Lansoprazole

Acid-related diseases such as peptic ulcer and reflux esophagitis have long ranked at the top of the list of visits to the gastroenterology department, and the emergence of proton pump inhibitors has completely changed the treatment path of such diseases. Lansoprazole is a second-generation proton pump inhibitor, which specifically inhibits the activity of H+/K+-ATPase in gastric parietal cells and blocks the final step of gastric acid secretion, with a long duration of acid inhibitory effect and better stability. It is not only clinically used for the conventional treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer and reflux esophagitis, but also can be combined with antibiotics for the eradication of Helicobacter pylori. The applicable population covers adults and adolescents over 12 years old, and it is currently one of the core medications for the treatment of acid-related diseases.

The global market size of lansoprazole-related preparations has remained above US$3 billion for many years, and the demand in the Chinese market has grown steadily in recent years, with an annual growth rate of around 4%. With the expiration of the core patents of the original research drug, the market share of domestic generic drugs has exceeded 85%. At present, the oral lansoprazole preparations of nearly 30 enterprises have passed the consistency evaluation, and the injection varieties have also been included in multiple rounds of national centralized drug procurement. The maximum drop of the winning bid price compared with the original research drug is more than 90%, which drives the continuous expansion of the demand for upstream API. Domestic API manufacturers are mainly concentrated in Jiangsu, Zhejiang and other regions, and the overall supply pattern is stable.

The original research enterprise of lansoprazole is Takeda Pharmaceutical Company Limited of Japan, and the original research brand name is "Takepron". Its core compound patent expired around 2009 in major markets such as Japan and the United States, and the compound patent in China also expired in 2009. The main dosage forms approved for the original research drug include oral enteric-coated tablets, enteric-coated capsules and lansoprazole for injection, with common specifications of 15mg and 30mg. The original research preparations have been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by NMPA, and also included in the FDA Reference Preparations Catalogue. Up to now, there are more than 20 registration information of lansoprazole API on the API registration platform of China CDE, of which more than 15 are in status A (approved for use in marketed preparations). The domestically approved and marketed lansoprazole preparations cover oral, injection and other dosage forms, and there are more than 60 approved enterprises. (Data as of November 2024, please refer to the official website of CDE for the latest data)

CATO can provide a full set of impurity reference standards for lansoprazole API. Most of the products can be supplied from 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 Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of R&D, quality research and production of pharmaceutical enterprises.