In a stock exchange filing, the company said it has received approval from the US drug regulator for Angiotensin II Acetate injection, 2.5 mg/mL, for treating blood pressure in adults with septic or other distributive shock.
The approved product is the generic equivalent of GIAPREZA, a drug developed by La Jolla Pharma LLC, the Hyderabad-based Gland Pharma said in a stock exchange filing.
The new drug is indicated for increasing blood pressure in adults experiencing septic or other forms of distributive shock, the company said.
Gland Pharma’s version has been confirmed as bioequivalent and therapeutically equivalent to the reference listed drug (RLD).
Also, Gland Pharma holds exclusive First-to-File (FTF) status for this product, making it eligible for 180 days of generic drug exclusivity in the US market.
According to IQVIA data, the US market for Angiotensin II Acetate Injection was valued at approximately $58 million for the twelve months ended March 2025.
Gland Pharma’s fourth quarter net profit declined 3.1% to ₹186.5 crore from the previous year’s ₹192.4 crore. It was also below CNBC-TV18’s poll of ₹219.8 crore.
Revenue from operations declined 7.3% to ₹1,424.9 crore from ₹1,537.5 crore in the previous year. This too missed expectations, with the CNBC-TV18 poll estimating a revenue of ₹1,484.3 crore.
The stock was trading 1.83% higher at ₹1618 apiece AR 10.35 am.
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