Recombinant Human Insulin (Bulk)
Recombinant human insulin is a protein hormone produced via biotechnology, used primarily for diabetes management. Classified in HTS 2937.19.00.00 as a protein hormone used primarily as a hormone. This applies to bulk API before formulation.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If imported as finished injection vials
Medicaments consisting of insulin in dosage form are specifically provided for in 3004.31.
If classified as sugar esters/modified
Chemically modified insulin derivatives with sugar moieties fall under Chapter 29 sugar derivative provisions.
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Import Tips & Compliance
• Maintain cold chain with validated shipping; provide recombinant production process validation; differentiate from dosage-form insulins under 3004
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