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Nebivolol Hydrochloride from Japan

Nebivolol hydrochloride, highly cardioselective with nitric oxide-mediated vasodilation, contains the requisite aromatic oxygen-function amino-compound structure for HTS 2922.50.1400 classification as a cardiovascular drug. Used in hypertension and heart failure management.

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

• Stereochemistry critical - specify (R,R,R,R)-enantiomer content >99.5%

• Provide particle size distribution data affecting dissolution profiles

• Comply with FDA's GDUFA requirements for generic API assessments