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3003.31.00.00/Bulk Insulin Glargine Solution/China

Bulk Insulin Glargine Solution from China

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 — China → United States

12.5%

Rate breakdown

9903.05.3112.5%Section 301 (forced labor) — additional 12.5% ad valorem on products of China
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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

Bulk Insulin Glargine Solution from China — Import Duty Rate | HTS 3003.31.00.00