Goserelin Acetate API manufacturer
Product Code: 4141427 Product Code GMP: 4111459
Key Information
Regulatory documentation
DMF: available
CEP: available
Chemical identifiers
CAS Number(s): 65807-02-5 (net), 145781-92-6 (acetate)
Synonyms:
- Goserelina
- (D-Ser(tBu)6,Azagly10)-LHRH
Sequence
Pyr-His-Trp-Ser-Tyr-D-Ser(tBu)-Leu-Arg-Pro-Azagly-NH2 acetate salt
Fields of application
- Advanced hormone-dependent prostate cancer
- Advanced hormone-dependent breast cancer
- Endometriosis
- Uterine myoma
- Use in reproductive medicine
Active Substance
Goserelin Acetate is a potent GnRH (LHRH) agonist. After a transient increase, continuous administration of goserelin results in downregulation of LH and FSH levels followed by a suppression of ovarian and testicular steroid biosynthesis.
Molecular information
Molecular formula:
C59H84N18O14
Relative molecular mass:
1269.43 g/mol
Long-term storage:
-20 ± 5°C
Discover how we use synergies to improve Goserelin production
Find more relevant information on Goserelin, Leuprorelin and Triptorelin and our unique synthesis approach, that ensures economies of scale for API manufacturing.
Certificate of suitability (CEP)
Goserelin Acetate Ph. Eur.
Certificates granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) for our peptide APIs.
Why choose Bachem as your Goserelin manufacturer
Leader in GnRH agonists
Bachem is a pioneer in large-scale GMP manufacturing of GnRH agonists (“relins”), delivering hundreds of kilograms annually with proven expertise.
Cost-Efficient LPPS production
Our liquid-phase peptide synthesis (LPPS) platform enables faster synthesis, consistent quality, and superior cost efficiency for Goserelin.
Robust regulatory support
Bachem provides readily available DMFs, CEPs, and strong regulatory guidance to accelerate global registrations.
Reliable, secure supply chain
With optimized processes, stocked inventory, and impurity management services, Bachem ensures dependable and uninterrupted supply.
High quality & sustainability focus
Quality is prioritized at every manufacturing step, and Bachem integrates sustainability principles that exceed industry standards.
Customer-centric service
Customers benefit from fast delivery, comprehensive impurity catalogs, and dedicated support that simplifies regulatory and operational workflows.
Additional information on Goserelin
What is Goserelin?
Goserelin acetate is a synthetic peptide of 10 amino-acids sold under the brand name
Zoladex®. It belongs to the family of the GnRH agonist (gonadotropin-releasing hormone) like leuprolide or triptorelin among others. It acts in the pituitary gland to repress the expression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). It is primarily used in the treatment of certain hormone-sensitive conditions, such as prostate cancer, breast cancer, and certain gynecological conditions.
How does Goserelin work?
Goserelin mechanism of action
Goserelin, being a synthetic GnRH agonist, emulates the functions of GnRH in the pituitary gland by stimulating the release of LH and FSH. LH and FSH are pivotal messengers directing the production of sex hormones testosterone in males and oestradiol in females.
Goserelin is administered via sub-cutaneous implant and because of the continuous administration, it desensitizes the pituitary gland receptors. This desensitization gradually leads to a reduction in LH and FSH production by the pituitary gland. From this sustained decrease in the secretion of LH and FSH, it results in a noteworthy reduction in testosterone for males and oestradiol for females.
For what is Goserelin used?
The hormonal suppression of goserelin has the following therapeutic applications:
In prostate cancer, which is often hormone-sensitive, reducing testosterone levels can help slow down the growth of cancer cells.
In certain gynecological conditions, such as endometriosis, suppressing oestradiol production can alleviate symptoms associated with these conditions.
In breast cancer, which can be influenced by oestradiol, goserelin may be used to suppress its growth.
What are the applications of Goserelin?
Initially marketed as a daily injection in 1987, goserelin acetate is sold under the brand name Zoladex® as an implant administered subcutaneously on a monthly or three monthly basis.
Zoladex® has also been approved by FDA for use in combination with the antiandrogen agent flutamide in prostate cancer and can be used in combination with tamoxifen and an aromatase inhibitor in breast cancer.
How is Goserelin produced?
Goserelin, like all others GnRH analogues, is synthesized via liquid-phase peptide synthesis (LPPS). As shown in the picture below, GnRH analogues possess a common segment conferring significant advantages when it comes to the manufacturing of these APIs. LPPS enables a convergent approach and offers a better cost efficiency, consistent quality, faster synthesis and secured supply chain.
Related Generic APIs
Leuprolide
Buserelin
