Glenmark Gets USFDA Approval For Fluticasone Propionate Nasal Spray USP; Shares Rise 0.75%

Mumbai August, 20: Glenmark Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for its Fluticasone Propionate Nasal Spray USP, 0.05 mg (50 mcg)/spray, adding another product to its U.S. pharmaceutical portfolio.

According to the company’s exchange disclosure dated August 20, 2026, the product is bioequivalent and therapeutically equivalent to Flonase Nasal Spray, 0.05 mg/spray, the reference listed drug marketed by Haleon US Holdings LLC.

The approved product will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA. The company said the approval is for the indications specified in its approved label.

Stock Market Snapshot

The Glenmark  Pharmaceuticals share price moved higher following the regulatory approval announcement.

As of 9:17 AM IST on August 20, 2026, Glenmark Pharmaceuticals shares were trading at ₹2,263.40, up ₹16.90 or 0.75% from the previous close, according to the market data provided.

The stock opened around ₹2,270 before easing to the quoted level, keeping the shares in positive territory during the early session.

The company’s disclosure also cited IQVIA data showing that the Flonase Nasal Spray market recorded annual sales of approximately $295.2 million for the 12-month period ended June 2026.

Glenmark Expands U.S. Portfolio With Additional Nasal Spray Product

The FDA approval adds another product to Glenmark’s established U.S. portfolio, where the company operates through its American subsidiary and focuses on branded, innovative and generic medicines.

Glenmark said the approval strengthens its presence in the therapeutic area and supports its efforts to expand access to medicines in the U.S. market. The company has a commercial presence across more than 80 countries and operates manufacturing facilities and research and development centres across multiple markets.

The latest approval is also relevant to Glenmark’s broader strategy of expanding its pharmaceutical offerings in the U.S., particularly through additional approved products in established therapeutic segments.

Conclusion

Glenmark Pharmaceuticals has secured U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray, which is therapeutically equivalent to the reference-listed Flonase Nasal Spray.

The company said the product will be distributed in the U.S. through Glenmark Pharmaceuticals Inc., USA. Shares responded positively in early trade, rising 0.75% to ₹2,263.40 as of 9:17 AM IST on August 20, 2026.

Source:

• https://www.nseindia.com/get-quote/equity/GLENMARK/Glenmark-Pharmaceuticals-Limited
• https://nsearchives.nseindia.com/corporate/GLENMARK_20082026084458_Press_Release_20282026_Signed.pdf