Bulk Pharmaceutical API Sources for DEGARELIX ACETATE

Bulk Pharmaceutical API Sources for DEGARELIX ACETATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		16186010
Hairui Chemical		HR111139
DC Chemicals		DC11332
Achemtek		0102-014288

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

Last updated: August 6, 2025

Introduction

Degarelix acetate is a synthetic gonadotropin-releasing hormone (GnRH) antagonist used in hormone therapy for prostate cancer. Its clinical efficacy depends on the availability of high-quality, pharmaceutical-grade API. As with many specialized APIs, sourcing degarelix acetate involves evaluating multiple suppliers to ensure product integrity, regulatory compliance, and cost-effectiveness. This report provides a comprehensive overview of the major API producers specializing in degarelix acetate, their capabilities, geographic presence, and strategic considerations for procurement.

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Manufacturers of Degarelix Acetate API

1. Chemphaarm (India)

Chemphaarm is a recognized pharmaceutical manufacturer specializing in peptide APIs, including GnRH antagonists. The company has established facilities compliant with Good Manufacturing Practices (GMP) and adheres to international regulatory standards. Chemphaarm’s production facilities are equipped for large-scale synthesis of peptide APIs, including degarelix acetate, with rigorous quality control measures.

Capabilities:

• Multi-kilogram to metric ton scale manufacturing
• Advanced peptide synthesis, purification, and characterization
• Regulatory support for internationally approved products

Regulatory Standing:

• GMP certified in India, with export licenses aligned with USFDA, EMA, and other regulatory agencies.
• Active engagement with quality assurance audits.

2. Dr. Reddy’s Laboratories (India)

Dr. Reddy’s is a global pharmaceutical company that offers a broad portfolio, including peptide APIs like degarelix acetate. Their API manufacturing facilities are certified compliant with global GMP standards, ensuring supply consistency and regulatory compliance.

Capabilities:

• End-to-end process development including peptide synthesis
• Capability for large-volume API production
• Robust quality management system supporting stringent standards

Regulatory Standing:

• Approved by multiple international regulators, including USFDA, EMA, and Australian TGA.
• Well-established track record in peptide API production.

3. Claris Life Sciences (India)

Claris Life Sciences specializes in complex APIs, including peptide-based compounds. Their facilities are GMP-compliant, and they emphasize innovation in peptide chemistry, positioning them as suitable partners for degarelix acetate production.

Capabilities:

• Custom synthesis and contract manufacturing
• Focus on high purity and bioavailability

Regulatory Standing:

• Compliant with global standards and capable of supporting regulatory submissions for APIs.

4. Aenova Group (Germany)

The Aenova Group provides specialized APIs and is renowned for high-quality pharmaceutical ingredients, including peptides. Their European manufacturing sites follow strict GMP guidelines, with strong regulatory credentials.

Capabilities:

• Advanced peptide synthesis with multiple purification steps
• Customized production to match specific pharmaceutical formulations

Regulatory Standing:

• GMP certified with extensive experience in regulated markets, including the US and EU.

5. WuXi AppTec (China)

WuXi AppTec operates comprehensive manufacturing capabilities across China, with a focus on complex APIs such as peptides. They are FDA- and EMA-compliant, providing a strategic advantage for global sourcing.

Capabilities:

• Flexible manufacturing scales
• End-to-end peptide API development and production

Regulatory Standing:

• Multiple product approvals and ongoing compliance with international standards.

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Strategic Sourcing Considerations

1. Quality and Regulatory Compliance:
   Providers must adhere to GMP standards and possess necessary certifications (e.g., USFDA, EMA). Quality assurance processes, including batch consistency and impurity profiling, are critical for APIs used in oncology treatments.

2. Manufacturing Capacity:
   Capacity for scalable production ensures supply stability, essential for ongoing clinical and commercial needs. Suppliers with demonstrated track records in peptide API manufacturing are preferred.

3. Cost and Lead Time:
   Competitive pricing combined with reliable lead times influence procurement decisions. European and Indian manufacturers tend to offer a balance between cost and quality.

4. Intellectual Property and Exclusivity:
   Ensure that suppliers have appropriate licensing agreements, especially if proprietary synthesis methods are involved.

5. Customization and Technical Support:
   Suppliers offering tailored processes, technical assistance, and co-development support provide strategic advantages.

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Emerging Trends in API Sourcing for Degarelix Acetate

• Global supply chain diversification: To mitigate geopolitical and logistical risks, companies increasingly diversify sources, engaging both Indian and Chinese suppliers alongside established European manufacturers.
• Heightened regulatory scrutiny: Post-pandemic quality standards have intensified, demanding suppliers demonstrate comprehensive compliance and transparency.
• Cost optimization: Pricing pressures motivate negotiations with multiple suppliers, fostering competitive bidding and continuous process improvements.

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Conclusion

Sourcing high-quality degarelix acetate API involves selecting suppliers with proven manufacturing capacity, robust regulatory compliance, and cost effectiveness. Indian manufacturers like Chemphaarm, Dr. Reddy's Laboratories, and Claris Life Sciences dominate the peptide API landscape, offering scalable, GMP-compliant production. European firms like Aenova and Asian suppliers such as WuXi AppTec expand options for global companies seeking diversified supply chains. Strategic partnerships with these manufacturers can secure reliable supply, crucial for the supply chain resilience of anticancer therapeutics.

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Key Takeaways

• GMP Compliance is Paramount: Only engage suppliers with validated GMP certification and proven regulatory track records.
• Evaluate Manufacturing Capacity: Ensure supplier capabilities match your volume needs for both clinical and commercial supply.
• Diversify Supplier Base: Reducing dependency on a single source mitigates risks associated with geopolitical factors or manufacturing disruptions.
• Prioritize Quality and Transparency: Close collaboration with suppliers on quality control and process validation enhances product integrity.
• Monitor Regulatory Landscape: Stay informed about evolving international standards to ensure continued compliance and market access.

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FAQs

1. Are there approved generic sources of degarelix acetate API globally?
Currently, no single globally recognized generic manufacturer has exclusive rights; however, multiple Indian and Chinese companies produce GMP-compliant peptide APIs suitable for clinical and commercial use.

2. How can I verify the regulatory credibility of a degarelix acetate API supplier?
Verify GMP certifications, conduct supplier audits, review previous regulatory approvals, and assess documentation such as batch records, stability data, and impurity profiles.

3. What factors influence the cost of degarelix acetate API?
Cost drivers include synthesis complexity, scale of production, purity requirements, raw material availability, and manufacturing efficiency.

4. Is peptide API manufacturing suitable for large-scale production?
Yes, established peptide API manufacturers have capacity and technical expertise for multi-kilogram to ton-scale production, ensuring supply security.

5. What are the risks integrating multiple API sources?
Risks include variability in quality, differences in impurity profiles, and logistical complexities. Proper qualification and harmonized quality standards mitigate these issues.

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Sources

[1] International Peptide Society. "Peptide API Manufacturers Directory," 2022.
[2] US Food and Drug Administration (FDA). "Guidance for Industry: Quality System Approach to Pharmaceutical Manufacturing."
[3] European Medicines Agency (EMA). "Good Manufacturing Practice (GMP) Guidelines."
[4] Pharma Intelligence, "Global API Manufacturing Market Analysis," 2023.