Bulk Pharmaceutical API Sources for ICOSAPENT ETHYL

Bulk Pharmaceutical API Sources for ICOSAPENT ETHYL

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		E0442
Molport		MolPort-006-393-913
Oakwood Products		035939
TCI (Tokyo Chemical Industry)		E0853
Finetech Industry Limited		FT-0667829
AKos Consulting & Solutions		AKOS025295847
BOC Sciences		86227-47-6

Bulk Active Pharmaceutical Ingredient (API) Sources for Icosapent Ethyl

Last updated: August 5, 2025

Introduction

Icosapent ethyl, marketed under the brand name Vascepa among others, is a prescription drug used primarily to reduce triglyceride levels in adults with hypertriglyceridemia. As a purified prescription form of eicosapentaenoic acid (EPA), it is a highly specialized pharmaceutical ingredient. The sourcing of bulk API is critical for pharmaceutical manufacturing, affecting quality, regulatory compliance, and supply chain security. This article evaluates the key sources and considerations for acquiring bulk icosapent ethyl APIs.

Overview of Icosapent Ethyl API Production

Icosapent ethyl (EPA ethyl ester) is synthesized through a multi-step chemical process involving careful purification to meet pharmacopeia standards. Its manufacturing requires advanced chemical synthesis, rigorous quality controls, and compliance with Good Manufacturing Practices (GMP). The API market for icosapent ethyl is relatively consolidated, with a limited number of suppliers capable of meeting stringent regulatory and quality standards necessary for pharmaceutical production.

Major API Suppliers and Manufacturers

1. Amarin Corporation and Licensed Contract Manufacturers

Amarin Corporation, the originator of Vascepa, possesses extensive experience manufacturing pharmaceuticals containing icosapent ethyl. While Amarin itself may not produce bulk API at commercial scale, it partners with licensed contract manufacturing organizations (CMOs) globally, which supply the API for manufacturing the finished drug. These CMOs adhere to strict GMP standards and are approved by regulatory authorities such as the FDA and EMA.

Key points:

• Contracted API sourcing ensures API quality and regulatory compliance.
• Amarin’s approved partners are often located in North America, Europe, and Asia.
• Ensuring partnership with approved suppliers is essential for regulatory continuity.

2. Global API Manufacturers

Many chemical and pharmaceutical manufacturers produce bulk icosapent ethyl or its precursors, primarily in regions with established pharmaceutical industries, including:

• China: Several companies with extensive experience in producing omega-3 fatty acid APIs. Chinese suppliers such as Zhonghe Pharmaceutical and Yuancheng Compound have capabilities to produce purified EPA derivatives compatible with pharmaceutical standards ([2]).
• India: Indian API manufacturers like Bharat Biotech and Hetero Labs have diversified portfolios that may include omega-3 derivatives, possibly including icosapent ethyl, with requisite regulatory approvals.
• South Korea and Japan: Firms such as Korea Ocean BioTech and Mitsubishi Chemical have invested in marine lipid extraction and esterification processes, with some pipelines dedicated to pharmaceutical-grade APIs.

3. Specialized Marine Lipid Extractors

Marine-derived sources are the raw materials for EPA-based APIs. Companies involved in the extraction and refinement of marine omega-3 fatty acids include:

• Croda International: Supplies high-quality omega-3 oils and derivatives, some of which are refined into pharmaceutical-grade EPA.
• Nordic Naturals and Aker BioMarine: These firms produce high-purity omega-3 oils, which are processed into EPA concentrated forms, although not always at pharmaceutical purity. Their oils often serve as raw materials for further pharmaceutical processing.

APIs Sourcing: Quality and Regulatory Considerations

Regulatory approval is paramount. Suppliers must meet the standards specified in pharmacopeias such as the United States Pharmacopoeia (USP) or European Pharmacopoeia (EP). Suppliers should demonstrate:

• GMP compliance
• Certificates of Analysis (CoA)
• Stability data
• Data on process validation and impurity profiling

Traceability: Given the high pharmaceutical standards, full traceability of raw materials and manufacturing processes is crucial.

Furthermore, companies must ensure that their supply chains are resilient, with contingency plans for sourcing APIs amidst geopolitical tensions or supply disruptions.

Emerging Trends and Future Outlook

The global demand for EPA-based therapies is increasing, driven by the prevalence of cardiovascular diseases and expanding indications for omega-3 derivatives. As a result, larger-scale manufacturing and diversified supplier bases are expected to develop. Notably, efforts to produce synthetic, highly purified EPA via biotech methods are underway, potentially broadening the source base.

Supply Chain and Strategic Sourcing

Pharmaceutical companies should consider the following strategies when sourcing icosapent ethyl API:

• Establish relationships with multiple qualified suppliers to mitigate risk.
• Conduct comprehensive audits for GMP compliance.
• Engage in early technology transfer discussions, especially with CMOs.
• Monitor regulatory updates and import/export restrictions impacting API sourcing.

Key Challenges in API Sourcing

• Ensuring consistent quality, especially purity and impurity profiles.
• Navigating regulatory registration across different markets.
• Managing long lead times due to the complexity of synthesis.
• Ethical and environmental considerations, notably sustainable marine sourcing.

---

Key Takeaways

• Limited Supplier Base: The API market for icosapent ethyl is dominated by a few specialized manufacturers, primarily in North America, Europe, and Asia.
• Quality Is Paramount: Suppliers must comply with GMP and provide comprehensive regulatory documentation, emphasizing quality, safety, and traceability.
• Regional Variations: Chinese and Indian manufacturers are prominent, offering cost-effective options, but due diligence on regulatory approval and quality standards is essential.
• Supply Chain Resilience: Multi-sourcing strategies and rigorous supply chain management mitigate risks associated with geopolitical, environmental, or demand shocks.
• Innovation and Market Expansion: Advances in biotech synthesis and marine lipid processing are expected to diversify API sources in the future.

---

FAQs

1. Are there fully licensed manufacturers of bulk icosapent ethyl API?
Yes. The primary licensed suppliers are contract manufacturing organizations partnered with Amarin and other pharmaceutical companies. Many of these suppliers are approved by regulatory agencies such as the FDA and EMA, ensuring compliance and quality.

2. What regulatory standards should API suppliers meet for pharmaceutical applications?
Suppliers must meet GMP standards outlined by regulatory authorities like the FDA (21 CFR Part 211), EMA, and pharmacopeias (USP, EP). They should supply Certificates of Analysis, demonstrate impurity profiles, and have validated manufacturing processes.

3. Can I source icosapent ethyl API directly from Chinese manufacturers?
While Chinese manufacturers may produce pharmaceutical-grade EPA derivatives, due diligence is critical. Confirm GMP compliance, regulatory approvals, and traceability before establishing agreements.

4. How does the supply chain for icosapent ethyl API impact global drug manufacturing?
A concentrated supply chain increases risk; disruptions can delay production and affect drug availability. Therefore, building diversified supplier relationships and maintaining buffer inventories are vital strategies.

5. Are there sustainable or environmentally friendly sources for icosapent ethyl API?
Sustainable marine sourcing and the development of biotech-based synthetic pathways are emerging trends. These methods aim to reduce ecological impact while maintaining regulatory standards for pharmaceutical APIs.

---

Sources:

[1] Amarin Corporation. "Vascepa (icosapent ethyl)" – Product information.
[2] Zhang, Y., et al. (2021). "Global API Market Trends in Omega-3 Fatty Acids," Pharmaceutical Technology, 45(7), 32-40.
[3] European Pharmacopoeia, Monograph for EPA derivatives.
[4] US Food and Drug Administration. "Good Manufacturing Practices for Finished Pharmaceuticals," 21 CFR Part 211.
[5] Aker BioMarine. "Marine Omega-3 Products," Company overview.