Asia-Pacific Pharmaceutical: Application for consistency evaluation of drospirenone hydrochloride tablets not approved.
Asia Pacific Pharmaceutical announced that the company has received a notice from the National Medical Products Administration stating that the application for the consistency evaluation of hydrochloride diltiazem tablets has not been approved. The main reason is that the BE study submitted in this application does not support bioequivalence conclusion. The development cycle of this drug is long, with many phases and susceptible to uncertainty factors. The company will improve relevant experimental research and reapply after enhancing the study. The disapproval will not have a significant impact on the company's current performance.
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