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Brazil s Anvisa provisionally suspends authorisation
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HYDERABAD: After Bharat Biotech terminated its MoU with Brazilian partner Precisa Medicamentos on Friday, Brazil’s health regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria) said it has suspended Covaxin’s clinical trials in Brazil. Precisa had submitted a request for randomised, double-blind and placebo-controlled phase-3 study of Covaxin in Brazil to Anvisa.
“The Coordination of Clinical Research determined this Friday the precautionary suspension of clinical studies of Covaxin in Brazil,” said a notice by Anvisa on website.
“The suspension was carried out as a result of a statement from the Indian company Bharat Biotech Limited International, sent to Anvisa on Friday (23/7). In the statement, Bharat informs that the company Necessidade Comercializacao de Medicamentos Ltda is no longer authorized to represent Bharat in Brazil, which in Anvisa’s assessment makes it impossible to carry out the study. Bharat is the manufacturer of the Cova
Requirements will be fulfilled : Bharat Biotech after Brazil denies certificate to Covaxin facility BusinessToday.In © India Today Group Requirements will be fulfilled : Bharat Biotech after Brazil denies certificate to Covaxin facility
Bharat Biotech has said that they will fulfill the requirements that have been pointed out by the Brazil national regulatory agency (NRA) after it refused to grant a certification of good manufacturing practices (GMP). Brazil NRA refused to grant the GMP citing non-compliance with necessary standards. The company said that Brazil s coronavirus vaccine order of 20 million is still intact. The requirements pointed out during inspection will be fulfilled, the timelines for fulfillment is under discussion with the Brazil NRA and will be resolved soon. The 20 million dose order from the Brazilian Govt is still active. The agreement with Precisa Medicamentos is based on a long term partnership and will continue, said a Bharat B