Linolenic acid

Against the background of the rising prevalence of cardiometabolic diseases, the clinical value of polyunsaturated fatty acids has received increasing attention. α-linolenic acid is an essential fatty acid of the ω-3 series, a core nutrient that cannot be synthesized by the human body and must be ingested from external sources. Its mechanism of action is mainly through metabolism in the body to produce eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which participate in regulating blood lipid metabolism, reducing inflammatory response, and maintaining vascular endothelial function. Meanwhile, it also has definite effects on fetal neurodevelopment and the protection of adult cognitive function. Its clinical indications include adjuvant treatment of hypertriglyceridemia, and it can also be used as a core ingredient of food for special medical purposes, suitable for people with dyslipidemia, pregnant and lying-in women, and the elderly at high risk of cognitive decline.

The global market size of α-linolenic acid API has exceeded 1.8 billion yuan in 2023, and it is expected to continue to expand at a compound annual growth rate of 7.2% by 2028. The current market presents a two-track competition pattern: the access barrier for medicinal-grade linolenic acid is relatively high, and leading enterprises are concentrated in Europe and the main linseed producing areas in northwest China. Domestic enterprises, relying on the advantages of raw material planting, have gradually occupied more than 35% of the global medicinal-grade production capacity; there are many participants in the food-grade linolenic acid track, and price competition is relatively sufficient. With the implementation of relevant policies on food for special medical purposes, the domestic market demand for medicinal-grade linolenic acid is expected to achieve an annual growth rate of more than 15% in the next 3 years.

There is no single original research enterprise for linolenic acid. Medicinal-grade linolenic acid preparations were first mass-produced by German enterprises. Most of the linolenic acid oral preparations already marketed in China are generic drugs, with soft capsules as the common dosage form, and the specifications include 0.5g and 1.0g. A number of preparations have been included in the National Medical Insurance Catalogue. Currently, there are 12 linolenic acid API registration entries on the CDE API Registration Platform, among which 6 have obtained A status after passing the joint review and approval with preparations, and can be directly used by domestic preparation enterprises for association; in addition, 3 enterprises have completed the filing of their linolenic acid DMF with the US FDA, and have export qualifications. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for linolenic acid API, covering the full spectrum of process impurities and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can meet the needs of the whole process of API R&D, registration and quality control.