Agila Specialties (Agila), the injectables unit of Strides Arcolab Ltd (Strides), has announced that it has received the USFDA approval for its Polish sterile facility.
According to a company release, the facility located in Warsaw, Poland, manufactures vials, ampoules, pre-filled syringes and lyophilised injections.
With this approval, all eight global sterile injectable sites of Agila are now approved by the USFDA and European authorities and places Agila among the largest global capacities for sterile injectables.
Shipments from the Polish facility will commence within the fourth quarter of 2012 and will run in full capacity by the first quarter of 2013, as product transfers have already commenced.
Commenting on the event, Venkat Iyer, CEO, Agila Specialties, said: “This approval for our Polish sterile facility offers significant flexibility to our manufacturing which is currently experiencing strong demand on a worldwide basis”.