Dr Reddy's Laboratories Gets CDSCO Panel Nod To Study Rebamipide, Sodium Alginate Suspension

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-19T18:00:38+05:30 | Updated On 19 July 2024 6:00 PM IST

New Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioavailability/bioequivalence (BA/BE) study of the gastroprotective drug Rebamipide and Sodium Alginate Suspension (100 mg and 500 mg per 10 mL) and (100 mg + 1000 mg per 10 mL) for export purposes only.

This came after Dr. Reddy's Laboratories presented Protocol No. CS23165, ver. 00, dated 05.01.2024 for BA/BE study for export purposes only.

Bioavailability and bioequivalence studies are important in the process of approving pharmaceutical products for marketing. Bioavailability is defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For a bioequivalence study, two or more bioavailability studies are conducted to compare the results between reference and test products.

Rebamipide belongs to the group of stomach drugs that have the effects of antacid, anti-reflux, and anti-peptic ulcer. Rebamipide is usually used to treat gastric ulcers and to improve gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis and acute exacerbation of chronic gastritis.

Sodium alginate (SA) is a natural anionic polysaccharide that exists abundantly on the seafloor. It was extracted from brown algae (such as Macrocystis aeruginosa and Sargassum) and bacteria (such as Pseudomonas aeruginosa and nitrogen-fixing bacteria). For industrial use, SA was mainly extracted from marine algae. Alginate salts are multivalent additives such as binder and thickening agents, emulsifiers, gelling agents, and stabilizers for suspensions.

At the recent SEC meeting for gastroenterology and hepatology held on June 20, 2024, the expert panel reviewed Protocol No. CS23165, ver. 00 dated 05.01.2024 for BA/BE study for export purposes.

After detailed deliberation, the committee recommended the grant of permission to conduct the proposed BA/BE study for export purposes only

Also Read: Cipla Gets CDSCO Panel Nod to Study Plazomicin Injection

dr reddys laboratoriescdscoRebamipidesodium alginatesuspensiong

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