Suppliers and packagers for OMNIPAQUE 240

OMNIPAQUE 240

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956	NDA	GE Healthcare Inc.	0407-1401-52	10 BOTTLE, PLASTIC in 1 BOX (0407-1401-52) / 50 mL in 1 BOTTLE, PLASTIC	2004-05-25
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956	NDA	GE Healthcare Inc.	0407-1411-10	10 VIAL, GLASS in 1 BOX (0407-1411-10) / 10 mL in 1 VIAL, GLASS	2004-07-15
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956	NDA	GE Healthcare Inc.	0407-1412-10	10 VIAL, GLASS in 1 BOX (0407-1412-10) / 10 mL in 1 VIAL, GLASS	1985-12-26

Suppliers for the Pharmaceutical Drug: OMNIPAQUE 240

Last updated: July 29, 2025

Introduction

OMNIPAQUE 240, a high-contrast iodinated radiocontrast agent, is widely used in diagnostic imaging, particularly in computed tomography (CT) scans and angiography. Its primary function is to enhance diagnostic clarity by providing high-density contrast within blood vessels and tissues. As a critical pharmaceutical substance, the procurement and supply chain of OMNIPAQUE 240 are vital for hospitals, imaging centers, and pharmaceutical distributors globally. This report explores the key suppliers, manufacturing landscape, and strategic considerations for sourcing OMNIPAQUE 240 effectively.

Background on OMNIPAQUE 240

OMNIPAQUE 240, with a concentration of 240 mg/mL iodine, is trademarked by GE Healthcare. Its formulation comprises iohexol, an iodine-based contrast agent, designed for rapid distribution and minimal adverse reactions. The drug's efficacy and safety profile have made it a preferred choice among radiologists and clinicians. The global demand for OMNIPAQUE 240 has risen in tandem with increasing diagnostic imaging procedures, especially in developed markets such as North America and Europe, and emerging markets experiencing healthcare expansion.

Manufacturers of OMNIPAQUE 240

GE Healthcare

As the original developer and patent holder of OMNIPAQUE 240, GE Healthcare remains the dominant global manufacturer. The company's manufacturing facilities are geographically dispersed, including sites in the United States, Europe, and Asia, ensuring broad supply coverage. GE guarantees compliance with stringent regulatory standards, such as FDA approvals in the U.S. and EMA approvals in Europe, positioning it as the primary, reliable supplier.

Authorized Distributors and Contract Manufacturing

Although GE Healthcare is the sole producer of OMNIPAQUE 240, the product is distributed through authorized medical and pharmaceutical distributors worldwide. These distributors often operate under strict contractual agreements, ensuring authenticity and regulatory compliance. Some regional distributors include:

• McKesson Corporation (United States)
• Cardinal Health (United States)
• GE Healthcare Life Sciences distributors in Europe and Asia
• Regional distributors in emerging markets like India and Southeast Asia

In specific markets, local contract manufacturing arrangements or authorized resellers facilitate distribution, particularly where importation barriers exist.

Third-party Contract Manufacturers

While GE Healthcare maintains manufacturing dominance, some regional companies may engage in contract manufacturing for the distribution of generic or equivalent iodinated contrast agents. However, these are not direct suppliers of OMNIPAQUE 240 but may produce biosimilar equivalents, which are not identical but serve similar clinical purposes.

Supply Chain Dynamics and Key Considerations

Regulatory Approvals and Quality Standards

Suppliers for OMNIPAQUE 240 must adhere to rigorous regulatory standards, predominantly from agencies such as the FDA (U.S.), EMA (Europe), and other regional authorities. Certification of Good Manufacturing Practices (GMP) and regular audits are prerequisites for supplier credibility.

Supply Chain Risks

Global supply chains for high-demand pharmaceuticals like OMNIPAQUE 240 are susceptible to disruptions from:

• Manufacturing plant closures due to regulatory issues or operational problems.
• Raw material shortages, especially iodine sources.
• Trade restrictions or tariffs impacting import/export.
• Logistical challenges, including transportation delays, especially during global crises like the COVID-19 pandemic.

Diversification of suppliers and regional manufacturing facilities mitigate these risks.

Pricing and Procurement Strategies

Procuring OMNIPAQUE 240 involves considerations of cost, supply reliability, and regulatory compliance. The high demand may lead to price volatility, necessitating strategic stockpiling or multi-supplier sourcing to ensure continuity of supply.

Emerging Trends and Market Outlook

Growth in Diagnostic Imaging

The rising incidence of cardiovascular diseases, cancers, and chronic conditions supports an increasing global demand for iodinated contrast agents like OMNIPAQUE 240. The expansion of imaging infrastructure in Asia-Pacific and Latin America further enhances supply needs.

Regulatory Approvals for Biosimilars and Generics

Although no generic versions of OMNIPAQUE 240 are currently approved or marketed, ongoing development of biosimilars and alternative contrast agents could influence future supply landscapes, encouraging price competition and supply diversification.

Environmental and Sustainability Initiatives

Manufacturers are emphasizing eco-friendly production methods, waste reduction, and sustainable sourcing of raw materials, aligning with the global push toward responsible manufacturing.

Strategic Sourcing Recommendations

• Establish relationships with authorized GE Healthcare distributors to ensure the authenticity and compliance of OMNIPAQUE 240.
• Engage with regional supply chain partners to diversify Sources, reducing dependence on a single manufacturer.
• Monitor regulatory developments and ensure supplier certifications remain up-to-date.
• Incorporate buffer stock policies during periods of known supply fluctuations or geopolitical instability.
• Evaluate potential for alternative contrast agents or generics, where applicable, to secure uninterrupted supply.

Conclusion

While GE Healthcare remains the exclusive producer of OMNIPAQUE 240, comprehensive understanding of its supply network, regulatory environment, and market trends is essential for reliable procurement. The global increase in diagnostic imaging services underscores the importance of strategic sourcing, supplier diversification, and proactive supply chain management to meet healthcare demands efficiently.

---

Key Takeaways

• Primary Manufacturer: GE Healthcare is the sole official producer of OMNIPAQUE 240, with supply distributed through regional authorized partners.
• Supply Chain Resilience: Diversify suppliers and establish regional partnerships to mitigate risks associated with manufacturing or logistical disruptions.
• Regulatory Compliance: Ensure suppliers maintain GMP certifications and comply with regional regulatory requirements to guarantee product safety and efficacy.
• Market Growth: Increased global imaging procedures drive demand, necessitating robust procurement strategies.
• Future Trends: Biosimilars and alternative contrast agents could influence market dynamics; staying informed ensures strategic advantage.

---

FAQs

1. Who are the main suppliers of OMNIPAQUE 240?
GE Healthcare is the exclusive manufacturer. Procurement is facilitated via authorized distributors and regional partners globally.

2. Can I source OMNIPAQUE 240 from regions outside the US and Europe?
Yes. Regional distributors and authorized resellers operate in Asia, Latin America, and other markets, complying with local regulatory standards.

3. Are there generic or biosimilar alternatives to OMNIPAQUE 240?
Currently, no approved generics or biosimilars exactly match OMNIPAQUE 240. However, alternative iodinated contrast agents exist and may serve similar diagnostic purposes.

4. What supply chain risks should I consider when sourcing OMNIPAQUE 240?
Risks include manufacturing delays, raw material shortages, regulatory issues, and logistical disruptions. Diversification and proactive management mitigate these risks.

5. How might upcoming regulations impact the supply of OMNIPAQUE 240?
Regulatory changes could alter import/export requirements, approval processes for biosimilars, or manufacturing standards, affecting availability and pricing.

---

Sources:

[1] GE Healthcare. "Omnipaque (Iohexol) Contrast Media." GE Healthcare, 2023.
[2] U.S. Food and Drug Administration. "Approvals for Iodinated Contrast Agents," 2023.
[3] MarketWatch. "Global Contrast Media Market Outlook," 2023.
[4] European Medicines Agency. "Medical Product Approvals," 2023.