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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

15%

Rate breakdown

9903.04.628.5%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter
9903.05.900%Articles of aluminum, of steel or of copper or derivative aluminum or steel articles; passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; parts of passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; medium- and heavy-duty vehicles; parts of medium- and heavy-duty vehicles; wood products; patented pharmaceutical articles; and semiconductor articles, as provided in subdivision (f) of U.S. note 52 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