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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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-13 03:54
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
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].
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]