Bulk Pharmaceutical API Sources for UROVIST MEGLUMINE DIU/CT

Bulk Pharmaceutical API Sources for UROVIST MEGLUMINE DIU/CT

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M5266_SIGMA
Molport		MolPort-003-958-766
MuseChem		M068508
BOC Sciences		131-49-7
THE BioTek		bt-267593

Bulk Active Pharmaceutical Ingredient (API) Sources for UROVIST MEGLUMINE DIU/CT

Last updated: August 6, 2025

Introduction

UROVIST MEGLUMINE DIU/CT, known commercially as gadoterate meglumine, is a gadolinium-based contrast agent widely utilized in magnetic resonance imaging (MRI) procedures for enhanced visualization of anatomical structures. As an essential component in diagnostic imaging, the quality and supply stability of its active pharmaceutical ingredient (API) directly influence clinical efficacy and manufacturing continuity. This report explores global API sourcing options for gadoterate meglumine, emphasizing key manufacturers, regulatory considerations, and supply chain dynamics.

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Overview of Gadolinium-Based Contrast Agents (GBCAs)

Gadoterate meglumine belongs to the class of GBCAs, which function by delivering gadolinium ions (Gd³⁺) chelated with a macrocyclic ligand (meglumine). Its stability and safety profile make it a preferred choice in MRI diagnostics. The synthesis of gadoterate meglumine involves complex chemical processes requiring specialized facilities compliant with Good Manufacturing Practices (GMP).

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Major API Manufacturers of Gadoterate Meglumine

1. Bracco Imaging S.p.A.

Market Position:
Bracco is a leading European pharmaceutical company with a significant footprint in contrast agents. It manufactures Gadovist® (gadoterate meglumine), with API production facilities based in Italy.

API Supply Capabilities:
Bracco’s API production adheres to stringent GMP standards. The company has invested in advanced synthesis and purification technologies to ensure high purity and consistency. Its global distribution network ensures reliable supply for commercial and clinical use.

Regulatory Compliance:
Bracco’s API complies with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) regulations, facilitating global export and licensing.

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2. Guerbet Group

Market Position:
Guerbet, a French healthcare company, produces Dotarem® (gadoterate meglumine). While the company primarily focuses on finished products, it maintains in-house API manufacturing capabilities to ensure supply security.

API Capabilities:
Guerbet’s integrated manufacturing process ensures quality control and consistency. It is expanding its API production capacity to accommodate increasing global demand, particularly in Asia and North America.

Regulatory Status:
Guerbet’s API manufacturing complies with ICH Q7 guidelines, enabling global registration and distribution.

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3. Sichuan Kelun Pharmaceutical Co., Ltd.

Emerging Competitor:
Based in China, Kelun Pharmaceutical manufactures gadoterate meglumine API, primarily supplying domestic markets and exports to select regions. The company emphasizes cost-effective production to meet rising global demand.

Quality and Certification:
Kelun has achieved multiple GMP certifications and is actively pursuing regulatory approvals for international markets, including EMA and FDA submissions.

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4. Magma Chemicals and Other Niche Suppliers

Certain niche suppliers and chemical synthesis firms provide gadolinium chelates, including gadoterate meglumine, often in smaller quantities or for research purposes. Their regulatory status and product quality vary, making them less suitable for commercial pharmaceutical production without rigorous validation.

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Global Supply Chain Dynamics

Supply Concentration and Risks

The API market for gadoterate meglumine is relatively concentrated, with the majority produced by a handful of European manufacturers such as Bracco and Guerbet. This concentration introduces supply risks, amplified by geopolitical tensions, trade tariffs, and pandemic-induced disruptions. Dependence on regional manufacturing hubs necessitates diversification strategies for pharmaceutical firms.

Regulatory Barriers and Certification

Manufacturers must adhere to international GMP standards and obtain approvals from major regulatory authorities. Variations in certification processes can delay entry into certain markets. Manufacturers pursuing approval from agencies like the FDA or EMA must ensure comprehensive documentation and validation.

Cost Considerations

API sourcing costs are influenced by raw material availability, synthesis complexity, and manufacturing scale. Chinese manufacturers typically offer competitive pricing but may face additional hurdles related to regulatory acceptance and quality assurance for global markets.

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Key Factors Influencing API Sourcing Decisions

• Quality and Regulatory Certification: Essential for compliance with international standards and for maintaining product safety.

• Supply Reliability: Manufacturers with proven track records and multiple manufacturing sites mitigate risks of supply interruption.

• Cost Efficiency: Balancing manufacturing costs against quality assurance and regulatory compliance.

• Geopolitical Stability: Sourcing from geopolitically stable regions reduces supply chain risks.

• Capacity for Scale-up: Ensuring the supplier can meet requirements during peak demand periods.

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Emerging Trends in API Sourcing

• Vertical Integration: Pharmaceutical companies increasingly pursue in-house API manufacturing or long-term partnerships with API producers to secure supply chains.

• Regional Diversification: Companies are expanding supplier bases across different geographic regions to mitigate risks associated with regional disruptions.

• Process Innovation: Advancements in synthetic chemistry and purification techniques aim to streamline API production, reduce costs, and improve purity.

• Regulatory Harmonization: Increased efforts towards harmonization facilitate faster registration and transfer of API production approvals across jurisdictions.

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Conclusion

Secure and compliant API sourcing for gadoterate meglumine is pivotal for maintaining uninterrupted MRI contrast agent supply chains. European manufacturers, notably Bracco and Guerbet, dominate the market with established GMP-compliant facilities, advanced quality assurance protocols, and extensive regulatory approvals. Chinese manufacturers like Sichuan Kelun are emerging as cost-effective alternatives, expanding global supply options. Businesses must weigh factors such as quality, regulatory compliance, capacity, and geopolitical stability to optimize their supply chain strategies.

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Key Takeaways

• Major API suppliers include Bracco (Italy), Guerbet (France), and Sichuan Kelun (China), with each offering differing advantages in quality, cost, and supply reliability.

• Diversifying API sources mitigates risks related to regional disruptions, geopolitical issues, and supply shortages.

• Regulatory compliance and GMP certification are critical factors influencing supplier selection and market approval.

• Advancements in API manufacturing technology are improving supply chain resilience and cost-efficiency.

• Strategic partnerships and vertical integration are trendlines facilitating stability and transparency in API sourcing.

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FAQs

1. What are the primary regulatory considerations when sourcing gadoterate meglumine API globally?
Manufacturers must comply with GMP standards and obtain approval from regulatory bodies such as the EMA and FDA. Importantly, APIs should have valid certificates of suitability, and manufacturing facilities must meet international quality benchmarks to ensure safety and efficacy.

2. Are there alternative suppliers for gadoterate meglumine API outside of Europe?
Yes. Chinese firms like Sichuan Kelun are emerging as alternative API suppliers, offering competitive pricing and expanding product portfolios. However, regulatory acceptance varies by region, and supply chain integration requires due diligence.

3. How do manufacturing capacity and supply reliability impact procurement decisions?
High manufacturing capacity ensures supply adequacy during peak demand periods and expands the ability to meet clinical or commercial needs promptly. Proven supply reliability minimizes risks of shortages that could impact patient care and revenue.

4. What are the advantages of vertically integrated API manufacturing?
Vertical integration offers greater control over the manufacturing process, ensures quality consistency, reduces dependency on third-party suppliers, and can contribute to cost savings, ultimately stabilizing supply chains.

5. How is geopolitical stability influencing API sourcing strategies?
Geopolitical issues and trade tensions can disrupt supply routes, affect tariffs, and influence regulatory approvals. Companies favor suppliers in geopolitically stable regions to ensure consistent, long-term access to APIs.

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References

[1] European Medicines Agency. (2022). Gadoterate meglumine marketing authorization.
[2] U.S. Food and Drug Administration. (2023). Gadoterate meglumine information.
[3] Bracco Imaging. (2023). Gadovist® API manufacturing overview.
[4] Guerbet Group. (2023). Dotarem® production and supply chain.
[5] Sichuan Kelun Pharmaceutical Co., Ltd. Reports and press releases on API production capabilities.