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Aurobindo Pharma gains on USFDA nod for a generic medicine

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Last Updated : Dec 13 2013 | 11:59 PM IST

Aurobindo Pharma rose 3.47% to Rs 308.30 at 15:14 IST on BSE after the company said it has received the final approval from USFDA to manufacture and market Duloxetine Hydrochloride Delayed-Release Capsules in 3 strengths in the United States.

The announcement was made during trading hours today, 13 December 2013.

Meanwhile, the S&P BSE Sensex was down 219.24 points or 1.05% at 20,706.37.

On BSE, so far 3.28 lakh shares were traded in the counter as against average daily volume of 3.15 lakh shares in the past one quarter.

The stock hit a high of Rs 311.35 and a low of Rs 295.50 so far during the day.

The stock had outperformed the market over the past one month till 12 December 2013, advancing 9.66% compared with the Sensex's 3.17% rise. The scrip had also outperformed the market in past one quarter, jumping 63.04% as against Sensex's 5.78% rise.

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Aurobindo Pharma said it has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base) which was earlier tentatively approved.

Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base) are the generic equivalent of Eli Lilly & Company's Cymbalta Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base). Duloxetine Hydrochloride Delayed-Release Capsules are indicated for the treatment of for the treatment of major depressive disorder (MDD) and falls under the Neurological (CNS) therapeutic category. According to IMS data, the market size of the product is estimated to be $5.4 billion for the twelve months ended September 2013.

Aurobindo now has a total of 188 abbreviated new drug application (ANDA) approvals (163 final approvals including 7 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA.

Aurobindo Pharma's consolidated net profit rose 5.7% to Rs 234.95 crore on 28.1% growth in net sales to Rs 1897.48 crore in Q2 September 2013 over Q2 September 2012.

Aurobindo Pharma, headquartered at Hyderabad 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, Gastroenterologicals, 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: Dec 13 2013 | 3:12 PM IST

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