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Glenmark Pharma gets USFDA nod for drug for patients on dialysis

Press Trust of India  |  New Delhi 

Monday said it has received final approval from the US health regulator for Hydrochloride tablets, used to control serum phosphorus in patients with disease on

The approved product is a generic version of Genzyme Corporation's tablets.

"Inc, USA (Glenmark) has been granted final approval by the Food and Drug Administration (USFDA) for Hydrochloride tablets in the strengths of 400 mg and 800 mg," the company said in a BSE filing.

For the 12 months to December 2018, tablets market achieved annual sales of approximately USD 102.1 million, Glenmark said, citing IQVIA sales data.

The company's current portfolio consists of 149 products authorised for distribution at the US marketplace and 53 Abbreviated New Drug Applications (ANDAs) pending approval with the

The company's stock was trading at Rs 604.25, down 1.66 per cent, on BSE.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, February 11 2019. 12:30 IST