Nanjing Vcare's Manufacturing Base Tianshu Pharmaceutical Obtains Marketing Approval for Vonoprazan Fumarate API

2025-12-18

　　Recently, Hubei Tianshu Pharmaceutical Co., Ltd. (Tianshu Pharmaceutical), the manufacturing base affiliated with Nanjing Vcare PharmaTech Co., Ltd. (Nanjing Vcare), has received the Chemical API Marketing Approval Notification issued by the NMPA. This marks the official launch of the company’s first generic drug API — Vonoprazan Fumarate (Registration No.: Y20240000846), a milestone in the company’s development history.

 

　　Vonoprazan Fumarate is a potassium-competitive acid blocker (P-CAB), mainly indicated for the treatment of acid-related diseases, including reflux esophagitis, gastric ulcer and duodenal ulcer. It is also used to prevent the recurrence of gastric or duodenal ulcers and eradicate Helicobacter pylori during treatment with low-dose aspirin or NSAIDs. Compared with traditional  PPIs, it features rapid onset of action, long-lasting efficacy, and food-independent acid-suppressing effect, enjoying continuously growing market demand in recent years.

 

　　The marketing approval of Vonoprazan Fumarate API fully demonstrates Tianshu Pharmaceutical’s strengths in R&D, quality management system and registration & application capabilities. It also reflects Tianshu Pharmaceutical’s vital role in Nanjing Vcare’s full industrial chain layout, accumulating valuable successful experience for the registration of other APIs under development. Going forward, adhering to market orientation and focusing on clinical application value, Tianshu Pharmaceutical will continuously advance the R&D and industrialization of high-barrier generic APIs for multiple therapeutic areas, providing safer, effective and reliable pharmaceutical products for patients worldwide.

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