fish oil triglycerides: Pharmaceutical manufacturers, suppliers, and wholesalers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Fish oil triglycerides have gained prominence in pharmaceutical formulations due to their high omega-3 fatty acid content, mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). As a key ingredient in dietary supplements, prescription medications, and functional foods, the demand for high-quality fish oil triglycerides continues to rise globally. This report provides a comprehensive overview of the leading suppliers in this market, emphasizing their capabilities, geographic presence, compliance standards, and strategic positioning.

Market Overview

The global market for pharmaceutical-grade fish oil triglycerides is driven by increasing awareness about cardiovascular health, cognitive benefits, and anti-inflammatory effects associated with omega-3 fatty acids. Industry players supply a complex mix of refined fish oils sourced from various marine species, including anchovies, sardines, mackerel, and krill. Suppliers focus on purity, concentration, and sustainable sourcing to meet stringent regulatory standards.

Leading Suppliers of Fish Oil Triglycerides

1. Garrycell Corporation

Garrycell, headquartered in South Korea, is a prominent supplier specializing in pharmaceutical-grade omega-3 triglycerides. Their products undergo rigorous distillation processes to ensure high purity (>95%), free from heavy metals and PCBs, complying with international standards like USP and GOED. The company emphasizes sustainable harvesting, sourcing fish from certification bodies such as the Marine Stewardship Council (MSC). Garrycell’s strategic focus on innovation and quality positions it as a preferred partner in the pharmaceutical industry.

2. Polaris Marine Ingredients

Based in Norway, Polaris Marine Ingredients supplies high-concentration fish oil triglycerides derived from wild-caught Atlantic anchovies and sardines. Their manufacturing process emphasizes supercritical CO2 extraction and molecular distillation to achieve pharmaceutical-grade purity. Polaris boasts certifications including HACCP, GMP, and ISO 22000, aligning with global pharmaceutical standards. Their focus on transparency and sustainability has enhanced their reputation among pharmaceutical companies worldwide.

3. FMC Corporation (Fish Oils Division)

A global leader in specialty chemicals, FMC’s fish oils division offers pharmaceutical-grade triglycerides with EPA and DHA concentrations exceeding 30%. Their products are characterized by extensive documentation of purity, stability, and bioavailability. FMC emphasizes sustainable sourcing and employs advanced purification techniques, including low-temperature winterization and bleaching. Their extensive distribution network ensures reliable supply chains across North America, Europe, and Asia.

4. KD Pharma Group

Based in Germany, KD Pharma specializes in high-concentration omega-3 triglycerides for pharmaceutical and nutraceutical applications. Their proprietary lipid purification technologies enable production of triglycerides with minimal oxidation products and high stability. KD Pharma’s products are used in several pharmaceutical formulations and are compliant with USP, EP, and other pharmacopeial standards. Their rigorous quality management and certifications support their position as a top-tier supplier.

5. Croda International Plc.

UK-based Croda’s Omega-3 triglyceride oils are extracted from sustainably sourced fish and krill. Croda emphasizes eco-friendly practices, including eco-harvesting and eco-innovation. Their products meet strict pharmaceutical purity standards and are used in prescription drugs, OTC products, and clinical nutrition. Croda’s global infrastructure facilitates broad distribution and customization per client specifications.

6. OmegaTech Corporation

OmegaTech, headquartered in the United States, provides pharmaceutical-grade fish oil triglycerides with high EPA/DHA ratios, focusing on advanced purification and concentration techniques. Their products are marketed as tailored solutions for TM (triglyceride matrix) formulations, emphasizing stability, bioavailability, and solubility. OmegaTech maintains strict adherence to cGMP guidelines and ISO standards to ensure product integrity.

7. Iberol S.L.

Spain-based Iberol specializes in marine-derived triglycerides for pharmaceutical and nutraceutical applications. Their extraction and refining processes are designed to ensure purity, potency, and sustainability. Iberol’s products are compliant with all major international pharmacopoeias, supporting global distribution.

Emerging and Niche Suppliers

8. Marvesa

Marvesa produces omega-3 triglycerides sourced from sustainable fish stocks within the Pacific Ocean. Their focus on eco-certifications and innovative extraction methods makes them a rising player in the quality-conscious pharmaceutical sector.

9. Aker BioMarine

Specializing in krill oil, Aker BioMarine offers pharmaceutical-grade triglycerides rich in EPA and DHA, along with astaxanthin. Their sustainable harvesting practices and unique lipid profiles appeal to drug developers targeting niche markets.

10. ELC Omega

ELC Omega offers a range of concentrated fish oil triglycerides designed for pharmaceutical use, emphasizing ultra-purification and minimal oxidation. Their strategic alliances with research institutions bolster their technological advancement.

Regulatory and Sustainability Considerations

Leading suppliers ensure compliance with global regulatory frameworks, including the U.S. Pharmacopeia (USP), European Pharmacopoeia (EP), and GOED standards. Sustainability certification from organizations like MSC and Friend of the Sea (FOS) adds value by aligning with corporate social responsibility mandates. Transparency in sourcing, extraction, and processing remains a critical differentiator among top suppliers.

Strategic Positioning and Market Dynamics

Global demand for pharmaceutical-grade fish oil triglycerides hinges on consistent quality, supply reliability, and sustainability. Suppliers investing in R&D, advanced purification technologies, and sustainable fisheries are better positioned for long-term growth. Strategic partnerships with pharmaceutical formulators, customization capabilities, and compliance with evolving regulations enhance vendor competitiveness.

Key Challenges for Suppliers

Ensuring consistent supply amid fluctuating wild-caught fish stocks.
Meeting increasingly stringent purity and stability standards.
Managing environmental impacts and maintaining sustainable sourcing.
Navigating complex regulatory landscapes across multiple jurisdictions.
Balancing cost-efficiency with high product quality.

Conclusion

The market for pharmaceutical-grade fish oil triglycerides features a diverse set of established global players and innovative niche suppliers. Leaders like Garrycell, Polaris Marine Ingredients, FMC, KD Pharma, and Croda maintain strong market positions through a focus on purity, sustainability, and regulatory compliance. Emerging manufacturers leverage technological advances and sustainability trends to carve their niches. Continued innovation, sustainable sourcing, and strict adherence to quality standards will underpin success in this competitive landscape.

Key Takeaways

The top suppliers of pharmaceutical-grade fish oil triglycerides emphasize purity, sustainability, and regulatory compliance to meet pharmaceutical standards.
Countries like Norway, Germany, the UK, South Korea, and Spain host leading manufacturers with advanced extraction and refinement technologies.
Sustainability certifications (MSC, FOS) are increasingly vital for market credibility and compliance.
Reliable supply chains and technological innovation are essential for competitive advantage amid fluctuating wild fish stocks.
Strategic partnerships and customization capabilities will shape future vendor success in this niche.

FAQs

What are the primary specifications for pharmaceutical-grade fish oil triglycerides?
They must contain high EPA and DHA concentrations (often >30%), be free from heavy metals, PCBs, and oxidation products, and comply with pharmacopeial standards like USP and EP.
How do sustainability practices influence supplier credibility?
Certification from organizations like MSC or FOS signals responsible sourcing, which is increasingly important for pharmaceutical manufacturers seeking environmentally conscious ingredients.
Can suppliers customize fish oil triglyceride formulations?
Yes, many suppliers provide tailored concentrations, encapsulation, and purification processes to meet specific drug formulation requirements.
What extraction technologies are common among leading suppliers?
Supercritical CO₂ extraction, molecular distillation, low-temperature winterization, and bleaching are employed to maximize purity and stability.
How does the market for fish oil triglycerides address supply chain risks?
Suppliers mitigate risks through diversified sourcing, establishing long-term fish supply agreements, maintaining strategic reserves, and investing in sustainable harvest practices.

References
[1] "Global Fish Oil Market and Industry Trends," MarketsandMarkets, 2022.
[2] "Sustainable Fish Oil Sourcing," Marine Stewardship Council, 2021.
[3] "Pharmaceutical Standards for Fish Oil," United States Pharmacopeia, 2023.
[4] "Extraction Technologies for Omega-3 Oils," Journal of Food Science, 2020.
[5] "Regulatory Landscape for Marine-derived Ingredients," European Medicines Agency, 2022.

Suppliers and packagers for generic pharmaceutical drug: fish oil triglycerides