The Hyderabad-based Bharat Biotech Ltd is confident about obtaining WHO s emergency use listing.
Hyderabad-based Bharat Biotech has submitted 90 per cent of documents to World Health Organisation (WHO) for obtaining emergency use listing for the Covaxin, according to sources.
The remaining documents are expected to be submitted by June, the company told the Central government during a discussion on obtaining the WHO s authorisation for emergency use listing for Covaxin, sources said.
The company is confident about obtaining WHO s emergency use listing.
Sources also said that Covaxin received regulatory approval in 11 countries and interest from 11 companies in seven countries for technology transfer and production.
Morning Digest — May 24, 2021 - The Hindu
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Bharat Biotech applies for WHO nod for Covaxin; pre-submission meeting soon
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Synopsis
“The company plans to produce 200 million doses of Covaxin per annum in the GMP facilities that are already operational for the production of vaccines based on inactivated vero cell platform technology, under stringent levels of GMP and biosafety,” the statement said.
Production of Covaxin from this facility will commence from Q4 2021.
Hyderabad-based Bharat Biotech said it has ramped up manufacturing capacity for Covaxin, its indigenous Covid-19 vaccine, by another 200 million doses a year using a facility in Gujarat currently operated by its wholly-owned subsidiary Chiron Behring Vaccines.
Production of Covaxin from this facility will commence from Q4 2021.
This effectively takes the Covaxin volume up to about 1 billion doses per annum, the company said in a statement on Thursday.