India Pharma Outlook Team | Friday, 06 March 2026
Gland Pharma, a large injectable-based pharmaceutical company, has declared that it has obtained a tentative approval of its Abbreviated New Drug Application (ANDA) of Brimonidine Tartrate Ophthalmic Solution 0.025, a company that has appointed itself as a pharmaceutical company, specializing in injectables.
The solution is reported to be used in the treatment of red eyes, and Gland Pharma claims that it is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lumify Ophthalmic Solution, 0.025 percent, of Bausch and Lomb Inc.
It has been a success in the market with IQVIA data showing that the US sales stand at about 39 million of the product over the 12 months to September 2025. This is a great milestone for Gland Pharma since it has increased its product line in the ophthalmic space.
“This tentative approval from the USFDA underscores our commitment to delivering high-quality, affordable ophthalmic solutions to patients. We believe that Brimonidine Tartrate Ophthalmic Solution will offer a valuable option for those seeking relief from eye redness and will contribute to our growing portfolio of treatments,” said Shyamakant Giri, CEO of Gland Pharma.
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Gland Pharma is an injectable-oriented company founded in 1978 in Hyderabad, which has risen to become one of the biggest companies of its kind across the world. Since its inception as a contract manufacturer of small-volume liquid parenteral products, the company has grown to become a significant player having global presence, operating in more than 60 countries, with the United States, Europe, Canada, Australia and India being the main markets.
The recent acceptance of Brimonidine Tartrate Ophthalmic Solution is expected to enhance the presence of Gland Pharma in the U.S. market and reinforce the contribution to the treatment of eye-related conditions across the globe.
