Ocugen Closes in on Seeking EUA for India-Developed COVID-19 Vaccine
Excerpt from the Article:
Pennsylvania-based Ocugen has moved one step closer to bringing a COVID-19 vaccine developed by India-based Bharat Biotech into the United States market. The company submitted a “Master File” to the U.S., Food and Drug Administration, a necessary step ahead of seeking Emergency Use Authorization.
Ocugen and Bharat Biotech have been working together since December to develop COVAXIN, a two-dose vaccine that has already received authorization in India for people ages 12 and above.
“We continue to believe this vaccine is a critical tool to include in our national arsenal to fight this pandemic. The Ocugen team submitted a comprehensive drug master file with the FDA and is currently diligently preparing the EUA application,” Shankar Musunuri, Chairman, Chief Executive Officer and co-founder of Ocugen, said after the Master File was submitted.
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