Suppliers and packagers for generic pharmaceutical drug: GADOTERATE MEGLUMINE

GADOTERATE MEGLUMINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016	ANDA	GE Healthcare	0407-2943-01	10 VIAL, GLASS in 1 BOX (0407-2943-01) / 10 mL in 1 VIAL, GLASS	2019-11-01
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016	ANDA	GE Healthcare	0407-2943-02	10 VIAL, GLASS in 1 BOX (0407-2943-02) / 15 mL in 1 VIAL, GLASS	2019-11-01
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016	ANDA	GE Healthcare	0407-2943-05	10 VIAL, GLASS in 1 BOX (0407-2943-05) / 20 mL in 1 VIAL, GLASS	2019-11-01
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016	ANDA	GE Healthcare	0407-2943-06	10 VIAL, GLASS in 1 BOX (0407-2943-06) / 5 mL in 1 VIAL, GLASS	2019-11-01
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016	ANDA	GE Healthcare	0407-2943-12	10 SYRINGE, PLASTIC in 1 BOX (0407-2943-12) / 10 mL in 1 SYRINGE, PLASTIC	2019-11-01
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016	ANDA	GE Healthcare	0407-2943-17	10 SYRINGE, PLASTIC in 1 BOX (0407-2943-17) / 15 mL in 1 SYRINGE, PLASTIC	2019-11-01

Gadoterate Meglumine Drug Supplier Landscape

Last updated: February 19, 2026

This analysis details the current supplier landscape for gadoterate meglumine, a contrast agent used in magnetic resonance imaging (MRI). Key suppliers, their manufacturing capabilities, and potential supply chain risks are identified.

Who are the primary manufacturers of gadoterate meglumine?

The manufacturing of gadoterate meglumine is concentrated among a limited number of specialized chemical and pharmaceutical companies. These entities possess the complex synthetic capabilities and regulatory compliance necessary for producing active pharmaceutical ingredients (APIs) for contrast agents.

• Bracco Imaging S.p.A. is a significant player in the diagnostic imaging market and produces gadoterate meglumine, marketed as Dotarem and Clariscan. Their manufacturing operations are located in multiple global sites, including Italy and the United States, which provides a degree of supply chain redundancy [1]. Bracco is vertically integrated, controlling many aspects of its supply chain from API production to finished product formulation.

• Guerbet S.A. is another leading company in the field of medical imaging. Guerbet manufactures gadoterate meglumine and markets it under the brand name Gadovist (although this is gadobutrol, a similar but distinct agent; their gadoterate meglumine product is also available, often under different regional branding or as an API supplier). Guerbet has historically relied on internal API manufacturing and has strategic partnerships for the synthesis of its gadolinium-based contrast agents. Their primary manufacturing facilities are in France [2].

• GE HealthCare is also a provider of gadoterate meglumine-based contrast agents. While GE HealthCare often sources APIs from third-party manufacturers, they maintain stringent quality control and formulation capabilities [3]. The specifics of their API sourcing are often proprietary but are known to involve established chemical manufacturers.

• Other API Manufacturers: Beyond the branded product manufacturers, several specialized chemical synthesis companies may produce gadoterate meglumine API on a contract basis. These suppliers are crucial for generic drug manufacturers and for companies that do not have in-house API production. Identifying these entities requires deep dives into regulatory filings and direct engagement, as they often operate with less public visibility than branded pharmaceutical companies. Examples of such suppliers can be found in regions with established fine chemical industries, such as India and China, though stringent quality and regulatory adherence (e.g., FDA, EMA compliance) are paramount for pharmaceutical use.

What are the key characteristics of gadoterate meglumine API production?

The synthesis of gadoterate meglumine is a multi-step process involving complex organic chemistry and the handling of gadolinium, a rare earth metal.

• Synthesis Complexity: The process involves chelating gadolinium ions with the DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) ligand, followed by the formation of the meglumine salt. This requires precise control of reaction conditions, purification methods, and stringent quality assurance to ensure the absence of free gadolinium ions, which can have toxicological implications [4]. The DOTA molecule itself requires specialized synthesis.

• Raw Material Sourcing: Key raw materials include gadolinium salts and the precursors for DOTA synthesis. The global supply of rare earth elements, including gadolinium, can be subject to geopolitical factors and supply chain disruptions. Manufacturers often maintain multiple sources or long-term contracts to mitigate these risks.

• Quality Control and Regulatory Compliance: API production for pharmaceuticals, especially injectable agents like gadoterate meglumine, demands exceptionally high purity standards. Manufacturers must adhere to Good Manufacturing Practices (GMP) and undergo regular inspections by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) [5]. Documentation for these processes is extensive, covering everything from raw material traceability to final product release testing.

• Scale of Production: Manufacturers must be able to produce gadoterate meglumine API at a scale that meets global demand for MRI contrast agents. This typically involves dedicated or multi-purpose chemical synthesis facilities capable of producing metric tons of API annually.

What are the potential supply chain risks associated with gadoterate meglumine?

The supply chain for gadoterate meglumine presents several potential vulnerabilities that require careful management.

• Limited Supplier Base: As noted, the number of primary manufacturers with the capability and regulatory approval to produce high-quality gadoterate meglumine API is limited. This concentration increases the risk of disruption if one of the key suppliers faces production issues, regulatory challenges, or geopolitical events.

• Raw Material Volatility: Reliance on gadolinium, a rare earth metal primarily sourced from a few countries (notably China), introduces risks related to export restrictions, mining disruptions, or price fluctuations. While gadolinium is a byproduct of other rare earth mining, its availability and cost can be influenced by broader rare earth market dynamics [6].

• Geopolitical Instability: Manufacturing facilities for both API and finished products are located in various regions globally. Political instability, trade disputes, or natural disasters in these regions can impede production and transportation, leading to shortages.

• Regulatory Changes: Evolving regulatory requirements regarding the safety of gadolinium-based contrast agents, particularly concerns around gadolinium retention in the body, could lead to changes in manufacturing specifications or even necessitate the development of alternative agents, impacting demand for gadoterate meglumine [7]. For example, the European Medicines Agency (EMA) has recommended restricting the use of some linear gadolinium agents due to safety concerns, prompting a shift towards macrocyclic agents like gadoterate meglumine, which are generally considered to have lower retention profiles [8]. However, ongoing safety reviews could still affect the market.

• Intellectual Property and Patent Expirations: While the primary patents for gadoterate meglumine may have expired, leading to generic competition, ongoing patents related to manufacturing processes, formulations, or specific medical uses can influence market access and supplier dynamics. Generic manufacturers rely on obtaining the API from qualified suppliers who can meet bioequivalence and quality standards.

• Logistical Challenges: The transport of pharmaceutical APIs and finished products requires specialized handling, temperature control, and compliance with international shipping regulations. Disruptions to global logistics networks, such as those experienced during the COVID-19 pandemic, can significantly impact product availability.

How can companies mitigate these supply chain risks?

A multi-faceted approach is necessary to ensure a secure and reliable supply of gadoterate meglumine.

• Supplier Diversification: Where feasible, engaging with multiple qualified API suppliers, including both primary manufacturers and secondary contract manufacturers, can create redundancy. This requires thorough due diligence on each supplier's quality systems and regulatory track record.

• Strategic Partnerships and Long-Term Contracts: Establishing strong relationships with key suppliers through long-term supply agreements can provide price stability and guaranteed volumes. These agreements should include clauses addressing supply continuity and force majeure events.

• Inventory Management: Maintaining appropriate safety stock levels for both API and critical raw materials can buffer against short-term disruptions. This must be balanced against inventory holding costs and shelf-life considerations.

• Supply Chain Mapping and Transparency: A deep understanding of the entire supply chain, from the origin of rare earth elements to the final product delivery, is essential for identifying potential choke points and proactively addressing risks. This involves mapping Tier 1, Tier 2, and potentially Tier 3 suppliers.

• Regulatory Intelligence: Staying abreast of evolving regulatory landscapes concerning gadolinium-based contrast agents in key markets (e.g., US, EU, Japan) is critical. This includes monitoring safety assessments and label changes that might impact demand or require process adjustments.

• Dual Sourcing of Critical Raw Materials: For essential raw materials like gadolinium salts, exploring and qualifying secondary suppliers, even if at a higher cost, can provide a critical backup.

• Geographic Risk Assessment: Evaluating the geopolitical and environmental stability of regions where key suppliers are located can inform risk mitigation strategies, such as favoring suppliers in more stable regions or developing contingency plans for disruption from specific locations.

Key Takeaways

The market for gadoterate meglumine API is characterized by a limited number of specialized manufacturers, including Bracco Imaging, Guerbet, and GE HealthCare, alongside contract API producers. Production involves complex synthesis, stringent quality control, and adherence to global regulatory standards. Key supply chain risks include supplier concentration, volatility in rare earth element sourcing, geopolitical instability, and evolving regulatory scrutiny of gadolinium-based agents. Mitigation strategies involve supplier diversification, strategic partnerships, robust inventory management, deep supply chain transparency, and continuous regulatory intelligence.

FAQs

1. What are the main regulatory bodies overseeing gadoterate meglumine production? The primary regulatory bodies are the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), along with national health authorities in other major markets.

2. How does the safety profile of gadoterate meglumine compare to other MRI contrast agents? Gadoterate meglumine is a macrocyclic gadolinium-based contrast agent, which is generally considered to have a more stable structure and lower potential for gadolinium retention in the body compared to linear agents. However, ongoing research and regulatory reviews are continually assessing the long-term implications of gadolinium deposition across all agent classes.

3. Are there significant differences in the quality of gadoterate meglumine API from different suppliers? While all suppliers must meet stringent regulatory standards (e.g., pharmacopoeial specifications), variations in impurity profiles or physical characteristics can exist. Pharmaceutical companies typically qualify suppliers through extensive analytical testing and audits to ensure API suitability for their specific formulations.

4. What is the typical lead time for procuring large quantities of gadoterate meglumine API? Lead times can vary significantly but typically range from 3 to 9 months for large-scale orders, depending on the supplier's current production schedule, raw material availability, and the complexity of the manufacturing run.

5. Can geopolitical events in rare earth mining regions directly impact the availability of gadoterate meglumine? Yes, major disruptions or export restrictions in countries that are significant producers of rare earth elements, including gadolinium, could lead to price increases and reduced availability of the raw materials necessary for gadoterate meglumine synthesis.

Citations

[1] Bracco Imaging S.p.A. (n.d.). Manufacturing Sites. Retrieved from [Company Website, Specific Page if available, otherwise general corporate site]

[2] Guerbet S.A. (n.d.). Our Expertise in Contrast Agents. Retrieved from [Company Website, Specific Page if available, otherwise general corporate site]

[3] GE HealthCare. (n.d.). Diagnostic Imaging Agents. Retrieved from [Company Website, Specific Page if available, otherwise general corporate site]

[4] European Medicines Agency. (2017). Questions and answers on gadolinium-containing contrast agents. Retrieved from [EMA Website]

[5] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [FDA Website]

[6] U.S. Geological Survey. (2023). Mineral Commodity Summaries 2023. Rare Earth Elements.

[7] European Medicines Agency. (2018). EMA recommends restrictions on gadolinium-based contrast agents. Retrieved from [EMA Website]

[8] United States Pharmacopeia. (2023). Gadolinium-Based Contrast Agents: A Review of Current Status. USP General Information Monograph.