CDMO's Fontaine Site Receives Approval for Supply of Manufactured Products to Japan

Recipharm’s solid dose facility 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 sites 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 within France.  

As a consequence of this latest regulatory approval, Recipharm now supplies an extensive range of products to the Japanese, the US and European markets from a number of it’s facilities located in Europe. Indeed, the development marks a further significant step forward in the company’s international drive to access and expand its reach into a multitude of key geographic regions and countries.    

Stéphane Guisado, Recipharm Fontaine´s General Manager, commented: “We are very pleased to have secured this approval. 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 that 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.”

Recipharm AB, +46 8 602 52 00, info@recipharm.com, www.recipharm.com.