USFDA nod to Gland Pharma Vitamin K deficiency treatment drug
Hyderabad: Gland Pharma Limited, 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.
Vitamin K is a fat-soluble vitamin essential for blood clotting (coagulation) and bone metabolism. A deficiency in vitamin K can lead to various health problems, primarily associated with bleeding and bone health.
The Company expects to launch this Product through its marketing partners in the near future.
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