Bharat Biotech manufactured COVID-19 vaccine Covaxin on Thursday received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities.
"Another milestone in our account as COVAXIN(r) receives GMP certificate from Hungary. This marks the 1st EUDRAGDMP compliance certificate received by Bharat Biotech from European regulatories. #BharatBiotech #COVAXIN #covaxininhungary," tweeted Bharat Biotech.
The approval was received from the National Institute of Pharmacy and Nutrition Hungary certifying the GMP for the manufacture of Covaxin.
With this approval, Bharat Biotech achieved another significant milestone in innovating and manufacturing vaccines at global quality standards and moving forward in the ongoing fight against the COVID-19 pandemic, read Bharat Biotech 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.
Bharat Biotech also intends to submit documentation for Emergency Use Authorization (EUA) in several additional countries worldwide.
"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.
Meanwhile, Bharat Biotech's COVID-19 vaccine Covaxin has shown less reduction in 'neutralizing activity' while comparing with Delta and Delta AY.1 (Delta plus) variants in those who are fully vaccinated with the vaccine according to a study by the Indian Council of Medical Research-National Institute of Virology (NIV).
This means that people vaccinated with Covaxin will be protected against the current variants Delta, Delta AY.1 and B.1.617.3.