Caplin Point Laboratories’ subsidiary -- Caplin Steriles 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 IQVIA (IMS Health), Phytonadione Injectable Emulsion had US sales of around $18.5 million for the 12-month period ending February 2025.
Caplin Point Laboratories is the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility.
