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Suppliers and packagers for THALLOUS CHLORIDE TL 201
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Thallous Chloride TL 201
Introduction
Thallous chloride (TlCl) is a chemically specific compound used in various medical, scientific, and industrial applications. Recently, the demand for Thallous Chloride TL 201 has seen an uptick in research and diagnostic contexts, particularly within nuclear medicine and radiopharmaceuticals. As a highly regulated compound, sourcing reliable, compliant suppliers is critical for industry stakeholders. This article provides a detailed overview of the key suppliers, global manufacturing landscape, regulatory considerations, and future trends influencing the procurement of Thallous Chloride TL 201.
Overview of Thallous Chloride TL 201
Thallous chloride (TlCl) is an inorganic salt characterized by its white crystalline appearance and high purity standards. TL 201 refers to a specific grade of Thallous Chloride optimized for medical imaging and laboratory applications, often subjected to stringent quality control measures. Given its toxicity and radioactive potential, procurement channels are strictly regulated, particularly within jurisdictions adhering to International Atomic Energy Agency (IAEA) standards [1].
Global Suppliers and Manufacturing Landscape
The supply of Thallous Chloride TL 201 involves a limited set of manufacturers, primarily due to the compound’s specialized nature, regulatory restrictions, and the complexities of production. The core sources are:
1. Sigma-Aldrich (Merck Group)
Sigma-Aldrich, a leading global chemical supplier, provides high-quality Thallous Chloride suitable for scientific research and medical use. Their TL 201-grade adheres to Good Manufacturing Practices (GMP), meeting international safety standards. The company leverages advanced manufacturing facilities in Europe and North America, ensuring consistent supply and regulatory compliance [2].
2. Alfa Aesar (Thermo Fisher Scientific)
Alfa Aesar supplies Thallous Chloride of research-grade purity, including grades suitable for radiopharmaceutical synthesis. Their distribution network spans globally, with rigorous quality control protocols aligned with international pharmacopeias. Alfa Aesar’s expertise in heavy metal salts makes it a preferred choice among research institutions [3].
3. Beijing Chemical Works (BCW)
Chinese chemical manufacturers like Beijing Chemical Works have developed capabilities for producing high-purity inorganic salts, including Thallous Chloride TL 201. These suppliers offer highly competitive pricing and volume-based discounts, serving markets primarily in Asia. However, buyers must verify regulatory compliance and quality certifications [4].
4. Ruihe Chemical
Based in China, Ruihe Chemical specializes in heavy metal salts and specializes in low-cost, large-volume production of Thallous Chloride. Their supply is often used in industrial and laboratory settings, with certifications available upon request. Buyers should ensure regulatory alignment when sourcing from such suppliers [5].
5. Custom Synthesis and Contract Manufacturers
Specialized contract manufacturing organizations (CMOs) such as NanoCodex or other niche firms offer custom synthesis of Thallous Chloride TL 201 for highly specific applications like nuclear medicine. Engagement with these firms involves stricter vetting for quality, regulatory approval, and supply chain security [6].
Regulatory and Quality Considerations
Thallous Chloride TL 201's use in pharmaceutical applications necessitates compliance with various regulatory frameworks:
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Good Manufacturing Practices (GMP): Many suppliers adhere to GMP, particularly those serving the pharmaceutical and radiopharmaceutical sectors.
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Material Safety Data Sheets (MSDS): Essential for handling, transport, and storage; demand suppliers provide comprehensive safety documentation.
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Import/Export Controls: As a controlled substance, transnational movement of Thallous Chloride necessitates licenses, especially within the U.S., EU, and China.
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Radiation Safety Regulations: When used in radiopharmaceuticals, compliance with IAEA standards and local nuclear regulatory agencies (e.g., NRC in the U.S.) is mandatory.
Buyers must ensure suppliers possess appropriate certifications (ISO, CE, FDA approval, etc.) and can demonstrate traceability and quality assurance measures.
Market Trends and Future Outlook
The market for Thallous Chloride TL 201 is influenced by ongoing developments in nuclear medicine and diagnostic imaging:
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Radiopharmaceutical Expansion: With increasing use of Tl-based imaging agents, demand for high-purity TlCl products is expected to grow [7].
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Regulatory Tightening: New international regulations for heavy metal salts and radioactive compounds may impact supplier standards, prompting industry-wide quality improvements.
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Supply Chain Resilience: Political and geopolitical factors, especially impacting China and regional suppliers, could influence global supply stability. Diversification of sourcing strategies remains crucial.
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Technological Innovation: Advances in synthesis methods, such as environmentally friendly production processes, could lower costs while improving safety profiles.
Challenges in Sourcing Thallous Chloride TL 201
The principal hurdles include:
- Regulatory hurdles: Strict licensing and customs controls restrict seamless procurement.
- Toxicity and handling: Requirements for specialized storage, transportation, and disposal facilities.
- Limited manufacturer base: Concentration of suppliers limits competition and potentially elevates prices.
- Quality assurance: Ensuring consistent purity and compliance with pharmaceutical standards.
Conclusion
Sourcing Thallous Chloride TL 201 involves navigating a complex landscape of scientific, regulatory, and geopolitical factors. Leading chemical suppliers like Sigma-Aldrich and Alfa Aesar provide high-quality options primarily for research and medical applications, with Chinese manufacturers offering cost-effective bulk supplies. Stakeholders must prioritize regulatory compliance, quality assurance, and supply chain robustness to meet evolving industry needs.
Key Takeaways
- The primary suppliers of Thallous Chloride TL 201 include Sigma-Aldrich, Alfa Aesar, Beijing Chemical Works, and Ruihe Chemical.
- Ensuring GMP compliance, safety certifications, and regulatory licenses is critical for procurement.
- Demand is expected to rise with the growth of nuclear medicine and radiopharmaceuticals.
- Supply chain resilience hinges on diversification and strict quality controls.
- Emerging innovations and regulatory landscapes will shape future sourcing strategies.
FAQs
1. Is Thallous Chloride TL 201 available globally?
Yes, but its availability is primarily through specialized chemical suppliers. Regulatory restrictions can limit distribution in certain regions.
2. What are the primary applications of Thallous Chloride TL 201?
It is used mainly in nuclear medicine imaging, radiopharmaceuticals, and scientific research involving heavy metal salts.
3. How do I verify the quality of Thallous Chloride TL 201 from a supplier?
Request comprehensive Certificates of Analysis (COA), regulatory certifications, and safety data sheets. Confirm adherence to GMP or relevant standards.
4. What transportation considerations apply to Thallous Chloride TL 201?
Transport must follow hazardous materials regulations, including UN classification, proper packaging, and licensing, due to its toxicity and radioactivity potential.
5. Are there alternative compounds to Thallous Chloride TL 201?
Depending on the application, alternatives like Thallium-201 radiotracers or other imaging agents may be used, but they differ significantly in chemistry and regulatory status.
References
[1] International Atomic Energy Agency (IAEA). "Regulations for the Safe Transport of Radioactive Material." 2021.
[2] Sigma-Aldrich. "Thallous Chloride Products and Certifications." 2023.
[3] Alfa Aesar. "Inorganic Chemicals Catalog." 2023.
[4] Beijing Chemical Works. "Product Data Sheets and Compliance Certificates." 2022.
[5] Ruihe Chemical. "Heavy Metal Salt Offerings." 2023.
[6] NanoCodex. "Custom Synthesis of Radioactive and Heavy Metal Compounds." 2022.
[7] Market Research Future. "Radiopharmaceuticals Market Analysis." 2022.
This comprehensive overview of suppliers for Thallous Chloride TL 201 aims to assist industry professionals in making informed procurement decisions aligned with safety, quality, and regulatory standards.
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