Last updated: August 5, 2025
Overview of OPTIRAY 350
OPTIRAY 350 is a high-contrast, non-ionic iodinated contrast agent primarily utilized in diagnostic imaging procedures such as computed tomography (CT) scans. Its composition includes iohexol, a widely used contrast medium that enhances the visualization of vascular structures and organ perfusion, improving diagnostic accuracy.
Given its critical role in medical imaging, the procurement of OPTIRAY 350 requires sourcing from reputable suppliers that comply with stringent regulatory standards, including Good Manufacturing Practices (GMP), FDA approvals, and international pharmacopoeia compliance.
Major Manufacturers and Authorized Suppliers
The market for OPTIRAY 350 is dominated by a few key pharmaceutical companies with extensive global distribution networks. Their reputation hinges on consistent product quality, regulatory compliance, and reliable supply chains. The primary suppliers include:
1. GE Healthcare (General Electric)
Profile:
GE Healthcare is a dominant player in medical imaging and contrast agents, with a significant portfolio including iodinated contrast media like OPTIRAY 350. They manufacture iohexol-based contrast agents under strict quality controls.
Supply Channels:
- Authorized distributors globally.
- Direct supply agreements with regional healthcare providers.
Regulatory Status:
- FDA-approved, supplemented by approvals from the European Medicines Agency (EMA) and other regulators.
Distribution:
- Wide presence in North America, Europe, Asia, and emerging markets through regional subsidiaries.
2. Bayer AG
Profile:
Bayer is a globally recognized pharmaceutical entity offering various imaging diagnostics, including contrast media such as Ultravist and Visipaque. While Bayer's primary contrast product is Ultravist, they are known to supply iohexol formulations comparable to OPTIRAY 350 through authorized channels.
Supply Channels:
- Regional distributors and direct supply agreements.
Regulatory Status:
- Approved by FDA, EMA, and other health authorities.
Distribution:
- Extensive global distribution with emphasis on Europe and North America; emerging markets through local partners.
3. Guerbet Group
Profile:
Guerbet specializes in contrast agents and has a product lineup including iopamidol, iohexol, and related formulations. They supply contrast solutions for radiology and angiography.
Supply Channels:
- Distributors and regional subsidiaries.
Regulatory Status:
- Licensed products across key markets, with approvals aligning with local standards.
Distribution:
- Presence across Europe, Asia, and the Middle East, with strategic partnerships for wider reach.
Regional and Local Suppliers
Beyond major global manufacturers, several regional suppliers and authorized distributors provide OPTIRAY 350 to healthcare institutions, particularly in markets with local manufacturing capabilities or import restrictions.
4. Local Pharmaceutical Distributors
In countries like India, China, and Brazil, licensed pharmaceutical imports and local manufacturing facilities often supply generic versions or equivalent formulations of OPTIRAY 350, subject to regulatory approval. These entities emphasize price competitiveness while maintaining compliance with local standards.
5. Contract Manufacturing Organizations (CMOs)
Some pharmaceutical companies outsource the manufacturing of contrast media to CMOs that produce under strict regulatory oversight, ensuring product quality and supply stability.
Regulatory and Procurement Considerations
- Certification & Compliance: Procurement must verify Good Manufacturing Practice (GMP) compliance, Regulatory Approval (FDA, EMA, etc.), and Quality Certifications.
- Supply Chain Integrity: Given the critical nature of imaging contrast media, supply chains should ensure cold chain management and expiry date integrity.
- Pricing & Contracts: Long-term contracts with major manufacturers or authorized distributors often provide better pricing, supply security, and technical support.
- Regional Restrictions: Import regulations, licensing requirements, and local drug approvals influence the selection of suppliers.
Future Market Trends
- The shift toward non-iodinated, low-osmolar contrast agents might impact the demand and supplier landscape.
- Regional manufacturers expanding capacity could alter current supplier dominance.
- Increased regulatory scrutiny encourages procurement from suppliers with strong compliance records.
- The potential for biosimilar or generic alternatives from emerging markets may diversify sourcing options.
Key Takeaways
- Leading Suppliers: GE Healthcare, Bayer AG, and Guerbet Group stand as primary global suppliers of OPTIRAY 350, offering high-quality, regulated contrast media.
- Regional Suppliers: Local distributors in emerging markets provide alternative sourcing options but require thorough verification of regulatory compliance.
- Due Diligence: Procurement should prioritize suppliers with robust quality assurance, regulatory approvals, and reliable logistics capabilities.
- Market Dynamics: Global supply stability depends on geopolitical factors, regulatory frameworks, and the evolving landscape of contrast media technology.
- Strategic Procurement: Long-term contracts and direct relationships with authorized manufacturers ensure consistent supply and favorable pricing.
FAQs
1. Are there generic alternatives to OPTIRAY 350?
Yes, several generic iohexol-based contrast agents are available in various markets, typically produced by regional manufacturers. These must meet regulatory standards to ensure safety and efficacy.
2. What should healthcare providers consider when sourcing OPTIRAY 350?
Procurement should focus on regulatory approval, supply chain reliability, product integrity, and compliance with local health authorities’ standards.
3. How does regulatory approval impact supplier selection?
Suppliers with approved manufacturing sites and active regulatory licenses ensure product safety, quality, and legal compliance, mitigating risks of substandard or counterfeit products.
4. Are there risks associated with regional or local suppliers?
Yes. These include potential quality disparities, supply chain interruptions, and regulatory non-compliance. Due diligence and certification verification are essential.
5. What are emerging trends influencing OPTIRAY 350 suppliers?
Developments include the rise of biosimilar contrast agents, regional manufacturing capacity expansion, and increasing regulatory oversight, all of which influence supply dynamics.
References:
- [1] GE Healthcare Product Portfolio. (2023). GE Healthcare Official Website.
- [2] Bayer AG Medical Imaging Solutions. (2023). Bayer Official Website.
- [3] Guerbet Group Product Information. (2023). Guerbet Official Website.
- [4] Regulatory Standards for Contrast Media. U.S. FDA, EMA guidelines.
- [5] Market Trends in Diagnostic Imaging Agents. Industry Reports, 2022-2023.
