南京健友生化制药股份有限公司 关于获得美国FDA盐酸尼卡地平注射液药品注册批件的公告

Group 1 - The company has received FDA approval for its Nicardipine Hydrochloride Injection, 25 mg/10mL (2.5 mg/mL) under ANDA number 216819, which is expected to positively impact its business performance [1][3] - The reference product for Nicardipine Hydrochloride Injection is held by HIKMA INTL PHARMS, which was approved for marketing in the U.S. on July 24, 2008 [1] - Currently, there are seven companies, including HIKMA INTL PHARMS, AM REGENT, and RK PHARMA, that have marketed this product in the U.S., while there is no such product available in the domestic market [1] Group 2 - The company has invested approximately RMB 18.35 million in the research and development of Nicardipine Hydrochloride Injection [2] - The newly approved product is expected to be launched in the U.S. soon, which is anticipated to have a positive effect on the company's operating performance [3]