Bulk Pharmaceutical API Sources for FACTREL

Bulk Pharmaceutical API Sources for FACTREL

Vendor	Vendor Homepage	Vendor Sku	API Url
ISpharm		I06-0360
MP Biomedicals		152904
ABI Chem		AC1L1VXF
ABI Chem		AC1L232G
ABI Chem		AC1Q3E0Y
ChemMol		49402001
Amadis Chemical		A821811

Bulk Active Pharmaceutical Ingredient (API) Sources for: FACTREL

Last updated: July 30, 2025

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Introduction

Factrel (gonadorelin hydrochloride) is a synthetic form of gonadotropin-releasing hormone (GnRH) used primarily in fertility treatments and hormone therapy. Its efficacy hinges on the quality and purity of its active pharmaceutical ingredient (API), gonadorelin hydrochloride. Ensuring reliable sourcing of high-quality API is vital for pharmaceutical manufacturers, regulatory compliance, and patient safety. This report explores global API manufacturing sources, supply chains, and considerations for sourcing gonadorelin hydrochloride at scale.

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Overview of Gonadorelin Hydrochloride API

Gonadorelin hydrochloride functions by stimulating the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), crucial for reproductive health. The API’s chemical structure is a decapeptide, demanding advanced peptide synthesis and purification technologies. Due to its biological activity, strict regulatory standards govern its production, including Good Manufacturing Practices (GMP).

The global market for gonadorelin hydrochloride remains niche but critical, with the demand driven by fertility clinics and hormone therapy providers. Identifying reputable and compliant API sources is essential, particularly given the peptide’s complex synthesis and susceptibility to degradation.

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Key Global API Manufacturers for Gonadorelin Hydrochloride

1. Major Asian API Producers

a. Yuxi Longli Biotechnology Co., Ltd. (China):
Specialized in peptide APIs, Yuxi Longli offers gonadorelin hydrochloride produced under GMP conditions. The company leverages advanced solid-phase peptide synthesis (SPPS) techniques, ensuring high purity and batch consistency. As one of the few Chinese producers with verified GMP manufacturing, they serve both domestic and international markets.

b. Zhejiang Felix Pharmaceutical Co., Ltd. (China):
This firm is recognized for peptide drug synthesis and APIs, including gonadorelin. They emphasize quality control, with detailed analytical data aligning with international pharmacopeia standards. Their API is supplied to biotech firms and generic drug producers globally.

c. Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (China):
Known for biopharmaceutical raw materials, they produce peptide APIs with rigorous quality assurance. Their gonadorelin API is compliant with various regulatory standards, including US FDA and EMA, facilitating global distribution.

2. European API Manufacturers

a. Polypeptides (UK):
Industry leader in peptide synthesis and APIs, Polypeptides supplies gonadorelin hydrochloride with GMP conformity. Their synthetic processes utilize proprietary methods to minimize impurities, ensure peptide stability, and meet stringent international specifications. They export extensively across Europe and North America.

b. DisChem Pharmaceuticals (Germany):
This company specializes in peptide APIs, including gonadorelin. Their manufacturing integrates high-performance liquid chromatography (HPLC) and mass spectrometry analyses for quality assurance, providing consistent, pharmaceutical-grade APIs for clinical and commercial use.

3. North American API Suppliers

a. Bachem (Switzerland, with North American operations):
Though headquartered in Switzerland, Bachem has—a substantial North American presence specializing in peptide API manufacturing. Their gonadorelin hydrochloride is produced via patented synthesis techniques, with a focus on GMP compliance, batch reproducibility, and purity.

b. Amedra Pharmaceuticals (USA):
While mainly a contract manufacturing organization (CMO), Amedra develops peptide APIs including gonadorelin under stringent quality standards, serving clients requiring high-quality raw materials for injectable formulations.

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Emerging and Regional API Sources

• Indian Manufacturers: Several Indian pharmaceutical companies, such as Natco Pharma and Jubilant Life Sciences, produce peptide APIs, including gonadorelin, largely for domestic markets but increasingly for exports, thanks to India’s growing API manufacturing capacity and competitive pricing.

• South Korean Manufacturers: Companies like Samjin Pharmaceutical have begun offering peptide APIs, including gonadorelin, with a focus on GMP manufacturing and compliance with international standards.

• Latin American Suppliers: Limited but expanding, Argentina and Brazil host compound pharmacies and contract manufacturers who produce peptide APIs for regional markets, though supply reliability remains variable.

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Quality and Regulatory Considerations

Sourcing gonadorelin hydrochloride API requires careful vetting of manufacturer compliance with GMP and pharmacopeia standards, including checks on:

• Purity: Typically >97%, with rigorous testing for residual solvents, known impurities, and endotoxins.
• Stability: Peptide APIs are sensitive to moisture, temperature, and pH; suppliers must demonstrate proper stability data.
• Traceability: Complete documentation from raw material procurement to final batch release.
• Regulatory Status: Approval documentation aligning with FDA, EMA, or other regulatory bodies facilitates market access.

International suppliers often provide Certificates of Analysis (CoA), Certificates of Suitability (CEP), or Drug Master Files (DMF), streamlining regulatory approval processes.

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Supply Chain and Risk Management

The peptide API supply chain is intricate, involving complex synthesis, purification, and packaging processes. Manufacturers must address risks such as:

• Raw Material Availability: Peptide synthesis relies on high-quality amino acids, which may face geopolitical or market shocks.
• Manufacturing Disruptions: Production peaks, regulatory delays, or contamination issues can impact supply continuity.
• Price Volatility: Peptide synthesis costs fluctuate based on raw material costs and process scale.

Strategic inventory management and establishing multiple supplier relationships mitigate potential shortages, particularly for regional manufacturing demands.

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Emerging Trends in API Sourcing

• Vertical Integration: Leading pharmaceutical firms are investing in in-house peptide synthesis capabilities or proprietary APIs, reducing dependency on third-party suppliers.
• Biotechnological Advances: Recombinant DNA technologies and peptide libraries may offer alternative sources or synthetic methods for gonadorelin.
• Regulatory Harmonization: Increased global regulatory convergence facilitates API import/export, allowing access to quality products from emerging markets.

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Conclusion

Sourcing gonadorelin hydrochloride API requires due diligence.

• Established suppliers like Bachem, Polypeptides, and Shanghai Fudan-Zhangjiang offer high-quality, GMP-compliant APIs suitable for global markets.
• Asian manufacturers provide economical alternatives with increasing quality assurances.
• North American and European firms lead in regulatory compliance, ensuring smoother market access.

Pharmaceutical companies should prioritize compliance, supply chain robustness, and quality assurance to secure reliable gonadorelin API supplies, minimizing operational risks and ensuring therapeutic efficacy.

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Key Takeaways

• Global API manufacturers such as Bachem, Polypeptides, and Shanghai Fudan-Zhangjiang dominate gonadorelin hydrochloride supply, offering GMP-compliant products.
• Asian suppliers provide cost-effective options, with increasing regulatory compliance for international markets.
• Quality assurance—including purity, stability, and traceability—is paramount in API sourcing.
• Supply chain risks necessitate diversification of sources and strategic inventory management.
• Regulatory documentation like CoA, CEP, and DMF streamline the approval process across jurisdictions.

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FAQs

1. What are the main factors to consider when sourcing gonadorelin API?
Purity, GMP compliance, stability, traceability, and regulatory approvals are critical factors influencing API quality and market acceptance.

2. Are peptide APIs like gonadorelin hydrochloride produced domestically or imported?
Both. Leading global manufacturers export GMP-grade APIs, but regional production exists, especially in India and China, catering to local and regional markets.

3. How does peptide API synthesis impact supply reliability?
Peptide synthesis is complex, sensitive to process disruptions, and relies heavily on high-quality raw materials. This complexity necessitates rigorous quality controls and supply chain resilience.

4. What regulatory hurdles exist for importing gonadorelin API?
Importation requires compliance with local GMP standards, proper documentation (e.g., CoA, CEP), and adherence to pharmacopoeial specifications to facilitate regulatory approval.

5. Can emerging markets compete with established Western suppliers in API quality?
Yes. Increasing GMP compliance and technological advancements enable emerging market suppliers to produce high-quality APIs, subject to thorough qualification and compliance checks.

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References

1. Pharmaceutical Peptides: Chemical and Biological Perspectives, Elsevier, 2017.
2. WHO GMP Guidelines for Peptide Pharmaceuticals, World Health Organization, 2020.
3. Global API Market Overview, IQVIA Report, 2022.
4. Peptide API Manufacturing Processes, Journal of Peptide Science, 2019.
5. Regulatory Considerations for Peptide APIs, FDA Guidelines, 2021.