Melitracen

Affected by the continuous rise in the prevalence of mood disorders, the clinical demand for compound components with both antidepressant and anxiolytic effects is increasingly urgent. Melitracen is a tricyclic antidepressant, which exerts antidepressant, anxiolytic and central excitatory effects by inhibiting the reuptake of 5-hydroxytryptamine and norepinephrine by the presynaptic membrane and increasing the concentration of monoamine neurotransmitters in the synaptic cleft. It is often clinically formulated into a compound preparation with flupentixol, which is used for mild to moderate depression and anxiety, neurasthenia, psychogenic depression, depressive neurosis, masked depression, psychosomatic diseases accompanied by anxiety and apathy, menopausal depression, restlessness and depression in alcoholics and drug addicts, covering people with mood disorders of all age groups among adults. Due to its fast onset of action and good tolerability, it has become a common medication option for primary mental illnesses.

At present, the market size of melitracen-related preparations in China exceeds 3 billion yuan, and the compound growth rate in the past three years has remained at around 7%. In terms of the competitive landscape, the original research product has long occupied a dominant position. As generic pharmaceutical companies have entered the market one after another after the expiration of the patent, the price has gradually declined under the promotion of the centralized procurement policy. In the provincial centralized procurement in 2023, the price reduction of relevant compound preparations exceeded 60%, and the market penetration rate continued to rise, driving the steady growth of demand for upstream API.

The original research enterprise of melitracen is H. Lundbeck A/S in Denmark, and the original trade name is Deanxit, which is a compound preparation of flupentixol and melitracen. The core compound patent expired in 2018. The original research dosage form approved in China is a tablet, with the specification that each tablet contains 0.5 mg of flupentixol and 10 mg of melitracen, which has been included in the China Listed Drug Catalogue as a reference preparation. As of now, a number of domestic enterprises have submitted melitracen API registration numbers in the CDE API registration database, among which more than 10 registration statuses are "A" (approved for use in marketed preparations), and a number of domestic enterprises have obtained the production approval documents for flupentixol and melitracen tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of melitracen impurity reference standards, covering various intermediates, by-products and degradation impurities that may be generated during the synthesis process. Most of the products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of impurity reference standards in the process of API R&D, quality research and production.