智通财经网·2025-11-28 09:10Core Viewpoint - Shanghai Pharmaceuticals (02607) announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration regarding the approval of the supplementary application for Tramadol Hydrochloride Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Product Approval and Market Context - Tramadol Hydrochloride Injection is primarily used for the treatment of moderate to severe pain and was developed by Grünenthal GmbH, first launched in Germany in 1977 [1] - The supplementary application for the consistency evaluation was submitted to the National Medical Products Administration in August 2024 and has been accepted [1] - As of the announcement date, the company has invested approximately RMB 1.52 million in research and development for this product's consistency evaluation [1] Group 2: Competitive Landscape - Major domestic manufacturers of Tramadol Hydrochloride Injection in China include Ruiyang Pharmaceutical Co., Ltd., Shijiazhuang Yiling Pharmaceutical Co., Ltd., Jiangsu Jiuxu Pharmaceutical Co., Ltd., and North China Pharmaceutical Co., Ltd. [1] - According to the IQVIA database, the procurement amount for Tramadol Hydrochloride Injection in hospitals in mainland China for 2024 is RMB 614.53 million [1]