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Aurobindo Pharma gains on USFDA nod for Ondansetron Injections

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Capital Market Mumbai

The company made the announcement during trading hours today, 24 December 2012.

Meanwhile, the BSE Sensex was up 43.11 points or 0.22% at 19,285.11.

On BSE, 1.38 lakh shares were traded in the counter as against average daily volume of 3.8 lakh shares in the past one quarter.

The stock hit a high of Rs 196.70 and a low of Rs 192.75 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 83.35 on 29 December 2011.

The stock had outperformed the market over the past one month till 21 December 2012, jumping 7.7% compared with the Sensex's 4.23% rise. The scrip had also outperformed the market in past one quarter, surging 47.66% as against Sensex's 2.61% 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 approvals from the US Food and Drug Administration (USFDA) to manufacture and market Ondansetron Injection USP 2 mg/ml packaged in 40mg/20ml Multiple-dose Vials and Ondansetron Injection USP 2mg/ml packaged in 4mg/2ml Single-dose Vials, Preservative-free. The products are ready for launch, Aurobindo Pharma said in a statement.

The approved Ondansetron Injections are the generic equivalent of GlaxoSmithKline's Zofran Injection and indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or postoperative nausea and/or vomiting, Aurobindo Pharma said in a statement. These are the first abbreviated new drug applications (ANDA) to be approved out of the company's Unit IV formulation facility at Hyderabad for manufacturing general liquid injectable and ophthalmic products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC, Aurobindo Pharma said in a statement.

Aurobindo now has a total of 169 ANDA approvals (143 final approvals including 2 from Aurolife Pharma LLC and 26 tentative approvals) from USFDA, the company said in a statement.

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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First Published: Dec 24 2012 | 11:32 PM IST

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