Human Insulin (rDNA) from Japan
Recombinant human insulin produced via DNA technology, a polypeptide hormone used primarily for treating diabetes mellitus. Classified under HTS 2937.12.00.00 as a synthetic reproduction of insulin, the exact structural analogue of natural human insulin. Meets chapter 29 requirements for chemically defined organic compounds used as hormones.
Duty Rate — Japan → United States
15%
Rate breakdown
9903.04.6215%Pharmaceuticals: patented pharma from JP/EU/KR/CH/LI — 15% floor rate
9903.05.860%Universal product exemption (U.S. note 52(b))
9903.05.900%Articles already subject to Section 232 (steel/aluminum/copper + derivatives, autos + parts, wood, medium/heavy vehicles + parts, semiconductors, patented pharma) — U.S. note 52(f)
Import Tips
• Requires FDA approval and biologics license; provide certificates of analysis confirming rDNA origin and purity
• Maintain strict cold chain (2-8°C) documentation throughout transport to preserve bioactivity
• Declare as 'insulin, synthetic' to avoid misclassification with pharmaceutical preparations in Chapter 30