Abbott to Conduct BE Study for Carbimazole 15 mg, Trial Waiver Granted In India Parthika Patel8 Aug 2025 2:34 PM ISTNew Delhi: Abbott Healthcare Pvt. Ltd has received the green signal from the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
MSN Labs Gets CDSCO Panel Nod to Begin Phase III Trial of Cenobamate Tablets, With Safety Caveat Dr. Divya Colin5 Aug 2025 4:15 PM ISTNew Delhi: Considering the bioequivalence study results of the MSN Labs Cenobamate Tablets 12.5 mg, 25 mg, 50mg, 100 mg, 150 mg & 200 mg, the...
Expert Committee Clears Ravenbhel to Begin Resmetirom Phase 3 Trial, Asks for BE Data First Parthika Patel27 July 2025 4:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation...
CDSCO Panel Seeks Safety Data on 5% Lenalidomide TDS Before Clearing 8% Patch Trial Parthika Patel25 July 2025 4:38 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has not granted...
CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide Dr. Divya Colin28 May 2025 3:00 PM ISTNew Delhi: In response to a proposal submitted by Intas Pharmaceuticals, the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
Zydus Lifesciences gets CDSCO Panel nod to study Aprepitant powder for Oral Suspension Dr. Divya Colin20 May 2025 6:15 PM ISTNew Delhi: Granting approval for conducting a bioequivalence (BE) study of Aprepitant powder for Oral Suspension 125 mg, the Subject Expert Committee...
CDSCO Panel Rejects Morepen Laboratories' Proposal To Waive local Phase III clinical trial of Resmetirom Tablet Dr. Divya Colin18 May 2025 6:00 PM ISTNew Delhi: Rejecting the proposal for the local Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
Hetero Labs gets CDSCO Panel nod to study Tegoprazan tablet 50 mg Dr. Divya Colin13 May 2025 5:45 PM ISTNew Delhi: Responding to the proposal presented by Hetero Labs, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
DTAB Approves Notification System for Application of new drug, IND for clinical trial, BA-BE study Dr. Divya Colin11 May 2025 5:45 PM ISTNew Delhi: With an aim to streamline the process for permission to manufacture new drugs and investigational new drugs (IND) for clinical trials,...
Torrent Pharmaceutical gets CDSCO Panel nod to conduct bioequivalence study of Prucalopride oral solution Dr. Divya Colin6 April 2025 2:00 AM ISTNew Delhi: Responding to the proposal presented by Torrent Pharmaceutical to manufacture and market Prucalopride oral solution 0.2 mg/ml, the Subject...
Zydus Lifesciences gets CDSCO panel nod to conduct bioequivalence study of Eltrombopag for oral suspension Dr. Divya Colin3 April 2025 6:00 PM ISTNew Delhi: Zydus Lifesciences has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
Windlas Biotech Gets CDSCO Panel Nod To study Bisoprolol Fumarate, Telmisartan, Chlorthalidone FDC Dr. Divya Colin26 March 2025 6:15 PM ISTNew Delhi: Windlas Biotech has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
