Approval

CanSino Receives GMP Certificate For Convidecia™ COVID-19 Vaccine

September 18,2021 09:36 AM
- By Admin

CanSino Biologics Inc has announced that its recombinant novel coronavirus vaccine, (Adenovirus Type 5 Vector) (‘Ad5-nCoV’, trade name: Convidecia™), has been granted a good manufacturing practice (GMP) 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 recognises that CanSinoBIO's manufacturing facilities and quality control system comply with the high production standards and guidelines required by the European Union (EU). The EU GMP certification is required to import COVID-19 vaccines into the European Union and is regarded as a recognition of leading industry standards by many authorities outside of the EU. This certification signifies CanSinoBIO's readiness to enter more markets in Europe and globally.

CanSinoBIO opened a new vaccine production site in Tianjin, China, with the expectation to produce over 200 million doses of Convidecia™ per annum. It will continue to expand its manufacturing capacity by collaborating with other top-tier pharmaceutical companies in China, including Shanghai Pharmaceuticals Holding Co, Ltd, to better meet the 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, marking another milestone in bringing more acceptable, affordable, timely and mass immune protection to the global population and reducing the burden placed on healthcare systems and medial workers