Amitriptyline

The global prevalence of depression and chronic neuropathic pain is increasing year by year, and the clinical demand for drugs with both mood regulation and analgesic effects continues to rise. Amitriptyline is a tricyclic antidepressant. By inhibiting the reuptake of serotonin and norepinephrine by the presynaptic membrane, it increases the concentrations of these two neurotransmitters in the synaptic cleft. It can not only improve the symptoms of low mood and anhedonia in patients with various types of depression, especially suitable for depressed people with anxiety or sleep disorders, but also be used as a second-line medication for chronic pain such as postherpetic neuralgia and fibromyalgia. It has a stable clinical application in both psychiatry and pain management departments.

At present, the global market size of amitriptyline preparations is stable at around US$1.2 billion, with a compound annual growth rate maintained at 2.1%. The growth momentum mainly comes from the improvement of the diagnosis and treatment rate of neuropsychiatric diseases in emerging markets. As a classic drug that has been on the market for more than half a century, its market has fully entered the stage dominated by generic drugs, with more than 70 generic drug enterprises around the world. China is the world's most important supplier of amitriptyline API, with production capacity accounting for about 62% of the global total production capacity. The domestic preparation market has completed multiple rounds of centralized procurement, with the average winning price dropping by 76% compared with the maximum procurement limit price, and the accessibility of medication for patients has been significantly improved.

The original research enterprise of amitriptyline is Sandoz Pharmaceuticals, and the original brand name is Elavil®. The core compound patent expired worldwide in 1985. At present, the main dosage form of the original research product on the market is tablet, with specifications including 10mg, 25mg, 50mg, 75mg, 100mg and 150mg, which has been included in the FDA Reference Listed Drug Catalog, and these specifications have also been listed as reference preparations in China. In terms of domestic API registration, 8 enterprises have completed the registration of amitriptyline API with CDE and obtained the A status, which can be legally supplied to preparation manufacturers. All the preparation varieties approved for marketing in China are oral tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for amitriptyline API. Most of the products are available from stock. Orders for in-stock products 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 reference standard needs of pharmaceutical enterprises in the whole process of API R&D, quality research and production release.