Caplin Steriles Ltd gets USFDA approval for Phytonadione Injectable Emulsion

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.

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 1887.90 as compared to the previous close of Rs. 1890.15. The total number of shares traded during the day was 8439 in over 1104 trades.

The stock hit an intraday high of Rs. 1913.35 and intraday low of 1878.00. The net turnover during the day was Rs. 15970827.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 Pharmaceuticals CaplinSteriles USFDA FinalApproval ANDA PhytonadioneInjectableEmulsion