Glenmark gets USFDA nod for potassium chloride tablets
New Delhi : Glenmark Pharmaceuticals has received final approval from the US health regulator for Potassium Chloride Extended Release Tablets, used in treating low levels of potassium in blood.
"Glenmark Pharmaceuticals Inc, USA has been granted final approval by the US Food and Drug Administration (USFDA) for Potassium Chloride Extended Release Tablets USP, 10 mEq (750 mg) and 20 mEq (1500mg)," it said in a BSE filing.
The tablet is a generic version of K-Dur extended release tablets of Merck Sharp and Dohme Corp.
As per IMS data, K-Dur achieved annual sales of around USD 283.2 million for the 12 months period ended May 2016.
Company's current portfolio consists of 117 products authorised for distribution in the US marketplace and 61 ANDA pending approval with the USFDA.
Shares of Glenmark Pharmaceuticals were trading 0.32 per cent up, at Rs 845.80 in the morning trade on BSE.