Gland Pharma receives approval from USFDA for Latanoprostene Bunod Opthalmic Solution

Gland Pharma Limited (Gland or Company), a generic injectable & ophthalmic focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Latanoprostene Bunod Ophthalmic Solution, 0.024%.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024%, of Bausch and Lomb, Inc.

This Product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity.

According to IQVIA, the product had US sales of approximately USD 171 million for the twelve months ending February 2025.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1404.70 as compared to the previous close of Rs. 1398.35. The total number of shares traded during the day was 3854 in over 500 trades.

The stock hit an intraday high of Rs. 1419.85 and intraday low of 1382.10. The net turnover during the day was Rs. 5413068.00.

Source : Equity Bulls

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GlandPharma INE068V01023 USFDA Approval LatanoprosteneBunod OphthalmicSolution