The company said the Malur and Ankleshwar plant in Gujarat had started production of Covaxin in June and it would take 120 days for manufacturing, testing, release, regulatory approvals and distribution.
Bharat Biotech on Thursday said that their new plant in Karnataka and their facility in Gujarat had started manufacturing their Covid-19 vaccine — Covaxin. The products manufactured from these facilities would be available for supplies from September.
The government had acknowledged some technical glitches at Bharat Biotech’s new facility at Malur in Karnataka which had delayed production of Covaxin. The company said the Malur and Ankleshwar plant in Gujarat had started production of Covaxin in June and it would take 120 days for manufacturing, testing, release, regulatory approvals and distribution.
The company said all the batches of Covaxin vaccine supplied till date was being manufactured and released only from their manufacturing facilities at Genome Valley Hyderabad, which was audited and approved by regulatory authorities. The company has supplied 70 million doses till date from this facility.
Allaying fears over quality of vaccines from its new plant, the company said vaccinology, vaccine manufacturing, testing, and release was a complex science. Bharat Biotech said they were the only company to develop a vaccine indigenously in India and manufacture it in scale. Covaxin had also demonstrated efficacy against the Delta variant in phase III human clinical trials.
Bharat Biotech said Covaxin had on Thursday received Good Manufacturing Practices (GMP) compliance certificate from the Hungarian authorities. The approval came from the National Institute of Pharmacy and Nutrition, Hungary, which has certified the GMP for the manufacture of Covaxin. The company now intends to submit documentation for emergency use authorisation to several additional countries worldwide. This was the first EudraGMP-compliance certificate received by Bharat Biotech from an European regulatory agency.