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.
Click here to connect with us on WhatsApp
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.
The pharma major reported 79.5% jump in consolidated net profit to Rs 908.75 crore on a 17.1% rise in revenue from operations to Rs 7,580.15 crore in Q4 FY24 over Q4 FY23.
Shares of Aurobindo Pharma rose 0.83% to Rs 1,450.55 on the BSE.
Powered by Capital Market – Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
First Published: Oct 03 2024 | 2:58 PM IST
