SITCSection 5
U.S. imports of alkaloid-based medicaments, bulk (non-dosage form) (SITC 54231) totaled $1.0M in April 2026, traded with 5 countries.
Alkaloid-Based Medicaments, Bulk (Non-Dosage Form) imports of $1.0M in April 2026 ran 34% below the year-to-date monthly average of $1.5M.
Last updated: April 2026 dataBulk medicaments containing alkaloids and their derivatives — not in dosage form or retail packaging — encompass a pharmacologically diverse group of APIs derived from plant or synthetic sources, including opioid alkaloids, xanthines, ergot alkaloids, and vinca alkaloids used in oncology and neurology. Many alkaloid-based APIs are controlled substances under the Controlled Substances Act, requiring DEA import permits in addition to FDA admissibility clearance, making dual-agency compliance a defining feature of this trade category. The NES designation excludes alkaloids classified elsewhere in the SITC schedule, so importers must confirm the specific compound is not captured by a more specific heading. These bulk materials typically move between API manufacturers and finished-drug producers under strict chain-of-custody documentation.
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Alkaloids that are scheduled under the Controlled Substances Act — including opioid alkaloids such as morphine, codeine, and thebaine, as well as cocaine alkaloids and certain ergot derivatives — require DEA Schedule I or II import authorization. The specific schedule and permit type depend on the compound; importers should consult DEA's Diversion Control Division and confirm scheduling status before arranging shipment.
Vinca alkaloids such as vincristine and vinblastine fall within this heading when imported in bulk, non-dosage form, provided they are not more specifically classified elsewhere in the schedule. Because these are cytotoxic APIs, importers should also confirm FDA establishment registration for the foreign manufacturer and ensure the shipment complies with any applicable hazardous materials handling requirements during transit.
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| Country | Imports | Exports | Balance |
|---|---|---|---|
| INDIA | $674K | $5K | -$670K |
| COLOMBIA | -- | $439K | +$439K |
| UNITED KINGDOM | $327K | -- | -$327K |
| ITALY | -- | $50K | +$50K |
| SAUDI ARABIA | -- | $45K | +$45K |
Monthly import values over time