Gland Pharma gets FDA Nod For Generic Drug

New Delhi: Gland Pharma on Wednesday said it has received approval from the US health regulator for a generic medication used to increase blood pressure. The Hyderabad-based firm has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Angiotensin II Acetate Injection 2.5 mg/mL, Gland Pharma said.

Gland Pharma is the exclusive “First-to-File” and is eligible for 180 days of generic drug exclusivity. The company’s product is therapeutically equivalent to La Jolla Pharma LLC’s reference listed drug Giapreza.

The drug is indicated for increasing the blood pressure in adults with septic or other distributive shock. According to IQVIA, the product had US sales of around USD 58 million for the 12 months ending March 2025. Gland Pharma is one of the largest injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets