Thursday, August 18, 2022

Covaxin gets approval from Hungary; Bharat Biotech says only the Ist step

In a big boost, Bharat Biotech’s Covid-19 vaccine Covaxin has received Good Manufacturing Practices (GMP) compliance certificate from Hungary.

Bharat Biotech took to Twitter to make the announcement and wrote, “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.” 

“The recognition complements our commitment to driving world-class innovation and being a frontrunner in the research and development of vaccines,” read the company’s statement. 

The certificate of GMP is now listed on the EudraGMDP database, which is the database of the European Community of manufacturing authorizations and certificates of the good manufacturing practice.

As per the information provided by the company, the approval received is from the National Institute of Pharmacy and Nutrition Hungary certifying the GMP for the manufacture of Covaxin.

Bharat Biotech is also likely to submit documentation for Emergency Use Authorization (EUA) in several additional countries worldwide.


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