Covaxin gets GMP certificate from Hungary: Bharat Biotech
Premium- Bharat Biotech intends to submit documentation for Emergency Use Authorization in several additional countries worldwide
New Delhi: Bharat Biotech’s covid-19 vaccine Covaxin has received good manufacturing practice (GMP) compliance certificate from the Hungarian authorities, the Hyderabad-based drugmaker said on Thursday.
The National Institute of Pharmacy and Nutrition, Hungary has certified the GMP for the manufacture of Covaxin. The certificate is now listed on the EudraGMDP , which is the database of the European Community of manufacturing authorizations and certificates of the good manufacturing practice.
“Bharat Biotech intends to submit documentation for Emergency Use Authorization (EUA) in several additional countries worldwide," the company said in a statement.
“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 recognition complements our commitment of driving world-class innovation and being a frontrunner in the research and development of vaccines," the company said.
On reports about Covaxin’s quality, Bharat Biotech said as of date all batches of the vaccine are manufactured and released only from manufacturing facilities at Genome Valley Hyderabad, which are fully audited and approved by regulatory authorities.
“Every batch of covaxin is subjected to more than 200 quality control tests at our facilities, followed by submission samples to Central Drugs Laboratory (CDL) Government of India, only based on approval/release by CDL, are batches released commercially," the company said in a statement.
Since early June, manufacturing of Covaxin has commenced at sites at 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, the company 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 said.
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The company said, “Since vaccines are administered to healthy individuals, safety is always our vital, primary criteria and we have an uncompromising policy on safety, and quality, whatsoever. This is evident from the excellent safety contours of covaxin with an impressive supply of ~ 70 million doses to date. It is emblematic that Bharat Biotech has not sought Indemnity from the Government of India for any adverse events from covaxin."
Bharat Biotech further said that the whole-virion Inactivated Vero Cell vaccines (covaxin technology platform) are highly complex to manufacture as the critical ingredient is based on live viruses which require highly sophisticated, multiple level containment and purification methods. Such extensive, high standards of purification naturally lead to significant process losses and low yields resulting in a highly purified and safe vaccine.
The SARS COV2 strains provided under material transfer agreements to Bharat Biotech are also readily available at the ICMR-NIV and are accessible to any organization that wishes to manufacture a similar Covid-19 vaccine, the company said.
Bharat Biotech said it is the only company to develop a vaccine indigenously in India and manufacture it on a large scale. It has accomplished this in a matter of 15 months, with 10 publications and global recognition for India as an innovator and product developer. Covaxin is the only vaccine to have demonstrated efficacy against the delta variant in phase III human clinical trials.
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