Aurobindo Pharma jumps on getting USFDA nod for Sildenafil injection

Aurobindo Pharma rose 2.13% to Rs 1,274.25 at 9:24 IST on BSE after the company said it received approval from the US health regulator to manufacture and market Sildenafil injection in the US market.

The announcement was made on Saturday, 4 April 2015.

Meanwhile, the BSE Sensex was up 18.52 points, or 0.07%, to 28,278.66.

On BSE, so far 28,000 shares were traded in the counter, compared with an average volume of 1.08 lakh shares in the past one quarter.

The stock hit a high of Rs 1,288.05 at the onset of trading session, which is also a record high for the counter. The stock hit a low of Rs 1,262.05 in early trade. The stock hit a 52-week low of Rs 528 on 17 April 2014.

The stock had outperformed the market over the past one month till 1 April 2015, rising 15.13% compared with 3.75% decline in the Sensex. The scrip had also outperformed the market in past one quarter, rising 10.66% as against Sensex's 2.74% rise.

The large-cap company has an equity capital of Rs 29.20 crore. Face value per share is Re 1.

Aurobindo Pharma said it received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil Injection,10mg/12.5ml (0.8mg/ml). Sildenafil Injection 10mg/12.5ml (0.8mg/ml) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD), Revatio (sildenafil) Injection, 10 mg/12.5 ml (0.8 mg/ml), of Pfizer. Sildenafil Injection is indicated for the treatment of adult patients (18 years and above) with pulmonary arterial hypertension who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable, Aurobindo Pharma said. This is the 9th ANDA (represented by 7 product classes) to be approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general injectable products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC, Aurobindo Pharma said in a statement.

On a consolidated basis, Aurobindo Pharma's net profit declined 7.93% to Rs 384.35 crore on 49.34% growth in total income to Rs 3202.08 crore in Q3 December 2014 over Q3 December 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.

Powered by Capital Market - Live News