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HSChapter 30
U.S. imports of insulin-containing medicaments in dosage form (no antibiotics) (HS 300431) totaled $87.8M in July 2026, traded with 7 countries.
Insulin-Containing Medicaments in Dosage Form (No Antibiotics) imports of $87.8M in July 2026 ran 272% above the year-to-date monthly average of $23.6M.
Last updated: July 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.
331 shipments/mo
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.
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HS10 import codes under this HS6 parent, each with its own page. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Import Value | Effective Tariff % | Dutiable Share |
|---|---|---|---|---|
| 3004310010 | Containing Insulin Glargine | $77.3M | 0.00% | 0.00% |
| 3004310090 | Medicaments Cont Insulin But not Cont Antibiotics | $10.5M | 0.00% | 0.00% |
| 3004310000 | Medicaments Cont Insulin But not Cont Antibiotics | $0 | -- | -- |
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 | $36.7M |
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
$87.8MYoY · Pro
Exports
$36.7MYoY · Pro
12-mo low · imports
YoY · ProThrough July 2026. Source: U.S. Census Bureau.
Imports · July 2026
origin
Germany and Malaysia together supply 97% of it.
customs district
destination
entry
rate provision · imports
100.0% enters free of duty; the effective duty rate is 0.00%.