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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.
Dr Reddy s to seek emergency use authorisation for Russia s Sputnik V in India
As part of the review process, Dr Reddy s will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21st February 2021.
BusinessToday.In | February 19, 2021 | Updated 15:48 IST
Sputnik V maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old, Dr Reddy s said.
Drug firm Dr Reddy s Laboratories on Friday said it has initiated the process with the Drugs Controller General of India (DCGI) for emergency use authorisation (EUA) for Russia s Sputnik V vaccine against COVID-19.