Qilu Pharmaceutical's Aripiprazole Orally Disintegrating Tablets Approved and Deemed to Have Passed Consistency Evaluation

On April 28, Qilu Pharmaceutical’s aripiprazole orally disintegrating tablets, submitted under the new Class 3 application pathway, were approved for marketing by the National Medical Products Administration (NMPA), deemed to have passed the consistency evaluation, making it the second such product in China.

Aripiprazole is a first-line, novel atypical antipsychotic agent that exerts its therapeutic effects primarily by acting on dopamine and serotonin receptors. As the first dopamine partial agonist introduced into clinical practice, it is mainly used for the treatment of schizophrenia. Compared with other psychotropic medications, aripiprazole offers advantages such as fewer side effects, significant efficacy, and lower relapse rates. It is recommended by the US Expert Consensus Guidelines as a first-choice drug, alongside risperidone, for the treatment of first-episode or recurrent schizophrenia.

Currently, Qilu Pharmaceutical has 28 products that have passed the consistency evaluation.