Melatonin

Against the background of the continuous rise in the global prevalence of sleep disorders, melatonin, as a core endogenous indole hormone that regulates circadian rhythms, exerts sedative and biological clock-adjusting effects by specifically agonizing MT1 and MT2 receptors. It is mainly used clinically to improve jet lag syndrome and delayed sleep phase disorder, and can also assist in alleviating difficulty falling asleep in special populations such as the elderly and shift workers. Due to its relatively mild action characteristics, it is a commonly used over-the-counter active ingredient in the field of sleep regulation.

The global market size of melatonin API reached USD 180 million in 2023, with a compound annual growth rate of approximately 8.2%. The demand growth mainly comes from the two terminal fields of dietary supplements and prescription drugs. China is the world's largest producer and exporter of melatonin API, with its production capacity accounting for more than 90% of the global total production capacity. The industry concentration is relatively high, with the annual shipment volume of leading enterprises all exceeding 100 tons, and the products are mainly exported to North America, Europe and Southeast Asian markets. Driven by the improvement of residents' awareness of sleep health in the domestic market, the domestic demand growth rate of API has stabilized at more than 12% in the past three years.

There is no clear single original research enterprise for melatonin. The world's first approved medicinal melatonin preparation was developed by the Swedish company Meda AB, with the trade name Circadin. Its core patent expired globally in 2018. The main dosage form is 2mg sustained-release tablet, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, as of now, more than 20 enterprises have obtained A-status registration numbers for their melatonin APIs after approval by the CDE, and domestic preparations of multiple dosage forms such as conventional tablets, sustained-release tablets and capsules have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for melatonin API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can effectively meet the full-process R&D needs of pharmaceutical enterprises such as API quality research and preparation stability investigation.