RDIF, Morepen Laboratories make test batch of Sputnik V in India
Premium- RDIF had signed agreements earlier with other leading pharmaceutical companies in India -- Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech
New Delhi: Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) and Morepen Laboratories on Tuesday announced production of the test batch of the Sputnik V coronavirus vaccine at the drugmaker's facility in Himachal Pradesh.
The first batch will be shipped to the Gamaleya Center for quality control. RDIF and Morepen Laboratories signed a cooperation agreement in June 2021 and are actively implementing the technology transfer.
Sputnik V was granted an emergency use authorization in India on April 12, 2021. India is the leading production hub for Sputnik V. RDIF had reached agreements earlier with other leading pharmaceutical companies in India -- Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech. In total, agreements with partners in India provide for production of more than 850 million doses of Sputnik V per year.
To date, Sputnik V has been registered in 67 countries globally with a total population of over 3.5 billion people. The data obtained by regulators of a number of countries during the vaccination of the population, including Argentina, Serbia, Bahrain, Hungary, Mexico and others, demonstrates that Sputnik V is one of the safest and most effective vaccines against coronavirus.
Sputnik V is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
“As the pandemic is yet far from over and new, more dangerous variants of coronavirus are being detected in various regions of the world, RDIF is increasing capacities for production of Sputnik V in India, one of the key hubs. Agreement with Morepen Laboratories provides for larger amount of Sputnik V to be available both for India and our partners globally to speed up the vaccination with one of the best vaccines in the world," Kirill Dmitriev, CEO of the Russian Direct Investment Fund said.
Morepen’s API facilities at Masulkhana and Baddi are approved by the US FDA and other regulatory bodies of Europe, Asia, and Australia. The company’s state-of-the-art manufacturing facility at Baddi comprises a scientifically integrated complex of 10 plants, each with a specific product profile exporting to over 80 countries worldwide.
“The partnership would be our privilege to work jointly on expanding the production base in India. We take this partnership as starting point for long term relationship with RDIF and its partner companies as we look forward for many more areas of common interest. Morepen’s commitment towards this project is step forward towards entry into biosimilars and other biologicals," Sushil Suri, chairman & managing director of Morepen Laboratories Limited, said.
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The Russian vaccine has already been launched in India under its nationwide covid-19 vaccination program. The efficacy of Sputnik V is 97.6% based on the analysis of data on the coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021.
The Sputnik V vaccine is based on the platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years. The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.
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