Suppliers and packagers for generic pharmaceutical drug: THALLOUS CHLORIDE TL-201

THALLOUS CHLORIDE TL-201

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	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	018150	NDA	Curium US LLC	69945-120-28	1 VIAL in 1 CAN (69945-120-28) / 2.8 mL in 1 VIAL	2015-11-04
Curium	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	018150	NDA	Curium US LLC	69945-120-56	1 VIAL in 1 CAN (69945-120-56) / 5.6 mL in 1 VIAL	2015-11-04
Curium	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	018150	NDA	Curium US LLC	69945-120-63	1 VIAL in 1 CAN (69945-120-63) / 6.3 mL in 1 VIAL	2015-11-04
Curium	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	018150	NDA	Curium US LLC	69945-120-99	1 VIAL in 1 CAN (69945-120-99) / 9.9 mL in 1 VIAL	2015-11-04

Suppliers for the Pharmaceutical Drug: Thallous Chloride (Tl-201)

Last updated: July 30, 2025

Introduction

Thallous chloride (Tl-201), a radioactive isotope used primarily in diagnostic imaging, especially in myocardial perfusion scans, remains a critical component in nuclear cardiology. As a radiopharmaceutical, its procurement is highly regulated, and sourcing reliable suppliers is essential for healthcare providers, nuclear medicine facilities, and pharmacological distributors. This article provides a comprehensive overview of current suppliers of Thallous chloride Tl-201, analyzing their market presence, manufacturing capabilities, regulatory compliance, and distribution networks.

Market Overview of Thallous Chloride (Tl-201)

Thallous chloride (Tl-201) is a cyclotron-produced isotope with a half-life of approximately 73 hours. Its primary application in medical imaging hinges on its ability to localize within the myocardium, aiding in the evaluation of coronary artery disease. Due to its radioactive nature, Tl-201 is classified as a controlled substance, with strict manufacturing, transportation, and handling protocols enforced on a global scale.

The acute and niche nature of Tl-201's market results in a limited number of suppliers. Historically, major pharmaceutical companies with nuclear medicine divisions or specialized radiopharmaceutical manufacturers have been the principal sources. Currently, the primary suppliers are concentrated in regions with advanced nuclear medicine infrastructure, notably North America, Europe, and parts of Asia.

Key Suppliers for Tl-201

1. GE Healthcare (formerly Amersham/GE Healthcare Nuclear)

   • Overview: GE Healthcare is among the most prominent producers in the radiopharmaceutical domain, including Tl-201. The company has historically supplied Tl-201 for diagnostic procedures, leveraging its extensive global distribution network.

   • Production & Capabilities: GE's manufacturing facilities are equipped with cyclotron technology to produce Tl-201 on a scalable basis, maintaining compliance with current Good Manufacturing Practices (cGMP). The company’s distribution system ensures rapid delivery, crucial for isotopes with short half-lives.

   • Regulatory Compliance: GE Healthcare adheres to international standards set by regulatory agencies such as the FDA, EMA, and respective national authorities. Their Tl-201 products are certified for clinical use in numerous countries.

2. Nihon Medi-Physics (Japan)

   • Overview: Nihon Medi-Physics is a leading Japanese radiopharmaceutical manufacturer specializing in nuclear diagnostic agents, including Tl-201.

   • Production & Capabilities: Utilizing localized cyclotrons, Nihon Medi-Physics produces Tl-201 primarily for the Japanese market, with capacity for exportation to select regions. Their production aligns with stringent Japanese pharmaceutical regulations.

   • Regulatory Compliance: The company meets Japan's Pharmaceuticals and Medical Devices Agency (PMDA) standards, with certification also recognized in some Asian markets.

3. General Nuclear Systems (GNS) / COVIDIEN

   • Overview: Previously, COVIDIEN (a Johnson & Johnson subsidiary) and its associated entities supplied Tl-201 in the United States and other regions. Current suppliers often operate under licensing agreements or licensing rights from original manufacturers.

   • Production & Capabilities: While COVIDIEN has sold or licensed its radiopharmaceutical divisions, key partnerships with manufacturing facilities ensure continuity of supply for Tl-201—though the core production often resides with specialized cyclotron facilities.

4. Nuclear Diagnostic Products Inc. (NDP)

   • Overview: NDP specializes in radiopharmaceutical production, including Tl-201, focusing on North American markets.

   • Production & Capabilities: Their facilities employ advanced cyclotron techniques capable of producing high-purity Tl-201, adhering to strict FDA cGMP standards.

5. International Suppliers and Emerging Markets

   • Countries with expanding nuclear medicine capabilities, such as India and China, have developed local production capacities for Tl-201, though suppliers are often limited to government or academic institutions rather than commercial vendors. These entities typically distribute domestically, with limited export potential.

Production and Supply Chain Considerations

• Cyclotron Dependency: As a cyclotron-produced isotope, Tl-201 manufacturing centers require sophisticated infrastructure, which limits the number of capable suppliers globally.

• Regulatory Challenges: The radioactive and pharmaceutical nature of Tl-201 mandates compliance with numerous regulatory frameworks, including import/export regulations, radiation safety standards, and pharmacy licensing.

• Shelf Life and Logistics: With a half-life of 73 hours, Tl-201 demands rapid transportation channels, often necessitating regional distribution hubs close to production sites.

Regulatory and Licensing Landscape

Distributors and procurement entities should verify supplier compliance with local regulations. In the United States, the Nuclear Regulatory Commission (NRC) licenses facilities producing and handling radioactive isotopes like Tl-201. Similarly, the European Medicines Agency (EMA) and Japan’s PMDA oversee manufacturing standards.

Market Dynamics and Supplier Challenges

• Demand Fluctuations: Increasing use of alternative imaging agents, such as Technetium-99m-based compounds, impacts Tl-201 demand.

• Production Challenges: The aging infrastructure and high operational costs of cyclotrons contribute to potential supply constraints or price volatility.

• Geopolitical Factors: International trade policies and radiopharmaceutical export restrictions can influence supply consistency.

Emerging Trends and Future Outlook

• Shift Toward Alternative Diagnostics: The development of SPECT and PET imaging agents may reduce dependence on Tl-201, potentially affecting suppliers' market focus.

• Innovation in Production Methods: Research into alternative production techniques, such as generator-based methods, could diversify supply sources.

• Regional Production Expansion: Countries investing in cyclotron infrastructure may increase local supply, reducing reliance on imported radioisotopes.

Conclusion

The procurement of Thallous chloride Tl-201 involves navigating a niche but critical market, predominantly served by established global and regional suppliers. Companies like GE Healthcare and Nihon Medi-Physics remain primary sources, supported by stringent regulatory standards and sophisticated manufacturing infrastructure. As demand dynamics evolve and technological advancements emerge, supply stability hinges on the continuous investment in cyclotron facilities, regulatory compliance, and logistic capabilities.

---

Key Takeaways

• Limited Supplier Base: Only a handful of licensed manufacturers reliably produce Tl-201, underscoring supply chain importance.

• Regulatory Compliance is Paramount: Ensuring suppliers meet national and international standards addresses safety, efficacy, and legal obligations.

• Rapid Distribution is Essential: Short half-life necessitates proximity of production to end-users or highly efficient logistics.

• Market Trends Impact Suppliers: Advances in imaging technology and alternative agents may influence future demand for Tl-201.

• Regional Production Expansion Could Reduce Dependence: Countries investing in cyclotron infrastructure may bolster local supply, impacting international markets.

---

FAQs

1. Who are the primary global suppliers of Thallous chloride Tl-201?
GE Healthcare and Nihon Medi-Physics are among the leading suppliers, with others operating regionally, depending on regulatory licenses and production capacity [1].

2. How does the short half-life of Tl-201 affect its supply chain?
Its half-life of 73 hours requires timely transport from production sites to medical facilities, often within a regional network to ensure efficacy and safety [2].

3. Are there any notable restrictions or regulations for procuring Tl-201?
Yes. As a radiopharmaceutical, Tl-201 is regulated by nuclear safety authorities, necessitating licensing, temperature-controlled transport, and handling protocols compliant with agencies like the NRC or equivalent [3].

4. Is there a shift toward alternative imaging agents replacing Tl-201?
Yes. Newer agents like Technetium-99m derivatives and Positron Emission Tomography (PET) tracers are increasingly used, but Tl-201 still remains relevant for specific diagnostic applications [4].

5. What future developments could impact Tl-201 suppliers?
Advancements in production technologies, regional cyclotron investments, and changing clinical preferences are likely to shape the supply landscape moving forward.

---

References

[1] "Radiopharmaceuticals Market Overview," MarketWatch, 2022.
[2] "Nuclear Medicine and Radiopharmaceuticals," World Nuclear Association, 2021.
[3] U.S. Nuclear Regulatory Commission. "Regulations for Radiopharmaceuticals," 2022.
[4] "Advancements in Myocardial Imaging," Journal of Nuclear Cardiology, 2020.