Gland Pharma Receives Tentative USFDA Approval for Latanoprostene Bunod Ophthalmic Solution

On July 23, 2024, Gland Pharma Limited, a company specialising in generic injectable drugs, announced via a stock exchange filing that it has received tentative approval from the USFDA (US Food and Drug Administration ) for its Latanoprostene Bunod Ophthalmic Solution, 0.024%. This product is considered equivalent to Bausch & Lomb Inc.’s Vyzulta® Ophthalmic Solution, 0.024%.

Gland Pharma believes it is the first company to file an Abbreviated New Drug Application (ANDA) with Paragraph IV certification for this product. If it receives final approval, it might get 180 days of exclusive rights to sell the generic version.

Latanoprostene Bunod Ophthalmic Solution, 0.024%, is used to lower high intraocular pressure in people with open-angle glaucoma or ocular hypertension. According to IQVIA, as of December 2023, this product had US sales of about USD 153 million.

Financial Highlights

In Q4 results, Gland Pharma reported consolidated profit after tax (PAT) more than doubled to ₹192 crore for the March quarter. This compares to a PAT of ₹79 crore in the same quarter last year, the Hyderabad-based pharmaceutical company said in a statement. Revenue from operations increased to ₹1,537 crore in the fourth quarter of FY24, up from ₹785 crore in the corresponding period the previous year. For the FY ending March 31, 2024, the company reported a PAT of ₹772 crore, slightly down from ₹781 crore in the 2022-23 fiscal year. The company has also announced that its board has recommended a final dividend of ₹20 per share for the FY ending March 31, 2024, pending approval from shareholders.

About Gland Pharma Limited

Founded in Hyderabad in 1978, Gland Pharma has evolved from a contract manufacturer of small liquid injectable products to one of the largest injectable-focused companies globally. It operates in 60 countries, including the US, Europe, Canada, Australia, India, and others. Gland Pharma mainly follows a business-to-business (B2B) model and has a strong record in developing, manufacturing, and marketing sterile injectables. Their product range includes vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. Notably, Gland Pharma pioneered Heparin technology in India.

On July 23, 2024, the share price of Gland Pharma Ltd opened at ₹2,006.45 and closed at ₹1,987.00 on the NSE.

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