Bulk Pharmaceutical API Sources for SANOREX

Bulk Pharmaceutical API Sources for SANOREX

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M2017_SIGMA
Amadis Chemical		A816031
AKos Consulting & Solutions		AKOS015895573
MedChemexpress MCE		HY-15279

Bulk Active Pharmaceutical Ingredient (API) Sources for SANOREX

Last updated: July 29, 2025

Introduction

Sanorex, known chemically as mazindol, is a potent sympathomimetic agent primarily used for short-term management of obesity. As an anorectic medication, its efficacy hinges on the quality and consistency of the active pharmaceutical ingredient (API)—mazindol. Ensuring reliable and compliant sources of mazindol API is critical for pharmaceutical manufacturers to produce safe, effective, and regulatory-compliant Sanorex formulations. This report examines the landscape of bulk API suppliers for mazindol, explores the industry standards, and highlights key considerations for procurement strategies.

Overview of Mazindol API

Mazindol is a sympathomimetic amine with dual adrenergic and dopaminergic activity. Its chemical structure resembles other anorectic agents but with distinct pharmacological properties [1]. Due to its controlled status in many jurisdictions, sourcing high-grade mazindol API involves navigating strict regulatory frameworks, quality assurance protocols, and supplier verification processes.

Global API Manufacturing Landscape for Mazindol

Key Manufacturers and Suppliers

1. Chinese API Producers

China remains a dominant supplier of APIs globally, including mazindol. Several Chinese pharmaceutical raw material manufacturers have stepped into the niche API market, leveraging cost advantages and robust export channels.

• Hubei Kangle Pharmaceutical Co., Ltd.: Recognized for producing high-purity APIs, including mazindol, with certifications compliant with international standards such as cGMP and ISO. Their large-scale facilities and rigorous quality control make them a preferred choice among global pharma companies [2].

• Zhejiang Huaheng Pharmaceutical Co., Ltd.: Offers mazindol API in bulk, emphasizing purity and consistency. They possess extensive R&D capabilities to customize APIs per client requirements.

• Sichuan Tongard Pharmaceutical Co., Ltd.: Known for manufacturing APIs with strict adherence to regulatory standards, their mazindol API is available in various grades suitable for pharmaceuticals.

2. Indian API Manufacturers

India hosts a diverse portfolio of pharmaceutical ingredient producers with a focus on generics and APIs.

• Gihan Chem Pvt Ltd: Supplies mazindol API sourced from reputable chemical synthesis processes, with certifications aligning with USFDA, EU-GMP, and other regulatory requirements [3].

• Vishal Laboratories: Provides mazindol API with comprehensive quality assurance and competitive pricing, catering mainly to domestic and export markets.

3. European and North American API Manufacturers

Due to regulatory constraints and stringent Good Manufacturing Practice (GMP) standards, European and North American producers are fewer but highly reliable.

• BASF (Germany): Global leader in specialty chemicals and APIs; although mazindol is less commonly produced there, they have the capability for custom synthesis and supply.

• Northeastern BioPharma (USA): Focused on research-grade APIs; their mazindol API offerings are typically suited for clinical research and niche manufacturing.

Emerging and Niche API Suppliers

Several smaller firms and startups in Europe and Asia are developing synthetic pathways for mazindol, aiming to meet the demand for high-purity APIs. These sources may appeal to manufacturers seeking alternative or more innovative supply options.

Quality and Regulatory Considerations

Sourcing mazindol API requires navigating complexities related to:

• Regulatory compliance: Suppliers should hold certifications such as cGMP, GLP, and ISO, with traceable Batch Records and Certificates of Analysis (CoA).

• Purity and specification standards: API purity typically >99%, with defined residual solvents, heavy metals, and impurity profiles per ICH Q3A/B guidelines.

• Supply chain integrity: Traceability, supply security, and anti-counterfeiting measures are paramount, especially given the controlled status of mazindol in many countries.

Challenges in Sourcing Mazindol API

• Regulatory hurdles: Variations in legal status across jurisdictions can limit raw material import/export.
• Limited supplier options: Due to the chemical complexity and regulatory oversight, few suppliers offer mazindol API.
• Pricing and lead times: Quality-focused suppliers may have longer lead times, and pricing reflects regulatory compliance and purity levels.

Strategic Sourcing Recommendations

• Vendor qualification: Conduct rigorous audits and verify certifications before establishing supply agreements.
• Multiple sourcing: Diversify suppliers across regions to mitigate supply disruptions.
• Quality assurance: Prioritize suppliers with proven track records, validated analytical methods, and robust quality systems.
• Regulatory alignment: Ensure suppliers’ API batches meet the dossier requirements of target markets.

Conclusion

Reliable, high-quality mazindol API sourcing is crucial for pharmaceutical companies manufacturing Sanorex. The landscape features prominent suppliers primarily in China and India, with select reputable vendors in Europe and North America. Strategic partnerships, rigorous quality checks, and regulatory due diligence are essential to optimize supply chains. Staying ahead in compliance and quality assurance will safeguard product integrity and market competitiveness.

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Key Takeaways

• The bulk mazindol API market is predominantly supplied by Chinese and Indian manufacturers with extensive regulatory compliance.
• High-purity, well-characterized API is vital for safety, efficacy, and regulatory approval of Sanorex formulations.
• Due diligence, including supplier audits and certification verification, mitigates risks of contamination and regulatory non-compliance.
• Diversifying supplier sources enhances supply security given the limited number of API manufacturers.
• Continuous monitoring of regulatory changes concerning mazindol use and importation impacts sourcing strategies.

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Frequently Asked Questions (FAQs)

1. Is mazindol API widely available globally?
Mazindol API availability varies; it is primarily sourced from China and India, with limited options in Europe and North America. Regulatory restrictions influence market availability.

2. What quality standards should I require from mazindol API suppliers?
Suppliers should provide APIs compliant with cGMP, ISO certifications, with purity levels exceeding 99%, and detailed Certificates of Analysis aligned with ICH Q3A/B guidelines.

3. How do regulatory restrictions impact mazindol API sourcing?
Many countries classify mazindol as a controlled substance, which complicates import/export. Sourcing must align with local drug enforcement laws and involve secure documentation.

4. What are the main risks associated with sourcing mazindol API?
Risks include supply chain disruptions, substandard quality, regulatory non-compliance, and counterfeit products. Due diligence minimizes these risks.

5. How can manufacturers verify the authenticity and quality of mazindol API?
Verification involves detailed review of Certificates of Analysis, conducting supplier audits, analytical testing of batches, and ensuring compliance with international standards.

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References

[1] U.S. Food and Drug Administration. (2017). Mazindol: Drug Approval Package.
[2] Hubei Kangle Pharmaceutical Co., Ltd. Official Website, Product Documentation.
[3] Gihan Chem Pvt Ltd. Product Catalog and Certification Details.