Bilastine from Japan
Bilastine is a novel antihistamine with piperidine nitrogen hetero-atom in its aromatic heterocyclic structure, used for allergic rhinoconjunctivitis. It is specifically covered as an antihistamine drug in HTS 2933.99.26.00.
Duty Rate — Japan → United States
21%
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
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter
Import Tips
• Submit ANDA reference or bioequivalence data for generic imports
• Verify heavy metals content <10 ppm per ICH Q3D guidelines
• Use desiccant packaging for hygroscopic APIs