Gland Pharma receives approval for Norepinephrine Bitartrate in 5% Dextrose Injection Bags

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 through its partner for Norepinephrine Bitartrate in 5% Dextrose Injection, 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL)Single-Dose Bags.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), NOREPINEPHRINE BITARTRATEIN 5% DEXTROSE of Baxter Healthcare Corp.

This Product is indicated to raise blood pressure in adult patients with severe, acute hypotension.

We are the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity. According to IQVIA, the product had USsales of approximately USD 55 million for the twelve months ending June 2025.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1936.40 as compared to the previous close of Rs. 1933.00. The total number of shares traded during the day was 3611 in over 392 trades.

The stock hit an intraday high of Rs. 1944.40 and intraday low of 1908.25. The net turnover during the day was Rs. 6960970.00.

Source : Equity Bulls

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GlandPharma INE068V01023 USFDA Approval NorepinephrineBitartrate