Gland Pharma gets US FDA approval for hypotension treatment drug Angiotensin II

Gland Pharma said that it has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Angiotensin II Acetate Injection.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) GIAPREZA of La Jolla Pharma LLC.

This product is indicated for increasing the blood pressure in adults with septic or other distributive shock.

Gland Pharma is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity.

According to IQVIA, the product had US sales of approximately $58 million for the twelve months ending March 2025.

 

Gland Pharma is one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered heparin technology in India.

The company's consolidated net profit declined 3.06% to Rs 186.54 crore as net sales fell by 7.32% to Rs 1424.91 crore in Q4 FY25 as compared with Q4 FY24.

The scrip rose 0.32% to currently trade at Rs 1598.95 on the BSE.

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