Clomipramine

For the clinical treatment of mental illnesses such as depression and obsessive-compulsive disorder, tricyclic antidepressants are common choices that combine economic efficiency and clinical verification value, and clomipramine is a representative variety among them. It inhibits the reuptake of serotonin and norepinephrine by the presynaptic membrane, increases the concentration of neurotransmitters in the synaptic cleft, and then exerts antidepressant and anxiolytic effects. At the same time, it is currently one of the few oral drugs recommended by guidelines for the first-line treatment of obsessive-compulsive disorder. It can also be used for symptomatic intervention of phobias, panic attacks and chronic pain syndromes, and the applicable population covers adult patients and some adolescent groups after strict clinical evaluation.

The global market size of clomipramine preparations is approximately US$320 million, with a compound growth rate of 2.1% in the past five years, and the growth mainly comes from the improvement of the diagnosis and treatment rate of mental illnesses in emerging markets. In terms of the domestic market, the annual sales at the terminal of public medical institutions are stable at 180 million yuan. Due to its early launch, a competitive pattern of coexistence of original research drugs and generic drugs has been formed at present, with domestic generic drugs accounting for about 62%. In the 2022 provincial-level centralized drug procurement, the average price reduction of winning clomipramine tablets reached 58%, which further promoted the improvement of clinical accessibility.

The original research enterprise of clomipramine is Novartis, and the original trade name is Anafranil. Its core compound patents in major global markets expired before 2002, and all core patents in China have also expired. The main dosage form approved for the original research drug is tablet, with specifications of 25mg and 50mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation listed by the FDA. In terms of domestic API registration, 6 enterprises have obtained A status for their clomipramine APIs through CDE registration, and the tablets of the original research enterprise and many local enterprises have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for clomipramine, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production.