The product dossier was presented by one of Recipharm’s contract manufacturing customers, which also secured regulatory approval for its supply to Japan.
The Fontaine plant, which employs 190 people, is one of Recipharm’s solid dose forms facilities 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 has a logistics and packaging centre.
Recipharm now supplies products to the Japanese, US, and European markets from a number of European facilities.
The Stockholm, Sweden-based firm says the development marks a significant step forward in its international expansion.
Stéphane Guisado, Recipharm Fontaine´s General Manager, said: ‘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.’