Dr. Reddy gets CDSCO Panel Nod for comparative bioavailability study of Rabeprazole Modified Release capsule

New Delhi: Granting approval to Dr. Reddy's Laboratories for conducting the comparative bioavailability study of the proton pump inhibitor Rabeprazole sodium Modified Release capsule 40mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has suggested that the result of the comparative bioavailability study should be presented before the committee for further decision on the grant of permission for the conduct of Phase III clinical trial. .
This came after the firm presented the proposal for the grant of permission for manufacturing and marketing of Rabeprazole Sodium modified release Capsules 40 mg for the treatment of patients with gastro-esophageal reflux disease (GERD) refractory to standard proton pump inhibitor (PPI) therapy along with Phase III clinical trial protocol and comparative bioavailability study protocol before the committee.
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