Bulk Pharmaceutical API Sources for BEMPEDOIC ACID

Bulk Pharmaceutical API Sources for BEMPEDOIC ACID

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-12357
AbaChemScene		CS-3952
Ark Pharm, Inc.		AK499358

Bulk Active Pharmaceutical Ingredient (API) Sources for Bempedoic Acid

Last updated: July 27, 2025

Introduction

Bempedoic acid is an oral hypolipidemic agent approved by the U.S. Food and Drug Administration (FDA) in 2020 under the brand name Nexletol® for the treatment of hypercholesterolemia. As a novel therapeutic, its API sourcing is critical for pharmaceutical manufacturers seeking reliable, compliant, and cost-effective supply chains. This article provides a comprehensive analysis of bulk API sources for bempedoic acid, addressing manufacturing regions, key suppliers, quality considerations, and sourcing strategies vital for stakeholders involved in drug development and commercialization.

Overview of Bempedoic Acid as an API

Bempedoic acid (chemical name: 4-[(3-carboxy-4-methyl-2-oxoquinazolin-1-yl)oxy]-2,6-dichlorobenzoic acid) functions as an ATP citrate lyase inhibitor, reducing cholesterol biosynthesis in the liver. Its synthesis involves complex multi-step processes requiring advanced chemical manufacturing expertise. Given its recent market entry, the API supply landscape remains developing, with limited established manufacturers specializing solely in bempedoic acid but opportunities for high-volume or strategic procurement via contract manufacturing organizations (CMOs).

Regional API Manufacturing Centers

1. China

China dominates the global API manufacturing environment, accounting for approximately 50% of the world's API production capacity. Chinese suppliers benefit from extensive chemical infrastructure, competitive pricing, and expanding capacity for novel APIs.

• Key Suppliers:
  • Fengdong Pharmaceutical Co., Ltd.
  • North China Pharmaceutical Group Corporation (NCPC)
  • Hubei Huatong Pharmaceutical Co., Ltd.

Chinese manufacturers invest in compliance with WHO-GMP standards, though regulatory oversight varies. Sourcing from Chinese suppliers requires diligent qualification processes, including audits and documentation review, especially considering recent geopolitical and trade considerations.

2. India

India remains a prominent API manufacturing hub, providing high-quality APIs across therapeutic areas, with a strong emphasis on quality standards suitable for global markets.

• Key Suppliers:
  • Laurus Labs
  • Aurobindo Pharma
  • Cipla Ltd.
  • Divi's Laboratories

Indian suppliers typically possess established Good Manufacturing Practice (GMP) certifications, often compliant with USFDA and EMA standards, making them attractive options for regulated markets.

3. Europe and the United States

While limited, some European and U.S.-based manufacturers focus on high-value or niche APIs, often engaging in custom synthesis for clinical or commercial quantities.

• Key Suppliers:
  • Piramal Pharma Solutions (Europe, USA)
  • Cambrex Corporation
  • Recipharm

These suppliers tend to operate in higher-cost regions but offer enhanced transparency, regulatory compliance, and supply chain security.

Leading API Manufacturers for Bempedoic Acid

As of the latest market intelligence, few manufacturers globally specialize solely in bempedoic acid. Most supply is via CMOs or multi-API producers capable of synthesizing the compound through bespoke processes. Notably:

• Dong-A Socio Holdings Co., Ltd. (South Korea): Historically active in producing various NCEs and APIs, possibly capable of supplying bempedoic acid.
• OEM/CMO Facilities: Contract manufacturers like Patheon, Fujifilm Diosynth, and Boehringer Ingelheim may offer custom synthesis services under confidentiality agreements.

Quality and Regulatory Considerations

When sourcing API for bempedoic acid, ensuring quality compliance is paramount. Suppliers must demonstrate adherence to:

• Current Good Manufacturing Practice (cGMP) standards
• Regulatory approvals or certifications (e.g., USFDA, EMA, WHO-GMP)
• Purity levels typically >99%, with detailed analytical data (HPLC, NMR, MS)
• Stability data supporting API shelf life and storage conditions

The relatively recent approval of bempedoic acid means some suppliers may lack extensive regulatory track records specific to this API, emphasizing the need for rigorous audits.

Sourcing Strategies

Developing a Diversified Supplier Base

Given the limited number of established suppliers, a diversified sourcing approach mitigates supply chain risks. Engaging both Chinese and Indian manufacturers ensures competitive pricing and supply security.

Long-term Partnerships with CMOs

Partnering with reputable CMOs capable of custom synthesis offers advantages in scale-up, quality assurance, and regulatory compliance. Such collaborations facilitate seamless transfer of manufacturing technology and process validation.

Quality Assurance and Qualification

Thorough supplier qualification, including onsite audits, technical audits, and batch testing, safeguards against quality issues. Establishing clear specifications and analytical acceptance criteria upfront is vital.

Regulatory Compliance Alignment

Ensuring suppliers hold valid certifications (USFDA, EMA, WHO) standardizes compliance efforts. Collaborating with suppliers familiar with international regulatory expectations accelerates approval pathways.

Market Outlook and Future Supply Trends

While current API supplies for bempedoic acid are somewhat limited, demand escalation as the drug gains market penetration is expected to incentivize production expansion. Contract manufacturing and licensing agreements may facilitate broader regional manufacturing capacity, reducing supply bottlenecks.

Furthermore, process innovations may enable cost reduction and yield improvements, making API more accessible. The entrance of additional manufacturers from Southeast Asia or Eastern Europe could diversify the market.

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Key Takeaways

• China and India dominate bulk API manufacturing for bempedoic acid, with established suppliers offering competitive pricing and compliance options.
• Regulatory-compliant suppliers are essential for global commercialization, necessitating rigorous qualification and audits.
• Partnerships with CMOs enable scalable, quality-assured production, especially for novel APIs like bempedoic acid.
• Supply chain diversification reduces risks associated with geopolitical tensions, regulatory shifts, and production capacity constraints.
• Market growth prospects are favorable, with potential new entrants expanding global API availability.

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FAQs

1. Are there USDA-approved or USFDA-registered API suppliers for bempedoic acid?
While specific API suppliers for bempedoic acid may not all be USFDA-registered, many Indian and Chinese manufacturers possess cGMP certification and have supplied APIs to regulated markets, ensuring adherence to quality standards.

2. What are the typical costs associated with sourcing bulk API for bempedoic acid?
Pricing varies based on supplier location, order volume, purity specifications, and production scale. As a relatively new API, costs are influenced by synthesis complexity; industry estimates range from $X to $Y per kilogram (exact figures depend on market dynamics and negotiations).

3. How is API quality ensured when sourcing from Chinese or Indian suppliers?
Through qualification audits, review of regulatory certifications, batch testing, and third-party analytical validation. Establishing technical transfer and quality agreements aligns production with specifications.

4. What are the logistics considerations for importing bempedoic acid API?
Logistics involve complying with import/export regulations, ensuring storage conditions (temperature, humidity), and managing customs clearance. Contracting reputable logistic providers mitigates logistical risks.

5. Are there prospects for domestic (U.S. or European) API production of bempedoic acid?
Given the current manufacturing landscape, domestic production is limited but may emerge as demand increases. Developing local synthesis capabilities could be strategic for reducing supply chain vulnerabilities.

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References

1. U.S. Food & Drug Administration. (2020). FDA approves Nexletol to reduce LDL cholesterol.
2. Market research reports on API manufacturing capacity and regional analysis.
3. Industry publications and supplier websites’ technical and compliance documentation.
4. Global chemical and pharmaceutical manufacturing directories.
5. Regulatory agencies’ approval and compliance standards.

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Note: Cost estimates and supplier specifics may vary; consult directly with suppliers and industry sources for current data.