finerenone: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-540-01	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01)	2021-07-09
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-540-02	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02)	2021-07-09
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-540-06	10 TABLET, FILM COATED in 1 BLISTER PACK (50419-540-06)	2021-07-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Finerenone, a novel therapeutic compound, has garnered significant interest in the pharmaceutical industry due to its potential in treating various cardiovascular and kidney disorders. As with any pharmaceutical product, the supply chain of Finerenone hinges on the presence of reliable and compliant suppliers capable of manufacturing, supplying, and distributing high-quality active pharmaceutical ingredients (APIs). This article examines the landscape of Finerenone suppliers, exploring their roles, market dynamics, and the strategic considerations for pharma companies seeking robust sourcing solutions.

Overview of Finerenone and its Market Relevance

Finerenone, a selective mineralocorticoid receptor antagonist, is under investigation for its efficacy in conditions like heart failure, hypertension, and chronic kidney disease. Its development involves complex synthetic pathways and stringent regulatory standards, necessitating suppliers with advanced capabilities in chemical synthesis, quality control, and regulatory compliance. The market for Finerenone is projected to expand as ongoing clinical trials progress, amplifying the demand for dependable manufacturing partners.

Key Categories of Suppliers for Finerenone

1. Active Pharmaceutical Ingredient (API) Manufacturers

API manufacturers play a pivotal role in supplying the raw materials required for Finerenone formulation. These suppliers must adhere to Good Manufacturing Practice (GMP) standards, ensuring purity, stability, and batch-to-batch consistency.

Leading API Suppliers:

Dr. Reddy’s Laboratories: Known for their expertise in complex organic syntheses, Dr. Reddy’s has a reputation for supplying high-quality APIs globally. Their facilities are compliant with international standards including FDA, EMEA, and PMDA.
Synthesis Pharma Inc.: Specializing in the synthesis of novel chemical entities, Synthesis Pharma offers custom API manufacturing with a focus on complex molecules like Finerenone. Their international GMP certifications make them a viable partner.
Sun Pharmaceutical Industries: With a broad portfolio and global manufacturing plants, Sun Pharma supplies APIs across various therapeutic areas, including cardiovascular drugs.
CordenPharma: A contract development and manufacturing organization (CDMO) with capabilities in small molecule APIs, CordenPharma provides scalable manufacturing solutions tailored to complex drugs.

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

For pharmaceutical companies lacking in-house synthesis capabilities, partnering with CMOs/CDMOs offers a streamlined pathway to produce Finerenone at scale.

Notable CMOs/CDMOs:

Fujifilm Diosynth Biotechnologies: With advanced chemical synthesis capabilities and a focus on high-potency APIs, they provide custom manufacturing services aligned with regulatory standards.
Catalent: Known mainly for formulation, Catalent also offers CMO services for API production, leveraging their global manufacturing footprint.
Lonza: A leader in small molecule API manufacturing, Lonza's expertise includes complex synthesis and process development for niche drugs like Finerenone.
Hovione: Recognized for process development and manufacturing of active ingredients, especially for high-value, complex molecules.

3. Raw Material and Chemist Supply Chain

Suppliers providing starting materials or intermediates essential for the synthesis of Finerenone are critical. These providers ensure the purity and consistency of initial compounds, directly impacting the final API quality.

Example Suppliers:

Alfa Aesar: Supplies high-purity reagents and intermediates utilized throughout the synthesis process.
Sigma-Aldrich (Merck): Offers a broad portfolio of chemicals necessary for complex syntheses.
TCI Chemicals: Provides specialized reagents for pharmaceutical synthesis.

Key Considerations in Selecting Suppliers for Finerenone

Regulatory Compliance: Suppliers must meet international GMP requirements, including FDA, EMA, and Japanese PMDA standards, to ensure quality and facilitate global approval processes.
Manufacturing Capabilities: The ability to scale production and handle complex synthetic pathways is essential for meeting market demand.
Quality Assurance & Control: Suppliers should have rigorous quality management systems, validated analytical methods, and documentation processes.
Supply Chain Security: Long-term partnerships with diversified sourcing reduce risks associated with geopolitical instability, supply disruptions, or raw material shortages.
Cost and Lead Time: Competitive pricing and reliable delivery timelines optimize profitability and market competitiveness.

Strategic Partnerships and Global Sourcing Trends

As pharmaceutical companies pivot toward globalized supply chains, strategic alliances—particularly with Asian manufacturers—become prominent. India and China lead in API manufacturing capacity, driven by cost efficiencies and expanding GMP-compliant facilities. Manufacturers like Dr. Reddy’s and Sun Pharma exemplify this trend, demonstrating their capacity to meet stringent quality standards for complex molecules such as Finerenone.

Furthermore, contract manufacturing models offer flexibility, risk mitigation, and accelerated development timelines. Partnering with established CMOs and CDMOs ensures regulatory alignment, proprietary process confidentiality, and access to innovative manufacturing techniques.

Regulatory Challenges and Opportunities

Navigating regulatory pathways is critical for suppliers handling Finerenone production. Ensuring compliance with evolving international standards minimizes approval delays and product recalls. Suppliers who invest in harmonized quality systems and transparent documentation stand to benefit from faster approvals and expanded market access.

The increasing scrutiny around supply chain transparency also prompts manufacturers to adopt serialization, track-and-trace technologies, and comprehensive audits—further emphasizing the importance of reputable, compliant suppliers.

Future Outlook and Industry Trends

The production landscape for Finerenone is poised to evolve with advances in synthetic chemistry, process optimization, and regulatory frameworks. Bioengineering techniques, such as flow chemistry, may enhance manufacturing efficiency and scalability. Additionally, increasing investment in Asian manufacturing hubs will likely bolster global supply capacities.

Pharma companies are also exploring strategic vertical integration—owning or partnering directly with suppliers—to ensure supply security amid rising demand and geopolitical uncertainties.

Key Takeaways

The supply chain for Finerenone involves a combination of API manufacturers, CMOs/CDMOs, and raw material suppliers, each demanding high standards of quality and regulatory compliance.
Global suppliers from India, China, and established Western firms currently dominate the landscape, driven by capacity, cost, and technical expertise.
Strategic and diversified sourcing mitigates risks associated with geopolitical, logistical, and regulatory factors.
Continuous investment in quality systems and regulatory adherence enhances supplier credibility and market access.
Future supply chain developments will likely incorporate innovative manufacturing technologies and increased regional manufacturing hubs.

FAQs

1. Who are the top API manufacturers for Finerenone?
Leading API manufacturers such as Dr. Reddy’s Laboratories, Synthesis Pharma Inc., and Sun Pharmaceutical Industries are known for supplying high-quality Finerenone APIs, leveraging their advanced synthesis capabilities and GMP compliance.

2. What criteria should pharmaceutical companies consider when selecting Finerenone suppliers?
Key criteria include GMP compliance, manufacturing capacity, quality assurance processes, regulatory track record, supply chain reliability, cost competitiveness, and scalability.

3. Are there any global regulatory hurdles in sourcing Finerenone from Asian suppliers?
Regulatory hurdles depend on the supplier’s compliance with international standards such as FDA and EMA. Many Asian suppliers have achieved such certifications, though due diligence and audits are essential to ensure compliance.

4. How does the supply chain of Finerenone impact its market availability?
A robust, compliant supply chain ensures consistent availability, meets clinical and commercial demand, and minimizes delays due to manufacturing or regulatory issues.

5. What emerging trends could influence the future supply of Finerenone?
Advancements include process intensification, flow chemistry, bioengineering, and increased regional manufacturing hubs, all contributing to scalable, cost-effective, and resilient supply chains.

References

[1] Global API Manufacturing Market Trends. Pharmaceutical Technology, 2022.
[2] Regulatory Guidelines for GMP Compliance. World Health Organization.
[3] Contract Manufacturing in the Pharmaceutical Industry. McKinsey & Company, 2021.
[4] Asian Manufacturing Growth and Impact on Pharma Supply Chains. Deloitte, 2022.
[5] Future Outlook of Small Molecule API Synthesis. PharmaExec, 2023.

Suppliers and packagers for generic pharmaceutical drug: finerenone

finerenone

Suppliers for the Pharmaceutical Drug: FINERENONE