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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 10

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

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

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

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

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

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

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...
Boehringer Ingelheims Vetmedin Becomes First USFDA-Approved Drug to Delay Heart Failure in Dogs

Boehringer Ingelheim Told to File Separate Phase IV Trial Plan for Empagliflozin

Susmita Roy1 Nov 2025 5:42 PM IST
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has directed Boehringer Ingelheim India to...
CDSCO Panel Seeks Revised Phase IV Trial Protocol for MSN Labs Nelarabine Injection

MSN Labs Gets SEC Go-Ahead to Conduct Phase IV Clinical Trial on Elagolix for Endometriosis

Parthika Patel1 Nov 2025 5:25 PM IST
New Delhi: Hyderabad-based MSN Laboratories Pvt Ltd has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs...
Cipla, Hetero win bid to supply widely prescribed diabetes drug in China

CDSCO Panel Seeks Anesthesiology Expert Review for AIIMS Raipur Trial on Gabapentin, Melatonin, Clonidine FDC

Susmita Roy31 Oct 2025 7:26 PM IST
New Delhi: After reviewing a clinical trial proposal submitted by Dr Pratibha R Mudgal from AIIMS Raipur, involving a fixed-dose combination of...
No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal

No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal

Susmita Roy30 Oct 2025 1:18 PM IST
New Delhi: In a major regulatory development aimed at strengthening transparency and efficiency in India's clinical trial oversight, the Central Drugs...
Zydus Settles Mirabegron Patent Dispute With Astellas for USD 120 Million

Zydus Lifesciences Told To Revise PMS Study For Tofacitinib ER Tablets

Parthika Patel30 Oct 2025 12:28 PM IST
New Delhi: Zydus Lifesciences Ltd. has been directed by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization...
Amazon Only a Platform, Not Seller of Abortion Pills: Court Quashes Notice Against Directors

Pulse Pharma Gets CDSCO Panel Nod to Manufacture, Market Aripiprazole Oral Solution

Susmita Roy29 Oct 2025 2:46 PM IST
New Delhi: In a recent development, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has...
Maha: Rs 14-Crore Mephedrone Unit Busted Near Police Station, Cop Suspended for Negligence

Maha: Rs 14-Crore Mephedrone Unit Busted Near Police Station, Cop Suspended for Negligence

Parthika Patel29 Oct 2025 2:45 PM IST
Mumbai: In a case of alleged negligence, a massive illegal mephedrone (MD) manufacturing unit valued at around Rs 14 crore was busted in Nalasopara...
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