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Suppliers and packagers for generic pharmaceutical drug: BEMPEDOIC ACID
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BEMPEDOIC ACID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616 | NDA | Esperion Therapeutics, Inc. | 72426-118-03 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03) | 2020-03-06 |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616 | NDA | Esperion Therapeutics, Inc. | 72426-118-99 | 7 TABLET, FILM COATED in 1 BLISTER PACK (72426-118-99) | 2020-03-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Bempedoic Acid
Introduction
Bempedoic acid, marketed under brand names such as Nexletol and Nexlizet, is a novel lipid-lowering agent approved by the U.S. Food and Drug Administration (FDA) in 2020. It functions as an ATP citrate lyase (ACLY) inhibitor, reducing hepatic cholesterol synthesis, and is primarily prescribed for patients with hypercholesterolemia or those who are statin-intolerant. The global demand for bempedoic acid is anticipated to grow as cardiovascular disease prevalence rises and more physicians seek alternative therapies. This growth accentuates the importance of understanding the supply landscape for raw materials and active pharmaceutical ingredients (APIs).
This article provides an in-depth examination of the suppliers for bempedoic acid, analyzing key manufacturing regions, active pharmaceutical ingredient (API) suppliers, and the industry's strategic supply channels.
Manufacturing and Supply Chain Overview of Bempedoic Acid
Bempedoic acid is a chemically complex molecule that requires specialized synthetic routes. Its production begins with the synthesis of high-purity precursors and proceeds through multi-step organic reactions in controlled environments. Due to its relatively recent approval and niche market, the supply chain involves a limited number of key players specializing in large-scale API manufacturing.
The supply chain broadly encompasses:
- Raw material suppliers (chemical building blocks)
- API manufacturers specializing in complex, high-purity active ingredients
- Contract manufacturing organizations (CMOs) for formulation and final product assembly
- Distribution channels aligning with pharmaceutical commercialization
Key API Suppliers for Bempedoic Acid
1. National and Regional Leaders
China and India remain dominant in the global API manufacturing landscape, primarily due to cost advantages, manufacturing expertise, and infrastructure.
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Chinese API Manufacturers
Several Chinese firms are known for their active ingredient production capabilities, including:
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North China Pharmaceutical Group Corporation (NCPC)
Known for high-volume chemical synthesis, NCPC may produce intermediates for bempedoic acid, leveraging Chinese government incentives for active ingredient manufacturing. -
Zhejiang NHU Co., Ltd.
Specializes in complex APIs and offers custom synthesis services, with capacity to produce ACLY inhibitors, making it a potential supplier or partner. -
Hunan Wuqiang Pharmaceutical Co., Ltd.
Focused on intermediates and specialty chemicals, with capacity to supply tailored raw materials.
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Indian API Manufacturers
India’s pharmaceutical sector, particularly firms certified by the pharmaceutical excipient and API regulatory bodies, are increasingly involved in complex molecule synthesis:
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Granules India Ltd.
Noted for mobilizing high-grade APIs, including cholesterol-related drugs. -
Divi's Laboratories Ltd.
A leading manufacturer of specialty APIs, possibly involved in the synthesis of advanced lipid-lowering agents. -
Ipca Laboratories
Known for producing complex APIs at high volumes with stringent quality controls.
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Note: While these companies are known for various APIs, specific publicly available data on bempedoic acid production is limited due to strategic confidentiality around proprietary synthesis and supply agreements.
2. Western and Multinational API Suppliers
Large pharmaceutical API producers based in Europe and North America tend to focus on high-margin, complex APIs and often supply through exclusive agreements with brand manufacturers:
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Lonza Group (Switzerland)
Renowned for custom synthesis and high-quality APIs, especially in the cardiovasculatory space, potentially involved as a key supplier or contract manufacturer of bempedoic acid intermediates or APIs. -
Corning (Bridge Pharmaceuticals)
Engages in advanced API synthesis for cardiovascular therapeutics; may participate in supply chains via licensing or partnerships. -
BASF SE (Germany)
Produces a wide range of chemical intermediates; may contribute relevant raw materials in the synthesis pathway.
Contract Manufacturing Organizations (CMOs) and Strategic Alliances
Given its recent market entry, bempedoic acid's supply chain heavily relies on CMOs to scale production efficiently and meet global demand.
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Catalent and Lonza are prominent CMOs specializing in complex API production, with facilities capable of producing biotech and chemical APIs at commercial scale.
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Recipharm and Boehringer Ingelheim have also been active in contract manufacturing for cardiovascular agents and may serve as manufacturing partners or licensors for bempedoic acid.
Supply Chain Trends and Challenges
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Geopolitical and Regulatory Factors: Supply chain security remains a concern, especially amid global trade tensions and COVID-19 disruptions, which have impacted chemical raw material flows.
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Quality and Regulatory Compliance: Suppliers must adhere to stringent cGMP standards to ensure API safety and efficacy, influencing supplier selection globally.
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Intellectual Property (IP) Considerations: Patent protections may restrict access to synthesis routes, limiting the pool of authorized suppliers.
Market Dynamics and Future Outlook
As demand for bempedoic acid increases, pharmaceutical companies may seek diversified, reliable sources for APIs to mitigate supply risks and regulate costs. Strategic partnerships, licensing agreements, and vertical integration are expected to play critical roles in stabilizing supply chains.
Emerging manufacturers in Southeast Asia and Eastern Europe could enter the market, offering alternative sources once intellectual property considerations are addressed. Additionally, advancements in synthetic chemistry may enable simplified manufacturing processes, broadening the supplier base.
Key Takeaways
- The API supply for bempedoic acid is concentrated primarily among Chinese, Indian, and select Western pharmaceutical manufacturers specializing in complex APIs.
- Major players include Chinese firms such as Zhejiang NHU and North China Pharmaceutical, Indian companies like Divi’s Laboratories, and high-quality European CMOs such as Lonza.
- Geopolitical, regulatory, and quality standards influence sourcing decisions, emphasizing the need for diversified supply chains.
- Strategic alliances and licensing agreements shape the global API supply ecosystem, with potential expansion into emerging markets.
- Ensuring supply chain resilience for bempedoic acid requires ongoing monitoring of manufacturing capacity, regulatory compliance, and geopolitical developments.
FAQs
Q1: Who are the main API manufacturers for bempedoic acid?
A: The primary API manufacturers are believed to include Chinese firms like Zhejiang NHU, Indian firms such as Divi’s Laboratories, and specialized European CMOs like Lonza, although specific production details are often proprietary.
Q2: Are there alternative sources for bempedoic acid API?
A: Currently, the supply is limited to leading regional manufacturers with advanced synthesis capabilities. Future entrants—particularly from Southeast Asia—may expand options, subject to patent and regulatory considerations.
Q3: What are the regulatory considerations affecting API suppliers?
A: Suppliers must comply with cGMP standards and regulatory requirements of markets in which the drug is marketed, impacting manufacturing practices, quality assurance, and export approvals.
Q4: How does geopolitical risk influence supplier choices?
A: Dependence on suppliers from a single country increases risks associated with trade tensions, tariffs, or supply disruptions. Diversification and multiple sourcing are strategies to mitigate such risks.
Q5: Will manufacturing innovations impact API supply for bempedoic acid?
A: Yes, advancements in synthetic chemistry and process optimization can reduce costs and increase capacity, potentially attracting new suppliers and reducing dependency on limited sources.
References
- U.S. Food and Drug Administration (2020). FDA Approves New Cholesterol-Lowering Therapy, Bempedoic Acid.
- Market research reports and industry analyses, providing insights into API manufacturing trends and regional capabilities.
- Company websites and public disclosures of Lonza, Zhejiang NHU, Divi’s Laboratories, and other key suppliers.
- Global regulatory standards for API manufacturing (e.g., ICH Q7, cGMP).
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