Glenmark Pharmaceuticals: Stock in focus on winning US FDA nod for Fluticasone inhaler with 180-day exclusivityGlenmark Pharmaceuticals: Stock in focus on winning US FDA nod for Fluticasone inhaler with 180-day exclusivity

Introduction

Leading pharmaceutical firm received U.S. FDA approval for Fluticasone Propionate Inhalation Aerosol 44 mcg with 180-day CGT exclusivity, strengthening its respiratory portfolio in the U.S.

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Share price movement of Glenmark Pharma

On March 4, 2026, Glenmark Pharmaceuticals Ltd opened at ₹2,096.75, down 1.26% from its previous close of ₹2,123.50. The stock reached a high of ₹2,108.90 (-0.69%) and a low of ₹2,031.55 (-4.34%). By 11:59 AM, it traded at ₹2,041.70, down 3.85%, with a market cap of ₹57,616.94 crore.

Glenmark Gets FDA Approval Fluticasone

Glenmark Specialty SA received final approval from the U.S. FDA for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation. The approval was granted on March 4, 2026.

The FDA determined Glenmark’s product to be bioequivalent and therapeutically equivalent to the reference listed drug, FloVent® HFA Inhalation Aerosol, 44 mcg, manufactured by GlaxoSmithKline Intellectual Property Ltd, England.

Glenmark has been granted Competitive Generic Therapy (CGT) designation as the first approved applicant. This provides 180 days of exclusivity upon commercialization in the U.S. market.

The inhalation aerosol will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA, starting March 2026. FloVent® HFA sales reached approximately $520.1 million in the 12 months ending January 2026.

Stock performance of Glenmark Pharma for period of 1 week, 6 months, and 1 year

Glenmark Pharmaceuticals Ltd gained 1.84% over the past week, rose 3.48% in the past six months, and increased 59.1% over the past one year.

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Shareholding pattern of Glenmark Pharma

Particulars	Dec 2025	Sep 2025	Jun 2025
Promoter	47%	47%	46.70%
FII	19.20%	20.70%	20.60%
DII	20.10%	18.70%	17.70%
Public	14.00%	14.00%	15.10%

About Glenmark Pharma

Glenmark Pharmaceuticals Ltd (NSE: GLENMARK) is a global research-led pharma company with 11 manufacturing sites, six R&D centres, and a portfolio in branded, specialty, generics, and consumer health.

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Disclaimer: The above article is written for educational purposes, and the companies’ data mentioned in the article may change with respect to time. The securities quoted are exemplary and are not recommendatory.

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