Aripiprazole

As a chronic severe mental disorder, schizophrenia has long been faced with clinical treatment pain points of high incidence of extrapyramidal reactions and poor compliance caused by traditional antipsychotics, while the advent of aripiprazole has opened up a new path for the management of this disease. As the first atypical antipsychotic of dopamine partial agonist class, it can bidirectionally regulate the level of central neurotransmitters through partial agonism on D2 receptors and 5-HT1A receptors and antagonism on 5-HT2A receptors. It can not only improve the positive and negative symptoms of schizophrenia, but also relieve the accompanying cognitive impairment and affective symptoms. Meanwhile, it has been approved for the treatment of manic episodes of bipolar disorder, adjuvant treatment of major depressive disorder and intervention of Tourette syndrome in children, with the applicable population covering adults and pediatric patients over 6 years old.

At present, the global market size of aripiprazole has exceeded USD 8 billion, and the market size in China is nearly RMB 3 billion, with a compound annual growth rate maintained at around 7%. As the core patents have long expired, generic drugs have become the mainstream of the market. More than 30 domestic enterprises have obtained approval for aripiprazole preparations, and the winning bid price in centralized procurement has dropped by more than 90% compared with the original drug, which has greatly reduced the medication burden of patients. The upstream API sector has sufficient domestic production capacity, and China has become one of the major global suppliers of aripiprazole API. In addition to meeting the demand of domestic preparation production, more than 40% of the output is exported to overseas markets.

The original developer of aripiprazole is Otsuka Pharmaceutical of Japan, with the original brand name "Abilify". The core compound patent of the original drug expired in 2014 in the United States, and the core compound patent in China expired in 2015. The main dosage forms approved for the original drug include tablets, orally disintegrating tablets and long-acting injections, with common specifications of 5mg, 10mg, 15mg, 20mg and 30mg. The original preparation has been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA reference preparation catalogue. In terms of domestic API registration, there are currently more than 20 aripiprazole API registration numbers, most of which are in the status of "A" (approved for use in marketed preparations). A variety of aripiprazole preparations, including tablets, orally disintegrating tablets, capsules and injections, have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a complete set of impurity reference standards for aripiprazole API, which can cover the research needs of all categories such as process impurities and degradation impurities. Most of the products are in stock, and in-stock products ordered before 16:00 can be dispatched on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable support for the quality research, registration and declaration and other work of API and preparation enterprises.