NATCO Pharma Limited announced on Tuesday that 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. According to reports from CNBC TV18, Rediff Money, The Hindu BusinessLine, and Business Standard, the product is a generic version of Balversa, originally developed by Janssen Biotech Inc. The regulatory filing notes that tentative approvals allow companies to secure marketing authorisation ahead of patent expiries or additional regulatory milestones, enabling earlier access to high-value markets. This approval makes NATCO Pharma eligible to market the product in the United States, subject to final compliance with regulatory requirements.
As reported by CNBC TV18, Rediff Money, The Hindu BusinessLine, and Business Standard, 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. The drug is specifically designed for patients with advanced urothelial carcinoma, positioning NATCO Pharma for entry into the U.S. oncology market with this targeted therapeutic approach. The indication targets adult patients with advanced urothelial carcinoma and Fibroblast Growth Factor Receptor 3 (FGFR3) genetic alterations who have progressed after at least one prior therapy.
According to CNBC TV18, Rediff Money, The Hindu BusinessLine, and Business Standard, 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. This represents a significant market opportunity for the generic version developed by NATCO Pharma. The approval adds to a growing portfolio of USFDA-cleared products in oncology and other therapeutic areas, reinforcing the company's strategy of focusing on regulated markets and diversifying its global revenue base.
As reported by CNBC TV18, Rediff Money, The Hindu BusinessLine, and Business Standard, shares of NATCO Pharma gained 3.63% on the Bombay Stock Exchange on Monday to end at ₹853.40. The positive market response reflects investor confidence in the company's new USFDA approval for the generic cancer drug and its expanding footprint in the U.S. generics arena. NATCO Pharma has scheduled its Board meeting for February 12, 2026 to consider and approve unaudited financial results for Q3FY26 and declare the 3rd interim dividend for FY 2025-26, as announced to BSE. The regulatory filing also notes that NATCO's shares responded positively to the news, reflecting investor optimism about the company's strategy of focusing on regulated markets.
According to CNBC TV18, 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. The company is yet to declare its Q3 results, with Q2 results showing a 23.5% year-on-year decline in net profit to ₹518 crore compared with ₹677.3 crore in the same period last year. The company's existing approvals and filings with the U.S. health regulator underscore an ongoing effort to diversify its global revenue base by leveraging its development capabilities and regulatory expertise.
