Bulk Pharmaceutical API Sources for ORINASE DIAGNOSTIC

Bulk Pharmaceutical API Sources for ORINASE DIAGNOSTIC

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		473-41-6
Alfa Chemistry		473-41-6
MuseChem		I011750
MolCore		MC555795
THE BioTek		bt-254838
Smolecule		S005496

Bulk Active Pharmaceutical Ingredient (API) Sources for: ORINASE DIAGNOSTIC

Last updated: August 2, 2025

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Introduction

Orinase Diagnostic refers to a diagnostic product linked to the pharmaceutical drug Orinase, whose active pharmaceutical ingredient (API) is Tolbutamide. A first-generation sulfonylurea, Tolbutamide plays a vital role in managing type 2 diabetes mellitus. Although primarily used therapeutically, its diagnostic applications—particularly in glucose regulation assessments—require high-quality APIs from reliable bulk sources. This article investigates the global landscape of API suppliers capable of providing high-grade Tolbutamide, focusing on manufacturing capabilities, regulatory compliance, and sourcing strategies relevant to diagnostic applications.

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Understanding Tolbutamide as an API

Chemical Profile and Therapeutic Use
Tolbutamide operates by stimulating pancreatic beta-cell insulin secretion, effectively lowering blood glucose levels. Its chemical designation is N-(4-Methylphenyl)sulfonylurea, with a molecular weight of approximately 270.33 g/mol. In diagnostic contexts, Tolbutamide serves as a substrate in testing insulin responsiveness and glucose tolerance, requiring APIs that meet strict purity standards.

Quality Standards for Diagnostic APIs
APIs intended for diagnostic use must adhere to regulatory standards such as Pharmacopoeial specifications (USP, EP, JP) or all applicable local regulations. Stability, purity (>99%), and consistent supply are mandates, ensuring diagnostic accuracy and patient safety.

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Global API Manufacturing and Sourcing Landscape

1. Leading Domestic and International API Manufacturers

Several pharmaceutical and chemical manufacturers globally produce Tolbutamide at scale. Larger players often cater to both therapeutic and diagnostic markets, with elaborate quality assurance processes.

• Sun Pharmaceutical Industries Ltd. (India)
  Sun Pharma offers a comprehensive portfolio of sulfonylureas, including Tolbutamide, adhering to strict quality norms aligned with international standards. Their manufacturing facilities in India are compliant with Good Manufacturing Practices (GMP), making them suitable suppliers for diagnostic API needs.

• Hetero Labs Ltd. (India)
  Hetero is a notable producer of sulfonylurea APIs, including Tolbutamide. Their facilities are licensed under stringent GMP standards, exporting to global markets, including regulatory-compliant APIs fit for diagnostic criteria.

• Dr. Reddy’s Laboratories (India)
  Dr. Reddy’s has capabilities in synthetic API production, including Tolbutamide, with an emphasis on purity and market-approved manufacturing processes.

• Glenmark Pharmaceuticals (India)
  Offering APIs compliant with international standards, Glenmark supplies Tolbutamide for different applications, including diagnostics.

• Teva Pharmaceutical Industries Ltd. (Israel)
  Teva produces generic APIs for sulfonylureas, including Tolbutamide, with high standards of quality suitable for laboratory and diagnostic applications.

• Aurobindo Pharma (India)
  Aurobindo’s API manufacturing facilities are GMP-certified, producing Tolbutamide with consistent quality, suitable for diagnostic reagent production.

2. Specialty API Manufacturers and Contract Manufacturers

• Azetica Chemicals (India)
  An API contract manufacturer with capabilities to produce Tolbutamide at GMP standards for diagnostic-grade applications.

• Lanin (China)
  Specializes in chemical synthesis and API production, with increasing compliance standards, offering Tolbutamide suitable for diagnostic use.

• Tianjin Fuyuanshengtai Pharmaceutical Co., Ltd. (China)
  Provides Tolbutamide APIs to international markets, emphasizing quality standards aligned with CE and GMP.

3. Regulatory and Quality Considerations

To ensure API suitability for diagnostic purposes, buyers must scrutinize manufacturing compliance documents, including:

• GMP certification from recognized authorities (e.g., US FDA, EMA, PMDA).
• Certificate of Analysis (CoA) confirming >99% purity, residual solvents, and absence of harmful impurities.
• Stability data confirming API integrity over storage periods consistent with diagnostic assay shelf lives.

4. Sourcing Strategies

Key factors in sourcing Tolbutamide API for diagnostics include:

• Regulatory acceptance: Suppliers with approval or prior submissions to regulatory agencies (FDA, EMA, etc.).
• Supply chain stability: Long-term, reliable supply agreements to prevent disruptions.
• Pricing: Competitive pricing aligned with high quality standards.
• Custom synthesis capabilities: For formulation-specific API modifications or impurity profile adjustments.

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Emerging Trends in API Sourcing for Diagnostics

• Enhanced Quality Assurance: Increasing emphasis on GMP and ISO certifications to meet diagnostic-specific standards.
• Regional Manufacturing Hubs: African, Asian, and Eastern European suppliers expanding compliance infrastructure.
• Supply Chain Transparency: Blockchain and digital traceability tools improving API provenance verification.

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Conclusion

The search for bulk Tolbutamide API sources suitable for diagnostic applications encompasses a diverse set of global manufacturers primarily based in India, China, and Israel. Ensuring strict compliance with GMP standards, rigorous quality controls, and stable supply contracts are critical in selecting suppliers for diagnostic reagents. The continued growth in regulation and quality expectations underscores the importance of partnering with suppliers demonstrating proven manufacturing excellence, regulatory adherence, and transparency.

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Key Takeaways

• Leading API suppliers include Sun Pharma, Hetero, Dr. Reddy’s, Teva, and Aurobindo, offering pharmaceutical-grade Tolbutamide suitable for diagnostic purposes.
• Regulatory compliance and thorough quality assurance are non-negotiable when sourcing APIs for diagnostic use.
• Manufacturing facilities in India and China are prominent but require careful due diligence regarding certifications and quality standards.
• Supply chain stability and consistent API qualities are critical to support reliable diagnostic testing environments.
• Emerging trends focus on transparency, digital traceability, and compliance enhancements in API sourcing.

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Frequently Asked Questions (FAQs)

1. Is Tolbutamide API available globally for diagnostic use?
Yes, Tolbutamide APIs are commercially available globally, primarily supplied by manufacturers in India, China, and Israel, with options meeting regulatory standards for diagnostic applications.

2. What regulatory certifications should API suppliers have for diagnostic purposes?
Suppliers should have GMP certification, ISO certifications, and Certificates of Analysis demonstrating high purity levels (>99%) and compliance with pharmacopeial standards.

3. How can I verify the quality suitability of Tolbutamide API for diagnostics?
Request detailed CoAs, verify regulatory certifications, and consider third-party testing or validation to ensure API purity, stability, and absence of harmful impurities.

4. Are there regional preferences when sourcing APIs for diagnostics?
While India and China dominate due to production capacity and cost advantages, Europe and Israel provide high-regulatory-compliant APIs, benefiting diagnostic applications requiring stringent standards.

5. What factors influence the pricing of Tolbutamide API for diagnostic manufacturing?
Pricing depends on purity levels, certification status, order volume, exclusivity agreements, and supply chain logistics. High-standard, certified APIs typically command a premium.

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References

[1] U.S. Pharmacopoeia (USP): Tolbutamide Monograph.
[2] European Pharmacopoeia (EP): Sulfonylureas, including Tolbutamide.
[3] Global API Supply Chain Analysis, Pharma Business Intelligence Reports, 2022.
[4] Indian Pharmaceutical Industry Reports, 2022.
[5] Chinese API Market Analysis, China Pharmaceutical Open Data Report, 2022.