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CDSCO (Central Drugs Standard Control Organisation) News - Page 11

Torrent Pharma Slapped with Rs 41.33 Crore GST Penalty for Alleged Erroneous Export Refunds

Torrent Pharma Gets CDSCO Panel Nod to Manufacture, Market Prucalopride Oral Solution

Written By Susmita Roy7 Nov 2025 6:31 PM IST
New Delhi: In a significant regulatory development, Torrent Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) under the...
Dr. Reddys Labs Bags Health Canada Nod for Ozempic Generic, OneSource to Scale Supply

Dr. Reddy's Gets CDSCO Panel Nod for BE Study on Resmetirom Tablets for NASH Treatment

Written By Susmita Roy6 Nov 2025 3:17 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Dr. Reddy's...
Johnson and Johnson Gets USFDA Nod for Oral Psoriasis Drug Icotyde

CDSCO Panel Approves Updated Package Insert for Johnson and Johnson's Stelara

Written By Susmita Roy5 Nov 2025 4:51 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval for the updated...
CDSCO Panel Flags Ethnic Variability, Seeks More Data from Takeda for Fruquintinib Hard Capsule Approval

CDSCO Panel Approves Updated Package Insert for Takeda's Vedolizumab

Written By Susmita Roy5 Nov 2025 4:16 PM IST
New Delhi: In a key regulatory development, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has...
CDSCO Panel Declines to Consider ACME Generics Phase IV Trial Results for Liothyronine Tablets

Ziller Medical Denied Manufacturing Nod for Cervical Cerclage Pessary Over Inadequate Safety Data

Written By Parthika Patel4 Nov 2025 4:49 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has refused to grant manufacturing...
Former GlaVellaian Karuppiah Joins Shilpa Medicare as COO

CDSCO Panel Asks Shilpa Biologicals to Revise Phase III Protocol for Recombinant Human Serum Albumin Study

Written By Susmita Roy4 Nov 2025 4:39 PM IST
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has sought major revisions in...
Low-Risk Medical Device Makers Get Clarity: CDSCO Publishes Class A Risk Classification List under MDR 2017

Low-Risk Medical Device Makers Get Clarity: CDSCO Publishes Class A Risk Classification List under MDR 2017

Written By Susmita Roy3 Nov 2025 9:07 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has released a detailed Risk Classification List of Class A (non-sterile and...
AstraZeneca Gets SEC Nod to Update Lokelma Prescribing Information for Hyperkalemia Treatment

AstraZeneca Gets SEC Nod to Update Lokelma Prescribing Information for Hyperkalemia Treatment

Written By Susmita Roy3 Nov 2025 7:08 PM IST
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval for...
CDSCO Expert Panel Backs Akums Faropenem Dispersible Tablets, Grants CT, BE Waivers

Akums Wins 20-Year Patent for Dual Release PPI, Promises Long-Lasting GERD Relief

Written By Farhat Nasim3 Nov 2025 6:02 PM IST
New Delhi: Akums Drugs and Pharmaceuticals Limited has announced that it has been granted a patent for its invention titled 'Dual Release...
CDSCO Panel Seeks Revised Phase IV Trial Protocol for MSN Labs Nelarabine Injection

MSN Labs Secures SEC Nod for Phase III Trial of Vibegron 75 mg, Excluding Refractory OAB Patients

Written By Susmita Roy2 Nov 2025 12:30 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has approved MSN Laboratories to conduct a...
Emcure Pharma Gets CDSCO Panel Nod to Conduct Phase IV Trial on Drospirenone Tablets

Emcure Pharma Gets CDSCO Panel Nod to Conduct Phase IV Trial on Drospirenone Tablets

Written By Parthika Patel2 Nov 2025 11:30 AM IST
New Delhi: Pune-based Emcure Pharmaceuticals Ltd has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs...
47 Drug Inspectors for 2.5 Lakh Batches: Kerala Faces Oversight Strain

Nearly 50% of Drug Inspector Posts Vacant at CDSCO, Reveals RTI Response

Written By Susmita Roy1 Nov 2025 10:22 PM IST
New Delhi: Nearly 250 Drug Inspector posts remain vacant across the regulatory and medical device divisions of the Central Drugs Standard Control...
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Timely Identification of Alzheimers Disease: Bridging the Diagnostic Gap and the Role of Biomarkers

Timely Identification of Alzheimer's Disease: Bridging the Diagnostic Gap and the Role of Biomarkers

Metformin: Anchor in the Metabolic Journey of Prediabetes Care- Dr Dwaipayan Deb

Metformin: Anchor in the Metabolic Journey of Prediabetes Care- Dr Dwaipayan Deb

Strengthening Adult Immunization in India: PCV20 and the Changing Landscape of Pneumococcal Disease Prevention

Strengthening Adult Immunization in India: PCV20 and the Changing Landscape of Pneumococcal Disease...

Efficacy and Safety of Injectable Semaglutide in Indian Patients with Type 2 Diabetes: Findings from a Phase III Study Presented at IDS 2026

Efficacy and Safety of Injectable Semaglutide in Indian Patients with Type 2 Diabetes: Findings from...

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