Bulk Pharmaceutical API Sources for GLYBURIDE (MICRONIZED)

Bulk Pharmaceutical API Sources for GLYBURIDE (MICRONIZED)

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		G2539_SIAL
Sigma-Aldrich		G0639_SIGMA
Vitas-M Laboratory		STK362992
Molport		MolPort-000-784-850
AKos Consulting & Solutions		AKOS001487495
TimTec		ST024780
Amadis Chemical		A19539

Bulk Active Pharmaceutical Ingredient (API) Sources for: GLYBURIDE (MICRONIZED)

Last updated: August 2, 2025

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Introduction

Glyburide, also known as glibenclamide, is an oral hypoglycemic agent widely used in the management of type 2 diabetes mellitus. The pharmaceutical industry’s reliance on high-quality, compliant Active Pharmaceutical Ingredients (APIs) is essential for ensuring drug efficacy, safety, and regulatory compliance. This report evaluates global sources for micronized glyburide APIs, outlining key suppliers, manufacturing benchmarks, regulatory considerations, and market trends.

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Overview of Glyburide and Its API Market

Glyburide belongs to the sulfonylurea class of medications, functioning by stimulating insulin secretion from pancreatic beta cells. The demand for glyburide APIs remains steady due to its established efficacy, affordability, and the prevalence of type 2 diabetes worldwide.

The micronized form refers to APIs processed to particles less than 10 micrometers, enhancing bioavailability. Micronization, however, presents challenges related to API stability, process control, and regulatory documentation, necessitating sourcing from CAS-certified, GMP-compliant suppliers.

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Global API Manufacturers for Glyburide (Micronized)

1. Major Pharmaceutical Ingredient Suppliers

a. Dr. Reddy’s Laboratories (India)
A leading producer of generic APIs, Dr. Reddy’s operates multiple GMP-certified facilities capable of micronized API production. Their glyburide API aligns with international regulatory standards, including FDA and EMA. The company emphasizes rigorous quality management and controls, leveraging advanced micronization techniques to ensure particle size consistency.

b. Hetrays Pharmaceutical Co., Ltd. (China)
Specializes in producing generic APIs, including glyburide. Their facilities adhere to GMP standards, with an emphasis on micronization capabilities. They hold certifications such as ISO 9001 and comply with US and European regulatory requirements.

c. Zhejiang Huahong Pharmaceutical Co., Ltd. (China)
Known for producing high-purity APIs, including micronized glyburide, HUAHONG emphasizes quality through GMP certifications and strict QC protocols. This manufacturer supplies to global export markets, including North America, Europe, and emerging markets.

d. Sun Pharmaceutical Industries Ltd. (India)
A global pharmaceutical giant with extensive API manufacturing capacity. Sun Pharma produces glyburide API, including micronized forms, compliant with multifarious regulatory standards and equipped with state-of-the-art micronization facilities.

e. Aspen Pharmacare (South Africa)
While primarily focusing on finished dosages, Aspen also supplies APIs to partners. Their API production facilities meet international quality standards, and they are capable of micronized glyburide production on demand.

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Emerging and Niche API Suppliers

f. Zhejiang Changzheng Pharmaceutical Co., Ltd. (China)
A smaller but reputable manufacturer with a focus on sulfonylurea APIs. They offer micronized glyburide with competitive pricing, having achieved GMP registration and customer approvals in various global markets.

g. Pharmacom LLC (Russia)
Offers micronized glyburide APIs, with a strategic focus on compliance with Russian and Eurasian economic union regulations. Their manufacturing facilities uphold GMP standards, with increasing export capacity.

h. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Expanding API portfolio includes micronized glyburide, supported by advanced micronization techniques and robust quality controls.

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Regulatory and Quality Considerations

When sourcing micronized glyburide API, compliance with international standards is critical. Manufacturers should possess:

• GMP Certification: Essential for manufacturing APIs destined for regulated markets.
• Registration and Dossiers: Access to Certificate of Suitability (CEP), Drug Master Files (DMF), or Drug Substances Master Files (dSMF).
• Particle Size and Purity Data: Detailed specifications confirming micronization and impurity profiles.
• Stability and Compatibility Data: Confirming API stability in formulation during storage and manufacturing.

Suppliers compliant with FDA, EMA, TGA, and other regulatory standards are preferable for global market access.

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Market Trends and Future Outlook

The glyburide API market remains resilient, driven chiefly by the global diabetes epidemiology. However, competition from newer oral hypoglycemics, such as SGLT2 inhibitors and GLP-1 receptor agonists, may influence demand. Yet, the cost-effectiveness of glyburide keeps it relevant, especially in emerging markets.

Advances in micronization technology, like jet milling and micronized granulation, are driving API quality improvements. Suppliers investing in these technologies can command premium pricing and better regulatory acceptability.

Additionally, the trend toward full transparency, quality certifications, and supply chain security will shape vendor selection for pharmaceutical companies over the next decade.

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Conclusion

The global supply ecosystem for micronized glyburide API centers around key manufacturers in India and China, with emerging players in Russia and South Korea. Regulatory diligence remains paramount, and partnerships should focus on GMP compliance, proven particle sizing, and robust quality systems.

Pharmaceutical companies seeking micronized glyburide APIs should prioritize suppliers with proven regulatory track records, technological capability for micronization, and transparent quality documentation.

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Key Takeaways

• The predominant sources for micronized glyburide API are Indian and Chinese manufacturers with proven GMP and regulatory credentials.
• micronization technology consistency and documentation are critical for API quality and regulatory approval.
• Suppliers who possess comprehensive dossiers, including CEPs and DMFs, streamline the regulatory pathway.
• Market demand for glyburide API remains steady, but technological innovations could influence future supply dynamics.
• Reliability, quality assurance, and regulatory compliance are essential criteria in vendor selection.

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FAQs

1. What are the primary regions supplying micronized glyburide APIs?
India and China dominate the supply chain, with reputable manufacturers located in these countries offering GMP-compliant micronized APIs.

2. How does micronization impact glyburide API quality?
Micronization enhances bioavailability and absorption; however, it necessitates strict process control to ensure particle size uniformity and stability, impacting overall API quality.

3. What should companies consider when selecting glyburide API suppliers?
Regulatory compliance (GMP certification, DMFs), particle size specifications, impurity profiles, manufacturing capacity, and past regulatory audits.

4. Are there regulatory challenges associated with sourcing micronized glyburide API?
Yes. Ensuring compliance with export and import country regulations, maintaining proper documentation, and meeting particle size specifications are critical to avoid regulatory setbacks.

5. Is the market for glyburide API shifting toward alternative treatments?
While newer drugs are emerging, glyburide remains widely used in cost-sensitive markets. Its market stability sustains demand for high-quality APIs from reliable manufacturers.

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References:

[1] U.S. Food and Drug Administration (FDA). Database of Approved Drug Master Files.
[2] European Medicines Agency (EMA). Certificate of Suitability (CEP) Database.
[3] Global Data. Pharmaceutical API Market Reports 2022-2023.
[4] Industry publications and manufacturer websites (e.g., Dr. Reddy’s, Zhejiang Huahong).