Brigatinib from Japan

Brigatinib is an ALK inhibitor for lung cancer treatment. This macrocyclic aromatic nitrogen-heterocycle drug substance imports under HTS 2933.99.75.00.

Duty Rate — Japan → United States

6.5%

Rate breakdown

9903.03.030%Articles the product of any country, as provided for in subdivision (aa)(ii) of U.S. note 2 to this subchapter

Import Tips

GMP compliance audit trail required from API manufacturer

Residual solvent analysis per ICH Q3C mandatory for entry

Avoid declaring as 'new chemical entity' after FDA approval