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Bharat Biotech's US Partner Ocugen Submits Covaxin Master File for FDA Review

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  • Ocugen Inc (NASDAQ: OCGN), India-based Bharat Biotech’s U.S. partner for COVID-19 vaccine Covaxin, has submitted a “Master File” to the FDA before seeking an emergency use authorization (EUA) in the U.S.

  • Ocugen submitted key information and data to date, including preclinical studies, chemistry, manufacturing, controls, and clinical studies as a Master File and input before a planned EUA submission.

  • As per Ocugen, it is still waiting for data from Bharat Biotech’s Phase-3 trials for Covaxin to apply for the EUA, which has been delayed due to the second wave in India.

  • The delay is primarily attributed to India’s decision to temporarily suspend the export of COVID-19 vaccines directing all resources domestically amid the resurgence of infections.

  • In February, Bharat Biotech entered into a definitive agreement with Ocugen to co-develop, supply, and commercialize, Covaxin for the U.S. market.

  • Ocugen said it is expecting Covaxin to roll out in the U.S. during the second half of the current year in an investor presentation.

  • The initial U.S. supply will be done by Bharat Biotech upon receiving authorization from the FDA, followed by a technology transfer to U.S. facilities.

  • Ocugen is targeting 100 million doses per annum beginning 2021.

  • Separately, The World Health Organisation has said “more information is required” from Bharat Biotech, which is seeking an emergency use listing for Covaxin.

  • Meanwhile, Bharat Biotech said that it had submitted 90% of the documents to WHO, and the remaining documents are expected to be submitted by June.

  • Price Action: OCGN shares are up 1.51% at $8.08 during the premarket session on the last check Tuesday.

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