Suppliers and packagers for OMNIPAQUE 350

OMNIPAQUE 350

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 350	iohexol	SOLUTION;INJECTION, ORAL	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 350	iohexol	SOLUTION;INJECTION, ORAL	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 350	iohexol	SOLUTION;INJECTION, ORAL	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 350

Last updated: August 4, 2025

Overview

OMNIPAQUE 350 is a widely utilized iodinated contrast agent primarily employed in intraoperative and diagnostic imaging procedures such as computed tomography (CT) scans. Its active component, iohexol, is distinguished by its high iodine content, facilitating enhanced radiopacity essential for clear imaging results. The drug’s efficacy and safety profile depend heavily on its sourcing from reliable suppliers who meet stringent regulatory standards across different markets. This article delineates the global supplier landscape for OMNIPAQUE 350, highlighting key manufacturers, distribution channels, regulatory considerations, and strategic implications for healthcare providers and stakeholders.

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Market Overview of OMNIPAQUE 350

OMNIPAQUE 350, developed by GE Healthcare, is part of a broader portfolio of contrast agents used in radiology. Its administration is critical in visualizing vascular structures, cerebral venography, and abdominal imaging, among other indications. The global demand for IOhexol-based agents like OMNIPAQUE has seen growth driven by technological advancements in imaging, increasing prevalence of diagnostic imaging procedures, and improved safety profiles compared to older contrast agents.

Key Manufacturers and Authorized Suppliers

The primary source of OMNIPAQUE 350 is GE Healthcare, which holds the original patent rights, manufacturing licenses, and distribution agreements. The company operates manufacturing facilities compliant with Good Manufacturing Practices (GMP) in various regions, including the United States, Europe, and Asia.

In addition to GE Healthcare, certain licensed generic manufacturers produce bioequivalent versions of iohexol under local regulatory approvals, though these may not carry the OMNIPAQUE branding. The following summarizes the key suppliers:

1. GE Healthcare
   As the originator, GE Healthcare remains the primary supplier for OMNIPAQUE 350, supplying directly to hospitals, pharmacies, and distributors worldwide. GE ensures rigorous quality control, regulatory compliance, and supply chain management.

2. Authorized Distributors and Regional Suppliers
   In regions where GE Healthcare’s direct distribution channels are limited, authorized regional distributors serve as intermediaries. These entities adhere to strict licensing agreements to ensure authentic products. Examples include McKesson, Cardinal Health, and Cencora, among others, which distribute in North America; and local distributors in Europe, Asia, and Africa.

3. Generic Manufacturers
   Licensed generic drug manufacturers produce iohexol formulations similar in composition but not branded as OMNIPAQUE. Notable names include Guerbet, Liebel-Flarsheim, and other regional pharmaceutical companies. These manufacturers often procure the active pharmaceutical ingredient (API) from licensed sources and produce their formulations under strict regulatory oversight.

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Regulatory Approvals and Certification

Reliability in the supply chain hinges on compliance with regulatory agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national authorities. Only licensed suppliers approved by these agencies can legally distribute OMNIPAQUE 350.

• FDA-approved suppliers must meet GMP standards and registration requirements before marketing the product in the U.S.
• EMA compliance is essential for European markets.
• WHO prequalification and adherence to International Organization for Standardization (ISO) standards enhance global credibility.

Unauthorized or counterfeit products pose significant risks, emphasizing the importance of procurement from vetted, licensed suppliers.

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Distribution Channels and Supply Chain Dynamics

Supply for OMNIPAQUE 350 follows a multi-tiered approach:

• Manufacturers to Distributors: Direct shipping from GE Healthcare’s manufacturing facilities to regional or national distributors.
• Distributors to Healthcare Providers: Distributors supply hospitals, imaging centers, and clinics, often through tender processes or direct procurement.
• Pharma Wholesalers: Large pharmaceutical wholesalers facilitate broader distribution, especially in emerging markets.

Recent supply chain disruptions, exemplified by the COVID-19 pandemic, have underscored the importance of diversified sourcing and inventory management. GE Healthcare and authorized distributors have invested in supply chain resilience to prevent shortages.

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Market Challenges and Considerations

• Patent Expiry and Generic Competition: Patent protections for iohexol formulations have led to increased generic manufacturing, impacting pricing and supply dynamics.
• Regulatory Variations: Different countries enforce varying approval standards, affecting supplier accessibility.
• Supply Security: Dependence on single-source manufacturing raises concerns of supply disruptions, especially amidst geopolitical uncertainties or manufacturing issues.

Strategic Procurement Recommendations:

• Engage with authorized distributors with proven compliance records.
• Monitor regional regulatory changes and import restrictions.
• Diversify supplier base within licensing constraints to mitigate risks.
• Verify authenticity via batch numbers, lot codes, and certification documents.

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Future Outlook

The demand for iodinated contrast media like OMNIPAQUE 350 is projected to grow steadily, driven by aging populations and expanding diagnostic imaging. Strategic sourcing from a combination of original and licensed generic manufacturers is essential to ensure continuous supply, competitive pricing, and regulatory compliance.

GE Healthcare continues to innovate, with potential pipeline updates and formulations targeting improved safety profiles, which could influence supplier dynamics. As third-party biosimilars and generics become more prevalent, stakeholders must navigate an increasingly complex supply landscape.

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Key Takeaways

• Primary supplier: GE Healthcare remains the main manufacturer and authorized supplier of OMNIPAQUE 350 globally.
• Regulatory compliance: Only suppliers approved by agencies like the FDA and EMA should be considered for procurement.
• Distribution strategy: Collaborate with reputable regional distributors to ensure product authenticity and reliable supply.
• Generic competition: Licensed generic producers provide alternative sources, often at reduced costs but with similar efficacy.
• Market resilience: Diversify sourcing and maintain inventory buffers to mitigate supply chain disruptions.

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Frequently Asked Questions (FAQs)

1. Who is the primary manufacturer of OMNIPAQUE 350?
   GE Healthcare is the sole original manufacturer and primary authorized supplier of OMNIPAQUE 350 globally.

2. Can I obtain OMNIPAQUE 350 from generic manufacturers?
   Yes, licensed generic manufacturers produce iohexol formulations comparable to OMNIPAQUE, but they may not carry the brand name. Ensure procurement from approved, compliant sources.

3. What should healthcare providers consider when sourcing OMNIPAQUE 350?
   Providers should verify supplier accreditation, confirm product authenticity, ensure regulatory approval, and assess supply chain reliability.

4. Are there regional differences in OMNIPAQUE supply?
   Yes. Distribution varies depending on regional licensing, regulations, and infrastructure, with some regions relying more heavily on local distributors or generic alternatives.

5. What are the risks associated with supply disruptions of OMNIPAQUE 350?
   Risks include imaging procedure delays, increased costs, and potential compromise of patient care. Establishing multiple supplier relationships mitigates these risks.

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References

[1] GE Healthcare. OMNIPAQUE product information.
[2] FDA Drug Approvals and Supply Chain Standards.
[3] EMA Regulations and Approved List of Contrast Agents.
[4] Global Market Reports on Contrast Media.
[5] WHO Prequalification Standards for Radiological Contrast Agents.