Gland Pharma Ltd receives tentative approval from USFDA

Gland Pharma Limited (Gland or Company), a generic injectable & ophthalmic focused pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (USFDA)for its Abbreviated New Drug Application filed for Brimonidine Tartrate Ophthalmic Solution,0.025% (OTC).

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lumify Ophthalmic Solution, 0.025%, of Bausch& Lomb Inc.

This Product is indicated to relieve redness of the eye.

According to IQVIA, the product had USsales of approximately USD 39 million for the twelve months ending September 2025.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1795.10 as compared to the previous close of Rs. 1823.00. The total number of shares traded during the day was 5687 in over 769 trades.

The stock hit an intraday high of Rs. 1800.05 and intraday low of 1700.05. The net turnover during the day was Rs. 10099155.00.

Source : Equity Bulls

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GlandPharma INE068V01023 Pharmaceuticals USFDA TentativeApproval