Suppliers and packagers for RENOGRAFIN-76

RENOGRAFIN-76

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	RENOGRAFIN-76	diatrizoate meglumine; diatrizoate sodium	INJECTABLE;INJECTION	010040	NDA	BRACCO DIAGNOSTICS INC	0270-0149-57	10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE	1970-11-03
Bracco	RENOGRAFIN-76	diatrizoate meglumine; diatrizoate sodium	INJECTABLE;INJECTION	010040	NDA	BRACCO DIAGNOSTICS INC	0270-0149-60	10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE	1970-11-03
Bracco	RENOGRAFIN-76	diatrizoate meglumine; diatrizoate sodium	INJECTABLE;INJECTION	010040	NDA	BRACCO DIAGNOSTICS INC	0270-1410-30	10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE	1982-11-09

Suppliers for the Pharmaceutical Drug: RENOGRAFIN-76

Last updated: August 8, 2025

Introduction

Renografin-76, also known by its generic name diatrizoate meglumine and sodium—a contrast agent predominantly used in diagnostic imaging—is a vital component in radiology. Its ability to enhance the visibility of internal structures, especially in angiography, cystography, and other gastrointestinal imaging procedures, has cemented its importance in medical diagnostics. The supply chain for Renografin-76 hinges upon specialized manufacturers, distributors, and regional suppliers who can ensure quality, consistency, and regulatory compliance. This report provides an in-depth overview of key suppliers, their market positions, and strategic considerations to inform stakeholders involved in procurement, distribution, and pharmaceutical manufacturing.

Overview of Renografin-76

Renografin-76 comprises diatrizoate sodium and meglumine salts dissolved in water, with osmolarity optimized for human use, typically around 76% concentration. It is produced under stringent pharmaceutical standards, with a focus on safety and efficacy. Its production requires advanced chemical synthesis, rigorous quality controls, and compliance with international pharmacopeial standards such as the US Pharmacopeia (USP) and European Pharmacopoeia (EP).

Leading Suppliers and Manufacturers

1. Dua Pharmaceuticals (Germany)

Dua Pharmaceuticals holds a prominent position in the global contrast media market. The company specializes in the development and manufacturing of iodinated contrast agents, including diatrizoate-based products like Renografin-76. Dua’s manufacturing facilities adhere to Good Manufacturing Practices (GMP) and ISO standards, facilitating supply to European, North American, and Asian markets.

Market Highlights:

• Extensive R&D capabilities for formulation innovation
• Robust quality assurance processes
• Global distribution network

2. Guerbet Group (France)

Guerbet is a leader in contrast media, with a portfolio that includes various iodinated contrast agents. Although more renowned for products like Omnipaque (iohexol), Guerbet also supplies diatrizoate-based contrast media. Their focus on safety profiles and secure supply chains makes them a key supplier for hospitals and imaging centers worldwide.

Market Highlights:

• Wide global reach with established regional offices
• Strong regulatory compliance and transparent manufacturing processes
• Investment in sustainable production practices

3. Bracco Imaging (Italy)

Bracco is a major multinational involved in the production of contrast agents and radiopharmaceuticals. They manufacture iodinated contrast media with a focus on patient safety and innovative delivery systems. While Bracco primarily markets the non-ionic contrast agents, their manufacturing capabilities include ionic contrast media like Renografin-76.

Market Highlights:

• Extensive regional distribution in Europe and Americas
• Collaborative research with medical partners
• Strict adherence to quality standards

4. Liebel-Flarsheim (United States)

Known for its infusion and contrast media solutions, Liebel-Flarsheim supplies various ionic contrast agents, including Renografin-76, to North American markets. The company emphasizes streamlined distribution channels and advanced logistics to ensure on-time delivery.

Market Highlights:

• Part of ICU Medical since 2015
• Regulatory compliance with FDA standards
• Focus on clinical safety and innovation

5. Other Regional and Contract Manufacturers

Due to the niche nature of ionic contrast media, certain regional pharmaceutical manufacturers may produce Renografin-76 under contract manufacturing arrangements. These include manufacturers in India, China, and Eastern Europe, often supplying to local markets or through global pharmacies.

Key Consideration:

• Quality and regulatory standards vary; due diligence is crucial to verify GMP compliance.

Regulatory and Supply Chain Challenges

Ensuring a consistent supply of Renografin-76 is challenged by regulatory approvals, geopolitical factors, and manufacturing complexities. The iodinated contrast media industry faces increasing scrutiny regarding safety, environmental impact, and patient-specific contraindications, with ongoing regulatory updates impacting supply contracts and market access.

The transition toward non-ionic, lower-osmolar contrast media, driven by safety concerns, has also influenced the demand landscape, prompting suppliers to diversify portfolios. Nonetheless, ionic agents like Renografin-76 remain critical in certain clinical contexts, maintaining their place in supplier inventories.

Key Factors for Stakeholders

• Quality Assurance: Verify GMP compliance, batch consistency, and pharmacovigilance records.
• Regulatory Approval: Confirm product registration status in target markets.
• Supply Reliability: Assess supplier capacity, logistics infrastructure, and contingency plans.
• Price Competitiveness: Consider cost-efficiency without compromising quality.
• Environmental Impact: Evaluate supplier sustainability practices, particularly waste disposal and production emissions.

Emerging Trends and Strategic Insights

• Manufacturing Consolidation: Industry consolidation trends aim to enhance supply stability but may impact pricing dynamics.
• Innovation in Contrast Media: Investment in safer, lower-osmolar contrast agents is gradually shifting market preferences.
• Regional Production Expansion: Countries like India and China are expanding local manufacturing capabilities, potentially influencing global supply chains.
• Regulatory Harmonization: Streamlined approval pathways could facilitate broader market access for suppliers.

Conclusion

The supplier landscape for Renografin-76 features established global entities with proven manufacturing standards and regional producers under contract arrangements. Stakeholders must prioritize quality assurance and regulatory compliance while considering logistical and geopolitical factors that influence supply continuity. As the industry evolves toward safer contrast media, maintaining relationships with key suppliers ensures access to essential diagnostic agents.

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Key Takeaways

• Major global suppliers include Dua Pharmaceuticals, Guerbet, Bracco, and Liebel-Flarsheim, each with established manufacturing capabilities and regional distribution channels.
• Ensuring GMP compliance and regulatory approval is critical when selecting suppliers for Renografin-76.
• Regional manufacturers, especially in Asia and Eastern Europe, play vital roles, often supplying under contract manufacturing agreements.
• Industry trends indicate an ongoing shift toward non-ionic, lower-osmolar contrast agents, but ionic agents like Renografin-76 remain necessary in specific clinical scenarios.
• Due diligence on quality, regulatory status, and supply chain resilience is vital to mitigate risks associated with geopolitical and industry-specific challenges.

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FAQs

1. What are the primary regions supplying Renografin-76?
Renografin-76 is primarily supplied by manufacturers in Europe (Germany, France, Italy), North America (United States), and increasingly by Asian regional producers, notably in India and China.

2. Are there alternative contrast agents to Renografin-76?
Yes, non-ionic, low-osmolar contrast media like Iohexol (Omnipaque) and Iopamidol (Isovue) are increasingly preferred due to improved safety profiles, though ionic agents remain in use for specific indications.

3. How does regulatory approval impact supply?
Regulatory approvals govern the legal sale and distribution of Renografin-76. Changes in approval status, new regulatory requirements, or delays can disrupt supply chains or restrict access in certain markets.

4. Can regional manufacturers produce Renografin-76 to international standards?
Yes, regional manufacturers can produce to international standards if they adhere to GMP and obtain appropriate regulatory certifications, though due diligence is essential.

5. What are the future prospects for suppliers of Renografin-76?
Supply will persist due to clinical necessity, but the industry’s focus on safer contrast agents may influence demand. Suppliers investing in compliance, innovation, and supply chain robustness will remain competitive.

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Sources
[1] Pharma intelligence databases (e.g., Informa, IQVIA)
[2] Company websites and press releases (Dua Pharmaceuticals, Guerbet, Bracco, Liebel-Flarsheim)
[3] Regulatory agency documents (FDA, EMA)
[4] Industry reports on contrast media market trends