上海医药：盐酸坦索罗辛原料药上市申请获得批准

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Tamsulosin hydrochloride, a drug used to treat benign prostatic hyperplasia (BPH) [1] Group 1: Company Developments - The approval was granted to Shanghai Pharmaceuticals' subsidiary, Shanghai Pharmaceuticals Kangli (Changzhou) Pharmaceutical Co., Ltd. [1] - The company has invested approximately RMB 1.5 million in research and development for Tamsulosin hydrochloride [1] - The drug is a third-generation ultra-selective long-acting α1 inhibitor, originally developed by Japan's Yamanouchi Pharmaceutical and approved by the FDA in July 1992 [1] Group 2: Regulatory and Market Implications - The approval indicates that the raw material meets the regulatory requirements for domestic drug registration, allowing it to be sold in the domestic market [1] - This experience will be valuable for the company in future raw material drug applications [1] - The approval is not expected to have a significant impact on the company's current operating performance [1]