Perphenazine

Schizophrenia is a chronic and severe mental disorder with a protracted course and high recurrence rate, so clinical practice imposes extremely high requirements on the safety and tolerability of long-term medication. Perphenazine is a first-generation phenothiazine antipsychotic drug, which exerts its antipsychotic effect by blocking dopamine D2 receptors in the mesolimbic system, and also has weak affinity for 5-hydroxytryptamine receptors and α-adrenergic receptors. Compared with similar drugs such as chlorpromazine, it has milder sedative effect and lower incidence of extrapyramidal reactions. In addition to controlling the positive symptoms of various types of schizophrenia (such as hallucinations, delusions, and thought disorders), it can also be used for patients with organic lesions and elderly patients with mental disorders, as well as for the symptomatic treatment of symptoms such as nausea and vomiting. Its clinical application scenarios cover adults and some elderly groups who require dose adjustment.

At present, the global market size of antipsychotic drugs has exceeded 40 billion US dollars. Among them, traditional antipsychotic drugs still account for about 15% of the share in primary medical scenarios due to their cost advantages. As an essential variety in the grassroots mental disease prevention and treatment catalog, the annual global demand for perphenazine remains above 200 tons. In terms of the domestic market, perphenazine is included in the National Essential Medicines List. In 2023, the winning price in provincial centralized procurement decreased by 42% compared with that before the pilot, and the overall market supply is stable. The existing production capacity is mainly dominated by domestic generic drug enterprises, and the import dependence of API is less than 5%. There is no publicly verifiable data on the annual growth rate of perphenazine's market size in the market segment.

The original developer of perphenazine is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, with the original brand name Trilafon, and its core compound patent in the US market expired in 1987. The main formulations approved for the original product include tablets (2mg, 4mg, 8mg, 16mg) and injections (5mg/ml), among which the 2mg and 4mg tablets have been included in the FDA Reference Listed Drug Catalog, and the original formulation has not been imported into China. There are currently 13 domestic registration entries for perphenazine API, 12 of which are in status A and can be supplied for associated preparation declaration; 25 perphenazine preparation products have been approved for marketing, covering two major dosage forms: tablets and injections. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the needs of impurity research and quality control of perphenazine, CATO can provide a full set of impurity reference standards for this API, and most of the products are available from stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of all links including API production, preparation research and development, and quality testing.