Glenmark Generics Inc, the US-based subsidiary of Glenmark Generics Limited, has been granted final abbreviated new drug approval (ANDA) from the US Food and Drug Administration (USFDA) for telmisartan tablets in the strength of 20 mg, 40 mg and 80 mg. Following the approval, Glenmark will commence distribution of the product immediately.
Telmisartan tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis. For the 12 month period ending March 2014, telmisartan, which is indicated for the treatment of hypertension, garnered annual sales of $ 250 million, according to IMS Health.
Glenmark’s current portfolio consists of 92 products authorised for distribution in the US marketplace and 73 ANDA’s pending approval with the USFDA.