Glenmark Pharmaceuticals Limited has received approval from the US Food and Drug Administration (US FDA) for Fluticasone Propionate Nasal Spray USP, 0.05 mg (50 mcg)/spray, adding another product to its respiratory medicines portfolio in the United States. The approved product is bioequivalent and therapeutically equivalent to FlonaseĀ® Nasal Spray, 0.05 mg/spray, the reference listed drug marketed by Haleon US Holdings LLC under NDA 020121.
Glenmark Pharmaceuticals Inc., USA, will distribute the product in the US market. The approval strengthens the company’s respiratory portfolio and expands its presence in a major pharmaceutical market. The product addresses a well-established respiratory treatment segment. According to IQVIA data, FlonaseĀ® Nasal Spray recorded approximately $295.2 million in annual sales in the United States during the 12-month period ended June 2026.
Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals, said the approval marks another step in the company’s efforts to expand its respiratory portfolio in the U.S. He added that Glenmark remains focused on increasing access to quality and affordable treatment options for patients and healthcare providers.
The latest approval builds on Glenmark’s established capabilities in respiratory care. The company has developed a portfolio covering branded, innovative, generic and consumer healthcare products, with key therapeutic focus areas including respiratory diseases, dermatology and oncology.
Glenmark has been expanding its presence across international markets while continuing to invest in research, product development and manufacturing capabilities. The company aims to address healthcare needs through medicines that combine quality, accessibility and affordability.
The US remains an important market for Glenmark’s generic and specialty pharmaceutical operations. The company has continued to add products to its portfolio across multiple therapeutic areas, supporting its strategy of expanding its global commercial footprint.
Glenmark Pharmaceuticals Ltd is a research-led pharmaceutical company focused on developing and commercialising medicines across selected therapeutic areas. Its portfolio includes branded, innovative, generic and consumer healthcare products. The company operates 11 manufacturing facilities across four continents and six R&D centres, with products and operations spanning more than 80 countries. Its research and commercial activities are focused particularly on respiratory diseases, dermatology and oncology.
