Milnacipran

The global prevalence of depression has exceeded 3%, and patients often suffer from somatic pain symptoms of varying degrees. Traditional antidepressants have limited effect on improving somatic symptoms, while the advent of milnacipran has filled this clinical gap. As a serotonin and norepinephrine reuptake inhibitor (SNRI) class antidepressant, it has a more balanced inhibitory effect on the reuptake of the two neurotransmitters, hardly binds to histamine, cholinergic and other receptors, and has a lower incidence of adverse reactions. It is clinically mainly used for the treatment of major depressive disorder in adults, and can also be used for symptom relief of fibromyalgia, with particularly significant benefits for depressed patients with comorbid somatic pain and fatigue.

The global market size of milnacipran is approximately USD 1.27 billion. Driven by the expansion of fibromyalgia indication and the growth of the depressed population in recent years, its compound annual growth rate has remained at around 4.8%. The domestic market is still in a period of rapid growth at present, with an annual growth rate of 11.2%. The competitive landscape is dominated by the original research drug and a small number of generic drug enterprises, among which overseas enterprises account for more than 60% of the API supply side, leaving a large space for domestic substitution. As milnacipran was included in the national centralized procurement catalogue in 2022, the market penetration rate of generic drugs has continued to increase, driving the steady rise in demand for upstream APIs.

The original research enterprise of milnacipran is Pierre Fabre Pharmaceuticals of France, with the original brand name "Ixel", and its core compound patent expired globally in 2010. The main dosage form approved for the original research drug is tablet, with specifications including 25mg, 50mg and 100mg, which has been included in the FDA Reference Listed Drug Catalogue and China's *Catalogue of Reference Preparations for Chemical Drugs*. As of now, a total of 3 Chinese enterprises have obtained CDE registration numbers (Status A) for milnacipran APIs, and multiple domestic enterprises have received approval for the marketing of generic preparations of milnacipran. The winning bid price in centralized procurement is more than 70% lower than that of the original research drug, which greatly reduces the medication burden of patients. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for milnacipran API. All impurities have undergone strict structural confirmation and purity calibration, complying with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process needs of pharmaceutical enterprises in R&D, quality research and compliance declaration.