Fluvoxamine

In response to the clinical pain point of long-term recurrent attacks of mental illnesses such as depressive disorder and obsessive-compulsive disorder, selective serotonin reuptake inhibitor (SSRI) drugs are the current first-line treatment regimen, and fluvoxamine is a classic variety among them with over 30 years of clinical application. It specifically blocks the reuptake of serotonin by the presynaptic membrane and increases the concentration of serotonin in the synaptic cleft, thereby improving core symptoms such as low mood and obsessive thinking. In addition, it has low affinity for cholinergic and histaminergic receptors, resulting in a lower incidence of adverse reactions. In addition to adult patients with depression and obsessive-compulsive disorder, it has also been approved for the treatment of obsessive-compulsive disorder in children and adolescents, and is one of the few SSRI drugs that cover the obsessive-compulsive disorder indication for all age groups.

In recent years, the global market size of fluvoxamine has been stable in the range of 1.2 to 1.5 billion yuan, the growth rate of the Chinese market is higher than the global average, with a compound annual growth rate of approximately 4.2%, and the core driving factors are the increase in the consultation rate of mental illnesses and the expansion of indications. In terms of the competitive landscape, the original research product still accounts for approximately 30% of the market share, and domestic generic drugs have passed the consistency evaluation to achieve import substitution. At present, 8 domestic enterprises have obtained preparation approvals, the supply of API is mainly dominated by local enterprises, the overall market competition is sufficient, and there are no monopolistic suppliers.

The original research enterprise of fluvoxamine is Solvay Pharmaceuticals, a subsidiary of Abbott, with the trade name "Luvox". Its core compound patent in the United States expired in 2007, and its core patent in China also expired in 2010. The main dosage form approved for the original research product is tablet, and the conventional specifications include 50mg and 100mg, which have been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA reference preparation catalogue. In terms of domestic API registration, at present, 6 enterprises have obtained A status for their fluvoxamine APIs through CDE registration, which can be associated with preparation declaration. A number of domestic manufacturers have obtained approval for the marketing of fluvoxamine tablets, among which 5 product specifications have passed the consistency evaluation. (Data as of April 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of fluvoxamine impurity reference standards, covering all categories such as synthesis process impurities and degradation impurities. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as API R&D, quality research, and registration declaration.