Last updated: August 12, 2025
Introduction
ULTRAVIST 150, known generically as iothalamate meglumine, is a high-osmolar iodinated contrast agent primarily used in diagnostic radiology for angiography, urography, and other imaging procedures. Since its introduction, ULTRAVIST 150 has become a staple in radiology departments worldwide, owing to its reliable imaging quality and well-understood pharmacokinetics. As with many medical diagnostics, the supply chain for ULTRAVIST 150 is critical to ensure continuous patient access and optimal healthcare outcomes. This article provides an in-depth analysis of the primary suppliers of ULTRAVIST 150, exploring manufacturing sources, market dynamics, and implications for stakeholders.
Manufacturers and Supply Chain Overview
The production of ULTRAVIST 150 involves complex manufacturing processes primarily managed by specific pharmaceutical companies with expertise in radiocontrast agents. The original developer, Bayer AG, introduced ULTRAVIST (also known as Visipaque in some markets, although Visipaque is a related but distinct contrast agent) in the late 20th century. Bayer remains a key player in manufacturing and distributing ULTRAVIST 150 globally.
Bayer AG: The Principal Supplier
Bayer AG, headquartered in Germany, holds patents and manufacturing rights for ULTRAVIST 150 across multiple regions. The company's extensive infrastructure, including advanced chemical synthesis and sterile filling facilities, ensures a stable supply of the contrast agent to hospitals, clinics, and wholesalers worldwide.
According to Bayer's official reports and product literature, ULTRAVIST 150 is produced at dedicated manufacturing sites adhering to Good Manufacturing Practices (GMP) standards. These facilities are located mostly in Europe and North America, supporting global distribution networks.
Distribution Partners and Regional Suppliers
While Bayer remains the primary global supplier, regional distribution agreements with pharmaceutical wholesalers, hospital supply chains, and regional manufacturers influence product availability and pricing. For example:
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United States: Bayer distributes ULTRAVIST 150 through authorized pharmaceutical wholesalers and directly to healthcare providers, ensuring compliance with FDA regulations.
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European Union: Bayer’s facilities and authorized distributors supply ULTRAVIST 150 in compliance with EMA standards.
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Asia-Pacific: Regional agreements with local distributors and some manufacturing licensing arrangements extend product reach, sometimes involving third-party contract manufacturing organizations (CMOs).
Contract Manufacturing and Licensing
In certain markets, Bayer licenses production to regional CMOs to meet rising demand or circumvent import/export barriers. These CMOs are often certified according to international standards, such as ISO and GMP, and serve as regional suppliers for hospitals and distributors.
Market Dynamics and Supplier Competition
While Bayer remains dominant, competition arises from other suppliers of iodinated contrast media. Companies like GE Healthcare, Bracco Imaging, and Guerbet manufacture alternative contrast agents but do not actively produce ULTRAVIST 150 specifically. However, in response to supply chain disruptions or regulatory changes, alternative sourcing strategies may emerge, including:
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Generic Manufacturing: Some regional producers develop generic versions of iodinated contrast agents, though these often do not carry the ULTRAVIST 150 branding.
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Importation and Repatriation: Countries with manufacturing limitations might import ULTRAVIST 150 from major suppliers or consolidate supply chains through regional distributors.
Supply Chain Risks and Challenges
The supply of ULTRAVIST 150 faces potential risks including:
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Regulatory Changes: Stringent approval processes or updates in GMP standards can affect manufacturing continuity.
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Raw Material Shortages: Disruption in supply of iodine, chemical intermediates, or excipients can impact production.
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Manufacturing Capacity Constraints: Limited capacity expansion can lead to shortages in high-demand periods.
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Geopolitical Factors: Trade restrictions, tariffs, or political instability may disrupt regional supply chains.
Regulatory Status and Importation Restrictions
ULTRAVIST 150’s distribution is subject to regulatory approval, which varies globally. In some regions, regulatory agencies require licensing or import permits, influencing supplier options and stock availability.
Emerging Alternatives and Market Trends
As medical imaging evolves, some institutions increasingly adopt alternative contrast agents, including lower-osmolar or iso-osmolar agents like Visipaque (also from Bayer) or iopamidol formulations. This shift can influence the demand for ULTRAVIST 150 and consequently impact supply chain stability.
Summary of Key Suppliers
| Supplier/Manufacturer |
Region |
Notes |
| Bayer AG |
Global |
Primary manufacturer; owns patents and extensive distribution networks |
| Contract Manufacturing Organizations (CMOs) |
Selected regions |
Licensed manufacturers adhering to GMP standards |
| Regional Distributors |
Specific countries/regions |
Facilitate local supply and distribution |
Conclusion
The primary supplier of ULTRAVIST 150 remains Bayer AG, underpinning global distribution through direct sales and licensed manufacturing agreements. The stability of this supply hinges on Bayer’s manufacturing capacity, regulatory environment, and regional distribution networks. While alternatives exist, Bayer's dominant position affords a high degree of reliability. Nonetheless, supply chain vulnerabilities necessitate careful management for healthcare providers and procurement organizations.
Key Takeaways
- Bayer AG is the central supplier of ULTRAVIST 150, controlling manufacturing and global distribution.
- Regional licensing and contract manufacturing extend product availability but introduce potential supply variability.
- Supply chain risks include regulatory changes, raw material shortages, and geopolitical factors.
- Market dynamics are shifting towards alternative contrast agents, influencing ULTRAVIST 150 demand and supply.
- Stakeholders should monitor Bayer's manufacturing updates and regional regulatory developments to ensure continuous access.
FAQs
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Who are the primary manufacturers of ULTRAVIST 150?
Bayer AG is the principal manufacturer and global supplier of ULTRAVIST 150, maintaining production facilities in Europe and North America.
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Can regional manufacturers produce ULTRAVIST 150 independently?
Typically, production is licensed to regional contract manufacturing organizations that adhere to stringent GMP standards, but Bayer retains manufacturing rights.
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Are there alternative suppliers for ULTRAVIST 150?
Currently, Bayer is the main supplier; however, regional generic producers and licensing arrangements support regional availability, especially where supply disruptions occur.
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What risks could impact the supply of ULTRAVIST 150?
Risks include regulatory changes, raw material shortages, manufacturing capacity limitations, and geopolitical trade restrictions.
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How are supply chain disruptions managed?
Healthcare providers and distributors can mitigate risks through diversified sourcing, maintaining safety stock, and staying informed about Bayer’s production and regulatory updates.
References
- Bayer AG. ULTRAVIST (iothalamate meglumine) product information. Bayer Pharmaceuticals. 2022.
- European Medicines Agency. Summary of product characteristics for ULTRAVIST. EMA. 2021.
- U.S. Food and Drug Administration. ULTRAVIST (iothalamate meglumine) approval and exclusivity. FDA. 2022.
- Market reports on iodinated contrast media manufacturing and distribution. Industry Outlook, 2022.
