Aurobindo Pharma shares jumped Wednesday morning, with an announcement from the company that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets.
The stock spurted to Rs 794.50 within minutes of commencement of trade, gaining almost 8.5% in the process. Despite paring some gains subsequently, it still remains well placed in positive territory at Rs 773.30, up 5.4% from previous closing price.
The stock, which had touched a high of Rs 895 in early October 2016, plunged to around Rs 503 by late May 2017 and has come back pretty strongly since then to its current level.
The drug, to be launched immediately by Aurobindo Pharma, is a therapeutic equivalent generic version of Genzyme's Renvela tablets. Sevelamer Carbonate tablets is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. The product has an estimated market size of US$ 1.9 billion for the twelve months ending May 2017 according to IMS.
With this nod from USFDA, Aurobindo Pharma now has 124 ANDA approvals (including 21 tentative approvals) out of Unit VII formulation facility in Hyderabad. The total ANDA approvals now stands at 331 (including 37 tentative approvals). According to reports, the approval pace remains one of the highest among peers with the company bagging 17 nods in the current financial year.
The company had announced last month that the US health regulator, on completion of inspection, cleared company's unit 7 at Hyderabad with zero observations. Unit 7 is one of the important and largest facilities for Aurobindo Pharma.
Aurobindo Pharma, which markets its products in over 150 countries, has a product portfolio that 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.
Aurobindo Pharma saw a drop in net profit in the January - March 2017 quarter, at Rs 532.4 crore. That was down by about 4%, compared to year-ago quarter. Revenue was down 2.8% at s 3641.6 crore in the fourth quarter. The pharma major's operating income declined 16% to Rs 721.2 crore from a year ago and operating margins contracted 170 basis points to 19.8%.
