Gland Pharma Limited, a Hyderabad-based generic injectable and ophthalmic-focused pharmaceutical company, announced 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. The company has also secured tentative approval for Vasopressin in 5% Dextrose Injection, 20 Units per 100 mL (0.2 Units per mL) RTU Vials.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) VASOSTRICT Injection (40 Units/100 mL and 20 Units/100 mL) marketed by PH Health Limited. Vasopressin injection is indicated for increasing blood pressure in adults with vasodilatory shock who remain hypotensive despite adequate fluid resuscitation and catecholamine support.
According to IQVIA data, the Vasopressin injection market in the United States recorded sales of around USD 45 million for the twelve months ending June 2025.
This latest USFDA approval further strengthens Gland Pharma’s injectable portfolio in regulated markets, highlighting its focus on expanding critical care therapies.
