KOMBIGLYZE XR bulk active fine chemical sources

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Starshine Chemical	⤷ Get Started Free	2023-05-19B2835	⤷ Get Started Free
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Last updated: August 10, 2025

Introduction

KOMBIGLYZE XR is an FDA-approved combination medication primarily used to manage type 2 diabetes mellitus. Its active ingredients are saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride, a biguanide. The quality and reliability of these APIs directly influence the safety, efficacy, and manufacturing consistency of KOMBIGLYZE XR. Sourcing high-quality APIs at scale requires careful evaluation of suppliers based on regulatory approval, manufacturing capacity, quality systems, and geographic considerations.

This analysis offers comprehensive insights into the leading global APIs suppliers for saxagliptin and metformin, emphasizing their manufacturing capabilities, regulatory standings, and strategic positioning within the pharmaceutical supply chain.

Overview of API Requirements for KOMBIGLYZE XR

Saxagliptin API: As a newer molecular entity born from complex synthetic processes, saxagliptin's API manufacturing demands high purity levels, sophisticated process controls, and rigorous quality assurance practices. It involves chiral synthesis steps to ensure enantiomeric purity, with strict impurity profiles mandated by international regulators.

Metformin Hydrochloride API: As one of the most established APIs, metformin’s manufacturing is more mature, emphasizing cost-efficiency and scale, alongside strict control of residual solvents and heavy metals. Its large-scale production necessitates robust, validated processes compliant with Good Manufacturing Practices (GMP).

Leading Global API Manufacturers for Saxagliptin

1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Capabilities: Zhejiang Hisun has established a dedicated synthesis route for saxagliptin, supported by extensive R&D investments. The company produces high-purity APIs in compliance with international standards.
Regulatory Status: Their APIs are registered in multiple markets, including the US, EU, and Asia, and comply with ICH Q7 guidelines.
Strengths: Competitive pricing, consistent supply, and comprehensive quality assurance systems.

2. Dr. Reddy’s Laboratories (India)

Capabilities: Dr. Reddy’s has advanced expertise in novel DPP-4 inhibitors, with scalable synthesis processes for saxagliptin that meet global standards.
Regulatory Status: Their API manufacturing facilities are inspected and approved by US FDA, EU EMA, and other global regulators.
Strengths: Strong quality controls, diversified manufacturing footprint, and reliable supply chain.

3. Teva Pharmaceutical Industries Ltd. (Israel)

Capabilities: Teva produces saxagliptin API as part of their comprehensive diabetes portfolio, leveraging their global manufacturing network.
Regulatory Status: APIs are often approved under major regulatory regimes, ensuring high-quality standard compliance.
Strengths: Extensive quality oversight, good manufacturing practices, and history of large-volume supply.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

Capabilities: Aggressive investment in API synthesis, Hengrui supplies high-purity saxagliptin to global markets.
Regulatory Status: The company has obtained approvals for their APIs for sale in North America and Europe.
Strengths: Competitive pricing, high output, and robust supply chain logistics.

Leading Global API Manufacturers for Metformin Hydrochloride

1. CordenPharma (Switzerland/India)

Capabilities: CordenPharma is a leading supplier for established APIs like metformin, offering both crystalline and hydrochloride forms, with cGMP certification.
Regulatory Status: Their APIs are approved by major agencies, including FDA and EMA.
Strengths: Proven quality track record, large manufacturing scale, and flexible supply options.

2. Jiangsu Shuangjian Pharmaceutical Co., Ltd. (China)

Capabilities: Specializes in metformin API manufacture, with high-volume capacity emphasizing affordability.
Regulatory Status: Approved by Chinese authorities, with international certifications for export.
Strengths: Cost-effectiveness, extensive experience, and ISO-certified facilities.

3. Hetero Labs Limited (India)

Capabilities: Hetero has longstanding expertise in metformin synthesis, with multiple manufacturing plants producing bulk API.
Regulatory Status: Various facilities inspected by US FDA and other regulators.
Strengths: Scale reliability, high purity standards, and extensive global distribution.

4. Teva Pharmaceutical Industries Ltd.

Capabilities: Apart from saxagliptin, Teva also manufactures metformin APIs at scale, with proven process robustness.
Regulatory Status: US FDA-approved, compliant with international quality standards.
Strengths: Integrated supply chain, high-quality standards, and extensive experience.

Supply Chain Considerations

Geographic Diversification: Multiple sourcing options across India, China, and Israel reduce supply risks and improve pricing competitiveness.
Regulatory Compliance: Ensuring APIs are manufactured under GMP conditions and compliant with ICH quality standards is non-negotiable.
Capacity and Scalability: High-volume API manufacturers like Hetero, Jiangsu Shuangjian, and Teva can meet increasing demands of KOMBIGLYZE XR's global market expansion.
Quality Assurance: Regular audits, transparent manufacturing practices, and rigorous impurity profiling are essential for continuous supply chain integrity.

Emerging Trends and Future Outlook

Strategic partnerships and CMOs (Contract Manufacturing Organizations) are increasingly pivotal, especially in China and India, to fulfill the rising demand.
Technology Transfer and IP Management: Manufacturers are adopting advanced synthesis and purification technologies to meet evolving regulatory standards.
Regulatory scrutiny is intensifying; suppliers must maintain high compliance standards to mitigate approval delays.
Supply security is increasingly prioritized by global pharmaceutical companies amidst geopolitical shifts and pandemic-related disruptions.

Conclusion

The global landscape for API sourcing of KOMBIGLYZE XR's active ingredients is characterized by well-established players with proven quality standards, scalable manufacturing capacities, and extensive regulatory approvals. Suppliers such as Zhejiang Hisun, Dr. Reddy’s, Jiangsu Hengrui, Hetero, and Teva present reliable options for high-quality saxagliptin and metformin APIs. Prioritizing rigorous quality assurance, diversified supply chains, and regulatory compliance will mitigate risks associated with API procurement and support consistent product supply.

Key Takeaways

Quality First: Select suppliers with FDA, EMA, or equivalent validation to ensure API purity and safety.
Diversify Sources: Leverage multiple approved manufacturers to reduce dependency risks.
Scale Capacity: Focus on high-volume providers to meet global demand efficiently.
Regulatory Alignment: Ensure APIs are compliant with current international standards to facilitate market approval.
Emerging Markets: Chinese and Indian manufacturers offer cost-effective, high-quality APIs with proven regulatory acceptance.

FAQs

1. What are the primary regions for sourcing APIs for KOMBIGLYZE XR?
Most APIs are sourced from India, China, Israel, and Switzerland, with manufacturers operating under stringent GMP standards and multiple regulatory approvals.

2. How do manufacturers ensure the quality of saxagliptin API?
Through rigorous process controls, impurity profiling, chiral purity verification, and adherence to ICH standards, especially under GMP certification.

3. Are there risk mitigation strategies for API supply chain disruptions?
Yes. Companies diversify suppliers, establish long-term partnerships, maintain safety stock, and engage in quality audits to mitigate supply risks.

4. What regulatory considerations are vital when sourcing APIs globally?
Manufacturers should possess approvals from major agencies like the US FDA, EMA, or WHO prequalification, alongside maintaining compliance with ICH guidelines.

5. How do emerging markets influence API sourcing strategies?
Growing manufacturing capacities and competitive pricing in India and China make them attractive for large-scale API procurement, provided quality standards are met.

References

U.S. Food and Drug Administration (FDA). Guidance for Industry: API Manufacturing Process.
International Council for Harmonisation (ICH). ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
Zhejiang Hisun Pharmaceutical Co., Ltd. Corporate Reports and Regulatory Approvals.
Dr. Reddy’s Laboratories. API Manufacturing Capabilities and Regulatory Approvals.
Jiangsu Hengrui Medicine Co., Ltd. Quality and Compliance Documentation.

Bulk Pharmaceutical API Sources for KOMBIGLYZE XR