Gland Pharma receives USFDA nod for Vasopressin in 5% Dextrose RTU injection

Gland Pharma announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vasopressin in 5% Dextrose injection, (0.4 Units/mL) RTU vials.

The company also received tentative approval for the (0.2 Units/mL) RTU vials of the same formulation.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection (0.4 Units/mL) and (0.2 Units/mL) of PH Health.

This product is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

According to IQVIA, the product recorded U.S. sales of approximately USD 45 million for the twelve months ending June 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 surged 49.88% to Rs 215.48 crore in Q1 FY26 as against Rs 143.76 crore posted in Q1 FY25. Revenue from operations increased by 7.41% YoY to Rs 1,505.62 crore for the quarter ended 30 June 2025.

The counter shed 0.05% to Rs 1,941 on the BSE.

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