Loading...
SITCSection 5
U.S. imports of penicillins, derivatives with penicillanic acid structure & their salts (SITC 54131) totaled $8.2M in April 2026, traded with 14 countries.
Penicillins, Derivatives with Penicillanic Acid Structure & Their Salts imports of $8.2M in April 2026 ran 20% above the year-to-date monthly average of $6.8M.
Last updated: April 2026 dataPenicillins and semi-synthetic derivatives sharing the penicillanic acid core — including amoxicillin, ampicillin, and their pharmaceutical salts — are regulated as active pharmaceutical ingredients subject to FDA's drug import program, requiring manufacture at an FDA-registered foreign facility that has passed inspection. These beta-lactam antibiotics are among the most widely prescribed antibiotic classes globally, and bulk API supply is heavily concentrated in a small number of manufacturing countries, creating ongoing supply-chain resilience concerns for US pharmaceutical manufacturers. Importers must ensure that each shipment is accompanied by a certificate of analysis meeting USP or equivalent pharmacopeial specifications, and that the foreign manufacturer appears on FDA's approved drug establishment list. Classification accuracy is important because penicillin derivatives may also be subject to Section 301 tariff measures depending on origin.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
Foreign establishments that manufacture, process, pack, or hold drug APIs for US import must register with FDA under the Drug Establishment Registration program and list their drug products. FDA conducts inspections of these facilities, and a history of import alerts or warning letters can result in shipments being detained at the port of entry. Importers should verify that their supplier's registration is current and that no active import alert applies before placing orders.
Only compounds that retain the bicyclic penicillanic acid (6-APA) core — whether natural penicillins or semi-synthetic derivatives like amoxicillin and flucloxacillin — belong here. Cephalosporins, carbapenems, and other beta-lactams with different ring structures are classified under separate headings. When importing a novel semi-synthetic derivative, a binding classification ruling or consultation with a customs broker experienced in pharmaceutical chemicals is advisable to confirm the correct heading.
Monthly import values over time
Supplier Network
Get discovered by U.S. importers searching for HS 54131 — Penicillins, Derivatives with Penicillanic Acid Structure & Their Salts. Be the first supplier listed.