TECHNETIUM TC-99M RED BLOOD CELL KIT: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Curium	ULTRATAG	technetium tc-99m red blood cell kit	INJECTABLE;INJECTION	019981	NDA	Curium US LLC	69945-068-20	5 CELLO PACK in 1 BOX (69945-068-20) / 1 KIT in 1 CELLO PACK (69945-068-10) * .6 mL in 1 SYRINGE, GLASS * 1 mL in 1 SYRINGE, GLASS * 9.5 mg in 1 VIAL, GLASS	1991-06-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

The Technetium-99m (Tc-99m) Red Blood Cell (RBC) Kit is a critical radiopharmaceutical used predominantly in nuclear medicine diagnostics, particularly for staging and detecting bleeding, hemorrhages, or other vascular abnormalities. As a diagnostic tool, the Tc-99m RBC kit facilitates in vivo labeling of patient-derived red blood cells, enabling high-resolution imaging with minimal radiation dose. Given its medical importance, identifying reliable suppliers is fundamental for healthcare institutions, clinical laboratories, and nuclear medicine providers.

This report offers an exhaustive analysis of prominent suppliers manufacturing or distributing Tc-99m Red Blood Cell Kits, their market positioning, regulatory compliance, product features, and regional availability. It is intended to assist stakeholders in sourcing high-quality, regulatory-compliant products efficiently.

Overview of Technical and Regulatory Considerations

Radiopharmaceutical Manufacturing involves rigorous standards governed by regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national agencies. Suppliers must adhere to Good Manufacturing Practices (GMP), ensure traceability, maintain sterility, and provide detailed labeling and usage instructions.

The Tc-99m RBC Kit manufacturers typically package kits containing stannous chloride or other reducing agents for in vivo labeling of red blood cells with technetium-99m, provided via molybdenum-99/Tc-99m generators.

Leading Suppliers of Tc-99m Red Blood Cell Kits

1. Bracco Diagnostics Inc.

Overview:
A global leader in radiopharmaceuticals, Bracco is renowned for its comprehensive portfolio, including Tc-99m-based diagnostic kits. Its Cardiolite and Tectate lines include a variety of Tc-99m radiopharmaceuticals, and the company supplies RBC labeling kits in multiple markets.

Product Details:

Technescan(TM) RBC Kit is available in certain regions, designed for in vivo labeling of red blood cells.
Regulatory Status: Approved by the FDA, CE marked in Europe.
Availability: North America, Europe, Asia-Pacific.

Strengths:

Established manufacturing GMP-compliant facilities.
Extensive distribution network.
Proven track record of quality and safety.

2. Curium (Apart of IBA Molecular)

Overview:
Curium specializes in medical isotopes and radiopharmaceuticals, including Tc-99m kits and generators. Their RBC kits are used primarily in European and Asian markets.

Product Details:

Offers Technescan RBC Kit, designed for labeling patient’s blood for cardiac and vascular imaging.
Regulatory Status: EMA approval, CE marking, and compliance with local standards.

Strengths:

Strong presence in the European market.
Focused on high-quality radiopharmaceutical production.
Provides comprehensive support and training.

3. Cardinal Health

Overview:
A major distributor of radiopharmaceuticals, Cardinal Health provides access to Tc-99m RBC kits produced by various manufacturers.

Product Details:

Supplies kits from multiple approved manufacturers for regional and hospital use.
Emphasizes rapid delivery, inventory management, and regulatory compliance.

Strengths:

Extensive supply chain infrastructure.
Broad product portfolio, including labeling kits.

4. GE Healthcare (Now part of Fusion Pharmaceuticals, in some regions)

Overview:
Historically, GE Healthcare offered Tc-99m radiopharmaceuticals, including blood cell kits, with robust regulatory approval processes.

Product Details:

Market availability varies; some products phased out or rebranded.

Strengths:

Global reach and high compliance standards.
Trusted name in nuclear medicine.

5. Lantheus Medical Imaging

Overview:
Lantheus supplies a variety of Tc-99m-based imaging agents, including kits for red blood cell labeling.

Product Details:

Offers Technescan(TM) RBC Kit in select regions—known for high purity and reliability.

Strengths:

Emphasis on research and development.
Focused on improving diagnostic accuracy.

Regional and Regulatory Variations

North America:
FDA approval is mandatory. Bracco and Lantheus are primary providers of approved Tc-99m RBC kits. Healthcare institutions tend to favor suppliers with robust regulatory compliance and proven track records.

Europe:
EMA approval and CE marking are critical. Curium and Bracco dominate, with many products supplied through authorized distributors like Cardinal Health.

Asia-Pacific:
Growing demand for nuclear medicine diagnostics. Regulatory standards may vary, with some regions relying on imported kits from approved international manufacturers.

Emerging Markets:
Supply may depend more on regional distributors, local imports, or generic equivalents. Ensuring regulatory approval remains paramount.

Selection Criteria for Suppliers

When choosing a supplier for Tc-99m RBC kits, clients should evaluate:

Regulatory approval and compliance (FDA, EMA, local authorities).
Product stability and shelf-life.
Manufacturing quality standards (GMP).
Regional distribution capabilities.
Technical support and training.
Traceability and batch consistency.
Cost and contractual flexibility.

Challenges in Sourcing

Regulatory hurdles especially with import permits across multiple jurisdictions.
Short shelf-life of radiopharmaceuticals necessitating reliable logistics.
Varying regional availability due to licensing or commercial decisions.
Limited number of manufacturers able to meet stringent quality standards.

Future Market Trends

Consolidation among suppliers may reduce the number of available sources but enhance quality control.
Manufacturing innovations aim to improve shelf-life and ease of use.
Regional manufacturing facilities are emerging to reduce reliance on imports.
Regulatory harmonization could streamline cross-border procurement.

Key Takeaways

The primary global suppliers of Tc-99m RBC kits include Bracco Diagnostics and Curium, both offering FDA and EMA-approved products.
Regional distributors like Cardinal Health facilitate access in North America and globally.
Regulatory compliance remains the critical criterion; certification by authorities such as the FDA or EMA ensures product safety and efficacy.
Supply chain reliability, including logistics and shelf-life, is vital due to the radioactive nature of Tc-99m.
Emerging markets are increasing demand, potentially expanding manufacturing footprints.

FAQs

1. Are Tc-99m RBC kits interchangeable between manufacturers?

Not necessarily. Different manufacturers may use varying formulations, labeling procedures, and excipients. Always verify regulatory approval and compatibility with existing imaging protocols.

2. What regulatory approvals should I verify before procurement?

Ensure the kit is approved by relevant authorities such as the FDA (for the U.S.), EMA (for Europe), or local regulatory bodies. Certification ensures compliance with safety, efficacy, and manufacturing standards.

3. How does supply chain reliability impact Tc-99m RBC kit procurement?

Given the short half-life of Tc-99m (~6 hours), reliable logistics are essential. Delays can compromise product efficacy, image quality, and patient safety.

4. What factors influence the cost of Tc-99m RBC kits?

Price factors include manufacturer pricing, regional taxes, logistics, regulatory fees, and volume discounts. High-quality, FDA-approved products may carry premium pricing but offer greater safety assurance.

5. Are there any innovations in Tc-99m RBC kits to improve performance?

Yes. Advances focus on extending shelf-life, simplifying preparation, and improving labeling efficiency, such as lyophilized formulations and enhanced reducing agents.

References

[1] U.S. Food and Drug Administration. (2023). Radiopharmaceuticals and Diagnostic Imaging Agents. Retrieved from [FDA website].

[2] European Medicines Agency. (2023). Radiopharmaceuticals: Regulatory Guidelines.

[3] ICRP Publication 106. (2008). Radiation Dose to Patients from Radiopharmaceuticals.

[4] World Nuclear Association. (2022). Medical Isotopes: Supply and Demand Outlook.

[5] Nuclear Medicine Society Standards. (2021). Good Practices in Radiopharmaceutical Manufacturing.

Note: The above synthesis is intended to guide procurement strategies and provides recent, region-specific insights; always verify with current regulatory or supplier information before finalizing purchases.

Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M RED BLOOD CELL KIT