NATCO Pharma gets USFDA nod for generic cancer drug Erdafitinib; shares jump 3%

NATCO Pharma Limited on Tuesday said it has received tentative approval from the US Food and Drug Administration (USFDA) for Erdafitinib tablets in 3 mg, 4 mg and 5 mg strengths. The product is a generic version of Balversa, originally developed by Janssen Biotech Inc.

According to the company, NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alterations, whose disease has progressed following at least one prior line of therapy.

Erdafitinib tablets recorded estimated sales of approximately USD 60 million in the USA for the 12 months ended September 2025, based on industry sales data.

NATCO Pharma Limited, headquartered in Hyderabad, India, is engaged in the development, manufacturing and distribution of generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products.

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The company is yet to declare its Q3 results. In Q2, it had reported a 23.5% year-on-year decline in net profit, which came in at ₹518 crore compared with ₹677.3 crore in the same period last year.

Revenue for the quarter dipped slightly to ₹1,363 crore from ₹1,371 crore a year ago.

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Shares of NATCO Pharma Ltd were trading at ₹852.50 on NSE, up ₹28.60, or 3.47%, as of 3:19 pm IST on February 3.