Bharat Biotech’s COVAXIN receives certificate of Good Manufacturing Practice from Hungarian authorities

COVAXIN received approval from the National Institute of Pharmacy and Nutrition Hungary certifying the GMP for the manufacture of the COVID-19 vaccine.

Created On: Aug 5, 2021 12:28 IST
Bharat Biotech's COVAXIN
Bharat Biotech's COVAXIN

COVAXIN, a COVID-19 vaccine manufactured by Bharat Biotech, on August 5, 2021, received a certificate of Good Manufacturing Practice (GMP) compliance from the authorities of Hungary.

The news was shared via a tweet by Bharat Biotech in which it mentioned that this marks the 1st EUDRAGDMP compliance certificate to the firm from the European authorities.

COVAXIN received approval from the National Institute of Pharmacy and Nutrition Hungary certifying the GMP for the manufacture of the COVID-19 vaccine.

In an official statement, Bharat Biotech said that with this approval, the firm has achieved another significant milestone in innovating and manufacturing vaccines at the global quality standards and moving forward in an ongoing fight against the Coronavirus pandemic.

It further added that the recognition by Hungary complements the firm’s commitment to driving world-class innovation as well as being a front-runner in the research and development of vaccines.

Key Highlights:

The certificate of Good Manufacturing Practice (GMP) is now listed on the EudraGMDP. It is the database of the European Community of Manufacturing authorizations and certificates of good manufacturing practice.

Bharat Biotech also intends on submitting the documentation for the Emergency Use Authorization (EUA) in several additional countries worldwide.

Bharat Biotech’s COVAXIN: Key Information

Meanwhile, as per the study by the Indian Council of Medical Research-National Institute of Virology, COVAXIN of Bharat Biotech has shown less reduction in ‘neutralizing activity’ while comparing with the Delta and Delta AY.1 (Delta Plus) variants in those who have been fully vaccinated with the COVID-19 vaccine.

This means that those who have been vaccinated with COVAXIN will be protected against the current variants Delta, Delta AY.1, and B.1.6.17.3.

COVAXIN is a Coronavirus vaccine that has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research. It is an inactivated virus-based vaccine.

The vaccine was granted emergency use authorization in January 2021 by India’s drug regulatory body. It was the third vaccine to apply for authorization after Serum Institute and Pfizer.

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