12 September 2013 | News | By BioSpectrum Bureau
Eisai gets US FDA nod to supply epilepsy drug Fycompa (perampanel) from its Hatfield site in UK to the US
Singapore: Japan-based Eisai recieved US FDA approval for the US supply of the epilepsy drug Fycompa (perampanel) from its EMEA (Europe, Middle East, Africa, Russia and Oceania) Knowledge Center, which is based in Hatfield, UK. The Hatfield site will manufacture six different strengths of tablet for export to the US.
The FDA supply approval for perampanel is the latest in a series of achievements for Eisai in the UK. In addition to its existing EMEA sales and marketing, R&D, and manufacturing operations in Hatfield.
Eisai recently announced the construction of a new 2,900 square-meter facility for the global packaging of potent compounds. This will expand the current 7,800 square-meter Hatfield site by nearly 40 percent.
Mr Gary Hendler, president and CEO, Eisai EMEA, said that, "The FDA approval for the supply of our epilepsy drug perampanel is testament to the commitment we have made at our EMEA Knowledge Center and the Hatfield manufacturing facility."
He added, "The UK is a competitive location for advanced manufacturing and packaging and I am delighted that we are now able to export products developed and manufactured here in the UK, to the US."