Glenmark Pharmaceuticals has received approval from the US Food and Drug Administration for Fluticasone Propionate Nasal Spray USP 0.05 mg per spray, strengthening its respiratory portfolio in the US market.

The company said the product is bioequivalent and therapeutically equivalent to Flonase Nasal Spray 0.05 mg per spray. The product will be distributed in the US by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA sales data for the 12 month period ended June 2026, the US market for Flonase Nasal Spray recorded annual sales of approximately $295.2 million, highlighting the commercial opportunity for the newly approved product.

Glenmark said the approval marks another step in expanding its respiratory portfolio in the US and builds on its established presence in the therapeutic segment. The company also remains focused on increasing access to quality and affordable treatment options for patients and healthcare providers.

Glenmark Pharmaceuticals has recently reported strong financial performance. For the quarter ended June 2026, consolidated net profit increased more than tenfold to Rs 483 crore from Rs 47 crore in the corresponding period of the previous year.

Revenue from operations rose 23% year on year to Rs 4,018 crore from Rs 3,264 crore, while EBITDA increased 38.6% to Rs 805 crore from Rs 581 crore. The EBITDA margin also improved to 20% from 17.8%.

The company's performance has been supported by its focus on specialty medicines, respiratory and oncology therapies, along with growth across India, North America and emerging markets. The latest US FDA approval further strengthens its product portfolio in the North American market.