Aurobindo Pharma inches up after USFDA nod for a drug

Aurobindo Pharma rose 0.49% to Rs 773.90 at 12:55 IST on BSE after the company said it has received final approval from the US Food and Drug Administration to manufacture and market Linezolid injection, 600 mg/300 ml.

The announcement was made during market hours today, 8 August 2016.

Meanwhile, the S&P BSE Sensex was up 82.63 points or 0.29% at 28,160.98.

On BSE, so far 1.14 lakh shares were traded in the counter as against average daily volume of 1.24 lakh shares in the past one quarter. The stock hit a high of Rs 781.90 and a low of Rs 768 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 underperformed the market over the past one month till 5 August 2016, advancing 0.12% compared with 3.36% rise in the Sensex. The scrip had also underperformed the market in past one quarter, declining 4.36% as against Sensex's 11.15% rise.

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

Aurobindo Pharma expects to launch the product in the current quarter (Q2 September 2016). The approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zyvox Injection, 600 mg/300 mL (2 mg/mL), of Pharmacia & Upjohn Company (Pharmacia). Linezolid Injection is an anti-infective used to treat infections caused by susceptible Gram-positivebacteria in some specific conditions. The approved product has an estimated market size of $87 million in the US for the twelve months ended June 2016 according to IMS.

On consolidated basis, Aurobindo Pharma's net profit rose 39.4% to Rs 562.85 crore on 16.9% growth in net sales to Rs 3674.70 crore in Q4 March 2016 over Q4 March 2015.

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, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. 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, supported by an outstanding R&D set-up. The company is marketing these products globally, in over 150 countries.

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