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Bharat Biotech Submits 2 New GMP Certification Applications to Brazilian Anvisa for Covaxin | India News

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HYDERABAD: Bharat Biotech has approached the Brazilian health regulator seeking Good Manufacturing Practice (GMP) certifications for the locally developed Covaxin production line, as well as its biological input.
The two new applications come almost two months after Anvisa (Agência Nacional de Vigilância Sanitária) rejected the request from the Brazilian Ministry of Health for authorization to import 20 million doses of Covaxin on the grounds that Bharat Biotech’s manufacturing facilities They did not meet their GMP standards.
“Regarding the compliance of the GMP by the manufacturer Bharat Biotech, one of the main aspects that motivated the previous decision, the company presented a new request for certification in Anvisa, referring to the production line of the finished product. The request is being analyzed in accordance with the law, ”said a loosely translated version of Anvisa’s announcement.
“… On Tuesday (May 25) a new application for GMP certification was submitted for the biological input produced by Bharat Biotech. The request for certification of the production of the input comes one day after the new request for certification of the vaccine production line, ”Anvisa said on its website.
“The two requests for certification, entry and production of the vaccine, cover the entire manufacturing chain of the immunizer. GMP certification of all stages of vaccine production is a prerequisite for immunizer registration in Brazil, ”he said.
“For the exceptional import order, only the minimum data of Good Production Practices are analyzed, but without the need for the certificate in question,” added Anvisa.
On May 24, the Brazilian Ministry of Health had submitted an application to Anvisa again seeking authorization to import 20 million doses of Covaxin ‘Made in India’.
Anvisa said that after rejecting the request from the Brazilian Ministry of Health to import and distribute Covaxin on March 31, 2021, Bharat Biotech’s partner, Precisa Medicamentos, had continued its negotiations to fix the problem areas that Anvisa had cited in rejecting. application.
“The requirements outlined during the inspection will be met, the deadlines for compliance are under discussion with the NRA of Brazil (national regulatory agency) and will be resolved soon,” Bharat Biotech said in a statement.



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