Ocugen Inc., Bharat Biotech’s US and Canada associate for its COVID-19 vaccine Covaxin, stated it has chosen Jubilant Hollistertier of Spokane, Washington, as its manufacturing associate for the vaccine for North American nations.
“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,” stated JP Gabriel, Senior Ocugen Vice President, Manufacturing and Supply Chain stated in a launch on Tuesday.
Bharat Biotech has entered right into a definitive settlement with US-based biopharmaceutical firm OKGenInc to co-develop, provide and commercialize its Covaxin for the US and Canadian markets.
The US Food and Drug Administration lately ‘advisable’ OcuGen to pursue the Biologics License Application (BLA) route for Covaxin as a substitute of Emergency Use Authorization (EUA).
“Securing US-based manufacturing capability is an important step as we prepare to submit our regulatory filings”
Submissions to the FDA and Health Canada.
Based on Bharat Biotech’s sturdy monitor report of growing and commercializing vaccines globally and
With Jubilants’ confirmed monitor report in manufacturing, we’re able to transition US manufacturing of Covaxin to our new associate.
Jubilant Pharma Ltd CEO Pramod Yadav stated that with two amenities in North America working to fabricate a number of COVID-19 vaccines and coverings, Jubilant is dedicated to supporting efforts to eradicate this world pandemic.
With inputs from TheIndianEXPRESS