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SITCSection 5
U.S. imports of insulin medicaments, dosage form or retail packings (SITC 54223) totaled $7.9M in April 2026, traded with 7 countries.
Insulin Medicaments, Dosage Form or Retail Packings 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, prefilled pens, and other measured-dose or retail-packaged forms — are among the most commercially significant pharmaceutical imports for the US healthcare system. FDA regulates these products as drugs (and increasingly as biologics), requiring foreign manufacturers to hold valid approvals or licenses and comply with cGMP; all shipments are subject to FDA admissibility review at entry. The dosage-form presentation distinguishes these patient-ready products from bulk insulin intermediates and triggers different supply-chain, cold-chain, and regulatory handling requirements. Importers should be aware that insulin biosimilars and interchangeable biologics have distinct regulatory pathways that affect admissibility.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
Finished insulin products require continuous refrigeration (typically 2–8°C) throughout transit, and importers should maintain temperature excursion logs, shipper qualification records, and carrier temperature monitoring data. While CBP does not mandate a specific cold-chain document set, FDA may request temperature records during admissibility review, and product exposed to out-of-range temperatures may be considered adulterated and refused entry.
No — insulin biosimilars and interchangeable biologics must receive their own FDA approval or licensure under the applicable biologics pathway before they can be legally imported and marketed in the US. A product approved in another country does not automatically qualify for US entry; the foreign manufacturer must have an FDA-approved application covering the specific product and presentation.
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Monthly import values over time