L-Ornithine L-Aspartate

In response to the clinical demand for hyperammonemia accompanied by acute and chronic liver diseases such as hepatic encephalopathy and fatty liver, L-ornithine L-aspartate is an active pharmaceutical ingredient (API) for adjuvant treatment of liver diseases, which improves liver function through a dual-pathway mechanism: the ornithine moiety in its molecule directly participates in the urea cycle, accelerating the metabolism of blood ammonia into non-toxic urea for excretion from the body, while aspartate can promote the synthesis of glutathione and energy production in hepatocytes to repair damaged liver cells. This drug is indicated for patients with elevated blood ammonia caused by various types of hepatitis and liver cirrhosis, and has a definite effect especially on improving consciousness disturbance in the early stage of hepatic encephalopathy. It is a first-line ammonia-lowering drug recommended by domestic and foreign liver disease guidelines.

At present, the global market size of L-ornithine L-aspartate is close to 400 million US dollars, with a compound annual growth rate of around 5.2% in the past five years. The core driver of growth comes from the continuous rise in the prevalence of chronic liver diseases. In the domestic market, generic drugs account for more than 90% of the market share, and this variety has been included in multiple batches of provincial centralized procurement catalogs. The average price reduction of winning bids in centralized procurement has reached 47%, further promoting the improvement of clinical penetration. The annual domestic demand for its API has exceeded 200 tons.

The original research enterprise of L-ornithine L-aspartate is Germany's MADAUS GmbH, with the original brand name "Hepa-Merz". Its core compound patent expired worldwide in 2010. The main dosage forms of the original marketed product include injection and granules, among which the specification of the injection is 5g/10ml, and the specification of the granules is 3g per bag. Both dosage forms have been included in the Catalogue of Marketed Drugs in China as reference listed drugs (RLD). At present, more than 20 domestic enterprises have obtained A status for their L-ornithine L-aspartate APIs through registration with the Center for Drug Evaluation (CDE), which can be legally supplied to preparation manufacturers, and the number of corresponding preparation approvals exceeds 60. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full range of impurity reference standards for L-ornithine L-aspartate, fully covering synthetic process impurities and degradation impurities. Most products are in sufficient stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as API R&D, quality research and consistency evaluation.