USFDA nod to Gland Pharma Latanoprost Ophthalmic Solution
Hyderabad: Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill).
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan, latanoprost ophthalmic solution 0.005% (50 μg/mL) held by UPJOHN US 2 LLC.
This Product is used for the treatment of high eye pressure/intraocular pressure (IOP) in patients with openangle glaucoma or ocular hypertension. The Company expects to launch this Product through its marketing partners in FY25.
According to IQVIA, the product had US sales of approximately USD 111.6 million for the twelve months ending December 2023.
Medical Dialogues team had earlier reported that Gland Pharma Limited, had received tentative approval from the USFDA for Latanoprostene Bunod Ophthalmic Solution, 0.024%.
Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and develops, manufactures, and markets sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
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