Acalabrutinib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Calquence

Category: Active Pharmaceutical Ingredient

Acalabrutinib is a covalent BTK inhibitor for CLL and mantle cell lymphoma, traded as free base or maleate monohydrate. It is sourced by oncology formulators, CDMOs and R&D teams.

Product Description:

Acalabrutinib is a second-generation Bruton tyrosine kinase (BTK) inhibitor that binds covalently to the enzyme and shuts down the B-cell receptor signals that malignant B cells rely on. It is approved for adults with chronic lymphocytic leukaemia or small lymphocytic lymphoma, for mantle cell lymphoma after at least one prior therapy, and, with bendamustine and rituximab, for previously untreated mantle cell lymphoma in patients not eligible for stem cell transplant (reference brand: Calquence).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 7 active Type II API DMFs for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. 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 (Nov 2026 (earliest DS patent)). European Union: No confirmed date.

Handling and quality points

Be clear from the start which drug substance your formulation needs, the free base or the maleate monohydrate, and make sure the supplier controls that solid form; for the maleate, hydrate state and salt stoichiometry need checking batch to batch. As a covalent kinase inhibitor with a reactive butynamide group, acalabrutinib is normally handled under high-potency controls, and buyers should ask how reactive and potentially mutagenic impurities are controlled. A nitrosamine risk assessment should form part of the standard package.

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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.