Gland Pharma 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 is eyeing to launch this Product through its marketing partners in the near future. According to IQVIA, the product had US sales of around $15 million for the twelve months ending September 2024.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
