252 million doses of Sputnik V to be manufactured by Gland Pharma

Hyderabad based, Gland Pharma all set to manufacture and supply 252 million (25.2 crore) doses of Sputnik V (Russian Covid-19 vaccine). Gland Pharma has entered into an agreement with Russian sovereign wealth fund, Russian Direct Investment Fund (RDIF) and the company expects to commence production of Sputnik V at its facilities in Hyderabad from the third quarter of 2021, with deliveries estimated to start from the fourth quarter of 2021.

 

News of the tie-up sent the scrip of the company, which listed on Indian bourses in November 2020, soaring to a record high of Rs 2,784.45 a share on the Bombay Stock Exchange on Tuesday, before settling down to close nearly 7% up at Rs 2,718.65 a share as compared to the previous day’s closing price.

“Under the terms of the agreement, Gland Pharma will first undertake technology transfer of the drug substance to 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,” it said in the regulatory filing. However, it was not clear whether the Sputnik V doses that Gland Pharma will churn out are meant solely for the Indian market or for global supplies as well.

The pharma company, which was set up by PVN Raju in 1978 but is now majority owned by Fosun Pharma of China, said it will be leveraging its expertise in manufacturing sterile injectables at scale for the production of Sputnik V and establishing a stable supply of Covid-19 vaccines. Gland Pharma said this is the first of multiple partnerships being explored by the company to leverage its manufacturing capacity and capabilities to support global supply of Covid-19 vaccine and will see it utilise its drug substance and drug product facilities at its sites in Hyderabad.

The latest tie-up comes even as Sputnik V has already applied for emergency use authorization (EUA) to the Indian drug regulator. However, in February end, Dr Reddy’s Laboratories, which is conducting Phase II/III trials on 1,600 volunteers in India as part of a bridging study to the larger global trials, was asked to submit safety and immunogenicity data of the Indian trials. Hyderabad-based Dr Reddy’s Labs had joined hands with RDIF in September 2020 for conducting clinical trials and distribution of 100 million doses of vaccine in India.