Suppliers and packagers for OPTIRAY 300

OPTIRAY 300

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710	NDA	Liebel-Flarsheim Company LLC	0019-1323-00	20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-00) / 100 mL in 1 SYRINGE, PLASTIC	2012-03-04
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710	NDA	Liebel-Flarsheim Company LLC	0019-1323-02	25 VIAL, GLASS in 1 CARTON (0019-1323-02) / 20 mL in 1 VIAL, GLASS	2012-03-04
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710	NDA	Liebel-Flarsheim Company LLC	0019-1323-04	25 VIAL, GLASS in 1 CARTON (0019-1323-04) / 30 mL in 1 VIAL, GLASS	2012-03-04
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710	NDA	Liebel-Flarsheim Company LLC	0019-1323-06	25 BOTTLE, GLASS in 1 CARTON (0019-1323-06) / 50 mL in 1 BOTTLE, GLASS	2012-03-04

Suppliers for the Pharmaceutical Drug: OPTIRAY 300

Last updated: August 5, 2025

Introduction

OPTIRAY 300, a contrast agent used primarily in medical imaging procedures such as angiography and venography, is a critical pharmaceutical product supplied by specialized manufacturers. As an iodine-based contrast medium, its role in facilitating high-resolution imaging makes it indispensable in diagnostic radiology. The supply chain for OPTIRAY 300 involves a niche group of pharmaceutical and medical device companies that produce and distribute iodine-based contrast agents globally. This article provides a comprehensive overview of key suppliers, analyzing their market positioning, regulatory compliance, and strategic importance.

Overview of OPTIRAY 300 and Market Context

OPTIRAY 300 is a non-ionic, low-osmolar iodine contrast agent manufactured for intravenous administration, distinguished by its high iodine concentration (300 mg/mL). It facilitates enhanced visualization of blood vessels and organs, improving diagnostic accuracy and patient outcomes. The global demand for contrast agents like OPTIRAY 300 is driven by the expanding prevalence of cardiovascular diseases, advances in imaging technology, and increasing adoption of minimally invasive procedures requiring high-contrast imaging.

The market for contrast media is competitive, with regional variances in supplier dominance influenced by regulatory approval, production capacity, and distribution networks. Major players often operate under strict regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and corresponding authorities worldwide, which influence supply stability and market access.

Key Suppliers of OPTIRAY 300

1. Bracco Imaging S.p.A.

Market Position & Capabilities:
Bracco, headquartered in Milan, Italy, is a global leader in the contrast media segment. Its broad portfolio includes Omnipaque, a prominent non-ionic, iodine-based contrast agent similar to OPTIRAY 300. Bracco’s manufacturing facilities are equipped with advanced technology ensuring high-quality production adhering to Good Manufacturing Practices (GMP).

Product Portfolio & Supply Chain:
While Bracco’s primary products are branded under Omnipaque, the company has historically supplied various iodine contrast agents with comparable specifications, including OPTIRAY. They operate regional manufacturing plants across Europe, North America, and Asia, enabling a robust supply chain.

Regulatory & Distribution:
Bracco’s global regulatory approval coverage simplifies the supply of OPTIRAY 300 across multiple territories. Their established distribution channels provide dependable supply, especially in North America and Europe, where they serve both hospital and outpatient imaging centers.

2. Guerbert, a Part of Guerbet Group

Market Position & Capabilities:
Guerbet, based in France, is a key player in the contrast media industry, offering a variety of iodine-based agents, including products comparable to OPTIRAY 300. Their focus on innovative formulation and safety features positions them as a strategic supplier.

Product Portfolio & Supply Chain:
Guerbet’s portfolio includes Lipiodol and other iodinated contrast media. The company’s manufacturing capabilities align with high-volume demand and regulatory standards, ensuring consistent supply. Their global footprint extends to manufacturing sites and distribution centers in Europe, Asia, and the Americas.

Regulatory & Distribution:
Guerbet maintains an extensive regulatory dossier, facilitating rapid approval processes. Their distribution partnerships ensure timely delivery for hospitals and imaging centers worldwide.

3. Bayer Healthcare (Now part of Siemens Group)

Market Position & Capabilities:
Historically, Bayer was a prominent manufacturer of contrast agents like Ultravist, a non-ionic iodine-based contrast medium. Following strategic restructuring, Bayer’s imaging contrast products are now integrated via collaborations within Siemens Healthineers.

Product & Supply Considerations:
Bayer’s longstanding reputation for quality and clinical testing supports their role in supplying high-quality contrast media. Although Bayer’s direct production of OPTIRAY 300 is limited, similar products are included in the supply ecosystem.

4. Pfizer Inc.

Market Position & Capabilities:
Pfizer has expanded its portfolio to include contrast agents, particularly focusing on innovations in both ionic and non-ionic agents. Their global manufacturing footprint and clinical research strength position them as significant players in the contrast media market, including potential supply of OPTIRAY 300 equivalents.

Supply Network & Distribution:
Pfizer’s extensive distribution channels, especially in North America and Europe, support drug availability and rapid delivery, though their direct role in OPTIRAY 300 supply remains limited and often as part of broader contrast agent offerings.

5. Local/Niche Manufacturers and Licensed Distributors

In addition to global giants, regional companies and authorized distributors supply OPTIRAY 300 in specific territories. These firms often operate under licensing agreements or import arrangements and provide critical roles in ensuring market availability, especially in markets with stringent regulatory hurdles or limited local manufacturing capacity.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Strict regulations influence manufacturing licenses, batch testing, and distribution. Companies must maintain GMP compliance, which affects production continuity.

• Manufacturing Capacity: Limited production facilities specialized in iodine contrast media lead to dependency on key suppliers, risking supply disruptions if unforeseen events occur.

• Distribution Networks: Geographical restrictions, customs, and import/export regulations impact timely delivery. Suppliers with extensive international logistics capabilities are better positioned to meet demand fluctuations.

• Pricing and Reimbursement Dynamics: Variations in healthcare reimbursement policies influence the procurement choices of hospitals and clinics, impacting supplier competitiveness.

Future Market Trends and Supplier Strategies

The contrast media market is experiencing shifts towards more sustainable, lower-osmolar, and macrocyclic iodine-based agents, including even non-iodine options in some applications. Suppliers are investing in research to develop safer, more effective contrast agents, which could influence the demand for OPTIRAY 300 specifically.

Strategic alliances, joint ventures, and regional manufacturing expansion are likely to enhance supply resilience. For instance, global suppliers investing in production capacity in Asia-Pacific will target regions with rapidly growing healthcare infrastructure.

Additionally, regulatory harmonization efforts facilitate smoother approval pathways, increasing supply stability. Companies that proactively align with evolving standards will position themselves favorably in providing OPTIRAY 300.

Conclusion

The supply of OPTIRAY 300 hinges on a small, specialized set of global pharmaceutical companies and regional distributors. Bracco Imaging and Guerbet are front-runners, offering extensive manufacturing and distribution networks that support broad availability. Bayer, Pfizer, and other firms contribute to the competitive landscape, contingent upon regional regulatory approvals and manufacturing capacities.

Business professionals seeking to secure reliable supply chains for OPTIRAY 300 should prioritize relationships with established, GMP-compliant suppliers that demonstrate global regulatory approval and resilient distribution networks. Navigating regulatory landscapes and monitoring market trends will be crucial in maintaining supply continuity and optimizing procurement strategies.

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Key Takeaways

• Major Suppliers: Bracco and Guerbet dominate the global supply of OPTIRAY 300, supported by extensive manufacturing and distribution capabilities.
• Regulatory Landscape: Compliance with international standards is pivotal for supply stability; suppliers with proven regulatory approvals are preferable.
• Supply Chain Risks: Limited manufacturing capacity, regulatory hurdles, and logistical complexities pose risks; diversification among reputable suppliers mitigates these.
• Market Trends: Emphasis on safer, lower-osmolar contrast agents and regional manufacturing investments influences future supply dynamics.
• Strategic Engagement: Long-term partnerships with leading suppliers will ensure consistent access to OPTIRAY 300 amid evolving healthcare demands.

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FAQs

1. How can I verify the authenticity and regulatory approval of OPTIRAY 300 from suppliers?
Always source from suppliers with validated regulatory approvals from agencies like the FDA or EMA. Request certification, batch testing reports, and verify approval numbers to ensure authenticity and compliance.

2. Are there regional differences in OPTIRAY 300 supply availability?
Yes. While global heavyweight suppliers like Bracco and Guerbet provide worldwide distribution, regional regulatory requirements and manufacturing licenses influence local availability. Local distributors are essential in regions with strict import regulations.

3. What supply risks should healthcare providers be aware of regarding OPTIRAY 300?
Risks include manufacturing disruptions, regulatory delays, logistical issues, or sudden demand spikes. Maintaining relationships with multiple reputable suppliers mitigates these risks.

4. How is the supplier landscape evolving for contrast media like OPTIRAY 300?
Innovation focuses on safety and efficacy, with investments in lower-osmolar, macrocyclic, and non-iodine contrast agents. Suppliers are also expanding regional manufacturing to enhance supply resilience.

5. What criteria should procurement teams consider when selecting an OPTIRAY 300 supplier?
Ensure supplier compliance with GMP, international regulatory approvals, reliable logistics, capacity to meet demand, and a track record of quality assurance.

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Sources

1. European Medicines Agency. "Guideline on contrast media." EMA, 2021.
2. Bracco Imaging. "Corporate Profile and Product Portfolio." Bracco Official Website, 2023.
3. Guerbet Group. "Contrast Media Portfolio." Guerbet Official Website, 2023.
4. U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations." FDA, 2022.
5. MarketResearch.com. "Global Contrast Media Market Report." 2022.