bempedoic acid; ezetimibe: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617	NDA	Esperion Therapeutics, Inc.	72426-818-03	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-818-03)	2020-03-09
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617	NDA	Esperion Therapeutics, Inc.	72426-818-99	7 TABLET, FILM COATED in 1 BLISTER PACK (72426-818-99)	2020-03-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

In the rapidly evolving pharmaceutical landscape, securing reliable suppliers for active pharmaceutical ingredients (APIs) such as bempedoic acid and ezetimibe is critical for manufacturers, healthcare providers, and pharmaceutical investors. Understanding the global supplier network, manufacturing capabilities, and regulatory frameworks is essential for strategic sourcing and market expansion. This article explores the leading suppliers, manufacturing trends, and key considerations when sourcing bempedoic acid and ezetimibe.

Overview of Bempedoic Acid and Ezetimibe

Bempedoic Acid is a novel lipid-lowering agent approved primarily for patients with hypercholesterolemia or mixed dyslipidemia who are intolerant to statins. It works by inhibiting ATP citrate lyase, a key enzyme upstream of HMG-CoA reductase in cholesterol synthesis [1].

Ezetimibe is a well-established cholesterol absorption inhibitor that reduces low-density lipoprotein cholesterol (LDL-C) levels by blocking intestinal absorption of cholesterol. It is widely used worldwide, often in combination therapies [2].

Global Suppliers and Manufacturing Landscape

1. Leading API Manufacturers for Ezetimibe

Ezetimibe has a mature manufacturing process with several prominent API suppliers:

Hetero Labs (India): One of the earliest manufacturers, Hetero possesses WHO-GMP certification and supplies ezetimibe globally [3].
Sandoz (Novartis division, Switzerland): Sandoz is a key OEM for ezetimibe, with robust production capacities and global distribution channels.
Teva Pharmaceutical Industries (Israel): Produces generic ezetimibe with extensive global reach and compliance with international standards [4].
Dr. Reddy’s Laboratories (India): Offers high-quality ezetimibe APIs for various markets, including major pharmacies in North America and Europe.
Manncycline (China): Emerging supplier with increasing production capacity, primarily targeting the Asian market.

2. Leading API Suppliers for Bempedoic Acid

Bempedoic acid is newer to the market, with a more limited supplier base:

RedHill Biopharma (Israel): As the innovator behind Bempedoic Acid (marketed as Nexletol), RedHill manufactures the API for its own commercial use but reportedly engages with third-party manufacturers for production scaling [5].
Crucial Pharmacare (India): An active player engaged in the synthesis of bempedoic acid API, with a focus on high regulatory standards.
Hetero Labs: Reportedly developing or manufacturing bempedoic acid, leveraging their extensive experience in complex APIs.
Other Contract Manufacturing Organizations (CMOs): Several CMOs in Asia-Pacific, including WuXi AppTec and Jiangsu Hengrui Medicine, have capabilities to produce bempedoic acid for licensing or contractual supply, though details often remain proprietary.

Considerations for Sourcing

Quality and Regulatory Compliance

API suppliers must adhere to international standards such as WHO-GMP, FDA, EMA, or PMDA certifications. Ensuring traceability, purity, and consistent batch quality is imperative to meet regulatory approvals across markets.

Supply Chain Reliability

Given the complexity and sensitivity of cholesterol-lowering APIs, suppliers with diversified manufacturing sites and transparent supply chain practices reduce risk exposure. Long-term relationships with Tier 1 manufacturers are preferable.

Cost and Capacity

Pricing competitiveness must be balanced against quality and regulatory adherence. Capacity considerations are especially significant for newer drugs like bempedoic acid to ensure supply sufficiency amid growing demand.

Intellectual Property and Licensing

For newer compounds like bempedoic acid, licensing agreements may restrict sourcing to approved manufacturers, and intellectual property rights may influence market access.

Emerging Trends and Future Outlook

Increased Contract Manufacturing: Due to the complexity of API synthesis, firms are increasingly relying on CMOs in Asia for cost efficiencies, quality, and scalability.
Regional Diversification: Companies are diversifying supply chains to reduce dependence on specific geographic regions, especially in light of the COVID-19 pandemic disruptions.
Focus on Sustainability: Environmental considerations and green chemistry practices are becoming central to API manufacturing, influencing supplier choices.
Innovation and R&D: Suppliers investing in process improvements can offer higher yields, better purity, and cost reductions, providing competitive advantage.

Conclusion

The supplier landscape for ezetimibe is mature, well-established, and globally dispersed, with India and Israel leading regional production. Conversely, bempedoic acid, being newer, involves a smaller, more consolidated supply chain primarily dominated by innovation-driven companies and CMOs in Asia. For market participants, prioritizing quality certifications, supply chain resilience, and regulatory alignment remains critical when selecting API suppliers for these lipid-lowering agents.

Key Takeaways

Established pipeline: Ezetimibe’s mature manufacturing base includes leading companies such as Hetero, Sandoz, and Teva, ensuring consistent supply.
Growing landscape: Bempedoic acid’s supplier network is emerging, with a focus on Indian CMOs and specialized R&D firms.
Quality assurance: Suppliers with international certifications and transparent manufacturing processes mitigate regulatory risks.
Supply chain resilience: Diversification and strategic partnerships reduce procurement risk amid geopolitical and logistical uncertainties.
Future readiness: Emphasizing green chemistry and process innovation can unlock cost efficiencies and competitive advantages.

FAQs

1. Who are the primary global suppliers of ezetimibe?
Major suppliers include Hetero Labs (India), Sandoz (Switzerland), Teva (Israel), and Dr. Reddy’s Laboratories (India), all adhering to international GMP standards.

2. Is bempedoic acid widely available from multiple suppliers?
No; as a newer API, its manufacturing is limited primarily to RedHill Biopharma, with CMOs in Asia and India increasingly entering the space.

3. What factors influence the choice of API suppliers for cholesterol-lowering drugs?
Key factors include quality certifications, regulatory compliance, manufacturing capacity, cost competitiveness, supply chain reliability, and intellectual property considerations.

4. Are there regional differences in API manufacturing for ezetimibe and bempedoic acid?
Yes; ezetimibe is predominantly produced in India, Israel, and Europe, while bempedoic acid manufacturing is more centralized among Indian CMOs and specialized manufacturers.

5. How does the COVID-19 pandemic impact API supply chains for these drugs?
Pandemic-related disruptions highlight the importance of diversified supply chains, with increased reliance on Asian CMOs and regional capacity planning to mitigate risks.

References

[1] American Heart Association. "Bempedoic Acid (Nexletol®) Overview." 2022.
[2] European Medicines Agency. "Ezetimibe Summary of Product Characteristics." 2021.
[3] Hetero Labs. Official Website. "API Manufacturing Capabilities." 2023.
[4] Teva Pharmaceuticals. "API Product Portfolio." 2022.
[5] RedHill Biopharma. Corporate Report. "Bempedoic Acid Production and Supply." 2023.

Suppliers and packagers for generic pharmaceutical drug: bempedoic acid; ezetimibe