Gland Pharma has partnered with the Russian Direct Investment Fund (RDIF) to make up to 252 million doses of Sputnik V, the Covid-19 vaccine developed in Moscow that is currently awaiting emergency authorization in India. The agreement is expected to boost India’s capacity to manufacture this vaccine to around 350 million doses a year. Hyderabad-headquartered Gland Pharma, a subsidiary of China’s Fosun Pharma, is the third drug maker to collaborate with RDIF for the Russian vaccine after Dr Reddy’s Laboratories and Hetero Biopharma. As per the terms of the agreement, Gland Pharma will first be given the know-how to make Sputnik V at its manufacturing facilities.
“After successful technology transfer, Gland Pharma will then undertake manufacturing of drug substance and drug product filling into vials under aseptic conditions,” the company told stock exchanges on Tuesday.
The agreement will see the company utilizing its drug substance and drug product facilities at its sites in Hyderabad. The company, in late January, had said it had a “readily available” capacity to manufacture nearly 40 million vials of finished products annually but was planning to add more capacities to support both its finished as well as drug substance manufacturing.
Gland Pharma’s production of Sputnik V is expected to begin from the third quarter of the 2021 calendar year and the company estimates to begin supply from the fourth quarter.
According to RDIF’s agreements in India so far, Dr Reddy’s has been in charge of conducting clinical trials of Sputnik V and applying for its regulatory authorization in the country. It will also be able to distribute around 200 million doses of the vaccine supplied by RDIF once it gets the nod.