FDA approves Pharming's new facility for expanded Ruconest production
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Netherlands-based specialty pharmaceutical company Pharming has received US Food and Drug Administration (FDA) approval for its new biologics facility in the Netherlands which it says will ensure sufficient manufacturing capacity for its acute hereditary angioedema treatment, Ruconest.
Pharming chief executive, Sijmen de Vries, said the new facility will help to support the "increasing demand" for its lead product, Ruconest in both the US and European markets.
"Following on from the European Medicines Agency approval announced earlier this year in January, this gives us sufficient capacity for current demands as we continue to build for the future," he added.
With this approval, Pharming will be able to release product that is manufactured with starting material from the facility for sale in the US.
Earlier this year, the facility was approved by the EMA. To date, Ruconest is approved in the US, Israel, South Korea, and all 28 EU countries plus Norway, Iceland and Liechtenstein.
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