Pulse Pharma Gets CDSCO Panel Nod to Manufacture, Market Aripiprazole Oral Solution
New Delhi: In a recent development, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Pulse Pharmaceuticals for the manufacture and marketing of Aripiprazole Oral Solution 1 mg/ml.
The recommendation follows the firm’s presentation of its Bioequivalence (BE) study report for the Aripiprazole Oral Solution before the committee, in accordance with the earlier SEC guidance issued on August 7, 2024.
Aripiprazole is an atypical antipsychotic used in the treatment of a wide variety of mood and psychotic disorders, such as schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's syndrome.
The antipsychotic action of aripiprazole is likely due to its partial agonist activity on D2 and 5-HT1A receptors as well as its antagonist activity at 5-HT2A receptors; however, the exact mechanism has not been fully elucidated.
One of the mechanisms that has been proposed is that aripiprazole both stimulates and inhibits dopamine as it engages the D2 receptor. It lowers dopamine neuronal firing at high dopamine concentrations and increases dopamine firing at low concentrations. Its partial agonist activity gives aripiprazole an intermediate level of dopaminergic neuronal tone between a full agonist and an antagonist of the D2 receptor.
At the recent SEC meeting for neurology and psychiatry, the expert panel reviewed the Bioequivalence (BE) study report for the Aripiprazole Oral Solution.
After detailed deliberation, the committee accept Bioequivalence results and recommended the grant of permission for the manufacture and marketing of Aripiprazole Oral Solution 1 mg/ml for the already approved indication of the tablet.
