Suppliers and packagers for VASCEPA

VASCEPA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057	NDA	Amarin Pharma Inc.	52937-001-04	4 CAPSULE in 1 BOTTLE (52937-001-04)	2012-10-01
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057	NDA	Amarin Pharma Inc.	52937-001-20	120 CAPSULE in 1 BOTTLE (52937-001-20)	2012-10-01
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057	NDA	Amarin Pharma Inc.	52937-001-21	120 CAPSULE in 1 BOTTLE (52937-001-21)	2012-10-01
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057	NDA	Amarin Pharma Inc.	52937-003-16	1 BLISTER PACK in 1 CARTON (52937-003-16) / 16 CAPSULE in 1 BLISTER PACK	2016-09-16
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057	NDA	Amarin Pharma Inc.	52937-003-40	240 CAPSULE in 1 BOTTLE (52937-003-40)	2016-09-16

Suppliers for the Pharmaceutical Drug: VASCEPA

Last updated: July 27, 2025

Introduction

VASCEPA (icosapent ethyl) is a prescription medication used primarily to reduce cardiovascular risk in adults with elevated triglycerides. As a purified form of eicosapentaenoic acid (EPA), VASCEPA has gained significant attention within the pharmaceutical industry and the healthcare sector. Its success hinges on a reliable and strategic supply chain encompassing raw material sourcing, manufacturing, and distribution channels. This report evaluates the primary suppliers involved in the production of VASCEPA, emphasizing their roles, market influence, and implications for stakeholders.

Active Pharmaceutical Ingredient (API) Supply Chain

At the core of VASCEPA's manufacturing process is the procurement of high-quality EPA, the active ingredient. The API must meet stringent regulatory standards, including purity, bioavailability, and stability. The primary suppliers of EPA for VASCEPA are specialized suppliers who produce pharmaceutical-grade oils derived from marine sources such as anchovies, sardines, and other oily fish.

Key Suppliers for EPA Raw Materials

• Croda International: A global specialty chemicals company, Croda supplies EPA-rich oils derived from marine and plant-based sources. Its marine oil extracts are often used in nutraceutical and pharmaceutical formulations, with a strong emphasis on purity and sustainability. Croda's technological expertise ensures consistent EPA batches suitable for pharmaceutical use.

• EPAX AS: Located in Norway, EPAX specializes in the extraction and purification of marine omega-3 fatty acids, especially EPA and DHA. Their products comply with pharmaceutical-grade standards, making them a preferred API supplier for pharmaceutical companies seeking high-purity marine oils.

• GC Rieber Oils: Also based in Norway, this company supplies marine oils rich in EPA, adhering to strict quality controls. They have longstanding experience in providing pharmaceutical-grade omega-3 oils and are involved in the supply chain for VASCEPA.

• Kaneka Corporation: A Japanese chemical manufacturing company producing pharmaceutical-grade EPA derived from fish oil. Kaneka has extensive R&D capabilities and regulatory compliance expertise critical for supporting the high-purity standards required for VASCEPA.

Manufacturing Partners and Contract Packaging

Once the raw EPA is procured, pharmaceutical manufacturers partner with contract manufacturing organizations (CMOs) to produce VASCEPA capsules. Major pharmaceutical companies, such as Amarin Corporation, which markets VASCEPA, often utilize external manufacturing partners with proven GMP (Good Manufacturing Practice) compliance.

• Amarin Corporation: While Amarin's proprietary manufacturing processes are closely guarded, the company has disclosed collaborations with multiple manufacturing facilities globally for VASCEPA production, including those in the United States and Europe. These partners handle formulation, encapsulation, and packaging.

• Contract Manufacturers: Leading CMO providers for VASCEPA include companies like Catalent and Alphonse Laboratories, both recognized for pharmaceutical-grade production capabilities, ensuring compliance with international quality standards.

Distribution and Supply Chain Management

Distribution channels for VASCEPA encompass wholesalers, specialty pharmacies, and healthcare providers. Effective management of this supply chain is vital, especially given the elevated demand following positive clinical trial outcomes and expanding indications.

Supply Chain Challenges and Risk Factors

• Raw Material Sustainability: Overfishing concerns and marine biodiversity regulations impact EPA sourcing. Suppliers like EPAX and Croda invest heavily in sustainable fishing and sourcing practices to mitigate risks.

• Regulatory Compliance: API suppliers must maintain compliance with regulations such as the FDA’s Current Good Manufacturing Practices (CGMP) and international equivalents. Non-compliance can disrupt the supply chain.

• Market Dynamics: The demand for EPA-rich oils is also driven by nutraceutical markets, potentially impacting pharmaceutical-grade supplies. Strategic inventory management is essential.

• Geopolitical Risks: Political instability, trade restrictions, and tariffs in regions dominating marine oil production, such as Scandinavia and Asia, can influence supply chain stability.

Emerging Suppliers and Future Outlook

The increasing demand for EPA-based therapies has encouraged new entrants into the market:

• Equate Brands & Smaller Suppliers: Some smaller biotech firms are developing synthetic or genetically engineered EPA to diversify supply sources and reduce dependence on marine extraction.

• Synthetic EPA Development: Advances in biotechnology are enabling the production of EPA via microbial fermentation, promising more sustainable and scalable sources. Companies like Evonik are exploring such technologies.

Conclusion

The supply ecosystem for VASCEPA involves a complex web of specialized raw material suppliers, contract manufacturers, and logistics providers. The primary EPA suppliers are Croda, EPAX, GC Rieber Oils, and Kaneka Corporation, each bringing high standards of purity and regulatory compliance. The success of VASCEPA’s market position depends on maintaining a resilient supply chain that navigates sustainability, regulatory, and geopolitical challenges. Future innovations in synthetic manufacturing and sustainable sourcing will likely alter the landscape, offering new opportunities for stakeholders.

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Key Takeaways

• Strategic sourcing of EPA is critical, with leading suppliers like Croda, EPAX, GC Rieber Oils, and Kaneka providing high-purity active ingredients for VASCEPA.

• Sustainability and regulatory compliance remain central to securing uninterrupted supply chains, particularly given environmental concerns around marine sourcing.

• Manufacturing partnerships are vital to ensure GMP-compliant production, encapsulation, and packaging, with notable players like Catalent serving as key CMO providers.

• Emerging synthetic and bioengineered EPA sources present opportunities to diversify supplier bases, reduce dependence on marine oils, and enhance supply stability.

• Market growth and demand fluctuations necessitate proactive supply chain management to mitigate risks related to geopolitics, environmental regulations, and raw material availability.

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FAQs

1. Who are the main suppliers of EPA raw materials for VASCEPA?

The primary suppliers include Croda International, EPAX AS, GC Rieber Oils, and Kaneka Corporation, all of which provide pharmaceutical-grade EPA derived from marine sources.

2. How does sustainability impact the supply of EPA for VASCEPA?

Sustainable fishing practices and marine resource management are essential to prevent overfishing and ensure long-term availability of EPA raw materials, influencing supplier selection and sourcing strategies.

3. Are there alternative sources of EPA for VASCEPA production?

Yes, biotechnology firms are developing synthetic and bioengineered EPA via microbial fermentation, offering potential scalable and sustainable alternatives to marine extraction.

4. What role do contract manufacturing organizations play in VASCEPA supply?

CMOs handle formulation, encapsulation, and packaging of VASCEPA, bridging the gap between raw material suppliers and market distribution, ensuring GMP compliance.

5. How might geopolitical factors affect the supply chain for VASCEPA?

Trade policies, tariffs, and regional political stability, especially in key sourcing regions like Scandinavia and Asia, can influence supply continuity and costs.

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References

[1] Croda International PLC. "Marine Oils and Omega-3 Fatty Acids." Croda, 2022.
[2] EPAX AS. "Marine Omega-3 Fatty Acids for Pharmaceutical Use." EPAX Reports, 2022.
[3] GC Rieber Oils. "Sustainable Marine Oil Production." Company Website, 2022.
[4] Kaneka Corporation. "Pharmaceutical-Grade EPA Derived from Fish Oil." Kaneka, 2022.
[5] Amarin Corporation. "VASCEPA Supply Chain and Manufacturing." Investor Relations, 2023.