Chennai, April 23, 2025: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phytonadione Injectable Emulsion USP, 10 mg/mL, Single Dose Vial, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) VITAMIN K1 Injection, from Hospira Inc.
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K and is indicated for coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. According to IQVIATM (IMS Health), Phytonadione Injectable Emulsion had US sales of approximately $18.5 million for the 12-month period ending February 2025.