人福医药(600079.SH):咪达唑仑注射液获得德国联邦药品和医疗器械管理局上市许可

Core Viewpoint - The company, Renfu Pharmaceutical, has received marketing authorization for Midazolam Injection from the German Federal Institute for Drugs and Medical Devices (BfArM), expanding its product offerings in the anesthetic market [1][2] Group 1: Regulatory Approvals - The company's subsidiary, Yichang Renfu, holds an 80% stake and has been granted marketing authorization for Midazolam Injection by BfArM [1] - The approved indications for Midazolam Injection include sedation before, during, and after diagnostic or therapeutic procedures, pre-anesthetic medication for adults, and sedation in the ICU [1] Group 2: Market Potential - The application for Midazolam Injection was submitted in December 2023 through a Decentralized Procedure (DCP) to both the French National Agency for Medicines and Health Products Safety (ANSM) and BfArM, with the latter granting approval [2] - The cumulative investment for the registration in France and Germany is approximately 10 million RMB, and the projected annual sales in the German market for 2024 are estimated at around 7 million USD [2]