Gland Pharma to make 252 million doses of Russia’s Sputnik V vaccine
- Gland Pharma will first undertake technology transfer of the drug substance to its manufacturing facilities, after which it will undertake manufacturing
Gland Pharma Ltd has entered into a partnership with Russian Direct Investment Fund (RDIF), under which the Hyderabad-based pharmaceutical firm will manufacture up to 252 million doses of the Sputnik V vaccine.
“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," the company said in a filing with exchanges.
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The Fosun Pharma subsidiary has a capacity to produce nearly 40 million vials of vaccines annually at its facility in Hyderabad and had said that it would scale up its capacity if needed.
Gland Pharma said that it is expected to start production from July-September for estimated delivery starting from October-December.
This is the Russian sovereign fund’s second manufacturing agreement after it had in November announced a pact with Hetero Biopharma to manufacture up to 100 million does of the vaccine annually.
The fund also has a production pact with companies abroad, such as Brazil’s União Quimica, Italy’s Adienne Pharma & Biotech, and South Korea’s Korus Pharm, among others.
RDIF is responsible for global commercialization of the vaccine that was developed by the Gamaleya Research Institute of Epidemiology and Microbiology at Moscow. In India, it has also signed an agreement with Dr Reddy’s Laboratories Ltd, in which the Indian firm would conduct a phase 2 and 3 bridging study of the vaccine, and on securing authorization.
Dr Reddy’s is expected to complete its bridging study soon, following which it will resubmit its data from the study to seek an emergency licensure from the Drugs Controller General of India (DCGI) V.G. Somani.
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The company had submitted an application for emergency licensure to the DCGI last month but a subject expert committee, tasked with vetting the application and making a recommendation to the regulator, deferred its decision while asking the company to provide additional data on immunogenicity of the vaccine from the applicant.
The Sputnik V vaccine, if it gets an authorization, will have the highest efficacy among the vaccines that are being commercialized.
A study, published in the peer-reviewed Lancet journal, in early February had showed that the vaccine has an efficacy of 91.6%, higher than the 53-81% efficacy of Serum Institute of India’s Covishield and 80.6% efficacy of Bharat Biotech International Ltd’s Covaxin, which are currently being administered in the country.
Apart from Russia, the vaccine has emergency authorization from regulators in over 40 countries, including Mexico, UAE, Egypt and Argentina.
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