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Gland Pharma Receives US FDA Approval for Phytonadione Injectable Emulsion

• Gland Pharma has secured US FDA approval for its phytonadione injectable emulsion, a generic version of vitamin K1 injectable emulsion. • The drug is indicated for treating coagulation disorders resulting from vitamin K deficiency 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's stock experienced a rally following the announcement, reflecting positive market sentiment.

Gland Pharma Ltd. has received approval from the United States Food and Drug Administration (FDA) for its phytonadione injectable emulsion 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 is indicated for coagulation disorders caused by vitamin K deficiency 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.
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Reference News

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Gland Pharma Shares Rally 5% on Securing USFDA Approval - Equitypandit
equitypandit.com · Dec 12, 2024

Gland Pharma shares rose 4.99% on 12 December following USFDA approval for Phytonadione Injectable Emulsion, used to tre...

[2]
Gland Pharma shares in focus after receiving US FDA approval for vitamin K deficiency injectable
m.economictimes.com · Dec 12, 2024

Gland Pharma shares in focus after FDA approval for phytonadione injectable emulsion USP, 10 mg/mL single-dose ampoules....

[3]
Gland Pharma gets US FDA approval for vitamin K deficiency injectable - CNBC TV18
cnbctv18.com · Dec 11, 2024

Gland Pharma Ltd received FDA approval for phytonadione injectable emulsion USP, 10 mg/mL single dose ampoules, bioequiv...

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