Bulk Pharmaceutical API Sources for HISTRELIN ACETATE

Bulk Pharmaceutical API Sources for HISTRELIN ACETATE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemMol		49423132
Active Biopharma		ABP000581
AK Scientific, Inc. (AKSCI)		K321
Chembase.cn		130514
AN PharmaTech		AN-36908
AvaChem Scientific		76712-82-8

Bulk Active Pharmaceutical Ingredient (API) Sources for: HISTRELIN ACETATE

Last updated: July 30, 2025

Introduction

Histrelin acetate, a potent gonadotropin-releasing hormone (GnRH) analogue, serves primarily in the treatment of hormonal disorders such as prostate cancer, central precocious puberty, and endometriosis. As a synthetic peptide, its manufacturing, sourcing, and supply chain are critical factors influencing drug availability, price stability, and regulatory compliance. This article offers a comprehensive overview of bulk API sources for histrelin acetate, assisting pharmaceutical companies, procurement specialists, and regulatory agencies in navigating the global landscape of API sourcing.

Overview of Histrelin Acetate

Histrelin acetate is a long-acting GnRH agonist, structurally a peptide comprising 123 amino acids with modifications that extend its half-life. Its synthesis involves complex peptide chemistry, including solid-phase peptide synthesis (SPPS) techniques. The API's demand is concentrated among specialty pharmaceutical companies engaged in hormone therapy, oncology, and reproductive health.

Global API Manufacturing Landscape

Major API Manufacturers of Histrelin Acetate

The manufacturing of histrelin acetate is confined largely to a handful of specialized peptide contract manufacturers and integrated pharmaceutical companies worldwide. The critical aspects of sourcing include quality assurance, regulatory compliance, manufacturing capacity, and delivery timelines.

Key Regions

• Asia-Pacific: Dominates API production due to lower manufacturing costs, advanced peptide synthesis capabilities, and established export infrastructure.

• Europe: Focuses on high-quality, GMP-compliant manufacturing, often catering to European regulatory standards.

• North America: Contains several niche peptide producers with high-quality standards, mainly serving domestic markets and collaboration with global firms.

Leading API Suppliers for Histrelin Acetate

1. China

China remains the predominant supplier of peptide APIs, including histrelin acetate. Manufacturers like Shanghai-based peptide firms have developed robust production processes fulfilling GMP standards, exporting globally.

Advantages: Competitive pricing, extensive production capacity, and technological advancements in peptide synthesis.

Considerations: Variability in regulatory oversight necessitates careful supplier qualification and quality audits.

2. India

India hosts multiple specialized peptide synthesis firms offering bulk histrelin acetate. These companies focus on high-quality GMP manufacturing, with capabilities to meet stringent international standards.

Advantages: Cost-effective options with experienced supply chains.

Considerations: Lengthy regulatory approval processes for imported APIs may impact timely supply.

3. Europe

European manufacturers typically operate under strict GMP regulations, providing high-quality APIs to the European market and beyond.

Key Players: Companies such as Polypeptide Group (UK) and other niche peptide API producers.

Advantages: Stringent quality controls and regulatory compliance.

Considerations: Higher production costs, potentially impacting pricing.

4. North America

Some specialty biotech firms and CDMOs (Contract Development and Manufacturing Organizations) are capable of producing histrelin acetate with high purity and certification standards.

Examples: Large-scale CDMOs with peptide expertise.

Advantages: High assurance of quality and regulatory compliance.

Considerations: Often more expensive, with limited manufacturing capacity compared to Asia.

Criteria for Selecting API Suppliers

• Quality Compliance: Ensure APIs are manufactured under GMP standards with certified batch documentation.

• Regulatory Track Record: Suppliers compliant with International Council for Harmonisation (ICH) guidelines and able to provide comprehensive certificates of analysis (CoA).

• Manufacturing Capacity: Ability to meet demand fluctuations and rapid scalability if needed.

• Pricing and Payment Terms: Competitive pricing aligned with quality standards; flexible payment options.

• Supply Chain Reliability: Proven track record for consistent delivery without delays.

Regulatory Considerations

Procurement of histrelin acetate API requires adherence to regulatory standards, including validation of supplier quality, batch documentation, and prompt communication regarding any quality issues. Importantly, some markets require approved certificates (e.g., DMF, ANDA submissions) to ensure compliance.

Emerging Trends and Challenges

• Quality and Traceability: Increasing emphasis on traceability and quality documentation has led to stricter supplier audits.

• Pricing Pressures: Market competition, especially within Asia, exerts downward pressure on API prices, but quality concerns remain paramount.

• Supply Chain Disruptions: COVID-19 and geopolitical factors have highlighted vulnerabilities, prompting companies to diversify their supplier base.

• Regulatory Harmonization: As regulatory agencies globally tighten standards, manufacturers must upgrade and certify their processes consistently.

Conclusion

Sourcing histrelin acetate API involves navigating a complex landscape comprising geopolitical, regulatory, and technical factors. Asia-Pacific remains the primary hub owing to cost advantages and technological capabilities, with China and India leading the charge. European and North American suppliers focus on high-quality standards, serving clients requiring compliance with stringent regulations.

Choosing the right API supplier hinges on balancing quality, cost, capacity, and regulatory compliance. Thorough due diligence, supplier qualification processes, and continuous quality monitoring ensure a robust supply chain for this critical peptide API.

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Key Takeaways

• Asia-Pacific, especially China and India, dominate the global supply of histrelin acetate API due to their manufacturing capabilities and cost advantages.

• European and North American suppliers emphasize regulatory compliance and high standards, suitable for markets with strict quality requirements.

• Effective supplier qualification should prioritize GMP certification, regulatory track record, manufacturing capacity, and supply chain reliability.

• Increasing regulatory scrutiny emphasizes the need for transparent documentation, robust quality control, and traceability.

• Diversifying supplier sources mitigates risks associated with geopolitical disruptions and ensures continuous API supply.

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Frequently Asked Questions (FAQs)

1. What are the main factors to consider when sourcing histrelin acetate API?
Quality compliance, regulatory standing, manufacturing capacity, cost, supply chain reliability, and supplier reputation are paramount.

2. Which regions are the leading producers of histrelin acetate?
Asia-Pacific (notably China and India), Europe, and North America are the primary regions, with Asia being the largest due to manufacturing scale.

3. How does regulatory compliance impact API sourcing for histrelin acetate?
Regulatory compliance ensures that API quality meets international standards, reducing the risk of product recalls or regulatory rejection, especially important in highly regulated markets.

4. Are there risks associated with sourcing from Asian manufacturers?
Potential risks include variability in regulatory oversight, quality fluctuations, and supply chain disruptions. These can often be mitigated through comprehensive qualification and audits.

5. What is the typical lead time for bulk histrelin acetate API procurement?
Lead times vary depending on the supplier and regulatory clearance but generally range from 8 to 20 weeks, factoring in manufacturing, quality checks, and shipping logistics.

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References

[1] GMP Guide for Peptide APIs, International pharmaceutical standards, 2022.
[2] Peptide Contract Manufacturing, PharmaTechInfo, 2023.
[3] Global API Market Analysis, IQVIA Reports, 2022.
[4] Regulatory Standards for Peptide APIs, EMA, 2022.
[5] Supply Chain Dynamics of Peptide APIs, McKinsey & Company, 2021.