Clozapine

Schizophrenia is a severe mental disorder characterized by high recurrence rate and high disability rate. Approximately 30% of patients, whose symptoms still cannot be effectively controlled after receiving conventional antipsychotic treatment, are classified as refractory cases. As a representative variety of atypical antipsychotics, clozapine exerts multiple regulatory effects by blocking central dopamine D2 receptors and 5-hydroxytryptamine 2A receptors. It is currently the clinically recognized first-line treatment drug for refractory schizophrenia, and can also be used to reduce the risk of suicide in patients with schizophrenia or schizoaffective disorder, providing a critical treatment option for patients who respond poorly to other drugs.

At present, the global market size of clozapine is stable at around 1.2 billion US dollars, with a steady compound annual growth rate of 2.3%. Due to its early launch time and long-expired patents, the market of this variety is completely dominated by generic drugs. China and India are the world's most important clozapine API manufacturers, collectively supplying more than 80% of the global market demand. In terms of the domestic market, clozapine preparations have been included in the National Essential Medicines List and the Class A Medical Insurance List. The selected price of small and medium-specification oral conventional-release dosage forms in centralized procurement is as low as 0.04 yuan per tablet, with extremely high clinical accessibility.

The original developer of clozapine is Novartis, with the original brand name Clozaril. The core compound patent expired globally in 1990. At present, the main formulations of the original drug approved are 25mg, 50mg, 100mg and 200mg oral tablets, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, nearly 30 enterprises have completed CDE registration of clozapine API with the status of "A", which can be supplied for domestic preparation production; there are more than 200 domestic approval documents for clozapine oral preparations, with sufficient supply. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full range of clozapine impurity reference standards. Most products are in stock, supporting compliance traceability in accordance with the pharmacopoeia standards of multiple countries including the Chinese Pharmacopoeia and FDA. All in-stock orders paid before 16:00 can be shipped on the same day, which can fully meet the full-scenario needs of pharmaceutical enterprises in R&D, quality research and routine quality control links.