Aurobindo Pharma gains after receiving USFDA approval for two new drugs

Aurobindo Pharma rose 1% to Rs 794.55 at 10:32 IST on BSE after the company received US FDA approvals for Levonorgestrel tablet and Eptifibatide injection.

The company made the announcement after market hours yesterday, 9 December 2015.

Meanwhile, the BSE Sensex was up 64.62 points, or 0.26%, to 25,100.23

On BSE, so far 32,423 shares were traded in the counter, compared with an average volume of 1.35 lakh shares in the past one quarter.

The stock hit a high of Rs 806.65 and a low of Rs 788 so far during the day. The stock hit a record high of Rs 860.80 on 29 October 2015. The stock hit a 52-week low of Rs 646.20 on 25 August 2015.

The large-cap company has an equity capital of Rs 58.40 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 Eptifibatide injection USP, 20 mg/10 mL, 75 mg/100 mL, and 200 mg/100 mL single-use vials. This product is expected to be launched in this month, Aurobindo Pharma said. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Integrilin Injection, 20 mg/10 mL, 75 mg/100 mL, and 200 mg/100 mL of Schering Corporation. Eptifibatide injection is used in the treatment of acute coronary syndrome. The approved product has an estimated market size of $137 million in the US for the twelve months ended October 2015 according to IMS.

Separately, Aurobindo Pharma also received final approval from the USFDA to manufacture and market Levonorgestrel tablet, 1.5 mg. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Plan B One-Step tablet of Teva Branded Pharmaceutical Products R&D, Inc. Levonorgestrel tablet is an oral contraceptive used for prevention of pregnancy. The approved product has an estimated market size of $64 million in the US for the twelve months ended October 2015 according to IMS.

Aurobindo Pharma's consolidated net profit rose 21.4% to Rs 451.76 crore on 14.6% rise in net sales to Rs 3280.11 crore in Q2 September 2015 over Q2 September 2014.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company is marketing these products globally, in over 150 countries.

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