Gland Pharma has announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Latanoprost Ophthalmic Solution, 0.005 per cent (2.5 mL fill).
The product is both bioequivalent and therapeutically equivalent to the reference listed drug Xalatan, manufactured by UPJOHN US 2 LLC. Latanoprost Ophthalmic Solution is indicated for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
According to IQVIA, the market for the product in the United States was valued at approximately USD 111.6 million for the twelve months ending December 2023. Gland Pharma plans to launch the product through its marketing partners in the financial year 2025, further enhancing its footprint in the ophthalmic segment.
The approval marks a key milestone for Gland Pharma, which has built a reputation for its expertise in sterile injectables and ophthalmic solutions. Established in 1978 in Hyderabad, the company has expanded its presence across 60 countries, including major markets in the United States, Europe, Canada, and Australia.
Operating primarily under a business-to-business (B2B) model, Gland Pharma has a robust portfolio spanning vials, ampoules, pre-filled syringes, lyophilised vials, infusions, oncology treatments, and ophthalmic products. It has also been a pioneer of Heparin technology in India.
The company’s state-of-the-art manufacturing facilities and compliance with global quality standards have enabled it to secure consistent regulatory approvals, reinforcing its reputation in the pharmaceutical sector.
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