Fluphenazine

As a chronic and severe mental disorder, schizophrenia has a protracted course and high risk of recurrence. Long-acting antipsychotics are the core treatment option to improve patients' medication adherence and reduce recurrence rate. Fluphenazine is a first-generation phenothiazine antipsychotic, which exerts antipsychotic effects by blocking central dopamine D2 receptors, and has a significant improvement effect on positive symptoms such as hallucinations, delusions and thought disorders. Meanwhile, its long-acting ester derivative fluphenazine decanoate can be administered once every 2 to 4 weeks, which is especially suitable for schizophrenia patients with poor medication adherence and those receiving chronic maintenance treatment, and can also be used to relieve manic episodes and the symptoms of excitement and agitation in other severe mental disorders.

The global market size of antipsychotics exceeds US$20 billion, among which long-acting antipsychotics account for approximately 25%, with a compound annual growth rate of over 6%. As a core variety of classic long-acting antipsychotics, fluphenazine has a stable global market demand, and generic drugs dominate the market. At present, a number of domestic enterprises have obtained approval for the production of its preparations and active pharmaceutical ingredients, and the demand in the primary medical market is rising steadily. There is no publicly verifiable data on the market size of this segment.

The original research enterprise of fluphenazine is Bristol-Myers Squibb, with the original brand name Prolixin, and its core compound patent expired in 1980. The main dosage forms approved for the original product include conventional tablets (1mg, 2.5mg, 5mg, 10mg) and injection (fluphenazine decanoate injection, 25mg/ml), and the original product has been included in the FDA Reference Listed Drug Catalog. At present, more than 10 fluphenazine active pharmaceutical ingredients have been approved for registration in China (A status), and both oral tablets and fluphenazine decanoate injection have been approved for marketing as domestic generic drugs, while no original preparation has been approved for import in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for fluphenazine, most of which are in stock. For in-stock orders placed before 16:00, delivery can be made 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 quality control needs in different scenarios such as active pharmaceutical ingredient R&D, quality research, and generic drug consistency evaluation.