Suppliers and packagers for LIPIODOL

LIPIODOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Guerbet	LIPIODOL	ethiodized oil	OIL;INTRALYMPHATIC, INTRAUTERINE	009190	NDA	Guerbet LLC	67684-1901-1	1 AMPULE in 1 CARTON (67684-1901-1) / 10 mL in 1 AMPULE	2014-03-21
Guerbet	LIPIODOL	ethiodized oil	OIL;INTRALYMPHATIC, INTRAUTERINE	009190	NDA	Guerbet LLC	67684-1901-2	1 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIAL	2014-03-21

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: Lipiodol

Introduction
Lipiodol, an iodine-based radiopaque contrast agent, is predominantly utilized in diagnostic imaging, interventional radiology, and, in certain cases, as an adjunct in therapeutic procedures. Due to its specialized composition and medical application, sourcing Lipiodol involves navigating a tightly regulated pharmaceutical supply chain characterized by limited global manufacturers and strict compliance standards. This article provides a comprehensive overview of the key suppliers, their manufacturing capabilities, and factors influencing procurement decisions within the Lipiodol marketplace.

Overview of Lipiodol
Lipiodol, or Ethiodol, was developed in the early 20th century and has since become a critical component in hepatic chemoembolization, lymphangiography, and other vascular imaging interventions. The compound’s unique ability to selectively localize in certain tissues and its radiopacity make it indispensable. Given its nature as a pharmaceutical requiring regulatory approval, suppliers must adhere to Good Manufacturing Practice (GMP) standards, ensuring safety, efficacy, and quality.

Major Suppliers and Manufacturers of Lipiodol

1. Guerbet Group
Guerbet, a global leader in contrast agents, is the primary manufacturer of Lipiodol. Founded in 1920 and headquartered in France, Guerbet holds extensive patents and manufacturing rights for Lipiodol, marketed under various brand names. Its lipiodol product line is distinguished by rigorous quality control, compliance with international standards, and ongoing innovation. Guerbet’s facilities are GMP-certified, and the company maintains a robust distribution network, supplying Lipiodol to over 130 countries.

2. IMBIOS (Imaging Biosciences)
IMBIOS, a healthcare company specializing in diagnostic agents, occasionally sources Lipiodol or similar iodinated oils through partnerships or authorized distribution channels. While not a primary manufacturer, IMBIOS plays a role in regional distribution, particularly in North America. The company emphasizes adherence to regulatory mandates and supply chain security, providing certified products aligned with healthcare provider standards.

3. Local and Regional Suppliers
Certain regional pharmaceutical distributors and chemical suppliers offer Lipiodol through authorized channels, especially in emerging markets where direct importation may be complex. These vendors typically source from primary manufacturers like Guerbet under strict licensing agreements. It is crucial for buyers to verify certificates of analysis (CoA), Good Distribution Practice (GDP) compliance, and regulatory approvals to ensure product integrity.

Supply Chain Dynamics and Regulatory Considerations

Regulatory Oversight and Compliance
The supply of Lipiodol is governed by strict regulatory frameworks established by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and national health authorities. Manufacturers must obtain marketing authorization, and suppliers must maintain traceability and quality records. Variations in regional approvals influence the availability and distribution channels of Lipiodol.

Manufacturing Concentration and Dependence
The global supply chain for Lipiodol exhibits significant concentration, with Guerbet dominating the market. This consolidation raises concerns about supply security, especially amid geopolitical fluctuations, regulatory shifts, or manufacturing disruptions. Diversification of suppliers remains a strategic consideration for healthcare providers.

Quality Assurance and Certification
Suppliers must provide documented compliance with GMP standards, certification of sterilization processes, and test results confirming iodine concentration, viscosity, and particulate matter. International standards such as ISO 13485 further underpin quality assurance mechanisms.

Emerging Market Trends and Challenges

Supply Chain Resilience
Recent disruptions, including the COVID-19 pandemic, have underscored the importance of resilient supply chains. Some regions have faced shortages due to limited manufacturing capacity and export restrictions, emphasizing the need for diversified sourcing strategies.

Regulatory Harmonization
Global efforts toward harmonizing regulatory standards aim to streamline approval processes but can also introduce delays. Suppliers investing in robust regulatory compliance are better positioned to meet market demands consistently.

Pricing and Market Competition
Lipiodol’s pricing is impacted by manufacturing costs, regulatory fees, and market demand. The limited supply base enhances the bargaining power of primary manufacturers, influencing procurement budgets for healthcare institutions.

Future Outlook

Innovation and New Formulations
While Lipiodol remains a standard, ongoing research explores alternative contrast agents and embolization materials. However, Lipiodol’s entrenched clinical role suggests stable demand for the foreseeable future. Manufacturers investing in innovative delivery methods and formulations could influence future supplier dynamics.

Potential for Market Entry
Barriers to new manufacturers include strict regulatory requirements and high capital investment. Nonetheless, emerging pharmaceutical companies with expertise in iodinated compounds could eventually challenge current supply dominance, especially in regions with evolving healthcare infrastructure.

Key Factors for Buyers

• Verification of Regulatory Compliance: Ensure suppliers hold valid GMP certifications and requisite local approvals.
• Supply Chain Security: Diversify sources to mitigate risks related to manufacturing disruptions.
• Quality Assurance: Request comprehensive testing data, stability reports, and certificates upon procurement.
• Cost Management: Engage in bulk purchasing agreements where feasible to reduce costs and ensure priority access.
• Stay Informed on Regulatory Changes: Monitor regional regulatory updates affecting Lipiodol approvals and import/export restrictions.

Conclusion
The global supply of Lipiodol hinges predominantly on Guerbet, with regional distributors supplementing availability in various markets. Given the therapeutic importance and regulatory sensitivity surrounding this contrast agent, procurement strategies must prioritize quality, compliance, and supply chain resilience. As the market stabilizes and regulatory landscapes evolve, stakeholders should remain vigilant to emerging suppliers and innovative alternatives to ensure consistent access to this vital diagnostic and therapeutic tool.

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Key Takeaways

• Guerbet remains the primary global supplier of Lipiodol, controlling extensive manufacturing and distribution channels.
• Due to market concentration, supply chain resilience and supplier diversification are critical for healthcare providers.
• Regulatory compliance, including GMP certification and regional approvals, is essential in sourcing Lipiodol.
• Regional suppliers and distributors fill supply gaps but require careful verification for quality assurance.
• Market developments such as regulatory harmonization and technological innovation could reshape the Lipiodol landscape in coming years.

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FAQs

1. Who are the main global manufacturers of Lipiodol?
Guerbet is the principal manufacturer and supplier of Lipiodol worldwide, with other regional distributors providing localized access.

2. What regulatory standards must Lipiodol suppliers meet?
Suppliers must comply with GMP standards, obtain appropriate regional approvals, and provide detailed quality certifications for safety and efficacy.

3. Are there alternative contrast agents to Lipiodol?
While alternative agents exist, Lipiodol’s unique properties, especially in embolization procedures, make it the preferred choice in specific applications.

4. How can healthcare providers mitigate supply risks for Lipiodol?
By diversifying suppliers, maintaining strategic stockpiles, and engaging in long-term procurement agreements, providers can enhance supply security.

5. What future trends could impact Lipiodol supply?
Emerging formulations, regulatory shifts, and potential market entrants could influence sourcing options and pricing dynamics in the coming years.

Sources
[1] Guerbet Corporate Website. Lipiodol Product Information.
[2] U.S. Food and Drug Administration (FDA) – Drug Approvals and Regulatory Guidance.
[3] European Medicines Agency (EMA) – Centralized Procedure for Contrast Agents.
[4] International Organization for Standardization (ISO) – Standards for Medical Devices and Pharmaceuticals.