Pharming receives FDA approval of new facility for expansion of RUCONEST® production
Pharming Group N.V. today announced it has also received US Food and Drug Administration (FDA) approval of Pharming’s Prior Approval Supplement to add the new Netherlands production facility of starting material to the Biologics License Application (BLA) to support its lead product, RUCONEST®.
- New production site for starting material will significantly increase production capacity of RUCONEST®
- Product manufactured with material from the new site during the approval process is now also immediately available for distribution within the USA.
''Following on from the EMA approval announced earlier this year in January, this gives us sufficient capacity for current demands as we continue to build for the future.''- Sijmen de Vries - CEO
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