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上海医药盐酸索他洛尔片通过仿制药一致性评价
Bei Jing Shang Bao· 2025-12-15 10:08
Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory, received approval from the National Medical Products Administration for the hydrochloride sotalol tablets, which passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Company Information - The hydrochloride sotalol tablets are primarily used for the conversion and prevention of supraventricular tachycardia, atrial flutter, atrial fibrillation, and various ventricular arrhythmias [1]
上海医药:子公司盐酸索他洛尔片通过仿制药一致性评价
Xin Lang Cai Jing· 2025-12-15 08:12
Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory, received the approval notice for the supplementary application of Sotalol Hydrochloride Tablets from the National Medical Products Administration, indicating that the drug has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approval of Sotalol Hydrochloride Tablets is expected to expand the market share of the drug and enhance its market competitiveness [1] - The drug's market performance may be affected by uncertainties related to national policies and market conditions, leading to potential sales not meeting expectations [1]
上海医药(601607.SH):盐酸索他洛尔片通过仿制药一致性评价
Ge Long Hui A P P· 2025-12-15 08:12
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Changzhou Pharmaceutical Factory, received a Drug Supplement Application Approval Notice from the National Medical Products Administration for its Sotalol Hydrochloride Tablets, which passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The Sotalol Hydrochloride Tablets are primarily used for: 1) conversion and prevention of supraventricular tachycardia, especially atrioventricular nodal reentrant tachycardia; 2) atrial flutter and atrial fibrillation; 3) various ventricular arrhythmias, including premature ventricular contractions and sustained/non-sustained ventricular tachycardia; 4) acute myocardial infarction complicated by severe arrhythmias [1]