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Aurobindo Pharma gains on bagging USFDA approval for asthma drug

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Capital Market
Last Updated : Aug 06 2013 | 9:32 AM IST

Aurobindo Pharma rose 1.15% at Rs 114.75 at 11:02 IST on BSE after the company received final approval from the US drug regulator to sell generic Singulair tablets, used for treating asthma and allergies, in the US market.

The announcement was made during trading hours today, 6 August 2012.

Meanwhile, the BSE Sensex was up 226.05 points, or 1.31%, to 17,423.98.

On BSE, 70,000 shares were traded in the counter as against an average daily volume of 1.26 lakh shares in the past one quarter.

The stock hit a high of Rs 115 and a low of Rs 112.55 so far during the day. The stock had hit a 52-week high of Rs 163.60 on 5 August 2011. The stock had hit a 52-week low of Rs 80.35 on 18 November 2011.

The stock had underperformed the market over the past one month until 3 August 2012, falling 2.53% compared with the Sensex's 1.31% fall. The scrip had also underperformed the market in past one quarter, sliding 9.02% as against 0.27% rise in the Sensex.

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The small-cap pharmaceutical company has an equity capital of Rs 29.11 crore. Face value per share is Re 1.

Aurobindo Pharma said it received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Montelukast Sodium Tablets 10 milligram (mg) and Montelukast Sodium Chewable Tablets 4 mg and 5 mg. The products are ready for a first-day launch.

Montelukast Sodium Tablets 10 mg and Chewable Tablets 4 mg and 5 mg are the generic equivalent of Merck & Co. Inc's Singulair Tablets 10 mg and Chewable Tablets 4 mg and 5 mg respectively.

Montelukast sodium is indicated for prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. It is also used in preventing exercise-induced broncho-constriction in patients 15 years of age and older. Further, it is used in relieving symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older).

The annual sales of Montelukast Sodium Tablets 10 mg is approximately $3.5 billion and that of Montelukast Sodium Chewable Tablets is $1.1 billion for the twelve months ending March 2012, according to IMS.

The products have been approved out of Unit VII (special economic zone) formulations facility in Hyderabad, India. Aurobindo now has a total of 157 abbreviated new drug application (ANDA) approvals (131 final approvals including 1 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA.

Aurobindo Pharma's consolidated net profit fell 13.6% to Rs 108 crore on 2.5% growth in net sales to Rs 1170.75 crore in Q4 March 2012 over Q4 March 2011. The company will announce Q1 results on Tuesday, 7 August 2012.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company's robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, astroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up. The company is marketing these products globally, in over 125 countries.

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First Published: Aug 06 2012 | 11:05 AM IST

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