Glenmark Pharma gets USFDA nod for Tacrolimus capsules

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Drug major Glenmark Pharma on Wednesday said it has received final approval from the US health regulator for Tacrolimus capsules, used as immuno-suppressant.

The approved product is a generic version of Prograf Capsules of Astellas Pharm US, Inc.

Tacrolimus capsule is an immunosuppressant and is used for preventing organ rejection in certain patients following liver, kidney, or heart transplant.

Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Tacrolimus Capsules USP in the strengths of 0.5 mg, 1 mg and 5 mg, Glenmark said in a regulatory filing.

Quoting IQVIA sales data for the 12 months ending September 2020, Glenmark said the Prograf Capsules, 0.5 mg, 1 mg and 5 mg market achieved annual sales of approximately USD 286.8 million.

Glenmark said current portfolio consists of 166 products authorised for distribution in the US marketplace and 45 abbreviated new drug applications are pending approval with the USFDA.

Shares of Glenmark Pharma were trading at Rs 479 per scrip on the BSE, up 0.94 per cent over the previous close.