HYDERABAD: Bharat Biotech’s US partner Ocugen Inc has entered into a partnership with Jubilant HollisterStier LLC, a step-down subsidiary of Jubilant Pharmova, for the manufacture of indigenously developed Covid-19 vaccine Covaxin for the United States and Canadian markets, Jubilant Pharmova said in a regulatory filing.
The announcement comes less than a week after Ocugen informed bourses in the US that it had dropped plans to seek an emergency use approval (EUA) from US Food & Drug Administration based on the regulator’s recommendation and would be taking the BLA (biologics licence application) route to bring Covaxin to the US market. Ocugen had also said it would be filing an EUA with Health Canada for taking Covaxin to Canada.
Ocugen’s senior vice president of manufacturing and supply chain, JP Gabriel, said in a statement that Ocugen was fully committed to bringing Covaxin to the US and Canadian markets because it has the potential to save lives by adding a weapon to the arsenal.
“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 Jubilant’s proven track record in manufacturing,” Gabriel added.
Jubilant Pharma Ltd CEO Pramod Yadav said: “With two facilities in North America working to manufacture multiple Covid-19 vaccines and therapies, we remain committed to supporting efforts to eradicate this global pandemic.”