Bulk Pharmaceutical API Sources for OMNIPAQUE 70

Bulk Pharmaceutical API Sources for OMNIPAQUE 70

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D2158_SIGMA
Molport		MolPort-003-931-371
Hangzhou APIChem Technology		AC-1934

Bulk Active Pharmaceutical Ingredient (API) Sources for: OMNIPAQUE 70

Last updated: July 30, 2025

Introduction

Omnipaque 70, recognizable by its generic name iohexol, is a non-ionic, water-soluble radiographic contrast agent primarily used in computed tomography (CT) imaging to enhance visualization of blood vessels, tissues, and organs. As a critical component in diagnostic imaging, the quality and reliability of the active pharmaceutical ingredient (API) — iohexol — significantly influence the safety, efficacy, and regulatory compliance of Omnipaque 70.

This article examines the global landscape of API sourcing for iohexol, focusing on manufacturers, regions, quality standards, and strategic considerations crucial for pharmaceutical companies seeking reliable API suppliers. Ensuring a stable, high-quality API supply chain is pivotal to maintaining consistent product quality and meeting regulatory requirements in the highly competitive contrast media market.

Overview of Iohexol API Market

Iohexol was first introduced in the 1990s and has been widely adopted in diagnostic imaging. The API market for iohexol is characterized by a limited number of specialized manufacturers due to complex synthesis processes, stringent quality requirements, and regulatory hurdles.

Key players include large, established pharmaceutical excipient and API manufacturers, many located in Europe, Asia, and North America. The market dynamics are further influenced by factors such as manufacturing capacity, regulatory approvals, pricing competitiveness, and supply chain robustness.

Major API Producers for Iohexol (OMNIPAQUE 70)

1. GE Healthcare (USA/Europe)

GE Healthcare, the original developer of Omnipaque, remains a top source of high-quality iohexol API, either through its manufacturing units or authorized third-party suppliers. The company emphasizes strict compliance with Good Manufacturing Practices (GMP) and certifications such as FDA, EMA, and other regional authorities.

• Manufacturing Locations: Mainly in the United States and Europe, with an extensive distribution network.
• Strengths: Proven quality standards, reliable supply, direct integration with the Omnipaque brand.
• Considerations: Higher pricing driven by brand reputation and quality assurance.

2. Guerbet (France)

Guerbet is a leading European manufacturer of contrast agents, including iohexol. The company produces its own API or sources from approved suppliers, maintaining a strong focus on purity and safety.

• Manufacturing Locations: France and other European facilities.
• Strengths: High-quality standards in line with European regulations, robust regulatory track record, and integrated R&D.
• Considerations: Potential supply chain limitations due to regional manufacturing.

3. JGL (Jelgava, Latvia)

JGL is recognized for developing and manufacturing pharmaceutical APIs, including iohexol, primarily for the European and Asian markets.

• Manufacturing Locations: Latvia, with additional production facilities in Asia.
• Strengths: Competitive pricing, ISO and GMP certifications, experienced in complex API syntheses.
• Considerations: Customer service and logistics capabilities to ensure adherence to strict timelines.

4. Zydus Cadila (India)

Zydus Cadila has expanded into the contrast media sector, sourcing iohexol from reputable API producers for formulations.

• Manufacturing Locations: India, with global export capabilities.
• Strengths: Cost advantages, robust manufacturing standards, and compliance with international regulations.
• Considerations: Variability depending on the specific API supplier.

5. Other Asian Manufacturers

Several other Chinese and Indian API manufacturers offer iohexol, often competing on price and capacity. These include companies like Delta Pharmaceuticals, Hetero Labs, and IPCA Laboratories.

• Manufacturing Locations: China and India.
• Strengths: Cost-effective and significant production capacity.
• Considerations: Variability in quality control, regulatory approvals, and consistency.

Criteria for Selecting API Suppliers

Choosing an API supplier for iohexol entails rigorous evaluation across several dimensions:

• Regulatory Compliance: Suppliers must hold GMP certifications (USFDA, EMA, PMDA) and adhere to quality standards such as ISO.
• Manufacturing Capacity and Lead Time: Reliable supply chains with sufficient capacity to meet demand fluctuations.
• Quality Assurance: High purity (>99%), low endotoxin levels, and batch-to-batch consistency.
• Regulatory Track Record: Proven compliance with customer and regional regulatory bodies.
• Cost and Logistics: Competitive pricing, favorable payment terms, and logistics capabilities, including temperature-sensitive shipping.

Regulatory and Quality Considerations

API suppliers must comply with international standards to facilitate seamless regulatory approvals for end products. Certificates of Analysis (COA), Certificates of Origin, stability data, and batch documentation are prerequisites for procurement.

In particular, sourcing from manufacturers with established records for purity, stability, and safety reduces compliance risks, which can otherwise translate into costly approval delays or product recalls.

Emerging Trends and Strategic Sourcing

The shift towards consolidating supply chains and increasing reliance on Asian API manufacturers presents opportunities and risks. While cost advantages are compelling, due diligence ensures quality assurance aligns with global standards.

Furthermore, increasing regulatory scrutiny necessitates strategic partnerships with suppliers maintaining transparent quality management systems and continual process validation. Pharmaceutical companies are also exploring dual-sourcing strategies to mitigate supply risks.

Challenges in API Sourcing for Iohexol

• Limited Supplier Pool: The complex synthesis process and regulatory barriers restrict the number of suppliers.
• Quality Variability: Ensuring consistent API quality across batches from multiple sources demands rigorous qualification processes.
• Regulatory Barriers: Different regulatory standards can limit the use of certain suppliers in specific markets.
• Price Fluctuations: Market demand and geopolitical factors influence pricing dynamics.

Conclusion: Optimal Strategies for API Procurement

Pharmaceutical firms manufacturing Omnipaque 70 should prioritize API suppliers with proven regulatory compliance, manufacturing excellence, and reliable logistics. Establishing long-term strategic partnerships with reputable suppliers like GE Healthcare and Guerbet can safeguard against supply disruptions. Additionally, vetting emerging Asian manufacturers through audits and validation processes can diversify the supply chain and reduce costs.

Key Takeaways

• The primary API providers for iohexol include GE Healthcare, Guerbet, JGL, Zydus, and select Asian manufacturers.
• Supplier selection hinges on quality standards, regulatory compliance, capacity, and logistical reliability.
• European manufacturers maintain stringent standards aligning with global regulatory requirements, albeit at higher costs.
• Asian suppliers offer economic benefits but require thorough validation to ensure quality and compliance.
• Strategic sourcing involves balancing cost, supply security, and regulatory adherence to sustain consistent Omnipaque 70 production.

FAQs

1. What are the critical quality parameters for Iohexol API?

Iohexol API should exhibit >99% purity, low endotoxin levels, and consistent batch-to-batch quality validated through comprehensive testing, including HPLC, residual solvents, and sterility assessments.

2. Which regulatory certifications should API manufacturers for iohexol possess?

Manufacturers should be GMP-certified (USFDA, EMA, or equivalent), ISO-certified, and able to provide detailed documentation such as Certificates of Analysis, Certificates of Origin, and stability data.

3. How does regional regulation influence API sourcing?

Regional regulations impact supplier acceptance, often necessitating specific certifications or compliance standards. European and US regulators emphasize strict quality and safety standards, limiting procurement to approved suppliers.

4. What are the risks of sourcing API from emerging Asian manufacturers?

Risks include variability in quality control, regulatory acceptance challenges, supply chain reliability, and potential delays due to inspection or compliance issues.

5. How can pharmaceutical companies mitigate supply chain risks for iohexol API?

By adopting dual-sourcing strategies, establishing long-term partnerships with verified suppliers, implementing rigorous quality audits, and maintaining safety stock levels based on forecasted demand.

Sources

1. [1] GE Healthcare: Iohexol API specifications and sourcing.
2. [2] European Pharmacopoeia, Monoograph: Iohexol.
3. [3] Guerbet official manufacturing and quality overview.
4. [4] Market analysis reports on contrast media APIs.
5. [5] International conference on pharmaceutical API sourcing and regulation updates.