Pharming Receives EMA Approval of New Facility for Expansion of RUCONEST® Production

LEIDEN, Netherlands, Jan. 21, 2020 /PRNewswire/ --Highlights:

New production facility will significantly increase production capacity of RUCONESTA®

Product manufactured at the new facility during the approval process is now available for distribution within the EU

Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced it has received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for the Company's lead product, RUCONESTA®. With the addition of this new facility, Pharming will significantly increase the production capacity of RUCONESTA® as it becomes fully operational over the coming year. Pharming is now also able to release the product that was manufactured at the facility during the approval process for commercialisationA in the EU. As previously announced, Pharming had identified a potential risk of short-term pressure on the supply of RUCONESTA® for the European market due to increasing demand for the product. With the approval of this new facility, the Company believes the risk to supply is now greatly reduced.The new facility's post-approval supplement (PAS) for the distribution of RUCONESTA® in the US is still under review by the Food and Drug Administration (FDA). Approval of the new facility for distribution in the US is expected in H1 2020.
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