Serotonin

Disorders of the neurotransmitter system are one of the core inducing factors for the onset of mental illnesses such as depression and anxiety. Serotonin (also known as 5-hydroxytryptamine), as a monoamine neurotransmitter, is a key signaling molecule that regulates emotional conduction in the central nervous system, peripheral vasoconstriction and smooth muscle movement. Its mechanism of action exerts physiological effects by binding to receptors of different subtypes: at the central level, it mainly regulates mood, cognition, sleep and appetite, and is the target of action for the vast majority of current antidepressant drugs; at the peripheral level, it participates in the regulation of gastrointestinal peristalsis, coagulation function and pain perception. Related preparations are not only suitable for adjuvant treatment of patients with depression and generalized anxiety disorder, but also can be used to relieve gastrointestinal disorders such as chemotherapy-related vomiting and irritable bowel syndrome.

At present, the global market size of serotonin-related drugs exceeds 18 billion US dollars, with a compound annual growth rate maintained at around 4.7%. The competitive landscape presents a stratified feature: the high-end original research preparation market is dominated by overseas pharmaceutical companies, while the supply of APIs and intermediates has been gradually transferred to the Asia-Pacific region such as China and India. Domestic enterprises account for nearly 35% of the global raw material supply share by virtue of cost advantages. Since serotonin itself is an endogenous substance and is not restricted by compound patents, there are more than 70 domestic enterprises approved to produce related preparations. Driven by the volume-based procurement policy, the demand of downstream preparations for cost-effective and compliant APIs continues to rise.

There is no single original research enterprise for serotonin. The first marketed selective serotonin reuptake inhibitor derived from it was originally developed by the US pharmaceutical company Eli Lilly, with the trade name Prozac (fluoxetine hydrochloride), and its core compound patent expired in 2001. At present, the serotonin-related preparations approved for marketing in China cover a variety of dosage forms such as tablets, capsules and injections, with specifications including 10mg, 20mg and other conventional clinical doses. According to the CDE API registration database, 11 domestic enterprises have obtained A-status registration numbers for serotonin APIs, which can be used as the corresponding raw material sources of reference preparations, and related varieties have been included in the FDA's public API DMF filing list. (Data as of November 2024, please refer to the official CDE website for the latest information)

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