Gland Pharma Limited, a prominent generic injectable pharmaceutical company, has announced the approval of Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules by the United States Food and Drug Administration (USFDA). This product, which is bioequivalent and therapeutically equivalent to the reference listed drug Vitamin K1 Injectable Emulsion USP, 10 mg/mL by Hospira, Inc., is indicated for coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.
The approval sets the stage for the company to launch the product through its marketing partners. According to IQVIA, the product had US sales of approximately USD 15 million for the twelve months ending September 2024.
Gland Pharma, founded in 1978 and headquartered in Hyderabad, has established itself as one of the largest injectable-focused companies in the world, with a footprint in over 60 countries, including the United States, Europe, Canada, Australia, and India.
