Last updated: August 1, 2025
Introduction
XIGDUO XR is a branded combination medication primarily prescribed for managing type 2 diabetes mellitus. It consists of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and extended-release metformin, a biguanide. Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, XIGDUO XR has become a prominent option for clinicians seeking to optimize glycemic control. Understanding the supply chain—particularly the key suppliers—is crucial for stakeholders involved in manufacturing, distribution, and procurement.
Overview of XIGDUO XR
XIGDUO XR is marketed by AstraZeneca, which holds the proprietary rights and oversees manufacturing. As with other complex pharmaceutical products, the supply chain involves multiple tiers—raw material suppliers, manufacturing facilities, distributors, and pharmacies. The integrity of this chain influences drug availability, pricing, and quality.
Primary Manufacturers
AstraZeneca
AstraZeneca is the patent holder and primary manufacturer of XIGDUO XR. The company controls the production process, ensuring compliance with Good Manufacturing Practices (GMP) standards. Their manufacturing facilities for XIGDUO XR are located globally, with significant operations in the United States and Europe.
Contract Manufacturing Organizations (CMOs)
While AstraZeneca manufactures the core active pharmaceutical ingredients (APIs) and finished products, it also relies on Contract Manufacturing Organizations (CMOs) for certain components or final formulation. Specific details of these partnerships are often proprietary, but notable CMOs in the industry participate in the supply chain for similar products.
Suppliers of Active Pharmaceutical Ingredients (APIs)
Dapagliflozin API Suppliers
Dapagliflozin, the SGLT2 inhibitor component, is sourced from specialized API manufacturers. Several suppliers globally produce dapagliflozin APIs, with notable players including:
- Celltrion (South Korea): Known for producing high-quality APIs and biosimilars, Celltrion supplies dapagliflozin APIs to multiple pharmaceutical entities.
- Yifan Pharmaceutical (China): A significant generic API manufacturer with capabilities for large-scale dapagliflozin production.
- Lunan Pharmaceutical (China): A supplier with extensive experience in producing diabetes-related APIs.
- Fresenius Kabi (Germany): Engages in API production, primarily for injectable formulations, but also for oral medications.
These API suppliers often supply to multiple branded and generic drug manufacturers, including AstraZeneca, via bilateral contracts or through intermediaries.
Metformin API Suppliers
Extended-release metformin's manufacturing inputs originate from several key producers:
- Hubei Great Lake Pharmaceutical (China): A major metformin API supplier with approvals for global markets.
- Cipla Ltd (India): Supplies high-quality APIs used in various formulations, including extended-release metformin.
- Sun Pharmaceutical Industries (India): Known for producing metformin APIs for both generic and branded medications.
The sourcing of metformin APIs often involves a combination of global suppliers, with quality certifications such as FDA, EMA, or equivalent certifications, essential for regulatory compliance.
Formulation and Final Product Manufacturing
XIGDUO XR's final formulation—combining dapagliflozin and extended-release metformin into a single, extended-release tablet—is produced within AstraZeneca’s manufacturing facilities or approved contract manufacturing sites. These sites undergo rigorous GMP audits and regulatory inspections to maintain product integrity.
Manufacturing of Extended-Release Formulations
Producing extended-release tablets involves complex processes such as controlled-release coating, matrix formation, and precise blending. Specialized excipients, such as release modifiers, are sourced from excipient suppliers, including:
- Dow Chemical (USA): Supplies polymers used in controlled-release formulations.
- Colorcon (USA/UK): Provides coatings and excipients tailored for extended-release tablets.
Distribution and Supply Chain Channels
After manufacturing, XIGDUO XR is distributed through a network of wholesalers, specialty pharmacies, and hospital supply systems. Key distribution partners include:
- AmerisourceBergen
- McKesson
- Cardinal Health
These distributors collaborate with regional and national pharmacies, ensuring broad accessibility. Supply chain disruptions are mitigated via diversified sourcing and strategic inventory management.
Regulatory and Quality Considerations
Suppliers participating in the XIGDUO XR supply chain must comply with strict regulatory standards, including:
- FDA compliance for APIs and finished drug products.
- EMA certifications for European markets.
- GMP adherence in manufacturing processes.
- Quality certifications: ISO standards and other international certifications.
Any lapse in quality standards can impact supply continuity, regulatory approval, and patient safety.
Emerging Trends and Implications
As biosimilars and generics enter the U.S. and global markets, competition may influence the supply chain dynamics of XIGDUO XR. AstraZeneca’s reliance on diversified suppliers for APIs is a strategic move to mitigate risks related to geopolitical issues, raw material shortages, or regulatory changes.
Furthermore, increasing demand for diabetes medications drives investments in API production capacity, with Chinese and Indian manufacturers expanding to meet global needs. Supply shortages experienced in the past have highlighted vulnerabilities, accentuating the importance of transparent sourcing and supply chain resilience.
Key Takeaways
- AstraZeneca is the primary proprietor and manufacturer of XIGDUO XR, collaborating with global CMOs and API suppliers.
- Notable API suppliers for dapagliflozin include Celltrion (South Korea) and Yifan Pharmaceutical (China), while metformin APIs are predominantly sourced from Hubei Great Lake Pharmaceutical (China) and Indian generic firms like Cipla.
- The integrity of the formulation process relies on sourcing high-quality excipients from reputable providers like Colorcon and Dow Chemical.
- The supply chain involves complex logistics, with key distributors such as McKesson, AmerisourceBergen, and Cardinal Health ensuring product availability.
- Maintaining compliance with GMP and regulatory standards is critical to supply continuity and product safety, especially amid global capacity expansions and geopolitical shifts.
FAQs
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Who are the main API suppliers for XIGDUO XR?
Key dapagliflozin API suppliers include Celltrion (South Korea) and Yifan Pharmaceutical (China). Extended-release metformin APIs are sourced from manufacturers like Hubei Great Lake Pharmaceutical (China) and Cipla (India).
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Does AstraZeneca rely solely on internal manufacturing for XIGDUO XR?
No. AstraZeneca utilizes both its manufacturing facilities and contracted CMOs to produce various components, ensuring redundancy and adherence to high-quality standards.
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Are there risks associated with the current supply chain?
Yes. Dependency on API suppliers from specific regions, such as China and India, can pose risks related to geopolitical policies, raw material shortages, or regulatory changes, potentially impacting product availability.
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How do regulatory standards impact suppliers of XIGDUO XR?
Suppliers must comply with GMP, ISO standards, and obtain necessary certifications (FDA, EMA) to ensure quality, safety, and regulatory approval in target markets.
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What are future trends affecting suppliers of XIGDUO XR?
The shift toward biosimilars, increased global production capacity, and supply chain diversification are expected to influence sourcing strategies, potentially reducing shortages and stabilizing prices.
Sources:
- FDA Approval Announcement – XIGDUO XR
- AstraZeneca Annual Reports and Fact Sheets
- Pharmaceutical API Market Reports (Frost & Sullivan, IQVIA)
- Industry publications on API manufacturing and supply chain dynamics
- Regulatory standards documentation (WHO, FDA, EMA)
