Alectinib Hydrochloride API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Alecensa

Category: Active Pharmaceutical Ingredient

Alectinib hydrochloride is a second-generation ALK inhibitor for ALK-positive lung cancer. Generic developers, CDMOs and research teams source the API.

Product Description:

Alectinib is an oral kinase inhibitor that targets ALK and RET and reaches the central nervous system. It is approved for ALK-positive metastatic non-small cell lung cancer and as adjuvant treatment after resection of certain ALK-positive non-small cell lung cancers (reference brand: Alecensa).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 9 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 (May 2031). European Union: No confirmed date.

Handling and quality points

Alectinib is generally handled as a potent kinase inhibitor with contained powder operations. It is very poorly soluble in water, so the crystalline form and particle size of the hydrochloride affect capsule performance and should be agreed with the supplier. The molecule contains morpholine and piperidine rings, so the nitrosamine risk assessment should consider N-nitrosomorpholine and related small nitrosamines from reagents.

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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.