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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

12.5%

Rate breakdown

9903.05.4912.5%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%

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