Aurobindo Pharma sweetens after USFDA nod

Aurobindo Pharma rose 2.11% to Rs 603.70 at 14:55 IST on BSE after the company said it received final approval from the USFDA to manufacture and market Bivalirudin injection, 250 mg/vial.

The announcement was made during market hours today, 30 July 2018.

Meanwhile, the S&P BSE Sensex was up 168.07 points, or 0.45% to 37,504.92

On the BSE, 90,000 shares were traded in the counter so far compared with average daily volumes of 1 lakh shares in the past two weeks. The stock had hit a high of Rs 606.60 and a low of Rs 587.65 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 the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bivalirudin injection, 250 mg/vial. The approved ANDA is a generic equivalent to the reference listed drug (RLD) product Angiomax Injection of The Medicines Company.

Bivalirudin injection is indicated for use as an anticoagulant in patients. Bivalirudin is intended for use in these indications with aspirin. The estimated market size of Bivalirudin injection is $101 million for the twelve months ended May 2018 according to IQVIA. The product will be launched in September 2018.

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. The company's robust product portfolio is spread over 7 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and AntiDiabetics, supported by an outstanding R&D set-up.

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