Product classification
HS code for Bulk insulin: 3003.31
Medicaments, containing insulin, for therapeutic or prophylactic uses, not packaged for retail sale.
Classification of bulk insulin under HS 3003.31
Heading 3003 of the Harmonized System (HS) is dedicated to medicaments (excluding those of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, but not put up in measured doses or in forms or packings for retail sale. Subheading 300331 specifically targets medicaments containing insulin. The \"not packaged for retail sale\" criterion is crucial, indicating that products classified here are typically in bulk form, intended for further processing, repackaging, or dispensing by healthcare professionals rather than direct sale to the end consumer. This classification ensures that unformulated or partially formulated insulin products, which are still considered medicaments due to their therapeutic intent, are appropriately categorized before they reach their final retail presentation.
- Covers
- Bulk insulin solutions
- Concentrated insulin preparations for dilution or formulation
- Unformulated insulin mixtures used in pharmaceutical manufacturing
- Large containers of insulin preparations supplied to hospitals or clinics for dispensing (not in measured doses or retail packaging)
- Also under 3003.31
- 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. 300431: This code is for \"Medicaments; containing insulin, for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale\". The primary distinction from 300331 is the retail packaging and measured doses. Products under 300431 are ready for direct consumer use (e.g., insulin pens, vials for patient self-administration), whereas 300331 covers bulk or intermediate forms. 293712: This code covers \"Insulin and its salts\" as pure chemical substances. While bulk insulin medicaments contain insulin, 293712 is for the isolated, unformulated chemical compound. HS 300331 applies when insulin has been combined with other constituents to form a medicament, even if in bulk.
Top exporters and importers of HS 300331 (the code used for bulk insulin), 2025
In 2025, the largest exporter of HS 300331 (the code used for bulk insulin) 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.
Figures cover everything classified under HS 300331, not only bulk insulin.
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 bulk insulin
Brazil classifies bulk insulin under NCM 3003.31.00: HS 3003.31 with 00 added.
Source: Siscomex NCM table, updated Oct 2026. The Portuguese text on each NCM page is the official one.
Questions about bulk insulin
What is the HS code for Bulk insulin?
The HS code for Bulk insulin is 300331 (Medicaments; containing insulin, for therapeutic or prophylactic uses, not packaged for retail sale). The Harmonized System (HS) code for bulk insulin, when presented as a medicament not packaged for retail sale, is 300331.
How do I classify Bulk insulin for customs?
Bulk insulin is classified under HS code 300331 — Medicaments; containing insulin, for therapeutic or prophylactic uses, not packaged for retail sale. This is a 6-digit subheading level code.
How does the \"not packaged for retail sale\" clause impact classification?
The \"not packaged for retail sale\" clause is a defining characteristic for HS 300331. It signifies that the product is not in a form or packaging suitable for direct sale to the end consumer. This typically means the product is in bulk containers, intended for further processing, repackaging, or professional dispensing. This distinction is critical for differentiating it from retail-ready medicaments classified under HS 3004.
Which countries are the top exporters of bulk insulin (HS 300331)?
In 2025, the top exporters of HS 300331 (the code used for bulk insulin) 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 bulk insulin (HS 300331)?
In 2025, the top importers of HS 300331 (the code used for bulk insulin) 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.
Is the HS code for Bulk insulin the same in all countries?
The base HS code 300331 for Bulk insulin is internationally standardized for the first 6 digits across 200+ countries. Individual countries may add additional digits for national tariff lines and specific classifications.
What is the NCM code for bulk insulin in Brazil?
In Brazil, bulk insulin (HS 300331) is classified under NCM 3003.31.00.