Amoxapine

As a highly disabling mental disorder, depressive disorder has an ongoing and urgent demand for antidepressants with fast onset of action and excellent safety in clinical treatment. Amoxapine is a dibenzoxazepine-class tricyclic antidepressant. It exerts its effect by inhibiting the reuptake of serotonin and norepinephrine in the central nervous system, and at the same time has a certain affinity for dopamine D2 receptors. It is not only suitable for patients with various types of depressive disorders, but also delivers definite clinical benefits for depression with psychotic symptoms and refractory depression. Compared with traditional tricyclic drugs, it has milder anticholinergic adverse reactions and better tolerance in elderly patients.

At present, the global antidepressant market size has exceeded 15 billion US dollars, among which the annual growth rate of drugs for the细分 indication of "depression with psychotic symptoms" maintains at around 7%. Due to its precise clinical positioning, the market expansion rate of generic amoxapine is significantly faster than that of common antidepressant varieties: currently, this variety is not covered by domestic centralized procurement, the number of approved preparation manufacturers is less than 5, there is still an obvious产能 gap on the API supply side, and the market competition landscape is relatively loose.

The original developer of amoxapine is Pfizer, with the original brand name Asendin. The compound patent in the US market expired in 1992. The main dosage form approved for the original drug is tablet, with specifications including 25mg, 50mg, 100mg and 150mg, and its tablets have been included in the FDA Reference Listed Drug Catalog. As of the search time point, there is no A status registration number of amoxapine on the domestic CDE API registration platform, and all approved marketed preparations are domestic generic drugs, with no original preparation imported. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for amoxapine API, with most products available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of the whole process including API R&D, quality research, consistency evaluation, etc.