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Homegrown pharmaceutical firm Wockhardt on Tuesday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to export up to 10 crore doses of Russian COVID-19 vaccine Sputnik.
The approval is for the export of up to 8 crore doses of Sputnik Light and up to 2 crore doses of Sputnik V Component I vaccines, Wockhardt Ltd said in a regulatory filing.
The company's bulk vaccine and fill-finish manufacturing facilities at Waluj and Shendra, Aurangabad, were "jointly inspected and approved by Drug inspectors from CDSCO (West zone) and Aurangabad State FDA and expert from CDL (Central Drugs Laboratory) Kasauli" to receive the export NOC (no objection certificate), it added.
The state-of-the-art automated manufacturing facilities in Aurangabad are dedicated to producing world-class high-quality injectable products, the company said.
Wockhardt said it had entered into an agreement with the Russian Direct Investment Fund and Enso Healthcare to manufacture and supply Sputnik V and Sputnik Light vaccines against COVID-19 based on the technology transfer from Gamaleya National Research Institute of Epidemiology and Microbiology.
On Sunday, Union Health Minister Mansukh Mandaviya had announced that the Drugs Controller General of India has granted emergency use permission to single-dose Sputnik Light COVID vaccine in the country.
Last year in April, India's regulator had granted permission for restricted emergency use of the Russian COVID-19 vaccine Sputnik V with certain conditions.
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