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