Gland Pharma Limited has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC).
The company stated that the product is bioequivalent and therapeutically equivalent to the reference listed drug Lumify Ophthalmic Solution, 0.025%, marketed by Bausch & Lomb.
Brimonidine Tartrate Ophthalmic Solution, 0.025% is indicated for relieving redness of the eye and is available as an over-the-counter treatment.
According to healthcare data analytics firm IQVIA, the reference product recorded US sales of approximately USD 39 million for the twelve months ending September 2025.
About Gland Pharma
Gland Pharma Limited was established in 1978 and is headquartered in Hyderabad, India. Over the years, the company has evolved from a contract manufacturer of small-volume liquid parenteral products into one of the largest injectable-focused pharmaceutical companies globally.
The company operates primarily through a business-to-business (B2B) model and has a presence in more than 60 countries, including the United States, Europe, Canada, Australia, and India.
Its portfolio includes a wide range of sterile injectable products such as vials, ampoules, pre-filled syringes, lyophilized vials, dry powder injectables, infusions, oncology drugs, and ophthalmic solutions. Gland Pharma also holds the distinction of pioneering Heparin technology in India, strengthening its position in the injectable pharmaceutical segment.
With the tentative USFDA approval for Brimonidine Tartrate Ophthalmic Solution, the company continues to expand its ophthalmic and injectable portfolio in regulated markets.