03 May 2025

Gland Pharma Gains After USFDA Nod for Eye Drug, Eligible for 180-Day Exclusivity

Gland Pharma is currently trading at RS. 1405.00, up by 6.65 points or 0.48% from its previous close of RS. 1398.35 on the BSE.

The stock opened at RS. 1390.65 and has touched a high of RS. 1419.85 and a low of RS. 1382.10 so far. A total of 3316 shares have been traded on the counter.

Classified under BSE group 'A', the stock with a face value of RS. 1 hit a 52-week high of RS. 2220.95 on August 6, 2024, and a 52-week low of RS. 1200.00 on April 7, 2025. Over the last week, the stock has fluctuated between RS. 1476.75 and RS. 1382.10. The current market capitalization of the company stands at RS. 23190.29 crore.

Promoters hold 51.83% stake in the company, while institutional investors and non-institutional investors hold 40.17% and 7.99%, respectively.

In a key development, Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024%.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) VYZULTA Ophthalmic Solution, 0.024% by Bausch and Lomb, Inc. It is indicated for reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Notably, Gland Pharma is the exclusive First-to-File applicant and is entitled to 180 days of generic drug exclusivity. As per IQVIA data, the product recorded US sales of approximately $171 million in the 12 months ending February 2025.

Gland Pharma specializes in developing, manufacturing, and marketing complex injectables, and primarily operates under a business-to-business model across various global markets.