NSEPress Release7h ago · 20 Aug 2026, 08:52 am

Press Release

Glenmark Pharmaceuticals Limited · GLENMARK

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Glenmark Pharmaceuticals Limited has received U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray, which is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase Nasal Spray, 0.05 mg/spray. The product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

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Full Announcement

Glenmark Pharmaceuticals Limited has informed the Exchange regarding a press release dated August 20, 2026, titled "Glenmark Pharmaceuticals receives U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray".

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GLENMARK_20082026084458_Press_Release_20282026_Signed.pdf

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August 20, 2026 To, To, National Stock Exchange of India Limited, BSE Limited, “Exchange Plaza”, Corporate Relationship Department, 5th Floor, Plot No. C/1, G Block, 2nd Floor, New Trading Ring, Bandra- Kurla Complex Bandra (East), Mumbai P.J. Towers, Dalal Street, – 400 051 Mumbai – 400 001 NSE Symbol: GLENMARK Scrip Code: 532296 ISIN: INE935A01035 ISIN: INE935A01035 Our Reference No. 51/26-27 Our Reference No. 51/26-27 Dear Sir/ Madam, Sub: Glenmark Pharmaceuticals receives U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray Glenmark Pharmaceuticals Limited (Glenmark) today announced the receipt of U.S. FDA approval1 for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. Glenmark’s Fluticasone Propionate Nasal Spray USP is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase®2 Nasal Spray, 0.05 mg/spray of Haleon US Holdings LLC [NDA 020121] and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. Kindly find attached media release which is self- explanatory. Request you to kindly take the same on record. Thanking You. Yours faithfully, For Glenmark Pharmaceuticals Limited Rashmi Khandelwal Company Secretary & Compliance Officer ACS - 28839 Encl: As above Glenmark Pharmaceuticals Limited Glenmark House, B D Sawant Marg, Andheri (E), Mumbai 400 099 T: 91 22 4018 9999 F: 91 22 4018 9988 CIN No: L24299MH1977PLC019982 W: www.glenmarkpharma.com Registered office: B/2, Mahalaxmi Chambers, 22 Bhulabhai Desai Road, Mumbai 400 026 E: complianceofficer@glenmarkpharma.com Glenmark Pharmaceuticals receives U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray Elmwood Park, New Jersey, August 20, 2026 – Glenmark Pharmaceuticals Limited (Glenmark) today announced the receipt of U.S. FDA approval1 for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. Glenmark’s Fluticasone Propionate Nasal Spray USP is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase®2 Nasal Spray, 0.05 mg/spray of Haleon US Holdings LLC [NDA 020121] and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. According to IQVIA® sales data for the 12-month period ending June 2026, the Flonase® Nasal Spray market3 achieved annual sales of approximately $295.2 million*. Commenting on the approval, Marc Kikuchi, President & Business Head, North America said, “The approval of Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area. We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.” 1Glenmark’s Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray is only approved for the indication(s) listed in Glenmark’s approved label. 2All brand names and trademarks are the property of their respective owners. 3Market includes brand and all available therapeutic equivalents. Note: IQVIA® data obtained by Glenmark is only available for all approved RLD indications. Glenmark’s product is only approved for and will only be marketed for the indications listed in Glenmark’s approved label, which may be different than the approved RLD indications. *IQVIA® National Sales Perspectives: Retail & Non-Retail, June 2026 About Glenmark Pharmaceuticals Limited Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global, research‐led pharmaceutical company with a unique focus on innovation and accessibility. We pioneer transformative breakthrough therapies that aim to redefine treatment while expanding access to high quality and affordable medicines for patients around the world. With 11 world-class manufacturing facilities across four continents, supported by six cutting-edge R&D centres, and a commercial footprint in 80+ countries, we deliver a diversified portfolio across branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology. Scrip 100 positions Glenmark among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024. For more information, visit www.glenmarkpharma.com. For more information, please contact: India United States Akhila Natarajan | Akhila Natarajan | mediarelations@glenmarkpharma.com mediarelations@glenmarkpharma.com Adfactors PR | Danielle Hagen | glenmark.ihcp@adfactorspr.com danielle@nahigianstrategies.com