Sertindole

As a severe mental disorder with high recurrence rate and high disability rate, schizophrenia often faces the pain points of many extrapyramidal reactions and insufficient improvement of negative symptoms of traditional antipsychotic drugs in clinical treatment. Sertindole is a second-generation atypical antipsychotic drug, which exerts its effect by selectively antagonizing dopamine D2 receptor, 5-hydroxytryptamine 2A receptor and α1 adrenergic receptor. It can not only effectively improve the positive symptoms (such as hallucinations and delusions) of patients with schizophrenia, but also has definite benefits for negative symptoms (such as apathy and social withdrawal) and cognitive function impairment. Moreover, compared with traditional drugs, it has a lower incidence of extrapyramidal adverse reactions, and is suitable for acute phase treatment and maintenance phase recurrence prevention of adult schizophrenia, especially for patients with poor tolerance to other antipsychotic drugs.

The global antipsychotic drug market scale continues to expand steadily, among which atypical antipsychotic drugs account for more than 80%. As a differentiated alternative variety for clinical use, the utilization rate of sertindole in primary mental health institutions in middle-income countries is increasing year by year. At present, the global production capacity of sertindole API is mainly concentrated in China and India, among which the API supplied by Chinese enterprises accounts for more than 65% of the production volume of global generic drug preparations. There is no relevant record of sertindole centralized procurement in China, and the market competition pattern is relatively loose. Due to its stable clinical usage and moderate process barriers, it is a niche popular variety for characteristic generic pharmaceutical enterprises to deploy.

The original research enterprise of sertindole is Lundbeck Pharma A/S of Denmark, and the original research trade name is Serdolect. Its core compound patent expired in 2010 in Europe and the United States, and expired in 2009 in China. The main dosage form of the original research product on the market is tablet, with specifications including 4mg, 12mg, 16mg and 20mg. The original research tablet has been included in the FDA Orange Book Reference Listed Drug Catalog, but has not been included in the Chinese Reference Listed Drug Catalog for the time being. Up to now, there is no approved sertindole preparation product on the market in China, and there is no valid registration number of sertindole in A status or I status on the CDE API registration platform. (Data as of October 2024, please refer to the official CDE website for the latest data)

CATO provides a full set of impurity reference standards for sertindole API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the impurity research needs of pharmaceutical enterprises in the whole process from process R&D to registration and declaration.