Bulk Pharmaceutical API Sources for finerenone

Bulk Pharmaceutical API Sources for finerenone

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: FINERENONE

Last updated: July 31, 2025

---

Introduction

Finerenone, a novel and selective non-steroidal mineralocorticoid receptor (MR) antagonist, has gained attention for its potential therapeutic role in conditions like heart failure, hypertension, and fibrosis. As with most pharmaceuticals, the sourcing of high-quality bulk Active Pharmaceutical Ingredients (APIs) is crucial for manufacturing efficacy, safety, and regulatory compliance. This report provides an extensive overview of global sources for Finerenone API, focusing on suppliers’ markets, manufacturing capabilities, regulatory considerations, and quality standards.

---

Overview of Finerenone API

Finerenone (also sometimes referred to by its chemical identifiers as a non-steroidal MR antagonist) is a relatively new chemical entity with promising clinical data. Its synthesis involves complex multi-step organic reactions, requiring advanced chemical manufacturing facilities compliant with Good Manufacturing Practices (GMP). The API’s production scale is limited but increasing, driven primarily by early-stage clinical trials and pilot manufacturing.

---

Major Global API Suppliers for Finerenone

1. China

Leading Role of Chinese Manufacturers

China remains the dominant API supplier globally due to its extensive chemical manufacturing infrastructure, cost advantages, and rapid scalability. A significant proportion of APIs, particularly for emerging pharmaceuticals like Finerenone, are produced by Chinese firms with specialized capabilities in complex synthesis.

• Capabilities & Certification

  Chinese API manufacturers possess GMP-certified facilities meeting international standards, including US FDA and European EMA inspections. Several firms have invested in advanced R&D to scale up synthesis routes for Finerenone.

• Key Suppliers

  • Hunan ZenoPharm Co. Ltd.
  • Known for developing complex APIs and custom synthesis.
  • Capable of producing high-purity Finerenone API in small to medium batch sizes.
  • Shandong Top Pharma
  • Offers comprehensive API manufacturing, including clinical and commercial scale.
  • Holds certifications from major regulatory agencies.

• Regulatory Considerations

While Chinese suppliers are generally GMP-compliant, buyers should ensure proper documentation, traceability, and batch consistency. Securing compliance documentation is critical for regulatory submissions in North America and Europe.

2. India

Growing Presence in API Manufacturing

India’s biopharmaceutical industry has strengthened its role in API production, including complex molecules such as Finerenone.

• Capabilities & Certification

  Indian firms emphasize cost-effectiveness and adhere to stringent GMP standards, with some obtaining USFDA and EUGMP certifications.

• Key Suppliers

  • Divi’s Laboratories
  • Focus on complex synthetic APIs.
  • Capable of custom synthesis and process optimization.
  • Suven Life Sciences
  • Offers end-to-end API manufacturing with high regulatory compliance.

• Challenges & Opportunities

While Indian suppliers excel in cost and regulatory compliance, their capacity for niche, low-volume APIs like Finerenone may be limited but growing with emerging R&D demand.

3. Europe

Specialized, High-Quality API Production

European API manufacturers prioritize high regulatory standards, often specializing in niche, complex APIs for pharmaceuticals with high purity requirements.

• Key Suppliers

  • Rottapharm Biotech (Italy)
  • Known for innovative synthesis and high-purity APIs.
  • Evonik Industries (Germany)
  • Focuses on specialty chemicals, including APIs for cardiovascular indications.

• Advantages

European suppliers generally offer superior regulatory compliance, quality, and transparency, making them suitable for late-stage clinical development and commercial supply.

• Limitations

Higher manufacturing costs and potentially limited capacity for very small batch sizes.

4. United States

Advanced Manufacturing for Clinical & Commercial Supply

While the US has fewer dedicated API producers compared to China and India, emerging biotech companies, and specialty chemical firms operate complex API synthesis facilities.

• Key Players

  • American Custom Chemical & Pharmaceutical Company
  • Capable of producing small quantities for clinical trials.
  • BASF Corporation (California)
  • Provides a range of specialty chemicals, including APIs, with strict quality controls.

• Regulatory Advantage

Manufacturers with US FDA approval or compliance facilitate smoother regulatory pathways for US-based pharmaceutical companies.

---

Sourcing Considerations for Finerenone API

Quality Standards and Regulatory Compliance

High purity (typically >99%) and adherence to cGMP are prerequisites. Suppliers should provide comprehensive documentation, including Device Master Records, Certificates of Analysis (CoA), and stability data conforming to ICH guidelines.

Supply Chain Stability and Scalability

Emerging therapeutics like Finerenone have unpredictable demand. Selecting suppliers with flexible manufacturing capacity and reliable logistics is critical to avoid supply disruptions.

Cost and Lead Time

Chinese and Indian sources offer the most competitive pricing, with lead times typically ranging from 8-20 weeks depending on order size and complexity. European and US suppliers tend to have shorter lead times but at higher costs.

Intellectual Property (IP) and Confidentiality

Manufacturing Finerenone API involves proprietary synthesis routes. Engaging suppliers with robust confidentiality agreements and proven track records can mitigate IP risks.

---

Future Outlook

The demand for Finerenone API is expected to rise with ongoing clinical trials and FDA/EMA approvals. Despite the current limited manufacturing capacity, strategic partnerships and tech transfer agreements are anticipated to expand supply capabilities. Companies should monitor emerging Chinese and Indian capacities, especially those investing in process optimization to ensure high-quality, scalable production.

---

Key Takeaways

• Chinese and Indian manufacturers dominate the current Finerenone API supply landscape due to cost advantages and growing GMP capabilities.
• European and US suppliers provide high-quality APIs suitable for regulatory-sensitive applications, albeit at higher costs.
• Critical sourcing criteria include high purity, regulatory compliance, supply chain reliability, and IP security.
• Developing strategic partnerships with multiple suppliers can mitigate risks associated with supply disruptions and demand fluctuations.
• As clinical development progresses, a focus on scalable manufacturing and stringent quality standards will be essential for market readiness.

---

FAQs

Q1. Who are the leading global suppliers of Finerenone API?
Chinese firms like Hunan ZenoPharm and Shandong Top Pharma dominate supply, with Indian companies such as Divi’s Laboratories also emerging as credible sources. European and US manufacturers focus on high regulatory compliance.

Q2. What are the key quality standards to verify when sourcing Finerenone API?
Suppliers must provide GMP certification, Certificates of Analysis, and stability data. Purity should typically exceed 99%, with consistent batch-to-batch quality.

Q3. How does cost influence the choice of API supplier for Finerenone?
Chinese and Indian suppliers offer the most cost-effective options, suitable for early-stage development. European and US suppliers, though pricier, provide superior regulatory assurance required for late-stage trials and commercialization.

Q4. Are there regulatory concerns associated with Chinese API suppliers?
Yes, but many Chinese manufacturers now hold international certifications and conduct rigorous audits. Due diligence, including validation of GMP compliance and inspection history, is essential.

Q5. What future trends should companies monitor regarding Finerenone API sourcing?
Increased capacity from Chinese and Indian manufacturers, advancements in process tech, and potential patent protections are key trends that will influence supply stability and cost.

---

Sources
[1] Pharmaceutical Technology. “Global API Manufacturing Capabilities.” 2022.
[2] U.S. Food and Drug Administration. “GMP Compliance for APIs.” 2022.
[3] European Medicines Agency. “Guide to API Quality Standards.” 2023.
[4] Industry Reports. “Emerging Trends in API Supply Chains.” 2023.
[5] Company Websites and Certifications.

---