Gland Pharma Limited (BSE: 543245, NSE: GLAND) has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).
The approved product is therapeutically equivalent to Pataday Once Daily Relief, 0.7%, marketed by Alcon Laboratories Inc. It is indicated for the treatment of ocular itching associated with allergic conjunctivitis, a common condition affecting seasonal and perennial allergy sufferers.
The approval enables Gland Pharma to market the product in the United States as an over-the-counter ophthalmic solution, strengthening its presence in the ophthalmic segment of the U.S. generics market. The product adds to the company’s expanding portfolio of sterile and non-sterile formulations developed for regulated markets.
Founded in 1978 and headquartered in Hyderabad, Gland Pharma has evolved from a contract manufacturer of small-volume parenterals into one of the largest injectable-focused pharmaceutical companies globally. The company operates primarily under a business-to-business model and supplies products to customers in more than 60 countries, including the United States, Europe, Canada, Australia, and India.
Gland Pharma has established a strong track record in the development, manufacturing, and commercialization of sterile injectables and ophthalmic products. Its product portfolio includes vials, ampoules, pre-filled syringes, lyophilized formulations, dry powders, infusions, oncology products, and ophthalmic solutions. The company is also recognized for pioneering heparin technology in India.
The latest approval reflects Gland Pharma’s continued focus on quality, regulatory compliance, and expanding access to affordable medicines in regulated markets. The company continues to invest in manufacturing capabilities and product development to support long-term growth in injectables and ophthalmic therapies.
