Pantoprazole

Proton pump inhibitors are core medications used in gastroenterology to inhibit gastric acid secretion. Compared with the early-generation H2 receptor antagonists, they have more precise action targets and longer duration of acid suppression. Pantoprazole is a representative variety of the third-generation proton pump inhibitors. It specifically inhibits the activity of H+/K+-ATPase in gastric parietal cells to block the final step of gastric acid secretion. It can not only be used for the conventional treatment of gastric ulcer, duodenal ulcer and reflux esophagitis, but also be combined with antibiotics for the eradication of Helicobacter pylori. Meanwhile, it is applicable for the intervention of severe digestive diseases such as acute gastric mucosal lesion and upper gastrointestinal bleeding, covering adults and special severe patients requiring acid suppression intervention.

The global market size of pantoprazole-related products is approximately USD 3.2 billion. Driven by the rising prevalence of peptic ulcer, the popularization of Helicobacter pylori screening and other factors, the overall market has maintained a compound annual growth rate of 4.1% in recent years. In the domestic market, pantoprazole is a commonly used variety in the gastroenterology field of public medical institutions, with annual sales exceeding RMB 4 billion, among which injections account for about 75%. In terms of competitive landscape, the original research product still accounts for about 15% of the market share, and domestic generic drugs have achieved import substitution through consistency evaluation. At present, more than 30 enterprises have obtained preparation approvals. China and India are the main core production regions of active pharmaceutical ingredients. After the implementation of domestic centralized procurement, the terminal price has dropped by more than 60%, and the accessibility for patients has been greatly improved.

The original research enterprise of pantoprazole is Takeda Pharmaceutical, with the original brand name "Pantoloc". Its core compound patent expired in the United States in 2017, and the core patent in China also expired in 2020. The main dosage forms approved for the original product include enteric-coated tablets (20mg, 40mg) and pantoprazole sodium for injection (40mg, 80mg). Relevant dosage forms have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, there are currently more than 20 A-status registration numbers for pantoprazole and pantoprazole sodium, and the number of approved domestic preparations exceeds 200, realizing the domestic supply of all dosage forms. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for pantoprazole API. Most 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 reliable reference standard support for API and preparation enterprises in the links of quality research, stability study, registration and declaration, etc.