Gland Pharma receives approval for Vasopressin in 5% Dextrose RTU Injection

Gland Pharma Limited (Gland or Company), a generic injectable & ophthalmicfocused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Vasopressin in 5% Dextrose Injection, 40 Units per 100 mL (0.4 Units per mL) RTU Vials and tentative approval for Vasopressin in 5% Dextrose Injection, 20 Units per 100 mL (0.2 Units per mL) RTU Vials.

The Product is bioequivalent and therapeutically equivalent to 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) of PH Health Limited (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 had US sales of approximately USD 45 million for the twelve months ending June 2025.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1941.95 as compared to the previous close of Rs. 1958.20. The total number of shares traded during the day was 3299 in over 508 trades.

The stock hit an intraday high of Rs. 1978.00 and intraday low of 1934.10. The net turnover during the day was Rs. 6450096.00.

Source : Equity Bulls

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GlandPharma INE068V01023 USFDA ANDA Approval