Gland Pharma Ltd Share Price – NSE  /  BSE

Pharmaceuticals, Small Cap

Gland Pharma announced that the United States Food and Drug Administration (US FDA) has conducted surprise inspection of the Company's Dundigal Facility at Hyderabad for Good Manufacturing Practices (GMP) between 22 July 2024 and 25 July 2024.

The inspection was concluded with TWO (2) 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity.

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Gland Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) 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%, registered by Bausch & Lomb Inc. (Bausch & 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%, 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.

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Gland Pharma will hold a meeting of the Board of Directors of the Company on 6 August 2024.

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Gland Pharma Ltd is up for a third straight session in a row. The stock is quoting at Rs 1950.1, up 3.45% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.3% on the day, quoting at 24393.55. The Sensex is at 80262.7, up 0.38%. Gland Pharma Ltd has risen around 3.33% in last one month.

Meanwhile, Nifty Pharma index of which Gland Pharma Ltd is a constituent, has risen around 3.66% in last one month and is currently quoting at 20325.8, up 0.85% on the day. The volume in the stock stood at 2.54 lakh shares today, compared to the daily average of 3.46 lakh shares in last one month.

The PE of the stock is 29.76 based on TTM earnings ending March 24.

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