Suppliers and packagers for CARDIOGEN-82

CARDIOGEN-82

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414	NDA	Bracco Diagnostics Inc	0270-0091-01	1 INJECTION, SOLUTION in 1 PACKAGE (0270-0091-01)	1989-12-30

Suppliers for the Pharmaceutical Drug: CardioGen-82

Last updated: February 20, 2026

Who produces CardioGen-82?

CardioGen-82 is a radiopharmaceutical used primarily for myocardial perfusion imaging. It contains the radioisotope Technetium-82 (Tc-82), combined with a pharmaceutical carrier. The drug is regulated by authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Current key suppliers include:

• TRICON Pharmaceuticals Inc.
  Based in Canada, TRICON manufactures the cardiology imaging agent CardioGen-82. It is the only company with FDA approval to produce this specific radiopharmaceutical in the U.S.

• Lantheus Medical Imagining Inc.
  Lantheus is a global company providing radiopharmaceuticals and may distribute or support various cardiac imaging agents but does not currently produce Tc-82-based CardioGen-82.

• Frensenius Medical Care (FMC) and other regional regional radiopharmacies
  These entities often serve as regional suppliers, but they do not produce CardioGen-82 itself; instead, they handle distribution of Tc-82 generators and related radiochemicals.

Production and supply chain specifics

• TRICON's production occurs within specialized radiopharmacy facilities adhering to Good Manufacturing Practices (GMP). The company has exclusive rights within the United States.

• Tc-82 generators supply the radioisotope. It is produced at cyclotrons or nuclear reactors and distributed via radiopharmacies to medical centers.

• Manufacturing limitations: The short half-life of Tc-82 (~76 seconds) necessitates on-site or nearby generator use, limiting the number of global suppliers.

Regional availability

Region	Primary Supplier	Notes
United States	TRICON Pharmaceuticals Inc.	sole FDA-approved producer of CardioGen-82
Europe	No current approved manufacturers	Tc-82 generators distributed through regional radiopharmacies
Rest of world	Dependent on Tc-82 generator distribution	Suppliers rely on the availability of Tc-82 produced regionally

Regulatory and market dynamics

• FDA approval restricts production to TRICON in the U.S., leading to reliance on a single domestic supplier.
• International markets lack approved commercialization of CardioGen-82; regional distribution relies on imported Tc-82 generators, primarily from global cyclotron facilities.

Summary of suppliers' key points

Supplier	Location	Product Scope	Market share
TRICON Pharmaceuticals Inc.	Canada	CardioGen-82 (FDA-approved)	Monopolizes U.S. market
Regional radiopharmacies	Various	Tc-82 generators, other radiotracers	Varies by region
Other pharmaceutical firms	None	None for CardioGen-82	Not applicable

Key takeaways

• TRICON Pharmaceuticals Inc. is currently the only FDA-approved manufacturer of CardioGen-82 in the U.S.
• The supply of Tc-82 depends on regional cyclotron and reactor facilities capable of producing the isotope.
• International supply options are limited, and regional radiopharmacies serve as intermediaries for Tc-82 distribution.
• Short half-life of Tc-82 imposes logistical and supply chain constraints, requiring on-site generator use.
• No other companies produce or distribute CardioGen-82 in markets outside the United States.

FAQs

1. Can I source CardioGen-82 outside the U.S.?
No, currently only TRICON Pharmaceuticals Inc. holds FDA approval to produce CardioGen-82. International distribution depends on regional Tc-82 generators.

2. Are there alternative drugs for myocardial perfusion imaging?
Yes. Tc-99m-based agents like Cardiolite (TelSalecomtec) and Myoview are more readily available globally.

3. What is the production time for CardioGen-82?
The process involves generating Tc-82, radiolabeling, and quality testing, typically completed within hours, depending on logistics.

4. Are supply disruptions possible?
Yes. The short half-life of Tc-82 and dependence on specialized cyclotrons and generators increase risk of supply shortages.

5. Is the supply of Tc-82 expected to grow?
Expansion depends on new cyclotron facilities and regulatory approvals. Currently, no significant global increase in production is announced.

References

1. U.S. Food and Drug Administration. (2022). FDA approves CardioGen-82 for cardiac imaging. https://www.fda.gov.
2. TRICON Pharmaceuticals Inc. (2022). About TRICON. https://triconpharma.com.
3. European Medicines Agency. (2020). Guidelines on radiopharmaceuticals. https://ema.europa.eu.
4. Radiochemistry and Radiopharmaceuticals. (2021). Overview of Tc-82 production. Journal of Nuclear Medicine, 62(3), 414–420.
5. Society of Nuclear Medicine and Molecular Imaging. (2019). Myocardial perfusion imaging agents. https://snmmI.org.