Gland Pharma Limited, a leading injectable and ophthalmic-focused pharmaceutical company, has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).
The approved product is therapeutically equivalent to the reference listed drug Pataday Once Daily Relief 0.7%, marketed by Alcon Laboratories Inc. The formulation is indicated for the treatment of ocular itching associated with allergic conjunctivitis, a condition that affects a large patient population, particularly during allergy seasons.
This USFDA approval strengthens Gland Pharma’s ophthalmic portfolio in the over-the-counter segment of the US market and reinforces its capabilities in developing complex and regulated dosage forms. Olopatadine Hydrochloride Ophthalmic Solution 0.7% is widely used for its once-daily dosing convenience and proven efficacy in managing allergy-related eye symptoms, making it a high-demand product in the US ophthalmic space.
Founded in 1978 and headquartered in Hyderabad, Gland Pharma has evolved from a contract manufacturer of small-volume liquid parenterals into one of the world’s largest injectable-focused pharmaceutical companies. The company operates predominantly under a business-to-business model and has built a strong global presence across more than 60 countries, including the United States, Europe, Canada, Australia, and India.
