亚太药业(002370.SZ):盐酸地尔硫䓬片一致性评价申请不予批准
Core Viewpoint - The company, Asia-Pacific Pharmaceutical (002370.SZ), has received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets has been rejected due to insufficient bioequivalence study results [1] Company Summary - The rejected application pertains to Diltiazem Hydrochloride Tablets, which are used for the treatment of angina pectoris and mild to moderate hypertension [1] - The reason for the rejection is that the bioequivalence study submitted does not support a conclusion of bioequivalence [1]