Harmonized System
U.S. imports of Insulin-Containing Medicaments in Dosage Form (No Antibiotics) (HS 300431) totaled $66.8M in August 2026, imported from 7 countries.
Importers of Insulin-Containing Medicaments in Dosage Form (No Antibiotics) paid $110K in duties in August 2026, an average duty rate of 0.16% — duty actually collected as a share of the imports that cleared customs, not the published tariff schedule. Insulin-Containing Medicaments in Dosage Form (No Antibiotics) imports of $66.8M in August 2026 ran 130% above the year-to-date monthly average of $29.0M.
Last updated: August 2026 dataFinished insulin products — vials, cartridges, pen-fill formulations, and other measured-dose presentations — enter under a single 10-digit line (3004310000) and represent one of the highest-value pharmaceutical import categories in the US market. Malaysia leads supply, followed by Germany, Denmark, France, and the United Kingdom, a geographic spread that reflects the global fill-finish manufacturing networks of major insulin originators. FDA approval of the specific product (via NDA, BLA, or biosimilar pathway) is required before importation, and the foreign fill-finish facility must appear on the approved establishment list. Biosimilar insulin products face additional regulatory scrutiny under the 351(k) pathway.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
253 import shipments a month
Biosimilar insulin products must be approved by FDA under the 351(k) biologics pathway, which requires demonstration of biosimilarity or interchangeability with a reference product. The foreign manufacturing and fill-finish facilities must be inspected and approved by FDA. Importers should confirm that the specific product and facility are listed on FDA's Purple Book before shipment.
Malaysia hosts major fill-finish manufacturing facilities operated by global insulin originators, making it a key node in the finished-product supply chain even though insulin API development is concentrated in Europe. This reflects a common pharmaceutical supply-chain pattern where API synthesis and finished-dose manufacturing occur in different countries, each classified under different HTS headings.
Subheading 6 of 12 in heading 3004
Subheading 300431 · $66.8M of $7.1B
Trade Directory
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HS10 import codes under this HS6 parent, each with its own page. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Imports for consumption | Average duty rate | Dutiable Share | Duty Collected |
|---|---|---|---|---|---|
| 3004310010 | Containing Insulin Glargine | $60.1M | 0.00% | 0.00% | -- |
| 3004310090 | Medicaments Cont Insulin But not Cont Antibiotics | $6.7M | 1.63% | 10.87% | $110K |
| 3004310000 | Medicaments Cont Insulin But not Cont Antibiotics | — | -- | -- | -- |
HS10 export codes under this HS6 parent, each with its own page. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3004310000 | Medicaments Cont Insulin But not Cont Antibiotics | $18.5M |
Import lines come from the U.S. Harmonized Tariff Schedule and export lines from Schedule B. The two are numbered by different agencies, so the same 10-digit code can appear in both tables describing a different product.
ImportsExports
Imports
$66.8MYoY · free account
Exports
$18.5MYoY · free account
12-mo low · imports
Low · free accountOver the twelve months to August 2026, the U.S. imported $278.5M of Insulin-Containing Medicaments in Dosage Form (No Antibiotics) and exported $224.2M.
Through August 2026. Source: U.S. Census Bureau.
Imports · August 2026
origin
Germany and Malaysia together supply 98% of it. France pays 15.0% duty; Germany 0.0%.
customs district
destination
entry
rate provision · imports
98.9% enters free of duty; duty collected equals 0.16% of imports for consumption.