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健友股份:子公司获得美国FDA依托泊苷注射液药品生产场地转移注册批件
news flash· 2025-07-22 08:22
Core Viewpoint - The company announced that its subsidiary, Meitheal Pharmaceuticals, Inc., received FDA approval for the production site transfer of Etoposide Injection in multiple dosages, which is expected to positively impact the company's operational performance [1] Group 1: FDA Approval - The FDA issued a production site transfer approval letter for Etoposide Injection (100mg/5mL, 500mg/25mL, and 1g/50mL) under ANDA number 074529 [1] - The approved production will take place at the subsidiary, Jianjin Pharmaceutical Co., Ltd. [1] Group 2: Financial Impact - The company has invested approximately 2.1561 million yuan in the research and development of Etoposide Injection [1] - The newly approved product is expected to be launched in the U.S. market soon, which may have a positive effect on the company's financial performance [1]