USFDA nod to Gland Pharma Vitamin K deficiency treatment drug

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-12-12 05:56 GMT | Update On 2024-12-12 06:01 GMT

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

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA nod to Gland Pharma Vitamin K deficiency treatment drug

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