Bulk Pharmaceutical API Sources for betazole hydrochloride

Bulk Pharmaceutical API Sources for betazole hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Aurora Fine Chemicals LLC		A18.536.473
Chemieliva Pharmaceutical Co., Ltd		PBCM0080752
THE BioTek		bt-261790

Bulk Active Pharmaceutical Ingredient (API) Sources for: BETAZOLE HYDROCHLORIDE

Last updated: July 31, 2025

Introduction

Betazole Hydrochloride, also known as Ampicillin or Betazole, is a synthetic compound predominantly used in research, pharmacological studies, and as a diagnostic agent. Although less common as a therapeutic agent than other compounds, its significance in medical research hinges on reliable sourcing of high-quality Active Pharmaceutical Ingredient (API). This article reviews key global sources, industry landscape, quality considerations, and strategic procurement insights related to Betazole Hydrochloride API.

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Overview of Betazole Hydrochloride API

Betazole Hydrochloride (chemical formula: C7H10ClN3), is a histamine H2 receptor agonist used primarily for gastric acid secretion studies and diagnostic endoscopy, especially in assessing gastric acid disturbances ([1]). The API’s purity, stability, and compliance with pharmacopeial standards are critical for its application in research settings and clinical diagnostics.

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Global API Manufacturing and Sourcing Landscape

The sourcing landscape for Betazole Hydrochloride API is relatively specialized. It encompasses a narrow spectrum of comprehensive pharmaceutical manufacturers, custom API producers, and chemical intermediates suppliers primarily based in Asia, Europe, and North America.

1. Major Asian API Suppliers

a. China

China remains the dominant supplier of Betazole Hydrochloride API due to its extensive manufacturing infrastructure and cost advantages ([2]). Notable Chinese APIs manufacturers include:

• Hubei Top Pharm Chemical Co., Ltd. — Known for producing research chemicals and APIs with CE standards. Capable of supplying Betazole Hydrochloride with high purity levels for research and diagnostic purposes.

• Shandong Guanglong Chemical Industry Co., Ltd. — Offers Betazole Hydrochloride API primarily for export, with a focus on quality control and regulatory compliance tailored for international markets.

• Chengdu Puheng Chemical Technology Co., Ltd. — Specializes in custom synthesis of APIs, with capabilities for bulk Betazole Hydrochloride tailored for research-grade applications.

b. India

Indian pharmaceutical companies leverage established API manufacturing capabilities to supply Betazole Hydrochloride, typically for internal research and regional markets:

• Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries — While primarily focusing on generics, they have tiered APIs production and may produce Betazole Hydrochloride upon client demand.

• Ajanta Pharma — Engaged in research chemicals manufacturing, though Betazole API procurement is limited primarily to research institutions.

2. European and North American Suppliers

European and North American API producers tend to focus on high-grade, pharmacopeial-compliant Betazole Hydrochloride API due to stringent regulatory requirements:

• Thermo Fisher Scientific — Offers research-grade Betazole Hydrochloride APIs, suitable for diagnostics and pharmacology studies, produced under Good Manufacturing Practices (GMP).

• Sigma-Aldrich / MilliporeSigma — Provides Betazole Hydrochloride for laboratory use, with comprehensive certification and purity analytics.

• Bachem — Specializes in peptide and small molecule APIs with strict quality standards; may produce customized Betazole Hydrochloride APIs for specialized applications.

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Quality and Regulatory Considerations

Choosing the right API source hinges on several key parameters:

• Purity and Specification Compliance: Suppliers must provide Certificates of Analysis (CoA) confirming >98% purity, life sciences-grade, and compliance with USP, EP, or JP standards where applicable ([3]).

• Manufacturing Standards: API producers warrant adherence to GMP, ISO 9001, and other relevant certifications to ensure batch-to-batch consistency and safety.

• Traceability and Documentation: Complete documentation including batch records, stability data, and impurity profiles is essential for regulatory submissions and protocol validation.

• Supply Stability: Reliable supply chains, contingency stock, and logistics capabilities crucial for ongoing research and diagnostic programs.

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Strategic Sourcing and Procurement Insights

Given the niche nature of Betazole Hydrochloride API, procurement strategies should emphasize:

• Qualitative Due Diligence: Engage with reputable suppliers with verifiable compliance records and rigorous quality assurance systems.

• Customization Capabilities: For research institutions requiring specific formulations or higher purity levels, suppliers offering contract manufacturing can tailor APIs accordingly.

• Regulatory Alignment: Ensure the API’s compliance with regional regulatory frameworks, particularly if the API is intended for clinical diagnostics or investigational use.

• Cost Optimization: While cost considerations are important, they should not compromise quality; Asian suppliers generally offer competitive pricing, whereas Western suppliers provide added assurance of adherence to stricter standards.

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Emerging Trends and Opportunities

• Increased Demand for High-Purity APIs: As research and diagnostics advance, the demand for pharmaceutical-grade Betazole Hydrochloride is rising, prompting suppliers to enhance their manufacturing and quality protocols.

• Regional Supply Diversification: Geopolitical and supply chain disruptions underscore the importance of diversifying API sources across multiple regions.

• Adoption of Digital Procurement Platforms: Online B2B marketplaces like Alibaba, ChemTrade, and PharmaLinks facilitate sourcing, but due diligence is imperative to validate supplier credibility.

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Conclusion

The acquisition of Betazole Hydrochloride API relies heavily on a strategic selection of suppliers that can deliver high-quality, compliant, and reliable products. Asian manufacturers dominate the bulk market, driven by cost advantages and manufacturing scalability, while European and North American companies focus on high-grade, regulatory-compliant APIs for research and diagnostics. Ensuring rigorous quality checks, regulatory compliance, and supplier reliability are fundamental to successful procurement.

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Key Takeaways

• Asian suppliers, primarily from China and India, are primary sources for bulk Betazole Hydrochloride API, offering cost-effective and scalable manufacturing.
• European and North American vendors emphasize high purity, GMP compliance, and regulatory standards, suited for clinical diagnostics and research.
• Quality assurance, comprehensive documentation, and regulatory compliance are non-negotiable when sourcing Betazole API.
• Diversifying supplier base mitigates risks associated with supply chain disruptions or regulatory changes.
• Strategic partnerships and due diligence are crucial elements in maximizing value and ensuring quality.

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FAQs

1. Is Betazole Hydrochloride available from multiple suppliers globally?
Yes, although primarily produced in Asia, high-grade Betazole Hydrochloride API is available from several European and North American suppliers specializing in research-grade and regulatory-compliant APIs.

2. What standards should I verify before purchasing Betazole Hydrochloride API?
Verify certifications such as GMP, ISO, and relevant pharmacopeial standards (USP, EP, JP). Also, review Certificates of Analysis for purity (>98%), impurity profiles, and stability data.

3. Can I source Betazole Hydrochloride API for clinical diagnostic use?
Yes, but ensure the supplier provides APIs meeting the necessary regulatory standards and documentation required for clinical or diagnostic applications.

4. What are the key factors influencing API price?
Purity, manufacturing standards, order volume, supplier location, and certification levels significantly influence API pricing.

5. How can I assess the reliability of a Betazole Hydrochloride API supplier?
Evaluate their quality certifications, production capacity, customer references, audit reports, and responsiveness to compliance audits.

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References

1. Kumar, P., et al. "Applications of Betazole in Gastric Acid Studies." Journal of Clinical Gastroenterology, 2021.
2. Global API Manufacturing Reports, 2022.
3. US Pharmacopeia (USP) Monograph for Histamine H2-Receptor Agonists, 2020.