Suppliers and packagers for diabeta

diabeta

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9364-01	100 TABLET in 1 BOTTLE (0093-9364-01)	1984-05-01
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9364-05	500 TABLET in 1 BOTTLE (0093-9364-05)	1984-05-01
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532	NDA AUTHORIZED GENERIC	TEVA Pharmaceuticals USA Inc	0093-9364-10	1000 TABLET in 1 BOTTLE (0093-9364-10)	1984-05-01

Suppliers for the Pharmaceutical Drug: Diabeta (Glibenclamide)

Last updated: July 29, 2025

Introduction

Diabeta, with the generic name Glibenclamide (also known as glyburide), is an oral antidiabetic agent primarily used in managing type 2 diabetes mellitus. The drug belongs to the sulfonylurea class, stimulating insulin secretion from pancreatic beta cells. As the prevalence of type 2 diabetes surges globally, demand for Diabeta has risen, prompting an expanding network of suppliers across the pharmaceutical supply chain. This report provides a comprehensive overview of the key suppliers, manufacturing landscape, regulatory considerations, and market dynamics integral to Diabeta’s global distribution.

Manufacturers and Key Suppliers

1. Originator Companies

The original development of Diabeta was by Pfizer Inc., which first introduced glyburide into the market in the 1960s. Pfizer remains a significant supplier, though production has diversified as patents expired, leading to generic manufacturing.

2. Generic Manufacturers

Since patent expiry, multiple generic pharmaceutical companies have entered the market, greatly increasing the drug's availability and reducing costs. Prominent generic manufacturers include:

• Mannkind Corporation: Notably involved in producing secondary formulations and alternative delivery systems for glyburide.

• Teva Pharmaceutical Industries Ltd.: A leading international generic drug manufacturer, Teva produces glyburide to meet global demand, often at lower costs.

• Sun Pharmaceutical Industries Ltd.: One of the largest pharmaceutical companies in India, manufacturing generic glyburide with extensive distribution networks.

• Aurobindo Pharma: An Indian pharmaceutical manufacturer with a broad portfolio of generics, including glyburide.

• Dr. Reddy's Laboratories: Another key Indian manufacturer, known for producing affordable formulations of glyburide.

3. Other Notable Suppliers

• Lupin Limited: Provides glyburide generics, especially targeting markets in Asia, Africa, and Latin America.

• Aventis Pharma (now part of Sanofi): Historically involved in production and distribution.

• Pfizer (still active in some formulations): Continues supplying specific formulations in certain markets.

4. Contract Manufacturing Organizations (CMOs)

Several CMOs provide manufacturing services for glyburide formulations, supporting both brand-name and generic producers.

• Catalent Inc.
• Baxter BioPharma Solutions
• Famar (Europe)
• Dr. Reddy’s CMO facilities

These organizations facilitate compliance, scale-up, and quality assurance.

Global Manufacturing and Supply Dynamics

Regional Production Hubs

• India: Leading producer of generic glyburide, with companies like Sun Pharma, Aurobindo, and Dr. Reddy’s dominating supply due to cost efficiency and large-scale manufacturing capabilities.

• China: Increasingly plays a role in the supply chain, particularly in intermediates and active pharmaceutical ingredient (API) synthesis.

• Europe & North America: Primarily focus on quality control, branded formulations, and specialty formulations, with Pfizer maintaining some of its original formulations.

API and Formulation Supply Chains

The supply chain for Diabeta involves sourcing active pharmaceutical ingredients (API)—primarily glyburide—from specialized chemical manufacturers. Major API suppliers include:

• Hetero Labs (India): Produces glyburide API.
• Macleods Pharmaceuticals: Also supplies API for glyburide.
• Suven Life Sciences: Adds to the API supply chain.

Formulation manufacturing combines these APIs into tablets, which are then packaged for distribution.

Regulatory Considerations and Compliance

GMP Standards

Suppliers must adhere to Good Manufacturing Practice (GMP) standards set by regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and national agencies like India's Central Drugs Standard Control Organization (CDSCO).

Quality Assurance and Certification

• FDA Approvals: Select suppliers possess FDA-approved manufacturing facilities, facilitating export to the U.S. market.
• EMA Certification: European suppliers often hold EMA approval.
• Cost-Effective Markets: Indian and Chinese suppliers primarily target emerging markets with varying regulatory requirements, often relying on WHO prequalification or local regulatory approvals.

Intellectual Property & Patents

Most patents on glyburide expired globally by the early 2010s, enabling widespread generic manufacturing. However, specific formulations or combinations might still be under patent, influencing supplier choices.

Market Trends and Future Outlook

Market Expansion

The increasing prevalence of type 2 diabetes in emerging economies drives demand for affordable glyburide formulations. This expands opportunities for suppliers, especially in India, China, and Latin America.

Innovation and Formulation Diversification

Suppliers are innovating to improve pharmacokinetics, reduce side effects, and develop combination therapies. Such advances require collaborations with research institutions and regulatory approvals.

Supply Chain Risks

Disruptions—such as geopolitical conflicts, regulatory changes, or raw material shortages—can impact supply stability. Diversification of manufacturing sources mitigates these risks.

Conclusion

The supply of Diabeta (glyburide) is characterized by a diversified network comprising original manufacturers, generic producers, and contract manufacturing organizations. India stands out as the dominant region for generic production, supported by numerous companies adhering to international GMP standards. Suppliers must navigate complex regulatory landscapes to ensure market access, with quality assurance being paramount. As demand for affordable antidiabetic medications continues to grow, the strategic sourcing of glyburide from reliable, compliant suppliers remains crucial for healthcare providers, pharmacists, and pharmaceutical distributors.

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Key Takeaways

• Diverse Supplier Base: Indian companies such as Sun Pharma, Dr. Reddy’s, and Aurobindo serve as primary suppliers due to cost advantages and manufacturing capacity.

• Regulatory Compliance: Suppliers with FDA or EMA approvals are preferred for high-quality, export-ready formulations in developed markets; others serve emerging markets with local regulatory alignments.

• Supply Chain Stability: Geographic diversification minimizes risks associated with geopolitical or logistical disruptions.

• Market Growth: Rising diabetes prevalence, especially in emerging economies, bolsters demand for glyburide, creating opportunities for existing and new suppliers.

• Innovation Focus: Future supplier strategies include developing modified-release formulations and combination therapies, which require cooperation with research entities and regulatory agencies.

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FAQs

1. Are there major differences between brand-name Diabeta and generic glyburide?
Generally, generic glyburide must meet the same regulatory standards as the brand-name product, ensuring comparable efficacy and safety. Differences may exist in excipients, formulations, or bioavailability, but bioequivalence studies are required.

2. Which countries are the primary sources of glyburide API?
India is the leading producer of glyburide API, with China also playing an increasing role. Other regions with API manufacturing capabilities include the European Union and North America, though in smaller volumes.

3. How do regulatory approvals influence supplier selection?
Approved suppliers with FDA or EMA certifications are preferred for exports to developed markets, ensuring compliance with stringent quality standards. For markets with less stringent regulations, local approvals suffice.

4. Are there risks associated with relying on Indian manufacturers for glyburide?
While cost-effective and robust, reliance on a specific region can pose risks related to quality lapses, regulatory changes, geopolitical tensions, or supply chain disruptions. Diversification and due diligence mitigate these risks.

5. Is innovation in glyburide formulations ongoing?
Yes, research focuses on improving pharmacokinetic profiles, reducing side effects, and developing combination therapies to better manage type 2 diabetes, which influences supplier offerings and market dynamics.

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Sources

[1] Pfizer Inc. Official Website and Historical Data.
[2] Teva Pharmaceutical Industries Ltd. Product Portfolio.
[3] Sun Pharmaceutical Industries Ltd. Reports.
[4] Indian Pharmacopoeia Commission – API Manufacturing Data.
[5] WHO Prequalification and GMP Standards.