Strides Arcolab (Strides) today said it has received USFDA approval for its Brazilian plant that produces sterile dry powder anti-biotic injectables.
"The approval is also the first USFDA approval for an international facility of Strides," the company said in a statement.
The plant has already been approved by other international regulatory agencies like MHRA and ANVISA and with this approval the company is in a position to commercialise products worldwide in the second half of 2012, it added.
Commenting on the development, Agila Specialties (specialties unit of Strides Arcolab) CEO Venkat Iyer said: "This approval for our Brazilian sterile penems manufacturing facility in the niche domain is another milestone in positioning Agila as a leading global injectable player."
Shares of Strides Arcolab were trading at Rs 524 in the afternoon trade, down 3.85% from the previous close on the BSE.