Palbociclib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Ibrance

Category: Active Pharmaceutical Ingredient

Palbociclib is an oral CDK4/6 inhibitor used for HR-positive advanced breast cancer. It is sourced by generic formulators, CDMOs and licensed importers.

Product Description:

Palbociclib selectively inhibits cyclin-dependent kinases 4 and 6, holding cancer cells in the G1 phase of the cell cycle so they stop dividing. It is approved with an aromatase inhibitor or fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer, and the US label also covers use with inavolisib and fulvestrant in PIK3CA-mutated disease and with trastuzumab-based therapy as maintenance in HR-positive, HER2-positive metastatic breast cancer (reference brand: Ibrance).

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 (Mar 2027 (compound patent with PTE)). European Union: Entry expected (2028 (basic patent + SPC)). Sources and updates are on our generic and biosimilar entry tracker.

Handling and quality points

Palbociclib is a potent oncology API with reproductive toxicity and is normally handled under high-potency controls. Solubility falls sharply above pH 4, so particle size and crystal form affect dissolution; ask for XRPD and particle size limits. The piperazine NH is a secondary amine, so a nitrosamine risk assessment covering the N-nitroso derivative of palbociclib, with testing where needed, belongs in the 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.