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.
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