The Hyderabad-based Bharat Biotech was given permission on the market and distribution of Covaxin with shelf life of six months when saved at two to eight levels Celsius.
“Now, we are herewith applying for the extension of shelf life from six months to 24 months when stored at 2-8 degreesCelsius,” the agency stated in its software to the Drugs Controller General of India.
In help of their proposal, Bharat Biotech has submitted up to date accelerated and real-time stability knowledge of Coaxin together with the justification for the extension of shelf-life.
The DCGI had prolonged the shelf-life of Covishield from six to 9 months from its manufacturing date in February.
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