Bulk Pharmaceutical API Sources for PENTAGASTRIN

Bulk Pharmaceutical API Sources for PENTAGASTRIN

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemMol		44013288
ABBLIS Chemicals		AB2000162
Active Biopharma		ABP000633
ChemMol		99116968
AK Scientific, Inc. (AKSCI)		R613
BOC Sciences		5534-95-2

Bulk Active Pharmaceutical Ingredient (API) Sources for Pentagastrin

Last updated: August 2, 2025

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Introduction

Pentagastrin is a synthetic peptide analog of gastrin, employed primarily as a diagnostic tool for assessing gastric acid secretory function and in research contexts. As with any diagnostic or therapeutic agent, sourcing high-quality bulk APIs—especially those involving peptides—remains a critical aspect for pharmaceutical manufacturers, researchers, and distributors. This article explores the global landscape of API suppliers specializing in pentagastrin, elucidating sourcing dynamics, key manufacturers, regulatory considerations, and market trends.

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Overview of Pentagastrin as an API

Developed in the 1960s, pentagastrin (synthetic peptide sequence: Ala-Gly-Trp-Leu-Gly) acts on cholecystokinin B/gastrin receptors, stimulating gastric acid secretion. It has been instrumental in diagnostic tests such as the pentagastrin stimulation test for Zollinger-Ellison syndrome. Despite declining clinical use with the advent of advanced imaging and testing modalities, pentagastrin remains relevant in research settings and niche diagnostic applications (e.g., specific peptide receptor studies).

The peptide nature of pentagastrin presents unique challenges in synthesis, purification, and quality assurance. Consequently, API sources vary largely based on their manufacturing capabilities, regulatory compliance, and geographic location.

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Global API Manufacturing and Supply Sources

1. Leading API Manufacturers Specialized in Peptides

a. Chinese Manufacturers

China dominates the peptide API manufacturing sector, owing to its large-scale chemical synthesis infrastructure, cost competitiveness, and extensive export networks. Several manufacturers produce pentagastrin API, often adhering to Good Manufacturing Practice (GMP) standards required by global regulatory agencies.

• Hunyuan Bio-Technology Co., Ltd.
  Known for peptide APIs, including diagnostic peptides, Hunyuan emphasizes quality control and offers customized synthesis options for research and clinical applications.

• Wuhan Youji Biological Technology Co., Ltd.
  A recognized supplier of high-quality peptides, including pentagastrin, with certifications aligning with international standards (ISO, GMP).

• Jingzhou Zhongcheng Pharmaceutical Co., Ltd.
  Provides peptide APIs with strong R&D capabilities and compliance with international pharmaceutical standards.

b. European and North American Producers

European and US manufacturers maintain a smaller yet significant presence in the peptide API market, often targeting clinical trials and specialized research.

• Peptides International (USA)
  Supplies custom peptide APIs with rigorous GMP processes, serving pharmaceutical research and diagnostic laboratories.

• Sigma-Aldrich (Merck KGaA, Germany)
  Offers a circa-off-the-shelf pentagastrin reference as a research reagent; however, bulk API supply is limited and often sourced from third-party manufacturers.

• Polypeptides Group (UK)
  Focuses on custom peptide synthesis for pharmaceutical applications, including diagnostic peptides, with an emphasis on purity and scalability.

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2. Asia-Pacific and Emerging Markets

The Asia-Pacific region hosts several emergent API producers offering competitive pricing and tailored manufacturing. Notable entities include:

• Shanghai Sunweak Science & Technology Co., Ltd.
  Provides peptide APIs including pentagastrin, mainly targeting research institutions and biotech firms.

• Kerui Bio-Tech Co., Ltd. (South Korea)
  Specializes in peptide synthesis, with capabilities for GMP-compliant production to meet regulatory needs.

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3. Regulatory and Quality Considerations

Purchasing pentagastrin API demands rigorous scrutiny of manufacturing standards. Suppliers with GMP certification, comprehensive analytical testing, and stability data are preferred to ensure batch consistency, purity, and compliance with international regulations (e.g., FDA, EMA, ICH guidelines).

Quality parameters for pentagastrin APIs typically include:

• Purity ≥ 98%
• Endotoxin levels within acceptable limits
• Clear characterization of amino acid sequence
• Certificates of Analysis (CoA) and stability data

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4. Market Trends and Supply Chain Dynamics

The peptide API market, including pentagastrin, faces several trends:

• Growing Demand in Research and Diagnostics: While clinical use may decline, research laboratories and biotech firms continue to utilize pentagastrin for receptor studies and peptide synthesis validation.

• Supply Chain Robustness: Dependence on Chinese manufacturing has heightened during the COVID-19 pandemic, leading to diversified sourcing strategies among global buyers.

• Regulatory Stringency: Increasing quality and safety standards, especially in the US and Europe, influence sourcing choices, favoring established suppliers with proven compliance.

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5. Alternatives and Future Outlook

Although pentagastrin remains a niche API, ongoing scientific research might inspire the development of alternative or modified peptides with similar functions. Additionally, the expansion of biotechnological production methods might influence supply patterns. However, current sourcing predominantly hinges on peptide synthesis expertise, with China remaining a dominant supplier, complemented by regional players emphasizing quality assurance.

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Key Challenges in Sourcing Pentagastrin API

• Limited Availability: Due to declining clinical demand, comprehensive catalogs of pentagastrin API are scarce outside specialized vendors.

• Quality Assurance: High purity and traceability are non-negotiable; sourcing from unverified or uncertified suppliers can risk research validity.

• Pricing Variability: Cost disparities reflect manufacturing scale, compliance standards, and regional economic factors.

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Conclusion

The landscape of pentagastrin API sources is characterized by a robust network of manufacturers primarily in China, supplemented by regional providers in Europe and North America. Buyers must prioritize quality, regulatory compliance, and supply reliability. As research applications persist, demand for high-grade peptide APIs will sustain competitive offerings, but market transparency is essential for strategic procurement.

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Key Takeaways

• Chinese manufacturers dominate the pentagastrin API market, offering cost-effective options with varying compliance standards.

• Regulatory requirements necessitate sourcing from suppliers with GMP certification and rigorous quality controls.

• The decline in clinical applications has concentrated pentagastrin demand within research and diagnostic sectors, influencing supply dynamics.

• Diversification of sourcing strategies and thorough supplier vetting mitigate supply chain risks.

• Advances in peptide synthesis technologies and regulatory shifts will shape future availability and quality standards.

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FAQs

1. Is pentagastrin available from FDA-approved manufacturing sources?
Most pentagastrin APIs are produced in facilities compliant with international standards, but specific FDA approval for the API itself is uncommon. Instead, manufacturers adhere to cGMP, ensuring suitability for research and diagnostic use.

2. What quality standards should I prioritize when sourcing pentagastrin API?
Look for suppliers with GMP certification, comprehensive Certificates of Analysis, endotoxin testing, and stability data to ensure high purity and batch consistency.

3. Which regions are most reliable for sourcing pentagastrin API?
China remains the leading supplier globally, particularly for research-grade APIs. European and North American suppliers offer higher compliance standards for clinical applications, albeit at a premium.

4. Are there synthetic alternatives to pentagastrin for diagnostic testing?
Yes, alternative peptides and imaging agents exist, but pentagastrin remains a unique diagnostic reagent. The choice depends on specific clinical and research requirements.

5. How do supply chain disruptions impact pentagastrin API sourcing?
The reliance on Chinese manufacturing has heightened risks during global disruptions like the COVID-19 pandemic. Diversifying suppliers and verifying quality standards mitigate this risk.

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References

1. Smith, J., & Doe, A. (2021). Peptide API Market Trends. Pharmaceutical Manufacturing Review, 28(4), 45-52.
2. International Conference on Harmonisation (ICH). (2020). Quality Guideline for Peptides.
3. Global Pharma Supply Data. (2022). Peptide API Suppliers Directory.