Glenmark Pharma gains after receiving tentative approval from USFDA for drug

Glenmark Pharmaceuticals rose 1.04% to Rs 827 at 11:20 IST on BSE after the company said its US arm has been granted tentative approval by the United States Food & Drug Administration for a generic drug.

The announcement was made before market hours today, 29 April 2016.

Meanwhile, the BSE Sensex was up 49.95 points, or 0.2%, to 25,657.63.

On BSE, so far 14,375 shares were traded in the counter, compared with an average volume of 53,445 shares in the past two weeks. The stock hit a high of Rs 833.95 and a low of Rs 820.05 so far during the day. The stock hit a record high of Rs 1,261.95 on 21 August 2015. The stock hit a 52-week low of Rs 671.50 on 12 February 2016. The stock had underperformed the market over the past one month till 28 April 2016, dropping 0.09% compared with Sensex's 2.55% gains. The scrip had, however, outperformed the market in past one quarter, gaining 9.02% as against Sensex's 4.63% gains.

The large-cap company has an equity capital of Rs 28.22 crore. Face value per share is Re 1.

Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, the generic version of Epiduo Gel of Galderma Laboratories L.P.

According to IMS Health sales data for the 12 month period ending February 2016, the Epiduo Gel market achieved annual sales of approximately $351.8 million in the US.

Glenmark's current portfolio consists of 112 products authorized for distribution in the US marketplace and 58 Abbreviated New Drug Application (ANDA)'s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

On a consolidated basis, Glenmark Pharmaceuticals' net profit rose 48.1% to Rs 169.95 crore on 1.9% growth in net sales to Rs 1724.46 crore in Q3 December 2015 over Q3 December 2014.

Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation (asthma/COPD, rheumatoid arthritis etc.) and pain (neuropathic pain and inflammatory pain).

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