Bharat Biotech on May 25 submitted a new request to the Brazilian regulator Anvisa for certification of Good Manufacturing Practices (GMP) for Covaxin.
Anvisa had in March denied a certificate for good manufacturing practices to Bharat Biotech citing certain violations of GMP at the Bharat Biotech facility.
The Brazilian government signed a contract with Precis Medicamentos, Bharat Biotech’s representative in Brazil, to buy 20 million doses of the vaccine. Anvisa’s clearance is a necessary step for the country’s process of authorising this vaccine for emergency use.
The application for GMP certification of production of the vaccine comes one day after Brazil's Ministry of Health filed a new application for authorisation to import 20 million doses of the Covaxin manufactured in India, where the vaccine is authorised for emergency use.
"The two requests for certification, input and production of the vaccine, cover the entire manufacturing chain of the vaccine," Anvisa said in a release.
GMP certification of all stages of vaccine production is a prerequisite for the registration of the vaccine in Brazil. For the exceptional import order, only the minimum data of Good Production Practices are analyzed, but without the need for the certificate in question.
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