Caplin Steriles Limited, a wholly owned subsidiary of Caplin Point Laboratories Limited, has secured 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. This product is a generic therapeutic equivalent of the Reference Listed Drug (RLD) Vitamin K1 Injection, marketed by Hospira Inc.
The injectable formulation is indicated for treating coagulation disorders stemming from vitamin K deficiency, specifically affecting clotting factors II, VII, IX, and X. Phytonadione has the same biological activity as naturally occurring vitamin K. According to IQVIA data, the US market for Phytonadione Injectable Emulsion was valued at approximately $18.5 million for the 12-month period ending February 2025.
Caplin Steriles has rapidly scaled up its regulatory presence, with 47 ANDAs filed in the US, 35 of which have already received approval. The company is also building a robust portfolio of 40+ injectable and ophthalmic products for future filings and maintains regulatory approvals in key international markets including the EU, Mexico, Australia, Canada, South Africa, and more.
Caplin Point Laboratories, known for its strong footprint in Latin America and Africa, has also earned consistent recognition, appearing seven times in Forbes Asia’s “200 Best Under a Billion” list over the past decade. With a strong record of profitability, cash flow generation, and operational excellence, Caplin Point continues to expand its sterile injectables segment through Caplin Steriles.
Disclaimer: The forward-looking statements in the press release are subject to risks and uncertainties, and actual performance may differ.