Gland Pharma said that it has received approval from the United States Food and Drug Administration (US FDA) for Cetrorelix Acetate for Injection.
The approved product is a bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Cetrotide for Injection.
The company expects to launch this product in the near-term through its marketing partner.
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.
According to IQVIA, the product had US sales of approximately USD 129 million for the twelve months ending February 2024.
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"Cetrorelix further expands the company's fertility product line, underscoring its commitment to developing and manufacturing complex injectables to meet patients' unmet needs, the company said in a statement.
Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India.
The companys consolidated net profit fell 17.28% to Rs 191.86 crore in Q3 FY24 as against with Rs 231.95 crore posted in Q3 FY23. Revenue from operations jumped 64.68% to Rs 1,545.2 crore in Q3 FY24 as against Rs 938.29 crore recorded in Q3 FY23.
The scrip fell 1.10% to currently trade at Rs 1710 on the BSE.
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