 "Ocugen selects Jubilant HollisterStier as manufacturer for Covaxin in US")
Ocugen Inc, Bharat Biotech's US
and Canada partner for its COVID-19 vaccine Covaxin, said it has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for the vaccine for the North American countries.
"We are fully committed to bringing Covaxin to the US and Canadian markets because we believe it has the potential to save lives by adding a weapon to the arsenal in the fight against emerging variants, J P Gabriel, Ocugen's Senior Vice President, Manufacturing and Supply Chain said in a release on Tuesday.
Bharat Biotech has entered into a definitive agreement with OcugenInc, a US-based biopharmaceutical company, to co-develop, supply, and commercialise, its Covaxin for the American and Canadian markets.
The US Food and Drug Administration recently 'recommended' Ocugen to pursue Biologics License Application (BLA) route for Covaxin instead of Emergency Use Authorisation (EUA).
"Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada.
Based on Bharat Biotech's strong track record of developing and commercializing vaccines globally and Jubilants proven track record in manufacturing, we are well-prepared to transition US manufacturing of Covaxin to our new partner" Gabriel further said.
With two facilities in North America working to manufacture multiple COVID-19 vaccines and therapies, Jubilant remains committed to supporting efforts to eradicate this global pandemic, Pramod Yadav, CEO Jubilant Pharma Limited said.
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