U.S. imports of Antibiotics (Not Elsewhere Specified), Bulk Pharmaceutical Grade (SITC 54139) totaled $30.2M in August 2026, imported from 28 countries.
Importers of Antibiotics (Not Elsewhere Specified), Bulk Pharmaceutical Grade paid $25K in duties in August 2026, an average duty rate of 0.09% — duty actually collected as a share of the imports that cleared customs, not the published tariff schedule. Antibiotics (Not Elsewhere Specified), Bulk Pharmaceutical Grade imports of $30.2M in August 2026 ran 24% below the year-to-date monthly average of $39.7M.
Last updated: August 2026 dataBulk antibiotic substances not elsewhere specified and not formulated as finished medicaments occupy a critical upstream position in pharmaceutical supply chains, serving as active pharmaceutical ingredients (APIs) for downstream drug manufacturing. FDA oversight applies at entry, and importers must ensure the exporting facility is registered and compliant with current Good Manufacturing Practice (cGMP) standards. Because many bulk antibiotic APIs originate from a concentrated set of foreign manufacturers, supply-chain resilience and facility qualification are persistent concerns for US pharmaceutical buyers.
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197 import shipments a month
FDA reviews these shipments under its drug import authority; the foreign manufacturing facility must be registered with FDA and subject to cGMP inspection. Shipments may be detained or refused if the facility is on an import alert or lacks adequate documentation of identity and purity.
The distinction turns on whether the substance is in a measured dose or retail packaging intended for therapeutic use. Bulk powders, granules, or solutions sold by weight to pharmaceutical manufacturers — without dosage form or retail labeling — fall here, while tablets, capsules, and vials ready for patient use are classified as medicaments.
Basic heading 132 of 465 in section 5
Basic heading 54139 · $30.2M of $27.5B
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Imports · August 2026
origin
China and Italy together supply 57% of it.
customs district
Census does not publish district detail for this classification system.
destination
Census does not publish state detail for this classification system.
entry
Census does not publish port detail for this classification system.
ImportsExports
Imports
$30.2MYoY · free account
Exports
$4.6MYoY · free account
12-mo low · imports
Low · free accountOver the twelve months to August 2026, the U.S. imported $459.1M of Antibiotics (Not Elsewhere Specified), Bulk Pharmaceutical Grade and exported $225.2M.
Through August 2026. Source: U.S. Census Bureau.