Intercell Receives Manufacturer's Licence for Future Commercial Manufacturing of its Vaccine Against Japanese Encephalitis
Intercell receives Manufacturer's Licence for its site in Livingston, Scotland
Intercell AG announced that its fully owned manufacturing site in Livingston, Scotland (Intercell Biomedical Ltd.), has been granted the Manufacturer's Licence for the commercial manufacturing of its vaccine against Japanese encephalitis. The issuance of the license is following a GMP (Good Manufacturing Practice) inspection performed by the Medicines and Healthcare products Regulatory Agency (MHRA).
The Manufacturer's Licence is required to support the Marketing Authorization Application (MAA) process in Europe which is being coordinated by the European Medicines Agency (EMEA) and represents the basis for future product release and export to the US.
The issuance of the Commercial Manufacturer's Licence is a key achievement on Intercell´s path to bringing our new investigational Japanese Encephalitis vaccine onto the market and should allow us to produce a sufficient launch stock for product approvals in the respective locations, states Gerd Zettlmeissl, Intercell´s Chief Executive Officer.
Intercell expects the preapproval inspection by the US FDA (Food and Drug Administration) in support of the US licensure process within the forthcoming months.
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