Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Ltd has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets, the company said in a filing to the BSE.
"Glenmark will commence distribution of the product immediately," it added.
The approval is for the 20 mg, 40 mg and 80 mg tablets.
Telmisartan tablets are Glenmark's generic version of Boehringer Ingelheim's Micardis. Telmisartan is indicated for the treatment of hypertension.
For the 12-month period ended March 2014, Telmisartan garnered annual sales of USD 250 million, according to IMS Health, the company said.
Glenmark's current portfolio consists of 92 products authorised for distribution in the US market and 73 ANDAs are pending approval with the USFDA.
Shares of Glenmark Pharmaceuticals were trading at Rs 595.60 per scrip in the mid-day trade, up 1.09 per cent from the previous close on the BSE.