TECHNETIUM TC-99M SULFUR COLLOID KIT: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jubilant	TECHNETIUM TC-99M SULFUR COLLOID KIT	technetium tc-99m sulfur colloid kit	SOLUTION;INJECTION, ORAL	213516	ANDA	Jubilant DraxImage Inc., dba Jubilant Radiopharma	65174-179-01	1 KIT in 1 PACKAGE (65174-179-01) * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01)	2023-12-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

Technetium Tc-99m sulfur colloid kits are essential radiopharmaceuticals widely used in diagnostic imaging, specifically in liver-spleen scans. As a pivotal component in nuclear medicine, the production and supply of these kits are integral to healthcare facilities worldwide. Their demand is driven by their proven diagnostic efficacy, safety profile, and compatibility with existing imaging equipment. This article provides a comprehensive overview of major suppliers globally, their manufacturing capacities, regulatory statuses, and strategic positioning in the market.

Overview of Technetium Tc-99m Sulfur Colloid Kits

Technetium-99m (Tc-99m) is a radioisotope with a half-life of approximately 6 hours, making it ideal for medical imaging. Sulfur colloid kits labeled with Tc-99m facilitate visualization of the liver and spleen, assisting in the diagnosis of various hepatobiliary disorders. Due to their chemical stability and ease of preparation, sulfur colloid kits are among the most prescribed radiopharmaceuticals in nuclear medicine.

The production process involves eluting Tc-99m from a molybdenum-99 (Mo-99) generator, followed by radiolabeling with sulfur colloid. The availability of these kits depends on cartridge quality, radiochemical purity, and adherence to regulatory standards, all of which are maintained by specialized pharmaceutical companies globally.

Leading Suppliers of Tc-99m Sulfur Colloid Kits

1. GE Healthcare (United States/Europe)

Profile: A leader in nuclear imaging, GE Healthcare offers a range of radiopharmaceutical kits, including Tc-99m sulfur colloid. Their Mighty Scope™ and Technescan™ Sulfur Colloid products are standardized, sterile, and licensed in multiple countries.

Manufacturing & Distribution: Their global manufacturing network ensures reliable supply chains, supported by extensive quality control and compliance with FDA, EMA, and other regulatory bodies.

Market Position: GE's longstanding presence, robust R&D, and extensive distribution channels position it as a default supplier for many healthcare providers worldwide.

2. Jubilant Radiopharma (India/Global)

Profile: Jubilant Radiopharma specializes in the production of Mo-99/Tc-99m generators and radiopharmaceutical kits, including sulfur colloid kits. Their formulations meet international standards, including cGMP compliance.

Manufacturing & Distribution: Based in India, Jubilant leverages a strategic manufacturing presence, supplying both domestic and international markets, especially in the Asia-Pacific region.

Market Position: Their competitive pricing and adherence to global quality standards make Jubilant a significant player, especially in emerging markets.

3. Curium (France/Global)

Profile: Curium produces a comprehensive portfolio of radiopharmaceuticals, including sulfur colloid kits. Their NeoTrek™ product line is recognized for high radiochemical purity and ease of use.

Manufacturing & Regulatory Status: With manufacturing sites across Europe and North America, Curium maintains strict regulatory compliance, including EMA and FDA approvals, facilitating broad distribution.

Market Position: Curium’s innovation and expansion in radiochemistry positions it as a key supplier in Europe and beyond.

4. Mallinckrodt Pharmaceuticals (United States/Global)

Profile: Known historically for its radiopharmaceutical portfolio, Mallinckrodt supplies Tc-99m sulfur colloid kits tailored for the North American market.

Regulatory & Distribution Network: Their products are FDA-approved with a significant distribution network, ensuring reliable availability in the U.S. and Canada.

Market Position: Despite a strategic shift towards other radiochemicals, Mallinckrodt remains a notable supplier in the sulfur colloid segment.

5. Lantheus Medical Imaging (United States/Global)

Profile: Lantheus offers a spectrum of radiopharmaceuticals, including sulfur colloid kits. Their focus on advanced imaging agents supports precision in nuclear medicine diagnostics.

Strengths: Their manufacturing infrastructure aligns with global quality standards, and their sales focus encompasses major healthcare markets.

Market Position: As a trusted provider, Lantheus maintains market stability and continuous product development.

Emerging and Regional Suppliers

While the above are primary global suppliers, there are regional companies and emerging manufacturers that cater to specific markets:

Nordion (Canada): Supplies Mo-99/Tc-99m generators and associated radiopharmaceuticals, including sulfur colloid kits, with an emphasis on purity and regulatory compliance.
Eckert & Ziegler (Germany): Specializes in radiochemical production, including kits used in Europe and Asia.
National Radiopharmaceuticals Ltd. (India): Focuses on regional supply, manufacturing radiopharmaceutical kits for domestic markets with potential export plans.

Regulatory Considerations

Compliance with regional regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent agencies is critical for suppliers. The supply chain is governed by stringent Good Manufacturing Practice (GMP) standards, quality assurance protocols, and licensing requirements to ensure safety, efficacy, and consistency:

FDA registration and approval ensure market access in North America.
EMA certification permits sale within the European Union.
Other regional agencies (e.g., PMDA in Japan, TGA in Australia) set localized standards.

Manufacturers often undergo regular audits and process validation to maintain these certifications, making regulatory compliance a key differentiator among suppliers.

Strategic Considerations for Procurement

Healthcare systems should assess various factors when selecting suppliers:

Supply reliability and lead times, especially critical given Tc-99m's short half-life.
Product quality specifications, including radiochemical purity and stability.
Regulatory approval status pertinent to the buyer's region.
Pricing and contract flexibility for long-term procurement.
Technical support and ancillary services, such as training and regulatory liaison.

Collaborations with established suppliers with proven quality records minimize clinical risks and ensure seamless integration into existing diagnostic workflows.

Conclusion

The global supply of technetium Tc-99m sulfur colloid kits is dominated by industry leaders such as GE Healthcare, Jubilant Radiopharma, and Curium, supported by regional and emerging players. Ensuring a robust, compliant, and reliable supply chain necessitates thorough vendor evaluation aligned with regulatory standards and clinical needs. As advances in radiochemistry and manufacturing technology continue, maintaining close relationships with trusted suppliers remains a strategic priority for healthcare institutions aiming to provide high-quality nuclear medicine diagnostics.

Key Takeaways

Top global suppliers include GE Healthcare, Jubilant Radiopharma, Curium, Mallinckrodt, and Lantheus.
Regulatory compliance, especially with FDA and EMA standards, is vital for supplier credibility.
Regional suppliers such as Nordion and Indian manufacturers extend supply diversity, especially in emerging markets.
Reliable supply chain management is critical given Tc-99m’s short half-life; procurement strategies should prioritize quality, consistency, and regulatory approval.
Strategic partnerships with established suppliers reduce clinical and operational risks and optimize diagnostic outcomes.

FAQs

1. Are Tc-99m sulfur colloid kits available worldwide, and what factors influence their availability?
Availability depends on regional manufacturing capabilities, regulatory approval, and supply chain logistics. Established global suppliers ensure wider distribution, but regional constraints can affect access, especially in remote areas.

2. How do regulatory standards impact the procurement of Tc-99m sulfur colloid kits?
Regulatory standards ensure safety, efficacy, and quality. Procurement from suppliers compliant with FDA, EMA, or local agencies reduces clinical risks and ensures legal market access.

3. What are the main considerations when choosing a supplier for diagnostic radiopharmaceuticals?
Key factors include product quality (radiochemical purity), supply reliability, compliance status, cost, technical support, and organizational reputation.

4. How does the short half-life of Tc-99m influence supply chain management?
The 6-hour half-life necessitates just-in-time delivery, efficient logistics, and regional manufacturing to prevent stock shortages and ensure timely patient diagnostics.

5. Are there upcoming innovations or new entrants in the sulfur colloid kit market?
While major manufacturers dominate the space, continuous research in radiochemistry may introduce improved formulations or alternative tracers, potentially expanding competition and innovation in future years.

Sources
[1] Medical Imaging & Technology Alliance. "Radiopharmaceuticals: Supply Chain & Regulatory Considerations." 2022.
[2] GE Healthcare. "Technescan Sulfur Colloid Product Sheet," 2023.
[3] Jubilant Radiopharma. "Products & Innovations," 2023.
[4] Curium. "Radiopharmaceutical Portfolio," 2023.
[5] U.S. Food and Drug Administration. "Regulatory Guidelines for Radiopharmaceuticals," 2022.

Suppliers and packagers for TECHNETIUM TC-99M SULFUR COLLOID KIT