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Covaxin has received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities, Bharat Biotech said on August 5.
"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 company tweeted.
This approval was received from the National Institute of Pharmacy and Nutrition, Hungary certifying the GMP for the manufacture of Covaxin.
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, the company said.
With this, Bharat Biotech also intends to submit documentation for Emergency Use Authorization (EUA) in several additional countries worldwide.
Covaxin was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and its subsidiary National Institute of Virology (NIV).
With this approval, Bharat Biotech has 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, the company said.
The recognition complements our commitment to driving world-class innovation and being a frontrunner in the research and development of vaccines, it added.
Meanwhile, the medical body ICMR in its study had said that Covaxin is effective against the Delta Plus variant of COVID-19.
Bharat Biotech on April 21 had also announced phase 3 interim analysis results of Covaxin that demonstrated that the COVID-19 vaccine has 78 percent efficacy which was slightly lower than the first interim data that indicated the efficacy of 81 percent at a four-week interval between two doses.
It was also found that Covaxin is 65 percent effective against the Delta variant of the coronavirus disease.
www.moneycontrol.com
COVID-19 Vaccine
"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 company tweeted.
This approval was received from the National Institute of Pharmacy and Nutrition, Hungary certifying the GMP for the manufacture of Covaxin.
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, the company said.
With this, Bharat Biotech also intends to submit documentation for Emergency Use Authorization (EUA) in several additional countries worldwide.
Covaxin was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and its subsidiary National Institute of Virology (NIV).
With this approval, Bharat Biotech has 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, the company said.
The recognition complements our commitment to driving world-class innovation and being a frontrunner in the research and development of vaccines, it added.
Meanwhile, the medical body ICMR in its study had said that Covaxin is effective against the Delta Plus variant of COVID-19.
Bharat Biotech on April 21 had also announced phase 3 interim analysis results of Covaxin that demonstrated that the COVID-19 vaccine has 78 percent efficacy which was slightly lower than the first interim data that indicated the efficacy of 81 percent at a four-week interval between two doses.
It was also found that Covaxin is 65 percent effective against the Delta variant of the coronavirus disease.
COVID-19 vaccine update | Covaxin receives GMP certificate from Hungary, says Bharat Biotech
The approval was received from the National Institute of Pharmacy and Nutrition, Hungary certifying the GMP for the manufacture of Covaxin.
COVID-19 Vaccine
