Canadian health regulator actively reviewing Covaxin data, says Bharat Biotech US, Canada partner
Hyderabad: Ocugen, the US and Canada partner of Bharat Biotech for Covaxin, has said it has submitted all data to the Canadian government and it is under active review of the health regulator there.
In June, Ocugen entered into an agreement with Bharat Biotech to develop, manufacture and commercialise the COVID-19 vaccine, Covaxin in Canada in addition to the existing rights in the United States. Ocugen has already approached Health Canada and submitted the Phase 3 clinical trial data of Covaxin seeking authorization to sell the jab in that country.
"We have submitted all the data, what is needed for the submission -- for Canadian submission. And again, on the specific timeline and the approval clock, we can't give you that at this stage," Shankar Musunuri--Chairman and Chief Executive Officer of Ocugen said on Friday in an Earnings call.
"All I can say is it's under active review by Health Canada. As we get questions, we're ready to respond to them very promptly and provide any information they need," he said.
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