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Goserelin acetate manufacturers

1 products found

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1 products found

goserelin acetate

Vials, lyophilized 3.6 mg, 10.8 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
PICS
Manufacturer #36647

Established in 2018, this manufacturer specializes in oncology, anti-cancer, cytotoxic, critical-care, life-saving, and general injectables, as well as oral solids like tablets and capsules. As a CTD dossier owner and manufacturer, it exports products to over 30 countries across Asia, Africa, LATAM, CIS, MENA, and Europe. Operating under WHO-GMP and PIC/S certifications, the GMP manufacturer maintains advanced production lines for liquid injectables, lyophilized injectables, pre-filled syringes, tablets, and capsules. As a CTD dossier owner and manufacturer, it upholds stringent quality standards and regulatory compliance

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Goserelin acetate

Goserelin acetate is an anti-cancer drug. It is classified as an analog of naturally occurring luteinizing hormone-releasing hormone (LHRH). Goserelin acetate is used to treat prostate cancer, breast cancer, endometriosis, and abnormal bleeding of the uterus. However, this medicine comes with a warning. Males patients who use Goserelin acetate for prolonged periods of time experience inhibition of pituitary gonadotropin secretion which leads to a significant decline in testosterone production. In females, long-term use results in a decrease in estradiol production.
Goserelin acetate implants are sold under the brand name Zoladex®. AstraZeneca markets Goserelin acetate. The US Food and Drug Administration (FDA) first approved it in 1996 for the treatment of localized prostate cancer in combination with radiation therapy and flutamide or as palliative treatment in patients suffering from advanced prostate cancer. Recently Goserelin acetate was also approved as a palliative treatment in premenopausal and perimenopausal women suffering from advanced breast cancer.
Goserelin acetate is available as an implant. Only medical practitioner under controlled clinical conditions should insert it, done through a syringe subcutaneously in the stomach area. Patients have to get the implanted with 3.6 mg of goserelin inserted every 4 weeks. Whereas the implant with 10.8 mg of goserelin is inserted every 12 weeks. The duration of the treatment depends on the condition being treated and the response to the medication.

Dose for Specific Conditions

In the treatment of breast cancer, the patient is given the three-month formulation of goserelin acetate in the form of a cylindrical implant with a 1.5 mm diameter that contains 10.8 mg of the drug. It is inserted through a subcutaneous injection. GA slowly biodegrades and dissolves in the process, giving the body a continuous supply at therapeutic levels for 12 weeks.

The cost of Goserelin Acetate

In the USA, depending on the pharmacy, consumers have to pay around $673 for subcutaneous implant 3.6 mg. this price is significantly cheaper in the developing world with the same medicines costing $120-$130.

How does Goserelin Acetate 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 Acetate Manufacturers and Suppliers:

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