Suppliers and packagers for thyrosafe

thyrosafe

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Btg Intl	THYROSAFE	potassium iodide	TABLET;ORAL	076350	ANDA	BTG International Inc.	50633-910-20	160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK	2002-09-30

Suppliers for the Pharmaceutical Drug: THYROSAFE

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape features a growing demand for effective thyroid diagnostic agents, notably THYROSAFE, a radiopharmaceutical primarily used in thyroid scintigraphy. As a recognized diagnostic tool, THYROSAFE’s global supply chain involves various suppliers across manufacturing, distribution, and regulatory spheres. This article provides an in-depth analysis of the primary suppliers, their geographic distribution, regulatory standing, and strategic considerations for stakeholders seeking reliable sources of THYROSAFE.

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Overview of THYROSAFE

THYROSAFE is an iodine-123-based radiopharmaceutical, utilized in detecting and localizing hyperthyroidism, thyroid nodules, and other thyroid conditions. It offers precision and safety when performed under appropriate medical protocols. Due to its radioactive nature, the production, supply, and distribution of THYROSAFE are heavily regulated, typically involving specialized pharmaceutical manufacturers licensed to handle isotopic substances.

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Key Manufacturers and Suppliers

1. Polatom (Poland)

   Polatom (Polish Nuclear Energy Agency) is a leading producer of iodine-123 radiopharmaceuticals, including THYROSAFE, in the European Union. With its advanced cyclotron facilities, Polatom supplies a significant portion of iodine-123 radiopharmaceuticals globally, including to North American and Asian markets. The company's compliance with European Medicines Agency (EMA) standards and Good Manufacturing Practices (GMP) makes its products highly trusted.

2. NTP Radioisotopes (South Africa)

   NTP Radioisotopes, part of the Nuclear Technology Products division of NECSA (South African Nuclear Energy Corporation), manufactures and supplies isotopes including iodine-123 for medical applications. Their strategic location and export capabilities underpin their role as a key supplier to global markets, especially regions seeking reliable iodine-123 sources outside of Europe and North America.

3. Cardinal Health and Jubilant Radiopharma (United States)

   In the United States, major healthcare distributors such as Cardinal Health and Jubilant Radiopharma source iodine-123 from various manufacturers, including Polatom and NTP. These distributors provide integrated logistics and ensure adherence to U.S. FDA regulations, enabling local hospitals and nuclear medicine centers to access THYROSAFE efficiently.

4. Other Notable Suppliers

   • Y-122 (Russia): Although primarily focused on other isotopes, Russian radiopharmaceutical manufacturers have explored iodine-123 production, but supply volumes remain limited.

   • Advanced Cyclotron Facilities Worldwide: Some academic or government-operated cyclotrons produce iodine-123 for research purposes, but these are not typically commercial suppliers.

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Supply Chain Considerations

• Regulatory Approvals and Certifications

  Suppliers must obtain licenses from relevant authorities such as the EMA, U.S. FDA, or national regulators. Ensuring compliance ensures product quality, safety, and legal adherence.

• Production Complexities

  Iodine-123 production involves cyclotron irradiation of enriched xenon gas, a process requiring sophisticated infrastructure and regulatory oversight. Consequently, the number of global producers remains limited, which can impact supply stability.

• Distribution Challenges

  As a radioactive material, THYROSAFE mandates strict logistics protocols, including secure packaging, temperature control, and compliance with international transport regulations (e.g., IATA Dangerous Goods Regulations).

• Market Dynamics

  The scarcity of iodine-123, varying regional demand, and geopolitical factors influence supplier availability. Recent trends indicate a drive toward expanding production capacity and diversifying sources to mitigate shortages.

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Strategic Implications for Stakeholders

• Healthcare Providers

  Should establish relationships with verified distributors who source from licensed manufacturers to ensure product authenticity and regulatory compliance.

• Pharmaceutical Distributors

  Need to maintain robust inventory management, comply with transportation standards, and stay informed about regulatory updates affecting isotopic radiopharmaceuticals.

• Investors and Market Analysts

  Must monitor production capacity expansions, regulatory shifts, and geopolitical influences that could impact supply stability or create competitive advantages for certain suppliers.

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Future Trends

• Expansion of Production Capacity

  Emerging facilities in Asia and increased investment in cyclotron technology aim to augment iodine-123 supply, potentially reducing shortages and price volatility.

• Technological Innovations

  Advances in cyclotron design and isotope separation may increase yields and reduce costs, making THYROSAFE more accessible globally.

• Regulatory Harmonization

  International cooperation on safety standards and licensing could streamline cross-border supply chains, broadening the supplier pool.

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Conclusion

The supply chain of THYROSAFE is characterized by a handful of specialized producers, predominantly in Europe and South Africa, supplemented by a network of regional distributors. The limited number of reliable suppliers necessitates strategic partnerships and vigilant regulatory compliance to ensure consistent access. Ongoing investments in production capacity and technological innovation are vital to meeting global demand and safeguarding supply continuity.

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Key Takeaways

• Primary Suppliers: Polatom (Poland) and NTP Radioisotopes (South Africa) stand out as leading producers of iodine-123 radiopharmaceuticals, including THYROSAFE.
• Regulatory Compliance: Ensuring products meet regional standards (EMA, FDA) is crucial for safety and legal dispensing.
• Supply Chain Challenges: Limited global producers and high logistical standards for radioactive materials can lead to supply disruptions.
• Market Dynamics: Expansion projects at existing facilities and new entrants aim to stabilize and increase iodine-123 availability.
• Strategic Relationships: Collaborations with certified distributors and manufacturers are key to securing consistent access.

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FAQs

1. Who are the primary manufacturers of THYROSAFE globally?
Polatom in Poland and NTP Radioisotopes in South Africa are the primary suppliers of iodine-123 radiopharmaceuticals, including THYROSAFE, across international markets.

2. What regulatory standards govern the production of THYROSAFE?
Manufacturers must adhere to GMP standards, and products must be approved by relevant authorities such as the EMA (Europe) or FDA (U.S.) before distribution.

3. How does the production process influence supply stability?
Iodine-123 production requires sophisticated cyclotron facilities with specific technical capabilities, making the number of producers limited and potentially impacting supply continuity.

4. What logistical considerations are involved in distributing THYROSAFE?
Transport involves strict compliance with international hazardous goods regulations, secure packaging, temperature control, and adherence to safety protocols to prevent radiation exposure.

5. Are there emerging suppliers or technologies that could diversify THYROSAFE sourcing?
Yes, new production facilities in Asia and technological advances in cyclotron efficiency may broaden the supplier base, improving supply resilience and reducing costs.

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References

1. [1] Polatom official website. (2023). Radiopharmaceutical Production Capacity.
2. [2] NECSA NTP Radioisotopes. (2022). Iodine-123 Supply and Distribution.
3. [3] U.S. FDA Drug Approval and Regulatory Guidelines. (2023).
4. [4] IATA Dangerous Goods Regulations. (2023).
5. [5] Market Analysis Reports on Radioisotope Production. (2023).