Bulk Insulin Glargine Solution from Japan
A pharmaceutical preparation containing recombinant human insulin glargine mixed with stabilizers and preservatives for therapeutic use in diabetes management. Classified under HTS 3003.31.00.00 as it contains insulin (a hormone of heading 2937) and is a mixed multi-constituent medicament not in measured doses or retail packaging.
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
• Obtain FDA approval and Drug Master File (DMF) for active pharmaceutical ingredients (APIs) like insulin
• Provide certificates of analysis (CoA) confirming insulin content and stability for customs valuation
• Avoid misclassification as unmixed hormones by documenting multi-constituent mixing process