Aurobindo Pharma receives USFDA approval for Risedronate Sodium Tablets, surges 1.75 percent

Indian pharmaceutical Aurobindo Pharma Ltd. (Aurobindo) today informed the exchange that it has received approval from US Food & Drug Administration (USFDA) to manufacture and market Risedronate Sodium Tablets USP, 5mg, 30 mg, 35 mg. The product is ready for launch. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) ACTONEL® Tablets of Warner Chilcott Co., LLC.

The drug is used in the treatment of Osteoporosis. According to IMS the approved product has an estimated market size of USD 113 million. Aurobindo now has a total of 219 ANDA approvals (191 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.

In terms of financials the total operating revenue of Aurobindo on year ending March 2015 stands at Rs.12120.52 crores an increase of 49.64 percent on yearly basis. The EBITDA of the company is at Rs. 2563.62 crores an increase of 20.25 percent  and the EBITDA margin is 21.15 percent as compared to 26.32 percent for the same period last year. The net profit of the company stands at Rs.1575.77 crores an increase of 34.35 percent on yearly basis.

The stock of the company is trading at Rs.825.25 an increase of 1.8 percent from the previous close.

Aurobindo is engaged in producing oral and injectable generic formulations and active pharmaceutical. Aurobindo also manufactures and commercializes the active pharmaceutical ingredients (APIs) and generic finished dosages for various markets. The Company's product portfolio is spread over six therapeutic/product areas, including antibiotics, anti-retrovirals, chorionic villus sampling (CVS), central nervous system (CNS), gastroenterologicals and anti-allergics.