Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%, an over-the-counter (OTC) product. The approved product is therapeutically equivalent to Pataday Once Daily Relief 0.7% Ophthalmic Solution, marketed by Alcon Laboratories, Inc. Olopatadine Hydrochloride Ophthalmic Solution is indicated for the temporary relief of itchy eyes caused by allergens such as pollen, ragweed, grass, animal hair and dander.
According to IQVIA data, the US market for the product was approximately US$20 million for the 12 months ended September 2026. The approval provides Alembic with an opportunity to participate in this market with its generic version of the established ophthalmic product.
The product has been developed in collaboration with Orbicular Pharmaceutical Technologies Pv. Ltd. The approval further strengthens Alembic’s ophthalmic product portfolio and adds to its range of USFDA-approved generic medicines. With this latest approval, Alembic’s cumulative number of USFDA ANDA approvals has reached 248. This includes 229 final approvals and 19 tentative approvals, reflecting the company’s continued focus on developing and filing generic pharmaceutical products for regulated markets.
The company continues to invest in research and development, product development capabilities and manufacturing infrastructure to expand its presence in international markets. Its strategy includes developing a diversified portfolio of generic medicines across therapeutic areas and dosage forms, with a focus on meeting regulatory requirements in major markets.
Alembic Pharmaceuticals Limited is an Indian pharmaceutical company with a legacy dating back to 1907. Headquartered in India, the company is engaged in the research, development, manufacturing and marketing of pharmaceutical products across global markets. It has established a presence in the generics business and is also a leading player in India’s branded generics market.
Alembic operates manufacturing facilities that are approved by leading regulatory authorities and has a strong research and development infrastructure supporting its product pipeline. Its portfolio covers multiple therapeutic segments and dosage forms, serving customers in India and international markets. The company has a field force of more than 5,800 employees supporting its branded generics business in India.
