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Gland Pharma Limited, a prominent generic injectable and ophthalmic-focused pharmaceutical company, has announced a significant achievement, receiving approval from the United States Food and Drug Administration (USFDA) for its Vasopressin 5% Dextrose Injection USP.
This crucial development, revealed on 26 August 2025, marks a milestone for the Hyderabad-based company, enhancing its portfolio in the highly competitive US market.
Dual Approvals from USFDA Bolster Gland Pharma’s Portfolio
The USFDA has granted Gland Pharma Limited full approval 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. This ready-to-use formulation is set to provide an important treatment option in the United States.
In addition to the full approval, the Company has also received a tentative approval from the USFDA for Vasopressin in 5% Dextrose Injection, 20 Units per 100 mL (0.2 Units per mL) RTU Vials.
These approvals underscore Gland Pharma‘s robust capabilities in developing and manufacturing complex sterile injectables, positioning it for further growth in key international markets.
Understanding the Product and its Market Impact:
The reference listed drug (RLD), **VASOSTRICT Injection 40 Units per 100 mL (0.4 Units per mL) and 20 Units per 100 mL (0.2 Units per mL), is *bioequivalent and therapeutically equivalent* to the approved product, Vasopressin in 5% Dextrose Injection, which is produced by PH Health Limited.
This equivalence ensures that Gland Pharma’s product will offer the same clinical benefits as the established brand.
Critically, this injectable product is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite receiving fluids and catecholamines.
Vasodilatory shock is a severe medical condition where blood vessels dilate excessively, leading to dangerously low blood pressure, and effective treatments are vital for patient outcomes.
The introduction of Gland Pharma’s generic version is expected to contribute to treatment accessibility. According to data from IQVIA, the product registered US sales of approximately USD 45 million for the twelve months ending June 2025, highlighting its significant market presence and the potential for Gland Pharma’s newly approved offering.
Gland Pharma: A Global Injectables Leader with a Rich Legacy
Gland Pharma Limited was founded in Hyderabad in 1978 and has gradually changed from being a contract maker of small-volume liquid parenteral medicines.
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