Strides Arcolab Ltd (Strides) has said that it has received the US Food & Drug Administration (USFDA) nod for Tacrolimus capsules, an immunosuppressant prescribed to prevent organ rejection in patients who have undergone organ transplant surgery.
The generic medicin will be produced at Strides' Bangalore facility.
In a filing with the stock exchanges, Strides said that it had got the approval from USFDA for Tacrolimus capsules USP 0.5 mg, 1 mg and 5 mg.
According to IMS data, the US market for generic Tacrolimus was around $676 million as on September 2013. The company would produce the capsule at its oral dosage facility at Bangalore and would market the drug directly in the US.
Strides said the capsule was an immunosuppressant prescribed to prevent organ rejection in certain patients after liver, kidney or heart transplant and may be used along with other medicines. It prevents the body from rejecting transplanted organs by blocking the action of some blood cells.
Shares of Strides were trading at Rs 685.45, a gain of Rs 11.45, on the NSE.