Aurobindo Pharma gains after receiving USFDA approval for anti-infective drug

Aurobindo Pharma rose 0.49% to Rs 756.85 at 12:30 IST on BSE after the company announced that it has received final approval from the US Food & Drug Administration to manufacture and market Polymyxin B for Injection USP, 5 lakh units/vial.

The announcement was made during market hours today, 5 April 2016.

Meanwhile, the S&P BSE Sensex was down 362.23 points or 1.43% at 25,037.42.

On BSE, so far 1.09 lakh shares were traded in the counter as against average daily volume of 2.2 lakh shares in the past one quarter. The stock hit high of Rs 767 and low of Rs 742.15 so far during the day. The stock had hit a record high of Rs 891.50 on 30 December 2015. The stock had hit a 52-week low of Rs 582 on 25 February 2016. The stock had outperformed the market over the past one month till 4 April 2016, gaining 7.36% compared with Sensex's 3.06% rise. The scrip had, however, underperformed the market in past one quarter, dropping 10.86% as against Sensex's 0.87% fall.

The large-cap company has equity capital of Rs 58.52 crore. Face value per share is Rs 1.

Aurobindo Pharma said that the product is expected to be launched in Q2 September 2016. The approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Polymyxin B for Injection USP, 5 lakh units/vial of Eurohealth International Sarl.

Polymyxin B for Injection is an anti-infective used in the treatment of infections of the urinary tract, meninges, bloodstream and eye caused by susceptible strains of Pseudomonas aeruginosa. The approved product has an estimated market size of $7.6 million in the United States for the twelve months ended February 2016 according to IMS.

Aurobindo Pharma's consolidated net profit rose 39.2% to Rs 534.95 crore on 9.2% growth in net sales to Rs 3432.08 crore in Q3 December 2015 over Q3 December 2014.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's robust product portfolio is spread over 7 major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, anti-allergies and anti-diabetics. The company is marketing these products globally, in over 150 countries.

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