Gland Pharma Limited based in Hyderabad received approval from the United States Food and Drug Administration (USFDA) to develop its Abbreviated New Drug Application (ANDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024% at its facilities. The firm proved that its product maintained bioequivalence alongside therapeutic equivalence to VYZULTA Ophthalmic Solution, 0.024%, which is a listed drug developed by Bausch and Lomb Inc.
The approved medication from the company operates by reducing IOP to treat open-angle glaucoma and ocular hypertension patients. Open-angle glaucoma stands as the prevalent glaucoma subtype which represent various diseases that damage the optic nerve when IOP reaches excessive levels. This generic medication secures Gland Pharma an exclusive First-to-File (FTF) status with a resulting 180-day sales period in the United States market.
The U.S. market sales for the product reached USD 171 million during the twelve months until February according to IQVIA data. The first FDA clearance occurred previously for Gland Pharma to market Latanoprost Ophthalmic Solution, 0.005% (2.5 mL) for eye pressure reduction in similar clinical indications. Gland Pharma started its operations in 1978 before shifting to become a global pharmaceutical leader focused on injectable products. Gland Pharma continues its export operation to a global network consisting of more than 60 countries which encompass major markets including the United States and Canada as well as Europe and Australia and India. Through its B2B business model Gland Pharma produces and markets numerous sterile injectable drug products including vials and ampoules, pre-filled syringes, lyophilized vials and dry powders and infusions as well as oncology and ophthalmic solutions.
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