Moneycontrol Bureau
Shares of Aurobindo Pharma spiked 2.7 percent to hit a record high of Rs 1,386.90 on Wednesday on US FDA nod for antibiotic drug.
"Aurobindo has received final approvals from the US Food and Drug Administration (USFDA) to manufacture and market Cefixime for oral suspension USP, 100mg/5mL and 200mg/5mL. The product is ready for launch," said the company in its filing to the exchange.
The approved ANDAs are bioequivalent and therapeutically equivalent to the reference listed drug product Suprax oral suspension USP 100mg/5mL and 200mg/5mL respectively of Lupin Pharmaceuticals Inc.
Cefixime for oral suspension is indicated for the treatment of adults and pediatric patients six months of age or older, with infections caused by susceptible strains of the designated organisms in urinary tract infections, otitis media, acute exacerbations of chronic bronchitis, uncomplicated gonorrhea (cervical/urethral), pharyngitis and tonsillitis.
The product has an estimated market size of USD 123 million for the twelve months ending February 2015, according to IMS.
Aurobindo said now it has 11 ANDAs (represented by 7 product classes) approved out of Unit VI formulation facility in Hyderabad, India for manufacturing oral cephalosporin products.
At 12:49 hrs Aurobindo Pharma was quoting at Rs 1,383, up Rs 32.20, or 2.38 percent on the BSE.
Posted by Sunil Shankar Matkar
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