TECHNETIUM TC 99M MERTIATIDE KIT: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jubilant Draximage	TECHNETIUM TC 99M MERTIATIDE KIT	technetium tc-99m mertiatide kit	POWDER;INTRAVENOUS	216820	NDA	Jubilant DraxImage Inc., dba Jubilant Radiopharma	65174-261-05	5 VIAL in 1 CARTON (65174-261-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-261-01)	2023-03-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The Technetium-99m Mertiatide Kit (commonly referred to as Tc-99m Mertiatide or Tc-99m MAG3) is a critical radiopharmaceutical used primarily in renal imaging to evaluate renal function and drainage. As a diagnostic agent in nuclear medicine, its availability hinges on a reliable supply chain involving specialized manufacturers and distributors. This article provides a comprehensive overview of the primary suppliers, market dynamics, and factors influencing procurement decisions for Tc-99m Mertiatide Kits.

Understanding the Product Profile

Technetium-99m Mertiatide (MAG3) is a technetium-based radiotracer, favored for its high extraction efficiency in renal tissue, minimal radiation dose, and clear imaging characteristics. Its synthesis involves complex supply chains where the key component—technetium-99m—is generated via technetium generators supplied by nuclear reactors.

Regulatory Classifications & Certifications

The U.S. Food and Drug Administration (FDA) approved the Mertiatide Kit for clinical use, with similar approvals or clearances in other regions like Europe (via the European Medicines Agency). Compliance with Good Manufacturing Practice (GMP) and strict handling regulations ensures safety and efficacy.

Primary Suppliers of Technetium-99m Mertiatide Kits

1. Bracco Diagnostics

Overview: Bracco Diagnostics, headquartered in Princeton, New Jersey, is a leading provider of radiopharmaceuticals, including Tc-99m Mertiatide Kits. As a pioneer in nuclear medicine tracers, Bracco’s formulations are widely available in North America, Europe, and select international markets.

Product Features:

Commercially available under the trade name MAG3 Kit.
Approved by the FDA and other regulatory bodies.
Known for high-quality production standards and consistent supply.

Distribution & Supply Chain:
Bracco maintains robust manufacturing facilities and distribution networks, ensuring timely delivery across hospitals and imaging centers. The company invests heavily in quality assurance, regulatory compliance, and supply logistics.

2. Curium (formerly IBA Molecular)

Overview:
Curium, a global radiopharmaceutical supplier, offers a variety of Tc-99m labeled compounds, including the MAG3 kits. The company is known for its extensive radiochemistry expertise and regional manufacturing hubs.

Product Distribution:

Supplies are mostly concentrated in Europe, the Middle East, and Asia-Pacific regions.
Curium leverages a network of radiopharmacies and direct distribution channels.

3. Menarini Pharma

Overview:
Menarini is an Italian pharmaceutical firm with a significant presence in radiopharmacy. They manufacture and supply Tc-99m Mertiatide kits primarily within European markets and some international territories.

Regulatory Status:
Menarini’s radiopharmaceuticals meet EU GMP standards and are licensed in multiple countries, with efforts underway to expand global reach.

4. Jubilant Radiopharma

Overview:
An emerging player in radiopharmaceutical manufacturing, Jubilant Radiopharma supplies Tc-99m radiotracers—including Mertiatide—in select regions, particularly in North America.

Supply Dynamics:
Jubilant emphasizes supply chain reliability, which is critical given the global shortages of reactor-produced technetium-99m.

5. Other Regional & Generic Suppliers

Several regional manufacturers and generic suppliers have begun to produce Tc-99m Mertiatide kits, often licensed through regional regulatory agencies. Their offerings can depend heavily on local approval and market demand, often involving smaller batch manufacturing.

Market Dynamics and Supply Chain Considerations

Dependence on Technetium-99m Generators

Because Tc-99m is derived from molybdenum-99 generators, supply disruptions in nuclear reactors (due to aging reactors or geopolitical factors) impact the availability of Tc-99m Mertiatide kits. Notably, the global shortage of molybdenum-99 in recent years has prompted industry shifts towards alternative supply models [1].

Regulatory Approvals and Reimbursement Frameworks

Suppliers must secure regulatory approvals in target markets, which can influence market penetration and supply security. Reimbursement policies by healthcare payers also affect the procurement strategies of hospitals and imaging centers.

Certification and Quality Assurance

Manufacturers adhering to strict GMP and ISO standards secure higher trust in their product consistency, critical for radiopharmaceuticals’ safety and efficacy.

Emerging Trends & Future Outlook

Innovations in Radiochemistry: Development of kit formulations with longer shelf-lives or alternative radionuclides.
Regional Production Initiatives: Countries aiming for self-sufficiency by establishing local production of molybdenum-99 and technetium generators.
Supply Chain Resilience: Manufacturers investing in diversified supply chains to mitigate shortages and geopolitical risks.
Regulatory Advances: Streamlined approval pathways for new formulations or generics, increasing market competition.

Key Considerations for Procurement

Verify supplier compliance with regional regulatory standards.
Assess supply chain stability, especially amid global Mo-99 shortages.
Confirm product compatibility with existing imaging infrastructure.
Evaluate cost, reimbursement options, and delivery timelines.

Key Takeaways

Major suppliers of Tc-99m Mertiatide kits include Bracco Diagnostics, Curium, Menarini Pharma, and Jubilant Radiopharma, with regional players supplementing supply.
Supply chain reliability heavily depends on the stability of molybdenum-99 production, which remains a global challenge.
Regulatory compliance and high manufacturing standards are essential for product safety and market access.
The market is evolving due to technological innovations, regional production initiatives, and efforts to reduce dependency on reactor-produced isotopes.
Procurement decisions should prioritize supplier reliability, regulatory status, and logistical considerations to ensure continuous availability.

FAQs

1. What factors influence the choice of supplier for Tc-99m Mertiatide Kits?

Factors include regulatory approval, product quality, supply chain reliability, cost, regional distribution network, and adherence to GMP standards.

2. Are all Tc-99m Mertiatide Kits standardized across regions?

While the active pharmaceutical ingredient remains consistent, formulations and approved indications may vary due to regional regulatory requirements, impacting interchangeability.

3. How have recent global molybdenum-99 shortages affected the supply of Tc-99m Mertiatide?

Shortages have caused delays and increased prices, prompting suppliers and healthcare providers to explore alternative radiopharmaceuticals and regional production efforts [1].

4. What innovations are emerging in the field of renal radiopharmaceuticals?

Developments include longer shelf-life kits, alternative radionuclides like Tc-99m labeled compounds with improved pharmacokinetics, and kit formulations allowing decentralised preparation.

5. How can healthcare providers ensure steady supply amidst market fluctuations?

By establishing multiple supplier relationships, participating in inventory management strategies, and engaging with regional production programs.

References

[1] Molybdenum-99 global supply crisis explained. Journal of Nuclear Medicine, 2022.

Suppliers and packagers for TECHNETIUM TC 99M MERTIATIDE KIT