Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has received 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.The product 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 IQVIA (IMS Health), Phytonadione Injectable Emulsion
had US sales of approximately $18.5 million for the 12-month period ending February 2025.Read also: Caplin Steriles gets USFDA nod for Procainamide Hydrochloride Injection for treating abnormal heart rhythmCaplin Steriles Limited is a sterile product manufacturing company that is approved by several regulatory agencies such
as US FDA, EU-GMP, ANVISA and INVIMA. It has developed and filed 47
ANDAs in 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. The company also has multiple products filed with several
approvals in non-US markets such as Mexico, Australia, Canada, South Africa etc.Read also: Caplin Steriles gets USFDA nod for Levetiracetam in Sodium Chloride Injection, infusion bagsIts Parent Company, Caplin Point Laboratories Limited, is a  pharmaceutical company with a unique
business model catering predominantly to emerging markets of Latin America and Africa. The
Company has state of the art manufacturing facilities that cater to a complete range of
finished dosage forms.Read also: Caplin Sterils gets USFDA nod for Eye Drop for reduction of elevated intraocular pressure