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Glenmark Pharma gains after USFDA approval for oral contraceptive drug

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Glenmark Pharmaceuticals rose 1.15% to Rs 890.10 at 9:47 IST on BSE after the company said it received US drug regulator's approval for an extended-cycle oral contraceptive drug in the US market.

The announcement was made before trading hours today, 15 June 2015.

Meanwhile, the BSE Sensex was up 163.01 points, or 0.62%, to 26,588.31.

On BSE, so far 18,000 shares were traded in the counter, compared with an average volume of 1.04 lakh shares in the past one quarter.

The stock hit a high of Rs 893.90 and a low of Rs 881.30 so far during the day. The stock hit a record high of Rs 940 on 15 April 2015. The stock hit a 52-week low of Rs 532 on 11 July 2014.

 

The stock had outperformed the market over the past one month till 12 June 2015, rising 1.14% compared with 1.68% fall in the Sensex. The scrip had also outperformed the market in past one quarter, rising 5.07% as against Sensex's 8.66% fall.

The large-cap company has an equity capital of Rs 28.21 crore. Face value per share is Rs 1.

Glenmark Pharmaceuticals announced that its US-based unit, Glenmark Pharmaceuticals Inc., USA, was granted final approval by the United States Food & Drug Administration (USFDA) for the extended-cycle oral contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, the AB-rated generic version of Seasonale by Teva Women's Health.

Seasonale is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. According to IMS Health sales data for the 12 month period ending April 2015, the Seasonale market achieved annual sales of approximately $53.7 million in the US, Glenmark Pharmaceuticals said in a statement.

Latest approval marks Glenmark's 12th oral contraceptive and 2nd extended-cycle oral contraceptive authorized for distribution by the USFDA. Glenmark said it plans to commence shipping of Levonorgestrel/Ethinyl Estradiol Tablets, 0.15 mg/0.03 mg immediately. Glenmark's current portfolio consists of 99 products authorized for distribution in the US marketplace and 66 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, the company said.

On a consolidated basis, Glenmark Pharmaceuticals' net profit declined 75.4% to Rs 10.61 crore on 5% rise in total income to Rs 1776.14 crore in Q4 March 2015 over Q4 March 2014.

Glenmark Pharmaceuticals (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenues. (SCRIP 100 Rankings published in the year 2014). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). 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]. The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has 14 manufacturing facilities in four countries and has six R&D centers.

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First Published: Jun 15 2015 | 9:40 AM IST

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