OMNIPAQUE 140 pharmaceutical API fine chemical vendors

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Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich	⤷ Get Started Free	D2158_SIGMA	⤷ Get Started Free
Molport	⤷ Get Started Free	MolPort-003-931-371	⤷ Get Started Free
Hangzhou APIChem Technology	⤷ Get Started Free	AC-1934	⤷ Get Started Free
Amadis Chemical	⤷ Get Started Free	A835339	⤷ Get Started Free
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Last updated: July 28, 2025

Introduction

OMNIPAQUE 140 is a medical imaging contrast agent containing iohexol, a nonionic, water-soluble radiographic contrast medium used primarily in computed tomography (CT) scans. As a critical component in diagnostic imaging, the quality, reliability, and sourcing of iohexol APIs are paramount to healthcare providers and pharmaceutical manufacturers. Ensuring a steady supply of high-quality IOhexol API requires an understanding of the key suppliers, manufacturing standards, geographic distribution, and market dynamics.

Overview of Iohexol API in OMNIPAQUE 140

Iohexol (chemical formula: Coptrogen 16, molecular weight: 821.1 g/mol) is synthesized through complex chemical processes involving multiple proprietary steps. As the API core in OMNIPAQUE 140 (which contains 140 mg/mL of iohexol), the API's purity, stability, and compliance with pharmacopeial standards (such as USP, EP, or BP) are critical in manufacturing.

The API is supplied by select global manufacturers, primarily based in Asia and Europe, adhering to Good Manufacturing Practices (GMP) and regulatory standards from agencies like the FDA, EMA, and others.

Key API Manufacturers for Iohexol

1. GE Healthcare (United States/Sweden)

GE Healthcare is a predominant producer of iohexol, including the API used in OMNIPAQUE. They maintain a vertically integrated manufacturing process, ensuring rigorous quality controls. Their facilities are GMP-certified, and they supply pharmaceutical companies and API producers worldwide.

Strengths: Global distribution, GMP compliance, advanced R&D capabilities.
Market focus: API manufacturing, finished drug products, and contract manufacturing.

2. Laboratorios Salvador (Mexico)

This Latin American pharmaceutical manufacturer produces iohexol API that complies with international standards. They focus on serving regional markets and are expanding their GMP-certified facilities to meet global demands.

Strengths: Cost-effective manufacturing, regional distribution.
Market focus: API for local and nearby markets, with increasing regulatory accreditation.

3. Leonhard Müller GmbH & Co. (Germany)

An established European producer specializing in excipients and specialty pharmaceuticals, Leonhard Müller also supplies iohexol API, emphasizing purity and regulatory compliance for export markets.

Strengths: European GMP standards, high-quality control, proven regulatory compliance.
Market focus: High-end pharmaceutical APIs for Tier 1 manufacturers.

4. Zhuhai Aosaike Medical Technology Co., Ltd. (China)

A rapidly growing Chinese manufacturer with GMP certification approved by the NMPA (National Medical Products Administration). They produce generic iohexol API for domestic and export markets.

Strengths: Significant cost advantages, scale of production.
Market focus: Domestic China market, Southeast Asia, and increasingly international markets.

5. Shanghai Justus Pharmaceutical Co., Ltd. (China)

This Chinese company offers iohexol API with an emphasis on quality and regulatory compliance. Their production processes are aligned with GMP standards, aiming at global export.

Strengths: Competitive pricing, expanding international footprint.
Market focus: Cost-sensitive markets, Asia-Pacific.

6. SPL (Synergy Pharmaceuticals Limited, India)

An Indian pharmaceutical company known for producing a range of radiocontrast agents, including iohexol API. They conform to US FDA and European GMP standards and are a reliable source for global markets.

Strengths: Cost competitiveness, high-quality API, established export channels.
Market focus: Asia, Africa, and emerging markets.

Market Dynamics and Supply Chain Considerations

Regulatory Compliance: Sourcing API from manufacturers compliant with GMP and meeting pharmacopoeial standards is essential for regulatory approval of finished contrast agents. Certifications like FDA approval, EMA Certification, and validation reports are critical factors.

Quality Assurance: Buyers should seek suppliers providing detailed Certificates of Analysis (CoA), stability data, and batch release documentation. API purity typically exceeds 99%, with low levels of residual solvents and impurities.

Capacity and Scalability: Manufacturers like GE Healthcare dominate market share, but newer entrants from China and India offer scalable options addressing the growing demand driven by global healthcare expansion.

Strategic Partnerships: Long-term contractual relationships with reputable API producers can mitigate shortages and ensure consistent supply, particularly amidst global disruptions like pandemics or geopolitical tensions.

Regulatory Considerations

API sourcing for OMNIPAQUE 140 must comply with regional regulatory requirements:

United States: FDA-approved API manufacturers with cGMP certification.
European Union: EMA-approved or compliant manufacturers with valid Manufacturing Authorization.
China & India: NMPA and CDSCO certifications, respectively, often considered equivalent under international equivalence standards when supply is verified.

Emerging Trends in API Sourcing for Iohexol

Shift to Regional Production: Countries like China and India are increasingly independent in API manufacturing, reducing reliance on Western producers.
Vertical Integration: Major pharmaceutical companies are investing directly in API production to control quality and supply chain security.
Sustainability Initiatives: Manufacturers emphasizing green chemistry and environmentally friendly processes are gaining accreditation, appealing to global buyers.

Conclusion

The sourcing landscape for Iohexol API in OMNIPAQUE 140 is characterized by a blend of established Western producers like GE Healthcare, alongside emergent Chinese and Indian manufacturers. Ensuring regulatory compliance, high purity, and reliable supply channels remains pivotal for pharmaceutical companies manufacturing contrast agents. Strategic partnerships, due diligence, and quality assurance measures are essential to mitigate risks and ensure continuity of supply.

Key Takeaways

Leading API producers for Iohexol include GE Healthcare, Laboratorios Salvador, Leonhard Müller, and Chinese manufacturers like Zhuhai Aosaike and Shanghai Justus.
Regulatory compliance and GMP certification are non-negotiable criteria for sourcing high-quality API.
Regional diversification helps mitigate supply chain disruptions and caters to specific market needs.
Emerging markets’ increased capacity offers cost-effective options but necessitate thorough due diligence.
Strategic partnerships with validated manufacturers are vital for consistent supply and regulatory success.

FAQs

1. What are the primary qualities to look for in an Iohexol API supplier?
Suppliers should demonstrate GMP compliance, high API purity (>99%), consistent manufacturing processes, comprehensive quality documentation, and reputable regulatory approvals.

2. How does regional manufacturing impact API quality standards?
While GMP standards are globally recognized, regional differences may influence manufacturing practices. Choosing certified GMP producers aligned with international standards minimizes quality risks.

3. Are Chinese and Indian iohexol API manufacturers reliable?
Yes, many have achieved GMP certification and export approvals, offering cost-effective options. Due diligence through audits and batch testing is essential.

4. Is vaccine or contrast agent API sourcing impacted by geopolitical issues?
Yes, geopolitical tensions can influence access and pricing, emphasizing the need for diversified sourcing strategies and regional suppliers.

5. What future trends are expected in API sourcing for contrast agents?
Increased regional production, vertical integration, focus on sustainability, and advanced quality assurance practices will shape the sourcing landscape.

Sources:

Bulk Pharmaceutical API Sources for OMNIPAQUE 140