Insulin Detemir (Levemir)
Soluble long-acting insulin analogue with fatty acid modification for albumin binding. HTS 2937.12.00.00 applies to this rDNA-produced derivative used primarily as a basal insulin hormone replacement.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If in dosage form with stabilizers/preservatives
Chapter 30 for medicaments; pure API hormones remain in Chapter 29 per notes.
If other protein/glycoprotein hormones
If not meeting specific insulin definition, may fall under broader 2937.19.
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Import Tips & Compliance
• FDA import alert 66-40 applies; pre-clearance with biologics license holder required
• Maintain 2-8°C throughout supply chain with calibrated data loggers
• Declare as 'pure insulin analogue substance' not 'medicament' for correct heading
Related Products under HTS 2937.12.00.00
Human Insulin (rDNA)
Recombinant human insulin produced via DNA technology, a polypeptide hormone used primarily for treating diabetes mellitus. Classified under HTS 2937.12.00.00 as a synthetic reproduction of insulin, the exact structural analogue of natural human insulin. Meets chapter 29 requirements for chemically defined organic compounds used as hormones.
Insulin Lispro (Humalog)
Rapid-acting insulin analogue created by recombinant DNA technology with amino acid modifications for faster absorption. Falls under HTS 2937.12.00.00 as a structural analogue of insulin used primarily as a hormone for glycemic control. Qualifies as a chain-modified polypeptide hormone per chapter notes.
Insulin Glargine (Lantus)
Long-acting basal insulin analogue produced by recombinant DNA, modified for prolonged release profile. HTS 2937.12.00.00 covers this as a derivative and structural analogue of insulin used primarily as a hormone. Chemically defined polypeptide meeting Chapter 29 hormone classification criteria.
Insulin Aspart (NovoRapid)
Fast-acting insulin analogue with aspartic acid substitution, rDNA origin, used for mealtime glycemic control. Classified in 2937.12.00.00 as insulin structural analogue per heading description for chain-modified polypeptides used as hormones.
Insulin Sodium Salt USP
Pharmaceutical grade sodium salt of bovine or porcine insulin meeting USP standards. Explicitly covered by HTS 2937.12.00.00 as 'insulin and its salts' for therapeutic hormone use.
Recombinant Insulin API Powder
Bulk active pharmaceutical ingredient powder of human insulin produced by recombinant E. coli or yeast. HTS 2937.12.00.00 for pure synthetic insulin substance before formulation into dosage forms.