Setback to Torrent: CDSCO Panel Rejects Phase III Waiver Plea for Prucalopride Over Safety Data Gaps Susmita Roy14 Aug 2025 9:28 PM ISTNew Delhi: Citing that Torrent Pharmaceuticals has not presented adequate safety data on the synergistic effect of added excipients (propylene glycol,...
CDSCO Launches One-Year Online Dual Use NOC System for Bulk Drug Imports Parthika Patel13 Aug 2025 6:07 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has introduced a new online Dual Use No Objection Certificate (NOC) system on its...
Emcure Pharma Gets CDSCO Panel Nod for Phase III Trial of Semaglutide in Chronic Weight Management Susmita Roy13 Aug 2025 5:39 PM ISTNew Delhi: Accepting the bioequivalence (BE) study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
Sun Pharma's Phase IV Study on Dual Release Pantoprazole for GERD Gets CDSCO Panel Acceptance Dr. Divya Colin12 Aug 2025 1:46 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has accepted the results of Sun Pharma's...
Precise Biopharma Gets CDSCO Panel Nod To Conduct Phase III Trial of Semaglutide Injection Susmita Roy12 Aug 2025 12:47 PM ISTNew Delhi: Accepting the bioequivalence study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
CDSCO Cancels Cosmetic Import Registration of Indian Agent for Proteos Biotech Parthika Patel11 Aug 2025 3:45 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has cancelled the Cosmetic Registration Certificate No. RC/COS-003595, held by NKG...
No More Physical WHO-GMP Certificate Applications After August 15: DCGI Alerts Pharma Firms Susmita Roy11 Aug 2025 5:45 AM ISTNew Delhi: Reaffirming that no further extensions will be granted, the Drugs Controller General of India (DCGI), Central Drugs Standard Control...
CDSCO Panel Accepts Glenmark's Apremilast Trial Report, Seeks 2-Year PSUR Data Parthika Patel10 Aug 2025 1:00 PM ISTNew Delhi: Glenmark Pharmaceuticals Limited has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs...
Sun Pharma Gets CDSCO Panel Nod For Alfuzosin-Tadalafil FDC Post-Marketing Study Dr. Divya Colin10 Aug 2025 12:30 PM ISTNew Delhi: Drugmaker Sun Pharmaceutical Laboratories Ltd has been granted conditional approval by the Subject Expert Committee (SEC), under the...
Abiogenesis Clinpharm To Conduct Phase III Trial of UTI Drug Phenazopyridine Susmita Roy10 Aug 2025 11:15 AM ISTNew Delhi: The Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to...
Eli Lilly Gets CDSCO Panel Nod for Ixekizumab Safety Label Update Dr. Divya Colin9 Aug 2025 12:30 PM ISTNew Delhi: Eli Lilly and Company (India) Pvt Ltd has secured regulatory clearance from the Subject Expert Committee (SEC) under the Central Drugs...
CDSCO Panel Approves New Indications for Novo Nordisk's Semaglutide, Mandates PMS Study Susmita Roy9 Aug 2025 12:18 PM ISTNew Delhi: Recommending to conduct post marketing surveillance (PMS) study in India, the Subject Expert Committee (SEC) functional under the Central...
