Crizotinib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Xalkori

Category: Active Pharmaceutical Ingredient

Crizotinib is an oral ALK, ROS1 and MET kinase inhibitor used in lung cancer and rarer ALK-positive tumours. Generic developers, CDMOs and R&D teams source the API.

Product Description:

Crizotinib is a small-molecule inhibitor of the ALK, ROS1 and MET receptor tyrosine kinases. It is approved for metastatic non-small cell lung cancer that is ALK- or ROS1-positive, for relapsed or refractory ALK-positive systemic anaplastic large cell lymphoma in children and young adults, and for ALK-positive inflammatory myofibroblastic tumour that is unresectable, recurrent or refractory (reference brand: Xalkori).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 4 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). European Union: Patent expiry; entry not confirmed (2027-2028).

Handling and quality points

Crizotinib is usually handled as a potent compound with contained charging and dispensing. The piperidine ring carries a secondary amine, so a careful nitrosamine risk assessment, including any N-nitroso derivative of the drug itself, is a routine buyer request. Chiral purity of the (R)-enantiomer and the crystalline form should both sit in the specification.

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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.