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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 7

Lupin Gets Zero USFDA Observations for Nagpur Plant

Lupin's Phase IV Report for Glycopyrronium, Vilanterol Inhalation Gets CDSCO Panel Nod

Parthika Patel3 Dec 2025 5:02 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has accepted the Phase IV clinical trial...
Alkem Gets CDSCO Panel Nod to Market Synthetic Semaglutide Injection in Multiple Strengths for Type 2 Diabetes

Alkem Gets CDSCO Panel Nod to Market Synthetic Semaglutide Injection in Multiple Strengths for Type 2 Diabetes

Susmita Roy2 Dec 2025 10:22 PM IST
New Delhi: Alkem Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control...
Akums Secures First UK MHRA Approval for Rivaroxaban

CDSCO Panel Approves Akums' Proposal to Manufacture, Market Nitisinone Dispersible Tablets for Hereditary Tyrosinemia Type 1

Susmita Roy30 Nov 2025 4:00 PM IST
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has recommended granting...
Sanofi Gets CDSCO Panel Nod to Update Prescribing Information for Xenpozyme

Sanofi Gets CDSCO Panel Nod to Update Prescribing Information for Xenpozyme

Susmita Roy29 Nov 2025 10:37 PM IST
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has recommended approval for...
medicines

DCC Flags State-Level Gaps, Calls for Nationwide Uniform Enforcement of Drug Quality Standards

Susmita Roy29 Nov 2025 10:34 PM IST
New Delhi: Aiming to tighten the nationwide oversight of drug quality, the Drugs Consultative Committee (DCC) has urged the Centre to address the...
CDSCO Panel Clears Bristol Myers Yervoy for Two New Cancer Indications

CDSCO Panel Clears Bristol Myers' Yervoy for Two New Cancer Indications

Susmita Roy28 Nov 2025 9:09 PM IST
New Delhi: In a significant regulatory development for cancer care in India, the Subject Expert Committee functioning under the Central Drugs Standard...
Mankind Pharma Gets Relief as CGST Appellate Authority Drops Rs 1.02 Cr Penalty

CDSCO Panel Directs Mankind Pharma to Conduct Phase I Trial of Sintilimab Before Phase III Launch

Susmita Roy27 Nov 2025 10:48 PM IST
New Delhi: The Subject Expert Committee functioning under the Central Drugs Standard Control Organisation (CDSCO) has opined Mankind Pharma should...
CDSCO Flags 68 Drug Batches Including Albendazole, Meropenem as Not of Standard Quality in January

State Drug Alert: 148 Medicine Samples Fail CDSCO Quality Tests in October

Susmita Roy27 Nov 2025 10:23 PM IST
New Delhi: Reflecting persistent drug quality concerns in India's pharmaceutical market, the Central Drugs Standard Control Organisation (CDSCO) has...
Intas Pharma

Intas Pharma Gets CDSCO Panel Nod to Conduct Phase I Trial of Pertuzumab, Trastuzumab Solution for Injection

Susmita Roy26 Nov 2025 6:32 PM IST
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Intas...
Azithromycin, Ofloxacin Combos Among 3 Drug Batches Flagged as Purportedly Spurious by CDSCO

CDSCO Flags 5 Batches of Widely Used Drugs Including Azithral-500, Telma-AM as Potentially Spurious

Susmita Roy25 Nov 2025 9:57 PM IST
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has flagged five widely used medicines, including Azithral-500, Telma-AM, Noophin,...
JnJ wins USFDA approval for subcutaneous Rybrevant Faspro for EGFR-Mutated NSCLC

Johnson and Johnson Told to Justify Phase III Icotrokinra Trial Design Over Sample Size, Patient Exposure

Parthika Patel25 Nov 2025 5:48 PM IST
New Delhi: Johnson & Johnson Pvt. Ltd. (JnJ) has been asked to justify key aspects of its proposed Phase III clinical trial protocol for...
Sun Pharma Rules Out Big-Bang Acquisitions, Bets on Organic Growth and Biosimilars

Sun Pharma Gets CDSCO Panel Nod to Conduct Active Post-Marketing Study for Antacid Combination Tablet

Parthika Patel24 Nov 2025 6:58 PM IST
New Delhi: Sun Pharma Laboratories Limited has received clearance from the Subject Expert Committee (SEC), under the Central Drugs Standard Control...
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