Bulk Pharmaceutical API Sources for KERENDIA

Bulk Pharmaceutical API Sources for KERENDIA

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemShuttle		139024
Angene Chemical		AGN-PC-0WD8AO
MuseChem		I006795
BioChemPartner		BCP24177
001Chemical		DY34184
MedChemexpress MCE		HY-111372
AbaChemScene		CS-0040097

Bulk Active Pharmaceutical Ingredient (API) Sources for KERENDIA

Last updated: July 28, 2025

---

Introduction

Kerendia (finerenone) is an oral non-steroidal mineralocorticoid receptor antagonist (MRA) developed primarily for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Approved by the U.S. Food and Drug Administration (FDA) in July 2021, Kerendia offers a novel approach to CKD management by reducing cardiovascular morbidity and slowing renal function decline. Central to the manufacturing of Kerendia is the sourcing of high-quality bulk Active Pharmaceutical Ingredient (API) — finerenone. Ensuring a reliable and compliant supply chain for finerenone API is crucial for pharmaceutical manufacturers, distributors, and stakeholders committed to patient safety and regulatory adherence.

This article provides a comprehensive analysis of the global sources for finerenone API, considering the key players, manufacturing locations, quality standards, and market dynamics that influence API sourcing strategies for Kerendia.

---

Understanding Finerenone API: Composition and Production

Finerenone (chemical formula: C23H28Cl2N4O) is a highly selective non-steroidal MRA with distinctive pharmacokinetic and pharmacodynamic profiles. Its synthesis involves complex multi-step chemical procedures that necessitate specialized facilities, stringent quality controls, and expertise in related chemical pharmaceutical synthesis.

Manufacture of finerenone API demands adherence to regulatory standards such as Current Good Manufacturing Practice (cGMP) outlined by authorities like the FDA, EMA, and other global agencies. Key parameters include purity (> 99%), stability, and absence of residual solvents or impurities.

---

Major API Suppliers for Kerendia (Finerenone)

1. Bayer AG – The Originator and Premier Supplier

Bayer AG, headquartered in Germany, pioneered the development of finerenone. The company holds the original patents and is the sole authorized commercial producer of finerenone API, ensuring tight control over its manufacturing quality and supply.

• Manufacturing Sites: Bayer's primary API production facilities are located in Europe and North America, equipped with advanced chemical synthesis technologies specifically designed for complex APIs like finerenone.
• Market Role: Bayer's exclusive role as the patent holder and primary API manufacturer positions it as the key supplier for global distribution of Kerendia.

2. Contract Manufacturing Organizations (CMOs) and Licensees

While Bayer remains the exclusive producer for the API, they collaborate with select Contract Manufacturing Organizations (CMOs) to augment production capacity and meet global demand. These CMOs, usually based in regions like India, China, and Eastern Europe, operate under strict regulatory oversight, including cGMP compliance.

• Example: A notable CMO working under Bayer’s guidelines is Zhejiang Huahai Pharmaceutical (China), known for its high-quality pharmaceutical synthesis capabilities, although no public confirmation indicates active finerenone API production at this site as of current data.

• Regulatory Compliance: All contract manufacturers must align with Bayer’s quality standards and undergo rigorous audits to qualify as authorized suppliers.

3. Regional API Producers in India and China

Although Bayer oversees API production, increased demand and supply chain diversification have led to the emergence of regional API suppliers particularly in India and China. These manufacturers often supply intermediates or generic APIs for other therapeutic areas but may have the technical capacity for finerenone synthesis under strict licensing.

• Key Players:
  • Divis Laboratories (India): Known for complex generic APIs, their focus remains primarily on established generics; however, they possess the capability for new chemical entities with appropriate licensing.
  • Hikal Limited (India): Specializes in custom synthesis, potentially providing finerenone API under licensing agreements.
  • Zhejiang Huahai Pharmaceutical (China): Major API manufacturer, mainly for generics, with an expanding portfolio.

Note: For Kerendia’s API, these regional producers typically operate as licensed partners or suppliers under Bayer’s direct or indirect oversight, emphasizing the importance of proprietary licenses and regulatory clearance.

---

Supply Chain Considerations and Quality Standards

Maintaining a supply chain for finerenone API involves navigating several challenges:

• cGMP Compliance: All suppliers must follow international standards to ensure API safety, efficacy, and regulatory acceptance.
• Supply Security: Given the complexity of synthesis, manufacturing bottlenecks pose risks. Bayer’s vertical integration with key manufacturing sites mitigates such issues, but reliance on regional suppliers necessitates strategic partnerships.
• Regulatory Surveillance: Suppliers must facilitate audits, provide comprehensive documentation, and comply with export/import regulations for international trade.
• Quality Assurance: High purity (>99%) and strict impurity profiles are non-negotiable standards set by regulators and Bayer, emphasizing the importance of validated manufacturing processes.

---

Regional Market Dynamics and Future Trends

The global API market for finerenone is influenced by patent protections, licensing agreements, and regional regulatory approvals. Bayer’s exclusive rights limit direct competition; however, future developments could involve sublicensing or development of biosimilar or generic versions as patents expire.

• Emerging Markets: Countries with strong pharmaceutical manufacturing sectors, including India, China, and some Southeast Asian nations, are poised to expand API production capabilities once licensing agreements are established.
• Regulatory Pathways: Additional approvals for finerenone in regions like Europe or Asia reinforce the need for local API production conforming to regional standards.

---

Market Outlook and Strategic Implications

For stakeholders aiming to source finerenone API effectively, the focus must remain on:

• Prioritizing Bayer as the primary authorized supplier.
• Maintaining relationships with licensed CMOs compliant with cGMP.
• Monitoring regional manufacturers' licensing and regulatory compliance status.
• Ensuring traceability and documentation to satisfy regulatory audits.
• Considering diversification strategies to mitigate supply chain disruptions.

---

Conclusion

The sourcing of bulk API for Kerendia (finerenone) hinges overwhelmingly on Bayer AG’s manufacturing capabilities, with regional CMOs supporting supply chain robustness under stringent regulatory oversight. The complexity of finerenone synthesis and regulatory demands underscores the importance of working with validated, licensed suppliers who can consistently deliver high-quality API in compliance with global standards.

As the market evolves, collaboration with regional manufacturers holding proper licensing and manufacturing capacity will be key to ensuring a resilient, compliant, and scalable supply chain. Companies that strategically align with Bayer or licensed partners and rigorously monitor quality parameters will better navigate the shifting dynamics of API sourcing for this novel therapeutic.

---

Key Takeaways

• Bayer AG remains the exclusive and primary global supplier of finerenone API for Kerendia, with manufacturing sites in Europe and North America.
• Regional manufacturers in India and China support supply consistency through licensed collaborations but face regulatory and quality standards that must be diligently managed.
• High purity, strict impurity profiles, and cGMP compliance are essential criteria for API sourcing in line with international regulatory standards.
• Diversification of sourcing strategies, including engagement with qualified CMOs and regional partners, enhances supply chain resilience.
• Ongoing regulatory developments and patent landscapes will influence future API sourcing options and regional manufacturing opportunities.

---

FAQs

1. Is Bayer the only supplier of finerenone API globally?
Yes. Bayer AG holds the patent rights and is the sole authorized manufacturer of finerenone API globally for commercial purposes, though licensed regional partners may produce under strict licensing agreements.

2. Are there generic versions of Kerendia available through alternative API sources?
Currently, no generic versions of Kerendia are authorized, as Bayer’s patent protections restrict third-party production unless licensed or post-patent expiration.

3. What quality standards must finerenone API manufacturers comply with?
Manufacturers must adhere to cGMP guidelines, ensuring high purity (>99%), controlled impurity profiles, and compliance with international regulatory requirements set by agencies such as the FDA and EMA.

4. How can companies ensure a reliable supply of finerenone API?
Establishing validated partnerships with Bayer or licensed CMOs, maintaining rigorous quality control, and diversifying supply sources within licensed frameworks are essential strategies.

5. What is the future outlook for regional API production for finerenone?
As patents evolve and regional regulations mature, local manufacturers in India, China, and other markets could develop licensed API production, increasing global supply resilience.

---

References

1. U.S. Food and Drug Administration. (2021). FDA approves Kerendia to treat CKD associated with diabetes.
2. Bayer AG. (2022). Finerenone (Kerendia) Highlights and Manufacturing Overview.
3. EMA. (2022). Regulatory status of new chemical entities and regional manufacturing standards.
4. Market insights and industry reports on pharmaceutical API manufacturing from IQVIA and PharmSource.