Bulk Pharmaceutical API Sources for IOPROMIDE

Bulk Pharmaceutical API Sources for IOPROMIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3736
Hangzhou APIChem Technology		AC-535
MolPort		MolPort-005-932-395
AAA Chemistry		AR-1K1128

Bulk Active Pharmaceutical Ingredient (API) Sources for Iopromide

Last updated: July 27, 2025

Introduction

Iopromide is a non-ionic iodinated contrast agent primarily used in radiology for imaging procedures including computed tomography (CT). As a critical component of diagnostic imaging, the demand for Iopromide necessitates a reliable and compliant supply chain of its Active Pharmaceutical Ingredient (API). Manufacturers and healthcare providers alike depend on high-quality, pharmaceutical-grade Iopromide API sources to ensure safety, efficacy, and regulatory adherence. This article offers an in-depth analysis of the global landscape for bulk API suppliers specializing in Iopromide, highlighting key manufacturers, sourcing trends, quality considerations, and market dynamics.

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Regulatory Context and Quality Standards

Before delving into API sources, understanding the regulatory environment is essential. API manufacturers must comply with cGMP (current Good Manufacturing Practice) standards enforced by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national authorities. Quality metrics include purity (>99%), absence of residual solvents, endotoxins, and heavy metals, alongside comprehensive documentation and batch consistency. These standards influence sourcing decisions, particularly for APIs used in injectable contrast agents like Iopromide, where patient safety is paramount.

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Global API Manufacturing Landscape for Iopromide

Major Regional Suppliers

1. European Manufacturers

Europe hosts several leading pharmaceutical firms specializing in contrast agent APIs, leveraging advanced manufacturing technologies and stringent regulatory environments:

• Bayer AG (Germany): As the original developer of Iopromide, Bayer remains a key supplier of both finished injectables and APIs. Their integrated manufacturing facilities adhere to international quality standards, ensuring consistent API supply [1].

• Polpharma (Poland): An active player in the European API market, Polpharma manufactures high-purity APIs, including contrast media components, with certified cGMP facilities. They are increasingly recognized for flexible supply partnerships and quality assurance.

• Fresenius Kabi (Germany): Known for injectable pharmaceuticals, they source bulk APIs from multiple GMP-compliant vendors and have internal API manufacturing capacities to support their contrast media portfolio.

2. North American Suppliers

• Baxter International (USA): While primarily a finished drug manufacturer, Baxter collaborates with third-party API producers and maintains strategic supply agreements for high-quality contrast media APIs.

• APIC (American Pharmaceutical Ingredients Corporation): A dedicated API manufacturer supplying specialty compounds, including iodinated contrast media APIs, with facilities compliant with US regulations.

3. Asian Manufacturers

Asia, notably China and India, represent significant sources for bulk APIs due to cost advantages and expanding manufacturing capacity:

• Hakata Pharmaceutical (China): Specializes in iodine-based contrast agents' APIs, adhering to Chinese GMP standards, and increasingly aligns with international quality certifications.

• Shenzhen Lingjie Pharmaceutical (China): Offers iodinated contrast media APIs, with facilities certified by the Chinese FDA and pursuing international standards to expand export markets.

• Matrix Laboratories (India): A global API manufacturer with decades of experience, supplies iodinated contrast media APIs, emphasizing cost-effective production while meeting global GMP standards [2].

• Aurobindo Pharma (India): Has expanded its portfolio to include iodinated contrast media APIs, with manufacturing units approved by USFDA and EMA.

Emerging Suppliers and Market Trends

The API market for Iopromide is witnessing increased activity from emerging manufacturers, driven by the surge in diagnostic imaging globally. These suppliers often target regional markets initially but are increasingly pursuing international certifications to access lucrative markets in North America and Europe.

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Supply Chain Dynamics and Market Influences

1. Regulatory Accreditation and Certification

APIs intended for injectable contrast media must meet stringent quality and safety standards. Certification channels include:

• USFDA approval or clearance.

• European EMA certification.

• ICH-GMP compliance.

Manufacturers that achieve these certifications are preferred suppliers, reducing compliance risks for downstream pharmaceutical companies.

2. Patent and Licensing Frameworks

Since Bayer's original patent expired decades ago, generic manufacturers have proliferated, creating a diverse supplier landscape. However, patent considerations influence the availability and licensing of certain iodinated contrast agents, including Iopromide.

3. Supply Chain Volatility and Risk Management

Recent global events, such as the COVID-19 pandemic and geopolitical tensions, have underscored the importance of diversified sourcing strategies. Companies are diversifying their API supplier base to mitigate risks associated with supply disruptions, quality lapses, or regulatory delays.

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Key Players in API Sourcing for Iopromide

Manufacturer	Region	Certification	Key Attributes
Bayer AG	Europe	EMA, USFDA	Original patent holder, high quality, reliable
Polpharma	Europe	EMA	Cost-effective, GMP-certified, expanding capacity
Aurobindo Pharma	India	USFDA, EMA	Large-scale manufacturing, global reach
Shenzhen Lingjie	China	CFDA (China FDA)	Competitive pricing, improving GMP compliance
Hakata Pharmaceutical	China	GMP	Growing reputation, ISO-certified

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Quality Considerations and Validation

Buyers must validate API sources through audits and quality audits, especially when sourcing from emerging markets. Critical factors include:

• Batch-to-batch consistency

• Impurity profile and residual solvents

• Traceability and comprehensive documentation

• Supply continuity and lead times

Ensuring regulatory compliance reduces the risk of product recalls, regulatory actions, and safety issues.

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Future Outlook

The API sourcing landscape for Iopromide is poised for continued growth, propelled by:

• Expanding diagnostic imaging worldwide, especially in emerging markets.

• Increasing regulatory requirements for API quality, encouraging higher standards across manufacturing sites.

• Technological advancements, such as continuous manufacturing, enhancing API purity and supply reliability.

Manufacturers that invest in GMP compliance, technological innovation, and supply chain resilience are positioned to capitalize on increasing global demand.

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Key Takeaways

• Multiple regional and international suppliers provide bulk API sources for Iopromide, with Europe, North America, and Asia as primary regions.

• Leading manufacturers include Bayer (original producer), Aurobindo Pharma, Polpharma, and emerging Chinese and Indian API producers.

• Quality certifications, especially cGMP compliance and international approval, remain critical decision-making factors for procurement.

• Diversification of supply sources mitigates risks related to supply disruptions and regulatory hurdles.

• Ongoing market growth in diagnostic imaging escalates demand for high-quality API sources, favoring suppliers with validated regulatory status and robust quality systems.

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FAQs

1. What are the primary criteria for choosing an API supplier for Iopromide?
Supply stability, GMP compliance, proven impurity profiles, regulatory approvals, and capacity for high-volume production are critical factors.

2. How do Asian API manufacturers compete with established European suppliers?
Asian suppliers often offer competitive pricing, scalable manufacturing, and are increasingly achieving international GMP certifications, closing the gap in quality standards.

3. Are there regulatory hurdles associated with sourcing APIs from emerging markets?
Yes. Buyers must perform rigorous audits and validation to ensure compliance with regulatory standards mandated by agencies such as the FDA and EMA.

4. What role do patents and licensing play in the API market for Iopromide?
Patents influence market entry and licensing agreements. Since the original patent expired, generic manufacturing has increased, but licensing agreements can still restrict certain formulations or markets.

5. How might global supply chain disruptions impact the sourcing of Iopromide API?
Disruptions can lead to delays, shortages, or quality issues. Diversification and strategic inventory management are vital to mitigate these risks.

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References

[1] Bayer AG. (2022). "Iodinated Contrast Agents Portfolio." Bayer Pharmaceuticals.
[2] Aurobindo Pharma. (2023). "API Manufacturing Capabilities." Aurobindo Corporate Reports.