Covaxin, the Covid-19 vaccine of Bharat Biotech International Ltd’s (BBIL), has obtained Hungary’s Good Manufacturing Practices or GMP compliance certificate.
“Another milestone in our account as COVAXIN® receives GMP certificate from Hungary. This marks the 1st EUDRAGDMP compliance certificate received by Bharat Biotech from European regulatories,” BBIL has said in a tweet. The approval received by the vaccine manufacturer is from Hungary’s National Institute of Pharmacy and Nutrition, which has certified the GMP for manufacturing Covaxin,” it added.
The GMP certificate has been put up on the EudraGMDP database, a collection of records of the European Community of manufacturing authorisations and certificates of good manufacturing practice, the company said. BBIL wants to submit documentation for emergency use authorisation or EUA for additional countries globally.