Strides Arcolab Limited has received US FDA approval for its new sterile injectable facility at Bangalore.
The company had recently announced specific approval for two products from this facility and this approval is for the entire facility. This would facilitate fast track commercialization of all approved injectable ANDAs in the US market.
This state-of-the-art facility manufactures lyophilized, liquid and dry powder injectables. With this approval, the overall injectable capacity for the US market will scale up by approximately five-fold and significantly enhance growth opportunities for Strides.
According to Venkat Iyer, CEO, Agila Specialties, “the US FDA approval for the new facility endorses the strong regulatory compliance processes in place. Further, this is an important milestone in establishing Strides as one of the largest global injectable players.”
Agila Specialties Private Limited is the specialties unit of Strides Arcolab which was spun off as a separate division post the company’s restructuring in 2009. It is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from 7 world class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world.