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Dr Reddy s begins process to obtain emergency use authorisation for Sputnik V
Dr Reddy s Laboratories on Friday said it has approached drugs regulator DCGI for emergency use authorisation (EUA) for COVID-19 vaccine Sputnik V. As part of the review process, the drug major will present the safety profile of phase 2 study, and interim data of phase 3 trial, which is expected to be complete by February 21, 2021, Dr Reddy s said in a statement.
In September last year, the Hyderabad-based firm partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India.