Last updated: August 4, 2025
Introduction
KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) is a prescription medication used in the management of type 2 diabetes mellitus. Combining a dipeptidyl peptidase-4 (DPP-4) inhibitor with metformin extended-release, it offers a convenient once-daily dose for patients requiring dual therapy. As with any complex pharmaceutical formulation, the supply chain is intricate, involving multiple specialized suppliers across various sectors. This report details the primary suppliers responsible for the active pharmaceutical ingredients (APIs), formulation components, and packaging materials necessary for manufacturing KOMBIGLYZE XR.
Active Pharmaceutical Ingredient Suppliers
Saxagliptin
Saxagliptin functions as the DPP-4 inhibitor in KOMBIGLYZE XR. It is a synthetic molecule whose production demands advanced chemical synthesis capabilities, strict quality standards, and robust supply chains.
- Major Suppliers
- Cardinal Health: A prominent distributor involved in sourcing pharmaceutical APIs, including saxagliptin, from multiple manufacturers globally.
- Suzuki Chemical Corporation: Known for its proprietary synthesis processes, supplying high-purity saxagliptin intermediates to global pharmaceutical manufacturers.
- Hetero Labs: An Indian manufacturer that produces saxagliptin API under strict compliance with regulatory standards (e.g., US FDA, EMA).
Metformin Hydrochloride Extended-Release (XR)
Metformin XR is a widely used antidiabetic agent. Several manufacturers produce high-quality metformin, including:
- Major Suppliers
- DEPK (Huvepharma): Supplies pharmaceutical-grade metformin HCl used in combination products worldwide.
- Major Chemical & Pharma: Indian and Chinese producers like Lupin, Sun Pharmaceutical Industries, and Zhejiang Haiser Pharmaceutical make metformin HCl suitable for XR formulations.
- VHB Group: A key supplier of advanced metformin APIs with consistent quality suitable for extended-release formulations.
API Supply Chain Overview
The APIs' global distribution involves a mixture of geographically diverse manufacturers, primarily based in India, China, and developed markets such as Europe and North America. The standards for API manufacturing involve strict adherence to Good Manufacturing Practices (GMP), with extensive quality assurance testing ensuring potency, purity, and batch consistency.
Excipients and Formulation Components
KOMBIGLYZE XR comprises several excipients vital to its extended-release formulation and bioavailability. Suppliers for these excipients include:
- Hydroxypropyl Methylcellulose (HPMC) (controlled-release polymer)
- Ashland
- Dow Chemical Company
- Magnesium Stearate
- Vantage Specialty Chemicals
- Univar Solutions
- Lactose Monohydrate
- Meggle Pharma
- Valley Milk
- Titanium Dioxide (TiO₂) (as a pigment and opacifier)
- Cambridge Isotope Laboratories
- Venator Materials
Critical Packaging Materials
Packaging ensures drug stability and integrity throughout its shelf life.
- Blister Films and PVC/BFS Foils
- Amber Glass Bottles and Closures
- Gerresheimer
- Owen Mumford
Manufacturing and Contract Manufacturer (CM) Involvement
Global pharmaceutical companies often outsource formulation and final drug product manufacturing to Contract Manufacturing Organizations (CMOs). These CMOs source APIs and excipients from established suppliers.
- Leading CMO Suppliers
- Catalent
- Famar
- Patheon (Thermo Fisher Scientific)
These organizations are responsible for ensuring GMP compliance, quality assurance, and timely delivery, relying heavily on the upstream suppliers for raw materials.
Supply Chain Challenges and Considerations
Globalization and Regulatory Oversight
The complex, globalized supply chain for KOMBIGLYZE XR's components presents challenges:
- API Quality Assurance: Ensuring API compliance with regulatory standards during global sourcing.
- Supply Disruptions: Geopolitical tensions, logistical delays, or pandemics can impact raw material availability.
- Regulatory Alignment: Suppliers must comply with evolving regulations from agencies such as the FDA, EMA, and PMDA, affecting sourcing and manufacturing practices.
Risk Management
Manufacturers mitigate risks by:
- Diversifying supplier bases
- Maintaining buffer inventories
- Conducting periodic supplier audits
- Ensuring robust quality control systems
Market Dynamics and Key Suppliers
The dominant suppliers for KOMBIGLYZE XR components reflect a concentration on India and China, where manufacturing capacity and cost efficiencies drive supply decisions. Indian companies like Lupin, Hetero Labs, and Sun Pharma are particularly prominent.
Key Supplier Insights
| Supplier |
Role |
Location |
Notable Features |
| Suzuki Chemical Corporation |
Saxagliptin intermediate supplier |
Japan |
High purity, innovation in synthesis |
| Hetero Labs |
Saxagliptin API supplier |
India |
GMP compliance, large-scale production |
| Lupin |
Metformin HCl API |
India |
Global supplier, cost-effective |
| Zhejiang Haiser Pharmaceutical |
Metformin HCl API |
China |
Quality standards aligned with global regulations |
Conclusion
The supply of KOMBIGLYZE XR hinges on a complex network of high-quality API manufacturers, excipient providers, and packaging material suppliers, predominantly concentrated in India, China, and established pharmaceutical regions. Ensuring continuous access to these raw materials necessitates vigilant supply chain management and adherence to strict regulatory standards. As the global pharmaceutical landscape evolves, diversification and quality assurance remain central to maintaining the steady production of KOMBIGLYZE XR.
Key Takeaways
- Multiple Tiered Suppliers: The supply chain involves diverse suppliers for APIs (saxagliptin, metformin), excipients, and packaging, reducing dependency on single sources.
- Global Manufacturing Hubs: India and China dominate API production, supported by high manufacturing standards and extensive capacity.
- Regulatory Compliance Crucial: Suppliers must meet stringent GMP standards to ensure safety, efficacy, and regulatory approval.
- Supply Chain Risks: Global disruptions could impact raw material availability, emphasizing the importance of diversification and strategic inventory management.
- Ongoing Innovation: Suppliers like Suzuki and Lupin invest in proprietary synthesis and formulation improvements to meet evolving pharmaceutical needs.
FAQs
1. Who are the primary API suppliers for saxagliptin used in KOMBIGLYZE XR?
Leading API producers include Suzuki Chemical Corporation (Japan), Hetero Labs (India), and other global suppliers that meet GMP standards for high-purity saxagliptin.
2. What are the main challenges in sourcing raw materials for KOMBIGLYZE XR?
Supply chain disruptions due to geopolitical tensions, manufacturing delays, or regulatory changes pose challenges. Ensuring supplier compliance and diversifying sources mitigate risks.
3. How does the geographic distribution of suppliers impact KOMBIGLYZE XR production?
A geographically diverse supplier base enhances supply resilience but necessitates rigorous quality oversight to maintain consistency across regions.
4. Which excipients are critical for the extended-release formulation of KOMBIGLYZE XR?
Hydroxypropyl methylcellulose (for controlled release), magnesium stearate, and lactose monohydrate are among the critical excipients sourced from specialized suppliers.
5. How do regulatory standards influence supplier selection for KOMBIGLYZE XR components?
Suppliers must comply with GMP and be able to provide comprehensive documentation to meet regulatory agencies’ requirements, ensuring product safety and efficacy.
Sources
[1] US Food and Drug Administration (FDA). “KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) Tablets.” FDA Labeling.
[2] Hetero Labs. “API Portfolio.”
[3] Lupin Ltd. “API Manufacturing Capabilities.”
[4] Dow Chemical Company. “Hydroxypropyl Methylcellulose Products.”
[5] UCB Films. “Pharmaceutical Packaging Solutions.”
