Rabeprazole

Excessive gastric acid secretion is the core inducing factor for upper gastrointestinal diseases such as peptic ulcer and gastroesophageal reflux disease, and clinical practice has long relied on proton pump inhibitor drugs to achieve precise acid suppression. As a second-generation proton pump inhibitor, rabeprazole blocks the final step of gastric acid secretion by specifically inhibiting the activity of H+/K+-ATPase in gastric parietal cells. It has a faster onset of acid suppression effect, longer duration and smaller individual differences. It is suitable for the treatment of active duodenal ulcer, benign active gastric ulcer, and erosive or ulcerative gastroesophageal reflux disease with clinical symptoms. It can also be used in combination with appropriate antibiotics to eradicate Helicobacter pylori, and is currently one of the core drugs for acid suppression therapy in gastroenterology.

The global rabeprazole market size has maintained a steady growth trend in recent years, with the overall market size exceeding USD 2.5 billion in 2023. As a region with a high incidence of digestive diseases, the sales volume of rabeprazole in domestic sample hospitals in China is nearly RMB 3 billion. As generic drugs have been launched one after another after the expiration of patents, the market has formed a competitive pattern where original research drugs and generic drugs coexist. After the coverage of domestic centralized procurement, the price of generic drugs has dropped significantly, the penetration rate in the primary market has continued to increase, and the overall market growth rate has remained at around 4%.

The original research enterprise of rabeprazole is Eisai Co., Ltd. of Japan, and the original research trade name is Pariet. The expiration time of its core compound patent in the United States is 2013, and the Chinese compound patent expired in 2008. The main dosage forms approved for the original research product include enteric-coated tablets and rabeprazole sodium for injection. The common specifications are 10mg and 20mg enteric-coated tablets and 20mg injection. The original research preparation has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also listed in the FDA Reference Preparation Catalogue. At present, the rabeprazole active pharmaceutical ingredients (APIs) of more than 30 domestic enterprises have obtained A status through CDE registration, and nearly 100 enterprises have obtained marketing approval for oral and injectable rabeprazole preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of rabeprazole impurity reference standards, which can fully meet the needs of the whole process of API R&D, quality research and compliance declaration. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide reliable support for the quality control links of pharmaceutical enterprises.