Gland Pharma Receives US FDA Approval for Phytonadione Injectable Emulsion
Key Insights
Gland Pharma has secured US FDA approval for its phytonadione injectable emulsion (search), a generic version of vitamin K1 injectable emulsion.
The drug is indicated for treating coagulation disorders (search) resulting from vitamin K deficiency (search) or interference with vitamin K activity.
The company plans to launch the product through its marketing partners, with US sales for the reference drug estimated at $15 million annually.
Gland Pharma Ltd. has received approval from the United States Food and Drug Administration (FDA) for its phytonadione injectable emulsion (search) USP, 10 mg/mL single-dose ampoules. This approval allows Gland Pharma to market a bioequivalent and therapeutically equivalent version of Hospira, Inc.'s vitamin K1 injectable emulsion USP, 10 mg/mL.
Therapeutic Indication
The approved phytonadione injectable emulsion (search) is indicated for coagulation disorders (search) caused by vitamin K deficiency (search) or interference with vitamin K activity. Vitamin K plays a crucial role in the synthesis of several coagulation factors, and its deficiency can lead to bleeding disorders. This medication provides a means to restore vitamin K levels and improve coagulation.
Market and Financial Impact
Gland Pharma intends to launch this product in the near future through its marketing partners. According to IQVIA data, the US market for this product had sales of approximately $15 million for the 12 months ending September 2024. The company's stock saw a positive reaction to the news, with shares rallying nearly 5% following the announcement before settling to close up 0.94% on the BSE.
Company Performance
In the second quarter of FY25, Gland Pharma reported a net profit of ₹163.5 crore, a 15.7% year-on-year decline compared to ₹194 crore in the corresponding quarter of the previous fiscal year. However, revenue from operations increased by 2.4% to ₹1,405.8 crore. The company's R&D expenses amounted to ₹49.3 crore, representing 4.6% of revenue.