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Gland Pharma Secures USFDA Nod for Vasopressin Injection
Gland Pharma receives USFDA approval for Vasopressin Injection in the U.S. market. The product is bioequivalent to VASOSTRICT, with U.S. sales of around USD 45 million in the last 12 months.
Gland Pharma Ltd has announced a key regulatory milestone with the U.S. Food and Drug Administration (USFDA) approval for its Vasopressin Injection.
The company has received full approval for Vasopressin 5% Dextrose Injection USP, 40 Units/100 mL (RTU vial).
Additionally, it has obtained tentative approval for Vasopressin 5% Dextrose Injection USP, 20 Units/100 mL (RTU vial).
The product is bioequivalent and therapeutically equivalent to VASOSTRICT, the reference listed drug.
According to IQVIA data, U.S. sales for the Vasopressin injection were approximately USD 45 million for the 12 months ending June 2025.
The approval enhances Gland Pharma’s specialty injectables portfolio in the U.S., strengthening its foothold in the critical care therapeutic category. With this, the company is expected to capture share in a niche but important segment, given the ongoing demand for hospital-use injectables.
