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Gland sets 252 million Sputnik V doses target
The company can produce nearly 40 million vials of vaccines annually at its facility in Hyderabad and is ready to scale up capacity if needed.
Gland Pharma Ltd, the Indian unit of China’s Fosun Pharma, said it has agreed to produce as many as 252 million doses of Russian Direct Investment Fund’s (RDIF’s) Sputnik V Covid-19 vaccine at its Hyderabad facility.
“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 regulatory filing to the stock exchanges.
The company can produce nearly 40 million vials of vaccines annually at its facility in Hyderabad and is ready to scale up capacity if needed.
Gland Pharma said that it expects to start production from July-September for delivery starting from October-December.
This is the Russian sovereign fund’s second manufacturing agreement in India, after announcing a pact with Hetero Biopharma in November to manufacture up to 100 million doses of the vaccine annually.
The fund also has similar agreements with companies outside India, including Brazil’s União Quimica, Italy’s Adienne Pharma and Biotech, South Korea’s Korus Pharm.
RDIF is responsible for the global commercialization of Sputnik V vaccine that was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow. In India, Dr Reddy’s Laboratories Ltd is conducting a phase 2 and 3 bridging study of the vaccine, and is in the process of securing regulatory authorization for it.
Dr Reddy’s is expected to complete the study soon, following which it will resubmit its data from the study to seek emergency licensure from the Drugs Controller General of India (DCGI), V.G. Somani.
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 the immunogenicity of the vaccine from the applicant.
If Dr Reddy manages to secure authorization, the Sputnik V vaccine will have the highest efficacy among vaccines that are currently being administered in India.
A study published in the peer-reviewed Lancet journal in early February had shown that the vaccine has an efficacy of 91.6%, higher than the 53-81% efficacy of Serum Institute of India’s Covishield and the 80.6% efficacy of Bharat Biotech International Ltd’s Covaxin, which are currently being used in the country.
Apart from Russia, the vaccine has secured emergency authorization from regulators in more than 40 countries, including Mexico, the United Arab Emirates, Egypt and Argentina.
