Gland Pharma gets US FDA approval for vitamin K deficiency injectable – CNBC TV18



Drug firm Gland Pharma Ltd on Wednesday (December 11) said it has received the approval of the United States Food and Drug Administration (FDA) for phytonadione injectable emulsion USP, 10 mg/mL single dose ampoules.

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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 in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.

The company expects to launch this product through its marketing partners in the near future. According to IQVIA, the product had US sales of approximately $15 million for the 12 months ending September 2024.

Also Read: Gland Pharma shares rise on USFDA nod for high eye pressure treatment solution

Gland Pharma reported a 15.7% year-on-year (YoY) decline in net profit at ₹163.5 crore for the second quarter that ended September 30, 2024. In the corresponding quarter of the previous fiscal, Gland Pharma posted a net profit of ₹194 crore.

Revenue from operations increased 2.4% to ₹1,405.8 crore against ₹1,373.4 crore in the year-ago period. At the operating level, EBITDA dipped 8.4% to ₹297 crore in the second quarter of this fiscal over ₹324.1 crore in Q2 of the previous fiscal.

The EBITDA margin stood at 21.1% in the reporting quarter versus 23.6% in the corresponding period in FY24. EBITDA is earnings before interest, tax, depreciation, and amortisation. Gland Pharma reported R&D expenses amounting to ₹49.3 crore, accounting for 4.6% of revenue.

Also Read: Gland Pharma shares jump 11% post Q2 results; Kotak upgrades on limited downside risk

Shares of Gland Pharma Ltd ended at ₹1,779.95, up by ₹16.50, or 0.94%, on the BSE.


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