Suppliers and packagers for generic pharmaceutical drug: EPLERENONE

EPLERENONE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	EPLERENONE	eplerenone	TABLET;ORAL	206922	ANDA	Accord Healthcare, Inc.	16729-293-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-293-10)	2018-10-09
Accord Hlthcare	EPLERENONE	eplerenone	TABLET;ORAL	206922	ANDA	Accord Healthcare, Inc.	16729-293-15	90 TABLET, FILM COATED in 1 BOTTLE (16729-293-15)	2018-10-09
Accord Hlthcare	EPLERENONE	eplerenone	TABLET;ORAL	206922	ANDA	Accord Healthcare, Inc.	16729-294-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-294-10)	2018-10-09

Suppliers for the Pharmaceutical Drug: Eplerenone

Last updated: July 28, 2025

Introduction

Eplerenone, marketed under brand names such as Inspra, is a selective mineralocorticoid receptor antagonist indicated primarily for managing heart failure and hypertension. As a cardio-protective agent, its manufacturing and distribution are critical for patient access worldwide. The supply chain for eplerenone is complex, involving multiple players across chemical synthesis, formulation, and distribution. This article examines the primary suppliers involved in the production of eplerenone, exploring the manufacturing process, key players, and market dynamics underpinning its global availability.

Manufacturing Overview of Eplerenone

Eplerenone's synthesis begins with complex chemical processes requiring advanced chemical manufacturing facilities. Its production demands high-quality raw materials, stringent regulatory compliance, and precise control to ensure purity and efficacy. Due to its sophisticated synthesis route, only select pharmaceutical-grade chemical suppliers and contract manufacturing organizations (CMOs) are capable of safely producing eplerenone at scale.

Key Raw Material Suppliers

Raw materials and intermediates form the backbone of eplerenone production. A crucial intermediate is the chemical (6S,11S)-11-(2-butoxyethoxy)-estra-4,9-dien-3-one, which requires specialized chemical synthesis expertise. Leading suppliers of raw intermediates include global chemical companies such as:

• MilliporeSigma (Merck KGaA): Supplies high-purity chemical intermediates utilized in pharmaceutical synthesis.
• Thermo Fisher Scientific: Provides reagents and chemical compounds critical in drug synthesis.
• Alfa Aesar (a Johnson Matthey company): Offers specialty chemicals used during the synthesis of complex pharmaceuticals.

While specific raw material suppliers for eplerenone are not publicly disclosed due to confidentiality and competitive considerations, these firms are known to supply critical intermediates for similar steroid-based pharmaceuticals.

Active Pharmaceutical Ingredient (API) Manufacturers

The API, eplerenone itself, is produced by a limited number of pharmaceutical and contract manufacturers, often under strict licensing agreements and compliance certifications.

Major API Suppliers

• Pfizer Inc.: As the original innovator, Pfizer holds the patent for eplerenone and controls a significant portion of its production capacity. The company produces eplerenone primarily for its proprietary distribution but also licenses manufacturing within strategic markets.

• Generic Manufacturers: After patent expiry, several generic companies entered the market, producing eplerenone at reduced costs, increasing global supply. Notable generic API producers include:

  • Hetero Labs (India): Known for producing affordable APIs, including cardiovascular drugs.

  • Biological E. Limited: An Indian pharmaceutical manufacturer with capabilities in steroid synthesis.

  • Sun Pharmaceutical Industries: Active in the production and distribution of generic eplerenone APIs.

Contract Manufacturing Organizations (CMOs)

CMOs such as Uta Pharma and Madaus (a part of Sanofi) have been involved in the synthesis and manufacturing of eplerenone formulas at different points in its supply chain, enabling pharmaceutical companies to expand capacities without fixed investments.

Formulation and Final Dosage Supplier Network

Once the API is produced, the formulation process involves combining the active ingredient with excipients to create tablets. Major pharmaceutical firms and contract manufacturers involved in formulation include:

• Pfizer Manufacturing Units: Responsible for finished product production under Good Manufacturing Practice (GMP) standards.
• Third-party Contract Manufacturers: Such as CordenPharma and Capsugel (a Lonza company), involved in tablet formulation and encapsulation for various markets.

Distribution and Global Supply Chain

Distribution infrastructure determines the availability of eplerenone across different geographies. Distribution companies such as McKesson, Cardinal Health, and regional distributors facilitate market access. Their partnerships with manufacturers ensure consistent supply chains, optimizing for quality, safety, and regulatory compliance.

Market Dynamics and Supply Chain Challenges

Factors influencing eplerenone supply include:

• Patent Status: Pfizer's patent expiration has encouraged a surge in generic API production, boosting global supply but also increasing competition.

• Regulatory Compliance: Suppliers must meet stringent standards from agencies such as the FDA, EMA, and Japan PMDA, which constrains manufacturing options.

• Supply Chain Disruptions: Like many pharmaceuticals, eplerenone supply chains have been vulnerable to geopolitical tensions, COVID-19 impacts, and raw material shortages. Ensuring uninterrupted supply requires diversified sourcing and strategic inventory management.

• Cost Pressures: As generics dominate, pricing pressures incentivize suppliers to maximize efficiency while maintaining quality standards.

Future Outlook

The increasing prevalence of cardiovascular diseases underscores the need for reliable eplerenone supply. As patent protections lapse and generic competition intensifies, supply networks are expected to expand, diversify, and incorporate emerging Asian manufacturing hubs. Innovations in synthetic pathways and supply chain transparency will be crucial for ensuring steady availability.

Key Takeaways

• The supply of eplerenone hinges on specialized chemical intermediates and high-quality API manufacturing, predominantly originating from Pfizer and a growing base of generic producers.

• India and China are pivotal regions for generic API production, contributing substantially to global availability.

• Contract manufacturing organizations enhance capacity and enable geographic diversification, reducing dependence on a limited number of suppliers.

• Regulatory compliance and raw material availability are principal challenges impacting supply stability.

• Monitoring patent status and market entrants remains essential for assessing future supply risk and opportunities.

FAQs

1. Who are the primary manufacturers of eplerenone worldwide?
Pfizer Inc. is the original developer and key producer of eplerenone. Post-patent expiry, multiple generic companies, mainly in India and China, now manufacture the active pharmaceutical ingredient (API).

2. Are there any regional suppliers dominating eplerenone’s supply chain?
Yes. Indian pharmaceutical companies like Hetero Labs and Sun Pharmaceutical Industries are significant generic API suppliers, supported by regional manufacturers in China and other Asian countries.

3. What are the main challenges faced by eplerenone supply chains?
Challenges include raw material shortages, strict regulatory requirements, manufacturing capacity constraints, geopolitical tensions, and disruptions caused by global events like pandemics.

4. How does patent expiry influence the supply of eplerenone?
Patent expiry opens the market to generic manufacturers, increasing API production and reducing costs, thereby expanding global supply and improving patient access.

5. What is the outlook for eplerenone suppliers in the next five years?
The market will likely see increased competition among generic producers, better supply chain diversification, and potential innovations in synthesis and formulation, all driven by the growing demand for heart failure and hypertension therapies.

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Sources:

[1] U.S. Food and Drug Administration. FDA Drug Approvals and Regulatory Reviews.
[2] Pfizer Inc. Filing and Corporate Reports.
[3] Market research reports on global pharmaceutical supply chains and API manufacturing.
[4] Industry publications on generic pharmaceutical manufacturing and Asian API suppliers.