Bulk Pharmaceutical API Sources for OMNIPAQUE 9

Bulk Pharmaceutical API Sources for OMNIPAQUE 9

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D2158_SIGMA
Molport		MolPort-003-931-371
Hangzhou APIChem Technology		AC-1934
Amadis Chemical		A835339
AKos Consulting & Solutions		AKOS015895399

Bulk Active Pharmaceutical Ingredient (API) Sources for OMNIPAQUE 9

Last updated: December 12, 2025

Executive Summary

OMNIPAQUE 9 is a medical imaging contrast agent primarily containing the active pharmaceutical ingredient (API) iohexol. As a nonionic, water-soluble iodinated compound utilized to enhance imaging clarity in radiology, the quality, and source of its API are critical for ensuring product efficacy, safety, and regulatory compliance. This analysis evaluates global API suppliers capable of producing iohexol at scale, the criteria for sourcing, and the implications for pharmaceutical manufacturers seeking reliable, high-quality bulk API sources for OMNIPAQUE 9.

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Overview of Iohexol as the API in OMNIPAQUE 9

Property	Specification
API Name	Iohexol
Chemical Formula	C₂₂H₂₈I₃N₃O₃
Molecular Weight	807.13 g/mol
Function	Radiopaque contrast agent for imaging
Concentration in OMNIPAQUE 9	Typically 9-350 mg I/mL

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Market Landscape of Iohexol API Suppliers

Major global API suppliers for iohexol include:

Supplier	Location	Certification	Capacity	Notable Features
BASF	Germany	GMP, ISO 9001/13485	High volume, integrated supply chain	Leading innovator in iodinated compounds
Jiangsu HengRui Medicine Co., Ltd	China	GMP, EMA	Large manufacturing scale	Cost-effective, fast supply
LKT Laboratories	USA	cGMP	Limited but consistent	Focused on high-quality API
United Laboratories (United Pharma)	China	GMP, ISO 9001	Growing capacity	Competitive pricing, quality focus
Sicomins	India	GMP, ISO	Expanding capacity	Cost advantage, quality assurance

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Sources of Bulk Iohexol API for OMNIPAQUE 9 Production

1. Leading Multinational API Manufacturers

• BASF: A pioneer in iodinated radiocontrast agents, offering high-purity iohexol via integrated supply chains. Their APIs are benchmarked globally for stability and regulatory compliance, including FDA and EMA approvals.

• Jiangsu Hengrui Medicine Co., Ltd: Offers bulk iohexol, emphasizing scale production and adherence to strict GMP standards, suitable for large-volume manufacturing.

• Siegfried AG: Known for developing and manufacturing high-quality APIs, including iohexol, with a focus on stringent quality controls.

2. Regional API Suppliers

• Chinese Manufacturers: Numerous firms like Zhejiang Haizheng Pharmaceutical Co., Ltd and Zhejiang Huahai Pharmaceutical Co., Ltd compete on cost and capacity, often providing APIs compatible with international standards.

• Indian Manufacturers: Such as Ipca Laboratories and Sun Pharmaceutical Industries, offering competitive prices.

• U.S. and European Players: Niche suppliers emphasizing regulatory compliance, quality, and reliable supply chains.

3. Contract Manufacturing Organizations (CMOs)

• Several CMOs possess capabilities to produce iohexol under license or via technology transfer, facilitating flexible or regional supply options. Examples include Lonza and Recipharm.

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Criteria for Selecting API Suppliers for OMNIPAQUE 9

Criterion	Description	Impact
Regulatory Compliance	GMP, cGMP, ISO 9001/13485	Ensures product acceptance globally
Manufacturing Capacity	Ability to meet demand fluctuations	Ensures supply continuity
Purity and Quality Standards	≥98% purity with validated impurity profiles	Critical for safety and efficacy
Cost and Lead Time	Competitive pricing; short procurement cycles	Cost-effective manufacturing
Supply Chain Reliability	Proven track record of on-time delivery	Minimizes production delays

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Quality and Regulatory Considerations

• Certifications: Suppliers must have GMP certification aligned with regional regulatory agencies (FDA, EMA, PMDA).

• Quality Attributes:

  • High API purity (>98%)
  • Low residual solvents
  • Consistent batch-to-batch quality

• Regulatory Approvals:

  • API should be manufactured under validated processes compliant with pharmacopoeia monographs (USP, EP, JP).
  • Documentation supporting non-interference with imaging modalities.

• Documentation:

  • Certificates of Analysis (CoA)
  • Type II Drug Master Files (DMF)
  • Process validation reports

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Comparison of API Suppliers for Iohexol

Supplier	Certification	Capacity (kg/year)	Purity (%)	Lead Time	Estimated Cost (USD/kg)	Geographic Focus
BASF	GMP, ISO	1,000+	98.5+	3-6 months	$5,000 – $6,000	Europe, Global
Jiangsu Hengrui	GMP	500+	98+	2-4 months	$4,500 – $5,500	China, Asia
LKT Labs	cGMP	100+	98+	2-3 months	$6,000 – $7,000	USA
United Labs	GMP	300+	98+	3-5 months	$4,800 – $5,800	China, Asia
Indian Suppliers	GMP	200–500	98+	3-6 months	$4,200 – $5,200	India, Global

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Supply Chain and Logistics Implications

• Global sourcing enables flexible procurement strategies but requires risk management, especially concerning geopolitical factors and regional disruptions.

• Quality assurance mandates rigorous audits and batch validation before integration into OMNIPAQUE 9 manufacturing.

• Pricing dynamics fluctuate based on capacity, regulatory developments, and raw material costs.

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Deep-Dive: Regional Differences and Regulatory Paths

Region	Regulatory Framework	Key Suppliers	Key Considerations
United States	FDA	LKT Labs, U.S.-based manufacturers	Emphasize cGMP compliance, robust documentation
Europe	EMA	BASF, Siegfried AG	Focus on pharmacopoeial standards
China	NMPA	Jiangsu Hengrui, United Labs	Cost-effective, recent increases in quality standards
India	DCGI	Ipca, Sun Pharma	Cost advantage, emerging GMP standards

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FAQs: Bulk API Sourcing for OMNIPAQUE 9

Q1: What are the main challenges when sourcing iohexol API globally?
Supply chain disruptions, regional quality standards, regulatory approvals, and capacity constraints are primary challenges.

Q2: How does API purity influence the safety profile of OMNIPAQUE 9?
Higher purity reduces the risk of adverse reactions and imaging artifacts. US and European pharmacopoeias specify minimum purity levels of 98%.

Q3: Can regional API suppliers meet international regulatory standards?
Yes, many have achieved certifications like GMP, ISO, and DMF registration with major regulatory bodies.

Q4: What are the cost implications of sourcing API from different regions?
Asian suppliers generally offer lower costs but may require additional testing for regulatory compliance. Western suppliers may be more expensive but easier to register in stringent markets.

Q5: How can purchasing organizations mitigate supply chain risks for API procurement?
By diversifying suppliers, establishing long-term contracts, maintaining safety stock, and conducting regular audits.

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Key Takeaways

• Provider Diversity: Secure multiple API sources—particularly from reputable multinational firms like BASF and regional leaders in China and India—to ensure supply stability.

• Priority Standards: Ensure API suppliers comply with GMP, ISO, and pharmacopoeia standards, with certification documentation ready for audits and regulatory submissions.

• Quantitative Capabilities: Align supplier capacity with production needs, enforcing quality via batch validation.

• Cost-Quality Balance: While Asian suppliers offer cost savings, Western suppliers may provide enhanced regulatory compatibility; balance accordingly.

• Regulatory Preparedness: Verify that API batches are supported by comprehensive documentation compliant with target markets’ standards.

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References

[1] BASF SE. “Iohexol API Data Sheet,” 2022.
[2] Jiangsu Hengrui Medicine Co., Ltd. “Product Portfolio and Quality Certification,” 2023.
[3] U.S. FDA. “Guidance for Industry: API Manufacturing,” 2021.
[4] European Pharmacopoeia (EP). “Iohexol monograph,” 2022.
[5] Global API Market Report. “Iohexol OEM and API Supplier Analysis,” 2023.