Caplin Steriles secures USFDA approval for phytonadione injectable emulsion

Caplin Point Laboratories announced today that its subsidiary, Caplin Steriles, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 10 mg/mL, Single Dose Vial. The product is a generic therapeutic equivalent to Hospira Inc.'s VITAMIN K1 Injection and is indicated for coagulation disorders due to Vitamin K deficiency. According to IQVIA (IMS Health) data, Phytonadione Injectable Emulsion had US sales of approximately USD 18.5 million for the 12-month period ending February 2025. Caplin Steriles has now secured 35 ANDA approvals. Caplin Point is focused on emerging markets in Latin America and Africa.