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SITCSection 5
U.S. imports of theophylline, aminophylline, their derivatives, and salts (SITC 54145) totaled $259K in April 2026, traded with 5 countries.
Last updated: April 2026 dataTheophylline — a methylxanthine bronchodilator chemically related to caffeine — and its ethylenediamine complex aminophylline are established APIs used in the treatment of asthma and chronic obstructive pulmonary disease. Both compounds have narrow therapeutic indices, making pharmaceutical-grade purity and consistent specification critical for downstream drug manufacturers. FDA cGMP requirements apply to imported bulk drug substances, and importers should verify that foreign suppliers hold current FDA facility registration and have not been placed on import alert.
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Because theophylline's toxic dose is close to its therapeutic dose, even minor impurities or potency deviations in the bulk API can create patient safety risks in finished drug products. FDA inspectors pay close attention to analytical method validation and impurity profiles when reviewing cGMP compliance at foreign theophylline manufacturing sites.
At the SITC level they share a single heading, but the HTS schedule may distinguish them at the 10-digit level. Importers should confirm the correct HTS subheading with a licensed customs broker, as the specific compound and its salt form can affect duty treatment and statistical reporting.
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Monthly import values over time