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Suppliers and packagers for OMNIPAQUE 140
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OMNIPAQUE 140
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 140 | iohexol | INJECTABLE;INJECTION | 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 140 | iohexol | INJECTABLE;INJECTION | 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 140 | iohexol | INJECTABLE;INJECTION | 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 |
| Ge Healthcare | OMNIPAQUE 140 | iohexol | INJECTABLE;INJECTION | 018956 | NDA | GE Healthcare Inc. | 0407-1412-20 | 10 VIAL, GLASS in 1 BOX (0407-1412-20) / 20 mL in 1 VIAL, GLASS | 1985-12-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: OMNIPAQUE 140
Introduction
OMNIPAQUE 140 is a widely used contrast agent primarily employed in diagnostic imaging procedures such as computed tomography (CT) scans. Its active ingredient, iohexol, is a non-ionic, water-soluble contrast medium that enhances visualization of vascular structures and internal organs, thereby facilitating accurate diagnosis. The pharmaceutical manufacturing landscape for OMNIPAQUE 140 is diverse, encompassing originators, branded manufacturers, and generic suppliers. This article explores the key suppliers within this market, evaluating their manufacturing capabilities, market presence, and strategic positioning to inform stakeholders’ procurement and partnership decisions.
Overview of OMNIPAQUE 140 Market Landscape
Initially developed by Guerbet, OMNIPAQUE 140 has attained widespread adoption due to its high safety profile and efficacy. Its global reach ensures extensive production networks, often involving licensed manufacturing agreements and regional subsidiaries. The market is characterized by established pharmaceutical companies, regional generics producers, and contract manufacturing organizations (CMOs) that facilitate supply continuity.
Key Suppliers and Manufacturers
1. Guerbet LLC
Role: Original Developer and Patent Holder
Market Position: Leading producer and principal supplier of OMNIPAQUE 140 globally
Guerbet LLC, headquartered in France, is the pioneer behind OMNIPAQUE 140. As the patent holder and brand owner, Guerbet maintains substantial control over the manufacturing and distribution network. The company operates multiple manufacturing plants, notably in France and the United States, ensuring supply stability across key markets.
Guerbet’s extensive distribution channels and strategic alliances facilitate worldwide access. Their focus on R&D enhances product formulation and manufacturing efficiency, maintaining their competitive edge. Guerbet’s compliance with international quality standards such as CE marking and FDA approvals underscores their reliability as a supplier.
2. Jiangsu Hengrui Medicine Co., Ltd.
Role: Licensed Manufacturer and Regional Supplier
Market Position: Asian manufacturing hub and regional supplier of iohexol-based contrast agents
Jiangsu Hengrui Medicine, a prominent Chinese pharmaceutical company, has entered licensing agreements with Guerbet to manufacture OMNIPAQUE 140 for Asian markets. Leveraging its advanced biopharmaceutical manufacturing infrastructure, Hengrui produces high-quality contrast agents that meet global standards.
Their manufacturing facilities adhere to Good Manufacturing Practices (GMP) and ISO certifications, supporting their role as a dependable regional supplier. Partnering with Hengrui allows for cost-effective procurement for Asian and some emerging markets, though supply volumes are subject to licensing agreements and regional demand.
3. Liomont S.A. de C.V. (Mexico)
Role: Regional Manufacturer and Distributor
Market Position: North American and Latin American regions
Liomont, based in Mexico, holds licensing for the local manufacturing of Iohexol-based contrast agents, including OMNIPAQUE 140, for North and Central American markets. Their facilities maintain strict compliance with US FDA and international standards, ensuring product safety and efficacy.
Liomont’s strategic location and robust distribution network position it as a key regional supplier. They serve hospitals, clinics, and diagnostic centers, with an emphasis on supplying high-quality contrast media reliably and competitively.
4. Contract Manufacturing Organizations (CMOs)
In addition to licensed pharmaceutical companies, several CMOs operate in the space, providing manufacturing services to brand owners and regional players. These organizations possess extensive capacity to scale production rapidly to meet fluctuating demand, especially during supply disruptions or surges in market demand.
Prominent CMOs include Baxter Biopharma Solutions, Fresenius Kabi, and Samsung Biologics. They often produce iohexol under contractual agreements, ensuring manufacturing flexibility and quality assurance.
Market Dynamics and Strategic Considerations
Supply Chain Concentration and Risks
The dominance of Guerbet as the original manufacturer results in a concentrated supply chain; disruptions at Guerbet’s production facilities could influence global availability. The reliance on licensed manufacturing in various regions introduces potential regulatory and licensing vulnerabilities but diversifies supply sources regionally.
Regulatory Approvals and Quality Standards
Suppliers must meet stringent regulatory requirements set by agencies such as the FDA, EMA, and regional authorities. Manufacturers maintaining certifications like GMP, ISO, and CE mark are preferred to mitigate quality risks.
Generic Market Emergence
The expiration of patents and ongoing biosimilar development have opened avenues for generic iohexol suppliers. These generics often compete on price and availability, especially in emerging markets.
Implications for Stakeholders
Procurement strategies should consider supplier reliability, manufacturing capacity, regional regulatory compliance, and cost-effectiveness. For large healthcare providers and national procurement agencies, establishing relationships with multiple licensed manufacturers, including local regional suppliers like Jiangsu Hengrui and Liomont, enhances supply resilience.
Pharmaceutical companies seeking to develop or expand contrast agent portfolios should pursue licensing agreements and technological collaborations with established manufacturers to ensure high-quality production and compliance.
Key Takeaways
- Guerbet remains the primary supplier and originator of OMNIPAQUE 140, controlling the bulk of global supply with established manufacturing and distribution networks.
- Regional suppliers like Jiangsu Hengrui (Asia) and Liomont (North and Latin America) provide critical manufacturing capabilities, often under licensing agreements, influencing regional availability.
- Contract manufacturing organizations contribute flexibility, especially during supply chain disruptions, by providing scalable manufacturing capacity.
- Supply chain reliability is crucial, given the concentrated nature of manufacturing at Guerbet; diversification through regional suppliers mitigates risks.
- Regulatory compliance and quality standards are critical selection criteria for procurement, with certifications serving as benchmarks of reliability.
FAQs
1. Who are the primary suppliers of OMNIPAQUE 140?
Guerbet LLC is the original manufacturer and primary global supplier. Regional players like Jiangsu Hengrui (Asia) and Liomont (North and Latin America) are licensed manufacturers providing regional supply.
2. Can generic manufacturers produce OMNIPAQUE 140?
While the patent rights have expired or are licensed, many manufacturers produce generic iohexol-based contrast agents. These generics often compete on price and regional availability but may vary in formulation and regulatory approval.
3. How does supply chain concentration affect procurement?
High reliance on Guerbet enhances risks related to supply disruptions. Diversifying suppliers through regional licensing and CMOs reduces vulnerability and ensures continuity.
4. What regulatory standards must suppliers meet?
Suppliers must comply with GMP, ISO, and regional drug authority standards such as FDA approvals or EMA certifications, ensuring product safety and efficacy.
5. What factors should buyers consider when selecting OMNIPAQUE 140 suppliers?
Key considerations include supply reliability, manufacturing capacity, regulatory compliance, product quality certifications, cost, and regional distribution capabilities.
Sources
[1] Guerbet. (2022). Company Information and Product Portfolio.
[2] China Food and Drug Administration. (2021). Regulatory approvals for Jiangsu Hengrui.
[3] Liomont. (2022). Product Certification and Manufacturing Standards.
[4] MarketWatch. (2022). Global Contrast Media Market Analysis.
[5] Pfizer, Merck, and generic manufacturers filings. (2022). Regulatory and Licensing Data.
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