Recombinant Insulin API Powder from Japan
Bulk active pharmaceutical ingredient powder of human insulin produced by recombinant E. coli or yeast. HTS 2937.12.00.00 for pure synthetic insulin substance before formulation into dosage forms.
Duty Rate — Japan → United States
15%
Rate breakdown
9903.04.6215%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
9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 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
• Reference Drug Master File (DMF) with FDA; provide manufacturing process validation
• Lyophilized powder stable at 2-8°C; avoid freeze-thaw cycles in transit
• Bulk API declaration prevents erroneous Chapter 30 pharmaceutical classification