Insulin Glargine (Lantus) from Japan
Long-acting basal insulin analogue produced by recombinant DNA, modified for prolonged release profile. HTS 2937.12.00.00 covers this as a derivative and structural analogue of insulin used primarily as a hormone. Chemically defined polypeptide meeting Chapter 29 hormone classification criteria.
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
• Provide recombinant production method validation and amino acid sequence confirmation
• Temperature-controlled shipping mandatory (2-8°C); include continuous monitoring records
• Pure substance declaration prevents reclassification as Chapter 30 pharmaceutical product