Gland Pharma Enters Into An Agreement To Manufacture 252 Million Doses Of Sputnik V

Under the terms of the agreement, Gland Pharma will first undertake technology transfer of the drug substance to its manufacturing facilities.

Hyderabad-based Gland Pharma has entered into an agreement with Russian sovereign wealth fund, Russian Direct Investment Fund (RDIF), to manufacture and supply 252 million (25.2 crore) doses of Russian Covid-19 vaccine Sputnik V.

The company said on Tuesday that it 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.

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 authorisation (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.

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