Caplin Steriles Gets USFDA Nod for Vitamin K Injection

24 Apr 2025 , 10:02 PM

Caplin Point Laboratories announced on 23rd April that its subsidiary, Caplin Steriles, has received approval from USFDA for Phytonadione Injectable Emulsion USP (10 mg/mL). The drug is the generic alternative of the Vitamin K1 Injection produced by Hospira Inc and is indicated in the treatment of Vitamin K deficiency-related coagulation disorders.

Phytonadione, a synthetic analogue of naturally occurring Vitamin K, is used to treat blood clotting disorders by facilitating the proper synthesis of clotting factors II, VII, IX, and X.

According to IQVIA (IMS Health) market data, the product made about $18.5 million in sales in the US market within the 12-month period ended February 2025. The approval boosts Caplin Steriles’ base in the US generics business, solidifying its position as a trusted supplier of sterile injectables.

Caplin Steriles has so far prepared and filed 47 ANDAs (Abbreviated New Drug Applications) with the USFDA, of which 35 have been cleared. The firm is internationally accredited with certifications by USFDA, EU-GMP, ANVISA (Brazil), and INVIMA (Colombia), signifying that it meets leading-edge regulatory requirements.

Looking forward, Caplin Steriles has a strong development pipeline in place, with more than 40 injectable and ophthalmic products scheduled to be filed with regulators in the next four years.