Gland Pharma shares rise 5% on receiving US FDA approval for vitamin K deficiency injectable

Drug firm Gland Pharma shares jumped 4.7% to their day’s high of Rs 1,860 on the BSE after the company announced it has received approval from the United States Food and Drug Administration (FDA) for phytonadione injectable emulsion USP, 10 mg/mL single-dose ampoules.


The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), vitamin K1 injectable emulsion USP, 10 mg/mL, from Hospira, Inc. It 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 approximately $15 million for the 12 months ending September 2024.

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In Q2 FY25, the company reported a 15.7% year-on-year (YoY) decline in net profit to Rs 163.5 crore, compared to Rs 194 crore in the corresponding quarter of the previous fiscal.

Revenue from operations increased 2.4% to Rs 1,405.8 crore, up from Rs 1,373.4 crore in the same period last year. At the operating level, EBITDA declined 8.4% to Rs 297 crore in Q2 FY25, compared to Rs 324.1 crore in Q2 FY24.

The EBITDA margin stood at 21.1% in the reporting quarter, down from 23.6% in the corresponding period of the previous fiscal.

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According to Trendlyne data, the average target price of the stock is Rs 1,813, which indicates an upside of 2% from the current market price. The consensus recommendation from 12 analysts is a 'Hold'.

Technically, the stock’s relative strength index (RSI) is at 51.5. According to Trendlyne, an RSI below 30 is considered oversold, while above 70 indicates overbought conditions. Additionally, the MACD stands at 14.5, which is above its center line but below the signal line.

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