Glenmark Pharmaceuticals Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

The company said the product has been determined by the USFDA to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Flovent HFA Inhalation Aerosol, 44 mcg, of GlaxoSmithKline (NDA ? 021433).

Fluticasone propionate is indicated as an inhaler for the treatment and management of asthma by prophylaxis as well as inflammatory and pruritic dermatoses. Fluticasone propionate nasal spray is indicated for managing allergic and nonallergic rhinitis

Glenmark has also been granted a Competitive Generic Therapy (CGT) designation for the product and has been recognised as the ?first approved applicant? under section 505(j)(5)(B)(v)(III) of the FD&C Act. With this approval, the company will be eligible for 180 days of CGT exclusivity upon commercial launch.

The inhalation aerosol will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA starting March 2026. The approval further strengthens Glenmark?s respiratory portfolio in the US and underscores its commitment to expanding access to complex inhalation therapies.

According to IQVIA sales data for the 12-month period ended January 2026, the Flovent HFA Inhalation Aerosol, 44 mcg market recorded annual sales of approximately $520.1 million.

Marc Kikuchi, President & Business Head, North America said, ?receiving approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation marks an important milestone in strengthening our respiratory portfolio in the U.S. The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams in bringing complex inhalation therapies to market. We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers.?

Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets.

Glenmark Pharmaceuticals, the company, reported a 15.9% jump in consolidated net profit to Rs 403.21 crore on a 17.8% increase in revenue from operations to Rs 3,888 crore in Q3 FY26 over Q3 FY25.

The counter dropped 4.07% to Rs 2,037 on the BSE.

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Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation.

Glenmark's Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation has been determined by the FDA to be bioequivalent and therapeutically equivalent1 to the reference listed drug (RLD), FloVent?2 HFA Inhalation Aerosol, 44 mcg of GlaxoSmithKline Intellectual Property Ltd. England (NDA - 021433).

Glenmark has been granted a Competitive Generic Therapy (CGT) designation for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation and is the ?first approved applicant as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act. Therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialization.

Glenmark's Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA starting in March 2026. The approval further strengthens Glenmark's respiratory portfolio in the U.S. and underscores its commitment to expanding access to quality inhalation therapies.

According to IQVIA sales data for the 12-month period ending January 2026, the FloVent? HFA Inhalation Aerosol, 44 mcg market3 achieved annual sales of approximately $520.1 million.

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The said injection is bioequivalent and therapeutically equivalent to the reference listed drug, Sodium Phosphates Injection USP, 45 mM P/15 mL (3 mM P/mL), of Hospira, Inc.

The company stated that the 15 mM P/5 mL and 150 mM P/50 mL presentations are expected to have the same therapeutic effect as the reference listed drug upon which the US Food and Drug Administration (FDA) relied as the basis for safety and effectiveness.

The pharma company will begin distribution in April 2026.

According to IQVIA sales data for the 12-month period ending December 2025, the Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials market achieved annual sales of approximately $66.8 million.

Marc Kikuchi, president & business head, North America said, ?We look forward to the upcoming launch of Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials, strengthening our commitment to bring to market quality and affordable alternatives for patients, while also further expanding our portfolio of products within the institutional channel.?

Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets.

The company?s consolidated net profit jumped 15.9% to Rs 403.21 crore on 17.8% increase in net sales to Rs 3888 crore in Q3 FY26 over Q3 FY25.

The counter shed 0.20% to Rs 2,122.80 on the BSE.

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Glenmark Pharmaceuticals Inc., USA (Glenmark) announced the upcoming launch of Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials.

Glenmark's Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Sodium Phosphates Injection USP, 45 mM P/15 mL (3 mM P/mL), of Hospira, Inc. [NDA 018892], with the 15 mM P/5 mL (3 mM P/mL) and 150 mM P/50 mL (3 mM P/mL) presentations expected to have the same therapeutic effect as that of the listed drug product upon which the FDA relied as the basis of safety and effectiveness.

Glenmark will begin distribution in April 2026.

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