Gland Pharma has secured approval from the United States Food and Drug Administration (US FDA) 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 KI1 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 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.

Gland Pharma was established in 1978 in Hyderabad and grew over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest 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 has an excellent track record in developing, manufacturing, and marketing sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology and ophthalmic solutions. It also enjoys the distinction of having pioneered Heparin technology in India.