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.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If pre-filled pens or cartridges with insulin lispro solution
Chapter 30 covers medicaments in dosage form; excludes pure hormones of Chapter 29.
If other polypeptide hormones not specifically insulin
If structural differences exceed 'insulin analogue' definition, may classify under other hormones.
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Import Tips & Compliance
• Submit FDA IND/BLA documentation; verify analogue structure matches declared sequence
• Use validated refrigerated shipping with temperature data loggers; insulin analogues are heat-sensitive
• Avoid bulk packaging declarations; pure API form stays in 2937, finished injectables move to 3004
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 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 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.
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.