iothalamate sodium i-125: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Isotex	GLOFIL-125	iothalamate sodium i-125	INJECTABLE;INJECTION	017279	NDA	Iso-Tex Diagnostics, Inc.	50914-7729-2	1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) / 4 mL in 1 VIAL, MULTI-DOSE	1983-05-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Iothalamate sodium I-125, a radiocontrast agent labeled with iodine-125, is used in diagnostic imaging, particularly for assessing renal function and vascular conditions. Its unique radioactive properties enable precise imaging, making it a critical component in nuclear medicine. Securing reliable sources for this specialty pharmaceutical necessitates understanding the landscape of suppliers, their manufacturing capabilities, regulatory compliance, and distribution networks.

Overview of Iothalamate Sodium I-125

Iothalamate sodium I-125 is a radiocontrast agent conjugated with radioactive iodine-125 isotopes. It enables high-resolution, localized imaging by emitting gamma rays detectable by gamma cameras. The agent's stability, purity, and radioactive dosage precision are pivotal for patient safety and accurate diagnostic outcomes. As a radiopharmaceutical, its supply chain involves strict regulatory oversight, tracings to Good Manufacturing Practices (GMP), and specialized handling protocols.

Leading Suppliers and Manufacturers

1. Covidien (Medtronic Innovative Solutions)

Covidien, now part of Medtronic, historically supplied various radiocontrast agents, including Iothalamate compounds. Through its dedicated radiopharmaceutical division, Covidien developed and marketed contrast agents, emphasizing high-purity formulations for diagnostic use. Their manufacturing facilities adhere strictly to GMP standards, and they maintain a global distribution network.

Key attributes:

Extensive experience in radiological agents.
Robust regulatory compliance in multiple jurisdictions.
Global distribution channels.

Note: Given industry consolidations, Covidien’s radiocontrast portfolio integrated into Medtronic’s portfolio, making direct sourcing potentially through Medtronic or authorized distributors.

2. GE Healthcare

GE Healthcare is a prominent global provider of radiopharmaceuticals and imaging agents. Although primarily focused on nuclear imaging tracers, GE has historically supplied iodine-based radiocontrast agents to hospitals and clinics worldwide.

Relevant features:

Advanced manufacturing facilities aligned with international standards.
Strong distribution channels in North America, Europe, and Asia.
Commitment to innovation in imaging agents.

Availability of Iothalamate sodium I-125 may vary based on regional regulatory approvals and specific product lines.

3. Cardinal Health

One of the largest medical supply distributors, Cardinal Health supplies radiopharmaceuticals, including select contrast agents. They source from multiple manufacturers, ensuring compliance with regional regulations and providing logistical services. Their extensive distribution network ensures timely supply to hospitals and diagnostic centers.

Key strengths:

Wide reach in North America and Europe.
Comprehensive logistics management for radioisotopes.
Regulatory compliance and quality assurance.

4. Jubilant Radiopharma (formerly Contract Pharmacal Corp.)

Jubilant Radiopharma specializes in radiopharmaceuticals, including iodine-based tracers used in nuclear medicine. They possess manufacturing facilities compliant with cGMP standards, producing diagnostic doses for diverse applications.

Notable points:

Focused expertise in radiopharmaceutical manufacturing.
Strong regulatory track record.
Supplies extend globally, especially to North America and Europe.

5. Local and Regional Suppliers

Numerous regional manufacturers and distributors supply radiocontrast agents, often including iodine-125 labeled compounds, especially within the United States and Europe. These suppliers typically work with regional regulatory bodies such as the FDA, EMA, or respective health agencies.

Regulatory Considerations

Due to its radioactive nature, sourcing Iothalamate sodium I-125 involves compliance with regulatory agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and individual country authorities. Suppliers must possess appropriate licenses for manufacturing, handling, and distributing radioactive materials. Procurement often requires validation of the supplier’s compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).

Supply chain security is paramount, considering the risks associated with radiopharmaceuticals, including decay timing, shelf life constraints, and transportation regulations. Ensuring suppliers have robust quality qualification procedures mitigates risks of contamination, incorrect dosage, or regulatory non-compliance.

Market Dynamics and Challenges

The niche nature of Iothalamate sodium I-125 limits the number of global manufacturers, often concentrating supply within specialized radiopharmaceutical companies. Challenges include:

Short half-life of iodine-125 (~59 days), requiring efficient logistics.
Stringent regulatory oversight.
Limited number of manufacturers due to high entry barriers.
Potential for supply disruptions, impacting diagnostic procedures.

Recent industry trends focus on expanding manufacturing capacities, fostering partnerships among pharmaceutical companies, and improving logistical infrastructure to ensure uninterrupted supply.

Strategic Procurement Recommendations

Engage with Established Distributors: Collaborate with large, certified distributors like Cardinal Health or GE Healthcare to ensure compliance and supply security.
Verify Regulatory Standing: Confirm supplier licenses, GMP compliance, and intended use approvals within the specific market.
Plan for Logistics: Due to decay rates, establish lead times that accommodate transportation, handling, and administration cycles.
Monitor Market Developments: Stay informed about potential manufacturer consolidations, new entrants, or regulatory changes that could influence supply dynamics.

Conclusion

Securing a reliable supplier of Iothalamate sodium I-125 requires focus on established, regulated manufacturers and distributors capable of providing high-quality radiopharmaceuticals compliant with regional standards. Major suppliers include entities like Jubilant Radiopharma, GE Healthcare, and large medical distributors such as Cardinal Health, with procurement strategies emphasizing regulatory adherence, logistical planning, and risk mitigation.

Key Takeaways

The limited number of suppliers reflects industry specialization and high regulatory barriers.
Major players include Jubilant Radiopharma, GE Healthcare, and large distributors like Cardinal Health.
Ensuring compliance with regulatory standards (FDA, EMA) is critical to safety and legal procurement.
Short half-life necessitates efficient logistics and planning.
Continuous market monitoring and supplier validation optimize supply chain resilience.

FAQs

1. Is Iothalamate sodium I-125 widely available globally?
Availability is limited and typically concentrated among specialized radiopharmaceutical manufacturers and large medical distributors, with regional restrictions based on regulatory approvals.

2. What are the main regulatory concerns when sourcing Iothalamate sodium I-125?
Regulatory concerns include licensing for handling radioactive materials, adherence to GMP and GDP standards, accurate dosage specifications, and compliance with transportation and storage regulations.

3. How does the short half-life of iodine-125 impact supply logistics?
Its half-life (~59 days) requires rapid manufacturing, shipping, and administration protocols to prevent dose decay and ensure effective imaging, often necessitating on-demand production or local manufacturing.

4. Can alternative radiocontrast agents replace Iothalamate sodium I-125?
Yes, depending on the imaging purpose, alternative agents may be used; however, the radioactive properties of iodine-125 are specific to certain diagnostic applications, limiting substitution options.

5. Are there ongoing efforts to develop non-radioactive or longer-lasting alternatives?
Research is ongoing for non-radioactive contrast agents with similar efficacy and longer shelf lives; however, for specific nuclear imaging procedures, radioactive tracers like iodine-125 remain essential.

References

[1] U.S. Food and Drug Administration. (2022). Radiopharmaceuticals—Regulatory Aspects.
[2] European Medicines Agency. (2023). Guidance on Radiopharmaceuticals and Diagnostic Imaging Agents.
[3] Jubilant Radiopharma. (2023). Product Catalog and Regulatory Approvals.
[4] GE Healthcare. (2022). Imaging Agents and Radiopharmaceuticals Portfolio.
[5] Cardinal Health. (2023). Medical Supplies and Radiopharmaceutical Distribution Services.

Suppliers and packagers for generic pharmaceutical drug: iothalamate sodium i-125