Bulk Pharmaceutical API Sources for GADOBUTROL

Bulk Pharmaceutical API Sources for GADOBUTROL

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		138071-82-6
Activate Scientific		AS113611
BioChemPartner		BCP13400

Bulk Active Pharmaceutical Ingredient (API) Sources for GADOBUTROL

Last updated: July 29, 2025

Introduction

Gadobutrol, a macrocyclic, Non-Ionic MRI contrast agent, is widely used in diagnostic imaging to enhance the clarity of MRI scans. Its high stability and low toxicity profile make it a preferred choice in neuroimaging, angiography, and other radiological procedures. Central to the manufacturing of gadobutrol are reliable, high-quality bulk API sources that comply with stringent regulatory standards. This article provides a comprehensive overview of the global supply landscape for gadobutrol API, highlighting key manufacturers, sourcing considerations, and market dynamics crucial for pharmaceutical developers and stakeholders.

Overview of GADOBUTROL API

Gadobutrol's chemical name is gadolinium (3,6,9-tris(carboxymethyl)-9-[(2- methyl-1-oxyl-2-propenyl)oxy]-4,7-dioxo-1,4,7,10-tetraazacyclododecane), and it belongs to the category of gadolinium-based contrast agents (GBCAs). The API's complex synthesis involves elaborate chelating processes, ensuring the stability and safety profile required for clinical use. The pharmaceutical-grade API must meet rigorous purity, stability, and regulatory standards, including those set by the FDA, EMA, and other health authorities, to guarantee patient safety.

Market Dynamics and Demand Drivers

The global demand for gadobutrol API is driven by increasing prevalence of neurological disorders, cardiovascular diseases, and oncology cases where enhanced MRI imaging is critical. The growing adoption of gadobutrol by healthcare providers, particularly in the United States, Europe, and emerging markets, propels the API's market trajectory. Additionally, the expansion of regulatory approvals and technological advancements in MRI imaging contribute to sustained growth.

Key API Manufacturers and Suppliers for GADOBUTROL

The reliable sourcing of high-quality gadobutrol API is pivotal for pharmaceutical companies. Several key players dominate this niche market, distinguished by their manufacturing capabilities, quality standards, and regulatory compliance.

1. SPL (Shanghai Pharma)

Shanghai Pharmaceutical Holding Co., Ltd., through its subsidiary Shanghai Liebel-Merck Pharmaceutical Co., Ltd., is among the prominent suppliers of gadobutrol API in Asia. SPL’s facilities are GMP-certified, adhering to international standards, and their API consistently meets global regulatory requirements. The company offers a comprehensive portfolio of contrast agents and APIs, emphasizing quality and supply stability.

2. Guerbet

A leading French biopharmaceutical company, Guerbet manufactures Gadavist (gadobutrol) as a finished dosage form but also supplies the API to select partners. Known for stringent quality controls and innovation, Guerbet's API sourcing approach involves collaborations with certified manufacturing units conforming to EU-GMP guidelines. Although primarily a finished product manufacturer, Guerbet’s API supplies are accessible through strategic partnerships.

3. GE Healthcare

While primarily focused on radiology products including contrast agents like Omniscan, GE Healthcare maintains a network of API suppliers capable of providing gadolinium-based compounds, including gadobutrol. Their supply chain emphasizes quality and regulatory conformity across Asia, Europe, and North America.

4. Research Pharmaceuticals and Custom Synthesis Providers

Several specialized chemical synthesis companies provide gadobutrol API for research and development purposes. Notable among them are:

• VVR Pharma: Offers gadolinium chelate APIs with certifications suitable for clinical trials.
• Spectra Gases & Chemicals: Provides gadolinium compounds tailored for preclinical research. These suppliers focus on custom synthesis, smaller batch sizes, and flexibility in formulation, but may not always meet full-scale commercial requirements.

5. Emerging Manufacturers and Regional Suppliers

In addition to established players, emerging manufacturers in India, South Korea, and Eastern Europe are penetrating the API market, offering cost-effective and compliant gadobutrol API. These providers often operate under strict quality assurance protocols and are working toward GMP certification to access international markets.

Supply Chain Considerations

• Regulatory Compliance: Only APIs from GMP-certified facilities should be considered for pharmaceutical manufacturing.
• Quality Standards: High purity (>99%), low residual solvents, and rigorous impurity profiling are essential.
• Supply Stability: Long-term contractual relationships or multiple sourcing options reduce supply disruptions.
• Cost Efficiency: Balancing quality with competitive pricing is critical, especially in large-volume production.

Current Trends and Future Outlook

The gadobutrol API market is poised for steady growth aligned with the global rise in MRI diagnostic procedures. Innovations in chelation chemistry and manufacturing processes aim to enhance stability, reduce side effects, and lower costs. Regulatory tightening, particularly in the context of gadolinium retention concerns, influences API quality improvements, with manufacturers investing in advanced purification technologies.

Additionally, the rising integration of digitized supply chain management and quality assurance systems fosters transparency and traceability for gadobutrol API sourcing. The advent of regional manufacturing hubs also mitigates dependency on a limited number of global suppliers.

Regulatory Landscape

Regulatory agencies emphasize the importance of API sourcing from approved, GMP-compliant facilities. For gadobutrol, the API must meet pharmacopoeial standards (USP, EP, JP) and be documented with comprehensive quality dossiers. Manufacturers are required to validate processes, monitor impurity profiles, and ensure batch-to-batch consistency, aligning with ICH Q7 guidelines [1].

Key Takeaways

• The primary sources of gadobutrol API are established pharmaceutical manufacturers in China, France, and the U.S., alongside emerging regional suppliers.
• Ensuring GMP certification, rigorous quality standards, and regulatory compliance is non-negotiable for secure API sourcing.
• Supply stability hinges on long-term relationships with multiple suppliers, diversified sourcing strategies, and adherence to international standards.
• Innovation in chelation chemistry and purification processes enhances API quality, safety, and manufacturing efficiency.
• The evolving regulatory landscape influences API quality requirements and drives continual industry improvement.

Conclusion

Securing a reliable, high-quality source of gadobutrol API remains fundamental for pharmaceutical manufacturers aiming to meet growing global demand for advanced MRI contrast agents. The landscape features a mix of established multinational suppliers, regional manufacturers, and specialized custom synthesis firms, each contributing to a resilient supply chain. Stakeholders must prioritize regulatory adherence, quality assurance, and supply continuity to capitalize on market opportunities and deliver safe, effective contrast agents to patients worldwide.

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FAQs

Q1: What are the main factors to consider when sourcing gadobutrol API?
A1: Key factors include GMP certification, product purity (>99%), impurity profile, supplier regulatory compliance, supply stability, and cost-effectiveness.

Q2: Are regional suppliers suitable for large-scale pharmaceutical manufacturing?
A2: Yes, provided they meet international GMP standards and quality requirements. Proper due diligence and certification validation are essential.

Q3: How does regulatory compliance affect gadobutrol API sourcing?
A3: Regulatory compliance ensures API safety and efficacy, minimizes compliance risks, and facilitates global market access. Non-compliant sources pose regulatory and quality risks.

Q4: What recent innovations have impacted gadobutrol API manufacturing?
A4: Advances include improved chelation stability, purification techniques reducing residual gadolinium, and process automation enhancing consistency and scalability.

Q5: What are the future trends in gadobutrol API sourcing?
A5: Increasing regional manufacturing, stricter quality standards due to safety concerns, and technological innovations are shaping a more secure and efficient API supply chain.

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References

[1] International Council for Harmonisation (ICH), Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.