Suppliers and packagers for generic pharmaceutical drug: GLYBURIDE; METFORMIN HYDROCHLORIDE

GLYBURIDE; METFORMIN HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	077870	ANDA	A-S Medication Solutions	50090-0887-0	60 TABLET, FILM COATED in 1 BOTTLE (50090-0887-0)	2007-11-14
Aurobindo Pharma	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	077870	ANDA	A-S Medication Solutions	50090-0887-1	30 TABLET, FILM COATED in 1 BOTTLE (50090-0887-1)	2007-11-14
Aurobindo Pharma	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	077870	ANDA	A-S Medication Solutions	50090-0887-2	180 TABLET, FILM COATED in 1 BOTTLE (50090-0887-2)	2007-11-14

Suppliers for the Pharmaceutical Drugs: Glyburide and Metformin Hydrochloride

Last updated: July 31, 2025

Introduction

Glyburide and Metformin Hydrochloride are cornerstone medications in the management of type 2 diabetes mellitus. Their widespread use necessitates a robust supply chain of reliable suppliers to ensure consistent availability, quality, and affordability. The pharmaceutical industry is intricately linked to a network of manufacturers, generic drug producers, and wholesalers that supply these medications globally. This article provides a comprehensive overview of the key suppliers, manufacturing hubs, and market dynamics influencing the distribution of Glyburide and Metformin Hydrochloride.

Global Manufacturing Landscape

1. Primary Manufacturers

Major pharmaceutical companies dominate the manufacturing of Glyburide and Metformin Hydrochloride. These include multinational pharmaceutical giants and generic drug producers that operate both domestically and internationally.

• Teva Pharmaceuticals: Based in Israel, Teva is one of the world’s leading generic drug manufacturers, supplying both Glyburide and Metformin to markets across North America, Europe, and other regions. Their extensive manufacturing capabilities and regulatory compliance standards position them as a key supplier [1].

• Sandoz (Novartis): Sandoz, Novartis’ generics division, is another notable provider of Metformin and Glyburide, particularly in developed markets. Their manufacturing facilities adhere to strict quality standards, including GMP (Good Manufacturing Practice).

• Mylan (now part of Viatris): Historically a significant supplier in the United States and Europe, Mylan supplied both drugs before its merger with Pfizer’s Upjohn unit to form Viatris. Viatris continues to be an active player in the global supply of these medications [2].

• Hsinhua Pharmaceutical: Based in China, Hsinhua is among the prominent regional manufacturers, supplying both drugs primarily within Asia and increasingly to other emerging markets. Their facilities are compliant with local regulatory standards.

• Lupin Limited: An Indian pharmaceutical firm, Lupin manufactures generic Glyburide and Metformin, targeting markets in Asia, Africa, and Latin America. India’s robust API (Active Pharmaceutical Ingredient) production capacity makes Lupin a significant supplier [3].

2. Regional and Emerging Market Suppliers

Generic manufacturers in India and China dominate the supply of these drugs in emerging markets, leveraging cost-effective manufacturing and export infrastructure.

• Sun Pharmaceutical Industries: India's Sun Pharma produces Glyburide and Metformin in several formulations, catering predominantly to developing countries.

• APL (Asian Pesquisa de Laboratórios): Based in India, APL supplies both drugs to Latin American and Southeast Asian markets.

• Shanghai Pharmaceuticals Holding Co., Ltd.: A leading Chinese producer serving domestic and regional markets.

3. API Producers

Active pharmaceutical ingredient (API) production is vital for the manufacturing of both Glyburide and Metformin Hydrochloride. The global API market for these compounds includes suppliers that primarily operate in India, China, and other API manufacturing hubs:

• Strides Pharma Science Ltd. (India) develops and supplies APIs for both drugs.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China) is known for API synthesis and bulk drug production.

• SAMI Pharmaceutical (India) also supplies high-quality API for international markets.

Supply Chain Dynamics

1. Quality and Regulatory Standards

Regulatory compliance, predominantly with Good Manufacturing Practices (GMP), remains vital to ensure drug safety and efficacy. Major suppliers with international approvals from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japan Pharmaceuticals and Medical Devices Agency) tend to dominate supply chains in sophisticated markets.

2. Cost-Effectiveness and Market Penetration

Indian and Chinese manufacturers benefit from lower manufacturing costs, allowing them to offer competitive pricing on Glyburide and Metformin. This advantage is crucial in expanding access in low- and middle-income countries (LMICs).

3. Supply Risks and Disruptions

The COVID-19 pandemic underscored vulnerabilities in the supply chain—disruptions in API manufacturing, transportation restrictions, and increased demand led to shortages in some markets. Supplier diversification strategies and local API production are emerging as solutions [4].

Leading Distributors and Wholesalers

Pharmaceutical wholesalers such as McKesson, Cardinal Health, and local distributors play a significant role in bridging suppliers and end-users. These entities source from primary manufacturers, ensuring broad availability across healthcare providers, hospitals, and pharmacies.

Market Outlook and Future Trends

1. Generic Market Expansion

The global generic drug market continues to grow, driven by patent expirations and demand for affordable medicines. Suppliers focusing on cost-effective, high-quality manufacturing are poised for growth, especially in LMICs.

2. Regulatory Harmonization

Increased efforts toward harmonizing regulations across regions—such as the ICH guidelines—will facilitate faster and more secure supply chains for Glyburide and Metformin.

3. Local API Production Initiatives

Countries like India and China are investing in local API manufacturing capacities to reduce dependency on imports, mitigate disruptions, and meet domestic and international demand.

4. Quality Assurance Initiatives

Intensified quality control standards and certification processes (e.g., WHO prequalification) enhance trust in supplier reliability and drug safety.

Conclusion

The supply of Glyburide and Metformin Hydrochloride hinges on a complex network of global manufacturers, API producers, and distributors. Leading companies such as Teva, Novartis (Sandoz), Mylan/Viatris, Lupin, and Sun Pharma dominate supply chains, especially in developed and emerging markets. Regional players in China and India fulfill the demand in LMICs due to cost advantages and capacity. Ensuring quality standards, diversifying suppliers, and strengthening local manufacturing capacities are key strategies to mitigate supply risks.

Key Takeaways

• Major global suppliers include Teva, Sandoz, Viatris, Lupin, and Sun Pharma, with regional suppliers in China and India.

• API manufacturing capacity is concentrated in India and China, supporting global supply chains.

• Regulatory compliance (GMP, WHO prequalification) is critical to supplier credibility.

• Supply chain disruptions during the COVID-19 pandemic highlight the need for diversification and local API production.

• The growth of the generic market and regulatory harmonization will shape future supply dynamics.

FAQs

1. Who are the leading global suppliers of Glyburide and Metformin Hydrochloride?
Major multinational companies like Teva Pharmaceuticals, Sandoz (Novartis), and Viatris dominate the global market, supplemented by regional manufacturers in India and China.

2. Which countries are the primary API producers for these drugs?
India and China are the primary API manufacturing hubs, supplying the majority of the world's Glyburide and Metformin APIs.

3. How does regulatory compliance influence supplier selection?
Regulatory standards such as GMP and approvals from agencies like the FDA or EMA ensure product quality and safety, making compliant suppliers more trustworthy and preferred.

4. What are the risks associated with the current supply chain?
Disruptions from pandemics, geopolitical issues, and dependency on regional API sources pose risks. Supply chain resilience strategies include supplier diversification and local API development.

5. What trends are shaping the future supply of these drugs?
Expansion in generic markets, increased regulatory harmonization, and investments in local API manufacturing are key trends that will strengthen supply stability.

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References

1. [1] Teva Pharmaceuticals. Company Profile. Teva.com.
2. [2] Viatris. Company Overview. Viatris.com.
3. [3] Lupin Limited. Annual Report 2022. Lupin.in.
4. [4] World Health Organization. Global Drug Shortages and Supply Chain Resilience. WHO.int.