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The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.
The European Medicines Agency (EMA) announced on July 2, 2021, that the agency’s committee for human medicines (CHMP) has approved scale-up of API manufacturing at the Janssen Biologics B.V. plant located in Leiden, the Netherlands. The plant produces all API for Janssen’s COVID-19 vaccine supply in the European Union and is expected to continue to supply the vaccine for the EU.
The scale up of the facility includes a new building, new equipment, and additional process optimizations. The approved modifications are anticipated to increase API manufacturing capacity. EMA states that the recommendation does not require a decision from the European Commission; therefore, the new building can immediately become operational.