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Goserelin Acetate

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Goserelin Acetate is a parenteral synthetic agonist analog of gonadotropin-releasing hormone (GnRH), also known as luteinizing hormone-releasing hormone (LHRH). Substitution of two amino acids normally found in GnRH leads to sustained activity of this drug that aids in hormonal control.
Goserelin Acetate is used for the suppression of gonadal sex hormone production in the treatment of malignant neoplasms of the prostate, in breast cancer in pre-and peri-menopausal women, and in the management of endometriosis and uterine fibroids. It is also given before surgery for endometrial reduction and as an adjunct to ovulation induction with gonadotrophins in the treatment of infertility. Goserelin is usually given as the acetate but doses are expressed in terms of the base; 10.5 mg of goserelin acetate is equivalent to about 10 mg of goserelin.

Goserelin Acetate’s innovator is Astra Zeneca-Global and is known world-wide by the brand name Zoladex.

 

Goserelin Acetate has actions similar to those of naturally occurring GnRH (also known as LHRH). GnRH released from the hypothalamus stimulates receptors on the pituitary gland, which then releases the gonadotropins luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Goserelin Acetate and other GnRH agonists provide a medical castration that deprives hormonally-dependent tumors of testosterone or estrogen. Normally, GnRH is released in a pulsatile manner to maintain levels of gonadotropins.
•Males: Following initial administration, Goserelin Acetate causes an initial increase in serum-luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels with subsequent increases in serum levels of testosterone.
•Females: Down-regulation of the pituitary gland by chronic exposure to Goserelin Acetate leads to suppression of gonadotropin secretion, and a decrease in serum estradiol to levels consistent with the postmenopausal state. These actions reduce ovarian size and function, reduce the size of the uterus and mammary glands, and regress the sex hormone-responsive tumors, if present.

Goserelin Acetate appears in the following formulation and dosage:
Implant 3.6mg (For 28 days), 10.8mg (For 12 weeks)

General data on Goserelin Acetate Active Pharmaceutical Ingredient

Molecular Formula: C35H49N11O9S2
Molecular Weight:832.0
CAS Registry: 148031-34-9;157630-07-4
ATC:B01AC16

TAPI's Goserelin Acetate Active Pharmaceutical Ingredient

TAPI's Goserelin Acetate Active Pharmaceutical Ingredient is produced in Assia Industries Limited –Teva Tech site in Beer Sheva, Israel.

Over the last 15 years TAPI has developed the expertise in developing and commercialization of peptide Active pharmaceutical ingredients, such as Goserelin Acetate. With numerous worldwide approvals, we are continuously driven by the goal of helping our customers achieve success-and ultimately approval for their peptide APIs. We offer grams to hundred kilograms production capabilities, comprehensive technology platform including solid phase, solution phase, and hybrid approach, combined with a well established scientific experience, enabling the implementation of efficient process aimed for high quality product. We offer Custom Synthesis and Manufacturing services on peptide Active pharmaceutical ingredients.

TAPI provide full service on Goserelin Acetate and other APIs in our portfolio. Our local sales offices provide full information on our product, regulatory compliance and documentation on Goserelin Acetate.

Other products, in the group of ANTINEOPLASTIC AGENTS - Hormone agonists and related agents available on TAPI's portfolio are:  Letrozole and Leuprolide (Leuprorelin Acetate).Contact us today for information on these products.

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