Bharat Biotech American partner submits Covaxin Master File to USFDA
In an investor presentation, Ocugen said it is expecting the vaccine to be rolled out in the US during the second half of the current year.;
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New Delhi: Ocugen, Bharat Biotech's American partner for Covid-19 vaccine Covaxin, has submitted a "Master File" to the US Food and Drug Administration, prior to seeking an emergency use authorisation in that country.
"The company is currently evaluating the clinical and regulatory path for Covaxin in the United States including obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Also, eventually biologic license application (BLA) approval in the United States, as well as the company's commercialization strategy, if authorized or approved," Ocugen has said in a recent regulatory filing.
Ocugen has submitted key information and data to date including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies as a Master File for FDA review and input prior to a planned EUA submission.
The company is currently awaiting additional data from Bharat Biotech from the ongoing Phase 3 clinical trial for a EUA submission, it further said.
Bharat Biotech on February 2 said it has entered into a definitive agreement with Ocugen Inc, a US-based biopharmaceutical company, to co-develop, supply, and commercialise, the Indian vaccine maker's Covaxin for the US market.
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