Talazoparib Tosylate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Talzenna

Category: Active Pharmaceutical Ingredient

Talazoparib tosylate is the tosylate salt of a PARP inhibitor used in oral cancer medicines. It is sourced by formulators, CDMOs and research teams preparing generic development work.

Product Description:

Talazoparib is a poly(ADP-ribose) polymerase (PARP) inhibitor: it blocks an enzyme that cancer cells use to repair DNA damage and traps it on the DNA, which is especially harmful to cells that already lack other repair routes. In the US it is approved for adults with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, and, with enzalutamide, for adults with HRR gene-mutated metastatic castration-resistant prostate cancer (reference brand: Talzenna).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 0 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 (2029 (2032 with pending PTE)). European Union: Protected beyond 2033 (2034).

Handling and quality points

Talazoparib is pharmacologically active at very low exposure, so buyers generally expect it to be made and handled in dedicated or fully contained high-potency areas, with the supplier's occupational exposure band and cleaning validation available on request. The molecule has two adjacent stereocentres, so the specification should control the other enantiomer and diastereomers as well as ordinary related substances. Ask for salt stoichiometry, residual solvents and a nitrosamine risk assessment, and agree particle size if the API is going into a capsule blend.

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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.