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Strides Pharma gets CDSCO nod to export 50 mn doses of Sputnik vaccine


Strides Pharma gets CDSCO nod to export 50 mn doses of Sputnik vaccine

Strides Pharma gets No Objection Certificate (NOC) from Central Drugs Standard Control Organization (CDSCO) to export 50 million doses of Russia based, Sputnik vaccine which is developed by RDIF. The Russian COVID-19 vaccine Sputnik V (Gam-COVID-Vac) is an adenoviral-based, two-part vaccine against the SARS-CoV-2 coronavirus. Initially produced in Russia, Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.

Stelis Biopharma Limited, the biotech division of Strides Pharma, has commissioned its large-scale fully integrated vaccine manufacturing facility at Bengaluru, India. The facility was successfully inspected by the CDSCO. Stelis Biopharma has also received an initial Export NOC from CDSCO to export up to 50 million doses of the Sputnik Light vaccine.

In March 2021, Stelis partnered with the Russian Direct Investment Fund (RDIF, Russias sovereign wealth fund) to produce and supply the Russian Sputnik vaccine. Stelis has now started manufacturing the Sputnik Light vaccine at a commercial scale, and as previously committed, the Company is on track to commercialize this vaccine for Global markets in Q4FY22.

Stelis greenfield vaccine facility was built in are cord time of less than 200 days with a best in class design and modularity to cater to several vaccine formats. It is also one of the largest viral vector manufacturing sites with a bespoke design for producing the Russian Sputnik Vaccine. In its current state, the site can offer flexible technologies to manufacture lentivirus, adenovirus and retrovirus products/ vaccines along with adherent and suspension-based processes.

The site is equipped with a 40,000L Drug Substance bioreactor capacity at a 2,000L scale, using Single-Use Biore actor technology, providing optimum flexibility and cost-effectiveness for any volume demand. The drug product block of the facility is designed to produce up to 720 million doses in a year.

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