Bulk Pharmaceutical API Sources for ANGIOVIST 282

Bulk Pharmaceutical API Sources for ANGIOVIST 282

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M5266_SIGMA
Molport		MolPort-003-958-766
MuseChem		M068508

Bulk Active Pharmaceutical Ingredient (API) Sources for Angiovist 282

Last updated: August 6, 2025

Introduction

Angiovist 282, also known by its generic name Gadoteridol, is a gadolinium-based contrast agent used extensively in magnetic resonance imaging (MRI) procedures to enhance diagnostic accuracy. As a crucial component in diagnostic imaging, the reliability, purity, and supply chain robustness of Gadoteridol are paramount for healthcare providers and pharmaceutical companies. This article delves into the landscape of bulk API sources for Angiovist 282, emphasizing key manufacturers, market trends, and considerations for procurement strategies.

Understanding Angiovist 282 and Its API: Gadoteridol

Gadoteridol (CAS Number: 125559-56-2) is a hydrophilic, macrocyclic gadolinium chelate with high thermodynamic stability, making it suitable for clinical imaging. Its formulation involves complex synthesis, purification, and stringent quality controls. The API sourcing process must adhere to Good Manufacturing Practice (GMP) standards to ensure safety and efficacy.

Key API Manufacturers for Gadoteridol

1. Bracco Imaging S.p.A.

Bracco is the original innovator of Gadoteridol and produces the API through its advanced manufacturing facilities. As an established leader in contrast agents, Bracco holds comprehensive intellectual property rights and manufacturing licenses for Gadoteridol, ensuring high-quality standards.

• Supply Capabilities: Bracco's vertically integrated manufacturing setup guarantees consistent API supply and quality control, making them the primary source for Angiovist 282's API.
• Market Position: They are considered the most authoritative and reliable API supplier due to their proprietary process and regulatory approvals, including FDA and EMA certifications.

2. Chengdu Desano Pharmaceutical Co., Ltd.

Chengdu Desano is a Chinese pharmaceutical company specializing in gadolinium-based contrast agents. They manufacture Gadoteridol API, serving the growing domestic and international markets.

• Quality and Compliance: The company complies with GMP standards and holds various regulatory certifications, though their API's global acceptance depends on rigorous validation.
• Supply Status: While primarily serving China, Desano has expanded exports, including to markets requiring high standards, though their supply surge may be subject to regional regulation approval.

3. Shanghai Integrity Pharmaceutical Co., Ltd.

This firm manufactures gadolinium contrast agents, including Gadoteridol API, emphasizing quality manufacturing aligned with international standards.

• Capabilities: They serve both domestic and select international clients, with a focus on cost-competitive API provision.
• Regulatory Considerations: Importing their API requires comprehensive documentation and regulatory clearance, especially for FDA or EMA-approved markets.

4. External API Suppliers and Market Dynamics

Emerging suppliers from India, Eastern Europe, and Southeast Asia are increasingly entering the market, driven by patent expirations and lower manufacturing costs. However, their API quality, regulatory compliance, and supply chain stability vary, necessitating thorough due diligence.

Considerations for Sourcing API for Angiovist 282

Regulatory Compliance

Choosing a supplier with approved GMP manufacturing facilities aligning with local and international standards is crucial. Certificates of Analysis (CoA), stability data, and licensing documentation are mandatory for quality assurance.

Supply Chain Stability

Dependence on single-source suppliers poses risks. Multi-sourcing strategies and long-term agreements can mitigate shortages and facilitate regulatory compliance.

Cost and Price Stability

While cost efficiency is attractive, compromising on quality or regulatory compliance can impact patient safety and lead to costly recalls. A balance between cost and quality must guide procurement decisions.

Lead Time and Logistics

Manufacturing lead times and logistics influence inventory management. Suppliers with regional manufacturing facilities and reliable distribution channels support timely delivery.

Intellectual Property and Patent Status

Bracco holds patents for Gadoteridol; thus, sourcing API from generic manufacturers involves navigating patent laws and licensing agreements to avoid infringement issues.

Emerging Trends in API Sourcing for Contrast Agents

• Shift towards regional manufacturing to reduce costs and mitigate supply chain disruptions.
• Regulatory harmonization efforts to streamline approval processes for APIs sourced from new suppliers.
• Advances in synthesis technology improving API purity, stability, and cost-efficiency.
• Increased due diligence and third-party audits in supplier qualification to ensure compliance and security.

Conclusion

The primary and most trusted API source for Angiovist 282 remains Bracco Imaging, owing to its proprietary manufacturing, established quality standards, and regulatory approvals. However, secondary suppliers, particularly from China and increasingly from India, are positioning themselves as alternative sources, demanding rigorous quality assurance and regulatory validation.

Healthcare providers and pharmaceutical companies should prioritize robust qualification processes, supply chain risk management, and compliance adherence when selecting API sources. As the market evolves, leveraging regional manufacturing capabilities and fostering strategic partnerships will become increasingly vital.

Key Takeaways

• Bracco Imaging remains the principal API provider for Gadoteridol, ensuring high quality and regulatory compliance.
• Regional manufacturers offer cost-effective alternatives but require thorough validation for quality and compliance.
• Supply chain resilience necessitates diversified sourcing and long-term supplier relationships.
• Regulatory considerations are critical; sourcing from approved facilities minimizes compliance risks.
• Market trends indicate increasing regional manufacturing and technological advances that may influence API sourcing strategies.

---

FAQs

1. What are the primary concerns when sourcing Gadoteridol API?
Ensuring regulatory compliance, high purity standards, reliable supply, and compatibility with existing manufacturing processes are vital considerations.

2. Can I source Gadoteridol API from suppliers outside Europe and North America?
Yes, emerging suppliers from China and India supply Gadoteridol API; however, verification of GMP compliance and regulatory approvals is essential before procurement.

3. How does patent status impact API sourcing for Angiovist 282?
Patents held by Bracco may restrict generic manufacturers from producing Gadoteridol unless licensing agreements are in place or patents expire, influencing market availability.

4. What logistical factors influence API procurement for contrast agents?
Lead times, regional manufacturing capabilities, shipping regulations, and climate factors impact overall logistics planning.

5. Are there alternative gadolinium-based contrast agents with different API sources?
Yes, agents like Gadobutrol (Gadovist) and Gadoterate meglumine (Dotarem) have different APIs and manufacturing sources, providing diversity in available contrast agents.

---

References

[1] Bracco Imaging S.p.A. Official Website. "Gadoteridol API information."
[2] U.S. Food and Drug Administration (FDA). "Regulatory approval details for Gadoteridol."
[3] European Medicines Agency (EMA). "Marketing authorization for Gadoteridol."
[4] Market intelligence reports on gadolinium contrast agents manufacturing and supply dynamics (2022).
[5] Industry analyses on emerging API manufacturers from Asia and Eastern Europe.