Suppliers and packagers for endari

endari

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Emmaus Medcl	ENDARI	l-glutamine	FOR SOLUTION;ORAL	208587	NDA	Emmaus Medical, Inc.	42457-420-60	60 PACKET in 1 CARTON (42457-420-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01)	2017-07-07

Suppliers for the Pharmaceutical Drug: ENDARI

Last updated: July 30, 2025

Introduction

ENDARI (L-glutamine oral powder) is a recognized therapeutic agent manufactured by Emmaus Life Sciences. It specifically targets sickle cell disease, functioning as a replacement therapy to reduce the frequency of painful crises and other complications. As a sophisticated biopharmaceutical product, ENDARI's supply chain involves multiple stakeholders, including raw material providers, manufacturing firms, and distribution channels. Understanding the supplier landscape is essential for healthcare providers, investors, and regulatory bodies to ensure consistent access, regulatory compliance, and supply chain resilience.

Chemical and Raw Material Suppliers

ENDARI’s active ingredient, L-glutamine, is a naturally occurring amino acid that can be synthesized or extracted from biological sources. The integrity and purity of L-glutamine are critical for the drug's efficacy and safety. Major suppliers of pharmaceutical-grade L-glutamine include global chemical and excipient manufacturers such as:

• Ajinomoto Co., Inc.
  A leading producer of pharmaceutical-grade amino acids, Ajinomoto supplies L-glutamine synthesized via fermentation processes, adhering to Good Manufacturing Practice (GMP) standards. Their supply chain encompasses raw materials like glucose and other fermentation inputs sourced from multiple regions, ensuring steady production capacity.

• Kyowa Hakko Kirin Co., Ltd.
  Also a significant player in amino acid manufacturing, Kyowa Hakko produces high-purity L-glutamine used in both pharmaceutical and nutritional applications. Their manufacturing facilities are ISO-certified, and they maintain rigorous quality control protocols.

• Evonik Industries
  Specializing in pharmaceutical excipients and amino acids, Evonik supplies pharmaceutical-grade L-glutamine with a focus on supply stability and compliance with international standards.

• Otsuka Pharmaceutical Co., Ltd.
  As a vertically integrated pharmaceutical firm, Otsuka develops and supplies amino acids, including L-glutamine, for various clinical applications, potentially serving as indirect suppliers for ENDARI’s raw material needs.

Manufacturing and Finished Product Suppliers

Emmaus Life Sciences' primary manufacturing facility is located in the United States, with robust quality assurance measures to meet FDA standards. The company also engages third-party contract manufacturing organizations (CMOs) to scale production, especially for bulk quantities. These CMOs are often large pharmaceutical contract manufacturing firms specializing in sterile processing, blending, and encapsulation.

• Emmaus Life Sciences
  The sole manufacturer of ENDARI, Emmaus maintains its own production facility in Los Angeles, California, certified under cGMP standards. They control the entire formulation process, from raw material acquisition to final packaging.

• Contract Manufacturing Organizations (CMOs)
  While specific CMO names are proprietary, industry reports indicate companies such as Patheon (a Thermo Fisher Scientific company), Catalent, and Lonza are frequently engaged in producing complex biopharmaceuticals and medical powders. Their extensive global manufacturing networks ensure supply continuity.

Distribution and Logistics Providers

Once produced, ENDARI’s distribution is managed through a combination of Emmaus's distribution channels and licensed pharmaceutical distributors. These include major healthcare logistics companies specializing in cold chain and temperature-sensitive shipments, such as:

• AmerisourceBergen
• McKesson Corporation
• Cardinal Health

These distributors ensure timely delivery to hospitals, pharmacies, and specialty clinics globally, maintaining strict control of storage conditions to preserve drug integrity.

Regulatory and Certification Bodies

Suppliers, especially raw material providers, must adhere to regulatory frameworks, including:

• FDA cGMP compliance in the US
• EMA standards in Europe
• ISO certifications (e.g., ISO 9001, 13485) for quality management
• Pharmacopeial standards (USP, EP, JP)

Suppliers compliant with these standards are preferred, ensuring that the raw materials and finished drugs meet quality, safety, and efficacy benchmarks.

Global Supply Chain Dynamics and Risks

The supply chain for ENDARI is sensitive to geopolitical, manufacturing, and logistical factors. Disruptions in raw material supply—particularly L-glutamine—due to geopolitical tensions, pandemics, or raw material shortages, can impact production. Emmaus mitigates these risks by sourcing from multiple suppliers and maintaining inventory buffers.

Emerging Trends and Supplier Landscape Expansion

Emerging trends include:

• Vertical integration: Emmaus might increasingly develop in-house raw material manufacturing or strategic partnerships.
• Global supplier diversification: To reduce reliance on specific regions—especially China and India—companies are diversifying sourcing.
• Regulatory stringency: Increasing standards demand rigorous supplier qualification processes, audit protocols, and continuous compliance monitoring.

Conclusion

The supply chain for ENDARI comprises key raw material vendors of pharmaceutical-grade L-glutamine, contract manufacturers, and distribution partners. Major raw material suppliers include Ajinomoto, Kyowa Hakko, Evonik, and Otsuka. Manufacturing is centralized within Emmaus's facilities and supplemented by global CMOs, with distribution managed by leading healthcare logistics firms. Ensuring stability in this supply chain requires ongoing regulatory compliance, strategic sourcing, and risk mitigation measures.

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Key Takeaways

• Major raw material suppliers for ENDARI include Ajinomoto, Kyowa Hakko, Evonik, and Otsuka, focusing on high-purity L-glutamine.
• Emmaus Life Sciences primarily manages manufacturing, leveraging both in-house facilities and third-party CMOs to ensure supply scalability.
• Distribution relies on established healthcare logistics providers specializing in temperature-sensitive pharmaceutical deliveries worldwide.
• Regulatory compliance at every level—raw material sourcing, manufacturing, and distribution—is critical to maintaining supply chain integrity.
• Diversification and supplier qualification are vital strategies for mitigating supply risks associated with geopolitical or logistical disruptions.

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FAQs

1. Who are the primary raw material suppliers for ENDARI's active ingredient?
Key suppliers include Ajinomoto, Kyowa Hakko, Evonik, and Otsuka, all of whom supply pharmaceutical-grade L-glutamine produced via fermentation and adhering to stringent quality standards.

2. Does Emmaus Life Sciences use third-party manufacturers for ENDARI production?
Yes. While Emmaus's own manufacturing facilities handle the core production, they also partner with Contract Manufacturing Organizations (CMOs) such as Patheon and Catalent to meet demand and scale production efficiently.

3. How does the supply chain ensure regulatory compliance for ENDARI?
Supply chain entities maintain certifications such as cGMP, ISO standards, and pharmacopeial compliance, supported by regular audits and quality assurance protocols aligned with FDA, EMA, and international standards.

4. What are potential risks in the ENDARI supply chain?
Risks include raw material shortages, geopolitical disruptions, manufacturing delays, and logistical challenges. Diversification of suppliers and inventory buffers help mitigate these risks.

5. Are there alternative suppliers or sources for L-glutamine in case of shortages?
While Emmaus predominantly sources from established suppliers like Ajinomoto and Kyowa Hakko, industry trends favor diversified sourcing, with alternative suppliers prepared to meet demand if needed.

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Sources

[1] Emmaus Life Sciences. (2023). ENDARI Clinical and Manufacturing Details.
[2] Ajinomoto Co., Inc. Corporate Site. (2023). Pharmaceutical Amino Acids.
[3] Kyowa Hakko Kirin. Product Portfolio. (2023).
[4] Evonik Industries. Pharmaceutical Amino Acids. (2023).
[5] U.S. Food and Drug Administration. Good Manufacturing Practice (GMP) Regulations.