Strides gets USFDA approval for its transplant drug

Pharmaceutical firm Strides Arcolab has received the regulatory approval to market Tacrolimus capsules in the US market

approval

product will be manufactured at the company's oral dosage facility at Bangalore

Strides Arcolab has announced that it has received approval from the United States Food and Drug Administration (USFDA) for the marketing of Tacrolimus capsules. The capsule is an immuno-suppressant used for preventing organ rejection following liver, kidney, or heart transplant.

"We have received approval from the USFDA for Tacrolimus capsules USP, 0.5 mg, 1 mg, and 5 mg and (they) will be launched immediately," the company informed.

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

According to IMS data as on September 2013, the US market for generic Tacrolimus is approximately $676 million.

 

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