Vonoprazan Fumarate API of Tianshu Pharmaceutical Approved for Marketing

　　Recently, Hubei Tianshu Pharmaceutical Co., Ltd. (Tianshu Pharmaceutical) has received the Approval Notice for Marketing Application of Chemical APIs issued and verified by the NMPA. This marks the official approval for marketing of the company's first generic drug API — Vonoprazan Fumarate (Registration No.: Y20240000846), which is a milestone in the company's development.

　　Vonoprazan Fumarate is a Potassium-Competitive Acid Blocker (P-CAB). It is mainly used for the treatment of acid-related diseases, including reflux esophagitis, gastric ulcer and duodenal ulcer. It also serves to prevent the recurrence of gastric or duodenal ulcers and eradicate Helicobacter pylori during treatment with low-dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs). Compared with traditional PPIs, this drug boasts clinical advantages such as rapid onset of action, long-lasting effect, and acid inhibition unaffected by food intake, witnessing sustained growth in market demand in recent years.

　　The marketing approval of Vonoprazan Fumarate API fully demonstrates Tianshu Pharmaceutical's comprehensive strengths in R&D, quality management system and registration & declaration capabilities, and accumulates valuable successful experience for the application of other APIs under research. In the future, adhering to market orientation and focusing on clinical application value, Tianshu Pharmaceutical will continuously advance the R&D and industrialization of high-tech barrier generic APIs in multiple disease areas, and provide patients with more safe, effective and reliable pharmaceutical products.