contractpharmaMay 25, 2021
Tag: CanSino , OGYÉI , GMP , Convidecia
CanSino Biologics Recombinant Novel Coronavirus Vaccine, (Adenovirus Type 5 Vector, trade name Convidecia), has been granted a Good Manufacturing Practice certificate by the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI). The certification was issued on May 21, 2021 after a thorough inspection of CanSinoBIO's production of Convidecia™.
The GMP certificate recognizes that CanSinoBIO's manufacturing facilities and quality control system comply with production standards and guidelines required by the EU. The certification is required to import COVID-19 vaccines into the EU and signifies CanSinoBIO's readiness to enter more markets in Europe and globally.
"We are pleased to receive the GMP certificate by the European Union, which is a testament to our capability to safely and reliably produce COVID-19 vaccines when many countries around the world are still in desperate need of mass protection from this pandemic. We will continue to support the supply of COVID-19 vaccines to China and other markets and contribute to the global fight against the pandemic by protecting more people's lives," said Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO.
CanSinoBIO opened a new vaccine production site in Tianjin, China, with the expectation to produce over 200 million doses of Convidecia per year. It will continue to expand its manufacturing capacity by collaborating with other pharma companies in China, including Shanghai Pharmaceuticals, to help meet growing global demand.
In March 2021, CanSinoBIO started the phase I clinical trial of an inhaled version of Convidecia immediately after receiving the approval from the National Medical Products Administration of China.
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