Last Updated on December 22, 2024 by The Health Master
USFDA approval
Gland Pharma Limited (Gland Pharma), a leading player in the generic injectable market, has secured a US Food and Drug Administration approval (USFDA approval) for its Cetrorelix Acetate for Injection (0.25 mg/vial, single-dose vial).
This USFDA approval opens doors to a substantial market for Gland Pharma and strengthens their position in the women’s health segment.
Bioequivalent and Therapeutically Equivalent
The USFDA approved Cetrorelix Acetate for Injection is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Cetrotide for Injection, 0.25 mg/vial, from EMD Serono, Inc.
his signifies that Gland Pharma’s product offers the same efficacy and safety profile as the established brand, making it a dependable alternative for healthcare providers and patients.
Targeting a High-Demand Market
The US market for Cetrorelix Acetate for Injection is substantial, with IQVIA estimating sales to be around USD 129 million for the twelve months ending February 2024.
This indicates a strong demand for this fertility medication, and Gland Pharma’s entry positions them to capture a significant share of this market.
Understanding Cetrorelix Acetate for Injection
Function:
Cetrorelix Acetate for Injection plays a crucial role in controlled ovarian stimulation (COS), a procedure used in assisted reproductive technologies (ART) like in-vitro fertilization (IVF).
Mechanism of Action:
It works by blocking the effects of gonadotropin-releasing hormone (GnRH), a natural hormone that regulates ovulation.
By doing so, it prevents premature surges of luteinizing hormone (LH), which can disrupt the carefully controlled hormonal environment needed for successful egg retrieval during COS.
Gland Pharma’s Commitment to Patient Needs
“Cetrorelix further expands our fertility product line, demonstrating our unwavering commitment to developing and manufacturing complex injectables that address unmet patient needs,” stated Gland Pharma in a BSE filing.
This USFDA approval reflects Gland Pharma’s dedication to innovation and their focus on providing patients with access to critical fertility treatment options.
Gland Pharma: A Legacy of Excellence in Injectables
Established in 1978, Gland Pharma has evolved from a contract manufacturer to a global leader in the injectable space.
With a presence in over 60 countries, they specialize in developing, manufacturing, and marketing sterile injectables across various formats, including vials, ampoules, pre-filled syringes, and more.
Their expertise encompasses a broad spectrum of injectable medications, including oncology, ophthalmology, and vital infusions.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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