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.
According to
IQVIA, the product had US sales of approximately USD 15 million for the twelve months ending September
2024
Read also: USFDA nod to Gland Pharma Latanoprost Ophthalmic Solution
Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and develops, manufactures, and markets sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
