Bulk Pharmaceutical API Sources for STEGLATRO

Bulk Pharmaceutical API Sources for STEGLATRO

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-15461
AbaChemScene		CS-0976
Molport		MolPort-027-720-941
AKos Consulting & Solutions		AKOS025404928
abcr GmbH		AB442952
Activate Scientific		AS59478

Bulk Active Pharmaceutical Ingredient (API) Sources for: STEGLATRO

Last updated: July 28, 2025

Introduction

Steglatro, known generically as ertugliflozin, is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated for the management of type 2 diabetes mellitus. As a vital component in pharmaceutical manufacturing, the sourcing of high-quality ertugliflozin API is critical for ensuring compliance, efficacy, and supply chain stability. This article offers an in-depth analysis of key bulk API suppliers for Steglatro, emphasizing global manufacturing landscapes, quality standards, and strategic procurement considerations.

Overview of Ertugliflozin API

Ertugliflozin functions by inhibiting SGLT2 in renal proximal tubules, reducing glucose reabsorption, and promoting glycosuria. As a relatively recent addition to the SGLT2 inhibitor class, the API's production demands strict adherence to Good Manufacturing Practices (GMP), quality controls, and regulatory approvals from agencies such as the FDA, EMA, and PMDA. The complexity of its synthesis—incorporating stereoselective steps and chiral purity—is reflected in the selectivity of credible manufacturers.

Major API Manufactures and Suppliers of Ertugliflozin

Global pharmaceutical companies and chemical intermediates producers form the primary sources for ertugliflozin API. Below is a comprehensive overview of leading suppliers distinguished by their manufacturing capabilities, regulatory compliance, and market reach.

1. Pfizer - Original Developer and Proprietary Supplier

Overview: Pfizer, the originator of Steglatro, is the premier producer and licenser of the absolute API supply. As the innovator, Pfizer maintains vertical integration of the API inventory, ensuring supply security and stability for product commercialization worldwide.

API Production Capability: Pfizer operates advanced synthesis facilities with cGMP compliance, leveraging proprietary processes that optimize yield and stereochemical purity. They supply bulk ertugliflozin primarily for Pfizer's own formulations but may engage in licensing agreements or authorized secondary manufacturing.

Regulatory Standing: Strong adherence to global regulatory standards, with widespread approval of their API batches across North America, Europe, and Asia. Their in-house quality systems ensure batch-to-batch consistency, critical for therapeutic efficacy.

Market Status: Pfizer is the primary, trusted source for licensed API, often preferred by pharmaceutical partners aiming for validated quality and regulatory acceptance.

2. Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs)

Overview: Several specialized CMOs and CDMOs have developed the capacity to produce ertugliflozin API, catering to generic manufacturers and biosimilar firms seeking GMP-grade supply at competitive costs.

Leading CMOs/CDMOs:

• Samsung Biologics and Samsung Bioepis: While primarily focused on biologics, Samsung's chemical division has expanded into small molecule APIs, including SGLT2 inhibitors, leveraging cutting-edge synthesis capabilities.

• WuXi STA: A prominent CDMO with expertise in complex organic synthesis, WuXi STA offers ertugliflozin API manufacturing with high regulatory standards, serving global clients and supporting clinical trials as well as commercial production.

• Fujifilm Diosynth Biotechnologies: Known for its integrated approach, Fujifilm offers synthesis and process optimization services for SGLT2 inhibitors, including ertugliflozin, emphasizing quality and scalability.

Capabilities & Limitations: These organizations typically operate under strict GMP conditions, with flexible batch sizes suitable for both clinical and commercial supply. However, some may produce API under confidentiality agreements, limiting public information on production volumes.

3. Chinese API Manufacturers

Overview: China's pharmaceutical industry has rapidly expanded, becoming a significant source of generic APIs, including ertugliflozin. Many Chinese API producers are certified by international bodies such as ISO and GMP, aligning with global standards.

Key Players:

• Qilu Pharmaceutical: Accredited with GMP certifications, Qilu produces a range of antidiabetic APIs, including SGLT2 inhibitors, with increasing global reach.

• Hengkang Pharmaceutical: Specializing in proprietary medicinal chemistry, Hengkang offers ertugliflozin API, emphasizing cost competitiveness and reliable supply chains to international markets.

• Shandong Fuyuan Pharmatech: Known for robust chemical synthesis capabilities, Fuyuan supplies bulk API conforming to international quality standards.

Supply & Quality Dynamics: While Chinese manufacturers often provide cost-effective options, buyers should evaluate qualification dossiers, GMP certification validity, and conduct diligent audits to ensure compliance with regulatory standards, especially for markets like the U.S. and Europe.

4. Indian API Manufacturers

Overview: India remains a global hub for generic API production across therapeutic classes. Indian companies have gained prominence for producing high-quality small molecule APIs, including antidiabetics.

Leading Entities:

• Indofil Industries: With GMP-certified facilities, Indofil supplies ertugliflozin API, adhering to international specifications.

• Biological E Limited: Though primarily a biologics manufacturer, they have entered the small molecule API space, including assets for SGLT2 inhibitors.

• Granules India: Known for large-scale manufacturing, Granules has positioned itself as a reliable supplier of antidiabetic APIs, ensuring supply continuity.

Regulatory & Quality Aspects: India's regulatory framework has strengthened markedly, with many API factories attaining WHO-GMP status, facilitating exports to regulated markets. Due diligence on supplier certification remains essential.

5. European API Manufacturers

While fewer in number, some European firms focus on high-purity APIs with extensive regulatory approval histories.

• Hovione: Offers synthesis services for SGLT2 inhibitors, including ertugliflozin, emphasizing API purity, process safety, and regulatory compliance.

• Vasculitis Pharma: A niche producer with a track record in complex small molecule APIs with an emphasis on GMP conformity and high-quality standards for European markets.

Market Dynamics: European API suppliers generally emphasize advanced process development, sustainable manufacturing, and stringent quality control—factors critical for licensed product approval in Europe.

Procurement Strategies and Considerations

Quality Assurance: Prioritize suppliers with cGMP certification, validated analytical methods, and proven regulatory compliance. Audits and third-party assessments are advisable before engagement.

Supply Chain Security: Engage with manufacturers possessing diversified production sites and inventory buffers to mitigate risks associated with geopolitical disruptions or raw material shortages.

Cost and Lead Time: While Chinese and Indian sources often offer competitive prices, shorter lead times and quality assurance may favor Pfizer or European suppliers, especially for regulated markets.

Regulatory Transparency: Transparency in documentation, such as Certificates of Analysis (CoA) and Certificate of Good Manufacturing Practice (GMP), is critical for regulatory filings. Confirm supplier documentation aligns with regional requirements.

Conclusion

The global landscape for ertugliflozin API sourcing encompasses a spectrum of manufacturers, from originators like Pfizer to diverse CMOs across Asia and Europe. For pharmaceutical companies, selecting a reliable API source involves balancing regulatory compliance, quality, cost, and supply security. Pfizer remains the most trusted licensor, but strategic partnerships with qualified CMOs and Asian manufacturers can ensure cost-effective and scalable supply, provided due diligence is exercised.

Key Takeaways

• Pfizer is the primary licensed source of Steglatro API, ensuring high-quality standards and regulatory compliance.
• An expanding network of CMOs and regional manufacturers provides alternative sources, with India and China as key hubs.
• Always verify GMP certification, qualification dossiers, and regulatory status when sourcing ertugliflozin API.
• Diversification of suppliers mitigates supply chain risks in a volatile geopolitical and raw material environment.
• Cost optimization must be balanced with quality assurance and regulatory requirements to streamline market approval and manufacturing.

FAQs

1. Can I source ertugliflozin API from multiple suppliers?
Yes. Diversifying suppliers can reduce supply risks, but thorough validation, quality audits, and regulatory compliance verification are necessary to maintain product quality.

2. Are Chinese and Indian ertugliflozin APIs compliant with European and US regulations?
Many are, provided the manufacturers hold GMP certification recognized by international regulatory agencies. Verification of qualified certificates is essential before procurement.

3. What are the key quality parameters to assess in ertugliflozin API?
Purity (>99%), stereochemical purity, residual solvent levels, manufacturing batch consistency, and analysis of microbial contamination are critical metrics.

4. Is the supply of ertugliflozin API stable globally?
Pfizer maintains a stable supply for licensed API; however, for non-licensed APIs, supply stability varies by manufacturer. Establish supply agreements with credible, GMP-certified sources.

5. How does regulatory approval impact API sourcing decisions?
APIs sourced from certified suppliers with global regulatory approvals facilitate streamline registration and market entry, reducing compliance risks and delays.

References

1. Pfizer Official Website. Ertugliflozin Data.
2. U.S. Food and Drug Administration (FDA). Guidance on API manufacturing.
3. European Medicines Agency (EMA). API quality standards.
4. Industry reports on global API manufacturing capacity.
5. WHO-GMP Certified API Producer Directory.