Aurobindo Pharma gains after USFDA nod for Amoxicillin generic

Aurobindo Pharma rose 2.45% to Rs 875.25 at 9:20 IST on BSE after the company said it received approval from the US health regulator to market generic version of Amoxicillin in the US market.

The announcement was made after market hours on Tuesday, 16 September 2014.

Meanwhile, the BSE Sensex was up 136.24 points, or 0.51%, to 26,628.75.

On BSE, so far 19,000 shares were traded in the counter, compared with an average volume of 1.61 lakh shares in the past one quarter.

The stock hit a high of Rs 880 and a low of Rs 871.25 so far during the day. The stock hit a record high of Rs 908 on 16 September 2014. The stock hit a 52-week low of Rs 171 on 17 September 2013.

The stock had outperformed the market over the past one month till 16 September 2014, rising 11.43% compared with 1.49% rise in the Sensex. The scrip had also outperformed the market in past one quarter, rising 20.68% as against Sensex's 5.17% rise.

The large-cap company has an equity capital of Rs 29.15 crore. Face value per share is Re 1.

Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Amoxicillin for Oral Suspension USP 125mg/5mL and 250mg/5mL. Amoxicillin for Oral Suspension is the generic equivalent to the reference listed drug product (RLD), Amoxicillin for Oral Suspension, of Teva Pharmaceutical Industries and indicated in the treatment of infections due to susceptible aetalactamase-negative strains of the designated microorganisms. The product has a market size of approximately $19 million for the twelve months ending July 2014 according to IMS. This Abbreviated New Drug Application (ANDA) has been approved out of Unit XII, Semi-Synthetic Penicillin (SSP) formulation facility in Hyderabad, India, Aurobindo Pharma said.

Aurobindo now has a total of 195 ANDA approvals (169 final approvals including 7 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA, the company said.

On a consolidated basis, Aurobindo Pharma's net profit rose 2133.5% to Rs 415.43 crore on 70.3% growth in net sales to Rs 2894.61 crore in Q1 June 2014 over Q1 June 2013.

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 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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