Gland Pharma Ltd. has secured tentative approval from the United States Food and Drug Administration (USFDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024 percent.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyzulta Ophthalmic Solution, 0.024 percent, registered by Bausch and Lomb Inc. (Bausch and Lomb)

Based on the available updates, the company believes that it is the first applicant to have filed its ANDA with Paragraph IV certification. Upon final approval, the company may be eligible for 180 days of generic drug exclusivity.

Latanoprostene Bunod Ophthalmic Solution, 0.024 percent, is indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. According to IQVIA, the product had US sales of approximately USD 153 million for the twelve months ended December 2023.

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 one of the largest and fastest 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 has an excellent track record in the development, manufacturing, and marketing of sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions, and also enjoys the distinction of having pioneered Heparin technology in India.