Aurobindo Pharma Receives USFDA Approval for Cephalexin Tablets

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cephalexin Tablets USP, 250 mg and 500 mg. The product is expected to be launched in Q3FY25 and is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms. Aurobindo Pharma was granted Competitive Generic Therapy (CGT) designation for Cephalexin Tablets USP, 250 mg and 500 mg, and is eligible for 180 days of shared generic drug exclusivity. The company now has a total of 523 ANDA approvals from USFDA.