Gland Pharma Ltd. has received approval from the US Food and Drug Administration for phytonadione injectable emulsion, which is used to treat disorders caused by vitamin K deficiency, according to an exchange filing on Wednesday.
The drug will be sold in single dose ampules of 10 mg/ml. It is bioequivalent and therapeutically equivalent to the reference listed drug, vitamin K1 injectable emulsion of Hospira Inc, it said.
The product is used to treat coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity in the body, Gland Pharma said.
The pharmaceutical company expects to launch the 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 ended September 2024, it said.
Gland Pharma's consolidated net profit declined 16% to Rs 163.5 crore in the second quarter of the current financial year from Rs 194.1 crore in the year-ago period, but met analyst's estimates. Revenue rose 2.4% to Rs 1,405.8 crore in the September quarter from Rs 1,373.4 crore in the same period in the last fiscal.
Shares of Gland Pharma rose as much as 1.56% during the day to Rs 1,788.30 apiece on the National Stock Exchange. The stock closed 0.82% higher at Rs 1,775.30 per share, compared to a 0.13% advance in the benchmark Nifty. The share price has fallen 7.75% on a year-to-date basis.
Eight out of the 16 analysts tracking the company have a 'buy' rating on the stock, two suggest 'hold' and six recommend 'sell', according to Bloomberg data. The average of 12-month analysts' price targets implies a potential upside of 3.8%.
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