news flash·2025-05-20 08:25Core Viewpoint - Shanghai Pharmaceuticals (601607) announced that its subsidiary, Changzhou Pharmaceutical Factory, has received notification from the U.S. Food and Drug Administration (FDA) that its abbreviated new drug application (ANDA) for rivaroxaban tablets has been approved, which is significant for expanding the company's overseas market presence [1] Summary by Relevant Sections - Drug Approval - The FDA has approved the ANDA for rivaroxaban tablets, which are primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation [1] - Application Timeline - The ANDA application was submitted in December 2021, and the approval was recently granted [1] - Research and Development Investment - As of the announcement date, the company has invested approximately 8.2 million yuan in research and development for this drug [1] - Market Potential - In 2023, the sales revenue of rivaroxaban tablets in the U.S. was approximately 8.13 billion dollars, with projected sales of about 6.33 billion dollars for the first three quarters of 2024 [1] - Strategic Importance - The approval is expected to have a positive impact on the company's efforts to further penetrate the overseas market [1]