Gland Pharma Receives USFDA Approval for Cetrorelix Acetate for Injection

On April 29, 2024, Gland Pharma Limited informed the stock exchanges that the company had received approval from the United States Food and Drug Administration (USFDA) for Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Vial.

The Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Cetrotide for Injection, 0.25 mg/vial, of EMD Serono, Inc.

Gland Pharma Limited anticipates launching this Cetrorelix Acetate for Injection 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.

Cetrorelix Acetate for Injection is utilised 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 luteinising hormone (LH), which induces ovulation during the menstrual cycle.

Cetrorelix further expands the company’s fertility product line, highlighting its commitment to developing and manufacturing complex injectables to meet patients’ unmet requirements.

On April 6, 2024, Gland Pharma got approval from the US Food and Drug Administration for Eribulin Mesylate Injection, 0.5 mg/mL Single Dose Vial (Product). According to IQVIA, the Eribulin Mesylate Injection has US sales of approximately USD 92 million for twelve months ending in February 2024.

About Gland Pharma Limited

Gland Pharma has evolved from being a contract manufacturer of small-volume liquid parenteral products to emerge as one of the leading and rapidly expanding generic injectables manufacturing firms. The company has a presence in 60 countries worldwide, including Europe, the United States, Australia, Canada, India, and other markets. It operates primarily under a business-to-business (B2B) model. Gland Pharma has established a commendable track record in pharmaceutical research and development, as well as in the manufacturing and marketing of complex injectables.

On April 29, 2024, the share price of Gland Pharma Ltd opened at ₹1,738.00, touching the day’s high at ₹1,747.20, as of 10:52 AM on the NSE.

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