Bulk Pharmaceutical API Sources for ONGLYZA

Bulk Pharmaceutical API Sources for ONGLYZA

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-6008
AKos Consulting & Solutions		AKOS015896547
MedChemexpress MCE		HY-10285
AbaChemScene		CS-0650
Finetech Industry Limited		FT-0660429
Molport		MolPort-021-783-241

Bulk Active Pharmaceutical Ingredient (API) Sources for Onglyza (Saxagliptin)

Last updated: July 27, 2025

Introduction
Onglyza, marketed by AstraZeneca, is the brand name for saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used in managing type 2 diabetes. As a prescription drug, the supply chain integrity of its bulk active pharmaceutical ingredient (API) is critical to ensure consistent quality, regulatory compliance, and market stability. This article provides an in-depth overview of sourcing options for saxagliptin API, including key manufacturers, geographic considerations, quality standards, and supply chain risks, tailored for industry professionals seeking reliable API sources.

Understanding Saxagliptin API Manufacturing
Saxagliptin’s synthesis involves complex multi-step chemical processes. Such manufacturing demands advanced capabilities in chemical synthesis, strict quality control, and regulatory adherence to cGMP (current Good Manufacturing Practices). Major API suppliers typically possess extensive experience in producing high-value, detail-sensitive APIs like saxagliptin, ensuring consistent batch-to-batch quality crucial for pharmaceutical compliance.

Major Global API Manufacturers for Saxagliptin

1. AstraZeneca
As the originator, AstraZeneca itself is a primary supplier of saxagliptin API. The company’s manufacturing facilities comply with stringent regulatory standards (FDA, EMA, PMDA). While it may primarily supply its own formulations, AstraZeneca also offers API to approved partners depending on jurisdictional licensing agreements. For pharmaceutical companies seeking to develop or produce generic versions, AstraZeneca remains a benchmark and often the first point of reference for API quality.

2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
This leading Chinese pharmaceutical company produces various APIs, including saxagliptin. Their manufacturing facilities have received GMP certification from Chinese and international regulatory bodies. Their ability to supply large quantities at competitive prices makes them a key player for bulk API sourcing, especially for regions where cost-effective manufacturing is prioritized.

3. Shionogi & Co., Ltd. (Japan)
Although primarily a proprietary medicinal products company, Shionogi possesses advanced API manufacturing units capable of producing saxagliptin with proven quality standards. Their expertise in complex synthesis and adherence to Japan’s rigorous regulatory environment positions them as a reliable source for high-quality API.

4. Mingi Industries (India)
A prominent Indian API manufacturer specializing in generics and complex APIs, Mingi Industries offers saxagliptin API compliant with international standards. Their strategic focus on innovation, quality, and cost competitiveness makes them suitable for companies seeking cost-efficient API sourcing.

5. Others
Various smaller contract manufacturing organizations (CMOs) and API suppliers across India, South Korea, and Southeast Asia also produce saxagliptin API, often under strict contractual controls and quality obligations suitable for clinical and commercial applications.

Regional Considerations and Regulatory Approvals
API sourcing strategies must account for regional regulatory acceptance, especially for markets with strict import requirements. European, U.S., and Japanese authorities demand compliance with cGMP, thorough documentation, and sometimes exclusive licensing arrangements. Suppliers from China and India often offer competitive prices but require thorough vetting for compliance with respective regulatory agencies.

Quality Standards and Certification
Reliable saxagliptin API suppliers adhere to international quality standards:

• cGMP compliance
• ISO certifications (e.g., ISO 9001)
• Pharmacopoeial compliance (USP, EP, JP)
• Batch documentation and stability data

Request for detailed Certificates of Analysis (CoA), Certificate of Suitability (CEP), or Drug Master Files (DMF) enhances due diligence and regulatory acceptance.

Supply Chain Risks and Management
Dependence on a limited number of suppliers for saxagliptin API exposes manufacturers to risks like supply disruptions, quality issues, geopolitical challenges, and regulatory changes. To mitigate these, companies often diversify sources, establish strategic partnerships, and maintain safety stocks aligned with forecasted market demand.

Emerging Trends in API Sourcing

• Localization: Increasing regional manufacturing to reduce logistical complexities.
• Vertical Integration: Some pharmaceutical firms acquire or partner with API manufacturers to control quality and supply.
• Offshore Manufacturing Growth: Rapid expansion in Chinese and Indian APIs offers cost benefits but necessitates rigorous oversight.
• Regulatory Harmonization: Growing global acceptance of APIs from specific regions accelerates sourcing options.

Conclusion
Reliable sourcing of saxagliptin API is vital for the consistent supply of Onglyza and other formulations. Leading global manufacturers—including AstraZeneca, Chinese, Japanese, and Indian companies—offer diverse options tailored to cost, quality, and regulatory requirements. Strategic supplier selection, rigorous qualification processes, and risk mitigation strategies are essential for maintaining a robust supply chain in the highly competitive and regulated pharmaceutical landscape.

---

Key Takeaways

• Major API producers for saxagliptin include AstraZeneca (originator), Zhejiang Hisun, Shionogi, and Mingi Industries.
• Regional regulatory compliance and certification are critical when selecting an API supplier.
• Quality standards such as cGMP, ISO, and pharmacopoeial adherence underpin reliable API sourcing.
• Diversification of suppliers mitigates supply chain risks, especially amid geopolitical and regulatory variability.
• Emerging trends favor regional manufacturing and strategic partnerships to ensure supply chain resilience.

---

FAQs

1. What are the key factors to consider when sourcing saxagliptin API?
Quality compliance, regulatory approval, production capacity, cost efficiency, supplier reputation, and supply chain stability.

2. How can companies verify the quality of saxagliptin API from a supplier?
Request Certificates of Analysis, review GMP certifications, access regulatory filings (DMF, CEP), and conduct audits and third-party testing.

3. Are Chinese API suppliers suitable for high-quality saxagliptin API?
Yes, many Chinese suppliers possess GMP certification and produce APIs meeting international standards. Due diligence and regulatory acceptance must be confirmed.

4. What impact do regional regulations have on API sourcing?
Regulatory requirements can restrict or facilitate imports; suppliers must meet target market standards, affecting sourcing strategy and supplier selection.

5. Is it advisable to diversify API sources for Onglyza?
Yes. Diversification reduces dependency, minimizes supply disruptions, and enhances supply chain resilience, especially for high-demand APIs like saxagliptin.

---

References
[1] AstraZeneca’s Official Website, Product Information.
[2] GMP certification details for Zhejiang Hisun Pharmaceutical.
[3] Japanese Pharmaceutical Regulatory Authority (PMDA) guidelines.
[4] Indian API manufacturing standards, Indian Pharmaceutical Alliance.