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Suppliers and packagers for OMEGA-3-ACID ETHYL ESTERS
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OMEGA-3-ACID ETHYL ESTERS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 204940 | ANDA | Amneal Pharmaceuticals LLC | 65162-034-06 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06) | 2015-11-30 |
| Amneal Pharms | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 204940 | ANDA | Amneal Pharmaceuticals LLC | 65162-034-16 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16) | 2015-11-30 |
| Amneal Pharms | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 204940 | ANDA | Amneal Pharmaceuticals LLC | 65162-034-32 | 360 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-32) | 2015-11-30 |
| Apotex | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 090973 | ANDA | Bryant Ranch Prepack | 72162-2111-2 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (72162-2111-2) | 2014-09-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Omega-3-Acid Ethyl Esters
Introduction
Omega-3-acid ethyl esters are a pharmaceutical formulation primarily used to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Marketed under brand names like Lovaza (by GlaxoSmithKline), the formulation offers a prescription-grade omega-3 supplement derived from fish oil. As demand for cardiovascular health treatments rises, identifying reliable suppliers for omega-3-acid ethyl esters becomes critical for pharmaceutical companies, distributors, and healthcare providers. This article presents a comprehensive overview of the primary suppliers, manufacturing sources, and industry dynamics influencing the supply chain.
Understanding Omega-3-Acid Ethyl Esters Production
Omega-3-acid ethyl esters are produced through a complex chemical process involving the purification of fish oil-rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). These fatty acids are esterified with ethanol to produce ethyl ester derivatives, which enhance bioavailability and stability. The manufacturing process requires high-grade raw materials, sophisticated purification techniques, and quality control compliant with regulatory standards such as those issued by the FDA and EMA.
Leading Suppliers and Manufacturers of Omega-3-Acid Ethyl Esters
1. KD Pharma Group
KD Pharma is recognized as one of the leading producers of pharmaceutical-grade omega-3 fatty acids, including omega-3-acid ethyl esters. Based in Germany, KD Pharma specializes in high-quality, clinically validated omega-3 solutions, supplying both active pharmaceutical ingredients (APIs) and finished formulations. The company has invested in robust extraction and purification facilities, ensuring consistent product quality, meets cGMP standards, and supplies to major pharmaceutical firms globally [1].
2. Pronova BioPharma (Part of S], A Novartis affiliate)
Pronova, a Norwegian company now part of Novartis, pioneered the commercial development of high-purity omega-3 fatty acids. Their manufacturing facilities produce pharmaceutical-grade fish oil concentrates, and their products have been integrated into several formulations, including omega-3-acid ethyl esters. Although production shifted post-acquisition, Pronova remains a significant technology and Quality leader in the field [2].
3. Therabal Pharma
Therabal Pharma, an Indian pharmaceutical company, has emerged as a notable supplier of omega-3 ethyl esters, catering to both domestic and international markets. Their manufacturing units adhere to stringent quality standards, and they produce bulk API ingredients supplied to pharmaceutical companies globally for the formulation of prescription and OTC omega-3 products [3].
4. Recipharm
Recipharm, a Swedish CDMO (Contract Development and Manufacturing Organization), offers manufacturing services for omega-3 fatty acid APIs, including ethyl esters. Their comprehensive portfolio encompasses synthesis, purification, and encapsulation processes, supported by strong regulatory compliance frameworks. Recipharm supplies APIs to several branded formulations [4].
5. FMC Corporation (formerly Omega Protein)
FMC Corporation’s acquisition of Omega Protein enabled it to produce omega-3 extracts derived from North American menhaden fish. FMC produces EPA and DHA-rich oils, which are used by pharmaceutical companies in manufacturing ethyl ester formulations. Their extensive fisheries and processing infrastructure give them a competitive advantage in raw material sourcing [5].
Emerging and Regional Suppliers
6. Croda International
Croda supplies omega-3 oils as part of their lipid-based ingredient portfolio. While primarily serving nutraceutical markets, Croda provides various fish oil concentrates suitable for pharmaceutical processing, especially when combined with other quality assurance measures. Their focus on sustainability and eco-friendly sourcing appeals to environmentally conscious segments [6].
7. Daiichi Sankyo (through licensing agreements)
While primarily a pharmaceutical developer, Daiichi Sankyo’s partnerships with raw material suppliers enable access to high-purity omega-3 oils, including ethyl esters. Such collaborations ensure reliable supply chains for their cardiovascular products [7].
8. Other Regional Suppliers
Countries like China, India, and Vietnam have burgeoning fish oil industries producing omega-3 products that meet GMP standards for pharmaceutical use. Notable regional suppliers include:
- BASF (now part of the newly created chemical conglomerate), which historically supplied omega-3 oils.
- Aker BioMarine, focusing on sustainable krill oils but also producing omega-3 concentrates suitable for API synthesis.
Supply Chain Considerations
The sourcing of omega-3-acid ethyl esters involves navigating several challenges:
- Sustainability and sourcing transparency: Overfishing concerns have prompted manufacturers to adopt sustainable fishing practices, ensuring long-term raw material supply.
- Quality and regulatory compliance: Strict adherence to GMP and cGMP standards is non-negotiable in pharmaceutical applications.
- Raw material availability: Fluctuations in fish oil production, driven by ecological or climatic factors, impact API availability.
- Price volatility: Raw material costs influence end-product pricing and supply reliability.
Market Dynamics
The global omega-3 market is projected to grow at a CAGR of 8% between 2022 and 2030, driven by increasing awareness of cardiovascular health and preventive medicine [8]. Suppliers competing for market share emphasize high purity, sustainability, and consistent supply. Contract manufacturing agreements and strategic partnerships are common, aiming to secure raw material flow and ensure regulatory compliance.
Future Outlook
Innovation in plant-based omega-3 sources (e.g., algal oils) is reshaping supply options, offering more sustainable, vegetarian alternatives to fish oil-derived ethyl esters. Mergers and acquisitions among raw material suppliers are expected to consolidate industry influence, enhancing supply stability.
Key Takeaways
- Primarily, KD Pharma, Pronova BioPharma, and FMC Corporation dominate the supply landscape for pharmaceutical-grade omega-3-acid ethyl esters.
- Regional suppliers and emerging players from Asia contribute to the diversity of raw material sources, impacting costs and supply security.
- Sustainability, quality assurance, and regulatory compliance remain pivotal for suppliers competing in the pharmaceutical market.
- Advances in plant-based omega-3 production could diversify and stabilize future supply chains.
- Pharmaceutical companies should secure multiple supply agreements and verify supplier compliance to mitigate risks.
FAQs
Q1: What are the main raw materials used by suppliers of omega-3-acid ethyl esters?
A1: The primary raw materials are fish oils rich in EPA and DHA, typically extracted from species like anchovy, sardine, or menhaden, processed to produce highly purified ethyl ester derivatives.
Q2: How do supply chain disruptions affect the availability of omega-3-acid ethyl esters?
A2: Disruptions due to ecological factors, overfishing, or geopolitical issues can lead to raw material shortages, affecting API production and leading to increased costs and potential delays.
Q3: Are there sustainable and plant-based alternatives for omega-3 raw materials?
A3: Yes, algae-based omega-3 oils are gaining prominence as sustainable and vegetarian-friendly raw materials that can meet pharmaceutical-grade standards.
Q4: What quality standards must suppliers meet for pharmaceutical-grade omega-3-acid ethyl esters?
A4: Suppliers must comply with cGMP, provide batch-specific certificates of analysis, and meet pharmacopoeia standards such as USP or Ph. Eur.
Q5: How can pharmaceutical companies ensure a reliable supply of omega-3-acid ethyl esters?
A5: By establishing long-term relationships with multiple certified suppliers, verifying compliance with regulatory standards, and monitoring raw material sourcing practices.
Sources:
[1] KD Pharma Group. “About us.” kdpharma.com.
[2] Novartis. “Pronova BioPharma History and Portfolio.” novartis.com.
[3] Therabal Pharma. “Product Overview.” therabal.com.
[4] Recipharm. “Omega-3 API manufacturing.” recipharm.com.
[5] FMC Corporation. “Omega-3 Fish Oil Production.” fmc.com.
[6] Croda International. “Lipid Solutions.” croda.com.
[7] Daiichi Sankyo. “Partnerships and Sourcing.” daiichisankyo.com.
[8] Research and Markets. “Global Omega-3 Market Report 2022–2030.” researchandmarkets.com.
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