Gland Pharma, specializing in generic injectable pharmaceuticals, has obtained approval from the US Food and Drug Administration (FDA) for their latanoprost ophthalmic solution, 0.005% (2.5 mL Fill).
The medication is deemed both bioequivalent and therapeutically comparable to the reference listed drug, Xalatan, which is a latanoprost ophthalmic solution 0.005% (50 pg/mL) owned by Upjohn US 2 LLC. This ophthalmic product is indicated for managing elevated intraocular pressure in individuals suffering from open-angle glaucoma or ocular hypertension.
The company plans to introduce this product to the market through its distribution partners in the fiscal year 2025. Based on IQVIA data, the product secured US sales amounting to around USD 111.6 million over the twelve months leading up to December 2023.
Founded in 1978 in Hyderabad, Gland Pharma evolved from a contract manufacturer of small-volume liquid injectable products to emerge as a leading company in the injectable sector, with a presence spanning 60 countries, including key markets like the United States, Europe, Canada, Australia, India, and beyond.