Chennai-based Caplin Steriles Ltd., a subsidiary company of Caplin Point Laboratories Ltd., 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.

It is 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 USD 18.5 million for the 12-month period ending February 2025.

Caplin Steriles is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. The company has developed and filed 47 ANDAs in the USA on its own and with partners, with 35 approvals so far.

The company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years. It also has multiple products filed with several approvals in non-US markets such as Mexico, Australia, Canada, South Africa etc.