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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report analyzes the global supply landscape for Lipiodol, a radiopaque contrast agent. Key suppliers, regulatory considerations, and market dynamics are detailed to inform strategic R&D and investment decisions.

Who are the Primary Manufacturers of Lipiodol?

The primary manufacturer and originator of Lipiodol is Guerbet, a French pharmaceutical company specializing in contrast agents. Guerbet holds extensive intellectual property and manufacturing expertise related to Lipiodol. The drug's active pharmaceutical ingredient (API) is iodized poppy seed oil.

Guerbet's Manufacturing and Distribution

Guerbet manufactures Lipiodol at its facility located in Aulnay-sous-Bois, France. This facility adheres to strict Good Manufacturing Practices (GMP) as required by regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Product Naming: Lipiodol is marketed under various brand names globally, including Lipiodol Ultra-Fluid and Lipiodol.
API Sourcing: The sourcing of poppy seeds for iodization is a critical component of Guerbet's supply chain. The quality and origin of these seeds directly impact the API's specifications and final product efficacy.

Regional Availability and Market Presence

Lipiodol is registered and available in numerous countries across North America, Europe, Asia, and other regions. Guerbet manages its distribution network through regional subsidiaries and strategic partnerships with local pharmaceutical distributors.

United States: Lipiodol Ultra-Fluid is FDA-approved for use in hysterosalpingography and lymphography [1]. Its availability in the U.S. is primarily through Guerbet's U.S. operations and selected distributors.
Europe: Lipiodol has a long-standing presence in European markets, utilized in various interventional radiology procedures, including chemoembolization for liver cancer.
Asia-Pacific: Guerbet actively markets Lipiodol in key Asian countries, often through local pharmaceutical partners.

What are the Regulatory Approvals and Compliance Requirements for Lipiodol?

Regulatory approvals for Lipiodol are essential for its market access and continued supply. These approvals vary by country and are overseen by national health authorities.

Key Regulatory Agencies and Their Roles

U.S. Food and Drug Administration (FDA): The FDA grants marketing authorization for drugs sold in the United States. Lipiodol Ultra-Fluid has received FDA approval for specific indications. Manufacturers must comply with FDA regulations regarding manufacturing, labeling, and post-market surveillance.
European Medicines Agency (EMA): For the European Union, the EMA plays a central role in the authorization of medicines. Lipiodol is authorized for use in EU member states. Compliance with EMA guidelines, including those on pharmacovigilance and manufacturing quality, is mandatory.
Other National Agencies: Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA) are examples of other national regulatory bodies that review and approve pharmaceuticals like Lipiodol.

Compliance in Manufacturing

Adherence to Current Good Manufacturing Practices (cGMP) is a cornerstone of pharmaceutical supply.

cGMP Standards: Guerbet's manufacturing facility must consistently meet cGMP requirements, ensuring the identity, strength, quality, and purity of Lipiodol. This includes rigorous process validation, quality control testing, and documentation.
API Quality: The quality of the iodized poppy seed oil API is paramount. Suppliers of poppy seeds and the process of iodization are subject to stringent quality controls and regulatory scrutiny.

Post-Market Surveillance and Pharmacovigilance

Regulatory bodies require ongoing monitoring of drug safety and efficacy after market approval.

Adverse Event Reporting: Manufacturers are obligated to report adverse events associated with Lipiodol to regulatory authorities. This contributes to the understanding of the drug's safety profile in real-world clinical practice.
Product Quality Monitoring: Regular quality testing and stability studies are conducted to ensure that Lipiodol remains within its specified quality parameters throughout its shelf life.

What are the Market Dynamics and Competitive Landscape for Lipiodol?

The market for Lipiodol is characterized by a proprietary formulation and limited direct competition for its specific applications. However, advancements in interventional radiology and emerging alternative therapies present indirect competitive pressures.

Guerbet's Market Dominance

As the originator and sole approved manufacturer of Lipiodol, Guerbet holds a near-monopoly in its specific market segment. This dominance is a result of:

Patent Protection: While initial patents may have expired, Guerbet has maintained strong market positioning through ongoing product innovation, regulatory exclusivity, and established distribution channels.
Specialized Application: Lipiodol's unique formulation of iodized poppy seed oil has established therapeutic niches, particularly in embolization therapies for liver tumors.

Indirect Competition and Alternatives

While direct generic competition for Lipiodol is limited due to its proprietary nature and complex manufacturing, alternative approaches exist for some of its indications:

Other Radiopaque Agents: For general imaging purposes, a variety of other iodinated or gadolinium-based contrast agents are available. However, these do not replicate the embolic properties of Lipiodol.
Newer Embolization Technologies: Advances in interventional radiology are leading to the development of alternative embolic agents and techniques, such as drug-eluting beads and microspheres, which may offer different therapeutic profiles or improved targeting for certain conditions.
Systemic Therapies: For liver cancer, systemic treatments like immunotherapy and targeted therapy are evolving and may reduce the reliance on localized embolization techniques for some patient populations.

Factors Influencing Market Growth

Oncology Trends: The increasing incidence of liver cancer and other malignancies where embolization is a treatment option drives demand for Lipiodol.
Interventional Radiology Adoption: The expanding use of minimally invasive interventional radiology procedures globally supports the market for specialized agents like Lipiodol.
Reimbursement Policies: Healthcare reimbursement policies for interventional procedures significantly impact the adoption and accessibility of Lipiodol.

What are the Supply Chain Risks and Mitigation Strategies?

The concentrated nature of Lipiodol's supply chain presents specific risks that necessitate proactive mitigation strategies.

Key Supply Chain Risks

Single-Source Dependency: Reliance on a single manufacturer, Guerbet, creates vulnerability. Any disruption to Guerbet's manufacturing operations, such as facility issues, raw material shortages, or regulatory enforcement actions, could lead to widespread product shortages.
Raw Material Volatility: The sourcing of poppy seeds is subject to agricultural variability, geopolitical factors, and potential contamination risks. Fluctuations in supply or quality of poppy seeds can impact API production.
Regulatory Hurdles: Changes in regulatory requirements, increased scrutiny of manufacturing processes, or unexpected withdrawal of approvals in key markets could disrupt supply.
Geopolitical Instability: The global nature of pharmaceutical supply chains means that geopolitical events, trade disputes, or natural disasters in regions relevant to manufacturing or raw material sourcing can pose risks.

Mitigation Strategies

Inventory Management: Maintaining adequate safety stock levels of Lipiodol at regional distribution centers and key healthcare facilities is crucial to buffer against short-term supply interruptions.
Diversification of Sourcing (Where Possible): While direct manufacturing cannot be easily diversified for Lipiodol itself, vigilance in diversifying suppliers for critical excipients or packaging materials can enhance overall supply chain resilience.
Robust Quality Control: Implementing stringent quality control measures at every stage of the supply chain, from raw material sourcing to finished product distribution, helps to prevent quality-related disruptions.
Regulatory Intelligence: Continuous monitoring of regulatory landscapes and proactive engagement with health authorities can help anticipate and address potential compliance challenges.
Supply Chain Transparency: Enhancing transparency throughout the supply chain, including deeper visibility into raw material origins and manufacturing processes, aids in identifying and addressing potential vulnerabilities.
Contingency Planning: Developing and regularly testing contingency plans for scenarios such as manufacturing outages or raw material shortages is essential. This includes identifying potential alternative logistics providers or emergency supply protocols.

Key Takeaways

Guerbet is the sole primary manufacturer of Lipiodol, holding exclusive rights and manufacturing capabilities for this specialized contrast agent. Regulatory approvals are country-specific, with stringent GMP compliance required by bodies like the FDA and EMA. The market is characterized by Guerbet's dominance, with indirect competition arising from alternative embolization technologies and systemic therapies. Key supply chain risks include single-source dependency and raw material volatility, necessitating strategies such as robust inventory management, rigorous quality control, and proactive regulatory engagement.

Frequently Asked Questions

Are there generic versions of Lipiodol available? No, due to its proprietary formulation and complex manufacturing process, there are no direct generic versions of Lipiodol available. Guerbet holds exclusive manufacturing and marketing rights.
What are the primary indications for Lipiodol? Lipiodol is used in various medical procedures, including hysterosalpingography, lymphography, and as an agent in chemoembolization for liver cancer treatment. Its specific approved indications vary by region.
What is the active pharmaceutical ingredient in Lipiodol? The active pharmaceutical ingredient in Lipiodol is iodized poppy seed oil, a radiopaque oil derived from poppy seeds.
Can other companies manufacture Lipiodol? Currently, Guerbet is the exclusive manufacturer of Lipiodol. Any company seeking to manufacture Lipiodol would require licensing agreements or face significant patent challenges.
How does Guerbet ensure the quality of its poppy seed oil supply? Guerbet employs rigorous quality control measures for its poppy seed sourcing, including supplier qualification, testing for contaminants, and adherence to specific agricultural and processing standards to ensure the quality of the iodized poppy seed oil API.

Cited Sources

[1] U.S. Food and Drug Administration. (n.d.). Lipiodol Ultra-Fluid prescribing information. Retrieved from [FDA Database or official product website if a direct link is available and stable]

Suppliers and packagers for lipiodol

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Lipiodol Supply Chain Analysis