Suppliers and packagers for OPTIRAY 320

OPTIRAY 320

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 320	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 320	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 320	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

Suppliers for the Pharmaceutical Drug: OPTIRAY 320

Last updated: August 5, 2025

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Introduction

OPTIRAY 320 is a radiopaque contrast agent primarily used in diagnostic imaging procedures such as angiography and computed tomography (CT) scans. Its formulation contains iohexol, a non-ionic, water-soluble contrast medium renowned for its safety profile and effective imaging enhancement. Understanding the global suppliers, manufacturing sources, and distribution channels for OPTIRAY 320 is vital for healthcare providers, pharmaceutical distributors, and regulatory bodies aiming to ensure steady supply, compliance, and quality assurance.

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Overview of OPTIRAY 320

OPTIRAY 320 is marketed as a high-concentration iodine-based contrast agent, with an iodine concentration of 320 mg/mL, suitable for intravenous, intra-arterial, or other contrast-enhanced imaging procedures. The formulation's efficacy depends on stringent manufacturing standards to ensure non-toxicity, stability, and optimal imaging quality. As with other contrast agents, its supply chain involves multiple players spanning from raw material suppliers to finished product distributors.

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Major Global Suppliers and Manufacturers

1. Guerbet Group
Guerbet, headquartered in France, is a leading manufacturer of contrast agents globally. Its product portfolio includes iohexol-based contrast media, such as Optiray, which closely corresponds to the generic OPTIRAY 320. Guerbet supplies its products worldwide, adhering to ISO standards and rigorous pharmacovigilance protocols. Their global manufacturing facilities include sites in France, the UK, and the US, ensuring comprehensive distribution networks. Guerbet's dominance in this sector makes it a primary supplier for OPTIRAY 320 in many regions.

2. GE Healthcare
GE Healthcare, headquartered in the United States, produces a range of contrast agents, including Iohexol-based products under various brand names like Omnipaque. While not branded OPTIRAY 320 specifically, GE Healthcare's iohexol products are often used interchangeably, and the company serves as a significant supplier in North America, Europe, and Asia-Pacific regions.

3. Bracco Imaging
An Italy-based multinational, Bracco specializes in radiology and contrast media. Its contrast agents, such as Visipaque (iodixanol), differ in formulation from iohexol but serve similar purposes. Bracco's extensive manufacturing and distribution channels make it a notable supplier for contrast agents comparable to OPTIRAY 320 in Europe and other markets requiring high-quality, regulatory-compliant products.

4. Tianjin Beifen-Ruibang Pharmaceutical Co., Ltd.
This Chinese manufacturer supplies iohexol-based contrast media domestically and for export. Their products often meet international standards, making them a viable source for regional distributors seeking cost-effective options aligned with OPTIRAY 320’s specifications.

5. Other Regional or Local Suppliers
Numerous regional pharmaceutical manufacturers in India, South Korea, and Southeast Asia produce generic or equivalent iohexol contrast agents, which can be utilized as alternatives or supplies for OPTIRAY 320, primarily in markets with local regulatory approvals.

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Key Factors Influencing Supplier Selection

• Regulatory Approval & Compliance: The supplier must meet international standards such as the US FDA, EMA, and PIC/S guidelines, ensuring safety and efficacy.

• Manufacturing Capacity & Reliability: The ability to meet demand, especially during shortages or surges, hinges on scalable manufacturing capabilities.

• Quality Assurance & Certification: GMP compliance, batch consistency, and traceability are critical for healthcare safety and regulatory audits.

• Distribution Channels & Geographic Reach: A supplier's logistics infrastructure determines timely delivery, especially in sensitive clinical scenarios.

• Pricing & Contractual Agreements: Cost considerations, including bulk purchasing discounts and long-term procurement contracts, influence supplier relationships.

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Supply Chain Dynamics and Market Trends

The global supply of OPTIRAY 320 is influenced by factors such as raw material availability, geopolitical stability, and manufacturing regulations. Recent supply chain disruptions, notably during the COVID-19 pandemic, prompted increased reliance on regional manufacturers and prompted pharmaceutical companies to diversify their supplier base. Furthermore, the rising demand for contrast agents in emerging markets has driven investment in local manufacturing capabilities, notably in India and China.

Additionally, ongoing innovation in contrast media — including formulations with reduced adverse effects and lower iodine doses — influences the competitive landscape among suppliers, prompting existing manufacturers to optimize production and licensing agreements.

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Regulatory and Ethical Considerations

Suppliers must adhere to strict manufacturing standards approved by relevant health authorities. Countries like the US and EU require extensive documentation, stability testing, and pharmacovigilance data. Off-label or unapproved supplies pose safety risks and legal liabilities, emphasizing the importance of sourcing from verified suppliers.

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Conclusion

The primary suppliers for OPTIRAY 320 include globally established companies such as Guerbet and GE Healthcare, alongside regional manufacturers in Asia and other emerging markets. While these companies dominate the high-quality contrast media landscape, numerous local producers also supply compatible products, especially in cost-sensitive regions. Healthcare providers should prioritize sourcing from manufacturers with proven regulatory compliance, robust quality systems, and reliable distribution networks to ensure patient safety and uninterrupted clinical operations.

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Key Takeaways

• Guerbet and GE Healthcare are the top-tier global suppliers of iohexol-based contrast agents similar to OPTIRAY 320.
• Regional manufacturers, especially in Asia, provide cost-effective alternatives, broadening supply options.
• Regulatory approval, quality assurance, and reliable logistics are critical factors in supplier selection.
• Supply chain diversification reduces dependency risks amid geopolitical or pandemic-related disruptions.
• Ongoing innovation in contrast media formulations could influence future procurement strategies.

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FAQs

1. Is OPTIRAY 320 exclusively manufactured by a specific company?
No. While brands like Optiray are produced by Guerbet, generic equivalents with similar formulation and specifications are supplied by multiple manufacturers globally, including generic pharmaceutical companies in Asia and Europe.

2. Can I substitute OPTIRAY 320 with other iohexol-based contrast agents?
Yes. As long as the alternative meets the same iodine concentration (320 mg/mL), osmolarity, and regulatory standards, substitution is feasible. Always consult with a radiologist or pharmacist prior to switching brands.

3. What should I consider when sourcing OPTIRAY 320 from regional suppliers?
Ensure products have appropriate regulatory approvals, GMP compliance, clear batch documentation, and align with patient safety guidelines. Verify the supplier’s reputation and logistical capabilities for timely delivery.

4. Are there any notable supply shortages of OPTIRAY 320?
Global supply may experience fluctuations due to manufacturing disruptions, raw material shortages, or regulatory issues. Monitoring health authority communications and establishing relationships with multiple suppliers mitigate risks.

5. What future trends could impact the supply of OPTIRAY 320?
Innovations in contrast media reducing iodine doses, new formulations with better safety profiles, and increased demand in emerging markets will influence manufacturing and supply chain dynamics.

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References

1. Guerbet Group. Official Website. Available at: https://www.guerbet.com
2. GE Healthcare. Contrast Media Portfolio. Available at: https://www.gehealthcare.com
3. Bracco Imaging. Product Information. Available at: https://www.bracco.com
4. World Health Organization (WHO). Guidelines for Quality Assurance of Pharmaceuticals.
5. Market reports on Radiocontrast Media Market, 2022-2027.