25
May
Indian vaccine manufacturer Bharat Biotech's American partner Ocugen submitted a 'Master File' to the US Food and Drug Administration on Tuesday in regards to its Coronavirus vaccine candidate-- Covaxin. Ocugen which is evaluating the clinical and regulatory path for Covaxin in the United States is working on obtaining the EUA for its commercialization in the US. Ocugen has submitted scores of data including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies to the FDA for review and input in its 'Master File'. In a recent regulatory filing, Ocugen has said. "The company is currently evaluating the clinical and regulatory path for COVAXIN in the United…