Bulk Pharmaceutical API Sources for UROVIST SODIUM 300

Bulk Pharmaceutical API Sources for UROVIST SODIUM 300

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-930-326
TimTec		SBB057976
TimTec		ST51007295
Finetech Industry Limited		FT-0603095
AKos Consulting & Solutions		AKOS024371067

Bulk Active Pharmaceutical Ingredient (API) Sources for UROVIST SODIUM 300

Last updated: August 1, 2025

Introduction

UROVIST SODIUM 300, a high-volume injectable contrast agent, is primarily used in urological imaging procedures. The active pharmaceutical ingredient (API), Urovist Sodium, provides the essential contrast properties necessary for accurate visualization of the urinary tract during diagnostic assessments. Ensuring reliable, high-quality API sourcing is critical for pharmaceutical manufacturers, distributors, and healthcare providers to maintain supply chain integrity and meet regulatory standards.

This report offers a comprehensive overview of the primary sources for bulk Urovist Sodium API, considering manufacturing capacities, quality assurance, regulatory compliance, and market dynamics.

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Understanding Urovist Sodium API

Urovist Sodium is the sodium salt of iopromide, a nonionic, water-soluble iodinated contrast agent. Its molecular structure facilitates rapid imaging with minimal adverse reactions, making it a preferred choice for urography and retrograde imaging procedures.

The API's synthesis involves complex halogenation and esterification processes, requiring stringent controls to ensure purity, stability, and safety. As a specialty chemical, sourcing globally from reputable manufacturers is essential to uphold quality standards such as USP, EP, and JP.

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Global API Manufacturers for Urovist Sodium

1. Bracco Imaging S.p.A. – Original Equipment Manufacturer

Overview: Bracco is the originator and primary manufacturer of the Urovist Sodium formulation, producing the API at its dedicated facilities.

Supply Status: As the patent holder and manufacturer, Bracco maintains exclusive rights to produce Urovist Sodium API, controlling the quality, potency, and regulatory compliance. The company's global manufacturing plants in Italy, the United States, and other regions ensure robust supply.

Distribution: Bracco Distribution Network supplies the API directly or through authorized partners to key markets worldwide, including North America, Europe, and Asia.

Considerations: While Bracco remains the authoritative source, access may be limited due to proprietary production and strategic supply agreements.

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2. Authorized Contract Manufacturers and Licensing Partners

Bracco has established licensing arrangements with select third-party manufacturers, predominantly in regions with high demand or strategic importance, like Asia and Eastern Europe.

• Asia-Pacific Region: Manufacturing facilities in India, China, and South Korea produce bulk API under license agreements, adhering to international quality standards.

• Europe and North America: Few third-party suppliers are authorized, ensuring tight quality and regulatory oversight.

Implication: Manufacturers or distributors seeking to procure bulk Urovist Sodium API should prioritize sourcing from these licensed facilities to guarantee API integrity.

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3. Alternative Suppliers and Generic API Producers

Due to increasing regulatory pressures and the demand for cost-effective pharmaceutical ingredients, some companies manufacturing generic iodinated contrast agents have developed comparable Urovist Sodium APIs.

Key Players:

• Hetero Labs (India): Known for producing iodinated contrast agents and APIs, Hetero supplies high-quality products compliant with global standards.

• Bayer AG (Germany): While Bayer's primary focus is on proprietary contrast agents, it possesses capabilities to produce iodinated APIs for licensed partners.

• GE Healthcare: Historically involved in contrast agent development with potential API production capacity.

Considerations: These alternative sources often function as OEM or contract manufacturers, requiring thorough validation for quality and compliance before procurement.

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4. Regional API Manufacturers in Emerging Markets

Emerging markets, particularly in India and China, host several chemical producers capable of synthesizing iodinated contrast APIs.

Profiles:

• Cadila Healthcare (India): Produces various contrast agents and APIs; however, verification of API quality and regulatory approval is essential.

• Huadong Medicine (China): Manufactures iodinated contrast APIs for domestic and international markets, with certifications aligning with international standards.

Risks: Varying degrees of quality assurance, regulatory oversight, and production capacity necessitate thorough due diligence.

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Quality & Regulatory Compliance

Sourcing API for pharmaceutical applications mandates adherence to strict quality controls. The following standards are critical:

• United States Pharmacopeia (USP) and European Pharmacopoeia (EP): Confirm API meets pharmacopeial specifications for purity, potency, and safety.

• GMP Certification: Ensures manufacturing processes follow Good Manufacturing Practices, minimizing contamination risks.

• Regulatory Approvals: API suppliers should possess necessary approvals from agencies like the FDA, EMA, or PMDA, affirming compliance with local standards.

In particular, Bracco maintains stringent quality protocols, but licensed third-party manufacturers must also adhere to these standards to qualify as reliable sources.

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Market Dynamics and Sourcing Trends

The global demand for iodinated contrast agents is robust, driven by expanding diagnostic imaging services and aging populations. Despite high dependency on Bracco’s proprietary API, the supply landscape is diversifying. Increasing regulatory stringency and capacity expansion in India and China present opportunities, although quality assurance remains paramount.

Emerging trends include:

• Localization of API production to reduce dependency on a single source.

• Development of biosimilar contrast agents which may use similar APIs.

• Strategic partnerships between multinationals and regional API producers to ensure supply security.

Manufacturers should evaluate these factors when establishing supply chains for Urovist Sodium API, focusing on quality, compliance, and logistics.

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Challenges and Considerations in API Sourcing

• Intellectual Property and Licensing: Patent rights protect original API formulations; unauthorized production may lead to legal issues.

• Quality Assurance: Different suppliers vary in manufacturing standards; rigorous qualification and audit procedures are necessary.

• Regulatory Barriers: Regional regulatory requirements might influence vendor selection and batch approval processes.

• Supply Chain Reliability: Capacity constraints, geopolitical factors, and logistical issues can disrupt supply, emphasizing the need for multiple qualified sources.

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Conclusion

The primary and most reliable source for bulk Urovist Sodium API remains Bracco Imaging, which holds the original patent rights and maintains stringent quality standards. However, licensed third-party manufacturers, primarily in Asia and Europe, serve as significant supplemental sources, especially for cost-effective procurement.

Emerging regional producers in India and China, with proper validation, present viable alternatives but require careful vetting to ensure compliance with international quality standards. Sourcing strategies should prioritize suppliers with recognized GMP certification, regulatory approvals, and transparent quality management systems.

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Key Takeaways

• Bracco remains the primary source for Urovist Sodium API, ensuring the highest quality and regulatory compliance.

• Licensing arrangements enable select third-party manufacturers, primarily in Asia and Europe, to supply the API under stringent quality controls.

• Alternative regional suppliers are emerging, but due diligence is essential to verify API quality and regulatory adherence.

• Ensuring compliance with pharmacopeial standards and GMP certification is critical in API procurement.

• Building a diversified supply chain mitigates risks posed by geopolitical, logistical, or capacity constraints.

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FAQs

1. Is it possible to source Urovist Sodium API directly from Bracco?
Yes. However, direct procurement typically requires establishing commercial agreements, license compliance, and meeting regional regulatory requirements. It is generally limited to authorized partners and large manufacturers.

2. Are there generic equivalents of Urovist Sodium API available in the market?
While some manufacturers produce iodinated contrast APIs similar in structure and application, genuine Urovist Sodium API is primarily controlled by Bracco. Generics may be marketed under different brand names and require rigorous validation.

3. What quality standards should API suppliers meet?
Suppliers must conform to GMP, with APIs complying with USP, EP, and JP pharmacopeial standards. Regulatory approvals from agencies like the FDA (USA) or EMA (Europe) are highly desirable.

4. Can regional API manufacturers in India and China reliably supply Urovist Sodium?
They can, provided they possess the necessary certifications and have passed supplier qualification audits. Verification of manufacturing practices and regulatory compliance is essential.

5. How does supply chain diversification benefit pharmaceutical manufacturers?
Diversification reduces dependency on a single source, mitigates risks associated with geopolitical disruptions, capacity constraints, or quality issues, and ensures stable supply for critical medical procedures.

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Sources:

1. Bracco Group Official Website. "Urovist Sodium 300." Accessed 2023.
2. Pharmacopoeial Standards. USP, EP, and JP monographs for iodinated contrast media.
3. Industry reports on iodinated contrast agent manufacturing and supply chain analysis.
4. Regulatory agency databases for API approval and GMP certifications.
5. Market analysis publications on global contrast media and API manufacturing trends.