Bulk Insulin Glargine Solution
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.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If supplied as unmixed insulin API without added excipients
Pure insulin hormones fall under heading 2937 for unmixed products, not mixed medicaments of 3003.
If repackaged into measured doses for retail sale
Medicaments in measured doses or retail forms shift to heading 3004, regardless of insulin content.
If classified as immunological product like insulin analogs for specific immune regulation
Certain peptides involved in immunological processes may qualify under 3002 if meeting chapter note definitions.
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Import Tips & Compliance
• 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
Related Products under HTS 3003.31.00.00
Insulin Lispro Premix Bulk Formulation
Bulk mixed suspension of insulin lispro protamine and regular insulin lispro for glycemic control, containing buffers and preservatives. Falls under HTS 3003.31.00.00 due to insulin hormone content and multi-constituent therapeutic mixture not suited for retail.
Recombinant Human Insulin Bulk Powder
Lyophilized powder formulation of recombinant human insulin mixed with mannitol and buffers for reconstitution in manufacturing. HTS 3003.31.00.00 applies as a mixed therapeutic containing insulin, bulk form excluding retail packing.
Insulin Aspart Injectable Bulk Solution
Sterile aqueous solution of insulin aspart with zinc and phenolic preservatives for diabetes therapy, supplied in bulk for further processing. Classified in 3003.31.00.00 for mixed insulin-containing medicaments not in retail forms.
Biphasic Isophane Insulin Bulk Mixture
Bulk biphasic mixture of human insulin isophane suspension and soluble insulin for prolonged action, with protamine and buffers. Meets HTS 3003.31.00.00 as multi-constituent bulk therapeutic with insulin.
Insulin Detemir Long-Acting Bulk Prep
Bulk formulation of insulin detemir fatty acid acylated analog mixed with phosphate buffers for basal insulin therapy. HTS 3003.31.00.00 for insulin-containing mixed bulk medicaments.
Regular Human Insulin Bulk for IV Use
Bulk regular human insulin solution with sodium chloride for intravenous hyperglycemic treatment, mixed for hospital compounding. Under 3003.31.00.00 as therapeutic mixed insulin not retail-packed.