Bulk Pharmaceutical API Sources for GADAVIST

Bulk Pharmaceutical API Sources for GADAVIST

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		138071-82-6
Activate Scientific		AS113611
BioChemPartner		BCP13400
001Chemical		DY571178
Hangzhou APIChem Technology		AC-30724
Biosynth		VFB69121
ChemFish Tokyo Co., Ltd.		6102852

Bulk Active Pharmaceutical Ingredient (API) Sources for Gadavist

Last updated: July 29, 2025

Introduction

Gadavist (gadobutrol) is a gadolinium-based contrast agent extensively used in magnetic resonance imaging (MRI) diagnostics, particularly for central nervous system, cardiac, and vascular imaging. As a macrocyclic, ionic gadolinium chelate, Gadavist offers high stability and low toxicity, making it a preferred choice among contrast agents. The production, procurement, and distribution of gadobutrol require reliable bulk API sourcing, critical for pharmaceutical manufacturers seeking consistent supply, quality, and regulatory compliance.

This analysis details current sources, key manufacturing geographies, supplier profiles, and strategic considerations for acquiring gadobutrol API.

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Global API Manufacturing Landscape for Gadovist

1. Primary API Manufacturing Countries

The core actors producing gadobutrol API are predominantly located in Europe, Asia, and North America, aligning with global pharmaceutical manufacturing hubs.

• Germany: As a leader in high-quality pharmaceutical API production, Germany hosts several contract manufacturing organizations (CMOs) specializing in gadolinium chelates. Baseline Suisse and other European firms often fulfill strict EU regulatory standards, including EMA approvals.

• China: Rapidly expanding its API manufacturing footprint, China offers cost-competitive gadobutrol APIs with increasing compliance to international standards. Several Chinese manufacturers are GMP-certified and export globally.

• India: An emerging hub integrating both large-scale and mid-sized API producers, India supplies gadolinium compounds to global markets, with some exporters adhering to US FDA and EMA standards.

• United States: Limited direct API manufacturing exists domestically; however, several U.S.-based firms focus on formulation and fill-finish, sourcing APIs from international producers.

2. Key API Suppliers for Gadolinium-Based Contrast Agents

The procurement of gadobutrol API generally involves established suppliers with proven regulatory and manufacturing credentials:

• Bayer AG: As the originator of Gadavist, Bayer maintains its own API manufacturing facilities and supplies for downstream production. Bayer's integrated supply chain provides consistency and compliance with international standards.

• Polpharma (Poland): A significant European API manufacturer with capabilities in gadolinium chelates, Polpharma supplies gadolinium-based API directly or through authorized distributors.

• WuXi AppTec (China): A prominent CMO offering gadolinium API production services, with GMP certification and global distribution network, enabling flexible sourcing options.

• CMOs and Contract Suppliers: Several specialized contract manufacturing firms across Europe and Asia provide gadolinium API synthesis, often catering to regional or global pharmaceutical companies seeking alternatives to primary suppliers.

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Considerations for API Sourcing

Regulatory Compliance

Quality assurance remains paramount. Suppliers must demonstrate adherence to Good Manufacturing Practice (GMP), provide batch records, stability data, and certification of assays aligning with pharmacopeial standards such as European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP). Importantly, gadolinium chelates, including gadobutrol, demand rigorous impurity profiling, particularly regarding residual gadolinium ions and chelate stability.

Quality and Purity

API suppliers should produce gadobutrol with high purity (>99%) and low residual impurities. Consistency batch-to-batch reduces regulatory risks and manufacturing disruptions.

Supply Chain Reliability

Selecting suppliers with a proven track record, flexible production capacity, and diversified manufacturing sites mitigates risks related to geopolitical factors, natural disasters, or pandemic disruptions.

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Strategic Approaches to API Procurement

• Direct Sourcing from Manufacturers: Engaging directly with Bayer or licensed API producers ensures control over quality and supply.

• Utilizing Authorized Distributors: For smaller or regional operations, authorized distributors provide a buffer but require diligent verification of supplier credentials.

• Long-term Supply Agreements: Establishing contracts with key suppliers secures stable supply, favorable pricing, and compliance assurances.

• Developing Multiple Sourcing Options: Diversification reduces dependency and adapts to fluctuating market conditions.

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Regulatory and Market Trends Impacting API Sourcing

The increasing emphasis on gadolinium retention and safety in MRI contrast agents has spurred innovation and possibly affected API synthesis protocols. Transition toward macrocyclic chelates like gadobutrol underscores the need for suppliers with advanced chelation technology and rigorous quality control.

Furthermore, tightening regulatory environments—especially in the EU and US—accentuate the importance of transparent, compliant supply chains, emphasizing the role of GMP-certified APIs and impurity profiles.

The ongoing global supply chain realignments, driven by geopolitical shifts and pandemic-related disruptions, require strategic foresight for API procurement.

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Future Outlook

The API supply landscape for gadobutrol is poised for moderate growth, aligned with the rising global demand for MRI diagnostics. Increased manufacturing capacity in Asia and Europe supports supply stability, with potential entrants focusing on innovation in chelate stability and safety. Additionally, growing regulatory scrutiny promotes high standards, favoring established suppliers with proven compliance record.

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Key Takeaways

• The primary sources of gadobutrol API are located in Germany, China, and India, with Bayer maintaining in-house manufacturing.
• High purity, GMP compliance, and robust regulatory adherence are critical benchmarks for API suppliers.
• Building diversified supplier relationships and long-term agreements enhance supply chain resilience.
• Changes in regulatory frameworks and technological advances influence API manufacturing and sourcing strategies.
• Staying informed about emerging manufacturers and technological developments ensures competitive advantage and supply security.

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FAQs

1. Who are the leading manufacturers of gadolinium chelate APIs?
   Bayer AG remains the original producer of gadolinium-based contrast agents, with other significant suppliers including Polpharma in Europe and WuXi AppTec in China.

2. What quality standards should I verify when sourcing gadobutrol API?
   Suppliers must comply with GMP, provide pharmacopeial compliance documentation (e.g., USP, Ph. Eur.), and demonstrate consistent impurity profiles and stability data.

3. Are there regional differences in gadolinium API quality?
   Yes, regulatory oversight varies between regions. European and US suppliers typically adhere to stricter standards, although several Chinese and Indian suppliers also meet international GMP standards.

4. What risks are associated with gadolinium API sourcing?
   Risks include supply chain disruptions, regulatory non-compliance, quality variability, and geopolitical factors.

5. How can I ensure the stability of gadobutrol API supply?
   Engage with multiple authorized suppliers, establish long-term contracts, monitor regulatory updates, and evaluate suppliers' manufacturing capacity and compliance history.

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References

[1] Bayer AG. Gadavist (gadobutrol) product information and API manufacturing insights.
[2] European Pharmacopoeia. Monograph on gadolinium-based contrast agents.
[3] WuXi AppTec. GMP-certified gadolinium API production and capabilities.
[4] Polpharma. API manufacture and regulatory compliance overview.
[5] Global API Industry Report 2022. Trends in gadolinium chelate production.

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Conclusion

Secure and compliant sourcing of gadobutrol API remains vital for pharmaceutical entities committed to producing high-quality contrast agents. By thoroughly evaluating supplier credentials, ensuring adherence to regulatory standards, and adopting a diversified procurement strategy, companies can achieve a resilient supply chain aligned with evolving technological and regulatory landscapes.