Bulk Pharmaceutical API Sources for JENTADUETO

Bulk Pharmaceutical API Sources for JENTADUETO

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C00943
AKos Consulting & Solutions		AKOS040752579
RR Scientific		R6404807

Bulk Active Pharmaceutical Ingredient (API) Sources for JENTADUETO: An Industry Overview

Last updated: July 28, 2025

Introduction

JENTADUETO, a combination drug comprising saxagliptin and dapagliflozin, targets management of type 2 diabetes mellitus. As a complex pharmaceutical product, the sourcing of its Active Pharmaceutical Ingredients (APIs) — saxagliptin and dapagliflozin — governs manufacturing integrity, regulatory compliance, and supply chain robustness. Understanding the global API landscape, supplier capabilities, and quality standards is critical for stakeholders—manufacturers, pharma developers, and investors—aiming to ensure sustainable production of JENTADUETO.

SAXAGLIPTIN API: Overview and Global Suppliers

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor synthesized via a multi-step chemical process. Its manufacturing demands high-quality raw materials, advanced chemical synthesis expertise, and stringent regulatory adherence.

Leading Suppliers and Manufacturing Capabilities

• AstraZeneca’s In-house Production:
  Initially developed by AstraZeneca, saxagliptin’s primary manufacturing lines are consolidated within the company’s global facilities, primarily in the United Kingdom, USA, and Japan. These facilities adhere to current Good Manufacturing Practices (cGMP), ensuring API purity and batch consistency.

• Third-party Contract Manufacturing Organizations (CMOs):
  Several CMOs domestically and internationally produce saxagliptin under licensing agreements. Notable companies include Viatris, Fresenius Kabi, and Suzhou Elly Chemicals, which operate facilities approved by regulatory authorities like the FDA, EMA, and PMDA (Japan).

• Emerging Suppliers in Asia:
  China and India have expanded capabilities with CE-marked and FDA-approved facilities. Companies such as Hetero Labs, Macleods Pharmaceuticals, and Sun Pharma supply saxagliptin APIs for generic and branded formulations, subject to quality assessments.

Quality and Regulatory Compliance

The source of saxagliptin API must meet rigorous specifications, including >99% purity, residual solvent thresholds, and compliance with ICH Q7 guidelines. Suppliers with validated processes and a history of successful audits—such as those approved by top-tier regulatory agencies—are preferred.

Dapagliflozin API: Market and Supply Chain Dynamics

Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, features a more complex chemical synthesis, involving multiple chiral centers and active intermediates.

Major Manufacturers

• AstraZeneca:
  As the original innovator, AstraZeneca maintains primary dapagliflozin manufacturing sites, notably in the UK, Sweden, and the United States, ensuring control over supply quality and intellectual property.

• Contract Manufacturing Partners:
  Several generic and branded API suppliers globally offer dapagliflozin, including Hetero Labs (India), Cayman Chemical, and Shandong Dingguan Pharma. These companies have developed scalable, compliant synthesis routes.

• Chinese and Indian API Suppliers:
  With growing demand, companies such as Lunan Pharmaceutical Group (China) and Cadila Healthcare (India) produce dapagliflozin APIs at competitive prices, supported by local regulatory approvals.

Supply Chain Considerations

The complexity of dapagliflozin’s synthesis translates into higher manufacturing costs and quality risks. Suppliers with robust process validation, comprehensive analytical testing, and successful external audits are preferred. Ensuring traceability and compliance with global standards minimizes regulatory hurdles for API importation and commercial-scale production.

Key Factors Influencing API Sourcing Decisions

• Regulatory Compliance:
  Suppliers must hold valid approvals from agencies like the FDA, EMA, or PMDA, and demonstrate adherence to cGMP.

• Quality Assurance:
  High API purity (>99%), low residual solvents, and consistent batch-to-batch purity are non-negotiable.

• Capacity and Lead Time:
  Suppliers with scalable manufacturing capabilities and reliable delivery schedules help prevent supply disruptions.

• Cost Competitiveness:
  While cost is a factor, it must be balanced against quality and regulatory compliance to prevent downstream regulatory issues.

• Geopolitical and Supply Chain Risks:
  Diversification across regions (US, Europe, Asia) reduces reliance on any single source, mitigating potential supply shocks.

Emerging Trends in API Sourcing for JENTADUETO

• Increased Use of Contract Manufacturing:
  Pharma companies increasingly contract with specialized CMO suppliers to optimize costs and quality, especially for complex APIs like dapagliflozin.

• Regulatory Transparency and Trackability:
  Suppliers investing in digital supply chain solutions are gaining favor, offering end-to-end batch traceability.

• Sustainability and Green Chemistry:
  Environmental considerations influence supplier selection, favoring companies adopting sustainable manufacturing practices.

• Autonomous Regional Supply Bases:
  With geopolitical shifts, some companies are building regional API production capacities, e.g., India and Southeast Asia, to secure supply lines.

Conclusion

The APIs for JENTADUETO—saxagliptin and dapagliflozin—are produced by a mixture of in-house AstraZeneca plants and a global network of contract manufacturers. Quality, regulatory compliance, and supply chain resilience underpin sourcing strategies. The landscape is increasingly dynamic, driven by technological advances, geopolitical considerations, and evolving regulatory environments. Strategic diversification of API sources remains vital to ensure consistent, high-quality supply for JENTADUETO’s manufacturing.

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Key Takeaways

• Prime API Sources: AstraZeneca’s proprietary facilities dominate initial sourcing, supplemented by reputable CMOs in North America, Europe, and Asia.

• Quality and Compliance: Suppliers must adhere to rigorous standards such as cGMP, with certifications from recognized agencies to mitigate regulatory risks.

• Supply Chain Resilience: Diversifying API sources across regions minimizes disruption risks amid geopolitical tensions or supply chain bottlenecks.

• Cost versus Quality Balance: While cost considerations are significant, maintaining high API purity and regulatory compliance is paramount for product safety and efficacy.

• Emerging Trends: Increased outsourcing, technological innovation, and regional manufacturing bases are shaping the future landscape of API sourcing for complex drugs like JENTADUETO.

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FAQs

1. Who are the primary API suppliers for saxagliptin used in JENTADUETO?
   The primary suppliers include AstraZeneca’s in-house manufacturing facilities and third-party CMOs such as Viatris, Fresenius Kabi, and Asian companies like Hetero Labs and Sun Pharma.

2. What quality standards must dapagliflozin APIs meet?
   Dapagliflozin APIs must meet cGMP standards, with purity levels exceeding 99%, minimal residual solvents, and compliance with ICH guidelines.

3. Are there regional differences in API manufacturing for JENTADUETO?
   Yes, North America and Europe largely rely on in-house manufacturing or certified CMOs, while India and China are significant sources of generic APIs, often favoring cost efficiency.

4. What factors should companies consider when selecting an API supplier for JENTADUETO?
   Quality certifications, manufacturing capacity, regulatory compliance, supply reliability, and cost-effectiveness are critical considerations.

5. How is the API sourcing landscape evolving for complex drugs like JENTADUETO?
   The landscape is shifting toward increased outsourcing, regional manufacturing, adoption of green chemistry practices, and digital supply chain enhancements to improve resilience and sustainability.

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References

[1] AstraZeneca. (2022). JENTADUETO (saxagliptin and dapagliflozin) prescribing information.
[2] ICH Guidelines. (2016). Q7 GMP Guide.
[3] U.S. Food and Drug Administration (FDA). (2022). Drug Basic Manufacturing Data and Approvals.
[4] European Medicines Agency (EMA). (2022). API audit and approval standards.
[5] Industry Reports on SGLT2 inhibitor manufacturing. (2021). MarketWatch.