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Results For "DCGI"

156 News Found

Zydus wins DCGI nod to launch Phase III trials of new anti-malarial drug Zintrodiazine
Clinical Trials | April 27, 2026

Zydus wins DCGI nod to launch Phase III trials of new anti-malarial drug Zintrodiazine

The first Phase III and second Phase III trials will be multi-centre, randomised, assessor-blind, active-comparator studies to determine the efficacy, safety and tolerability of orally administered Zintrodiazine


CDSCO reforms cut trial approval timelines by over 50%: DCGI Dr Rajeev Raghuvanshi
Drug Approval | April 14, 2026

CDSCO reforms cut trial approval timelines by over 50%: DCGI Dr Rajeev Raghuvanshi

Outlines 1,500-member internal cadre, digital regulatory system, and faster SEC-led reviews


Dr. Reddy’s Laboratories launches India’s first DCGI-approved Semaglutide injection ‘Obeda’ for type 2 diabetes
News | March 21, 2026

Dr. Reddy’s Laboratories launches India’s first DCGI-approved Semaglutide injection ‘Obeda’ for type 2 diabetes

The announcement marks Dr. Reddy’s Day?1 entry into the GLP?1 receptor agonists therapy space and readiness to serve patients in India


Sun Pharma gets DCGI nod to launch generic Semaglutide injection for weight loss in India
Drug Approval | January 24, 2026

Sun Pharma gets DCGI nod to launch generic Semaglutide injection for weight loss in India

Company to launch product after the expiry of semaglutide patent in India


Glenmark Pharmaceuticals to launch DCGI-approved BRUKINSA in India for treatment of hematological malignancies
News | June 10, 2025

Glenmark Pharmaceuticals to launch DCGI-approved BRUKINSA in India for treatment of hematological malignancies

Globally, BRUKINSA is approved in more than 70 countries


Wockhardt files fast-acting Insulin Aspart injection with DCGI
News | October 16, 2024

Wockhardt files fast-acting Insulin Aspart injection with DCGI

The market size of Aspart in India is currently estimated over Rs. 260 crore with only 2 players


Orchid Pharma receives DCGI approval for combination of Cefepime and Enmetazobactam
Drug Approval | June 07, 2024

Orchid Pharma receives DCGI approval for combination of Cefepime and Enmetazobactam

DCGI has also granted permission to manufacture and market FDF of Cefepime and Enmetazobactam as a dry powder injectable


AstraZeneca India receives permission from DCGI for Dapagliflozin
Drug Approval | July 25, 2023

AstraZeneca India receives permission from DCGI for Dapagliflozin

The approval allows treatment of heart failure patients irrespective of the ejection fraction based on new trial DELIVER conducted by AstraZeneca


Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing
Drug Approval | February 18, 2023

Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing

Themis will market this drug with the brand name REMITHEM.


DCGI approves AstraZeneca 's Olaparib film-coated tablets
Drug Approval | August 20, 2022

DCGI approves AstraZeneca 's Olaparib film-coated tablets

Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer