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DCGI grants SII permission to manufacture Sputnik V for specific regulatory purposes

ANI Jun 05, 2021

The Drug Controller General of India (DCGI) on June 4 granted approval to the Serum Institute of India (SII) for the initial manufacture of the Russian COVID-19 vaccine Sputnik V for testing, examination, and analysis purposes with certain conditions at its licensed facility in Hadapsar, Pune.

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The SII has submitted an application to the DCGI in this regard on 3 June. The Pune-based company has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia to develop Sputnik V in India. The SII will be the Sixth company to manufacture Sputnik V India. The companies like Hetero Biopharma, Gland Pharma, Panacea Biotec, Stelis Biopharma, and Virchow Biotech will be manufacturing Sputnik V in India.

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