Gland Pharma Ltd. has received approval from the United States Food and Drug Administration (USFDA) for cetrorelix acetate for injection, 0.25 mg/vial, a single-dose vial.
As per the stock exchange filing, the product is bioequivalent to the reference listed drug (RLD), cetrotide for injection, 0.25 mg/vial, of EMD Serono, Inc.
According to IQVIA, the product had US sales of approximately $129 million for the twelve months ending February 2024.
Cetrorelix acetate for injection is used to prevent premature LH surges in women undergoing controlled ovarian stimulation. It blocks the effects of a natural hormone called gonadotropin-releasing hormone (GnRH), which controls the secretion of another hormone called luteinizing hormone (LH), which induces ovulation during the menstrual cycle.
Gland Pharma stock traded at ₹1,734.30 on the NSE, up 0.34 per cent as of 10.34 am.
The company’s board has approved the appointment of Satnam Singh Loomba as its Chief Operating Officer (COO) with effect from May 01, 2024.