Imipramine

Depression is one of the mental disorders with the highest prevalence in the world. Patients are often accompanied by persistent low mood, cognitive function impairment and other symptoms, which seriously affect social function. As a classic representative of tricyclic antidepressants, the mechanism of action of imipramine is to inhibit the reuptake of serotonin and norepinephrine by the presynaptic membrane, and increase the concentrations of these two neurotransmitters in the synaptic cleft, so as to improve depressive mood. It can also be used for the adjuvant treatment of nocturnal enuresis in children. The applicable population covers adult patients with depression and children with enuresis aged over 6 years old. It is one of the commonly used drugs in the field of mental disease treatment that has been launched for a relatively early time with sufficient clinical evidence.

At present, the overall global market size of tricyclic antidepressants is approximately USD 1.8 billion. Due to the market squeeze from new antidepressants, the growth rate has maintained at around 1.2% in recent years. However, as a basic clinical drug, imipramine still maintains stable demand in primary medical care and low-income countries. In terms of the domestic market, imipramine is a Class B variety under the national medical insurance. Currently, only 3 enterprises hold preparation approvals, and the API supply side has not yet formed sufficient competition, so the overall market supply and demand relationship is relatively stable.

The original research enterprise of imipramine is Novartis, and the original research trade name is Tofranil. The core compound patent has expired globally in 1980. The main dosage forms approved for the original research are tablets, with specifications of 10mg, 25mg and 50mg. The original research preparation has been included in the FDA Reference Listed Drug Catalog, while the original research product has not been included in the domestic reference listed drug catalog yet. No valid A-status registration number of imipramine has been found on the domestic API registration platform for the time being. Only 2 domestic imipramine hydrochloride tablets have been approved for marketing, and no imported preparation has entered the Chinese market. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for imipramine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet various reference standard requirements in the stages of API R&D, quality research and declaration.