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Famotidine API from Japan

Famotidine is an aromatic imine-function histamine H2-receptor antagonist used for acid reflux treatment. It qualifies for HTS 2925.29.20.00 as a drug with carboxyimide and imine characteristics. Widely imported for generic antacid tablet production.

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

• Submit BE/ANDA documentation linking to approved reference product

• Include thioether oxidation stability data for impurity control

• Verify dual function classification maintains 'drugs' status under 2925