Recipharm manufacturing site in France approved by Japanese drug
19 April 2013
Recipharm’s solid dose facility located in Fontaine,
France, has been approved for supply of manufactured products to the
Japan’s pharmaceuticals market following a recent inspection by the
PMDA, the Japanese drug agency.
The product dossier was presented by an existing contract
manufacturing customer, also securing regulatory approval for its
supply to Japan.
The Fontaine site is one of Recipharm’s solid dose forms site and
until 2009 was owned by Solvay Pharma (now Abbott). The facility is
also approved to supply to the US. In addition to manufacturing, the
site also has a distribution centre for delivery to pharmacy level
Stéphane Guisado, Recipharm Fontaine´s General Manager,
commented, “Supplying products to Japan involves carrying out a
substantial number of additional activities and meeting stringent
requirements for enhanced quality control and we have met these
challenges head on. We were also able to draw upon experience from
other Recipharm sites which are already supplying this key market.
As a result of this approval, we are now in a good position to
further support other customers with their plans to penetrate and
expand sales in specific pharmaceutical markets within Japan.”