NATCO Pharma gets approval for its ANDA for Everolimus tablets

NATCO Pharma said that it has received approval of its ANDA for Everolimus tablets for oral suspension (TFOS), a generic version of AFINITOR DISPERZ by Novartis Pharmaceutical Corporation.

The companys marketing partner for the ANDA, Breckenridge Pharmaceutical, Inc plans to launch the product immediately in the US market.

Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

Everolimus tablets for oral suspension (TFOS) had estimated sales of $112 million in the U.S. for 12 months ending Sep24 as per industry sales data.

Natco Pharma is engaged in the business of pharmaceuticals which comprises research and development, manufacturing and selling of bulk drugs and finished dosage formulations. The company has manufacturing facilities in India, which cater to both domestic and international markets, including regulated markets like the United States of America and Europe.

The companys consolidated net profit surged 83.55% to Rs 677.30 crore on a 32.93% increase in revenue from operations to Rs 1,371.1 crore in Q2 FY25 over Q2 FY24.

The scrip fell 1.01% to currently trade at Rs 1163.15 on the BSE.

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