MOSCOW (Reuters) -South Korean biotech firm GL Rapha has secured regulatory approval from Russia to produce and market the Sputnik family of coronavirus vaccines, the company and Russian sovereign fund RDIF said on Tuesday.
The certification paves the way for the first overseas production of the shot to ease a supply shortage and allows GL Rapha to carry out the full production cycle, as opposed to other foreign manufacturers that rely on Russian-supplied ingredients.
“This is the first time a foreign production partner of RDIF obtains a Russian GMP (good manufacturing practice) certificate,” the two said in a joint statement.
RDIF and GL Rapha have agreed to produce more than 150 million doses per year of Sputnik V.
The certification comes more than a year after the two sides first started cooperation talks, which accelerated after Sputnik’s Russian developer Gamaleya Research Institute transferred technology to GL last October, underscoring the complications facing global efforts to rapidly boost vaccine supply.
GL, which oversees the entire production of the vaccine from drug substance to packaging in its facility in Chuncheon, east of Seoul, has at least 10 million doses of Sputnik Light, the single-dose version of the vaccine, already in storage ready for shipment pending approval.
“In total, the existing RDIF contracts with international partners enable the annual production of more than 1 billion doses of the Sputnik V and Sputnik Light vaccines per year outside of Russia,” the companies said.
(Reporting by Anton ZverevWriting by Olzhas Auyezov; Editing by Kirsten Donovan)