Exemed's Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit Parthika Patel18 Jun 2025 5:53 PM ISTNew Delhi: In a setback for Exemed Pharmaceutical, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
Fresenius Told to Submit Global Data for Calcium Chloride Infusion Approval Parthika Patel18 Jun 2025 4:36 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has asked Fresenius Medical Care India...
Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Semaglutide Injection for Weight Management Parthika Patel17 Jun 2025 6:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has accepted the Bioequivalence (BE)...
Windlas Biotech Gets SEC Nod to Manufacture Dapagliflozin-Pioglitazone FDC Parthika Patel17 Jun 2025 6:20 PM ISTNew Delhi: The Subject Expert Committee (SEC) for Endocrinology & Metabolism under the Central Drugs Standard Control Organisation (CDSCO) has...
Dr Reddy's Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived Dr. Divya Colin15 Jun 2025 12:30 PM ISTNew Delhi: Granting the bioequivalence study waiver and clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central...
Gufic Bioscience Told To Submit More Data for Piperacillin-Tazobactam-Sodium Chloride FDC Dr. Divya Colin15 Jun 2025 9:30 AM ISTNew Delhi: In response to the proposal presented by Gufic Bioscience, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification Dr. Divya Colin14 Jun 2025 6:19 PM ISTNew Delhi: In response to the proposal presented by Abbott, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Accepts Mylan's Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection Dr. Divya Colin14 Jun 2025 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended to accept the...
Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Pertuzumab Biosimilar for Breast Cancer Dr. Divya Colin11 Jun 2025 5:45 PM ISTNew Delhi: Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs Standard...
Lupin's TB Drug Isoniazid Dispersible Tablets Cleared for Launch by CDSCO Panel Dr. Divya Colin10 Jun 2025 5:30 PM ISTNew Delhi: In response to a proposal submitted by Lupin Limited, the Subject Expert Committee (SEC) operating under the Central Drugs Standard Control...
CDSCO Panel Approves Bayer's Real-World Use Study for Heart Failure Drug Vericiguat Dr. Divya Colin8 Jun 2025 12:56 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Bayer...
CDSCO Panel Approves Updated Prescribing Information for AstraZeneca's Rosuvastatin (Crestor) Dr. Divya Colin8 Jun 2025 12:43 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval for the updated...
