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上海医药集团股份有限公司 关于阿立哌唑片获得菲律宾药品注册证书的公告
Drug Overview - Shanghai Pharmaceuticals has received a drug registration certificate from the Philippines Food and Drug Administration for Aripiprazole Tablets, allowing the product to be marketed in the Philippines [1] - Aripiprazole is an antipsychotic medication primarily used for the treatment of schizophrenia and manic episodes of bipolar disorder, and can also be used as an adjunct treatment for depression [1] - The drug was first approved by the FDA in the United States in November 2002 and was approved for domestic sale in China in October 2004 [1] Market Competition - In the Philippines, Aripiprazole Tablets face competition from five other companies, including OTSUKA PHARM, ZYDUS PHILS. INC., and MULTICARE PHARM [2] - The total sales revenue for Aripiprazole Tablets (10 mg) in the Philippines is projected to be $2.39 million in 2024 according to IQVIA data [3] Impact on Company - The approval of Aripiprazole Tablets in the Philippines is expected to positively impact the company's efforts to expand into overseas markets and accumulate valuable experience [4]
上海医药(02607.HK):阿立哌唑片获得菲律宾药品注册证书
Ge Long Hui· 2025-09-12 08:41
Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) has received approval from the Philippines Food and Drug Administration for the marketing of Aripiprazole tablets, an antipsychotic medication used for treating schizophrenia and manic episodes of bipolar disorder, and as an adjunct treatment for depression [1] Group 1 - The product approved is Aripiprazole tablets, which are primarily used for the treatment of schizophrenia and manic episodes of bipolar disorder [1] - Aripiprazole can also be used as an adjunct treatment for depression [1] - The approval signifies a potential expansion of the company's product offerings in the pharmaceutical market [1]
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
智通财经APP讯,上海医药(02607)发布公告,近日,上海医药集团股份有限公司(以下简称"上海医 药"或"公司")下属上海上药中西制药有限公司(以下简称"上药中西")生产的阿立哌唑片(以下简称"该药 品")收到菲律宾食品药品监督管理局颁发的药品注册证书,该药品获得批准上市。 阿立哌唑片是一种抗精神病药物,主要用于治疗精神分裂症和双相情感障碍的躁狂发作,也可作为抑郁 症的辅助治疗药物。由美国百时美-施贵宝公司和日本大冢公司研发,2002 年 11 月首次获得美国 FDA 批准上市(商品名 Abilify®)。 2004 年 10 月,上药中西的阿立哌唑片在国内获批上市;2021 年 3 月,阿 立哌唑片及阿立哌唑胶囊的 5mg 规格通过了仿制药一致性评价。截至本公告日,公司针对该药品在菲 律宾的上市投入注册相关费用约人民币 5 万元。 ...
上海医药(601607.SH):阿立哌唑片获得菲律宾药品注册证书
Ge Long Hui A P P· 2025-09-12 07:49
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd. (referred to as "Shiyou Zhongxi"), has received a drug registration certificate from the Philippines Food and Drug Administration for Aripiprazole Tablets, which have been approved for market launch [1] Group 1 - The drug Aripiprazole is an antipsychotic medication primarily used for the treatment of schizophrenia and manic episodes of bipolar disorder, and it can also be used as an adjunct treatment for depression [1]
上海医药:阿立哌唑片获得菲律宾药品注册证书
Zhi Tong Cai Jing· 2025-09-12 07:46
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyou Chinese-Western Medicine Co., Ltd., has received a drug registration certificate from the Philippines Food and Drug Administration for Aripiprazole tablets, which have been approved for market launch [1] Group 1 - The drug Aripiprazole is an antipsychotic medication primarily used for the treatment of schizophrenia and manic episodes of bipolar disorder, and it can also be used as an adjunct treatment for depression [1]
上海医药:阿立哌唑片获菲律宾药品注册证书
Xin Lang Cai Jing· 2025-09-12 07:41
Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has received a drug registration certificate from the Philippines Food and Drug Administration for Aripiprazole tablets, allowing the product to be marketed in the Philippines [1] Company Summary - 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 company incurred approximately 50,000 yuan in registration-related expenses for the product's market entry in the Philippines [1] Market Summary - The total sales revenue for Aripiprazole tablets (10 mg) in the Philippines is projected to be 2.39 million USD in 2024 [1]