New Delhi: Drug maker Strides Arcolab on Monday said it has received approval from the US health regulator for its new facility in Bangalore.
The company has received 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).
“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,” Agila Specialties CEO Venkat Iyer said.
The company’s newly established facility manufactures lyophilized, 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 firm recently received USFDA nod for two of its products from the same facility.
According to the company, the approval for facility would help fast track commercialization of all approved injectable ANDA’s 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.
Shares of Strides Arcolab were today trading at Rs372 on the Bombay Stock Exchange (BSE) in the late afternoon trade, down 4.79% from its previous close.