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Zydus Cadila submits additional data to DCGI: Sources

By ANI | Updated: July 27, 2021 19:10 IST

Ahmedabad-based Zydus Cadila has submitted additional data related to immunogenicity and safety to India's drug regulator Drugs Controller General of India (DCGI), as per sources.

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Ahmedabad-based Zydus Cadila has submitted additional data related to immunogenicity and safety to India's drug regulator Drugs Controller General of India (DCGI), as per sources.

Earlier the drug regulator had asked the Ahmedabad-based pharma company to come back with more data, the sources informedearlier.

DCGI will consider giving emergency use authorisation (EUA) after review of data recommended in the meeting of regulator's Subject Expert Committee (SEC). If data is found to be satisfied then final approval from DCGI may be granted in August.

Previously, the sources had toldthat a continuous and rolling review of data was being undertaken and final approval would take a few more days.

Zydus Cadila had on July 1, requested emergency use approval for ZyCoV-D, its three-dose COVID shot - the world's first Plasmid DNA vaccine. If approved it will be the country's second indigenous vaccine after Bharat Biotech's Covaxin.

( With inputs from ANI )

Disclaimer: This post has been auto-published from an agency feed without any modifications to the text and has not been reviewed by an editor

Tags: Dechen Consulting Group, Inc.Eua
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