Gland Pharma gets US FDA approval for vitamin K deficiency injectable – CNBC TV18
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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.
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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.
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Shares of Gland Pharma Ltd ended at ₹1,779.95, up by ₹16.50, or 0.94%, on the BSE.
(Edited by : Shoma Bhattacharjee)