Reboxetine

As a highly disabling psychiatric disorder worldwide, selective serotonin reuptake inhibitors (SSRIs) are the mainstream clinical medications for depression, but approximately 30% of patients still have poor response. Reboxetine, as the first approved and marketed selective norepinephrine reuptake inhibitor (NRI), specifically blocks norepinephrine transporters to increase the concentration of norepinephrine in the synaptic cleft, and hardly affects the reuptake of serotonin or dopamine. It is more suitable for adult depression patients with insufficient response to SSRIs, accompanied by fatigue, cognitive decline and severe retardation symptoms. It can also be used as an adjuvant treatment for social anxiety disorder, providing a differentiated option for individualized treatment of depression.

In recent years, the global market size of reboxetine has maintained in the range of USD 210 million to 250 million. Affected by the popularization of generic drugs, the growth rate is gentle, with a compound annual growth rate of approximately 1.2%. In terms of the domestic market, only one imported preparation has been approved for marketing at present, and no domestic generic drug has passed the consistency evaluation. The annual sales volume in public medical institutions is approximately RMB 32 million. With the improvement of domestic depression diagnosis rate and the optimization of the medication structure of psychotropic drugs, the growth rate is expected to rebound to 5%-7% in the next three years.

The original research enterprise of reboxetine is Pharmacia & Upjohn (a subsidiary of Pfizer), with the original brand name Edronax. The core compound patent expired globally in 2010. The main dosage form approved for the original drug is tablet, with two specifications of 4mg and 8mg. Its 4mg tablet has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (Fifth Batch)* of China. In terms of domestic API registration, there is currently no approved domestic reboxetine API registration number with A status. Only the imported API corresponding to the original drug is registered and publicized in CDE. The only domestically approved and marketed preparation is the original imported reboxetine tablet, which has not been included in the national centralized volume-based procurement scope. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for reboxetine API, which can meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurities are available from stock. Stock orders paid before 16:00 can be shipped on the same day, which fully meets the reference standard supply needs of pharmaceutical enterprises in R&D, quality research and production links.