Sun Pharma Gets CDSCO Panel Nod for Phase IV Trial of Esomeprazole Dual Release Tablets 80 mg
New Delhi: Sun Pharma has received approval from the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct a Phase IV clinical trial of Esomeprazole Dual Release Gastro-resistant Tablets 80 mg, based on its revised study protocol.
According to the minutes of the 12th/25 SEC (Gastroenterology & Hepatology) meeting held on August 20, 2025, at CDSCO headquarters, the proposal was taken up under the SND Division.
In continuation with earlier SEC (Gastroenterology & Hepatology) recommendation dated 27/02/2025, the firm presented revised protocol for Phase-IV clinical trial of Esomeprazole Dual release gastro-resistant tablets 80 mg before the Committee.
The committee carefully examined the revised Phase IV clinical trial protocol presented by Sun Pharma. After detailed deliberation, the SEC issued its recommendation, stating:
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