IOTHALAMATE SODIUM I-125: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Start Trial
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: February 19, 2026

Iothalamate sodium I-125 is a radiocontrast agent used in medical imaging. Its production involves specialized radiochemical synthesis and stringent quality control. This report identifies key suppliers and analyzes the manufacturing landscape for this critical pharmaceutical component.

What are the Primary Uses of Iothalamate Sodium I-125?

Iothalamate sodium I-125 is primarily employed as a diagnostic imaging agent. Its ability to absorb X-rays allows it to enhance the visibility of internal body structures during radiological procedures.

Angiography: Used to visualize blood vessels.
Urography: Employed to assess kidney function and visualize the urinary tract.
Computed Tomography (CT) Scans: Enhances contrast in CT imaging, particularly for identifying tumors or vascular abnormalities.

The radioisotope Iodine-125 provides a specific energy signature that is detectable in nuclear medicine imaging techniques.

Who are the Leading Manufacturers and Suppliers of Iothalamate Sodium I-125?

The supply chain for radiopharmaceuticals, including iothalamate sodium I-125, is concentrated among a limited number of specialized manufacturers possessing the necessary expertise in radioisotope handling and pharmaceutical production.

Key Suppliers and Their Product Offerings:

GE HealthCare: A prominent global provider of medical imaging and diagnostic products. GE HealthCare offers a range of radiopharmaceuticals, and their portfolio has historically included iodine-based contrast agents. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP) and regulatory standards.
Curium Pharma: Curium is a significant player in the nuclear medicine market, focusing on the development and manufacturing of radiopharmaceuticals. They produce a broad spectrum of diagnostic and therapeutic radiotracers. Their operations are designed for safe and efficient production of radioactive materials.
Cardinal Health: While primarily known for pharmaceutical distribution, Cardinal Health also has a role in the radiopharmaceutical supply chain, often through partnerships or specialized divisions. They facilitate the delivery of these critical agents to healthcare providers.
Bracco Imaging: A leading company in diagnostic imaging solutions, Bracco Imaging develops, manufactures, and markets contrast agents for various medical imaging modalities. Their product lines include iodinated contrast media.

Note: Specific product availability and trade names may vary by region and regulatory approval. Companies often adapt their offerings based on market demand and technological advancements.

What is the Regulatory Framework Governing Radiopharmaceutical Production?

The production and distribution of radiopharmaceuticals are subject to strict regulatory oversight by national and international health authorities. This ensures the safety, efficacy, and quality of these products.

U.S. Food and Drug Administration (FDA): The FDA regulates radiopharmaceuticals under its Center for Drug Evaluation and Research (CDER). Manufacturers must comply with Current Good Manufacturing Practices (cGMP) for radiopharmaceuticals [1]. This includes requirements for facility design, equipment, personnel, quality control, and documentation.
- Investigational New Drug (IND) Applications: Required for the clinical investigation of new radiopharmaceuticals.
- New Drug Applications (NDAs): Submitted for marketing approval of new radiopharmaceuticals.
- Post-market Surveillance: Ongoing monitoring of product safety and efficacy.
European Medicines Agency (EMA): In the European Union, radiopharmaceuticals are regulated by the EMA. Manufacturing sites are subject to inspection and must hold a Manufacturing Authorization.
- Marketing Authorisation Application (MAA): The process for obtaining approval to market a medicinal product in the EU.
- GMP Compliance: Adherence to EudraLex Volume 4, which details EU guidelines on GMP.
International Atomic Energy Agency (IAEA): The IAEA provides international standards and guidance on the safe use of radiation in medicine, including the production and quality control of radiopharmaceuticals. While not a direct regulatory body for marketing approval, their guidelines are influential in setting global standards.
National Regulatory Authorities: Individual countries have their own specific regulatory bodies (e.g., Health Canada, Pharmaceuticals and Medical Devices Agency (PMDA) in Japan) that oversee radiopharmaceutical approval and manufacturing.

Compliance with these regulations involves rigorous validation of manufacturing processes, extensive testing of raw materials and finished products, and continuous monitoring of radiation safety protocols.

What are the Key Manufacturing Challenges and Considerations?

The synthesis of iothalamate sodium I-125 presents unique challenges due to the incorporation of a radioactive isotope.

Radioisotope Handling and Safety: Iodine-125 is a gamma-emitting radionuclide. Manufacturing facilities must be designed with specialized shielding, ventilation systems, and waste disposal protocols to protect personnel and the environment from radiation exposure. Strict radiation safety officers and comprehensive training programs are mandatory.
Radiochemical Purity and Specific Activity: Achieving high radiochemical purity (the percentage of radioactivity present as the desired compound) and specific activity (radioactivity per unit mass or volume) is critical for diagnostic accuracy and minimizing radiation dose to the patient. Impurities can lead to misinterpretation of imaging results or adverse effects.
Sterility and Aseptic Processing: As an injectable pharmaceutical, iothalamate sodium I-125 must be sterile. Manufacturing processes typically involve aseptic techniques, cleanroom environments (e.g., ISO Class 5), and terminal sterilization methods where feasible, though the radioactivity can complicate some sterilization processes.
Stability and Shelf-Life: Radiopharmaceuticals have a limited shelf-life determined by the half-life of the radioisotope. Iodine-125 has a half-life of approximately 59.4 days. This necessitates efficient production and distribution to ensure that the product is used within its recommended activity and expiration date. Storage conditions (e.g., temperature, light protection) are critical for maintaining stability.
Quality Control and Assurance: Comprehensive quality control testing is essential at every stage of production. This includes:
- Assay for total radioactivity.
- Radiochemical purity analysis (e.g., using High-Performance Liquid Chromatography - HPLC).
- Sterility testing.
- Endotoxin testing.
- pH and osmolality measurements.
- Radionuclidic identity and purity.
Supply Chain Logistics: The short shelf-life and specialized handling requirements of radiopharmaceuticals create complex logistical challenges. Distribution networks must be robust and capable of delivering products rapidly and securely to healthcare facilities, often under temperature-controlled conditions and with appropriate radiation safety measures.

What is the Market Outlook for Iothalamate Sodium I-125?

The market for iothalamate sodium I-125 is influenced by the broader trends in diagnostic imaging and the development of newer contrast agents.

Aging Population and Chronic Diseases: The increasing prevalence of chronic diseases and an aging global population drives demand for diagnostic imaging procedures. This indirectly supports the market for contrast agents.
Technological Advancements: While iothalamate sodium I-125 remains relevant, newer generations of contrast agents, including non-ionic and low-osmolar iodinated contrast media, and gadolinium-based agents for MRI, offer improved safety profiles and imaging characteristics in certain applications. This competition can impact market share.
Radiopharmaceutical Research: Ongoing research into novel radiotracers for molecular imaging (e.g., PET, SPECT) presents both an opportunity and a competitive threat. The development of targeted radiopharmaceuticals for specific disease biomarkers could shift diagnostic paradigms.
Regulatory Hurdles and Manufacturing Costs: The high cost of establishing and maintaining GMP-compliant radiopharmaceutical manufacturing facilities, coupled with stringent regulatory requirements, acts as a barrier to entry and can limit the number of producers.
Geographic Demand: Demand for iothalamate sodium I-125 is concentrated in regions with advanced healthcare infrastructure and high utilization of radiological procedures.

The long-term market outlook for iothalamate sodium I-125 is likely to be characterized by steady but potentially moderate growth, influenced by competition from newer agents and the evolving landscape of medical imaging technologies.

What are the Key Supply Chain Risks?

The specialized nature of iothalamate sodium I-125 production introduces specific supply chain risks that can impact availability.

Single-Source Dependencies: For certain radioactive precursors or specialized manufacturing components, there may be a limited number of global suppliers. Disruptions at these single sources can have cascading effects on iothalamate sodium I-125 production.
Geopolitical Instability and Raw Material Sourcing: The sourcing of raw materials, including the isotopes of iodine, can be affected by geopolitical events or trade restrictions, impacting production timelines and costs.
Manufacturing Facility Incidents: Unforeseen events at manufacturing sites, such as equipment failures, quality control issues, or regulatory non-compliance, can lead to production halts or product recalls, creating shortages.
Transportation and Logistics Disruptions: The specialized shipping requirements for radioactive materials make the supply chain vulnerable to disruptions in air cargo, customs delays, or specialized transport availability.
Regulatory Changes: Evolving regulatory requirements or changes in import/export controls for radioactive materials can impact supply chain operations and market access.
Staffing and Expertise: The highly specialized technical and regulatory expertise required for radiopharmaceutical manufacturing means that a shortage of qualified personnel can pose a risk.

Mitigation strategies often involve dual sourcing where possible, robust inventory management, contingency planning for transportation, and close collaboration with regulatory bodies.

Key Takeaways

Iothalamate sodium I-125 is a radiocontrast agent with applications in angiography, urography, and CT scans.
Key suppliers include GE HealthCare, Curium Pharma, Cardinal Health, and Bracco Imaging.
Production is governed by stringent regulations from bodies such as the FDA and EMA, emphasizing GMP compliance and radiation safety.
Manufacturing challenges include radioisotope handling, achieving high radiochemical purity, maintaining sterility, and managing a limited shelf-life.
The market outlook is influenced by an aging population and disease prevalence, balanced by competition from newer contrast agents and advancements in molecular imaging.
Supply chain risks are significant due to single-source dependencies, logistics complexities, and the potential for manufacturing or regulatory disruptions.

Frequently Asked Questions

1. What is the half-life of Iodine-125 used in iothalamate sodium I-125, and how does this affect its shelf-life?

The half-life of Iodine-125 is approximately 59.4 days. This relatively short half-life dictates a limited shelf-life for iothalamate sodium I-125, typically requiring its use within a defined period after manufacturing to ensure sufficient radioactivity for diagnostic imaging.

2. Are there alternative radiopharmaceuticals that serve a similar purpose to iothalamate sodium I-125?

Yes, other iodinated contrast agents exist, and depending on the specific imaging application, radiopharmaceuticals utilizing different isotopes or entirely different imaging modalities (e.g., MRI contrast agents) may be considered. The choice is application-specific and based on imaging requirements, patient factors, and diagnostic goals.

3. What are the typical storage conditions for iothalamate sodium I-125?

Iothalamate sodium I-125 typically requires storage at controlled room temperature, protected from light, and within designated radioactive material storage facilities that adhere to radiation safety regulations. Specific temperature ranges and handling instructions are detailed in the product's labeling and accompanying documentation.

4. How is the radiochemical purity of iothalamate sodium I-125 ensured during manufacturing?

Radiochemical purity is ensured through rigorous quality control measures at multiple stages of the manufacturing process. Analytical techniques such as High-Performance Liquid Chromatography (HPLC) are employed to separate and quantify the desired iothalamate sodium I-125 from any radioactive or chemical impurities.

5. What is the primary difference between iothalamate sodium I-125 and non-radioactive iodinated contrast agents?

The primary difference lies in the presence of the radioactive isotope Iodine-125. While both are used to enhance imaging, non-radioactive iodinated contrast agents rely on their high atomic number (iodine) to attenuate X-rays, and are detected by conventional X-ray or CT scanners. Iothalamate sodium I-125, with its radioisotope, is also used in nuclear medicine imaging techniques where its emitted radiation is detected by specialized scanners (e.g., gamma cameras).

Citations

[1] U.S. Food and Drug Administration. (n.d.). Radiopharmaceuticals. Retrieved from https://www.fda.gov/drugs/radiopharmaceuticals

Suppliers and packagers for generic pharmaceutical drug: IOTHALAMATE SODIUM I-125