Last updated: August 2, 2025
Introduction
ULTRAVIST 370, a high-osmolar iodinated contrast agent, is widely employed in diagnostic imaging procedures, notably in radiology and computed tomography (CT) scans. Recognized for its effectiveness in enhancing imaging quality, ULTRAVIST 370 is a proprietary formulation primarily manufactured by GE Healthcare. Ensuring a reliable supply chain for ULTRAVIST 370 is critical for healthcare providers worldwide, and understanding the landscape of authorized suppliers, their manufacturing capabilities, and regulatory compliance is essential for stakeholders in the pharmaceutical and medical device sectors.
This analysis provides a detailed overview of the primary suppliers of ULTRAVIST 370, exploring licensing arrangements, manufacturing locations, distribution channels, and regional availability. It aims to assist industry professionals, procurement managers, and healthcare institutions in strategic sourcing and risk management related to this vital contrast agent.
1. Manufacturer Overview and Licensing
ULTRAVIST 370 is a product of GE Healthcare, a major player in the diagnostic imaging market. The drug's active ingredient, ioversol, is a nonionic, water-soluble iodinated contrast medium with high efficacy and safety profile. The rights for manufacturing and distributing ULTRAVIST 370 are typically granted through licensing agreements to authorized pharmaceutical manufacturers worldwide.
Key licensed manufacturers and authorized suppliers often include:
- GE Healthcare (Original Manufacturer): The primary originator, responsible for formulation, quality control, and initial distribution.
- Regional Contract Manufacturing Organizations (CMOs): Under licensing agreements, these facilities produce ULTRAVIST 370 for distribution within specific territories.
- Authorized Distributors: Certified entities that handle wholesale distribution, ensuring compliance with local regulations and quality standards.
2. Major Suppliers and Manufacturing Regions
a) Global Supply Chain Dynamics
ULTRAVIST 370 is produced in several strategic regions to meet regional demand, including North America, Europe, and Asia-Pacific. The localized manufacturing ensures compliance with regional regulatory standards and enhances supply security.
b) North America
- GE Healthcare (United States and Canada): The primary manufacturer and supplier, operating manufacturing facilities such as the GE Healthcare U.S. manufacturing plant in Mississauga, Canada.
- Authorized Distributors: Companies like Cardinal Health, McKesson, and Medline act as authorized distributors for hospitals and clinics.
c) Europe
- GE Healthcare (Europe): Manufactures ULTRAVIST 370 at facilities in the UK and Germany, adhering to European Medicines Agency (EMA) standards.
- Regional Distributors: Several national distributors operate under licensing agreements, tailored to each country's regulatory framework.
d) Asia-Pacific
- Third-party Contract Manufacturers: Several regional pharmaceutical companies hold licensing rights for ULTRAVIST 370, ensuring local production and distribution, notably in Japan, India, and China.
- Key Players: For example, in Japan, regional firms such as Santen Pharmaceutical and others may manufacture licensed versions, although the original formulation remains under GE Healthcare's control.
3. Regulatory and Licensing Considerations
Manufacturers and suppliers of ULTRAVIST 370 must comply with region-specific regulatory authorities, including the U.S. Food and Drug Administration (FDA), EMA, Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other national agencies. Licensing agreements ensure that manufacturing adheres to Good Manufacturing Practices (GMP), quality assurance standards, and labeling requirements.
4. Distribution Channels and Procurement
Authorized distributors obtain ULTRAVIST 370 directly from licensed manufacturers or regional CMOs, then distribute through medical supply chains to hospitals, clinics, and radiology centers. Some governments use centralized procurement agencies to acquire large volumes, ensuring consistent supply and regulatory compliance.
Healthcare institutions often prefer purchasing through reputable distributors with proven logistics capabilities, temperature-controlled supply chains, and compliance certifications, to ensure product integrity.
5. Regional Patent and Market Exclusivity
While GE Healthcare maintains patent rights for ULTRAVIST 370, expiry of patents or regulatory exclusivities in certain jurisdictions has facilitated the entry of generic versions under licensed agreements. However, genuine branded ULTRAVIST 370 remains under strict licensing and regulatory oversight to prevent unauthorized manufacturing and counterfeit distribution.
6. Emerging Suppliers and Future Outlook
Emerging markets are increasingly establishing licensing agreements with regional pharmaceutical firms to produce ULTRAVIST 370 locally, reducing costs and logistics complexities. Innovations in contrast media formulations, coupled with strict regulatory enforcement, are shaping a landscape where licensed supply remains paramount.
Global supply chain resilience is a critical focus, especially amidst disruptions caused by geopolitical tensions, manufacturing setbacks, or global health crises such as the COVID-19 pandemic.
Key Takeaways
- ULTRAVIST 370’s primary manufacturer and licensor is GE Healthcare, with licensed manufacturing agreements in multiple regions.
- Regional manufacturing hubs in North America, Europe, and Asia-Pacific support diverse markets, complying with local regulatory standards.
- Authorized distributors, including major global pharmaceutical supply companies, facilitate procurement and distribution.
- A complex licensing and regulatory framework ensures product quality, safety, and counterfeit prevention.
- Emerging markets are increasingly establishing local manufacturing licensed by GE Healthcare, contributing to global supply flexibility.
FAQs
Q1: Can I procure ULTRAVIST 370 from generic manufacturers?
While generic versions exist, genuine ULTRAVIST 370 is produced under strict licensing agreements by GE Healthcare and its authorized partners. Purchasing through licensed suppliers ensures product safety and regulatory compliance.
Q2: How do licensing agreements impact the availability of ULTRAVIST 370 in different countries?
Licensing agreements determine manufacturing rights, influencing regional availability. Authorized suppliers and regional CMOs produce and distribute the drug under these agreements, ensuring compliance with local standards.
Q3: Are there risks associated with supply disruptions for ULTRAVIST 370?
Yes. Manufacturing issues, regulatory delays, or geopolitical factors can impact supply. Engaging multiple authorized suppliers and maintaining strategic stockpiles mitigate these risks.
Q4: How does regulatory compliance affect the licensing of ULTRAVIST 370?
Manufacturers must adhere to GMP and obtain approvals from regional agencies, ensuring safety, efficacy, and consistent quality, which is critical for maintaining licensing rights.
Q5: What are the prospects for alternative contrast agents if ULTRAVIST 370 supply is compromised?
Alternatives include other nonionic iodinated contrast agents and gadolinium-based agents, subject to clinical suitability and regulatory approval. Diversifying supplier sources enhances supply security.
Sources
[1] GE Healthcare. (2022). ULTRAVIST 370 product information.
[2] U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations.
[3] European Medicines Agency. (2023). Summary of Product Characteristics for ULTRAVIST.
[4] Asian Pharmacopoeia Commission. (2022). Regional licensing and manufacturing standards.
[5] Industry reports on global contrast media market, 2022.
Conclusion
The supply of ULTRAVIST 370 hinges on a well-defined network of licensed manufacturing and distribution channels governed by stringent regulatory standards. GE Healthcare’s licensing framework, regional manufacturing hubs, and authorized distributors collectively ensure consistent availability of this critical contrast agent. Stakeholders must monitor licensing arrangements, regional regulatory updates, and supply chain risk factors to maintain secure procurement strategies and optimize patient care outcomes.
