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HSChapter 30
U.S. imports of insulin-containing medicaments in dosage form (no antibiotics) (HS 300431) totaled $7.9M in April 2026, traded with 7 countries.
Insulin-Containing Medicaments in Dosage Form (No Antibiotics) imports of $7.9M in April 2026 ran 42% below the year-to-date monthly average of $13.5M.
Last updated: April 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.
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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Monthly import values over time
HS10 import codes under this HS6 parent. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Import Value | Effective Tariff % |
|---|---|---|---|
| 3004310000 | MEDICAMENTS CONT INSULIN BUT NOT CONT ANTIBIOTICS | $7.9M | -- |
MEDICAMENTS CONT INSULIN BUT NOT CONT ANTIBIOTICS
HS10 export codes under this HS6 parent. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3004310000 | MEDICAMENTS CONT INSULIN BUT NOT CONT ANTIBIOTICS | $18.7M |
MEDICAMENTS CONT INSULIN BUT NOT CONT ANTIBIOTICS
99.6K kg
MEDICAMENTS NESOI, MEASURED DOSES, RETAIL PK NESOI
HS 300490
IMMUNOLOGICAL PRODUCTS, IN MEASURED DOESE/RTL SALE
HS 300215
VACCINES FOR HUMAN MEDICINE
HS 300241
HORMONES ETC. (NO ANTIBIOTICS CONTAINED) DOSAGE FM
HS 300439
ANTISERA AND OTHER BLOOD FRACTIONS
HS 300212
IMMUNOLOGICAL PRODUCTS, MIXED, NOT IN MSRED DOSES
HS 300214
| State | Imports | Exports | Balance |
|---|---|---|---|
| Indiana | $225K | $10.9M | +$10.7M |
| North Carolina | -- | $6.4M | +$6.4M |
| Tennessee | $6.0M | -- | -$6.0M |
| Port | Imports | Exports | Balance |
|---|---|---|---|
| LAREDO, TX | -- | $8.7M | +$8.7M |
| CHICAGO, IL | $5.9M | $841K | -$5.0M |
| NORFOLK-NEWPORT NEWS, VA | $81K | $4.4M | +$4.4M |