Hyderabad: Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Vial (Product).
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Cetrotide for Injection, 0.25 mg/vial, of EMD Serono, Inc.

The Company expects to launch this Product in the near-term through its marketing partner. 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 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.
"Cetrorelix further expands the company's fertility product line, underscoring its commitment to developing and manufacturing complex injectables to meet patients' unmet needs," Gland stated in a BSE filing.
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Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and has an excellent track record in developing, manufacturing, and marketing sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
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