HS Code:
The category 'Containing amiodarone or its salts' refers to pharmaceutical products that include amiodarone, a medication primarily used to treat and prevent various types of cardiac dysrhythmias. This category falls under the Harmonized System (HS) Code related to medicaments containing specific active ingredients (typically under HS 3004 for medicaments in measured doses). Amiodarone is critical in managing life-threatening ventricular arrhythmias and atrial fibrillation, making it a vital product in the global healthcare sector. Trade in this category is influenced by factors such as patent status, generic drug production, regulatory approvals, and healthcare demand.
Total Trade Volume
Approximately USD 320 million
Data from 2022
Source
UN Comtrade Database and International Trade Centre (ITC)
USD 85 million
26.6% of total trade of total trade
Increasing
USD 60 million
18.8% of total trade of total trade
Stable
USD 45 million
14.1% of total trade of total trade
Increasing
USD 30 million
9.4% of total trade of total trade
Stable
USD 25 million
7.8% of total trade of total trade
Increasing
Average Rate
5.2% ad valorem
Highest Rate
12% (applied by certain developing countries)
Lowest Rate
0% (under free trade agreements like USMCA and EU trade pacts)
Rising demand for generic amiodarone
Increased trade volume from countries like India and China due to lower production costs and patent expirations, making the drug more accessible in developing markets.
2021-2022
Stringent regulatory frameworks
Trade barriers in developed markets due to rigorous quality control and clinical trial requirements, slowing down market entry for new exporters.
2020-2022
Aging population driving demand
Higher consumption in markets like the US and Europe due to increased prevalence of cardiovascular diseases among older demographics.
2019-2022
The European Union introduced stricter guidelines for importing active pharmaceutical ingredients (APIs) like amiodarone, requiring additional documentation and compliance with EU GMP standards.
March 2023
Potential delays in trade flows to EU countries and increased compliance costs for exporters.
India's government launched incentives for pharmaceutical exporters, leading to a surge in exports of generic amiodarone to African and Southeast Asian markets.
July 2022
Strengthened Indiaโs position as a key supplier, potentially shifting market share from traditional exporters like Germany.
The US Food and Drug Administration approved a new intravenous formulation of amiodarone, spurring demand for imports of raw materials and finished products.
October 2022
Increased trade volume to the US, benefiting major API suppliers like China and India.