Lupin Secures FDA Nod For Vitamin K Injection
(RTTNews) - Lupin Limited (LUPIN) said the U.S. FDA has approved its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe, adding another product to the company's U.S. injectable medicines portfolio.
Phytonadione, commonly known as vitamin K1, is used to treat and prevent hypoprothrombinemia, a condition in which the blood does not clot properly, as well as vitamin K deficiency. These conditions can increase the risk of excessive bleeding and may occur due to certain medical conditions or medications.
The FDA approved Lupin's product through the Abbreviated New Drug Application (ANDA) pathway. According to the company, the product has been found to be a bioequivalent to the reference listed drug, Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, manufactured by International Medication Systems, Limited.
The approved therapy is supplied as a single-dose prefilled syringe, a format designed to facilitate preparation and administration in clinical settings.
According to IQVIA data cited by the company, the product had estimated annual sales of $52.3 million as of August 2026.
The approval further strengthens Lupin's presence in the U.S. generics and injectable medicines market as the company continues to expand its portfolio across hospital and specialty care.
LUPIN has traded between INR 1,900.00 and INR 2,529.50 over the past year The stock closed Thursday's trading at INR 1,936.90, down 3.78%
