Strides arm gets US FDA nod for sterile injectables facility in Poland

Agila Specialties (Agila), an injectables business unit of Bangalore-based pharma company Strides Arcolab Limited has received US FDA approval for its Polish Sterile facility located in Warswa, Poland. The unit 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 EU authorities and places Agila amongst the largest global capacities for sterile injectables.

The company will commence shipments from the Polish facility by the fourth quarter of 2012 and will run in full capacity by the first quarter of 2013 as product transfers have already commenced.

"This approval for our Polish sterile facility offers significant flexibility to our manufacturing which is currently experiencing strong demand on a worldwide basis," Venkat Iyer, CEO, Agila Specialties said.

Agila focusses on key domains such as oncolytics, penems, penicillins, cephalosporins, opthalmics, peptides and biosimilars. It operats from nine global manufacturing facilities, including India.