Sun Pharma Gets CDSCO Panel Nod for Active PMS of Fexuprazan Hydrochloride Tablets
New Delhi: Sun Pharma Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) for conducting an active post-marketing surveillance (PMS) study of Fexuprazan hydrochloride tablets 40 mg.
This came after the firm presented the active PMS study protocol for the drug Fexuprazan hydrochloride tablets 40 mg before the committee in light of earlier SEC recommendations dated 12.12.2024 and as per condition no. 9 of the new drug permission for Fexuprazan hydrochloride tablets 40 mg.
Fexuprazan Hydrochloride is used for the treatment of acid-related gastrointestinal disorders, and the PMS study will monitor its safety and efficacy in real-world clinical use.
Fexuprazan is a drug for the treatment of gastroesophageal reflux disease (GERD).It is a potassium-competitive acid blocker, which is a class of drugs that suppresses gastric acids.
Fexuprazan has a fast onset of action and stable suppression of gastric acid. It can be taken regardless of food intake. Fexuprazan has the longest half-life of 9 hours among potassium-competitive acid blockers (P-CABs), implying a longer duration of acid suppression, which helps to achieve optimal nocturnal symptom control.
At the recent SEC meeting for gastroenterology and hepatology held on 29th July, 2025, the expert panel reviewed the active PMS study protocol for the drug Fexuprazan hydrochloride tablets 40 mg.
After detailed deliberation, the committee recommended the grant of permission to conduct active PMS study for Fexuprazan hydrochloride tablets 40 mg as per the protocol presented.
