Bulk Insulin Glargine Solution from Germany
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 — Germany → United States
10%
Rate breakdown
9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter
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