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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 3

Fresenius Told to Submit Global Data for Calcium Chloride Infusion Approval

Fresenius Told to Submit Global Data for Calcium Chloride Infusion Approval

Parthika Patel18 Jun 2025 4:36 PM IST
New 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

Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Semaglutide Injection for Weight Management

Parthika Patel17 Jun 2025 6:30 PM IST
New 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

Windlas Biotech Gets SEC Nod to Manufacture Dapagliflozin-Pioglitazone FDC

Parthika Patel17 Jun 2025 6:20 PM IST
New Delhi: The Subject Expert Committee (SEC) for Endocrinology & Metabolism under the Central Drugs Standard Control Organisation (CDSCO) has...
Dr Reddys Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived

Dr Reddy's Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived

Dr. Divya Colin15 Jun 2025 12:30 PM IST
New 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

Gufic Bioscience Told To Submit More Data for Piperacillin-Tazobactam-Sodium Chloride FDC

Dr. Divya Colin15 Jun 2025 9:30 AM IST
New Delhi: In response to the proposal presented by Gufic Bioscience, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Abbott Gets SEC Nod to Market Chlordiazepoxide Tablets for Anxiety, Alcohol Withdrawal

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 IST
New Delhi: In response to the proposal presented by Abbott, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Accepts Mylans Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection

CDSCO Panel Accepts Mylan's Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection

Dr. Divya Colin14 Jun 2025 6:00 PM IST
New 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 Semaglutide Injection for Weight Management

Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Pertuzumab Biosimilar for Breast Cancer

Dr. Divya Colin11 Jun 2025 5:45 PM IST
New Delhi: Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs Standard...
Lupins TB Drug Isoniazid Dispersible Tablets Cleared for Launch by CDSCO Panel

Lupin's TB Drug Isoniazid Dispersible Tablets Cleared for Launch by CDSCO Panel

Dr. Divya Colin10 Jun 2025 5:30 PM IST
New Delhi: In response to a proposal submitted by Lupin Limited, the Subject Expert Committee (SEC) operating under the Central Drugs Standard Control...
EMA Committee recommends marketing nod for Bayer advanced prostate cancer drug darolutamide

CDSCO Panel Approves Bayer's Real-World Use Study for Heart Failure Drug Vericiguat

Dr. Divya Colin8 Jun 2025 12:56 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Bayer...
Label Update for AstraZenecas Olaparib Cleared by CDSCO Panel

CDSCO Panel Approves Updated Prescribing Information for AstraZeneca's Rosuvastatin (Crestor)

Dr. Divya Colin8 Jun 2025 12:43 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval for the updated...
SEC Approves Serums Salk Polio Vaccine for Commercial Use, Recommends Phase I Trial for 21-valent Pneumococcal Vaccine

SEC Approves Serum's Salk Polio Vaccine for Commercial Use, Recommends Phase I Trial for 21-valent Pneumococcal Vaccine

Parthika Patel5 Jun 2025 6:17 PM IST
New Delhi: The Subject Expert Committee (SEC) on Vaccines under the Central Drugs Standard Control Organization (CDSCO) has recommended the conduct of...
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Dapagliflozin Shines in Post-TAVI Patients:DAPA-TAVI Trial Findings

Dapagliflozin Shines in Post-TAVI Patients:DAPA-TAVI Trial Findings

Identifying Candidates for Aspirin in Primary Prevention: Men Aged 40-50 with Hypertension, Dyslipidemia, and Familial ASCVD Risk

Identifying Candidates for Aspirin in Primary Prevention: Men Aged 40-50 with Hypertension,...

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Beyond BMI: Why Pioglitazone Deserves a Place in Managing Thin-Fat Type 2 Diabetes in India

Beyond BMI: Why Pioglitazone Deserves a Place in Managing 'Thin-Fat' Type 2 Diabetes in India

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