Aurobindo Pharma gallops after USFDA nod for generic drug

Aurobindo Pharma rose 5.83% to Rs 636.50 at 11:38 IST on BSE after the company said it received US drug regulator's approval for Sevelamer Carbonate oral suspension.

The announcement was made during trading hours today, 15 June 2017.

Meanwhile, the S&P BSE Sensex was down 17.86 points, or 0.06% to 31,138.05.

On the BSE, 4.48 lakh shares were traded in the counter so far, compared with average daily volumes of 2.99 lakh shares in the past one quarter. The stock had hit a high of Rs 640.80 and a low of Rs 600.75 so far during the day. The stock hit a record high of Rs 895 on 6 October 2016. The stock hit a 52-week low of Rs 504 on 29 May 2017.

The stock had underperformed the market over the past one month till 14 June 2017, falling 2.12% compared with 1.87% rise in the Sensex. The scrip had also underperformed the market in past one quarter, falling 12.48% as against Sensex's 5.31% rise. The scrip had also underperformed the market in past one year, falling 18.99% as against Sensex's 16.57% rise.

The large-cap company has equity capital of Rs 58.59 crore. Face value per share is Re 1.

Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm. Sevelamer Carbonate oral suspension, a therapeutic equivalent generic version of Genzyme's Renvela oral suspension. The product is being launched immediately.

Sevelamer Carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The approved product has an estimated market size of $140 million in the US for the twelve months ending April 2017 according to IMS.

This is the 116th Abbreviated New Drug Application (ANDA) (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 323 ANDA approvals (288 Final approvals including 16 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.

On a consolidated basis, net profit of Aurobindo Pharma declined 4.02% to Rs 532.45 crore on 2.50% decline in net sales to Rs 3582.13 crore in Q4 March 2017 over Q4 March 2016.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients.

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