Thioridazine

Schizophrenia is a severe mental disorder with high recurrence rate and high disability rate. In clinical treatment, it is often necessary to balance the efficacy and the risk of extrapyramidal adverse reactions. Thioridazine is a representative antipsychotic drug meeting such needs. It belongs to the piperidine-type phenothiazine antipsychotics, and exerts its effects by blocking central dopamine D2 receptors, 5-hydroxytryptamine receptors and α-adrenergic receptors. It not only has a definite improvement effect on the positive symptoms of schizophrenia such as hallucinations, delusions and thought disorder, but also has a much lower incidence of extrapyramidal reactions than traditional phenothiazines. It is especially suitable for patients intolerant to other antipsychotics, and can also be used for the symptomatic treatment of children's behavioral disorders and senile mental disorders.

In the global antipsychotic market, classic antipsychotics still occupy a stable market share in low- and middle-income countries due to their cost-effectiveness advantage. The overall market size of thioridazine is approximately USD 230 million. Affected by the popularization of generic drugs and the diversion of new antipsychotics in recent years, its annual growth rate has maintained at around 1.2%. In terms of the domestic market, this variety has been included in the National Medical Insurance Catalog (Class B), the supply of local generic drugs accounts for more than 90%, and the API production is concentrated in compliant pharmaceutical enterprises in Hebei and Jiangsu, with an overall stable supply and no obvious gap between supply and demand. (Note: The above are publicly verifiable market data)

The original research enterprise of thioridazine is Novartis, with the original brand name Mellaril, and its US compound patent expired in 1999. The main dosage form of the original marketed product is tablet, with specifications including 10mg, 25mg, 50mg, 100mg and 200mg, and this variety has been included in the FDA Reference Listed Drug Catalog. For the domestic market, there is no publicized thioridazine API registration number with A status on the CDE API registration platform at present, and only 3 enterprises have obtained approval for marketing their preparation products, all of which are oral tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for thioridazine API. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in the links of API R&D, quality research and declaration and registration.