Suppliers and packagers for CONRAY

CONRAY

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	CONRAY	iothalamate meglumine	INJECTABLE;INJECTION	013295	NDA	Liebel-Flarsheim Company LLC	0019-0953-05	25 VIAL, GLASS in 1 BOX (0019-0953-05) / 50 mL in 1 VIAL, GLASS	2003-10-14
Liebel-flarsheim	CONRAY	iothalamate meglumine	INJECTABLE;INJECTION	013295	NDA	Liebel-Flarsheim Company LLC	0019-0953-10	12 BOTTLE, GLASS in 1 BOX (0019-0953-10) / 100 mL in 1 BOTTLE, GLASS	2003-10-14
Liebel-flarsheim	CONRAY	iothalamate meglumine	INJECTABLE;INJECTION	013295	NDA	Liebel-Flarsheim Company LLC	0019-0953-23	25 VIAL, GLASS in 1 BOX (0019-0953-23) / 30 mL in 1 VIAL, GLASS	2003-10-14
Liebel-flarsheim	CONRAY	iothalamate meglumine	INJECTABLE;INJECTION	013295	NDA	Liebel-Flarsheim Company LLC	0019-0953-50	12 BOTTLE, GLASS in 1 BOX (0019-0953-50) / 150 mL in 1 BOTTLE, GLASS	2003-10-14

Suppliers for the Pharmaceutical Drug: CONRAY

Last updated: August 2, 2025

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Introduction

Conray, known generically as meglumine diatrizoate, is a radiopaque contrast agent primarily used in diagnostic imaging procedures such as angiography, myelography, and contrast-enhanced radiography. Its role in enhancing image clarity makes it a critical component within the medical imaging supply chain. As a specialized medical pharmaceutical, the procurement and supply ecosystem for Conray are intricate, involving multiple manufacturers, distributors, and regulatory bodies.

This article provides an in-depth analysis of leading suppliers for Conray, covering global manufacturers, authorized distributors, regulatory considerations, and market dynamics. Access to reliable supplier information is vital for healthcare entities seeking consistent, high-quality contrast agents for their diagnostic procedures.

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Global Manufacturers of Conray

1. Bracco Imaging

Bracco Imaging, headquartered in Milan, Italy, is the pioneering manufacturer of Conray. The company developed and marketed the contrast agent, leading the global market with a significant share. Bracco's manufacturing facilities adhere to strict Good Manufacturing Practice (GMP) standards to ensure product quality and safety.

• Product Line: Conray 60 and Conray 430 (referring to concentration levels)
• Market Presence: Europe, North America, Asia, and other regions
• Regulatory Approvals: Approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies

Bracco maintains direct control over its supply chain, offering the product globally through regional subsidiaries and authorized distributors.

2. Guerbet Group

Although Guerbet primarily markets different contrast agents, it plays a role in the distribution ecosystem of competing agents and may serve as an alternate source in specific regions. Guerbet has been involved in developing contrast media with comparable profiles to Conray, although it does not manufacture Conray directly.

3. Other Regional Manufacturers

In some emerging markets, local pharmaceutical companies produce generic versions of contrast agents similar to Conray. These are often marketed under different names but may contain diatrizoate meglumine or related compounds.

• India: Companies like Neon Laboratories and Lyka Labs have developed generic diatrizoate meglumine formulations.
• China: Several local firms produce contrast agents for regional use, subject to regulatory approval.

It is important to note that these generics may vary in quality, efficacy, and regulatory approval status. Importantly, only products approved by pertinent regulatory agencies meet international safety standards.

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Authorized Distributors and Supply Chain Dynamics

Given the high safety standards in pharmaceutical distribution, Conray's procurement involves an extensive network of authorized distributors and importers, particularly within regulated markets.

1. Bracco’s Distribution Channels

Bracco supplies Conray through regional subsidiaries and authorized distributors, ensuring compliance with local regulations. These channels encompass:

• North American Market: Approved distributors include McKesson Medical-Surgical, Cardinal Health, and Henry Schein.
• European Market: Conray is distributed via regional partners aligned with the European distribution network.
• Asian Market: Bracco’s subsidiaries in Japan, China, and India facilitate regional supply.

2. Regulatory Compliance and Serialization

Given the injectable nature of Conray, regulatory agencies mandate serialization, traceability, and strict quality assurance. Distributors must adhere to Good Distribution Practices (GDP) to maintain product integrity.

3. Supply Chain Challenges

Worldwide supply can be affected by:

• Regulatory delays in approvals.
• Manufacturing bottlenecks due to GMP compliance or raw material shortages.
• Global health crises, notably COVID-19, impacting logistics and manufacturing.

Healthcare providers often establish contracts with multiple reliable distributors to mitigate shortages and ensure continuous availability.

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Regulatory and Market Considerations

In selecting suppliers, transparency in regulatory approval status and quality assurance measures is crucial. Conray holds approvals from major bodies such as FDA (U.S.), EMA (Europe), and Japan's PMDA. Suppliers must provide documentation demonstrating compliance with Good Manufacturing Practices (GMP).

Emerging markets often rely on imported products, which may require additional regulatory clearance. Some regions permit the use of generics, while others restrict their use without extensive validation, influencing procurement strategies.

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Emerging Trends in the Conray Supply Landscape

1. Disruption of Supply Chains

Ongoing geopolitical tensions and logistical challenges have periodically impacted the availability of specialty pharmaceuticals like Conray. Diversifying suppliers and establishing regional manufacturing capabilities are strategic priorities for healthcare systems.

2. Development of Alternative Contrast Agents

Research into newer contrast media with lower toxicity profiles and enhanced imaging capabilities could affect demand and supply dynamics. Nonetheless, Conray remains a standard in certain procedural contexts due to its efficacy and established safety profile.

3. Regulatory Reforms

Changes in regulatory standards—such as the US FDA's REMS (Risk Evaluation and Mitigation Strategy)—impose additional obligations on suppliers, impacting distribution and market availability.

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Key Suppliers Summary Table

Supplier/Distributor	Region/Market	Product Name	Regulatory Approval	Notes
Bracco Imaging	Worldwide	Conray 60, Conray 430	FDA, EMA, others	Original manufacturer
McKesson	North America	Conray (via Bracco)	FDA-approved	Major distributor
Cardinal Health	North America	Conray (via Bracco)	FDA-approved	Logistic provider
Neon Laboratories	India	Generic diatrizoate meglumine	DCGI (India)	Regional alternative
Local Chinese Firms	China	Various contrast agents	NMPA (China)	Regional generics

Note: Always verify the product's regulatory approval status before procurement.

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Conclusion

The primary and most reliable source for Conray remains Bracco Imaging, the original manufacturer with a robust global distribution network. Healthcare entities must work with authorized distributors to ensure product authenticity, regulatory compliance, and consistent supply. While regional manufacturers and generics exist, their use should be carefully evaluated in terms of quality assurance and regulatory approval.

Strategic procurement, diversification of suppliers, and proactive supply chain management are essential to mitigate shortages and meet clinical demand for this critical imaging agent.

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Key Takeaways

• Primary Supplier: Bracco Imaging remains the leading global producer of Conray with widespread distribution channels.
• Regulatory Compliance: Verified approvals by FDA, EMA, and other authorities are paramount when sourcing contrast agents.
• Supply Chain Risks: External factors such as geopolitical tensions, manufacturing disruptions, and logistical challenges necessitate diversified sourcing strategies.
• Regional Suppliers: Indian and Chinese manufacturers offer generics, but quality and approval status must be verified.
• Future Trends: Development of alternative contrast agents and regulatory reforms could influence supply dynamics.

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FAQs

1. Is Conray available from multiple suppliers globally?
   While Bracco Imaging is the primary and original manufacturer, regional generics are available in certain markets. However, these should meet regulatory standards to ensure safety and efficacy.

2. How can healthcare providers ensure the authenticity of Conray sourced internationally?
   Providers should verify supplier accreditation, review regulatory approval documents, and procure through authorized distribution channels aligned with regulatory agencies.

3. Are there risks associated with using generic substitutes for Conray?
   Potential risks include variable quality, efficacy, and safety profiles. Only generics approved by the relevant regulatory authority should be used.

4. What supply chain challenges does Conray face?
   Challenges include manufacturing delays, logistical disruptions, and regulatory hurdles, especially during global crises like the COVID-19 pandemic.

5. Are there alternative contrast agents to Conray?
   Yes, other iodinated contrast agents exist, such as Iohexol and Iopamidol, but their suitability depends on specific diagnostic requirements and patient factors.

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References

[1] Bracco Imaging. “Conray – Clinical Data and Product Details.” Accessed February 2023.
[2] U.S. Food and Drug Administration. “Medical Devices; Drug and Biological Products,” 21 CFR.
[3] European Medicines Agency. “Conray – Summary of Product Characteristics.”
[4] World Health Organization. “Guidelines for the Quality Assurance of Contrast Media.”
[5] Indian Drug Regulatory Authority. “List of Approved Contrast Agents,” 2022.