Recently, two high-end injectable-grade medicinal lipid APIs developed and manufactured by Sichuan GOWELL Pharmaceutical Co., Ltd. ("GOWELL Pharmaceutical"), a core manufacturing base of the GOWELL Group (Chengdu GOWELL) — namely Olive Oil, Refined and Fish Oil, Rich in Omega-3 Acids (28% omega-3 acids) — have both successfully passed the formality review for CEP (Certificate of Suitability to Monographs of the European Pharmacopoeia) applications filed with the European Directorate for the Quality of Medicines (EDQM), officially entering the critical stage of technical assessment.

△ GOWELL Olive Oil, Refined — EDQM CEP Formality Review Acknowledgment

△ GOWELL Fish Oil, Rich in Omega-3 Acids (28% omega-3 acids) — EDQM CEP Formality Review Acknowledgment

This represents a significant advancement for GOWELL Pharmaceutical in the high-difficulty injectable-grade medicinal lipids and high-purity marine lipid API sectors, and marks a crucial step forward in the company's strategic direction of internationally compliant high-end injectable lipid API development. GOWELL Pharmaceutical is also one of the few companies in China to have simultaneously achieved independent development, industrialization, and EDQM CEP registration filing for both of these injectable-grade medicinal oils. As the CEP review process progresses, GOWELL Pharmaceutical is steadily building the capability to supply domestic medicinal lipid APIs and standardized API support solutions that meet European Pharmacopoeia compliance standards and stable production volumes to global manufacturers of nutritional injectable formulations and fat emulsion preparations. Commercial supply is expected to commence following the issuance of CEP certificates.

Olive Oil, Refined and Fish Oil (28% Omega-3 Acids): Core Upstream Raw Materials for High-End "Four-in-One" Balanced Fat Emulsions

Parenteral nutrition (PN) fat emulsion injections are a critical clinical vehicle for energy and essential fatty acids, while also providing immunomodulatory and organ-protective effects[1]. Traditional pure soybean oil long-chain triglyceride (LCT) fat emulsions are rich in pro-inflammatory omega-6 linoleic acid and phytosterols. Long-term, high-dose infusion can readily induce oxidative stress and impede bile acid excretion, making them a major contributor to parenteral nutrition-associated cholestasis (PNAC) and parenteral nutrition-associated liver disease (PNALD).

To address these clinical challenges, the industry has evolved toward a "four-in-one" balanced multi-oil fat emulsion injection (C6~24) formulated with soybean oil, medium-chain triglycerides (MCT), refined olive oil, and fish oil. This formulation is recommended by multiple authoritative clinical guidelines, including the *Clinical Application Guidelines for Fat Emulsion Injections in Adult Parenteral Nutrition (2023 Edition)*[2], and is widely used in critically ill patients, perioperative patients, and pediatric patients requiring long-term parenteral nutrition support. In this formulation, approximately 25% of the lipid component is provided by refined olive oil and approximately 15% by fish oil (28% omega-3 acids), making both indispensable core upstream raw materials.

△ Schematic illustration of the lipid composition of refined olive oil and fish oil (28% omega-3 acids) in the "four-in-one" multi-oil fat emulsion

Refined Olive Oil: A Naturally Antioxidant Energy Foundation

Olive oil is rich in monounsaturated oleic acid (C18:1 ω-9), an omega-9 monounsaturated fatty acid whose chemical structure provides inherent resistance to lipid peroxidation. The incorporation of approximately 25% refined olive oil into the "four-in-one" emulsion not only delivers ample energy but also substantially reduces the proportion of polyunsaturated omega-6 fatty acids introduced by soybean oil, mitigating lipid peroxidation risk and minimizing free radical damage to cell membranes — thereby preserving emulsion physical stability while protecting patient organ function.

Fish Oil (28% Omega-3 Acids): An Anti-Inflammatory and Lipid-Modulating Functional Component

The high EPA and DHA content in fish oil can be incorporated into cell membrane phospholipids, serving as precursors for anti-inflammatory mediators, suppressing excessive release of pro-inflammatory cytokines, and alleviating systemic inflammatory response syndrome (SIRS). The addition of approximately 15% fish oil to the composite fat emulsion significantly improves liver function and effectively reduces the risk of cholestasis in children and preterm infants receiving long-term parenteral nutrition.

By reducing the proportion of soybean oil and precisely blending olive oil and fish oil, this formulation achieves an omega-6/omega-3 fatty acid ratio of approximately 2.5:1 — within the recognized balanced anti-inflammatory range. This synergistic effect can shorten hospital stays, reduce postoperative infection risk, and ameliorate liver injury, offering significant comprehensive clinical advantages. The simultaneous CEP filing of both APIs establishes a solid upstream quality foundation for the high-end balanced composite fat emulsion industry chain.

Five Core Industrial Capability Matrices: Ensuring Global Compliance, Stability, and High-Quality Supply of Both APIs

For the two CEP-filed products — Olive Oil, Refined and Fish Oil (28% Omega-3 Acids) — GOWELL Pharmaceutical has leveraged its proprietary high-purity lipid multi-component technology platform to build a comprehensive capability matrix encompassing five core areas: proprietary purification processes, large-scale production and supply, end-to-end GMP quality systems, full-process antioxidant closed-system quality control, and one-stop registration and audit services. This integrated approach ensures long-term, stable commercial supply of medicinal lipid APIs and provides high-quality raw material support to global customers.

1. Proprietary Purification Processes

Olive Oil, Refined: Utilizes proprietary patented processes to deeply remove pigments, free fatty acids, and oxidative impurities while preserving natural α-tocopherol (Vitamin E) in the olive oil, enhancing the raw material's intrinsic antioxidant capacity.

Fish Oil (28% Omega-3 Acids): Employs specialized processes for deep purification of crude oil, reducing persistent organic pollutants — including dioxins, PCBs, PAHs, PBDEs, and plasticizers — to levels compliant with EP and USP standards.

2. Large-Scale Industrialization and Scale-Up Capabilities

The GMP-certified API manufacturing base in Meishan, Sichuan, is equipped with specialized production lines for medicinal oils with an annual capacity of hundreds of metric tons, featuring a complete commercial-scale bulk supply chain. Production capacity is stable and controllable, capable of simultaneously meeting the varying procurement volume requirements of global formulation customers across R&D, clinical, and commercial stages.

3. API Quality System Support

Leveraging a comprehensive GMP production and quality management system for APIs, GOWELL Pharmaceutical strengthens process control, batch-to-batch consistency, data integrity, quality traceability, and supply stability, providing global formulation customers with auditable, traceable, and compliant raw material support.

4. Full-Process Antioxidant Closed-System Quality Control

Given the susceptibility of highly unsaturated oils such as fish oil to oxidation, all finished product filling and terminal filtration are conducted in a cleanroom under nitrogen-blanketed, closed-system conditions to prevent oxygen from damaging unsaturated double bonds, ensuring long-term raw material quality stability.

5. One-Stop Registration and Audit Coordination Services

Olive Oil, Refined and Fish Oil (28% Omega-3 Acids) have now completed EDQM formality review and entered the CEP technical assessment stage. Following certificate issuance, GOWELL can issue Letters of Access (LoA) for CEP references to formulation customers, accelerating their domestic and international formulation filings. Concurrently, the company provides full-process support for remote and on-site GMP audits.

Building Independent Voice for China's High-End Injectable Medicinal Lipid Industry on the Global Compliance Stage

The simultaneous successful passage of EDQM formality review for these two APIs marks a new beginning for GOWELL Pharmaceutical's globalization journey. Leveraging this review opportunity, the company will respond efficiently to all technical assessment requirements and, with its four core strengths — proprietary patented processes, high-standard GMP quality control, global compliance credentials, and large-scale stable supply — deliver compliant raw material solutions from China to high-end fat emulsion and injectable formulation manufacturers worldwide.

Through years of sustained scientific research, GOWELL Pharmaceutical has achieved independent technological breakthroughs and industrialization in high-purity omega-3 fatty acids and high-end injectable medicinal lipids, making it one of the first domestic manufacturers to achieve an integrated "oral-to-injectable" full-category lipid raw material and formulation portfolio. Concurrently, GOWELL Pharmaceutical has built a comprehensive product matrix spanning generic injectables, oral prescription drugs, and health foods in this field: Omega-3 Fish Oil Fat Emulsion Injection (Liyouwei®) received marketing approval in 2023; Long-Chain Fat Emulsion Injection (OO) (Linapu®) received approval in 2024; high-purity omega-3 prescription drug Lilexin® (Omega-3 Fatty Acid Ethyl Esters 90 Soft Capsules) received approval in 2021; Liruixin® (Icosapent Ethyl Soft Capsules) received approval in 2023; and the high-purity fish oil health food product (Ou Cuien® Fish Oil Soft Capsules) received its initial national registration approval in 2014. The company has established a multi-category product system covering both APIs and formulations, and both oral and injectable dosage forms, accumulating comprehensive technical and industrialization capabilities in the clinical nutrition and anti-inflammatory fat emulsion sector. The simultaneous CEP review of Olive Oil, Refined and Fish Oil (28% Omega-3 Acids) represents a pivotal moment for GOWELL Pharmaceutical to export "China Quality" to the global high-end injectable API and pharmaceutical excipient market, and officially ushers in a new era of globalization for China's high-end medicinal lipids.

 GOWELL Core Lipid Products 

About the GOWELL Group

 Sichuan GOWELL Pharmaceutical Co., Ltd. is the core manufacturing entity under the GOWELL Group (Chengdu GOWELL). Founded in 2005 and headquartered in the Chengdu High-Tech Zone, the Group is a professional, innovation-driven pharmaceutical group integrating drug R&D, manufacturing, and sales. The Group includes subsidiaries such as Sichuan GOWELL Pharmaceutical Co., Ltd., Shanghai Ou Cuien Biotechnology Co., Ltd., and Chengdu Zhengkang Pharmaceutical Co., Ltd., with over 800 employees.

△ GOWELL Pharmaceutical

△ GOWELL Pharmaceutical — Meishan, Sichuan GMP API Manufacturing Base

GOWELL has established three major R&D technology platforms covering generics, innovative drugs, and fish oil. Core R&D team members have been recognized under prestigious talent programs including the Tianfu Qingcheng Plan, Tianfu Emei Plan, and Rongpiao Plan. From 2017 to 2025, cumulative R&D investment exceeded RMB 700 million, fueling sustained innovation.

In terms of patent portfolio, the company has filed a total of 123 patent applications, with 43 granted, including 33 invention patents, and has registered 185 trademarks.

Looking Forward Together: Embarking on the Lipid Journey with Compliance as Our Anchor

With the successful passage of the European CEP formality review for both Olive Oil, Refined and Fish Oil (28% Omega-3 Acids) as a new starting point, GOWELL offers global high-end fat emulsion and injectable formulation customers a compliant raw material option from China, backed by stable quality, proprietary processes, compliant international outreach, and reliable supply capabilities. In addition, GOWELL's Multi-Oil Fat Emulsion Injection (C6~24) has also entered Phase III clinical studies. The company looks forward to collaborating with domestic and international formulation companies and CRO/CDMO partners to jointly advance the R&D and industrialization of high-end parenteral nutrition and composite lipid emulsions.

Business Inquiries and Technical Support

For samples, Certificates of Analysis (COA), technical documentation, registration standards, commercial quotations, or to request remote or on-site quality audit support for Olive Oil, Refined and Fish Oil (28% Omega-3 Acids), please contact Sichuan GOWELL Pharmaceutical Co., Ltd.

  △ For more product details or to request a technical information package, please contact the GOWELL sales team. We will match you with the corresponding product specifications and supply solutions as quickly as possible.

This document is intended for industry exchange and technical reference only and does not constitute a commercial offer or product commitment. Product specifications are subject to the final contract and COA.

References:

[1-2] Chinese Society of Parenteral and Enteral Nutrition, Chinese Medical Association; Clinical Nutrition Expert Working Group of the Surgeons' Branch of the Chinese Medical Doctor Association. Clinical Application Guidelines for Fat Emulsion Injections in Adult Parenteral Nutrition (2023 Edition) [J]. *Chinese Journal of Digestive Surgery*, 2023, 22(11): 1-16. DOI: 10.3760/cma.j.cn115610-20230915-00106.