HS Code Subheading

Medicaments; containing insulin, for therapeutic or prophylactic uses, packaged for retail sale

3004.31 Subheading
Section VI — Products of the chemical or allied industries

About HS Code 300431

HS 300431 specifically covers medicaments containing insulin, packaged for retail sale. This category is vital for the global management of diabetes, encompassing various types of insulin (e.g., rapid-acting, long-acting, intermediate-acting) in different delivery formats such as vials, cartridges, and pre-filled pens. These life-saving medications are traded internationally by major pharmaceutical companies to distributors, pharmacies, and healthcare systems worldwide. The trade is characterized by high demand, significant research and development investment, and strict cold chain logistics to maintain product integrity. Regulatory approvals are crucial for market access, and pricing often remains a contentious issue globally, impacting patient access. The continuous innovation in insulin formulations and delivery devices drives ongoing international trade and competition in this specialized pharmaceutical segment.

Products Under This Code

Insulin glargine injection, Insulin aspart injection, Insulin detemir injection, Human insulin isophane suspension, Insulin lispro injection, Insulin regular injection, Insulin degludec injection

Real World Examples

Lantus, Novolog, Levemir, Humulin N, Humalog, Apidra

Common Misclassification

Could be confused with 300439 if it contains other hormones, or 300331 if insulin is in bulk form and not packaged for retail sale.

Products Classified Under 3004.31

Industry

This code belongs to the Chemicals industry.

Trade Overview

Denmark (Novo Nordisk), France (Sanofi), and the USA (Eli Lilly) are leading exporters, serving a global patient population.

Frequently Asked Questions

What is HS code 300431?

HS code 300431 covers: Medicaments; containing insulin, for therapeutic or prophylactic uses, packaged for retail sale. HS 300431 specifically covers medicaments containing insulin, packaged for retail sale. This category is vital for the global management of diabetes, encompassing various types of insulin (e.g., rapid-acting, long-acting, intermediate-acting) in different delivery formats such as vials, cartridges, and pre-filled pens. These life-saving medications are traded internationally by major pharmaceutical companies to distributors, pharmacies, and healthcare systems worldwide. The trade is characterized by high demand, significant research and development investment, and strict cold chain logistics to maintain product integrity. Regulatory approvals are crucial for market access, and pricing often remains a contentious issue globally, impacting patient access. The continuous innovation in insulin formulations and delivery devices drives ongoing international trade and competition in this specialized pharmaceutical segment.

What products fall under HS code 300431?

Insulin glargine injection, Insulin aspart injection, Insulin detemir injection, Human insulin isophane suspension, Insulin lispro injection, Insulin regular injection, Insulin degludec injection

What are common misclassifications for HS code 300431?

Could be confused with 300439 if it contains other hormones, or 300331 if insulin is in bulk form and not packaged for retail sale.

How is HS code 300431 structured?

HS code 300431 is a 6-digit subheading under the Harmonized System. The first 2 digits (30) identify the chapter, digits 3-4 (04) identify the heading, and digits 5-6 (31) specify the subheading. This code is standardized globally by the World Customs Organization.