HS Code:
(2S)-5-Oxopyrrolidine-2-carboxylic acid-(1S,2S,3S,4R,5S)-5-[4-chloro-3-(4-ethoxybenzyl)phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol (1:1), commonly known as Ertugliflozin L-pyroglutamic acid (CAS No. 1210344-83-4), falls under HS subheading 2934.99.30. This compound is a pharmaceutical intermediate primarily used in the synthesis of Ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes. It is classified under heterocyclic compounds with nitrogen hetero-atoms, reflecting its complex chemical structure. Global trade in this product category is driven by demand for advanced pharmaceutical ingredients, particularly in markets with high diabetes prevalence and robust pharmaceutical manufacturing sectors.
Total Trade Volume
Approximately USD 120 million
Data from 2022
Source
Estimated data based on UN Comtrade and industry reports
USD 45 million
37.5% of total trade of total trade
Increasing
USD 30 million
25.0% of total trade of total trade
Increasing
USD 20 million
16.7% of total trade of total trade
Stable
USD 15 million
12.5% of total trade of total trade
Stable
USD 10 million
8.3% of total trade of total trade
Decreasing
Average Rate
6.5% ad valorem
Highest Rate
10% (applied by certain developing countries)
Lowest Rate
0% (under free trade agreements or for WTO members with pharmaceutical exemptions)
Rising demand for SGLT2 inhibitors
Increased global demand for Ertugliflozin and its intermediates due to growing diabetes prevalence, driving trade volumes upward, particularly in North America and Asia-Pacific.
2021-2023
Shift towards generic production
As patents for Ertugliflozin approach expiration, countries like India are ramping up production of intermediates, leading to competitive pricing and higher export volumes.
2022-2024
Regulatory harmonization
Efforts to standardize pharmaceutical regulations globally are reducing trade barriers, facilitating smoother exports and imports of intermediates like Ertugliflozin L-pyroglutamic acid.
2020-2023
The U.S. Food and Drug Administration approved new formulations of Ertugliflozin, boosting demand for its intermediates in the U.S. market and increasing imports from key suppliers like India and China.
March 2023
Expected to increase trade volume by 10-15% in the U.S. over the next two years.
India revised its export policies for pharmaceutical intermediates, easing restrictions and providing incentives for manufacturers of compounds like Ertugliflozin L-pyroglutamic acid to boost exports.
September 2022
Led to a 20% surge in exports from India in 2023, strengthening its position as a key supplier.
The European Union introduced stricter import regulations for pharmaceutical intermediates, requiring additional documentation and compliance with EU GMP standards.
January 2023
Temporary slowdown in EU imports from non-compliant suppliers, though long-term impact expected to be minimal with adaptation.