Aurobindo Pharma gains after receiving final approval from USFDA for drug

Aurobindo Pharma rose 0.13% to Rs 787.10 at 12:15 IST on BSE after the company received final approval from United States Food & Drug Administration to manufacture and market Bupivacaine Hydrochloride Injection.

The announcement was made during market hours today, 16 May 2016.

Meanwhile, the BSE Sensex was down 82.56 points, or 0.32%, to 25,408.70.

On BSE, so far 33,349 shares were traded in the counter, compared with an average volume of 1.98 lakh shares in the past one quarter. The stock hit a high of Rs 799.10 and a low of Rs 785 so far during the day. The stock hit a record high of Rs 891.50 on 30 December 2015. The stock hit a 52-week low of Rs 582 on 25 February 2016. The stock had outperformed the market over the past one month till 13 May 2016, gaining 0.34% compared with 0.54% decline in the Sensex. The scrip had also outperformed the market in past one quarter, rising 19.17% as against Sensex's 10.89% gains.

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

Aurobindo Pharma said that Bupivacaine Hydrochloride Injection USP, 0.25% (2.5 mg/mL) and 0.5% (5 mg/mL) multiple dose vials is expected to be launched in Q2 September 2016. Bupivacaine Hydrochloride Injection is used for the production of local or regional anesthesia or analgesia for surgery, diagnostic and therapeutic procedures, and for obstetrical procedures. The approved product has an estimated market size of $5.6 million in the US for the twelve months ended 31 March 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 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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