Strides receives US FDA approval for Polish sterile facility
Agila Specialties (Agila), injectables unit of global pharmaceutical company Strides Arcolab Limited (Strides) on Thursday announced that it has received US FDA approval for its Polish sterile facility.
This state-of-the-art facility located in Warsaw, Poland, manufactures vials, ampoules, pre-filled syringes and lyophilized injections.
With this approval all eight global sterile injectable sites of Agila are now approved by the US FDA and EU authorities and places Agila amongst the largest global capacities for sterile injectables.
Shipments from the Polish facility will commence within Q4' 2012 and will run in full capacity by Q1' 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".
Strides Arcolab develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.