Aurobindo Pharma Gets USFDA Approval

Hyderabad based, Aurobindo Pharma has recently received a final approval from United States Food & Drug Association (USFDA) for abbreviated new drug application (ANDA) to manufacture and market amoxicillin for oral suspension USP 125mg/5ml. It is a generic equivalent to the reference listed drug product (RLD) respectively of Teva pharmaceuticals industries and indicated in treatment of infections due to susceptible Betalactamase- negative strains of designated micro-organisms.
 
This product approximately has a size of USD 19 million for the 12 months ending July 2014 according to IMS. This product has been approved out of the XIIth unit of Semi Synthetic Penicillin facility in Hyderabad, India. Till date Aurobindo has 195 ANDA approvals, including this. Aurobindo Pharma is a manufacturer of generic pharmaceuticals and active pharmaceutical ingredients. It has a strong product portfolio spreading over various areas such as anti-biotics, anti-retrovirals, CVS, CNS, gastroenterological and anti allergic.
 
The net sales of the company rose to Rs 2911.07 crore in June 2014 quarter as compared to Rs 1715.56  in June 2013 quarter. The net profit of the company rose to Rs 414.27 crore in June 2014 quarter as compared to Rs 17.46 crore in June 2013 quarter. The EBITDA stood at Rs 658.2 crore in June 2014 quarter as compared to Rs 307.70 crore in June 2013 quarter. The EBITDA margins also increased 22.60 % in June 2014 quarter as compared to 17.90% in June 2013 quarter.