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The Russian Direct Investment Fund (RDIF) has signed an agreement with Virchow Biotech Pvt. Ltd for production of up to 200 million doses per year of Sputnik V at the latter’s facility in Hyderabad.

RDIF is expected to complete technology transfer in April-June, after which full-scale commercial production of Sputnik V will begin, said the Russian sovereign fund, which is the global commercialization partner for the vaccine.

“We are glad to sign a cooperation agreement with RDIF to produce Sputnik V vaccine. Virchow’s proven capabilities in large-scale drug substance manufacturing should help meet the global demand for this vaccine," Virchow Biotech managing director Tummuru Murali Krishna Reddy said.

Virchow Biotech is the fourth Indian company to sign a production agreement with RDIF, the other three being Hetero Biopharma, Gland Pharma, and Stelis Biopharma. With the addition of Virchow, RDIF has secured production of around 750 million doses of the Sputnik V vaccine.

However, all the four companies do not have strong experience in manufacturing vaccines, and all, except Gland Pharma, are repurposing their biopharma facilities to manufacture the shot. Gland Pharma is in the process of commissioning its vaccine manufacturing facility, which has an annual capacity of 40 million doses, but has signed a pact for up to 252 million doses.

RDIF also has a partnership with Dr Reddy’s Laboratories, under which the latter (Dr Reddy’s) is conducting a phase 2 and 3 bridging study in India to prove that its vaccine produces a similar immune response as it does in the Russian population, where an efficacy study has been conducted. The vaccine has been found to have an efficacy of 91.6%.

After the vaccine gets an emergency use authorization in India, Dr Reddy’s can also market up to 250 million doses in the country. The fund also has similar agreements with firms outside India, including Brazil’s União Quimica, Italy’s Adienne Pharma and Biotech, and South Korea’s Korus Pharm.

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