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

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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
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
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 28, 2025

Introduction

Technetium-99m (Tc-99m) Mertiatide Kit, commercially known as MAG3, is a critical radiopharmaceutical used predominantly in renal imaging to evaluate renal function and drainage. Its precise and reliable performance makes it an indispensable tool in nuclear medicine departments worldwide. Securing reputable suppliers for this radiopharmaceutical kit involves understanding the manufacturing landscape, regulatory landscape, and distribution networks, as well as evaluating the quality and supply chain reliability of different vendors.

This article provides a comprehensive overview of the prominent suppliers of Tc-99m Mertiatide Kits, highlighting their market presence, regulatory status, production capabilities, and strategic positioning to assist healthcare providers, procurement specialists, and investors in making informed decisions.

Market Overview and Demand Drivers

The global nuclear medicine market is projected to grow at a CAGR of approximately 7% from 2022 to 2030, driven by increasing prevalence of chronic kidney diseases, expanding applications of nuclear imaging, and technological advancements in radiotracers. Tc-99m Mertiatide Kit remains among the top renal imaging agents due to its high efficacy and safety profile.

Key factors influencing supplier selection include:

Regulatory approvals: FDA, EMA, and other major health authorities.
Supply chain robustness: Ability to meet high demand and maintain consistent supply.
Production capacity: Facility accreditation and technological sophistication.
Cost competitiveness: Pricing strategies and reimbursement considerations.
Shelf-life and stability: Logistics compatibility, especially for radiopharmaceuticals with short half-lives.

Major Suppliers of Tc-99m Mertiatide Kits

1. Bracco Diagnostics Inc.

Overview:
Bracco is a leading global provider of imaging agents and radiopharmaceuticals. Its Tc-99m Mertiatide Kit enjoys widespread use across hospitals in North America and Europe. Bracco’s manufacturing facilities are certified under ISO 13485, ensuring high quality standards.

Product Portfolio & Supply Capabilities:

MAG3 (Technetium Tc-99m Mertiatide) is available in multiple vial sizes, offering flexibility for different patient loads.
Distribution: Extensive network spanning North America, Europe, and select Asian markets.
Regulatory Status: FDA-approved in the U.S., CE marked in Europe.

Strengths:

Proven manufacturing reliability.
Strong regulatory compliance.
Established distribution channels.

Limitations:

Pricing may be higher compared to regional competitors due to premium branding.

2. GE Healthcare

Overview:
GE Healthcare offers a broad portfolio of nuclear medicine products, including radiopharmaceuticals. While primarily known for imaging equipment, GE also supplies radiopharmaceutical kits in select markets, including Tc-99m Mertiatide in some regions, often through licensing agreements.

Product & Supply:

Focuses on regional markets; capacity varies based on regulatory approvals.
Emphasizes integrated imaging and radiotracer solutions.

Regulatory & Distribution:

Approved through respective national agencies; distribution mainly through regional partners.

Strengths:

Strong integration with imaging hardware.
Innovative diagnostic solutions.

Limitations:

Limited global market share specifically for Tc-99m Mertiatide.
Availability may depend on regional licensing.

3. Curium Pharmaceuticals

Overview:
Curium is a notable independent radiopharmaceutical provider with a focus on nuclear medicine imaging agents. Its product pipeline includes Tc-99m-based radiotracers, and it has expanded its manufacturing capabilities recently.

Product & Supply:

Offers Tc-99m Mertiatide in various markets, with supply agreements in North America and Europe.
Invests heavily in manufacturing capacity, including modern cyclotron and generator facilities.

Regulatory Status:

FDA approval in the United States.
CE marking for European distribution.

Strengths:

Clear focus on radiopharmaceuticals.
Faster adaptability to market demands.

Limitations:

Market share smaller than industry giants like Bracco.

4. Mallinckrodt Pharmaceuticals

Overview:
A historic player in radioisotopes and radiopharmaceuticals, Mallinckrodt supplies several Tc-99m kits, including renal imaging agents. Its distribution network spans globally, providing a reliable supply chain for hospitals.

Product & Supply:

Provides Tc-99m Mertiatide kits compatible with regional regulatory standards.
Continuous investments in manufacturing to modernize production lines.

Regulatory & Quality:

Approved by FDA and other relevant agencies; maintains high Quality Management System standards.

Strengths:

Established global logistics.
Broad product portfolio enhancing procurement flexibility.

Limitations:

Market shortages occasionally occur due to supply chain disruptions.

Emerging and Regional Suppliers

In addition to the established multinational corporations, regional suppliers in Asia, Eastern Europe, and Latin America are increasing their market presence. These suppliers often provide competitively priced kits suitable for lower-cost healthcare settings:

Nihon Medi-Physics (Japan): FDA-approved products for domestic markets.
PharmaGroup (Russia): Gaining regulatory approvals in local markets.
Lantheus Medical Imaging: Primarily known for other radiotracers but expanding portfolio.

Their role is significant in fulfilling regional demand, though limited in global distribution capacity for Tc-99m Mertiatide.

Regulatory and Licensing Considerations

Suppliers must maintain compliance with regulatory standards—including FDA in the US, EMA in Europe, and other national agencies. Licensing agreements and supply contracts often influence geographic distribution limitations. Healthcare providers must verify the approval status, batch release regulations, and expiration dates to ensure safe and effective use.

Supply Chain and Logistics

The short half-life of Tc-99m (~6 hours) necessitates swift, reliable logistics. Facilities must operate near reactor sites or generator suppliers to minimize decay. Reliable suppliers maintain robust cold chain logistics, quality controls, and contingency plans to avoid shortages, which have historically impacted the availability of Tc-99m-based radiopharmaceuticals.

Conclusion

The primary global suppliers of Tc-99m Mertiatide Kit include Bracco Diagnostics Inc., Curium Pharmaceuticals, Mallinckrodt Pharmaceuticals, and regional players such as Nihon Medi-Physics. Healthcare entities should prioritize suppliers with proven regulatory compliance, robust supply chains, scalable manufacturing capacity, and competitive pricing.

Choosing the right supplier depends on regional regulatory approvals, logistical capabilities, and the specific needs of healthcare facilities. Establishing relationships with multiple approved vendors may mitigate risk and ensure continuous access to this vital diagnostic agent.

Key Takeaways

Market leaders such as Bracco and Curium dominate global supply, offering high-quality Tc-99m Mertiatide Kits with extensive regulatory approvals.
Supply chain robustness is critical due to the isotope’s short half-life; suppliers with proximity to reactor sites and advanced logistics are preferable.
Regulatory compliance ensures safe, legal use; verify the approval status in each target market.
Regional suppliers serve vital roles, especially in low-resource settings, but may have limited distribution reach.
Diversification of suppliers minimizes risk and guarantees continuous renal imaging capacity.

FAQs

1. What factors should hospitals consider when selecting a Tc-99m Mertiatide Kit supplier?
Hospitals should evaluate regulatory approval status, supply chain reliability, production capacity, product stability, cost, and existing vendor relationships to ensure uninterrupted and compliant services.

2. Are there alternative radiopharmaceuticals to Tc-99m Mertiatide for renal imaging?
Yes, agents like DMSA and MAG3 alternatives exist, but Tc-99m Mertiatide remains the gold standard in many settings due to its superior renal drainage evaluation capabilities.

3. How does the short half-life of Tc-99m impact procurement and distribution?
It necessitates that suppliers be geographically close to dose preparation sites to avoid decay-related losses, and demands efficient logistics for timely distribution.

4. Can I use Tc-99m Mertiatide Kits from regional suppliers in other countries?
This depends on regulatory approval and licensing agreements. Always verify the product’s approval status in your jurisdiction before procurement.

5. What are the regulatory hurdles for new suppliers entering the Tc-99m Mertiatide market?
New suppliers must obtain regulatory approvals such as FDA clearance or CE marking, ensuring manufacturing practices meet international standards, and establish distribution channels compliant with local regulations.

References

Global Nuclear Medicine Market Analysis, Markets and Markets, 2022.
FDA Approval Summary for Technetium Tc-99m Mertiatide, U.S. Food and Drug Administration, 2014.
European Medicines Agency (EMA) Info on Tc-99m Radiopharmaceuticals, 2022.
Industry Reports on Radiopharmaceutical Supply Chain, Radiology Business, 2021.
International Atomic Energy Agency (IAEA) Guidelines on Radionuclide Production, 2020.

For tailored procurement strategies or further industry insights, consult with regulatory agencies and radiopharmaceutical experts.

Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M MERTIATIDE KIT