Gland Pharma receives approval for Phytonadione Injection Emulsion

Gland Pharma Limited (Gland or Company), a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vitamin K1 Injectable Emulsion USP, 10 mg/mL, of Hospira, Inc.

This Product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.

The Company expects to launch this Product through its marketing partners in the near future. According to IQVIA, the product had US sales of approximately USD 15 million for the twelve months ending September 2024.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1775.35 as compared to the previous close of Rs. 1763.45. The total number of shares traded during the day was 4592 in over 588 trades.

The stock hit an intraday high of Rs. 1787.10 and intraday low of 1755.70. The net turnover during the day was Rs. 8153997.00.

Source : Equity Bulls

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GlandPharma INE068V01023 USFDA Approval PhytonadioneInjectableEmulsion