Mumbai: Glenmark Generics Inc, USA, a subsidiary of Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan tablets, indicated for the treatment of hypertension. Glenmark is to commence distribution of the product immediately.
Telmisartan tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis. The approval is for the 20 mg, 40 mg and 80 mg tablets. For the 12-month period ended March 31, 2014, Telmisartan garnered annual sales of $250 million, according to IMS Health.
Glenmark’s current portfolio consists of 92 products authorised for distribution in the US market and 73 ANDAs pending approval with the USFDA. In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.
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.
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