Dr. Reddy's gets CDSCO panel Nod To market Omeprazole Delayed-release orally disintegrating tablets

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-04T18:00:34+05:30 | Updated On 21 March 2024 9:12 PM IST

Open to expand US manufacturing as tariff threat looms: Dr Reddys Labs

New Delhi: In a significant development, the drug major Dr. Reddy's Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Omeprazole delayed-release orally disintegrating tablet 10 mg.

This came after the drug major Dr. Reddy’s Laboratories presented the proposal for the manufacture and marketing of the drug Omeprazole delayed-release orally disintegrating tablet 10 mg before the committee along with the bioequivalence study report of Omeprazole delayed-release orally disintegrating tablet 20 mg and stated that this higher-strength proposal was earlier deliberated and recommended in the SEC (Gastroenterology & Hepatology) held on 21-Nov-2023.

Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). Omeprazole is a specific inhibitor of H+, K(+)-ATPase or 'proton pump' in parietal cells. This enzyme is responsible for the final step in the process of acid secretion; omeprazole blocks acid secretion in response to all stimuli.

Omeprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus.

At the recent SEC meeting for the Gastroenterology and Hepatology held on 15th February 2024, the expert panel reviewed the proposal presented by the drug major Dr Reddy's Laboratories to manufacture and market the proton pump inhibitor Omeprazole delayed-release orally disintegrating tablet 10 mg.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Omeprazole delayed-release orally disintegrating tablet 10 mg. However, the expert panel suggested that the firm is required to comply with the requirement of Chemistry, Manufacturing, and Controls (CMC) data.

Also Read:CDSCO Panel Approves Roche's protocol amendment proposal for anti-cancer drug Atezoluzumab study

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751