Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cephalexin Tablets USP, 250 mg.
The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Keflet Tablets, 250 mg and 500 mg, of Eli Lilly and company. The product will be launched in Q3FY25.
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.
Cephalexin Tablets USP, 250 mg and 500 mg are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms.
The drug maker now has a total of 523 ANDA approvals (506 Final approvals and 17 tentative approvals) from USFDA.
Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services.
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The pharma major reported 61.1% surge in consolidated net profit to Rs 919.22 crore on a 9.8% rise in revenue from operations to Rs 7,457.65 crore in Q1 FY25 over Q1 FY24.
Shares of Aurobindo Pharma rose 0.83% to Rs 1,450.55 on the BSE.
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