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Suppliers and packagers for nexlizet
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nexlizet
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 | 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 |
Suppliers for the Pharmaceutical Drug: Nexlizet
Introduction
Nexlizet, a novel therapeutic combination for managing cholesterol levels, has garnered significant attention within the pharmaceutical industry following its approval by regulatory agencies such as the U.S. Food and Drug Administration (FDA). The drug merges two active components—bempedoic acid and ezetimibe—that synergistically lower low-density lipoprotein cholesterol (LDL-C), presenting an alternative for patients intolerant to statins or seeking enhanced efficacy. Given its recent market entry, identifying reliable suppliers for Nexlizet is critical for pharmaceutical companies, healthcare providers, and supply chain stakeholders aiming to ensure consistent availability and compliance with regulatory standards.
Manufacturers of Active Pharmaceutical Ingredients (APIs)
Central to the production of Nexlizet are the APIs: bempedoic acid and ezetimibe. These ingredients are sourced from specialized chemical manufacturers with authorized facilities meeting stringent quality standards, such as Good Manufacturing Practice (GMP) accreditation.
Bempedoic Acid Suppliers
Bempedoic acid, a prodrug targeting ATP-citrate lyase, is licensed and produced by several pharmaceutical companies. The commercial rights and manufacturing licenses for bempedoic acid primarily reside with Esperion Therapeutics, which markets Nexlizet in the United States. However, the raw API manufacturing is often contracted to third-party suppliers globally.
Major API manufacturers of bempedoic acid include:
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CordenPharma: A leading global producer of complex APIs and intermediates, CordenPharma holds multiple GMP certifications and supplies bempedoic acid to various markets under contractual agreements.
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Hetero Labs: An Indian pharmaceutical manufacturer with a strong reputation in generic APIs, Hetero Labs produces bempedoic acid complying with international quality standards. Their involvement has expanded access to affordable APIs for emerging markets.
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Zhejiang Hisun Pharmaceutical: Based in China, this manufacturer supplies bempedoic acid to global clients, benefiting from advanced R&D and manufacturing capacity.
Ezetimibe Suppliers
Ezetimibe, a cholesterol absorption inhibitor, was initially developed by Schering-Plough (now part of Merck & Co.). Currently, multiple API suppliers globally produce ezetimibe, adhering to regulatory requirements for quality and bioequivalence.
Key suppliers include:
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Accord Healthcare (India): A prominent producer of generic APIs, Accord supplies ezetimibe to both the branded and generic markets, ensuring cost-effective procurement channels.
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Hikma Pharmaceuticals: With manufacturing plants in Europe and the Middle East, Hikma markets ezetimibe APIs widely, in compliance with international standards.
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Fresenius Kabi: Known for extensive API manufacturing capabilities, Fresenius Kabi supplies ezetimibe for various formulations globally.
Formulation and Finished Dosage Suppliers
Beyond API production, the formulation of Nexlizet involves blending and encapsulating APIs into the prescribed dosage form. Contract manufacturing organizations (CMOs) supporting Nexlizet production include:
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Catalent: A global leader in oral solid dosage production, Catalent offers formulation, encapsulation, and packaging services with rigorous quality controls.
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Patheon (Thermo Fisher Scientific): Provides end-to-end manufacturing services, from API blending to finished product packaging.
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Recipharm: Offers flexible manufacturing solutions for small and large batch sizes, supporting local and international distribution.
Supply Chain Dynamics and Regulatory Considerations
The global supply chain for Nexlizet-related APIs is complex, involving multiple geo-regional sources — primarily North America, Europe, China, and India. Ensuring consistent quality, compliance with GMP, and adherence to regulatory standards such as those from the FDA, the European Medicines Agency (EMA), and other national agencies is crucial. Companies sourcing from these suppliers must establish due diligence processes, including quality audits and supplier qualification protocols.
Suppliers must also navigate the evolving landscape of trade policies, tariffs, and export restrictions, which can impact the availability of APIs. Recent geopolitical tensions and regulatory shifts have increased scrutiny on supply chains, emphasizing the necessity of diversified sourcing strategies.
Emerging Suppliers and Future Trends
As demand for Nexlizet increases globally, emerging suppliers focusing on process optimization and cost competitiveness are entering the market. Biotechnology companies exploring biosimilar or novel API production methods present potential future suppliers, aiming to improve supply resilience and reduce costs.
Additionally, increasing regulatory expectations for sustainability and environmental compliance are influencing supplier selection and procurement strategies, with companies favoring suppliers adhering to environmentally responsible manufacturing practices.
Conclusion
The supply landscape for Nexlizet involves a diverse network of API manufacturers and formulators across multiple regions. Key suppliers include CordenPharma and Hetero Labs for bempedoic acid, alongside Accord Healthcare and Hikma for ezetimibe. These suppliers are supported by reputable CMOs like Catalent and Patheon for formulation and finished product manufacturing. Robust supplier qualification, a resilient supply chain, and compliance with international standards remain essential for uninterrupted access to Nexlizet.
Key Takeaways
- Multiple global suppliers provide the APIs necessary for Nexlizet, enhancing supply security but requiring diligent quality assurance.
- Key API manufacturers include CordenPharma, Hetero Labs, Zhejiang Hisun, Accord Healthcare, and Hikma, offering diverse sourcing options.
- Formulation and packaging are typically handled by specialized CMOs, ensuring scalability and compliance with manufacturing standards.
- Regulatory compliance and supply chain resilience are critical factors in maintaining consistent availability of Nexlizet.
- Emerging suppliers and sustainable manufacturing processes may influence future sourcing strategies, driven by industry trends and geopolitical factors.
FAQs
1. Who are the main API suppliers for Nexlizet?
CordenPharma and Hetero Labs are among the primary suppliers for bempedoic acid, while Accord Healthcare and Hikma supply ezetimibe. These companies operate under strict GMP standards to ensure product quality.
2. Can I obtain Nexlizet from multiple suppliers?
Pharmaceutical companies typically engage multiple suppliers to mitigate supply risks and meet global demand. Suppliers are qualified through rigorous audits and compliance checks.
3. Are there regional differences in suppliers for Nexlizet?
Yes. North American and European companies often source APIs from regional manufacturers, while Chinese and Indian API producers support global markets, especially for cost-sensitive regions.
4. How does supply chain regulation impact Nexlizet availability?
Regulatory standards impose strict requirements on manufacturing quality and traceability, which can influence supplier qualification, lead times, and market availability.
5. What future trends might affect Nexlizet suppliers?
Increased focus on sustainability, regulatory evolution, and technological innovation in API manufacturing could diversify and strengthen supply options for Nexlizet.
Sources
[1] U.S. Food and Drug Administration (FDA). Nexlizet (bempedoic acid and ezetimibe) Prescribing Information.
[2] Esperion Therapeutics. Nexlizet Product Overview.
[3] CordenPharma. API Manufacturing Capabilities.
[4] Hetero Labs. API Production and Quality Standards.
[5] Accord Healthcare. API and Formulation Manufacturing.
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