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Suppliers and packagers for GLYBURIDE (MICRONIZED)
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GLYBURIDE (MICRONIZED)
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Teva | GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8034-01 | 100 TABLET in 1 BOTTLE (0093-8034-01) | 1999-05-11 |
| Teva | GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8035-01 | 100 TABLET in 1 BOTTLE (0093-8035-01) | 1999-05-11 |
| Teva | GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8035-05 | 500 TABLET in 1 BOTTLE (0093-8035-05) | 1999-05-11 |
| Teva | GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8036-01 | 100 TABLET in 1 BOTTLE (0093-8036-01) | 1999-05-12 |
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Suppliers for the Pharmaceutical Drug: GLYBURIDE (MICRONIZED)
Introduction
Glyburide (also known as glibenclamide) is a long-standing oral hypoglycemic agent used primarily to manage type 2 diabetes mellitus. Its micronized form enhances bioavailability, potentially improving therapeutic outcomes. As global demand for effective diabetes management persists, identifying reliable suppliers of micronized glyburide is essential for pharmaceutical companies, generic manufacturers, and healthcare providers. This analysis comprehensively reviews key suppliers, their regions, certifications, and market penetration, providing insights for strategic sourcing.
Market Overview of Glyburide (Micronized)
Glyburide's market remains robust due to its inclusion in many national formulary guidelines and its cost-effective profile. Micronized formulations are preferred for their improved dissolution characteristics, leading to potentially better patient adherence and efficacy. Suppliers of micronized glyburide typically operate under stringent regulations, including Good Manufacturing Practices (GMP) and certifications from agencies like the FDA, EMA, or equivalent authorities.
Leading Suppliers of Micronized Glyburide
1. Dr. Reddy’s Laboratories
- Headquarters: India
- Overview: A global pharmaceutical powerhouse, Dr. Reddy’s supplies a broad portfolio of generic drugs, including micronized glyburide. Their manufacturing facilities are GMP-certified, with a focus on quality and affordability. They possess multiple international regulatory approvals, including US FDA and EMA compliance.
- Market Position: One of the most prominent suppliers for high-quality micronized glyburide, particularly to North America, Europe, and emerging markets.
2. Mylan (Now part of Viatris)
- Headquarters: United States (Viatris)
- Overview: Mylan has a substantial portfolio of generic anti-diabetic medications, including micronized glyburide. Their manufacturing is certified by the FDA and other major health authorities. They leverage extensive distribution networks to supply the drug worldwide.
- Market Position: A reliable, globally recognized manufacturer with a focus on affordable价药品 and consistent quality.
3. Sun Pharmaceutical Industries Ltd.
- Headquarters: India
- Overview: As one of India's largest pharmaceutical firms, Sun Pharma manufactures micronized glyburide with high GMP standards. Their global supply chain supports both branded and generic markets, with regulatory approvals spanning multiple jurisdictions.
- Market Position: Strong presence in Asia, Africa, and Latin America, with expanding footprints in Europe and North America.
4. Hikma Pharmaceuticals
- Headquarters: United Kingdom
- Overview: Hikma produces a range of generic medicines, including micronized glyburide. Their manufacturing facilities are GMP-certified, with a significant presence in emerging markets. They are known for high-quality standards and reliable supply chains.
- Market Position: Particularly active across Middle East, Africa, and parts of Europe.
5. Zhejiang Huahai Pharmaceutical Co., Ltd.
- Headquarters: China
- Overview: As a leading Chinese API manufacturer, Zhejiang Huahai offers micronized glyburide API to international markets. They hold multiple certifications, including GMP and ISO standards, and supply both bulk API and finished formulations.
- Market Position: Growing global presence, especially appealing due to competitive pricing.
Regional Suppliers and Emerging Markets
While the above represent established multinational suppliers, emerging regional manufacturers often serve local markets with competitive API costs.
- India: Other notable APIs include Natco Pharma and Lupin Limited, both producing micronized glyburide meeting international quality standards.
- China: Beyond Zhejiang Huahai, companies like Jiangsu Hengrui Medicine also contribute to the API supply chain.
- Brazil and Latin America: Local producers such as Eurofarma and Tecnoquímica manufacture generic formulations, including micronized glyburide, primarily for regional markets.
Criteria for Selecting Suppliers
When sourcing micronized glyburide, consider the following:
- Regulatory compliance: GMP certification, FDA, EMA, or equivalent approvals.
- Quality standards: Consistency in API purity, particle size specifications, and stability.
- Manufacturing capacity: Ability to meet demand fluctuations.
- Pricing: Cost competitiveness while maintaining quality.
- Supply chain reliability: Logistics, shipping terms, and lead times.
- Market approvals: Certificates of Analysis (CoA), Drug Master Files (DMF), and registration status in target markets.
Supply Chain Dynamics and Trends
The market for micronized glyburide is influenced by generic drug policies, patent expirations, and global diabetes prevalence. Suppliers investing in capacity expansion and compliance are poised for growth. Notably, Chinese and Indian API manufacturers dominate the price-sensitive segments, often partnering with local pharmaceutical companies for formulation development.
Emerging trends include increasing regulatory scrutiny, demand for high-quality micronized particle formulations, and shifts toward biosimilar and novel insulin therapies, which could impact demand dynamics in the long run.
Risks and Considerations
Risks related to supplier selection include quality variability, geopolitical trade restrictions, and capacity limitations. Ensuring thorough validation processes, conducting supplier audits, and establishing long-term agreements mitigate these risks.
Conclusion
The supply chain for micronized glyburide is characterized by well-established global players primarily hailing from India, China, and Europe. Major suppliers such as Dr. Reddy’s, Viatris (formerly Mylan), Sun Pharma, Hikma, and Zhejiang Huahai are industry leaders owing to their regulatory compliance, manufacturing excellence, and extensive distribution networks.
Securing reliable high-quality suppliers requires due diligence encompassing regulatory certifications, capacity assessments, and supply chain robustness. As the demand for affordable, effective glyburide solutions continues, strategic partnerships with these manufacturers will be pivotal for pharmaceutical corporations seeking consistent supply and competitive advantage.
Key Takeaways
- The global glyburide micronized market is dominated by Indian and Chinese API manufacturers and European generic producers.
- Regulatory certification (GMP, FDA, EMA) and consistent quality are critical selection criteria for reliable suppliers.
- Leading multinational suppliers include Dr. Reddy’s, Viatris (Mylan), Sun Pharma, Hikma, and Zhejiang Huahai.
- Emerging regional players serve local markets, providing cost-effective options.
- Diversifying suppliers and conducting rigorous audits mitigate supply chain risks amid geopolitical and regulatory changes.
FAQs
1. What are the primary considerations when sourcing micronized glyburide?
Regulatory compliance, product quality (purity, particle size), manufacturing capacity, pricing, and supply chain reliability are critical considerations.
2. Which countries dominate the production of micronized glyburide APIs?
India and China are the primary API producers, with European companies providing finished formulations and some APIs meeting high regulatory standards.
3. How does micronization improve glyburide's efficacy?
Micronization reduces particle size, increasing surface area, leading to faster dissolution and potentially improved bioavailability.
4. Are there regulatory challenges in importing micronized glyburide from emerging markets?
Yes, regulatory compliance, including GMP standards and approval from local health authorities, is essential to ensure safety and efficacy.
5. Can smaller manufacturers supply micronized glyburide at competitive prices?
They can, but thorough validation of quality, regulatory compliance, and supply stability is necessary to avoid risks associated with less established suppliers.
Sources
[1] International pharmaceutical manufacturer profiles and industry reports.
[2] Company disclosures and official websites of Dr. Reddy’s, Viatris, Sun Pharma, Hikma, and Zhejiang Huahai.
[3] Regulatory agency guidelines and certifications databases.
[4] Global drug market analyses and trend reports (IQVIA, EvaluatePharma).
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