Bharat Biotech’s COVID-19 vaccine Covaxin has received Good Manufacturing Practices (GMP) compliance certificate from Hungary, the vaccine maker said on Thursday in a tweet.
The company in a separate press release said Covaxin production, which started in early Junein Malur andAnkleshwar facilities, will be available for commercialsupplies in September.
“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 tweet said.
The approval received is from the National Institute of Pharmacy and Nutrition, Hungary certifying the GMP for the manufacture of Covaxin, a note posted on twitter said.
The certificate of GMP is now listed on the EudraGMDP database which is the collection of records of the European Community of manufacturing authorisations and certificates of good manufacturing practice, Bharat Biotech said.
Bharat Biotech intends to submit documentation for emergency use authorisation to several additional countries worldwide, the company said.
“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 note said.
The recognition compliments the firm’s commitment of driving world class innovation and being a frontrunner in the research and development of vaccines, it added.
Meanwhile, the vaccine maker in a separate press release said every batch of Covaxin is subjected to more than 200 quality control tests at its facilities, followed by submission of samples to Central Drugs Laboratory (CDL) and the batches are released commercially only based on approval/release by the Lab.
Refuting reports on the quality of the vaccine, Bharat Biotech said as of date all batches of Covaxin are manufactured and released only from its manufacturing facilities at Genome Valley here, which are fully audited and approved by regulatory authorities.
Since early June, manufacturing of Covaxin has commenced at the companys 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,” Bharat Biotech said.
Bharat biotech 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 scientific publications on vaccine trials, it said.