Strides Arcolab gets USFDA approval to sell transplant drug

NEW DELHI: Pharmaceutical firm Strides Arcolab has received the regulatory approval to market Tacrolimus capsules in the US market.

The capsule is an immuno-suppressant used for preventing organ rejection in certain patients following liver, kidney, or heart transplant.

The company has been allowed by United States Food and Drug Administration (USFDA) to sell Tacrolimus capsules in the strengths of 0.5 mg, 1 mg and 5 mg, Strides Arcolab said in a BSE filing.

The US market for generic Tacrolimus is approximately USD 676 million, the company said, citing IMS data.

"The product will be manufactured at the company's oral dosage facility at Bangalore and marketed directly by Strides in the US market," the company said in a statement.

Strides Arcolab's shares were trading 0.62 per cent down at Rs 670 apiece during afternoon trade on the BSE.