Shares of Gland Pharma Ltd rallied 4.99% on 12 December after the company announced securing drug approval from the US Food and Medication Administration (USFDA).

Phytonadione Injectable Emulsion was approved by the USFDA for the generic medication manufacturer. The vitamin K1 injectable emulsion from Hospira, Inc. is the reference-listed drug (RLD) that the product is both bioequivalent and therapeutically equivalent to. 

The drug is used to treat coagulation disorders resulting from vitamin K deficiency or disruption of its activity.

The business plans to launch the medication through its marketing partners shortly, according to a statement issued by Gland Pharma on Wednesday. 

According to IQVIA, the medication sold roughly $15 million in the US over the 12 months that concluded in September 2024.

With earnings of Rs 163.5 crore for the second quarter of the fiscal year 2024-25, which concluded on 30 September 2024, the pharmaceutical company recorded a 15.7% year-over-year (YoY) decline in net profit. According to a regulatory filing from the prior fiscal year, the business made Rs 194 crore in net profit during that same quarter. From Rs 1,373.4 crore to Rs 1,405.8 crore during the same time last year, operational revenue grew by 2.4%.
 
Operating-wise, EBITDA decreased 8.4% to Rs 297 crore in the second quarter of the current fiscal year from Rs 324.1 crore in the same period last year. In the reporting quarter, the EBITDA margin also dropped to 21.1% from 23.6% during the same time last year.

On the stock market side, Gland Pharma’s stock has lagged the market so far this year, declining 5% and 0.5% over the past year. The BSE Sensex, in contrast, has increased by 13% so far this year and by 17% in only one year.

At 12:38 pm, the shares of Gland Pharma were trading 1.18% higher at Rs 1,796.20 on NSE.

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