Sulpiride

For clinical manifestations of patients with schizophrenia such as positive symptoms, negative symptoms, and depressive withdrawal, benzamide drugs with both antipsychotic and mood-regulating effects are often selected in clinical treatment, and sulpiride is one of the varieties with relatively mature clinical application among them. Its mechanism of action is to selectively block dopamine D2 receptors in the mesolimbic system, and at the same time inhibit the chemoreceptor trigger zone of the medulla oblongata to exert an antiemetic effect. Low doses can improve depression and anxiety states, while high doses have definite efficacy on psychotic symptoms such as hallucinations and delusions. In addition to the treatment of various subtypes of schizophrenia, it can also be used for symptomatic intervention of intractable nausea and vomiting and senile mental disorders, and the applicable population covers adult patients with mental illnesses and elderly patients with related symptoms.

The continuous rise in the prevalence of mental diseases in China has driven the expansion of the antipsychotic drug market. Data show that the domestic market size of antipsychotic API (Active Pharmaceutical Ingredient) has exceeded 2.8 billion yuan in 2023, with a compound annual growth rate maintained at around 6.2%. As a commonly used variety of first-generation antipsychotic drugs, sulpiride has a stable proportion in primary medical institutions and long-term prescriptions of psychiatry specialists due to its outstanding cost-effectiveness and controllable adverse reactions. At present, domestic sulpiride API manufacturers are mainly local pharmaceutical enterprises, with the CR3 proportion exceeding 75%. Sulpiride has been included in the National Essential Medicines List, and the generic drug substitution rate has reached more than 90% under the promotion of the centralized procurement policy. The overall market supply pattern is stable, and the price fluctuation range is small.

The original research enterprise of sulpiride is Sanofi-Aventis, with the original brand name Dogmatil, and its core compound patent expired worldwide in 1989. The main dosage forms of the original product are tablets, with specifications including 50mg, 100mg and 200mg. Among them, the 100mg tablet has been included in the FDA Reference Listed Drug Catalog, and the domestic reference preparation is recorded in the *Collection of Chemical Drug Catalogs*. As of October 2024, there are a total of 12 sulpiride API registration records on the CDE API Registration Platform, among which 8 are in Status A and can be used for associated evaluation. A total of 27 domestic enterprises have obtained marketing approval for sulpiride preparations such as tablets and injections. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of sulpiride impurity reference standards, most of which are available directly from stock. Spot orders submitted before 16:00 can be shipped on the same day. All products comply with multiple regulatory standards such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance requirements of all stages of API R&D, quality research and registration declaration.