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Aripiprazole

CAS No.

129722-12-9

Reference product

ABILIFY/OTSUKA

Polymorphic form

Type I

Therapeutic Area

Nervous system

Status

commercial

EU DMF readiness

US DMF readiness

023314

CEP

💉 Available also
in injectable form

Drug description:

Aripiprazole is an antipsychotic agent.
Aripiprazole is indicated for the treatment of psychotic conditions such as bipolar disorder and schizophrenia in adults and adolescents 13 to 17 years old, symptoms of mood swings, temper tantrums, aggression, self-injury related to autistic disorder in pediatrics and irritability, moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 and older. It is also employed in combination therapy for the treatment of major depressive disorder in adult patients.
It is formulated as tablets and solution for oral route of administration and injection solution for intramuscular route of administration.

Mechanism of action:

It has partial agonistic activity at dopamine D2 receptors and serotonin 5-HT1A receptors, as well as potent antagonistic activity on serotonin 5-HT2A receptors. It stabilizes dopamine and serotonin activity in the limbic and cortical system. This stabilization is useful in managing symptoms of schizophrenia and of acute manic and mixed episodes associated with bipolar I disorders.

Disclaimer
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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