Aurobindo Pharma Receives USFDA Approval for Cephalexin Tablets | Capital market news

Aurobindo Pharma has received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Cephalexin Tablets USP, 250 mg and 500 mg, which are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD). ), Keflet tablets, 250 mg. and 500 mg, from Eli Lilly and Company.

Aurobindo Pharma has obtained 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 product is expected to be launched in the third quarter of FY25.

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Cephalexin Tablets USP, 250 mg and 500 mg, are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms.

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