Gland Pharma Secures USFDA Tentative Approval for Generic Lumify Eye Drops
Hyderabad: Gland Pharma Limited has announced that it 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).
The product is bioequivalent and therapeutically equivalent to the reference listed drug Lumify Ophthalmic Solution 0.025% developed by Bausch & Lomb Inc. The ophthalmic formulation is indicated for the temporary relief of eye redness.
According to IQVIA market data, the product recorded US sales of approximately USD 39 million for the twelve months ending September 2025, indicating a significant market opportunity for the product in the United States.
Gland Pharma, headquartered in Hyderabad, is a pharmaceutical company primarily focused on sterile injectables and ophthalmic products. Established in 1978, the company has expanded its presence to more than 60 countries, including the United States, Europe, Canada, Australia, and India. It operates mainly under a business-to-business (B2B) model and has developed expertise in the manufacturing and marketing of sterile injectable formulations.
The company’s product portfolio includes vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology drugs, and ophthalmic solutions. Gland Pharma is also known for pioneering Heparin technology in India.
The tentative approval from the USFDA represents an important regulatory milestone and is expected to strengthen the company’s ophthalmic product portfolio in the US market.
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