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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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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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