Aurobindo Pharma Receives US FDA Approval For An Antibiotics Tablet
Aurobindo Pharma has also been granted competitive generic therapy designation for these Cephalexin Tablets, qualifying the company for 180 days of shared generic drug exclusivity.
(Source: Company website)
Aurobindo Pharma Ltd. has received final approval from the US Food and Drug Administration to manufacture and market Cephalexin Tablets USP, an antibiotic, in 250 mg and 500 mg dosages.
These tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Keflet tablets, 250 mg and 500 mg, according to an exchange on Tuesday.
The company has also been granted competitive generic therapy designation for these cephalexin tablets, qualifying the company for 180 days of shared generic drug exclusivity, the filings said.
The tablet is expected to be launched in the third quarter of the financial year 2025. Cephalexin tablets USP, 250 mg, and 500 mg are used for the treatment of infections caused by susceptible strains of the specific microorganisms, the company said.
Aurobindo Pharma is a global pharmaceutical company headquartered in Hyderabad. It develops, produces, and commercialises a wide range of generic pharmaceuticals.
Shares of Aurobindo Pharma closed 1.53% lower at Rs 1438.55 apiece, compared to a 0.04% decline in the benchmark BSE Sensex. The stock has risen 58.29% in the last 12 months and 32.68% year-to-date. The relative strength index was 35.32.
Out of 29 analysts tracking the company, 20 maintain a 'buy', five suggest a 'hold' and four recommend a 'sell', according to Bloomberg data. The average 12-month analysts' consensus price target implies an upside of 9.6%.
