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

TECHNETIUM TC-99M SESTAMIBI 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
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001-20	20 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIAL	1990-12-20
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001-55	5 VIAL in 1 BOX (11994-001-55) / 5 mL in 1 VIAL	1990-12-20
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-003-20	20 VIAL in 1 BOX (11994-003-20) / 5 mL in 1 VIAL	1990-12-20
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001-20	20 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIAL	1990-12-20
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001-55	5 VIAL in 1 BOX (11994-001-55) / 5 mL in 1 VIAL	1990-12-20
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-003-20	20 VIAL in 1 BOX (11994-003-20) / 5 mL in 1 VIAL	1990-12-20

Suppliers for the Pharmaceutical Drug: TECHNETIUM Tc-99m Sestamibi Kit

Introduction
Technetium-99m (Tc-99m) Sestamibi kits are a cornerstone in nuclear medicine, primarily used for myocardial perfusion imaging and parathyroid adenoma detection. The demand for these kits hinges on reliable supplier networks, stringent regulatory compliance, and consistent product quality. This article provides an in-depth analysis of key suppliers globally, outlining their capabilities, regulatory status, and market positioning to inform procurement and strategic decision-making.

Overview of Tc-99m Sestamibi Kits
Tc-99m Sestamibi is a radiopharmaceutical combined with Tc-99m, a metastable isotope with a 6-hour half-life, enabling high-resolution imaging with low radiation dose. The kits are designed for radiolabeling with Tc-99m, which is typically sourced from Mo-99/Tc-99m generators. The manufacturing process requires adherence to Good Manufacturing Practices (GMP) and regulatory approvals from agencies like the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency).

Key Global Suppliers of Tc-99m Sestamibi Kits

1. GE Healthcare

Overview: GE Healthcare has been a leading name in nuclear medicine, offering Tc-99m Sestamibi kits under the brand name Cardiolite in the United States and Myoview internationally. Their kits are recognized for high radiochemical purity, stability, and established supply chains.

Capabilities: GE’s products are FDA-approved and distributed worldwide through a robust network. The company ensures consistent radiochemical yields and documentation compliance, facilitating large-scale utilization in hospitals and diagnostic centers.

Regulatory Status: Approved by FDA, CE marked in Europe, and registered in multiple countries. GE’s manufacturing facilities adhere to GMP standards, contributing to product reliability.

Market Position: Dominates the North American market with extensive distribution channels and strong partnerships with healthcare providers.

2. Jubilant Radiopharma (formerly Jubilant DraxImage)

Overview: Jubilant Radiopharma is a prominent Canadian pharmaceutical and radiopharmaceutical supplier providing Tc-99m Sestamibi kits, marketed as DraxImage Sestamibi.

Capabilities: Known for high-quality kits with straightforward radiolabeling procedures and compatibility with multiple generators. Their portfolio extends into other radiopharmaceuticals, reinforcing their market presence.

Regulatory Status: Holds FDA approval, CE marking, and certifications across multiple jurisdictions. Their manufacturing complies with GMP standards, ensuring regulatory adherence.

Market Position: Well-established in North America and expanding into international markets, focusing on reliable supply and patient safety.

3. Sirtex Medical

Overview: Sirtex specializes in targeted radiotherapy but also supplies radiopharmaceuticals including Tc-99m Sestamibi kits for diagnostic purposes.

Capabilities: Their kits are known for advanced formulation stability, ease of use, and compatibility with existing radiochemistry infrastructure. They leverage global distribution channels to reach hospitals and clinics.

Regulatory Status: Approved by major regulatory agencies including FDA and EMA. Their manufacturing facilities follow GMP and quality assurance protocols.

Market Position: Focused on high-margin specialized indications, with a growing footprint in Asia-Pacific and Europe.

4. Institute of Nuclear Medicine and Allied Sciences (INMAS) / National Institute of Science Education and Research (NISER)

Overview: Government and academic institutions in India such as INMAS and NISER develop radiopharmaceuticals, including Tc-99m Sestamibi kits, for domestic use and export.

Capabilities: These institutions often produce cost-effective kits, enhancing local supply, and addressing shortages particularly in emerging markets. Their production facilities are compliant with Indian regulatory standards (Drugs and Cosmetics Act).

Regulatory Status: Approved by the Atomic Energy Regulatory Board (AERB) in India and registered with the Central Drugs Standard Control Organization (CDSCO).

Market Position: They predominantly serve the Indian subcontinent, bridging gaps in supply chain and affordability.

5. Other Notable Suppliers

• Best Cyclotron & Medical Equipment Co. (Turkey): Supplies radiopharmaceutical kits with growing regional presence.
• Molmed (Italy): Offers radiopharmaceutical services, including kits for diagnostic imaging, with compliance to European standards.
• Lantheus Medical Imaging: Primarily known for PET tracers, but also involved in SPECT radiopharmaceuticals and kits.

Emerging Trends and Considerations

Supply Chain Stability

Dependence on Mo-99/Tc-99m generators introduces vulnerability to reactor outages and geopolitical issues. Suppliers investing in alternative production methods, such as cyclotron-based technetium, present future supply stability.

Regulatory Compliance and Approvals

Procurement from FDA- and EMA-certified suppliers ensures quality and reduces regulatory risks. Regional approval status influences distribution scope, especially in emerging markets.

Product Shelf Life and Storage

Most kits have limited shelf life (typically 6-12 months). Suppliers providing reliable cold chain logistics and inventory management mitigate stock shortages.

Market Dynamics and Competition

The global shortage of Mo-99 prompted diversification in supply sources. Suppliers investing in dual production methods or alternative isotopes may gain competitive advantages.

Pricing and Contracting

Prices are influenced by generator costs, regulatory premiums, and procurement scale. Long-term contracts with reputable suppliers safeguard against price volatility.

Regulatory and Quality Assurance

Last updated: July 27, 2025

Adherence to international standards, including GMP and ISO certifications, is critical. Suppliers with a strong regulatory framework, validated manufacturing processes, and continuous quality control offer higher assurance of consistent product quality.

Conclusion

The procurement landscape for Tc-99m Sestamibi kits is characterized by a select group of reputable international suppliers, complemented by regional manufacturers addressing local needs. Major players like GE Healthcare and Jubilant Radiopharma dominate Western markets, supported by robust regulatory approvals and extensive distribution networks. Emerging suppliers in Asia, Eastern Europe, and India provide cost-effective alternatives, often overcoming supply chain vulnerabilities. Ensuring regulatory compliance, product stability, and supply chain resilience remains paramount for healthcare providers relying on these radiopharmaceuticals.

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Key Takeaways

• Global Leaders: GE Healthcare and Jubilant Radiopharma are primary suppliers with extensive distribution and regulatory approval.
• Regulatory Compliance: FDA and EMA approvals are essential for high-quality, internationally accepted Tc-99m Sestamibi kits.
• Supply Chain Risks: Dependence on Mo-99/Tc-99m generators necessitates diversification, including cyclotron-based production.
• Regional Manufacturers: Indian and Turkish suppliers address local demands with cost-effective solutions, vital for emerging markets.
• Future Outlook: Innovation in alternative production methods and advanced formulation stability will shape supply dynamics and procurement strategies.

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FAQs

1. How do I verify the regulatory status of Tc-99m Sestamibi kit suppliers?
Check for approvals from regulatory agencies like the FDA, EMA, or AERB, and confirm GMP certification and product registration records.

2. What factors influence the pricing of Tc-99m Sestamibi kits?
Pricing depends on production costs, generator expenses, regulatory compliance, supply chain logistics, and procurement volume.

3. How does supply chain stability impact procurement of Tc-99m kits?
Supply disruptions from Mo-99 generator shortages or geopolitical issues require diversifying suppliers or investing in alternative isotope production methods.

4. Can regional suppliers meet international quality standards?
Yes. Many regional suppliers comply with global standards like GMP and ISO, supported by local regulatory certifications, ensuring quality for export markets.

5. What are emerging trends in radiopharmaceutical supply for cardiac imaging?
Growing innovations include cyclotron-based technetium production, development of longer shelf-life kits, and integration of digital supply chain logistics to enhance reliability.

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Sources
[1] GE Healthcare: Cardiolite Overview.
[2] Jubilant Radiopharma: Product Portfolio and Approvals.
[3] European Medicines Agency (EMA): Radiopharmaceuticals Regulations.
[4] Indian Atomic Energy Regulatory Board: Radiopharmaceutical Licensing.
[5] World Nuclear Association: Mo-99 Supply Market.