Racecadotril

Acute diarrhea in children is one of the high-incidence diseases among children under 5 years old worldwide. Reducing excessive loss of water and electrolytes during antidiarrheal treatment is the core clinical need. Racecadotril is an antidiarrheal drug belonging to the enkephalinase inhibitor class. It reversibly inhibits the activity of enkephalin in the intestinal tract, prolongs the physiological action time of endogenous enkephalin, and reduces excessive intestinal secretion without affecting the enkephalin level in the central nervous system. It is the only peripheral antidiarrheal drug recommended by multiple guidelines. This drug is indicated for acute diarrhea in infants and children over 1 month of age, and can be used in combination with oral rehydration salts without dietary adjustment. Its incidence of adverse reactions is far lower than that of traditional antidiarrheal drugs, and it has a significant safety advantage in clinical application.

The global racecadotril market size was approximately USD 320 million in 2023, with a compound annual growth rate of 7.2% from 2019 to 2023, among which the pediatric drug market in the Asia-Pacific region contributed 62% of the market share. In terms of the domestic market, the total sales of public medical institutions and retail terminals exceeded RMB 800 million in 2024. With the gradual standardization of the clinical pathway for pediatric diarrhea medications, the growth rate is expected to remain above 8% in the next three years. Currently, generic drugs account for more than 90% of the domestic market. A total of 17 enterprises have obtained marketing authorization for preparation production, and 12 enterprises have completed CDE registration on the API supply side. The overall centralized procurement pressure is moderate, and the supplier competition pattern is relatively fragmented.

The original research enterprise of racecadotril is Laboratoires Beaufour Ipsen in France, with the original brand name "Durolab". Its core compound patent expired in Europe and the United States in 2005, and the compound patent in China expired in 2003. The dosage forms approved for the original drug include granules, oral suspension and tablets. The mainstream pediatric specifications are 10mg/bag granules and 30mg/tablet oral tablets. The original preparation has been included in the China Listed Drug Catalog, and is the reference preparation for domestic generic drug research and development. As of now, there are 12 racecadotril API registration entries on the CDE API registration platform in China, 9 of which are in status A and can be legally supplied to preparation manufacturers. The domestically approved racecadotril preparations cover three dosage forms: granules, tablets and dispersible tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the research and development and quality control needs of racecadotril, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support the optimization of API synthesis processes, impurity profile research and preparation quality consistency evaluation work.