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Bangalore-based drug company Strides Arcolab said the US FDA had approved its new sterile injectable facility at Bangalore. This would scale up nearly five-fold the overall injectables capacity meant for the US market and also speed up commercialisation of the approved injectable new drug applications in that country, the company said. Two products made at the facility were recently approved for the US market.
The plant manufactures lyophilised (freeze dried), liquid and dry powder injectables. Mr Venkat Iyer, CEO of Agila Specialties, the subsidiary focussing on steriles, said, “The US FDA approval for the new facility endorses the strong regulatory compliance processes in place. This is an important milestone in establishing Strides as one of the largest global injectable players.” Agila focuses on cancer drugs, penems, penicillins, cephalosporins, ophthalmics, peptides and biosimilars.
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