舍曲林

The number of patients with depressive disorder worldwide has exceeded 300 million, and selective serotonin reuptake inhibitors (SSRIs) are the core category of first-line drugs for the current treatment of depressive disorder. As a representative variety of SSRIs, sertraline exerts its antidepressant and anxiolytic effects by specifically inhibiting the reuptake of serotonin by the presynaptic membrane of neurons and increasing the concentration of serotonin in the synaptic cleft. Its clinical indications cover depression, obsessive-compulsive disorder, post-traumatic stress disorder, social anxiety disorder, etc. Due to its low affinity for cholinergic and histaminergic receptors and few cardiovascular adverse reactions, it can be safely used by elderly patients and depressed people with underlying diseases, and it is one of the antidepressants with the highest prescription volume in the world.

The global market size of sertraline preparations has stabilized at around US$3 billion in recent years, and the annual growth rate of the Chinese market has remained in the range of 5%-8%. In 2023, the terminal sales of domestic public medical institutions exceeded RMB 2 billion. In terms of the competitive landscape, the original research product accounts for about 25% of the market share, and domestic generic drugs have achieved large-scale substitution. Nearly 30 domestic enterprises have obtained the production approval of sertraline preparations, and this variety has been included in the fifth batch of nationally organized drug centralized procurement. The winning bid price has dropped by more than 70% compared with that before the centralized procurement, and the clinical accessibility has been greatly improved. The expansion of the downstream preparation market also directly drives the steady growth of the demand for active pharmaceutical ingredients (APIs).

The original research enterprise of sertraline is Pfizer, and the original research trade name is "Zoloft". Its core compound patent in the United States expired in 2006, and its compound patent in China expired in 2005. The main dosage form of the original research product is tablet, with specifications including 50mg and 100mg. Its tablets have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also reference preparations recognized by the FDA. In terms of the marketing registration of APIs in China, there are nearly 20 valid registration numbers of sertraline APIs including that of Pfizer on the CDE API registration platform at present, among which more than 10 are in status A, which can be directly associated with preparation declaration and use. In addition, sertraline preparations of a number of domestic enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

In the process of preclinical research and preparation quality control, qualitative and quantitative analysis of impurities is a key link in the compliance declaration of sertraline API and preparations. CATO provides a full set of impurity reference standards for sertraline API, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the relevant needs of pharmaceutical enterprises in R&D, production and quality inspection.