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NovoLog FlexPen Insulin from Germany

NovoLog FlexPen contains rapid-acting insulin aspart for mealtime blood glucose control in diabetic patients. The pre-filled 3mL pen (100 units/mL) provides dialable measured doses suitable for retail sale. HTS 3004.31.00.00 applies to this insulin-containing medicament in therapeutic dose form.

Duty Rate — Germany → 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

EU/US insulin imports often qualify for zero duty under pharmaceutical appendices or FTAs—verify HS preferences

Include GMP certificates and stability data; FDA may require comparative dissolution profiles for biosimilars