Aurobindo Pharma rose 1.42% to Rs 616.35 at 11:04 IST on BSE after the company said it received final approval from the US drug regulator for Ertapenem injection.
Meanwhile, the S&P BSE Sensex was up 86.61 points, or 0.24% to 35,556.96.On the BSE, 5.91 lakh shares were traded in the counter so far compared with average daily volumes of 1.70 lakh shares in the past two weeks. The stock had hit a high of Rs 621 and a low of Rs 613.05 so far during the day. The stock hit a 52-week high of Rs 808.95 on 7 November 2017. The stock hit a 52-week low of Rs 527.05 on 4 June 2018.
Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Ertapenem injection 1 g/vial. Aurobindo's Ertapenem injection is a generic equivalent of Merck Sharp & Dohme Corp's Invanz injection. The product will be launched in July 2018.
The approved product has an estimated market size of $387 million for the twelve months ending April 2018 according to IQVIA. Ertapenem injection is used for the treatment of moderate to severe infections caused by susceptible bacteria. Also indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
This abbreviated new drug application (ANDA) is approved out of Auronext Pharma's (wholly owned subsidiary) formulation facility in Bhiwadi, India used for manufacturing penem injectable products. Aurobindo now has a total of 371 ANDA approvals (338 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.
On a consolidated basis, net profit of Aurobindo Pharma declined 0.74% to Rs 528.51 crore on 11.35% rise in net sales to Rs 3988.63 crore in Q4 March 2018 over Q4 March 2017.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients.
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