HS code · 6-digit subheading
HS Code 3003.31 – Medicaments; containing insulin, for therapeutic or prophylactic uses, not packaged for retail sale
HS code 3003.31 is the 6-digit subheading for medicaments, containing insulin, for therapeutic or prophylactic uses, not packaged for retail sale. It is used for recombinant human insulin bulk solution, insulin glargine API, insulin aspart API, insulin lispro API and isophane insulin bulk suspension.
What HS 3003.31 covers
This HS code specifically covers bulk medicaments containing insulin, intended for therapeutic or prophylactic use, but not yet in measured doses or packaged for retail sale. This category primarily involves the active pharmaceutical ingredient (API) of insulin, which is a critical hormone used in the treatment of diabetes. The international trade in bulk insulin is dominated by a few major pharmaceutical companies that specialize in its production, often through recombinant DNA technology. Importers are typically other pharmaceutical manufacturers or contract manufacturing organizations (CMOs) that purchase bulk insulin to formulate it into various finished dosage forms, such as vials, cartridges, or pre-filled pens, for distribution to patients globally. Exporters are usually countries with advanced biopharmaceutical manufacturing capabilities. Key considerations include maintaining the cold chain during transport, ensuring high purity and potency, compliance with strict regulatory standards (e.g., GMP), and managing a global supply chain for a life-saving drug. The market is driven by the increasing global prevalence of diabetes.
- Covers
- Recombinant human insulin bulk solution
- Insulin glargine API
- Insulin aspart API
- Insulin lispro API
- Isophane insulin bulk suspension
- Insulin detemir API
- Insulin degludec API
- Examples
- Novo Nordisk bulk insulin
- Eli Lilly and Company insulin API
- Sanofi bulk insulin glargine
- Biocon bulk human insulin
- Gan & Lee Pharmaceuticals insulin API
Codes often confused with 3003.31
Common mistake. This code is distinct from 300431 (Medicaments containing insulin, put up in measured doses or for retail sale) which covers the finished, packaged product. It should also not be confused with 293712 (Insulin and its salts) which refers to the pure chemical compound, as 300331 implies a medicament preparation.
Top exporters and importers of HS code 300331, 2025
In 2025, the largest exporter of HS code 300331 in UN Comtrade data was the United States, with 73% of world exports; the largest importer in UN Comtrade data was Denmark, with 42% of world imports. Countries that did not report 2025 data are estimated from partner records, which can understate them.
Top exporters 2025 · share of world exports
- 1 United States $16M 73% of world exports
- 2 Morocco $1.8M 8.1% of world exports
- 3 China $1.5M 7.1% of world exports
World total: $22M Reported figures on UN Comtrade ↗
Top importers 2025 · share of world imports
- 1 Denmark $9.3M 42% of world imports
- 2 Nigeria $1.9M 8.8% of world imports
- 3 United Arab Emirates* ~$1.7M 7.9% of world imports · partner records ↗
World total: $22M Reported figures on UN Comtrade ↗
How these figures are built
109 countries reported 2025 trade to UN Comtrade in HS 2022, and their own totals are used. Countries marked * did not, so their figures add up what other countries recorded trading with them, and their exports are valued at buyers' CIF prices. Those estimates miss trade with other non-reporting countries, so they can be low, and a non-reporting country can rank higher than shown or be missing from the list. World totals add both and leave out trade between two non-reporting countries. Figures are in current US dollars; reported imports are mostly valued CIF and exports FOB, and exports include re-exports. The UN Comtrade links show the underlying records; they can also list a few reporters left out here (regional groups and older HS editions).
Source: UN Comtrade (United Nations Statistics Division), 2025 annual data.
Brazil NCM code for 3003.31
Brazil does not split HS 3003.31: its NCM code is 3003.31.00.
All Brazil NCM codes in heading 30.03 →
Source: Siscomex NCM table, updated Oct 2026. The Portuguese text is official; the English is our translation.
Questions about HS 3003.31
What is HS code 300331?
HS code 300331 is a 6-digit subheading in the Harmonized System that covers: Medicaments; containing insulin, for therapeutic or prophylactic uses, not packaged for retail sale. This HS code specifically covers bulk medicaments containing insulin, intended for therapeutic or prophylactic use, but not yet in measured doses or packaged for retail sale. This category primarily involves the active pharmaceutical ingredient (API) of insulin, which is a critical hormone used in the treatment of diabetes. The international trade in bulk insulin is dominated by a few major pharmaceutical companies that specialize in its production, often through recombinant DNA technology. Importers are typically other pharmaceutical manufacturers or contract manufacturing organizations (CMOs) that purchase bulk insulin to formulate it into various finished dosage forms, such as vials, cartridges, or pre-filled pens, for distribution to patients globally. Exporters are usually countries with advanced biopharmaceutical manufacturing capabilities. Key considerations include maintaining the cold chain during transport, ensuring high purity and potency, compliance with strict regulatory standards (e.g., GMP), and managing a global supply chain for a life-saving drug. The market is driven by the increasing global prevalence of diabetes.
What products fall under HS code 300331?
Recombinant human insulin bulk solution, Insulin glargine API, Insulin aspart API, Insulin lispro API, Isophane insulin bulk suspension, Insulin detemir API, Insulin degludec API
What are common misclassifications for HS code 300331?
This code is distinct from 300431 (Medicaments containing insulin, put up in measured doses or for retail sale) which covers the finished, packaged product. It should also not be confused with 293712 (Insulin and its salts) which refers to the pure chemical compound, as 300331 implies a medicament preparation.
Which countries are the top exporters of goods under HS code 300331?
In 2025, the top exporters of HS code 300331 in UN Comtrade data were the United States ($16M, 73% of world exports), Morocco ($1.8M) and China ($1.5M). World exports came to about $22M, adding countries' reported figures and partner-based estimates for those that did not report (UN Comtrade data). Countries that did not report 2025 data are estimated from partner records, which can understate them.
Which countries are the top importers of goods under HS code 300331?
In 2025, the top importers of HS code 300331 in UN Comtrade data were Denmark ($9.3M, 42% of world imports), Nigeria ($1.9M) and the United Arab Emirates (about $1.7M). World imports came to about $22M, adding countries' reported figures and partner-based estimates for those that did not report (UN Comtrade data). Countries that did not report 2025 data are estimated from partner records, which can understate them.
How is HS code 300331 structured?
HS code 300331 is a 6-digit subheading under the Harmonized System. The first 2 digits (30) identify the chapter, digits 3-4 (03) identify the heading, and digits 5-6 (31) specify the subheading. This code is standardized globally by the World Customs Organization.
What is the Brazil NCM code for HS code 300331?
In Brazil, HS code 300331 is NCM 3003.31.00. The last two digits are 00 because Brazil does not split this HS code further.