Dr Reddy's Laboratories Gets CDSCO Panel Nod To Manufacture, Market Esomeprazole Magnesium
New Delhi: Reviewing the bioequivalence study report of the gastric drug Esomeprazole Magnesium for delayed release oral suspension 10 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug major Dr. Reddy’s Laboratories to manufacture and market Esomeprazole Magnesium for delayed release oral suspension 10 mg.
This nod came after Dr. Reddy’s laboratories presented the bioequivalence study report before the committee.
Esomeprazole is a proton pump inhibitor used to treat GERD, reduce the risk of NSAID-associated gastric ulcers, eradicate H. pylori, and to treat conditions causing gastric acid hypersecretion.
Esomeprazole is indicated for the treatment of acid-reflux disorders, including healing and maintenance of erosive esophagitis, symptomatic gastroesophageal reflux disease (GERD), peptic ulcer disease, H. pylori eradication, prevention of gastrointestinal bleeds with NSAID use, and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the (H+, K+)-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, esomeprazole's duration of antisecretory effect that persists longer than 24 hours.
At the recent SEC meeting for gastroenterology and hematology held on November 14, 2024, the expert panel reviewed the bioequivalence study report of the gastric drug Esomeprazole Magnesium for delayed release oral suspension.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and market of Esomeprazole Magnesium for Delayed Release Oral Suspension 10 mg for the applied indication.
