Gland Pharma gets USFDA approval for Vasopressin injections

Gland Pharma Limited announced on August 26, 2025, that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vasopressin in 5% Dextrose Injection, 40 Units per 100 mL (0.4 Units per mL) RTU Vials. Additionally, the company secured a tentative approval for Vasopressin in 5% Dextrose Injection, 20 Units per 100 mL (0.2 Units per mL) RTU Vials.

These approvals are for products bioequivalent and therapeutically equivalent to VASOSTRICT Injection from PH Health Limited. The injections are indicated to increase blood pressure in adults experiencing vasodilatory shock who remain hypotensive despite fluid and catecholamine treatments.

According to IQVIA, the product generated approximately $45 million in US sales for the twelve months ending June 2025. Gland Pharma, established in 1978, is a prominent injectable and ophthalmic-focused pharmaceutical company with a global presence across 60 countries.