Rebamipide

Gastric mucosal injury is the core pathological feature of upper gastrointestinal diseases such as chronic gastritis and gastric ulcer. Existing mucosal protectants mostly focus on symptom relief, and have limited long-term intervention effects on injury repair. Rebamipide, as a new generation of gastric mucosal protectant, belongs to quinolinone derivatives. It exerts dual effects of enhancing mucosal defense and promoting injury repair simultaneously through three mechanisms: promoting the proliferation of gastric mucosal epithelial cells, up-regulating prostaglandin synthesis, and scavenging oxygen free radicals. In clinical practice, it is not only used to improve symptoms such as gastric mucosal erosion and bleeding in acute gastritis and acute exacerbation of chronic gastritis, but also can be used as a long-term maintenance treatment for gastric ulcer. The applicable population covers adult patients of all ages with high risk of gastric mucosal injury, such as those with Helicobacter pylori infection and history of taking non-steroidal anti-inflammatory drugs.

The global market size of rebamipide was approximately USD 420 million in 2023, with China's market share accounting for more than 45%. The compound annual growth rate in the past three years has maintained at 6.8%, which is higher than the global average. The domestic market is currently dominated by generic drugs, and more than 20 enterprises have obtained preparation approvals. After the implementation of the centralized procurement policy, the average drop in the winning bid price of oral dosage forms reached 58%, which further promoted the increase of penetration rate in the primary market, and the demand of downstream preparation enterprises for high-quality active pharmaceutical ingredients (APIs) continues to be released.

The original research enterprise of rebamipide is Otsuka Pharmaceutical of Japan, and the original brand name is "Mucosta". The expiration time of its core compound patent in major markets such as Japan and the United States was 2009, and the compound patent in China also expired in 2009. The mainstream dosage form of the original product is 100mg oral tablet, which has been included in the China Listed Medicines Catalogue as the reference listed drug (RLD), and also included in the FDA Reference Listed Drug Catalog. In terms of domestic API registration, nearly 10 enterprises have obtained CDE registration numbers for rebamipide APIs, among which the registration with A status accounts for more than 60%. Corresponding oral preparations have multiple domestic varieties approved for marketing, with sufficient clinical accessibility. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for rebamipide, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference substance support for API research and development, quality research and preparation consistency evaluation.