Lorlatinib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Lorbrena, Lorviqua

Category: Active Pharmaceutical Ingredient

Lorlatinib is a third-generation ALK inhibitor for ALK-positive lung cancer. Formulators, CDMOs and research teams source it for development and generic programmes.

Product Description:

Lorlatinib is a macrocyclic kinase inhibitor of ALK and ROS1, designed to reach the brain as well as the rest of the body. It is approved for adults with metastatic non-small cell lung cancer whose tumours are ALK-positive (reference brand: Lorbrena, Lorviqua).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 1 active Type II API DMF 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 (2033). European Union: Protected beyond 2033 (2034).

Handling and quality points

Lorlatinib is normally handled as a high-potency kinase inhibitor, so contained weighing and dispensing, and a clear exposure band from the maker, are standard requests. It is a single enantiomer, so chiral purity belongs in the specification alongside the crystalline form. Aqueous solubility falls steeply as pH rises (from about 32 mg/mL at pH 2.55 to 0.17 mg/mL at pH 8.02), which makes particle size worth agreeing early; ask too for the nitrosamine risk assessment.

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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.