Lupin Limited announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.
The U.S. FDA approved Lupin's product as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited. The product is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency.
According to IQVIA data, Phytonadione Injectable Emulsion had estimated annual sales of USD 52.3 million in the U.S. market for the period ending August 2026.
The disclosure was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 and was signed by Amit Kumar Gupta, Company Secretary & Compliance Officer of Lupin Limited.
Company Background
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with presence across India, the U.S., Other Developed Markets, and Emerging Markets. The company's products are distributed in over 100 markets and include generics, complex generics, specialty medicines, and biosimilars. Lupin maintains strong leadership in the U.S. and India across therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. The company operates 15 manufacturing facilities and 6 research centers with over 26,000 professionals.