亚太药业盐酸地尔硫䓬片一致性评价申请不予批准

Core Viewpoint - Recently, Asia-Pacific Pharmaceutical (002370) received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets was not approved due to the inability of the bioequivalence study to support a bioequivalence conclusion [1] Group 1 - The application for the consistency evaluation was submitted in November 2024 and was accepted by the National Medical Products Administration [1] - The reason for the disapproval was that the bioequivalence study conducted could not support the conclusion of bioequivalence [1] - The company stated that this disapproval will not have a significant impact on its current performance and plans to improve the relevant experimental research before resubmitting the application [1]