Gland Pharma Limited has informed the Exchange regarding a press release dated August 26, 2025, titled "Gland Pharma receives approval from the United States Food and Drug Administration (USFDA) for Vasopressin 5% Dextrose Injection USP (RTU vial)".
GLAND · price
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Gland Pharma has received USFDA approval for its generic Vasopressin in 5% Dextrose Injection, 40 Units per 100 mL RTU vial, along with a tentative approval for the 20 Units per 100 mL variant. The product is bioequivalent to the branded reference drug VASOSTRICT sold by PH Health Limited. It is used to increase blood pressure in adults with vasodilatory shock who do not respond to fluids and catecholamines. According to IQVIA, the US market for this product was approximately USD 45 million for the twelve months ending June 2025.
Positive for shareholders — this approval allows Gland Pharma to tap into a ~USD 45 million US market with its generic version, potentially boosting future US revenues. Gland operates primarily as a B2B injectable manufacturer, so the actual commercial impact will depend on supply contracts and launch timing with channel partners.