Olaparib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Lynparza

Category: Active Pharmaceutical Ingredient

Olaparib is a PARP inhibitor used in oral oncology tablets. It is sourced by oncology formulators, CDMOs and generic R&D teams with contained facilities.

Product Description:

Olaparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes, which tumour cells with faulty homologous recombination repair, such as those with BRCA mutations, depend on to repair DNA damage. It is approved for defined groups of patients with ovarian, fallopian tube or primary peritoneal cancer, breast cancer, pancreatic cancer and prostate cancer, usually selected by BRCA or other DNA-repair gene status (reference brand: Lynparza).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 27 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 (2027 (compound patent)). European Union: Entry expected (2029 (compound patent + SPC)). Sources and updates are on our generic and biosimilar entry tracker.

Handling and quality points

Olaparib is genotoxic and toxic to reproduction, so it is handled under high-potency containment with closed transfers and verified cleaning. The phthalazinone ring is typically built with hydrazine, a mutagenic reagent that should be controlled to low levels in the API. The piperazine in the molecule also makes a nitrosamine risk assessment necessary, and the solid form should be confirmed by XRPD.

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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.