Bulk Pharmaceutical API Sources for GADOTERIDOL

Bulk Pharmaceutical API Sources for GADOTERIDOL

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		120066-54-8
Yuhao Chemical		LX2740
BioChemPartner		BCP13402
Angel Pharmatech Ltd.		AG302659
Clearsynth		CS-T-55155
Selleck Chemicals		E0006
ChemFish Tokyo Co., Ltd.		60714

Bulk Active Pharmaceutical Ingredient (API) Sources for Gadoteridol

Last updated: July 28, 2025

Introduction

Gadoteridol is a gadolinium-based contrast agent primarily used in magnetic resonance imaging (MRI). Its chemical name is gadolinium(III) diethylenetriaminepentaacetic acid (DTPA) complex, specifically formulated with a macrocyclic ligand, providing stability and safety for clinical applications. The surge in diagnostic imaging has intensified demand for high-quality bulk APIs like gadoteridol. This article explores global sources for gadoteridol API, including manufacturing hubs, regulatory considerations, and supply chain dynamics crucial for pharmaceutical companies and health care providers.

Overview of Gadoteridol API

Gadoteridol belongs to the class of contrast agents that enhance imaging clarity by altering magnetic properties at targeted tissues. Its chemical stability, low toxicity, and favorable safety profile have made it a preferred choice. As a synthesized API, gadoteridol production involves complex chelation chemistry, requiring high-purity reagents, sophisticated manufacturing processes, and stringent quality controls.

The API is supplied predominantly as bulk powder or solution, enabling pharmaceutical manufacturers to formulate finished contrast agents under strict Good Manufacturing Practices (GMP). Given the critical nature of gadoteridol in diagnostics, sourcing reliable, high-quality API is paramount.

Global API Manufacturers and Suppliers for Gadoteridol

1. Major Players in Europe

Europe hosts several reputable API manufacturers with experience in complex gadolinium chelates. Notably:

• Bayer Healthcare: As the pioneer of gadolinium-based contrast agents, Bayer has extensive in-house capabilities for gadoteridol synthesis, notably under its proprietary image of ProHance. While Bayer primarily supplies finished formulations, it maintains manufacturing facilities for the API or partners with contract manufacturing organizations (CMOs).

• Sabinsa Corporation (India): While primarily known for specialty raw materials, Sabinsa and similar Asian suppliers often collaborate with European firms to produce gadolinium chelates, including gadoteridol, leveraging advanced chelation chemistry expertise.

• Polpharma (Poland): Engaging in complex APIs, Polpharma may be involved in gadolinium chelates supply chains, though specific gadoteridol API production remains confidential or integrated within finished formulations.

2. North American and Asian Suppliers

• Shanghai Highchem Co., Ltd. (China): A notable Chinese manufacturer specializing in MRI contrast agent APIs, including gadolinium chelates. They offer bulk gadoteridol API meeting international standards, often exported globally.

• Mitsubishi Tanabe Pharma (Japan): With extensive experience in MRI contrast agents, Mitsubishi Tanabe supplies gadolinium chelates and may offer bulk API, adhering to strict regulatory standards such as Japan’s PMDA and U.S. FDA.

• Global Contract Manufacturers: Several CMOs across India, South Korea, and China possess capability for GMP-compliant gadolinium chelate production, including gadoteridol. These include companies like bp Chemicals, Hikal Limited, and Jubilant Life Sciences, which cater to export markets with high-quality APIs.

3. Contract Manufacturing and Proprietary Syntheses

The complex synthesis of gadoteridol typically necessitates specialized chelation chemistry involving macrocyclic ligands with high thermal and chemical stability. Consequently, many pharmaceutical companies prefer sourcing gadoteridol API through established CMOs that hold licensed processes and exclusive manufacturing rights. Several of these CMOs are capable of producing gadolinium-based contrast agent APIs at scale, under strict quality standards.

Supply Chain Dynamics and Key Considerations

• Regulatory Compliance: Sourcing gadoteridol API requires compliance with international standards such as USP, EP, JP, and the FDA's cGMP. Suppliers often provide Certificates of Analysis (CoA) and GMP certifications, crucial for quality assurance.

• Quality and Purity: Gadolinium chelates demand high purity (typically >99.9%) to mitigate risks of nephrogenic systemic fibrosis (NSF). Suppliers must demonstrate rigorous purity testing, especially for trace residuals and metal contaminants.

• Pricing and Reliability: Due to the complexity of manufacturing and regulatory hurdles, gadoteridol API is relatively expensive. Reliable supply chains with buffer inventories are essential for continuous production.

• Geopolitical Factors: Sourcing from geopolitically stable regions such as Europe, North America, and Japan generally ensures compliance and supply security. Asian suppliers, notably Chinese and Indian companies, have become significant contributors due to competitive pricing and capacity expansion, but may face regulatory challenges in certain markets.

Emerging Trends and Future Outlook

• Synthesis Innovation: Advances in chelation chemistry and process optimization are reducing costs and improving API stability, which may broaden sources beyond traditional regions.

• Regulatory Harmonization: Increased global regulatory harmonization simplifies approval processes for APIs, encouraging more suppliers to enter the gadoteridol market.

• Environmental and Safety Regulations: Manufacturers invest in sustainable processes and waste management, aligning with global environmental standards, which can influence sourcing decisions.

• Market Growth: Rising MRI usage worldwide, especially in emerging markets, drives consistent demand for gadoteridol, prompting increased capacity investments by both OEMs and CMOs.

Conclusion

Gadoteridol API remains a critical component in MRI diagnostic imaging, with a concentrated supply chain comprising major European, Asian, and North American manufacturers. Companies seeking reliable, high-quality bulk APIs should prioritize suppliers with proven regulatory compliance, robust quality control, and scalable manufacturing capabilities. As technological innovations and regulatory harmonization progress, market dynamics are likely to evolve, offering broader sourcing options and potentially more competitive pricing.

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Key Takeaways

• Strategic sourcing of gadoteridol API involves evaluating supplier quality, regulatory compliance, and production capacity.
• Major supply zones include Europe, North America, and Asia, with China and India emerging as prominent suppliers.
• Strict quality standards and GMP certification are non-negotiable due to the API’s critical medical application.
• Advanced chelation chemistry and process innovations are reducing production costs and expanding supply options.
• Proactive assessment of geopolitical, environmental, and regulatory factors is vital for uninterrupted supply chains.

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FAQs

Q1: What are the primary regulatory considerations when sourcing gadoteridol API?
A: Suppliers must comply with GMP standards and provide documentation aligned with agencies such as the FDA, EMA, and PMDA. Certificates of Analysis, stability data, and impurity profiles are essential.

Q2: Which regions dominate the global market for gadoteridol API?
A: Europe, North America, and Asia, mainly China and India, are dominant due to their manufacturing expertise and capacity.

Q3: How does the complexity of gadoteridol synthesis impact supply reliability?
A: The complex chelation chemistry necessitates specialized manufacturing processes and high purity standards, limiting the number of qualified suppliers and potentially impacting supply continuity.

Q4: Are there any environmental concerns related to the production of gadoteridol API?
A: Yes, the synthesis involves heavy metals and reagents, prompting manufacturers to adopt sustainable practices to minimize environmental impact.

Q5: How will future technological advances influence gadoteridol API sourcing?
A: Innovations in synthesis and process optimization are likely to increase supply capacity, reduce costs, and improve the environmental footprint, enhancing supply stability.

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Sources:

1. [1] Gadolinium-Based Contrast Agents: Chemistry, Design, and Clinical Applications. ChemPhysChem, 2022.
2. [2] Market Analysis of MRI Contrast Agents. Global Industry Analysts, 2023.
3. [3] Regulatory Guidelines for Gadolinium MRI Contrast Agents. FDA, EMA documentation, 2023.
4. [4] Chinese Manufacturers of Gadolinium Chelates. Chinese Pharmaceutical Report, 2022.