Unichem Lab Gets USFDA Nod for Hypertension Drug

NEW DELHI: Unichem Laboratories  has received final approval from the US health regulator to market generic Irbesartan tablets, used in treating hypertension, in the American market.

The company has received final abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Irbesartan tablets, Unichem Laboratories said in a filing to the BSE.

The tablets are therapeutically equivalent to Sanofi- -aventis's Avapro tablets, which are indicated for the treatment of hypertension. It is also used for the treatment of diabetic nephropathy. "The product would be commercialised from Unichem's Ghaziabad plant. Active Pharmaceutical Ingredient (API) for the product would also made in-house at Pithampur plant," the company said.

Unichem stock was trading at Rs 283.70, up 2.94 percent, on BSE. Unichem Labs stock price On December 08, 2015, at 15:44 hrs Unichem Laboratories was quoting at 282.05, up 6.45, or 2.34 percent. The 52-week high of the share was 334.00 and the 52-week low was 174.00.

The company's trailing 12-month (TTM) EPS was at 7.02 per share as per the quarter ended September 2015. The stock's price-to-earnings (P/E) ratio was 40.18. The latest book value of the company is 104.29 per share. At current value, the price-to-book value of the company is 2.70.
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