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Glenmark Shares Rise After US Approval Of Seasonale Copy

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The shares of Mumbai-based drugmaker Glenmark Pharmaceuticals witnessed a sudden jump in Monday's trade on the BSE after it received marketing approval from the US Food and Drug Administration for its generic equivalent of Seasonale, one of the most used oral contraceptives owned by the world's largest generic drugmaker Teva Pharmaceuticals Industries.
 
The stock at Rs 893.10 was up 1.55 per cent from the Friday closing of Rs 880 a unit  in the in the morning trade at 10.50 am on the BSE. The benchmark Sensex was up 0.54 per cent to 26,566.96 points.
 
Glenmark's generic tablet - a combination of levonorgestrel and ethinyl estradiol is an extended-cycle oral contraceptive and an AB-rated copy of Seasonale.
 
This drug combination is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception, and according to drug market researcher IMS Health, Teva's Seasonale had sales of some $54 million in 12 months ended April, 2015 in the US.
 
The new generic drug approval marks Glenmark's 12th oral contraceptive and second extended-cycle oral contraceptive authorized for distribution by the US drug regulator in that market.
 
Glenmark plans to commence shipping of this tablets (levonorgestrel/ethinyl estradiol) immediately to the US distributors, the company said on Monday.
 
Glenmark's current portfolio in the US consists of 99 products authorised for distribution in the market and 66 generic applications pending approval with the regulator.
 
In addition to these internal filings, Glenmark also continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing product pipeline and portfolio.
 
GlenSaldanah-led Glenmark Pharma is one of the research-driven integrated pharmaceutical company in India and is currently ranked among the top 80 pharmaceuticals and biotech companies of the world in terms of revenues.
 
The company, which also follows a business model of licensing early stage research molecules to big global drug makers, is one of the leading players in the new chemical and biological entities discovery business.
 
It has several molecules in various stages of clinical development and is primarily focused in the areas of inflammation, asthma, COPD, rheumatoid arthritis and pain management among others.
 
With a significant presence in branded generics markets across emerging economies including India, Glenmark operates 14 manufacturing facilities 6 research and development centres across the globe.