Aurobindo Pharma gains after receiving USFDA approval for Entecavir tablets

Aurobindo Pharma gained 2.83% to Rs 743.45 at 13:45 IST on BSE after the company announced that it has received the final approval from the US Food & Drug Administration to manufacture and market Entecavir tablets, 0.5mg and 1mg.

The announcement was made during market hours today, 27 August 2015.

Meanwhile, the BSE Sensex was up 491.61 points, or 1.29% to 26,046.74.

On BSE, so far 72,486 shares were traded in the counter, compared with an average volume of 1.73 lakh shares in the past one quarter.

The stock hit a high of Rs 749.85 and a low of Rs 733.10 so far during the day. The stock had hit record high of Rs 832.50 on 20 August 2015. The stock hit a 52-week low of Rs 382.50 on 24 September 2014.

The stock had outperformed the market over the past one month till 26 August 2015, falling 1.63% compared with 8.53% fall in the Sensex. The stock had also outperformed the market in past one quarter, gaining 7.15% as against Sensex's 6.6% decline.

The large-cap company has an equity capital of Rs 58.40 crore. Face value per share is Re 1.

Aurobindo Pharma said the approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Baraclude Tablets, 0.5mg and 1mg, of Bristol-Myers Squibb. Entecavir tablets are indicated for treatment of chronic hepatitis B virus infection of the liver. The product has an estimated market size of $294 million for the twelve months ending June 2015 in the US, according to IMS.

This is the 44th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing oral non-antibiotic products. Aurobindo now has a total of 209 ANDA approvals (181 Final approvals including 9 from Aurolife Pharma LLC and 28 tentative approvals) from the US Food & Drug Administration (USFDA).

Aurobindo Pharma's consolidated net profit rose 4.1% to Rs 432.40 crore on 14.6% growth in total income to Rs 3349.47 crore in Q1 June 2015 over Q1 June 2014.

Aurobindo Pharma, headquartered at Hyderabad, manufactures generic pharmaceuticals and active pharmaceutical ingredients.

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