Gland Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC). This ophthalmic solution is bioequivalent to the reference listed drug, Lumify Ophthalmic Solution. The product targets relieving redness of the eye, capitalizing on a market segment generating approximately USD 39 million in US sales annually.
Gland Pharma Secures Tentative Approval
On March 04, 2026, Gland Pharma Limited announced that it has successfully received tentative approval from the United States Food and Drug Administration (USFDA). This approval pertains to its Abbreviated New Drug Application (ANDA) for the Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC).
Product Details and Market Context
The forthcoming product is confirmed to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is Lumify Ophthalmic Solution, 0.025%, manufactured by Bausch & Lomb Inc. The primary indication for this ophthalmic solution is the relief of redness of the eye.
The market opportunity is substantial. According to IQVIA data cited in the release, the product generated US sales approximating USD 39 million for the twelve months ending in September 2025, positioning Gland Pharma to enter a significant market segment upon final approval.
About Gland Pharma
Gland Pharma, established in 1978 in Hyderabad, has evolved into one of the world’s largest injectable-focused pharmaceutical companies. Operating primarily under a business-to-business (B2B) model, the company boasts a global footprint spanning 60 countries. Gland Pharma maintains a strong track record in developing and manufacturing a diverse portfolio of sterile injectables, including vials, ampoules, pre-filled syringes, and specialty solutions like oncology and ophthalmic products. The company also holds the distinction of pioneering Heparin technology in India.
Source: BSE
