Bulk Pharmaceutical API Sources for goserelin acetate

Bulk Pharmaceutical API Sources for goserelin acetate

Vendor	Vendor Homepage	Vendor Sku	API Url
MolPort		MolPort-006-823-830
ChemMol		2100039
Chembase.cn		154183

Bulk Active Pharmaceutical Ingredient (API) Sources for: Goserelin Acetate

Last updated: July 28, 2025

Introduction

Goserelin acetate is a synthetic luteinizing hormone-releasing hormone (LHRH) analogue used primarily in hormone-responsive cancers such as prostate and breast cancer, as well as in other indications like endometriosis and menopausal management. As a peptide hormone, the production and sourcing of goserelin acetate involve complex synthesis and stringent regulatory standards. Identifying reliable bulk API sources is critical for pharmaceutical manufacturers aiming for quality, consistency, and supply security.

Understanding Goserelin Acetate

Goserelin acetate is a potent synthetic peptide comprising 10 amino acids linked to acetate, with the chemical formula C59H84N18O14. Its synthesis involves peptide chain assembly via solid-phase or solution-phase peptide synthesis techniques, followed by purification, lyophilization, and stabilization. These complex manufacturing processes demand meticulous quality control to ensure purity, bioactivity, and stability, conforming to Good Manufacturing Practices (GMP) and regulatory guidelines.

Global API Suppliers for Goserelin Acetate

The sourcing landscape for goserelin acetate is characterized by specialized peptide manufacturers primarily based in Europe and Asia. The following summarizes prominent API suppliers with proven expertise in peptide API synthesis.

European Suppliers

1. Polypeptide Group (UK)

• Overview: Polypeptide Group boasts over five decades of experience in peptide synthesis, offering a broad portfolio of peptide APIs, including goserelin acetate.
• Capabilities: They utilize advanced solid-phase peptide synthesis (SPPS) technology under GMP conditions, ensuring high purity (>98%) and batch-to-batch consistency.
• Regulatory Compliance: Their manufacturing facilities comply with EMA standards, facilitating regulatory approval for APIs supplied to the EU and other markets.
• Supply Chain Strength: Extensive inventory and manufacturing capacity enable reliable large-volume supply.

2. Bachem (Switzerland)

• Overview: Bachem is a leading peptide manufacturer with a focus on research, development, and large-scale production.
• API Offerings: They produce various peptide APIs, including ready-to-ship goserelin acetate, marketed under their proprietary or custom synthesis services.
• Quality & Compliance: Bachem adheres to GMP regulations, with ISO certifications ensuring adherence to international quality standards.
• Key Strengths: Expertise in complex peptide synthesis, scalable manufacturing, and robust quality control processes.

3. ACL Bio (Germany)

• Overview: Specializing in peptide APIs and intermediates, ACL Bio offers customized synthesis tailored to pharmaceutical needs.
• Capabilities: Utilizes advanced peptide synthesis and purification techniques, with a focus on purity and stability.
• Regulatory Support: Provides comprehensive documentation aligning with international regulatory requirements.

Asian Suppliers

4. Ningbo Inno Pharmchem Co., Ltd. (China)

• Overview: A major supplier of peptide APIs, including goserelin acetate, with extensive manufacturing capacity.
• Capabilities: Combines solid-phase synthesis and purification processes at scale, with GMP-certified facilities.
• Market Focus: Serves global pharmaceutical clients, emphasizing cost competitiveness alongside quality.
• Regulatory Considerations: Offers documentation compliant with international standards; however, due diligence is advised for regulatory approvals in specific regions.

5. Zhejiang Anhui Huangshan Pharmaceutical Co., Ltd. (China)

• Overview: Focuses on peptide API manufacturing, with a portfolio including goserelin acetate.
• Quality Assurance: Emphasizes strict process validation, impurity profiling, and compliance with GMP regulations.
• Supply Chain Benefits: Competitive pricing with flexible batch sizes tailored to client needs.

6. Shanghai Science & Protein Biotechnology Co., Ltd. (China)

• Overview: Provides peptide synthesis services of mature APIs like goserelin acetate, with advanced R&D capabilities.
• Customization: Capable of producing customized peptide APIs for clinical and commercial use.
• Certifications: GMP, ISO, and other certifications support their qualification as a reliable supplier.

Emerging and Specialty Suppliers

Several smaller-scale or emerging manufacturers globally are increasingly focusing on peptide APIs, including goserelin acetate. They often position themselves as cost-effective or boutique suppliers that can accommodate rapid lead times and flexible order quantities. Rigorous review of quality systems and regulatory compliance remains essential when engaging such vendors.

Criteria for Selecting Goserelin Acetate API Suppliers

• Quality Assurance: Verification of GMP compliance, purity levels, residual impurity profiles, and stability.
• Regulatory Documentation: Availability of technical transfer dossiers, COAs (Certificates of Analysis), GMP certificates, and regulatory filings.
• Manufacturing Capacity and Scalability: Ability to meet current and projected demand without compromising quality.
• Supply Chain Reliability: Proven track record of timely delivery, contingency planning, and customer support.
• Cost Structure: Competitive pricing balanced with compliance and quality standards.

Regulatory and Quality Considerations

Given goserelin acetate’s use in oncological and hormonal treatments, regulatory scrutiny is paramount. Suppliers must demonstrate adherence to international drug manufacturing standards, including GMP, and provide comprehensive documentation supporting batch consistency, stability data, and impurity profiles. For API sourcing from Asia, due diligence is recommended to validate certifications and compliance levels, especially for markets with stringent regulatory environments like the US (FDA), EU (EMA), or Japan (PMDA).

Recent Trends and Market Dynamics

The demand for peptide APIs like goserelin acetate is driven by expanding indications and biosimilar development. This surge fosters increased competition among suppliers, leading to price erosion and technology transfer opportunities. However, supply chain disruptions caused by geopolitical factors, raw material shortages, and regulatory changes underscore the importance of diversification strategies in API sourcing.

Conclusion

This comprehensive overview highlights key global API suppliers capable of delivering high-quality goserelin acetate for pharmaceutical manufacturing. European firms such as Polypeptide Group, Bachem, and ACL Bio are recognized for stringent quality standards, while Asian manufacturers like Ningbo Inno Pharmchem, Zhejiang Huangshan Pharmaceutical, and Shanghai Science & Protein Biotechnology offer cost-competitive options with scalable capacity.

Key Takeaways

• Selecting a reliable goserelin acetate API supplier hinges on compliance with GMP standards, quality assurance protocols, and regulatory documentation.
• European suppliers generally offer higher regulatory assurance, often preferred for markets with strict approval processes.
• Asian suppliers can provide competitive pricing and flexible capacity but require thorough validation of certification and quality systems.
• Diversification of supply sources mitigates risks associated with market volatility and supply interruptions.
• Continuous monitoring of technological advancements and regulatory updates in peptide synthesis is essential for maintaining a reliable supply chain.

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FAQs

1. What are the primary considerations when sourcing goserelin acetate API?
Ensuring GMP compliance, high purity (>98%), consistent batch quality, regulatory documentation, and reliable supply chain management are critical considerations.

2. Are Asian suppliers suitable for supplying goserelin acetate to global markets?
Yes, several Asian manufacturers, such as Ningbo Inno Pharmchem and Zhejiang Huangshan, meet international quality standards. Due diligence on certifications and regulatory compliance is essential.

3. How does European regulation influence API sourcing for goserelin acetate?
European suppliers adhere to EMA-guided GMP practices, often simplifying regulatory approval for markets requiring high compliance, thus preferred for stringent regulatory contexts.

4. What challenges exist in sourcing peptide APIs like goserelin acetate?
Challenges include ensuring supplier quality assurance, managing supply chain disruptions, navigating regulatory differences, and verifying impurity and stability profiles.

5. What future trends are expected in the goserelin acetate API market?
Increased demand driven by expanded indications, biosimilar development, and technological advances in peptide synthesis will shape the marketplace, emphasizing quality, cost-effectiveness, and supply reliability.

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References

[1] Polypeptide Group. "Peptides & Chemical Synthesis." Accessed 2023.
[2] Bachem. "Goserelin Acetate API Data Sheet." 2022.
[3] Ningbo Inno Pharmchem Co., Ltd. Official website. 2023.
[4] European Medicines Agency. "Guidelines on Good Manufacturing Practice." 2022.