Cariprazine Hydrochloride API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Vraylar, Reagila

Category: Active Pharmaceutical Ingredient

Cariprazine hydrochloride is an atypical antipsychotic API used in oral capsules. It is sourced by CNS formulators, CDMOs and generic R&D teams preparing filings.

Product Description:

Cariprazine is an atypical antipsychotic that acts as a partial agonist at dopamine D3 and D2 receptors, with a preference for D3, and at serotonin 5-HT1A receptors. In the US it is approved for schizophrenia and for manic or mixed episodes of bipolar I disorder (each including some younger patients), and in adults for bipolar depression and as add-on treatment for major depressive disorder; in the EU it is approved for schizophrenia in adults (reference brand: Vraylar, Reagila).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 19 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (Sep 2029 (Mar 2030 with paediatric)). European Union: No confirmed date.

Handling and quality points

Cariprazine is pharmacologically active at very low amounts and has long-lived active metabolites, so many makers treat it as a potent compound with containment and cleaning limits to match. The specification should control the cis isomer and dichlorophenylpiperazine-related impurities. A nitrosamine risk assessment is important: the aryl piperazine and the dimethylurea group mean both piperazine-derived nitrosamines and NDMA need to be considered.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.