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Results For "Central-Drugs-Standard-Control-Organisation"

57 News Found

Study demonstrates Covaxin safe for kids in the age 2-18 years
News | December 30, 2021

Study demonstrates Covaxin safe for kids in the age 2-18 years

Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. Neutralizing antibodies in children on an average 1.7 times higher than in adults


JB Chemicals and Pharmaceuticals to launch molnupiravir next month
Drug Approval | December 29, 2021

JB Chemicals and Pharmaceuticals to launch molnupiravir next month

It will be marketed under the brand name Molunamax


Cipla receives EUA for Cipmolnu
Drug Approval | December 28, 2021

Cipla receives EUA for Cipmolnu

The Subject Expert Committee (SEC), on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday recommended granting permission to manufacture and market anti-Covid pill molnupiravir for restricted emergency use


CDSCO expert committee recommends Emergency Use Authorisation to Covovax and Corbevax
News | December 28, 2021

CDSCO expert committee recommends Emergency Use Authorisation to Covovax and Corbevax

All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.


CDSCO increases shelf life of Covaxin
Drug Approval | December 21, 2021

CDSCO increases shelf life of Covaxin

The approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO


Boehringer Ingelheim gets CDSCO nod for Jardiance
Drug Approval | November 23, 2021

Boehringer Ingelheim gets CDSCO nod for Jardiance

Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease


Shilpa Biologics permitted to conduct Phase 1 study on NavAlbumin
Biotech | November 05, 2021

Shilpa Biologics permitted to conduct Phase 1 study on NavAlbumin

The product is synthetically developed as compared to the current process of drawing the same from blood plasma and is backed by a granted global patent


Covaxin shelf-life extended to 12 months from the date of manufacture
News | November 03, 2021

Covaxin shelf-life extended to 12 months from the date of manufacture

This approval of shelf-life extension was based on the availability of additional stability data, which was submitted to CDSCO


India approves LumiraDX’s Antigen test kit
Medical Device | October 21, 2021

India approves LumiraDX’s Antigen test kit

The test combines sensitivity with speed and is designed to be used in health care settings to aid with rapid diagnosis of Covid-19


Covaxin for kids gets nod, final approval awaited
Drug Approval | October 12, 2021

Covaxin for kids gets nod, final approval awaited

The two doses of Covaxin are likely to be administered to children with a gap of 28 days