Swedish CDMO Recipharm has been cleared by French regulators to fill biotech drug products at its site in Tours.
The contract development and manufacturing organisation announced it has been approved by the Agence Nationale de securite du medicament (ANSM) to fill drug products into glass vials at the facility earlier this week, adding that it can expand and diversify its combined offering.
The Tours site employs 200 personnel and houses three filling lines, two large capacity lines for glass vials for injectable products and a third aseptic line that fills cartridges.
Michel Saudemon, General Manager at Recipharm Monts, commented: “We are delighted to have the opportunity to expand our sterile product manufacturing services with the authorised capability to fill biotech products.”
He added: “This regulatory approval, coming at a time when we have already set in place a programme of strategic expansion at the Monts site with the installation of a new service line, will serve to increase the range of sterile product manufacturing services that we can offer to the markets.”
The news follows just a few months after Recipharm announced plans to install a new vials line at the site.
In June the firm said it will spend €600,000 in new filling capacity, including a ‘state of the art’ integrated Dara cartridge filling machine for injectable drugs at its facility, which it claimed can fill and close as many as 7200 units per hour without causing particulate release.
At the time Saudemon, general manager of the plant, said: “Whilst we have for many years filled cartridges in Monts,this new machine allows us to offer a wider client base access to this capability. This should not only reduce lead times but also increase reliability and flexibility."