Caplin Steriles bags USFDA approval for generic therapeutic equivalent version of VITAMIN K1 Injection
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.
Caplin 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.
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Its 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.
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