Aurobindo Pharma gains on USFDA nod for Rizatriptan Benzoate Tablets

Meanwhile, the BSE Sensex was up 160.02 points or 0.82% at 19,586.73.

On BSE, 1 lakh shares were traded in the counter as against average daily volume of 3.54 lakh shares in the past one quarter.

The stock hit a high of Rs 193.90 and a low of Rs 190.40 so far during the day. The stock had hit a 52-week high of Rs 201.40 on 5 December 2012. The stock had hit a 52-week low of Rs 85.05 on 2 January 2012.

The stock had outperformed the market over the past one month till 31 December 2012, rising 0.66% compared with the Sensex’s 0.45% rise. The scrip had also outperformed the market in past one quarter, jumping 33.59% as against Sensex’s 3.54% gain.

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

Aurobindo Pharma has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Rizatriptan Benzoate Tablets 5mg (base) and 10mg (base), which was earlier tentatively approved. The product is ready for launch, Aurobindo said in a statement.

Rizatriptan Benzoate Tablets 5mg (base) and 10mg (base) is the generic equivalent of Merck and Co’s Maxalt Tablets 5mg (base) and 10mg (base) and is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. According to IMS data, the annual sales of Rizatriptan Benzoate Tablets were approximately $300 million in the United States for the twelve months ended March 2012.

The product has been approved out of Unit VII (SEZ) formulations facility at Hyderabad, Aurobindo said.

Aurobindo now has a total of 171 abbreviated new drug application (ANDA) approvals (146 final approvals including 2 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA.

Aurobindo Pharma reported consolidated net profit of Rs 222.35 crore in Q2 September 2012, compared with net loss of Rs 80.16 crore in Q2 September 2011. Net sales rose 40.9% to Rs 1481.05 crore in Q2 September 2012 over Q2 September 2011.

Aurobindo Pharma, headquartered at Hyderabad in Andhra Pradesh, manufactures generic pharmaceuticals and active pharmaceutical ingredients (APIs). 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. The company is marketing these products globally, in over 125 countries.

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