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goserelin Injection, pre-filled syringe 3.6 mg, 10.8 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #38470

Manufacturer serves global markets in 30+ countries and regions worldwide, leveraging its role as CTD dossier owner and manufacturer and operating as a GMP manufacturer. Founded in 2008 in Warngau (Germany) with approximately 150 employees, the Manufacturer acts as CTD dossier owner and manufacturer and holds EU GMP certification (DE_BY-04_GMP_2024_0040, valid from 12 Mar 2024) for its facilities. Production lines focus on biodegradable sustained-release implants and transdermal delivery systems, covering formulation, extrusion, aseptic assembly and packaging. The Manufacturer is CTD dossier owner and manufacturer and continues to expand as a dedicated GMP manufacturer.

GOSERELIN

Goserelin is used to reduce the production of sex hormones, namely testosterone in men and estrogen in women. It is particularly effective in the treatment of breast and prostate cancer. Goserelin is a therapy to treat hormone-sensitive cancers of the breast, in both, pre- and peri-menopausal women, prostate, and some benign gynaecological disorders such as endometriosis, a condition in which the tissue that lines the uterus grows in other areas of the body and causes pain, heavy or irregular menstruation and other symptoms. It is also prescribed to treat abnormal bleeding of the uterus, uterine fibroids and endometrial thinning. In addition, Goserelin is used to treat precocious puberty, hormone to help transgender people, and is a favoured anti-androgen in UK. Goserelin implant is inserted in addition to radiation and other medications used to treat localized prostate cancer. It also used alone to treat the symptoms of advanced prostate cancer. Goserelin implant is a gonadotropin-releasing hormone (GnRH) agonist that works by decreasing the levels of hormones in the body. Goserelin is sold under the brand name Zoladex among others. Neorx Corporation filed the first patent of Goserlin in 1993, which was approved in 1998. Since then, pharmaceuticals companies have filed additional patents.

Forms and administration:

Goserelin is available as an implant for a 1-month depot or a long-acting 3-month depot. Goserelin implant is inserted with a syringe subcutaneously in the stomach. An implant with 3.6 mg is inserted, usually every 4 weeks. An implant with 10.8 mg is usually inserted every 12 weeks. The length of treatment depends on the patient’s condition and response to the medication. The Doctor will determine how long the patient should use this implant.

The price of Goserelin:

In the USA, the consumers have to pay $673 for one subcutaneous implant of 3.6 mg. in the developing world, the generic version of this medicine in countries like India can cost as low as USD100.

How does Goserelin work?

Goserelin acetate actions stimulate the production of the sex hormones testosterone and estrogen in a non-physiological manner. The resulting outcome is a disruption of the endogenous hormonal feedback systems. This in turn results in the down-regulation of testosterone and estrogen production.

Finding Goserelin Manufacturers and Suppliers:

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