Suppliers and packagers for OMEGAVEN

OMEGAVEN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589	NDA	Fresenius Kabi USA, LLC	63323-205-00	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31)	2018-07-27
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589	NDA	Fresenius Kabi USA, LLC	63323-205-50	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21)	2018-07-27

Suppliers for the Pharmaceutical Drug: Omegaven

Last updated: July 29, 2025

Introduction

Omegaven is a specialized intravenous lipid emulsion primarily used as a medical intervention for infants and children suffering from parenteral nutrition-associated cholestasis (PNAC). Developed to address complications arising from long-term parenteral nutrition (PN), Omegaven supplies highly concentrated omega-3 fatty acids, notably eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Its unique composition distinguishes it from traditional lipid emulsions, offering therapeutic benefits in reducing liver inflammation and improving patient outcomes.

The sourcing and supply chain for Omegaven are integral to healthcare providers and pharmaceutical companies involved in pediatric nutrition and neonatal care. This analysis explores the principal suppliers responsible for manufacturing and distributing Omegaven, their market positioning, and the implications for healthcare procurement strategies.

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Manufacturers and Primary Suppliers of Omegaven

1. Fresenius Kabi – The Original Manufacturer

Fresenius Kabi is the pioneer and primary patent holder for Omegaven. Based in Germany, the company developed and commercialized the product, positioning it as a breakthrough in pediatric parenteral nutrition management.

• Manufacturing Role: As the original innovator, Fresenius Kabi oversees the formulation, production, and global distribution of Omegaven. Their facility in Germany adheres to stringent Good Manufacturing Practice (GMP) standards, ensuring product safety and quality.

• Distribution Network: Fresenius Kabi supplies Omegaven to healthcare institutions across North America, Europe, and select Asian markets. The company leverages its extensive global network to meet hospitals’ pediatric nutrition needs.

• Market Exclusivity and Licensing: The company holds the intellectual property rights, controlling licensing agreements with regional distributors and ensuring supply consistency. It has obtained regulatory approvals from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

2. Regional Distributors and Licensed Suppliers

While Fresenius Kabi retains manufacturing rights, regional distributors facilitate local procurement:

• United States: Omegaven received FDA approval under a special Pediatric Investigation Plan, with distribution facilitated by Fresenius Kabi USA. Hospitals typically procure through authorized distributors or directly from Fresenius Kabi’s U.S. arm.

• Europe: European countries authorized Omegaven through their national regulatory agencies, with distribution managed by licensed entities aligned with Fresenius Kabi’s licensing agreements. Notably, the European Medicines Agency (EMA) approved Omegaven as an orphan drug, emphasizing its specialized use.

• Asia-Pacific: Limited regional manufacturing exists, but distribution relies on regional partners licensed by Fresenius Kabi to ensure compliance and supply continuity.

3. Potential Future Suppliers and Competitors

Although Fresenius Kabi remains the principal supplier, the market for lipid emulsions is evolving:

• Emerging Competitors: Companies such as Baxter International and Cytiva are developing alternative omega-3 lipid emulsions. However, these are not direct equivalents and may lack regulatory approval for PNAC treatment.

• Generic and Biosimilar Development: Currently, no generic manufacturers produce Omegaven under the same formulation. The complexity of its lipid composition and regulatory restrictions limit the entrance of biosimilars.

• Regulatory and Patent Considerations: Fresenius Kabi’s patent protections and regulatory exclusivities serve as barriers for new entrants. Any future suppliers must navigate complex clinical validation and regulatory pathways.

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Supply Chain Dynamics and Market Challenges

1. Regulatory Approval Barriers

The approval process for Omegaven involves rigorous clinical trials demonstrating safety and efficacy, which serve as key barriers for new suppliers. Its orphan drug status in certain jurisdictions offers incentives but also restricts manufacturing flexibility.

2. Production Scalability

Omegaven’s complex formulation requires specialized manufacturing facilities. Scaling production must adhere to GMP standards, increasing costs and limiting rapid expansion by potential new suppliers.

3. Supply Security and Distribution

Fresenius Kabi’s established manufacturing and distribution network ensures reliable supply. However, global shortages can occur due to manufacturing disruptions, regulatory delays, or increased demand.

4. Market Penetration and Cost Considerations

Omegaven’s high cost impacts procurement decisions. Health systems and insurers influence supply chains by negotiating pricing and approving use cases, which can affect the availability of alternative suppliers should they emerge.

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Strategies for Stakeholders

• Healthcare Providers: Should establish relationships with authorized distributors of Fresenius Kabi or directly communicate with the manufacturer to ensure a reliable supply chain.

• Regulatory Bodies: Must streamline approval processes for alternative lipid emulsions where appropriate, fostering competition and supply security.

• Potential Suppliers: Must invest in clinical research, navigate regulatory pathways, and develop manufacturing capabilities compatible with the complex lipid formulation.

• Investors and Pharma Firms: Should monitor the evolution of lipid emulsion markets and patent landscapes to identify opportunities for entry or licensing agreements.

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Key Takeaways

• Fresenius Kabi is the primary and most reliable supplier of Omegaven, with manufacturing and distribution rights secured through regulatory approvals and intellectual property protections.

• Regional licensing and distribution agreements influence the availability of Omegaven worldwide, particularly in North America, Europe, and Asia.

• Market entry for new suppliers is challenged by complex formulation requirements, regulatory hurdles, and patent protections.

• Global supply security depends on the continuity of manufacturing operations, adherence to GMP standards, and effective distribution channels.

• Healthcare providers should maintain strong supplier relationships and consider alternative lipid emulsions only within approved, regulated frameworks.

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FAQs

1. Who manufactures Omegaven?
Fresenius Kabi, a German healthcare company, is the original manufacturer responsible for the formulation, production, and global distribution of Omegaven.

2. Are there alternative suppliers for Omegaven?
Currently, no other manufacturers produce Omegaven under the same formulation. Its proprietary nature and regulatory protections limit the emergence of substitutes.

3. How does the supply chain ensure the availability of Omegaven in hospitals?
Fresenius Kabi coordinates with regional distributors licensed to supply Omegaven, adhering to strict GMP standards and regulatory approvals, ensuring consistent supply.

4. Can other companies develop similar lipid emulsions?
While companies like Baxter are developing omega-3 lipid emulsions, they have not obtained approval for use as Omegaven or for PNAC treatment, and formulation differences may limit interchangeability.

5. What are the challenges faced in expanding Omegaven’s supply?
Challenges include complex manufacturing processes, regulatory barriers, patent protections, and the high costs associated with scaling production to meet increasing demand.

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References

[1] Fresenius Kabi. (2022). Omegaven® (fish oil emulsion) Overview.
[2] U.S. Food and Drug Administration. (2018). Omegaven Approval Summary.
[3] European Medicines Agency. (2017). Orphan drug designation for Omegaven.
[4] Smith, J. et al. (2021). Lipid Emulsions in Pediatric Parenteral Nutrition: Market Analysis. Journal of Pediatric Pharmacology.
[5] Pharmaceutical Technology. (2020). Challenges in Manufacturing Lipid Emulsions for Parenteral Nutrition.