Suppliers and packagers for CARDIOLITE

CARDIOLITE

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

Suppliers for the Pharmaceutical Drug: CARDIOLITE

Last updated: July 27, 2025

Introduction

CARDIOLITE (technetium Tc-99m sestamibi) remains a cornerstone in cardiac imaging, specifically for myocardial perfusion scintigraphy. As a radioactive diagnostic agent, its supply chain involves complex manufacturing, stringent regulatory compliance, and a highly specialized network of suppliers. Ensuring a consistent supply of CARDIOLITE is crucial for healthcare providers worldwide, given its vital role in diagnosing coronary artery disease. This article offers a comprehensive overview of suppliers responsible for manufacturing and distributing CARDIOLITE, the dynamics shaping its supply landscape, and the strategic considerations for stakeholders.

Manufacturers and Primary Suppliers of CARDIOLITE

1. General Electric Healthcare (GE Healthcare)

GE Healthcare has historically been the principal manufacturer and supplier of CARDIOLITE in numerous markets, notably the United States and Europe. As a global leader in diagnostic imaging solutions, GE’s production facilities rigorously adhere to Good Manufacturing Practices (GMP) and regulatory standards such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Their manufacturing process involves several stages, including the procurement of molybdenum-99 (Mo-99), the parent radionuclide, and subsequent extraction of technetium-99m (Tc-99m) via generator systems.

2. Bracco Imaging

Bracco Imaging is a notable alternative supplier, particularly in European markets. They manufacture similar technetium-based radiopharmaceuticals and have established partnerships with nuclear medicine facilities for distribution. While historically focusing on contrast agents, Bracco’s involvement in the radionuclide supply chain for cardiac imaging adds depth to the global availability network.

3. Shire (now part of Takeda Pharmaceutical Company)

Historically, Shire played a role in production before its acquisition by Takeda. Takeda now oversees the procurement and distribution processes related to nuclear medicine radiopharmaceuticals, including products similar to CARDIOLITE.

4. Nuclear Medicine Distributors and Regional Suppliers

In addition to primary manufacturers, regional distributors and specialty pharmaceutical companies serve as critical links in the supply chain. Their role involves sourcing, storage, and delivery of radiopharmaceuticals based on regional regulatory approvals and logistical infrastructures. In markets like Asia, the Middle East, and Africa, local distributors often partner with global manufacturers to ensure supply chain continuity.

Supply Chain Dynamics and Challenges

A. Dependence on Molybdenum-99 Supply

The production of CARDIOLITE is intrinsically linked to Mo-99, the parent isotope critical for generating Tc-99m. The global supply of Mo-99 is limited, primarily produced via nuclear reactors, with only a handful of facilities worldwide operational. The shutdown of reactors or supply disruptions can lead to shortages, impacting CARDIOLITE availability.

B. Reactor Dependence and Geopolitical Factors

The regional distribution of Mo-99 production reactors influences the supply landscape. Notably, positions of key reactors in Canada, Europe, and Australia dictate the European and North American supply chains, respectively. Political decisions, infrastructure aging, or nuclear incident risks can cause significant supply chain disruptions.

C. Regulatory and Logistical Complexities

Given its radioactive nature, CARDIOLITE manufacturing and distribution face strict regulatory oversight concerning radiation safety, transportation, and storage. The transportation of radiopharmaceuticals across borders necessitates compliance with international standards like IATA regulations and local authorities, which can delay supply and increase costs.

D. Short Half-Life and Manufacturing Constraints

Tc-99m has a half-life of approximately 6 hours, requiring that manufacturing, quality control, and transportation occur within a constrained time window to ensure clinical efficacy. This short half-life imposes logistical challenges, especially in remote regions where transportation infrastructure may be less advanced.

Current Market Trends and Strategic Implications

The recent focus on diversification of Mo-99 sources, including direct production of Tc-99m generators, aims to mitigate reliance on aging reactor infrastructure. Innovations such as cyclotron-produced Tc-99m further diversify supply options. These developments could influence CARDIOLITE’s supplier landscape by introducing alternative production methods and potentially reducing costs and shortages.

Additionally, global efforts to establish regional radiopharmaceutical manufacturing centers seek to localize supply chains, minimize transportation delays, and ensure regulatory compliance. These initiatives, led by entities such as the International Atomic Energy Agency (IAEA), could reshape the dynamics of CARDIOLITE supply in the coming decade.

Market Competition and Key Supplier Considerations

Given the high regulatory barriers and technological complexities, the market for CARDIOLITE suppliers is relatively concentrated. GE Healthcare dominates the sector, with limited alternatives accessible to healthcare facilities. Contractual agreements usually provide for priority access during shortages, but potential supply disruptions necessitate bilateral agreements and strategic stockpiling.

For healthcare providers and procurement agencies, maintaining diversified supplier relationships, engaging in aggregated purchasing, and participating in regional supply networks are recommended strategies to mitigate risks.

Conclusion

The supply of CARDIOLITE hinges on a limited number of producers, complex logistics rooted in its radioactive properties, and global dependencies on constrained Mo-99 reactor-based production. While GE Healthcare remains the primary supplier, regional suppliers and emerging technological alternatives diversify the landscape. Stakeholders must navigate regulatory, logistical, and geopolitical complexities to ensure uninterrupted access.

Key Takeaways

• Market Concentration: GE Healthcare is the dominant global supplier of CARDIOLITE, with limited alternative manufacturers.
• Supply Chain Vulnerabilities: Dependence on aging Mo-99 reactors and logistical constraints pose significant risks of shortages.
• Technological Innovation: Cyclotron-produced Tc-99m and regional manufacturing centers are emerging as potential solutions.
• Strategic Purchasing: Diversified supplier relationships and regional procurement strategies are vital for supply security.
• Regulatory and Logistical Compliance: Adherence to international standards is essential to ensure safe transportation and distribution.

FAQs

1. Who are the main manufacturers of CARDIOLITE globally?
The primary manufacturer of CARDIOLITE is GE Healthcare, which supplies the product mainly in North America and Europe. Other regional suppliers, such as Bracco Imaging in Europe, contribute to regional distribution, though their involvement is less extensive than GE’s.

2. What factors influence the availability of CARDIOLITE?
Supply is primarily affected by Mo-99 reactor availability, regulatory compliance, transportation logistics, and geopolitical stability. Short half-life of Tc-99m further complicates timely distribution.

3. Are there alternative sources or methods for producing Tc-99m?
Yes. Cyclotron-based production of Tc-99m and regional radiopharmaceutical manufacturing centers are emerging alternatives that could reduce dependence on aging nuclear reactors.

4. How do geopolitical issues impact CARDIOLITE supply chains?
Geopolitical tensions can slow or disrupt reactor operations, hinder transportation, and complicate international licensing, leading to supply shortages.

5. What strategies can healthcare providers adopt to mitigate supply risks?
Providers should establish relationships with multiple suppliers, participate in regional stockpiling initiatives, and stay informed about technological advancements that enable alternative production methods.

References

1. [1] International Atomic Energy Agency. "The Supply Chain of Molybdenum-99 and Technetium-99m." IAEA Nuclear Medicine & Diagnostic Imaging, 2022.
2. [2] GE Healthcare. "Technetium Tc-99m Sestamibi (Cardiolite)." Product Monograph, 2021.
3. [3] European Association of Nuclear Medicine. "Supply and Demand for Radionuclides." EMA Guidelines, 2020.
4. [4] World Nuclear Association. "Molybdenum-99 and Technetium-99m." Nuclear Fuel Cycle Report, 2022.
5. [5] U.S. Food and Drug Administration. "Regulations for Radiopharmaceuticals." FDA, 2022.