Caplin Point Lab arm receives final approval for Phytonadione Injectable Emulsion

Caplin Point Laboratories announced that its subsidiary, Caplin Steriles, has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 10 mg.

The approved product is a generic therapeutic equivalent of the Reference Listed Drug (RLD), VITAMIN K1 Injection, manufactured by Hospira Inc.

Phytonadione Injectable Emulsion, a synthetic form of vitamin K, is used to treat bleeding and clotting disorders caused by vitamin K deficiency, certain medications such as warfarin, or medical conditions like obstructive jaundice and ulcerative colitis. It is effective in correcting coagulation disorders resulting from impaired synthesis of clotting factors II, VII, IX, and X.

According to IQVIA, Phytonadione Injectable Emulsion USP, 10 mg, has an estimated U.S. market size of $18.5 million for the twelve months ending February 2025.

Caplin Point Laboratories is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets in Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms.

The companys consolidated net profit grew 18.6% to Rs 138.96 crore on a 13.2% increase in revenue from operations to Rs 492.96 crore in Q3 FY25 over Q3 FY24.

Shares of Caplin Point Laboratories rose 0.03% to Rs 1,890.65 on the BSE.

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