Bulk Pharmaceutical API Sources for ULTRAVIST (PHARMACY BULK)

Bulk Pharmaceutical API Sources for ULTRAVIST (PHARMACY BULK)

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-535
Molport		MolPort-005-932-395
Finetech Industry Limited		FT-0627283
AvaChem Scientific		1659
AvaChem Scientific		73334-07-3

Bulk Active Pharmaceutical Ingredient (API) Sources for: Ultravist (Pharmacy Bulk)

Last updated: July 31, 2025

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Introduction

Ultravist, known chemically as iopromide, is a non-ionic, water-soluble radiopaque contrast agent widely used in diagnostic imaging, particularly computed tomography (CT) scans. Its efficacy and safety depend heavily on high-quality bulk API sourcing, which influences product consistency, regulatory compliance, and supply chain stability. This article explores leading sources, industry standards, and strategic considerations for procurement of Ultravist's API—iopromide—in bulk form for pharmaceutical manufacturing.

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Overview of Iopromide as a Bulk API

Iopromide belongs to the non-ionic, low-osmolality iodinated contrast media class, characterized by specified chemical purity, endotoxin limits, and stability profiles. Its synthesis involves complex multistep chemical processes, demanding strict quality control. Pharmaceutical companies utilize high-grade iopromide bulk API that meets pharmacopeial standards—mainly US Pharmacopeia (USP), European Pharmacopeia (EP), and Indian Pharmacopeia (IP)—to ensure safety and efficacy.

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Major Sources of Iopromide API

1. Contract Manufacturing Organizations (CMOs) and API Producers

Several specialized chemical and pharmaceutical companies act as primary suppliers of iopromide bulk API. These include:

• Bracco Pharma (Italy): As the originator of Ultravist, Bracco supplies high-purity iopromide globally. The company's vertically integrated manufacturing assures quality and supply reliability. Bracco also collaborates with authorized CMO partners for bulk API production, adhering to Good Manufacturing Practice (GMP) standards [1].

• Jiangsu Hengrui Medicine Co., Ltd. (China): A leading Chinese pharmaceutical firm with capabilities in iodinated contrast agent synthesis, Hengrui produces bulk iopromide meeting international standards. Their facilities incorporate advanced process controls and quality assurance protocols [2].

• Fresenius Kabi (Germany): While primarily focused on finished dosage forms, Fresenius Kabi also sources bulk API from certified manufacturers to ensure product integrity across supply chain.

• Baxter International (USA): Baxter collaborates with specialized API producers, emphasizing compliance with US and global regulations, for supplying raw materials in contrast media production.

2. API Suppliers from India and China

India and China are significant players in the generic API market, producing bulk iodinated contrast agents, including iopromide for export and domestic use:

• Gland Pharma (India): Known for high-quality iodinated contrast agents, Gland Pharma’s manufacturing facilities conform to cGMP and ISO standards, with capabilities to supply bulk APIs globally.

• Hetero Labs (India): Specializes in generic pharmaceutical APIs, including radiocontrast agents, and has a track record of producing compliant bulk iopromide.

• Shanghai Haohong Pharmaceutical (China): Offers iodinated contrast API meeting international pharmacopoeia standards, catering to generic drug manufacturers.

3. Chinese API Manufacturers

The Chinese pharmaceutical industry has expanded rapidly, with several API producers offering competitively priced iopromide:

• Hengrun Pharmaceutical Co., Ltd.
• Sinochem.cn

These firms possess modern facilities accredited by GMP and ISO, with exports aligned with international quality standards.

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Quality and Regulatory Considerations

API Quality Standards:
For Ultravist manufacturing, API suppliers must adhere to pharmacopoeial specifications, including:

• Iodine Content: 50.0%–53.0%
• Water Content: < 0.5%
• Endotoxins: < 0.5 EU/mg
• Impurity Limits: As specified by USP/EP/IP

Regulatory Compliance:
Suppliers must demonstrate compliance with:

• GMP certification
• World Health Organization (WHO) prequalification (if applicable)
• Regulatory approval by agencies like the FDA, EMA, or comparable authorities

Traceability & Certification:
Batch traceability, Certificates of Analysis (CoA), and stability data are crucial for regulatory filing and validation processes.

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Strategic Sourcing and Supply Chain Considerations

Diversification:
Relying on multiple suppliers mitigates risks associated with supply disruptions, geopolitical factors, and quality fluctuations.

Supplier Qualification:
Engage in rigorous qualification processes, including on-site audits, process validation data review, and sample testing.

Pricing & Lead-time:
Balancing quality with competitive pricing and reliable lead-times requires partnering with established, compliant suppliers capable of scaling production.

Technological Transfer & Capacity Expansion:
Explore collaborative agreements that enable process transfer or capacity upgrades to secure long-term supply.

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Future Trends and Industry Outlook

• Increased Regulatory Scrutiny: Growing emphasis on traceability and batch-to-batch consistency will shape sourcing strategies.
• Emerging Manufacturers: New entrants in China and India may offer competitive alternatives but require careful qualification.
• Supply Chain Resilience: Developing stockpiles and diversified supplier bases will be central to mitigating global disruptions.

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Conclusion

The procurement of high-quality iopromide bulk API is critical for the consistent production of Ultravist. Leading suppliers include established originators like Bracco Pharma and certified generic API manufacturers across China and India. Strategic sourcing, strict quality adherence, and comprehensive supplier qualification underpin supply chain resilience and compliance. As regulatory landscapes evolve, proactive engagement with reputable API producers remains essential for pharmaceutical success.

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Key Takeaways

• Quality Assurance: Prioritize suppliers with rigorous GMP certification, comprehensive documentation, and proven regulatory compliance for iopromide API.
• Diversification Strategy: Engage multiple qualified sources to safeguard against supply interruptions.
• Regulatory Vigilance: Ensure API batch documentation aligns with pharmacopoeial standards and regulatory requirements.
• Cost vs. Quality: Balance competitive pricing with quality controls to optimize supply for Ultravist manufacturing.
• Future Preparedness: Invest in supplier relationships and capacity planning to anticipate industry shifts and demand fluctuations.

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FAQs

1. What are the primary regulatory standards for sourcing iopromide API?
Answer: Suppliers must comply with pharmacopeial standards (USP, EP, IP), have GMP certification, and provide comprehensive documentation like Certificates of Analysis and stability data, ensuring safety and consistent quality suitable for pharmaceutical manufacturing.

2. Which regions dominate the bulk API supply for iodinated contrast agents?
Answer: China and India are the leading regions due to their large-scale manufacturing capabilities, competitive pricing, and growing exports. Europe and the USA host key originators like Bracco and Baxter.

3. What are the critical quality attributes for iopromide API?
Answer: Iodine content (50-53%), low water content (<0.5%), endotoxin limits (<0.5 EU/mg), and minimal impurities per pharmacopeial specifications form the basis of quality attributes.

4. How can manufacturers ensure supply chain resilience for iopromide API?
Answer: By establishing relationships with multiple certified suppliers, conducting rigorous qualification audits, maintaining safety stocks, and monitoring supply chain risks.

5. Are there any emerging competitors or alternative suppliers for iopromide API?
Answer: Yes, several emerging players in Asia aim to enter the market, but due diligence is essential to verify compliance, quality, and capacity before engagement.

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References

[1] Bracco Imaging. Ultravist Product Information.
[2] Jiangsu Hengrui Medicine Co., Ltd. Corporate Website and Product Data.