Natco Pharma seeks USFDA nod for generic Erdafitinib Tablets
Hyderabad: NATCO Pharma Limited has announced the submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Erdafitinib Tablets 3 mg, 4 mg, and 5 mg strengths.
Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). The company's focus is primarily on niche therapeutic areas and complex products. It markets and distributes products in over 40 countries. It sells FDF products in the United States, India, Europe and the rest of the world (“RoW”). Natco also operates in certain key geographies through its subsidiaries.
Natco Pharma is also engaged in contract manufacturing business, whereby it undertakes selected contracts with pharmaceutical companies to manufacture and supply pharmaceutical products.
Read also: Natco Pharma posts Rs 715.3 crore of Profit after tax for year ended March 31st, 2023
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