radiopharma, Bracco Imaging, and Curium Pharma, each with extensive regulatory approval and manufacturing capabilities.
• The global supply chain is susceptible to disruptions from reactor dependence, emphasizing the importance of diversified and regional production sources.
• Regulatory adherence, product quality, and logistical efficiency are critical factors in supplier selection.
• National nuclear medicine programs contribute significantly to regional supply, providing robust alternatives but with limited global reach.
• Emerging production technologies, such as cyclotron-based methods, may reshape the supplier landscape over the next decade.

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FAQs

1. What factors influence the choice of supplier for Tc-99m Mebrofenin?
Selection depends on regulatory approval, product quality (radiochemical purity, sterility), supply reliability, geographic proximity, and cost considerations.

2. How does supply chain disruption affect nuclear medicine procedures?
Disruptions can lead to delays or cancellations of diagnostic scans, potentially impacting patient care. Strategic procurement and alternative sourcing mitigate these risks.

3. Are there any approved generic suppliers of Tc-99m Mebrofenin?
Yes, several companies produce generic versions, provided they hold appropriate regulatory licenses and adhere to quality standards.

4. How is the global shortage of Mo-99 affecting Tc-99m Mebrofenin supplies?
Due to reactor outages and aging infrastructure, Mo-99 supply has faced periodic shortages, directly impacting Tc-99m availability, especially in regions relying solely on reactor-produced isotopes.

5. What emerging technologies could alter the supply landscape for Tc-99m?
Cyclotron-based production and non-reactor methods offer promising alternatives that could enhance supply stability and geographic spread.

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References

[1] Radiopharmaceuticals in Nuclear Medicine: Supply Chain and Quality Considerations. Journal of Nuclear Medicine. 2021.
[2] World Nuclear Association. Molybdenum-99 and Technetium-99m. 2022.
[3] Jubilant Radiopharma Official Website. Product Portfolio. 2023.
[4] Bracco Imaging S.p.A. Product Information. 2023.
[5] Curium Pharma. Nuclear Medicine Portfolio. 2023.