Natco Pharma Receives Tentative Approval for Erdafitinib Tablets
Filing Summary
Natco Pharma Limited has received tentative approval for its generic version of Erdafitinib tablets, equivalent to Balversa by Janssen Biotech Inc. The approval covers 3 mg, 4 mg, and 5 mg dosages. Erdafitinib is indicated for adult patients with locally advanced unresectable or metastatic urothelial carcinoma with FGFR3 genetic alterations. The tablets had estimated sales of approximately USD 60 million in the U.S. for the 12 months ending September 2025. This development is in accordance with Regulation 30 of SEBI’s Listing Obligations and Disclosure Requirements.
Natco Pharma Limited has announced the receipt of tentative approval for its generic version of Erdafitinib tablets, which corresponds to Balversa by Janssen Biotech Inc. The approval includes 3 mg, 4 mg, and 5 mg dosages. This approval is intended for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma that harbors susceptible FGFR3 genetic alterations. The patients must have experienced disease progression during at least one line of prior therapy.
The estimated sales for Erdafitinib tablets in the United States were approximately USD 60 million for the 12 months ending September 2025, according to industry sales data. This information was disclosed under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Natco Pharma Limited, listed on both BSE and NSE under the codes 524816 and NATCOPHARM respectively, is involved in the development, manufacturing, and distribution of generic and branded pharmaceuticals. The company focuses on specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products. Natco is recognized as a research and development-oriented entity, particularly in the field of oncology and targeted therapies within the domestic market. The company also emphasizes limited competition molecules in the U.S. market.
Natco operates nine manufacturing sites and two research and development facilities in India. These facilities have received approvals from several leading regulatory authorities, including the U.S. FDA, Brazil ANVISA, Health Canada, and WHO, among others. The company’s products are distributed across more than 50 global markets.