Last updated: July 28, 2025
Introduction
OPTIRAY 240 is a trademarked radiopaque contrast agent primarily used in radiographic and fluoroscopic imaging procedures. The active ingredient, iohexol, belongs to the class of iodinated contrast media widely employed in diagnostic imaging to enhance vascular and tissue visibility. Given the critical role of OPTIRAY 240 in medical diagnostics, an understanding of its supplier landscape is essential for healthcare providers, distributors, and procurement specialists aiming to ensure continuous access, regulatory compliance, and competitive pricing.
Manufacturers of OPTIRAY 240
1. Guerbet LLC
Guerbet is a global leader in contrast agents, notably manufacturing and marketing OPTIRAY 240. Headquartered in France, Guerbet has a robust manufacturing presence across various continents, ensuring regional supply and distribution networks. The company’s products are approved by regulatory agencies such as the FDA in the United States, EMA in Europe, and health authorities worldwide.
2. Iatrobe Laboratories
While Guerbet holds a significant market share, Iatrobe Laboratories, based in India, is a notable regional supplier synthesizing similar iodinated contrast agents. Though Iatrobe does not produce OPTIRAY 240 under that exact name, it supplies comparable products with equivalent formulations for domestic and export markets.
3. Other Regional Distributors
In addition to primary manufacturers, regional distributors and importers play a vital role, especially in markets where direct procurement from Guerbet or licensed manufacturers is limited. These entities often source from authorized channels or regional manufacturing units, ensuring availability locally.
Supply Chain Dynamics
Authorized Distributorships and Licensing Agreements
Guerbet maintains an extensive network of authorized distributors in key markets, including the United States, Europe, Asia, and Africa. Licensing agreements may also involve regional pharmaceutical companies licensed to manufacture or distribute OPTIRAY 240 under strict regulatory compliance. These partnerships facilitate expedited supply and adherence to local pharmacovigilance requirements.
Manufacturing Facilities and Regulatory Approvals
Guerbet's manufacturing facilities in Europe and Asia are compliant with Good Manufacturing Practices (GMP), which ensure product quality and safety. Regulatory approvals from agencies like the FDA and EMA are prerequisites for distributing OPTIRAY 240 in respective regions. In some emerging markets, local manufacturers may produce equivalent formulations under license, expanding supply options but potentially affecting product consistency.
Market Outlook and Emerging Suppliers
Despite Guerbet’s dominant position, supply chain disruptions, regulatory changes, and global health crises have prompted interest in alternative suppliers or biosimilar products. Manufacturers in China, India, and other emerging regions are increasingly pursuing regulatory approval to produce iodinated contrast media. However, these products often face stringent quality controls due to safety concerns associated with iodinated contrast agents.
Innovations and biosimilar development are on the rise, which could introduce new suppliers into the OPTIRAY 240 market. These developments aim to address supply shortages, reduce costs, and increase accessibility.
Navigating Regulatory & Procurement Considerations
Healthcare organizations sourcing OPTIRAY 240 should verify the supplier’s regulatory approvals, manufacturing compliance, and quality certifications. Engaging with authorized distributors directly affiliated with Guerbet minimizes risks related to counterfeit or substandard products. Additionally, some institutions prefer to establish formal procurement agreements to secure consistent supply and favorable terms.
Key Supply Chains & Regional Markets
| Region |
Primary Supplier(s) |
Notes |
| North America |
Guerbet LLC |
FDA-approved supplier, extensive distribution network |
| Europe |
Guerbet S.A. |
European Regulatory approvals, local manufacturing |
| Asia-Pacific |
Guerbet, regional distributors |
Approved suppliers; local manufacturing in some countries |
| Latin America |
Regional distributors |
Importers with licensing agreements |
| Africa & Middle East |
Local distributors |
Often sourced via regional partners; regulatory hurdles vary |
Challenges and Opportunities in the Supply of OPTIRAY 240
Supply Chain Disruptions: Problems like manufacturing delays, logistics issues, or international trade restrictions temporarily impact availability.
Regulatory Barriers: Variations in approval processes can impede market entry for new suppliers, emphasizing the importance of robust regulatory compliance.
Emerging Biosimilars & Alternatives: While currently limited, biosimilar contrast agents could diversify the supply landscape, offering competitive pricing and increased availability.
Strategic Procurement: Hospitals and healthcare providers should develop relationships with multiple authorized suppliers to mitigate risks associated with supply interruptions.
Conclusion
Guerbet LLC stands as the primary and most trusted supplier of OPTIRAY 240, with an extensive global distribution network supported by rigorous regulatory compliance and manufacturing standards. Secondary suppliers, regional distributors, and emerging manufacturers contribute to a diverse supply landscape, particularly in developing markets. Healthcare organizations should prioritize partnerships with authorized, regulatory-approved distributors and continuously monitor market developments to ensure an uninterrupted supply of this critical diagnostic agent.
Key Takeaways
- Guerbet LLC is the main manufacturer and supplier of OPTIRAY 240, with widespread global distribution.
- Regional distributors and local manufacturers often supply OPTIRAY 240 in emerging markets, emphasizing the importance of verifying regulatory approvals.
- Supply chain resilience can be enhanced by establishing relationships with multiple authorized suppliers.
- Emerging biosimilars and contrast media alternatives may influence future supply dynamics.
- Regulatory compliance, quality assurance, and procurement agreements are crucial to secure a reliable supply chain.
FAQs
1. How can healthcare providers ensure the authenticity of OPTIRAY 240 received from suppliers?
Always verify that suppliers are authorized distributors with valid regulatory approvals from agencies like the FDA or EMA. Request documentation such as certificates of authenticity and manufacturing licenses.
2. Are biosimilar contrast agents a viable alternative to OPTIRAY 240?
Currently, biosimilars are limited in this segment. While some manufacturers develop iodinated contrast media, their approval and equivalence to OPTIRAY 240 require rigorous regulatory evaluation.
3. What are the primary regions where OPTIRAY 240 is most readily available?
North America, Europe, and Asia-Pacific have the most developed supply channels, with Guerbet and regional distributors facilitating distribution.
4. How might supply chain disruptions impact clinical operations involving OPTIRAY 240?
Interruptions can delay diagnostic procedures and increase operational costs. Establishing multiple supply sources and maintaining adequate inventory minimizes such risks.
5. What role do local manufacturers play in the supply of OPTIRAY 240?
Local manufacturers often produce generic or equivalent iodinated contrast agents under license, especially in markets with import restrictions or high demand, thus enhancing regional supply security.
References
- Guerbet, "OPTIRAY 240 Specifications," Guerbet official website, 2023.
- U.S. Food and Drug Administration, "Approved Contrast Media," FDA Database, 2023.
- European Medicines Agency, "Marketing Authorization for Contrast Agents," EMA, 2023.
- World Health Organization, "Guidelines on Iodinated Contrast Media," WHO, 2022.
- Market research reports on contrast agents, IQVIA, 2023.
