Bharat Biotech’s Covid-19 vaccine, Covaxin, has received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities.
The approval received is from the National Institute of Pharmacy and Nutrition, Hungary, certifying the GMP for the manufacture of Covaxin, said the Hyderabad-based company in a statement on Thursday.
“Bharat Biotech intends to submit documentation for Emergency Use Authorisation (EUA) in several additional countries worldwide,” said the statement.
“The recognition complements our commitment of driving world-class innovation and being a frontrunner in the research and development of vaccines,” it added.
Supply of Covaxin
The supply of Covaxin will be augmented soon. Since early June, vaccine production had commenced at its sites in Malur, Karnataka, and Ankleshwar, Gujarat, prior to which engineering batches were also executed to study equipment functionality.
“Products manufactured from these facilities will be available for supplies during September. This is based on our 120-day timeline for manufacturing, testing, release, regulatory approvals and distribution,” said the company in a separate statement. So far, the company has supplied 70 million doses of Covaxin till date.
Referring to some recent articles in social media and media outlets regarding the quality of Covaxin, Bharat Biotech said: “As of date all batches of Covaxin are manufactured and released only from our manufacturing facilities at Genome Valley, Hyderabad, which are fully audited and approved by regulatory authorities; hence, we wish to put to rest any concerns on the quality of Covaxin,” it said.
Vaccine manufacturing, testing, and release at Bharat Biotech follow “validated, stringent GMP processes”, which were established over 20 years, with several billion doses of vaccines supplied within India and globally, it added.