上海医药(02607):阿立哌唑片获得菲律宾药品注册证书
智通财经网·2025-09-12 08:37

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Philippines Food and Drug Administration for the marketing of Aripiprazole tablets produced by its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd. This approval marks a significant milestone for the company in expanding its product offerings in the international market [1]. Group 1: Product Information - Aripiprazole tablets are an antipsychotic medication primarily used for the treatment of schizophrenia and manic episodes of bipolar disorder, and can also serve as an adjunct treatment for depression [1]. - The drug was developed by Bristol-Myers Squibb and Otsuka Pharmaceutical, first receiving FDA approval in the United States in November 2002 under the brand name Abilify® [1]. - Shanghai Shiyou Zhongxi's Aripiprazole tablets were approved for domestic sale in China in October 2004, and the 5mg specification of both Aripiprazole tablets and capsules passed the consistency evaluation for generic drugs in March 2021 [1]. Group 2: Financial and Regulatory Aspects - The company has invested approximately RMB 50,000 in registration-related expenses for the drug's approval in the Philippines [1].