Ammoxetine

In the clinical treatment of major depressive disorder in adults, serotonin and norepinephrine reuptake inhibitors (SNRIs) are first-line medication categories. Amoxetine, a novel SNRI drug independently developed in China, exerts an antidepressant effect by dually inhibiting the reuptake of serotonin and norepinephrine to increase the concentrations of these two neurotransmitters in the synaptic cleft. Meanwhile, it can also improve anxiety symptoms and cognitive function impairment associated with depression, and is mainly used for the treatment of major depressive disorder in adults. Compared with traditional drugs of the same category, it has a weaker inhibitory effect on dopamine reuptake, lower risk of cardiovascular-related adverse reactions, and better tolerability, providing a new medication option for patients with depression.

At present, the lifetime prevalence of depressive disorder among adults in China reaches 6.8%, of which patients with major depressive disorder account for more than 40%. The corresponding market size of antidepressant drugs has exceeded 10 billion yuan, with an annual compound growth rate remaining above 8%. As a domestic Class 1 innovative antidepressant drug, amoxetine is currently in the initial stage of market promotion. Only the original research manufacturer has the production right, and it has not yet been included in the national centralized procurement catalogue. With the subsequent improvement of clinical recognition and the layout of generic pharmaceutical enterprises after the patent expires, its market penetration rate is expected to further increase. There is no publicly verifiable segmented market size data available at present.

The original research manufacturer of amoxetine is Jiangsu Hansoh Pharmaceutical Group Co., Ltd., and the original research brand name is "Amoxetine". The expiration date of its core compound patent is 2035. The main dosage form currently approved is amoxetine hydrochloride enteric-coated tablets, with a specification of 20mg, which has been included in the China Listed Medicines Catalogue as a reference listed drug. As of the retrieval time point, no other amoxetine API registration information except that of the original research manufacturer has been found on the CDE API registration platform, and only the amoxetine hydrochloride enteric-coated tablets of the original research manufacturer have been approved for marketing in China. (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 amoxetine API, which can fully meet the impurity reference standard needs of pharmaceutical enterprises in the whole process of API R&D, quality research, and registration declaration. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can simultaneously provide complete technical materials such as structure confirmation and purity testing, helping enterprises shorten the R&D cycle.