Sun Pharma Bags CDSCO Approval to Produce Fexuprazan Hydrochloride Tablets

The Subject Expert Committee (SEC) operating under the Central Drug Standard Control Organisation (CDSCO) has permitted drug giant Sun Pharma Laboratories to produce and sell Fexuprazan Hydrochloride Tablets 40 mg. Nonetheless, this approval is contingent upon the requirement that the company implement an active post-marketing surveillance (PMS) study. Moreover, the panel of experts indicated that medications ought to be sold at retail solely with the prescription of licensed healthcare professionals.

This followed the company's release of the Phase III clinical trial (CT) report (A Randomized, Multi-Centric, Two-Arm, Active-Controlled, Parallel, Double-Blind, Double-Dummy, Comparative Study to Assess Efficacy and Safety of Fexuprazan Tablets made by Daewoong Pharmaceutical Co., Ltd., South Korea in Comparison to Esomeprazole Tablets produced by M/s.

Sun Pharmaceutical Industries Ltd presented a study report on Patients With Erosive Esophagitis and bioequivalence (BE) (An open-label, balanced, randomized, single-dose, two treatments, two sequences, two periods, crossover, comparative bioavailability study of Fexuprazan Hydrochloride tablets 40 mg against Fexuclue (Fexuprazan Hydrochloride) Tablets 40 mg produced by Daewoong Pharmaceutical Co., Ltd., South Korea in healthy adult human subjects under fasting conditions, before the committee.

The company also submitted prescribing details for an innovator product along with India-specific prescribing information for the tested product Fexuprazan Hydrochloride Tablets 40 mg, to the committee. The Committee observed that Fexuprazan Hydrochloride Tablets 40 mg are authorized in South Korea for the management of erosive esophagitis (EE).