Bulk Pharmaceutical API Sources for THYROSAFE

Bulk Pharmaceutical API Sources for THYROSAFE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		204102_ALDRICH
Sigma-Aldrich		429422_ALDRICH
Sigma-Aldrich		P2963_SIAL
Sigma-Aldrich		P8166_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: THYROSAFE

Last updated: August 1, 2025

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Introduction

ThyroSAFE is a diagnostic radiopharmaceutical primarily used in thyroid scintigraphy, an imaging technique to assess thyroid function. Its active ingredient typically involves Iodine-123 (I-123), a radioisotope used due to its optimal gamma-ray emission profile and favorable half-life. Ensuring reliable sourcing of high-quality API (Active Pharmaceutical Ingredient) such as Iodine-123 is critical for manufacturers, healthcare providers, and regulatory bodies to sustain supply chains, meet compliance standards, and support medical diagnostics globally.

This report examines the global landscape of API sources for ThyroSAFE, emphasizing key suppliers, manufacturing jurisdictions, industry trends, and validation processes.

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Understanding the API: Iodine-123 for ThyroSAFE

Iodine-123 is a radioisotope produced chiefly through nuclear reactor irradiation or cyclotron bombardment. Its application extends beyond diagnostic imaging to include peptide labeling and other therapeutic diagnostics. For ThyroSAFE, its high purity, suitable half-life (~13 hours), and gamma emissions make it ideal for imaging purposes.

The API must conform to stringent pharmacopeial standards, including USP, EP, or BP, ensuring high radiochemical purity, specific activity, and minimal contaminants.

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Global API Sources for Iodine-123

1. Direct Reactor-based Production

The predominant method producing Iodine-123 involves neutron irradiation of Tellurium-122 (Te-122) nuclei in nuclear reactors. Notable global sources include:

• Australia (ANSTO - Australian Nuclear Science and Technology Organisation):
  ANSTO operates nuclear reactors capable of producing Iodine-123 with high purity, primarily for research and medical use. Australia’s strategic investment in nuclear infrastructure supports consistent supply chains.

• Belgium (SCK•CEN):
  The Belgian Nuclear Research Center employs reactors for radioisotope production. Although primarily focused on research, their capacity extends to medical isotopes including Iodine-123.

• United States (NRU Reactor, until shutdown):
  Historically, facilities like the Canadian NRU reactor produced medical isotopes. Current US-based reactor capacity for Iodine-123 production is limited, prompting reliance on foreign sources.

• Japan (JAEA’s Japan Nuclear Cycle Development Institute):
  Japan's nuclear technology sector includes radioisotope production capabilities, with ongoing R&D to optimize production methods.

2. Cyclotron-based Production

While reactor-based methods dominate, cyclotron production has emerged as an alternative:

• Siemens Healthineers (Germany) and others:
  Cyclotron facilities in Germany, India, and Russia are developing synthetic routes to produce Iodine-123 via proton irradiation of enriched Te-122 or other precursors. Cyclotron production offers advantages in decentralization and reduced nuclear proliferation concerns.

3. Contracted Suppliers and Licensed Distributors

Major pharmaceutical companies and specialized radioisotope suppliers hold strategic contracts with nuclear reactors and cyclotrons to ensure steady API supply.

• Rotem Amfert Negev (Israel):
  Engaged in producing medical isotopes, including Iodine-123, for regional and international distribution.

• ISOTOPES: Medical isotopes LLC (India):
  Operates cyclotron facilities capable of producing Iodine-123 and meets stringent quality standards for export.

• Eczacıbaşı-Laboratuvar (Turkey):
  Has established capabilities for radioisotope production and supply, including Iodine-123, primarily for regional clinics.

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Industry Trends and Challenges

Global Supply Constraints:
Limited reactor capacity, aging infrastructure, and geopolitical factors often disrupt consistent Iodine-123 supply. Notably, the shutdown of reactors like Canada's NRU has led to supply shortages and increased reliance on alternative production methods.

Decentralization and On-site Production:
Industry shifts favor local or regional cyclotron-based production to mitigate transportation delays and logistical complexities inherent in reactor-based isotope delivery.

Regulatory Considerations:
API sources must adhere to stringent quality assurance, including Good Manufacturing Practice (GMP) standards, and obtain approvals from bodies such as the FDA, EMA, and regional regulatory authorities.

Innovation in Production Methods:
Research bodies and companies invest in cyclotron methods and alternative nuclear reactions to diversify supply chains and enhance resilience.

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Validation and Quality Standards

API for ThyroSAFE must conform to:

• USP <821> Radioactive Drugs Standards
• European Pharmacopeia Monograph on Iodine-123
• ISO 13485 Quality Management Systems for Medical Devices (when applicable)

Manufacturers must validate assays for radiochemical purity (>95%), specific activity, and sterility. Certification from recognized pharmacopoeia ensures regulatory acceptance in diverse markets.

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Conclusion

Reliable bulk API sources for ThyroSAFE, notably Iodine-123, are concentrated among a few regions with nuclear research infrastructure, including Australia, Belgium, Japan, and specialized cyclotron facilities in Germany, India, and Israel. The industry faces ongoing challenges from supply chain vulnerabilities, necessitating diversification of production technologies and locales.

Emerging trends favor cyclotron-based and regional production capabilities to enhance supply resilience. As demand for diagnostic imaging grows, strategic partnerships, continuous technological innovation, and regulatory compliance will be vital in securing stable API sources for ThyroSAFE.

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Key Takeaways

• The primary API for ThyroSAFE, Iodine-123, is predominantly produced via reactor irradiation and increasingly through cyclotron methods.
• Major sources include Australia’s ANSTO, EU-based cyclotron facilities, and specialized suppliers in Israel and India.
• Supply chain disruptions highlight the need for regional, decentralized production approaches.
• Strict adherence to pharmacopeial standards and regulatory validation underpins API quality and availability.
• Industry trends favor innovation and diversification to ensure uninterrupted supply aligning with global diagnostic demand.

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FAQs

1. What are the primary manufacturing methods for Iodine-123 API?
Iodine-123 is mainly produced through neutron irradiation of Tellurium-122 in nuclear reactors. Cyclotron-based synthetic methods are also under development, offering decentralized production possibilities.

2. Which regions are leading suppliers of Iodine-123 API?
Australia, Belgium, Japan, Germany, India, and Israel are prominent regions with established capabilities for Iodine-123 production, supported by nuclear reactors and cyclotrons.

3. How does supply chain stability affect ThyroSAFE manufacturing?
Limited reactor capacity and geopolitical factors can cause shortages of Iodine-123, impacting the availability of ThyroSAFE. Diversification and regional production help mitigate these risks.

4. What quality standards govern Iodine-123 API?
The API must meet standards set by USP, EP, or BP, including specifications for radiochemical purity (>95%), specific activity, and sterility, validated through rigorous testing protocols.

5. Are there ongoing innovations in API production for diagnostic radiopharmaceuticals?
Yes, ongoing research focuses on cyclotron-based production, alternative nuclear reactions, and automation to improve yield, purity, and supply resilience for diagnostic isotopes like Iodine-123.

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References

1. [1] International Atomic Energy Agency. "Production and Quality Control of Medical Radioisotopes," IAEA Nuclear Energy Series, 2017.
2. [2] European Pharmacopoeia. "Iodine-123," EDQM, 2022.
3. [3] U.S. Pharmacopeia. "Radioactive Drugs," USP, 2021.
4. [4] ANSTO. "Medical Radioisotopes Production," ANSTO Annual Report, 2022.
5. [5] Siemens Healthineers. "Cyclotron Resources for Medical Isotopes," 2023.

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This comprehensive assessment provides healthcare entities and pharmaceutical manufacturers with targeted insights into the bulk API sourcing landscape for ThyroSAFE, emphasizing strategic considerations in procurement, supply chain management, and regulatory compliance.