Gland Pharma Limited announced today that it has received United States Food and Drug Administration (USFDA) approval for Latanoprost Ophthalmic Solution, 0.005 per cent (2.5 mL Fill).
The pharmaceutical company’s latest product is bioequivalent to Xalatan, the reference listed drug held by UPJOHN US 2 LLC.
The shares of Gland Pharma Limited were trading at ₹1,807 up by ₹26.90 or 1.51 per cent on the NSE today at 12.18 pm.
The ophthalmic solution is designed to treat high intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
According to IQVIA data, the product segment generated approximately $111.6 million in US sales for the twelve months ending December 2023.
Gland Pharma, established in 1978 in Hyderabad, has evolved from a contract manufacturer of small-volume liquid parenteral products to a major injectable-focused pharmaceutical company.
With a global presence across 60 countries, the company operates primarily on a business-to-business model, specializing in sterile injectables including vials, ampoules, pre-filled syringes, and ophthalmic solutions.
The company plans to launch the product through its marketing partners in the fiscal year 2025. Gland Pharma expects this FDA approval to further strengthen its position in the US pharmaceutical market.
