Gland Pharma receives USFDA tentative approval for Brimonidine Tartrate Ophthalmic Solution

Gland Pharma announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC).

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

Brimonidine Tartrate Ophthalmic Solution, 0.025% is indicated for the relief of redness of the eye. According to IQVIA data, the product recorded US sales of approximately $39 million for the twelve months ended September 2025.

Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.

The company reported a 27.7% increase in consolidated net profit to Rs 261.48 crore on a 22.5% rise in net sales to Rs 1,695.36 crore in Q3 FY26 as compared with Q3 FY25.

The counter slipped 3.26% to Rs 1,736.60 on the BSE.

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