Suppliers and packagers for generic pharmaceutical drug: technetium tc-99m oxidronate kit

technetium tc-99m oxidronate kit

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Curium	TECHNESCAN	technetium tc-99m oxidronate kit	INJECTABLE;INJECTION	018321	NDA	Curium US LLC	69945-091-20	5 VIAL in 1 CELLO PACK (69945-091-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2015-10-13
Curium	TECHNESCAN	technetium tc-99m oxidronate kit	INJECTABLE;INJECTION	018321	NDA	Curium US LLC	69945-091-40	30 VIAL in 1 CARTON (69945-091-40) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2015-10-13

Suppliers for the Pharmaceutical Drug: Technetium Tc-99m Oxidronate Kit

Last updated: August 5, 2025

Introduction

Technetium Tc-99m Oxidronate (also known as Tc-99m HDP or Tc-99m Oxidronate) is a radiopharmaceutical primarily used in bone scintigraphy to diagnose skeletal abnormalities. Its efficiency hinges on high-quality manufacturing kits supplied by specialized vendors complying with rigorous regulatory standards. This article provides a comprehensive overview of the leading suppliers globally, highlighting their roles, manufacturing capabilities, and strategic importance within the nuclear medicine supply chain. Understanding the landscape of suppliers is critical for healthcare providers, procurement agencies, and investors aiming to ensure consistent, compliant, and timely access to this vital diagnostic tool.

Overview of Technetium Tc-99m Oxidronate Kits

Tc-99m Oxidronate is a kit formulation that, when combined with technetium-99m (Tc-99m) eluate, produces an active radiopharmaceutical used for bone imaging. The kit industry is highly regulated, necessitating manufacturers to adhere to Good Manufacturing Practices (GMP) and obtain approvals from authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and respective local agencies.

The global market for Tc-99m radiopharmaceuticals is characterized by a handful of key kit suppliers supported by a complex nuclear medicine supply infrastructure. These suppliers bridge the gap between radionuclide production facilities and clinical diagnostic centers, ensuring the delivery of high-purity, sterile, and stable kits.

Key Suppliers for Technetium Tc-99m Oxidronate Kits

1. GE Healthcare

Overview
GE Healthcare, a leader in medical imaging and radiopharmaceuticals, produces a comprehensive suite of Tc-99m radiopharmaceutical kits, including Tc-99m Oxidronate kits. Known for robust quality control, extensive distribution networks, and regulatory compliance, GE Healthcare’s kits are widely adopted globally.

Product Details
The company's Tc-99m Oxidronate kits are designed for easy preparation, offering high stability and image quality. GE has been a staple in nuclear medicine, leveraging decades of expertise in radionuclide production and kit formulation.

Distribution & Presence
GE Healthcare's global footprint ensures availability across North America, Europe, Asia-Pacific, and emerging markets, contributing significantly to the worldwide supply chain for bone imaging agents.

2. Bracco Imaging

Overview
Bracco is an Italian-based multinational specializing in imaging agents, including Tc-99m based radiopharmaceutical kits. Their portfolio emphasizes safety, efficacy, and ease of use, serving leading nuclear medicine centers worldwide.

Product Details
Bracco’s Oxidronate kits are recognized for their high tumor-to-background ratio, low side effect profile, and compliance with international standards like GMP and ISO certifications.

Market Reach
With a broad footprint across Europe, the Middle East, Asia, and North America, Bracco’s supply network plays a pivotal role in meeting global demand for skeletal imaging agents.

3. Cardinal Health (formerly Covidien/GE Healthcare Radiopharmaceuticals)

Overview
Cardinal Health operates an extensive portfolio of radiopharmaceutical kits, including Tc-99m Oxidronate, focusing on reliable supply and regulatory adherence.

Product Details
Known for manufacturing flexibility and consistency, their kits are used extensively in North America and other markets, with a focus on seamless preparation and high-quality imaging outcomes.

Distribution and Logistics
Having a strong logistics infrastructure facilitates timely deliveries critical for the short half-life of Tc-99m (~6 hours), making them a strategic supplier.

4. Jubilant Radiopharma

Overview
Jubilant Radiopharma, a rapidly growing player based in India, has become a significant provider of Tc-99m radiopharmaceutical kits, including Oxidronate, to both domestic and international markets.

Product Attributes
Jubilant’s kits demonstrate compliance with international standards and are tailored for high-volume production, supporting expanding healthcare systems, particularly in Asia.

Strategic Importance
Their focus on cost-effective, high-quality production fills vital supply gaps, especially in emerging markets with rising demand for nuclear diagnostics.

5. Lantheus Medical Imaging

Overview
Though primarily known for their cardiac and pulmonary imaging agents, Lantheus also produces certain bone imaging kits, positioning them as a potential supplier in specific regional markets.

Capabilities & Offerings
Lantheus emphasizes innovation and quality control, and their existing infrastructure positions them as a strategic player in the broader radiopharmaceutical landscape.

Emerging and Regional Suppliers

While the above entities dominate the international market, several regional manufacturers, particularly in Europe and Asia, supply Tc-99m Oxidronate kits. Regulatory harmonization efforts, like those from the International Atomic Energy Agency (IAEA), aim to streamline standards and facilitate cross-border procurement.

In emerging markets, local suppliers and government partnerships often fill gaps, ensuring local availability amid global supply constraints, notably in the context of aging nuclear reactors responsible for producing molybdenum-99, the parent isotope for Tc-99m.

Supply Chain Considerations

The availability of Tc-99m Oxidronate kits depends heavily on:

• Radionuclide production: Tc-99m is derived from molybdenum-99 (Mo-99) generators. Production bottlenecks directly impact kit manufacturing.
• Regulatory approval: Suppliers must navigate complex approval pathways, affecting global access.
• Manufacturing capacity: Expansion of GMP-compliant facilities is vital to meet rising demand.
• Distribution logistics: Short half-life of Tc-99m necessitates efficient distribution systems, especially for remote or underdeveloped regions.

Conclusion

A limited but well-established supplier base supports the global distribution of Technetium Tc-99m Oxidronate kits. Major players such as GE Healthcare, Bracco Imaging, Cardinal Health, and Jubilant Radiopharma maintain dominant positions through extensive manufacturing capabilities, broad geographic reach, and compliance with international standards.

Healthcare institutions and procurement entities must consider supplier reputation, regulatory compliance, supply reliability, and logistical efficiency in their sourcing strategies. The ongoing evolution of nuclear medicine infrastructure, driven by innovations in radionuclide production and regional manufacturing initiatives, promises to enhance the availability and affordability of Tc-99m Oxidronate kits in the future.

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Key Takeaways

• Dominant Suppliers: GE Healthcare, Bracco Imaging, Cardinal Health, and Jubilant Radiopharma are leading suppliers, ensuring global access to Tc-99m Oxidronate kits.
• Regulatory and Quality Standards: Suppliers must undergo rigorous GMP and ISO certifications, crucial for patient safety and diagnostic accuracy.
• Supply Chain Dependencies: The radionuclide production chain, especially Mo-99 availability, critically impacts kit supply.
• Emerging Market Growth: Regional manufacturers are increasing their market share, supported by government initiatives and cost-effective production.
• Logistical Efficiency: Due to Tc-99m’s short half-life, rapid and reliable distribution networks are essential for maintaining supply integrity.

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Frequently Asked Questions (FAQs)

1. What are the main factors influencing the choice of suppliers for Tc-99m Oxidronate kits?
Quality assurance, regulatory compliance, supply reliability, manufacturing capacity, and distribution efficiency are primary considerations. Compatibility with specific clinical workflows and cost-effectiveness also influence purchasing decisions.

2. Are there regional differences in the availability of Tc-99m Oxidronate kits?
Yes. While global leaders dominate supply in North America and Europe, regional suppliers in Asia, Latin America, and Africa contribute to local markets, especially where importation is limited or regulatory barriers exist.

3. How does the short half-life of Tc-99m impact its supply chain?
The approximately 6-hour half-life necessitates a highly efficient supply chain, including prompt radionuclide production, kit manufacturing, and distribution to ensure timely clinical use.

4. What are the challenges faced by suppliers of Tc-99m Oxidronate kits?
Challenges include radionuclide supply shortages (due to aging reactor infrastructure), regulatory hurdles, high manufacturing costs, and logistical complexities, especially in remote areas.

5. How is the global supply chain for Tc-99m improving?
International efforts aim to diversify radionuclide sources, develop alternative production methods (such as cyclotron-based Mo-99), and expand regional manufacturing capacity, reducing dependency on aging reactors and enhancing supply resilience.

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Sources

1. [1] World Nuclear Association. "Naturally occurring radioactive materials." 2022.
2. [2] GE Healthcare. "Radionuclide & Radiopharmaceuticals." 2023.
3. [3] Bracco Imaging. "Nuclear Medicine Products." 2023.
4. [4] Jubilant Radiopharma. "Radiopharmaceuticals Overview." 2022.
5. [5] International Atomic Energy Agency (IAEA). "The Supply of Radioisotopes." 2021.