U.S. exports of Insulin Medicaments, Bulk (Non-Dosage Form) (SITC 54221) totaled $420K in December 2025, exported to 2 countries.
Last updated: December 2025 dataBulk insulin medicaments — not yet put up in measured doses or retail packaging — serve as critical intermediates in the pharmaceutical supply chain, typically moving from API manufacturers to finished-drug producers who formulate vials, cartridges, or pens. FDA regulates insulin as a biological drug product, meaning imports must comply with both drug establishment registration requirements and, for biologics, applicable biologics license provisions. The non-dosage classification distinguishes these bulk materials from the retail insulin products that reach patients, and the distinction carries real duty and regulatory consequences. Supply-chain resilience for bulk insulin is a recurring concern given the concentration of global insulin API manufacturing.
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Insulin is regulated as a drug product by FDA under the Federal Food, Drug, and Cosmetic Act, and since March 2020, certain insulin products have transitioned to biologic status under the Public Health Service Act. The applicable regulatory pathway depends on the specific insulin product and its approval status; importers should confirm the regulatory classification with FDA or a regulatory affairs specialist before entry.
Bulk insulin in non-dosage form is the active pharmaceutical ingredient or an intermediate concentrate not yet formulated into individual patient doses or retail-ready packaging such as vials or pens. Once the insulin is measured into unit doses or packaged for retail or clinical dispensing, it falls under the dosage-form heading. The distinction is determined by the state of the product at the time of importation.
Basic heading 284 of 465 in section 5
Basic heading 54221 · $420K of $26.2B
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Exports · December 2025
destination
France and Bahamas together take 97% of it.
customs district
Census does not publish district detail for this classification system.
origin
Census does not publish state detail for this classification system.
entry
Census does not publish port detail for this classification system.
ImportsExports
Imports
—YoY · free account
Exports
$420KYoY · free account
Low of 5 reported months · imports
Low · free accountFewer than 6 of the last 12 months reported trade, or the latest month was under $500K; the trend chart is not shown for thin series.
Through December 2025 · imports 5 of 12 months reported, exports 5 of 12 months reported. Source: U.S. Census Bureau.