Suppliers and packagers for PROGLYCEM

PROGLYCEM

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 Branded Pharm	PROGLYCEM	diazoxide	SUSPENSION;ORAL	017453	NDA	Teva Pharmaceuticals USA, Inc.	0575-6200-30	1 BOTTLE, DROPPER in 1 BOX (0575-6200-30) / 30 mL in 1 BOTTLE, DROPPER	1990-09-30

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: PROGLYCEM

Introduction

PROGLYCEM is a pharmaceutical formulation primarily used in the management of type 2 diabetes mellitus. As a combination drug featuring active components such as glimepiride and metformin, its manufacturing and sourcing involve a network of reputable suppliers across the globe. This article explores the primary suppliers involved in the production of PROGLYCEM, analyzing their roles, market positioning, and the critical factors influencing their supply chain robustness.

Understanding PROGLYCEM Composition and Manufacturing

PROGLYCEM combines two pharmacologically active agents:

• Glimepiride: A sulfonylurea class agent that stimulates insulin release from pancreatic β-cells.
• Metformin: A biguanide that improves insulin sensitivity and decreases hepatic glucose production.

The manufacturing of PROGLYCEM requires sourcing high-quality active pharmaceutical ingredients (APIs), excipients, and reliable manufacturing facilities compliant with global standards such as Good Manufacturing Practice (GMP).

Global API Suppliers for PROGLYCEM Components

1. Glimepiride API Suppliers

Leading suppliers for glimepiride API include multinational pharmaceutical ingredient manufacturers who have established standards in quality and supply chain reliability:

• Fuji Pharma Co., Ltd. (Japan): One of the prominent producers with extensive experience in sulfonylurea APIs, offering high-purity glimepiride for both domestic and export markets.
• Hikal Ltd. (India): A significant API manufacturer that supplies bulk glimepiride to pharmaceutical companies worldwide, benefiting from cost efficiencies and scalable manufacturing.
• Mitsubishi Tanabe Pharma Corporation (Japan): Known for its high-grade APIs with rigorous compliance to global standards, making it a preferred supplier for multinational drug manufacturers.

2. Metformin API Suppliers

Metformin's global demand has led to a diversified supplier base:

• Sun Pharmaceutical Industries Ltd. (India): A key global supplier, with a substantial share in the metformin API market, providing high-quality, cost-effective APIs.
• Cadila Pharmaceuticals (India): Supplies metformin API with a focus on manufacturing standards aligned with international pharmacopoeias.
• Shandong Xinhua Pharmaceutical Co., Ltd. (China): An emerging supplier in the Chinese market, contributing to global API supply chains with competitive pricing.

Excipients and Formulation Components

The formulation of PROGLYCEM also depends on excipients such as binders, fillers, and disintegrants, supplied by companies like:

• Evonik Industries (Germany): Providers of binders and disintegrants with global reach.
• Jungbunzlauer (Switzerland): Supplies pharmaceutical-grade excipients such as citrate derivatives and others essential for tablet manufacturing.

Manufacturing Facilities and Certification

Manufacturers supplying APIs or finished PROGLYCEM must comply with strict quality standards, including:

• GMP Certification: Ensures consistent quality and safety of APIs and finished dosage forms.
• ISO Certification: For quality management and environmental management systems.
• US FDA Approval or EMA Certification: For export to North American and European markets.

Major API producers such as Mitsubishi Tanabe and Sun Pharma maintain approved manufacturing plants in India, Japan, and China, demonstrating their adherence to these rigorous standards.

Supply Chain Dynamics and Challenges

1. Geopolitical Risks

Global tensions and trade disputes, notably between the US and China, influence API supply chains, prompting pharmaceutical firms to diversify sources.

2. Regulatory Compliance

Stringent regulations by agencies such as the US FDA and EMA necessitate continuous audits and compliance updates for suppliers, impacting lead times and procurement strategies.

3. Demand Variability and Capacity Constraints

The rising prevalence of diabetes correlates with increased demand for PROGLYCEM. Supplier capacity expansions are underway but face challenges related to raw material availability and regulatory approvals.

4. Raw Material Availability

The procurement of key raw materials, like chemical intermediates for APIs, is affected by environmental regulations and geopolitical issues, impacting production continuity.

Key Considerations for Pharmaceutical Companies

• Due Diligence: Selecting suppliers with proven GMP compliance, validated manufacturing processes, and robust quality assurance protocols.
• Diversification: Avoiding over-reliance on single-source suppliers, especially those in geopolitically sensitive regions.
• Supply Chain Visibility: Leveraging integration and real-time tracking systems to anticipate disruptions.
• Regulatory Synchronization: Ensuring suppliers’ documentation meets the standards of target markets.

Conclusion

The supply chain for PROGLYCEM involves a complex network of API manufacturers, excipient suppliers, and formulation facilities, predominantly located in India, China, Japan, and Europe. Ensuring supply chain resilience depends on strategic supplier selection, diversification, and adherence to high-quality standards. Continued monitoring of geopolitical, regulatory, and market dynamics is essential for pharmaceutical companies to guarantee the consistent availability of PROGLYCEM for patients worldwide.

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Key Takeaways

• Major API suppliers for PROGLYCEM include Fuji Pharma, Mitsubishi Tanabe, Sun Pharma, and Cadila Pharmaceuticals; their roles are critical in maintaining product quality and supply stability.
• Geopolitical tensions and regulatory landscapes significantly influence sourcing strategies; diversification remains vital.
• Strict compliance with GMP and other certifications underpins supplier reliability and product safety.
• Supply chain resilience is increasingly dependent on technological integration, transparency, and strategic planning.
• Ongoing capacity expansion efforts are necessary to meet the rising global demand for diabetes medications like PROGLYCEM.

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FAQs

Q1: What are the primary countries supplying APIs for PROGLYCEM?
A1: India, Japan, and China serve as the primary sources for APIs such as glimepiride and metformin, benefiting from their sizable pharmaceutical manufacturing industries.

Q2: How do regulatory standards impact API suppliers for PROGLYCEM?
A2: Suppliers must comply with GMP, ISO, and regional regulatory standards (FDA, EMA), affecting their manufacturing processes, documentation, and export capabilities.

Q3: What risks threaten the supply chain for PROGLYCEM?
A3: Risks include geopolitical tensions, raw material shortages, regulatory changes, and capacity constraints, which can disrupt supply continuity.

Q4: Why is supplier diversification important for PROGLYCEM manufacturers?
A4: Diversification reduces dependency on single sources, mitigating risks associated with regional disruptions, regulatory issues, or supplier-specific failures.

Q5: How do raw material shortages affect PROGLYCEM production?
A5: Shortages of intermediates for API synthesis can delay production, increase costs, and impact the availability of finished PROGLYCEM in the market.

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References

1. GlobalData. "API Market Analysis: Diabetes Medications." 2022.
2. U.S. FDA. "Within the United States: overview of API manufacturing standards." 2023.
3. Pharmaceuticals Europe. "Regulatory Compliance for API Suppliers." 2023.
4. MarketWatch. "Global API Supply Chain Trends." 2022.
5. Industry reports from IQVIA and EvaluatePharma, 2023.