Gland Pharma shines on getting USFDA’s approval for Phytonadione Injectable Emulsion

Shares of Gland Pharma jumped 1.4% on Thursday after the company announced USFDA approval for injectable ampules, which had sales worth $15 million in the US.

Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vitamin K1 Injectable Emulsion USP, 10 mg/mL, of Hospira, Inc.

This Product is indicated for coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity. The company plans to launch this Product through its marketing partners in the near future. According to IQVIA, the product had US sales of around $15 million for the twelve months ending September 2024.

The September 2024 quarter revenue stood at ₹1062.9 crore, up 5.18% as compared to ₹1,010 crore during the corresponding quarter last year. A moderate rise of 9.39% was recorded in the net profit for the quarter ended September 2024 to ₹281.7 crore From ₹257.5 crore. The operating profit of the company witnessed a marginal growth to ₹421.6 crore from ₹388.2 crore in the same quarter last year.

Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.