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Drug maker Strides Arcolab has received approval from the US health regulator for its new facility in Bangalore.
The company has received the US Food and Drug Administration (USFDA) approval for its new sterile injectable facility, Strides Arcolab said in a filing to the Bombay Stock Exchange (BSE) today.
“The USFDA 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,” the Agila Specialties CEO, Mr Venkat Iyer, said.
The company’s newly established facility manufactures lyophilised, liquid and dry powder injectables.
“With this approval, the overall injectable capacity of for the US market will scale up by nearly five-fold and significantly enhance growth opportunities for Strides,” the company said.
The company recently received USFDA nod for two of its products from the same facility. According to the company, the approval for the facility would help in fast track commercialisation of all approved injectable ANDAs in the US market.
Agila Specialties is the specialities unit of Strides Arcolab which was spun off as a separate division post the company’s restructuring in 2009.
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