Panacea Biotec announced that it had received a license from the Drugs Controller General of India (DCGI) to manufacture Sputnik V vaccine against COVID-19 at its Baddi facility in Himachal Pradesh.
The license is a necessary condition for using Sputnik V produced by Panacea Biotec in India.
Panacea said the batches produced at Panacea Biotec’s facilities at Baddi, Himachal Pradesh were earlier shipped to the Gamaleya Center in Russia for quality control.
"The said batches have successfully passed all the checks for quality parameters both at the Gamaleya Center in Russia and at the Central Drug Laboratory, Kasauli, Himachal Pradesh in India," Panacea told stock exchanges on July 5.
Panacea is manufacturing Sputnik V in a collaboration with Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF). RDIF has signed fixed price manufacturing contracts with half a dozen India companies including Panacea. Except for Panacea, others were manufacturing the vaccine for the first time. Dr Reddy's will be distributing the first 250 million doses that inoculate (125 million people).
Sputnik V was registered in India under the emergency use authorization procedure on April 12, 2021 and vaccination against Covid-19 with the Russian vaccine started on May 14, 2021.
Sputnik V has been registered in 67 countries globally with a total population of over 3.5 billion people.
The vaccine is based on a proven and well-studied platform of human adenoviral vectors and usesduration than vaccines using the same delivery mechanism for both shots.
“Panacea Biotec is delighted to announce the obtaining of the manufacturing license to produce