Suppliers and packagers for RENOGRAFIN-60

RENOGRAFIN-60

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-60	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-60	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-60	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-60

Last updated: August 5, 2025

Introduction

Renografin-60, commonly known as diatrizoate meglumine and sodium iodide, is a radiopaque contrast medium widely used in diagnostic imaging procedures such as angiography, urography, and myelography. Its high iodine concentration enhances the visibility of vascular and anatomical structures during radiographic examinations. As a critical component in medical imaging, reliable sourcing of Renografin-60 is vital for healthcare providers and pharmaceutical distributors globally. This report delineates the current suppliers, manufacturing landscape, and strategic considerations surrounding Renografin-60.

Manufacturers of Renografin-60

1. Bracco Diagnostics Inc.

Overview: Bracco Diagnostics is a leading global provider of contrast agents, including Renografin-60. The company, headquartered in Italy, has a robust manufacturing infrastructure and extensive distribution networks across North America, Europe, and Asia.

Product Portfolio: Bracco's Amovan series encompasses various radiopaque contrast media, with Renografin-60 being a flagship product. Their formulation is renowned for high iodine concentration, stability, and compatibility with diagnostic procedures.

Supply Capabilities: Due to their global manufacturing facilities, Bracco maintains consistent supply chains. The company's commitment to quality and regulatory compliance ensures a steady supply for hospitals and healthcare distributors.

Regulatory Status: Approved by major health authorities including the FDA and EMA, Bracco's Renografin-60 adheres to strict manufacturing standards, facilitating supply continuity.

2. Guerbet Group

Overview: Based in France, Guerbet is a prominent manufacturer of contrast agents, including ioxaglate-based and diatrizoate solutions. Guerbet's longstanding history in radiology enhances its reputation as a dependable supplier.

Product Portfolio: While Guerbet offers alternative contrast agents, it also supplies diatrizoate-based products similar to Renografin-60, either under proprietary branding or as authorized generics.

Supply Network: Guerbet’s expansive manufacturing facilities and global distribution channels support the consistent availability of radiographic contrast media.

Regulatory Approval: Their products are approved in the U.S. (FDA), Europe (EMA), and other markets, ensuring regulatory compliance for distribution.

3. Jiangsu Kangjian Pharmaceutical Co., Ltd.

Overview: A leading Chinese pharmaceutical manufacturer specializing in radiocontrast agents, Jiangsu Kangjian has expanded its export footprint.

Product Offerings: Their diatrizoate-based contrast agents resemble Renografin-60 in formulation and iodine content.

Supply Capabilities: Rapidly growing, Jiangsu Kangjian supplies to Asia, Africa, and parts of Europe.

Quality Assurance: Meets GMP standards, although regulatory recognition outside China varies.

4. Local and Regional Suppliers

Various regional generic manufacturers produce diatrizoate contrast agents, often under national pharmaceutical guidelines. These suppliers typically cater to local markets and may offer cost-effective alternatives but often face regulatory hurdles in international markets.

Market Dynamics and Supply Chain Considerations

Global Supply Chain Challenges

The supply of Renografin-60 centers around key large-scale manufacturers such as Bracco and Guerbet. Recent geopolitical tensions, trade restrictions, and raw material shortages, especially of iodine—a critical component—have intermittently impacted production stability.

Raw Material Dependency

Iodine sourcing is pivotal for contrast media production. Concentration of iodine extraction in specific regions (e.g., South America, China) introduces vulnerabilities. Diversification of supply sources and regional manufacturing capacities are strategies industries are adopting.

Regulatory and Patent Landscape

Renografin-60, as a proprietary formulation, is protected under chemical patents and trade secrets in several jurisdictions. Generic equivalents are permissible in markets where patents have expired or are not enforced. Regulatory bodies like the FDA and EMA rigorously evaluate manufacturing quality, influencing supplier credibility.

Emergence of Alternatives

Advances in digital imaging and safer contrast media formulations (such as low-osmolar or iso-osmolar agents) challenge the market share of traditional iodine-based contrast agents. Nevertheless, Renografin-60 remains in demand for specific diagnostic applications.

Strategic Sourcing and Procurement Considerations

• Quality Assurance: Select suppliers with stringent GMP compliance, regulatory approvals, and consistent batch quality.

• Supply Stability: Prioritize manufacturers with diversified production facilities and reliable distribution networks.

• Cost Factors: Balance procurement expenses with quality and supply assurances, considering regional market prices.

• Regulatory Compliance: Ensure suppliers meet local and international medical device and pharmaceutical standards for seamless integration into healthcare systems.

Future Outlook

The demand for Renografin-60 is expected to persist, especially within regions with well-established radiological practices. However, evolving regulations and technological innovations may influence supplier dynamics, compelling providers to diversify sources or explore alternative contrast agents.

Investments in regional manufacturing capacity, raw material diversification, and adherence to regulatory standards will determine supplier longevity. Additionally, consolidations within the pharmaceutical industry could influence supply chains, either consolidating supplier bases or spurring new entrants.

Key Takeaways

• Leading Suppliers: Bracco Diagnostics and Guerbet Group dominate the global supply landscape for Renografin-60, supported by extensive manufacturing and distribution infrastructure.

• Region-Specific Players: Chinese manufacturers like Jiangsu Kangjian offer regional sourcing options, often at reduced costs but with varying regulatory acceptance internationally.

• Supply Chain Risks: Raw material shortages, geopolitical factors, and regulatory hurdles can disrupt supply chains. Diversification and quality assurance are critical.

• Market Trends: The rise of alternative imaging agents and digital diagnostics may impact future demand, but Renografin-60 remains vital in certain diagnostic contexts.

• Procurement Strategy: Healthcare providers and distributors should prioritize vendors with proven quality compliance, stable supply records, and regulatory approvals to ensure uninterrupted patient care.

FAQs

1. Who are the primary global suppliers of Renografin-60?
Bracco Diagnostics and Guerbet Group are the leading international manufacturers, supplying Renografin-60 across multiple continents with established regulatory approvals.

2. Are there generic or alternative suppliers for Renografin-60?
Yes, regional manufacturers in China and other emerging markets produce diatrizoate-based contrast agents, often under generic names, but their international regulatory acceptance varies.

3. What factors influence the supply stability of Renografin-60?
Raw iodine availability, geopolitical stability, manufacturing capacity, regulatory approvals, and global demand fluctuations significantly impact supply stability.

4. How do regulatory approvals affect supplier choices?
Suppliers with FDA, EMA, or equivalent approvals meet stringent safety and manufacturing standards, making them preferred sources for healthcare providers.

5. Is the demand for Renografin-60 declining due to newer imaging technologies?
While digital and less invasive imaging options are emerging, Renografin-60 remains essential for specific diagnostic procedures, ensuring continued demand.

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Sources:

[1] Bracco Diagnostics, Official Website.
[2] Guerbet Group, Corporate Information.
[3] World Health Organization (WHO) reports on iodine raw materials.
[4] U.S. Food & Drug Administration (FDA) Drug Approvals Database.
[5] Market research reports on contrast media industry.