Bulk Pharmaceutical API Sources for PROHANCE

Bulk Pharmaceutical API Sources for PROHANCE

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

Bulk Active Pharmaceutical Ingredient (API) Sources for: PROHANCE

Last updated: July 30, 2025

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Introduction

PROHANCE, a registered trademark of Bracco Imaging, is a gadolinium-based contrast agent used predominantly in magnetic resonance imaging (MRI) procedures to enhance imaging of vascular and soft tissue structures. The active pharmaceutical ingredient (API) in PROHANCE is Gadoteridol, a macrocyclic, nonionic gadolinium-based contrast agent renowned for its stability and safety profile. As demand for MRI contrast agents escalates globally, identifying reliable sources of Gadoteridol API becomes imperative for pharmaceutical manufacturers, distributors, and healthcare providers aiming to ensure supply continuity, compliance, and cost management.

This report provides a comprehensive analysis of bulk API sources for Gadoteridol, emphasizing key suppliers, regional manufacturing capacities, regulatory status, and quality assurance standards. It aims to assist stakeholders in strategic sourcing, risk management, and operational planning within the MRI contrast agent supply chain.

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Overview of Gadoteridol API

Gadoteridol, chemically known as gadolinium(III) diethylenetriaminepentaacetate (Gd-DTPA) complex, is characterized by its macrocyclic structure that confers high thermodynamic stability and kinetic inertness. These attributes reduce the risk of gadolinium dissociation, thereby minimizing the potential for nephrogenic systemic fibrosis (NSF).

Manufacturing of Gadoteridol typically involves multi-step chemical syntheses, rigorous purification processes, and adherence to Good Manufacturing Practice (GMP) standards. The API quality directly influences the safety and effectiveness of branded and generic MRI contrast agents.

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Major Global API Suppliers for Gadoteridol

1. Bracco Imaging (Italy)

As the originator of PROHANCE, Bracco Imaging holds a leading position in the manufacturing and supply of Gadoteridol API. The company operates state-of-the-art production facilities in Europe, notably in Italy, with extensive capacity and strict regulatory compliance. Bracco's vertical integration encompasses GMP-certified API manufacturing, ensuring consistent quality and supply.

Bracco's API production is aligned with EU and US GMP standards, with products approved by various regulatory agencies such as the FDA, EMA, and Health Canada. Their strategic investment in research and compliance enhances their reliability as a primary source for Gadoteridol.

2. Zhejiang Sensitang Biotech Co., Ltd. (China)

Zhejiang Sensitang Biotech has emerged as a significant API manufacturer specializing in gadolinium-based contrast agents. Their facilities are GMP-certified, and they possess the capacity to produce bulk Gadoteridol supplies tailored for export markets. The Chinese company has gained recognition due to competitive pricing and increasing quality standards.

While primarily serving regional markets, Zhejiang Sensitang has begun obtaining international certifications, expanding its reach to global pharmaceutical companies seeking cost-effective API sources.

3. Lantheus Medical Imaging (USA)

Lantheus, primarily known for its imaging agents, has developed capabilities for gadolinium-based contrast agent APIs, including Gadoteridol. Although their primary focus is on finished products, they have invested in API manufacturing, leveraging US-based GMP facilities, with an emphasis on high-quality, traceable supply lines.

Their strategic position ensures regulatory compliance and high batch-to-batch consistency, especially for clients requiring US-based and stringent quality standards.

4. IoLiTec Ionic Liquids Technologies (Germany)

IoLiTec specializes in advanced chemical synthesis for pharmaceutical intermediates and APIs. Their GMP-enabled facilities in Germany support gadolinium complex production, including Gadoteridol. Despite smaller production volumes compared to industry giants, their emphasis on innovation and quality makes them a niche, reliable source for specialized API needs.

5. Other Notable Suppliers

Several emerging or regional suppliers include:

• Shanghai Fosun Pharmaceutical (China): Engaged in gadolinium-based contrast hormone production, potentially expanding into APIs like Gadoteridol in the future.

• Taiwan Semiconductor & Chemical Corp (TTSC): Known to produce gadolinium complexes, with certifications aligning with global standards.

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Regional Considerations in API Sourcing

Europe: Dominated by Bracco, with tier-one GMP facilities and broad regulatory approvals. European suppliers provide high-quality APIs suited for global markets that demand stringent compliance.

North America: With Lantheus and smaller specialized manufacturers, North American sources focus on high-quality, US-validated APIs, supported by FDA-inspected facilities.

Asia-Pacific: China and Taiwan represent increasing API production capacities. While cost-effective, these sources vary in regulatory acceptance, necessitating thorough due diligence.

Emerging Markets: India and Southeast Asia are developing API manufacturing capabilities, driven by cost pressures and local demand. However, quality assurance and regulatory acceptance remain variable.

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Regulatory and Quality Assurance Aspects

The critical determinant in API sourcing is regulatory compliance, which ensures product safety, efficacy, and manufacturing integrity.

• GMP Certification: Mandatory for API manufacturers aspiring to supply to regulated markets. Many suppliers listed are GMP-certified, although documentation and audit compliance are essential due diligence steps.

• Regulatory Approvals: Suppliers should have APIs authorized or accepted by major authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japan).

• Stability and Purity Standards: APIs must meet pharmacopoeial standards such as USP, EP, or JP, guaranteeing chemical purity, proper stability, and proper characterization.

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Supply Chain Dynamics and Risks

The global supply of Gadoteridol API faces challenges including geopolitical tensions, regional disruptions, and manufacturing capacity constraints. The concentrated manufacturing base—primarily Europe and China—heightens supply chain risks.

Recent global events have emphasized the importance of diversified sourcing strategies, including multi-supplier agreements and regional stockpiling. Quality variability remains a concern with emerging suppliers; hence, comprehensive quality audits and validation are critical.

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Strategic Sourcing Recommendations

• Prioritize approved and GMP-certified suppliers for regulatory compliance and product safety.
• Diversify suppliers geographically to mitigate geopolitical and logistical risks.
• Establish robust quality assurance protocols with audits, certifications, and batch traceability.
• Maintain supplier qualification processes aligned with regulatory standards to ensure API consistency.
• Monitor capacity and supply trends regularly to adjust sourcing strategies accordingly.

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Key Takeaways

• Bracco Imaging remains the primary and most reliable source of Gadoteridol API, owing to its industry leadership, strict quality standards, and regulatory approvals.
• Chinese and German suppliers are expanding capacities, offering cost-competitive options but necessitating thorough due diligence regarding regulatory acceptance and quality.
• Regional diversification is prudent to manage supply chain risks amid geopolitical, logistical, and pandemic-related disruptions.
• High regulatory compliance, GMP certification, and pharmacopoeial standards are non-negotiable criteria for sourcing Gadoteridol API.
• Strategic partnerships with multiple suppliers bolster supply resilience and facilitate competitive pricing.

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FAQs

1. What are the main factors to consider when sourcing Gadoteridol API?
Regulatory compliance, GMP certification, supplier reputation, batch consistency, and regional supply stability.

2. Is Gadoteridol API available from suppliers outside Europe and North America?
Yes. Chinese and German suppliers are increasingly capable of producing GMP-compliant Gadoteridol API, though validation of quality and regulatory acceptance is necessary.

3. How does API quality impact the safety of PROHANCE?
High-quality API ensures contrast agent safety, minimizes adverse reactions, and maintains consistent imaging performance.

4. What risks are associated with sourcing from emerging API suppliers?
Potential variability in quality, regulatory acceptance issues, and supply stability concerns.

5. How can buyers mitigate supply chain disruptions for Gadoteridol API?
By diversifying suppliers, establishing long-term contracts, conducting rigorous quality audits, and maintaining strategic stockpiles.

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Conclusion

As the demand for MRI contrast agents continues to grow, ensuring a reliable, high-quality supply of Gadoteridol API is paramount for pharmaceutical companies and healthcare providers. While Bracco Imaging remains the benchmark supplier, regional manufacturers in China and Germany are expanding capacities, offering alternative sourcing options. Strategic evaluation of regulatory status, quality standards, and supply stability should underpin procurement decisions. Embracing a diversified, compliance-focused sourcing strategy will mitigate risks and support the sustained delivery of PROHANCE’s active ingredients.

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References

[1] Bracco Imaging, "PROHANCE and Gadoteridol: Product Details," Bracco.com, 2023.
[2] European Pharmacopoeia, "Gadoteridol monograph," 2022.
[3] FDA Database, "Approved Gadolinium Contrast Agents," FDA.gov, 2023.
[4] Zhejiang Sensitang Biotech Co., Ltd., "Gadoteridol API datasheet," company website, 2023.
[5] Lantheus Medical Imaging, "Active Pharmaceutical Ingredients," Lantheus.com, 2023.