奥美拉唑

Acid-related diseases such as peptic ulcer and gastroesophageal reflux disease have long ranked high in the incidence list of digestive system diseases, and the advent of proton pump inhibitors has completely revolutionized the clinical treatment pathway of such diseases. As the first marketed benzimidazole proton pump inhibitor, omeprazole specifically inhibits the activity of H+/K+-ATPase in gastric parietal cells to block the final step of gastric acid secretion from the source, with a long-lasting and highly targeted acid-suppressive effect. It is not only used for the routine treatment of gastric ulcer, duodenal ulcer and reflux esophagitis, but also can be combined with antibiotics to eradicate Helicobacter pylori. Meanwhile, it is suitable for the treatment of stress ulcer and Zollinger-Ellison syndrome, covering related indication populations of adults and children, and is a basic drug for the treatment of acid-related diseases worldwide.

At present, the global market size of omeprazole is stably maintained at more than 4 billion US dollars, and as a major consumer market, China's overall market size exceeds 3 billion yuan. Due to its early launch, generic drugs have rapidly expanded their volume after patent expiration. Currently, the domestic market has formed a pattern of full competition between original research drugs and generic drugs, among which oral preparations have been included in multiple rounds of national centralized procurement, and the maximum price reduction of winning bids has exceeded 90% compared with the original research drugs, which has greatly improved the accessibility of drugs for patients. At the API level, China is the world's largest producer and exporter of omeprazole APIs, with domestic production capacity accounting for more than 70% of the total global production capacity, and its products are mainly exported to Europe, America, Southeast Asia and other regions.

The original research enterprise of omeprazole is AstraZeneca, and the original research trade name is Losec. Its core compound patent first expired in Europe in 1999, the core US patent expired in 2001, and the Chinese compound patent expired in 2005. The main dosage forms approved for the original research product include enteric-coated tablets, enteric-coated capsules and powder for injection, and common specifications cover 10mg, 20mg and 40mg. The original research product has been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA Reference Preparation Catalogue. Up to now, China's NMPA has approved the marketing of omeprazole preparations from dozens of enterprises, and the CDE API registration platform has more than 60 omeprazole API registration records, most of which are in status A and can be used for associated review. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of omeprazole impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in various links such as API R&D, quality research, registration and declaration.