Generic injectable-focused pharmaceutical firm Gland Pharma Ltd on Wednesday announced receiving tentative approval from the United States Food and Drug Administration (USFDA) for an injection used in the treatment of low blood pressure.

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The Hyderabad-based company has received approval for the Angiotensin II Injection, 2.5 mg/mL Single Dose Vial, according to a stock exchange filing.

Gland Pharma informed the bourses that it might be eligible for 180 days of generic drug exclusivity as it is the only company with the first to file for the product.

The company will launch the product with its marketing partner after receiving final approval from the US drug regulator, as stated in the filing.

According to IQVIA data, the Angiotensin II Injection, 2.5 mg/mL Single Dose Vial, had sales of around $38 million for 12 months to September 2023 in the US.

Angiotensin II injections are used to treat low blood pressure. The medicine constricts blood vessels, making them narrower, and helps raise blood pressure.

Gland Pharma reported a 5% increase in revenue from the US market at ₹708.2 crore for the September quarter as against 673.8 crore in the year-ago period. The US market accounted for 54% of Q2 FY24 revenue, as against 65% in Q2FY23.

Its total revenue from operations was ₹1,373.4 crore in the July-September quarter against ₹ 1,044 crore in the year-ago quarter, reflecting a rise of 32% YoY.

Its operating profit, or EBITDA, rose by 17% YoY to ₹ 347.3 crore in Q2 of FY24 against ₹296.9 crore in the same quarter a year ago. Profit after tax, however, dropped 20% to ₹194.1 crore in Q2FY24 compared to ₹241.2 crore in the year-ago quarter.

#JustIn | Gland Pharma gets tentative US FDA nod for Angiotensin II Injection- Alert: Angiotensin II injection is used to increase blood pressure in adults pic.twitter.com/6mJxTX6FRt

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Gland Pharma shares were trading 0.96% lower at ₹1608.80 apiece on BSE at 12.12 PM.

(Edited by : Ajay Vaishnav)

First Published:Nov 15, 2023 1:26 PM IST