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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 17

Unaccounted Pregabalin Stock Seized in FDA Raid: Amritsar Chemist Loses License

CDSCO Cancels Cosmetic Import Registration of Indian Agent for Proteos Biotech

Parthika Patel11 Aug 2025 3:45 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has cancelled the Cosmetic Registration Certificate No. RC/COS-003595, held by NKG...
DCGI Orders Nationwide GMP Inspection Drive to Enforce Revised Schedule M

No More Physical WHO-GMP Certificate Applications After August 15: DCGI Alerts Pharma Firms

Susmita Roy11 Aug 2025 5:45 AM IST
New Delhi: Reaffirming that no further extensions will be granted, the Drugs Controller General of India (DCGI), Central Drugs Standard Control...
CDSCO Panel Accepts Glenmarks Apremilast Trial Report, Seeks 2-Year PSUR Data

CDSCO Panel Accepts Glenmark's Apremilast Trial Report, Seeks 2-Year PSUR Data

Parthika Patel10 Aug 2025 1:00 PM IST
New Delhi: Glenmark Pharmaceuticals Limited has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs...
Sun Pharma Asked to Resubmit Revised Phase III Protocol for Delafloxacin CABP Trial

Sun Pharma Gets CDSCO Panel Nod For Alfuzosin-Tadalafil FDC Post-Marketing Study

Dr. Divya Colin10 Aug 2025 12:30 PM IST
New Delhi: Drugmaker Sun Pharmaceutical Laboratories Ltd has been granted conditional approval by the Subject Expert Committee (SEC), under the...
Ropanicant Phase-2b trial for Major Depressive Disorder achieves 100 percent enrollment ahead of schedule: Suven Life Sciences

Abiogenesis Clinpharm To Conduct Phase III Trial of UTI Drug Phenazopyridine

Susmita Roy10 Aug 2025 11:15 AM IST
New Delhi: The Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to...
Eli Lilly Jaypirca met its primary endpoint in head-to-head Phase 3 study versus Imbruvica

Eli Lilly Gets CDSCO Panel Nod for Ixekizumab Safety Label Update

Dr. Divya Colin9 Aug 2025 12:30 PM IST
New Delhi: Eli Lilly and Company (India) Pvt Ltd has secured regulatory clearance from the Subject Expert Committee (SEC) under the Central Drugs...
Novo Nordisk gets UK nod for Concizumab to prevent bleeding episodes frequency

CDSCO Panel Approves New Indications for Novo Nordisk's Semaglutide, Mandates PMS Study

Susmita Roy9 Aug 2025 12:18 PM IST
New Delhi: Recommending to conduct post marketing surveillance (PMS) study in India, the Subject Expert Committee (SEC) functional under the Central...
Intas Pharma

Intas Pharma Gets Expert Panel Nod For PMS Data On Tofacitinib Ointment In Atopic Dermatitis

Parthika Patel9 Aug 2025 11:30 AM IST
New Delhi: Intas Pharma has received approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
Abbott to Conduct BE Study for Carbimazole 15 mg, Trial Waiver Granted In India

Abbott to Conduct BE Study for Carbimazole 15 mg, Trial Waiver Granted In India

Parthika Patel8 Aug 2025 2:34 PM IST
New Delhi: Abbott Healthcare Pvt. Ltd has received the green signal from the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
Pfizer cuts BioNTech stake by 54.7 percent

Pfizer Gets Expert Panel Nod to Update Etanercept Pre-Filled Injection Label

Susmita Roy8 Aug 2025 2:08 PM IST
New Delhi: Following a thorough review of post-marketing safety data, published literature, and clinical trial findings, the Subject Expert Committee...
No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal

CDSCO Committee Asks Elevate Scientific To Prove Back Pain Gel In Indian Trial

Susmita Roy7 Aug 2025 11:55 PM IST
New Delhi: With an aim to demonstrate the safety and efficacy on lower back pain, the Subject Expert Committee (SEC) functioning under the Central...
Dr Reddys Gets CDSCO Panel Approval To Begin Phase III Trial of Tapinarof Cream

Dr Reddy's Gets CDSCO Panel Approval To Begin Phase III Trial of Tapinarof Cream

Parthika Patel7 Aug 2025 11:41 PM IST
New Delhi: Dr. Reddy's Laboratories Limited has received approval from the Subject Expert Committee (SEC) under CDSCO to conduct a Phase III clinical...
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Uncontrolled T2DM in India and Application of Trusted Molecules Empagliflozin, Sitagliptin, and Metformin Coming Together

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