Gland Pharma rises on USFDA nod for vitamin-K deficiency drug

Gland Pharma added 1.75% to Rs 1,806.45 after the pharmaco 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.

The approved drug is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.

The pharma company expects to launch this Product through its marketing partners in the near future.

According to IQVIA, the product had US sales of approximately $15 million for the twelve months ending September 2024.

 

Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India.

On a consolidated basis, the firms net profit declined 15.74% to Rs 163.53 crore despite a 2.36% increase in revenue from operations to Rs 1,405.83 crore in Q2 FY25 over Q2 FY24.

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