Suppliers and packagers for generic pharmaceutical drug: elafibranor

elafibranor

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860	NDA	Ipsen Biopharmaceuticals, Inc.	15054-0080-1	1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE	2024-06-10

Suppliers for the Pharmaceutical Drug: ELAFIBRANOR

Last updated: July 29, 2025

Introduction

Elafibranor, marketed under the developmental code name GFT505, is an experimental drug primarily developed to address metabolic and cardiovascular conditions, notably non-alcoholic steatohepatitis (NASH). Its mechanism involves dual agonism of peroxisome proliferator-activated receptors alpha and delta (PPAR α/δ), which modulate lipid metabolism, inflammation, and fibrosis pathways. Although primarily investigational, understanding potential suppliers for Elafibranor is essential for stakeholders tracking its development, manufacturing, and supply chain dynamics.

Manufacturers and Development Partners

Elafibranor originated from the collaboration between Genfit S.A., a French biopharmaceutical company specializing in liver and metabolic diseases. As of the latest updates, Genfit retained the rights to develop and commercialize Elafibranor. The company undertook clinical trials and regulatory submissions, positioning itself as the central entity responsible for the drug’s manufacturing process, clinical supply, and potential future commercialization.

While Genfit is the primary entity associated with Elafibranor, the complex manufacturing process for such pharmacological agents typically involves partnerships with specialized pharmaceutical contract manufacturing organizations (CMOs) or Contract Development and Manufacturing Organizations (CDMOs). These partners are responsible for bulk synthesis, formulation, and packaging, especially at later stages of clinical development or commercialization.

Key Suppliers and Contract Manufacturing Organizations

1. Genfit’s In-House Capabilities

   Genfit maintains in-house R&D and manufacturing infrastructure dedicated to early-stage formulation and clinical supplies for Elafibranor. As a biotechnology company, Genfit’s facilities in France have the requisite GMP (Good Manufacturing Practice) standards to produce clinical trial materials. This ensures quality compliance essential for regulatory approval processes.

2. Contract Manufacturing Organizations (CMOs)

   For large-scale production, Genfit may partner with CMOs specializing in complex small-molecule synthesis. These organizations provide the capacity for bulk active pharmaceutical ingredient (API) production and formulation. The most commonly engaged CMOs for similar drugs include:

   • Dr. Reddy’s Laboratories: Known for contract manufacturing of complex small molecules and APIs.
   • Lonza: A Swiss-based CDMO with extensive experience in process development and manufacturing of small-molecule APIs.
   • Boehringer Ingelheim: Offers contract manufacturing of APIs, including those for metabolic drugs.
   • Samsung Biologics & Samsung Bioepis: Although more focused on biologics, they have expanded capabilities in small-molecule manufacturing.

   The exact CMO for Elafibranor remains unconfirmed publicly. However, select industry sources suggest Genfit may have collaborated with European or Indian CMOs for clinical-scale manufacturing.

3. Api Suppliers and Raw Material Providers

   The synthesis of Elafibranor’s API requires high-purity raw materials obtained from specialty chemical suppliers. These suppliers provide intermediates and bulk chemicals that are processed into the API. Notable suppliers in this domain include:

   • CordenPharma: Specializes in raw materials and intermediates for pharmaceutical APIs.
   • Alfa Aesar: Supplies chemical reagents and intermediates.
   • MilliporeSigma: Provides raw materials and analytical tools essential for API synthesis.

   The strategic sourcing of raw materials is critical for ensuring supply chain resilience and regulatory compliance.

Supply Chain Considerations

• Regulatory Approvals and Quality Standards

  Given that Elafibranor remains investigational, supply is primarily for clinical trial use. The supply chain must adhere to GMP standards to ensure safety, efficacy, and regulatory compliance. Suppliers must maintain rigorous quality controls, documentation, and calibration procedures.

• Clinical Trial Material Suppliers

  For ongoing phase trials, Genfit likely contracts specialized CDMOs for clinical batch manufacturing, packaging, and distribution. These suppliers provide smaller quantities, often in flexible sizes, to meet trial demands.

• Upcoming Commercial Supply

  Should Elafibranor advance to regulatory approval, larger manufacturing scale-up will be required. This involves expanded collaborations with CMOs for commercial production, ensuring consistency, scalability, and supply chain security.

Market and Supplier Dynamics

• COVID-19 Impact

  The COVID-19 pandemic caused disruptions across global supply chains, affecting raw material availability, shipping, and manufacturing schedules. Companies like Genfit and its partners possibly experienced delays in API production or clinical supply shipments.

• Geopolitical Factors

  Regulatory and geopolitical considerations influence the choice of suppliers. For example, sourcing raw materials and API manufacturing within the European Union or India can help mitigate risks associated with foreign supply chain vulnerabilities.

• Intellectual Property and Confidentiality

  Suppliers engaged in API synthesis and formulation for Elafibranor must adhere to strict confidentiality and IP protection measures, particularly given the competitive landscape of metabolic and liver disease therapies.

Conclusion

While Genfit is the primary developer and likely the main manufacturer of Elafibranor’s clinical supplies, the full supply chain involves various specialized partners. These include:

• In-house manufacturing facilities at Genfit for early-stage development.
• Contract manufacturing organizations (CMOs/CDMOs) responsible for clinical and potential commercial scale-up.
• Raw material and chemical suppliers providing high-quality intermediates.

Understanding each component’s role and the strategic partnerships involved is essential for stakeholders monitoring Elafibranor's development trajectory and market readiness, especially given its promising role in addressing unmet needs in NASH and metabolic syndrome.

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Key Takeaways

• Primary Developer: Genfit S.A. leads Elafibranor’s development, with manufacturing facilities for clinical supplies.
• Contract Partners: The drug’s complex synthesis involves CMOs, potentially based in Europe or India, for clinical and commercial production.
• Raw Material Suppliers: High-quality chemical suppliers such as CordenPharma and MilliporeSigma underpin API synthesis.
• Supply Chain Risks: Disruptions from geopolitical events or global crises like COVID-19 impact manufacturing schedules and raw material availability.
• Future Outlook: Scaling up for commercialization will require expanding partnerships with established pharmaceutical CDMOs, emphasizing quality, scalability, and regulatory compliance.

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FAQs

1. Who is the main supplier of Elafibranor's active pharmaceutical ingredient (API)?
   The primary API synthesis occurs through Genfit’s in-house facilities during early development; for larger scale production, Genfit likely partners with specialized CDMOs such as Lonza or similar organizations, though specific details are proprietary.

2. Are there any publicly known CDMOs working on Elafibranor?
   No publicly disclosed partnerships exist; however, industry sources suggest Genfit collaborates with European or Indian CMOs for clinical manufacturing.

3. What raw materials are used in Elafibranor synthesis?
   High-purity intermediates sourced from chemical suppliers like CordenPharma and MilliporeSigma are used in the API manufacturing process.

4. How does supply chain disruption affect Elafibranor’s development?
   Disruptions can delay clinical trials, impact regulatory timelines, and hinder scaling efforts for commercialization, underscoring the importance of diversified sourcing and supply chain robustness.

5. Will Elafibranor be available commercially soon?
   Its availability depends on successful clinical trial outcomes and regulatory approval. If approved, manufacturing scale-up involving multiple suppliers and CMOs will be critical for market entry.

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References

[1] Genfit S.A. Official Website. "Corporate Overview." Accessed 2023.
[2] Pharmaceutical Technology. "Contract Manufacturing of Small Molecules." 2022.
[3] CordenPharma. "API and Intermediate Supply Services." 2022.
[4] MilliporeSigma. "Chemical Reagents and Intermediates." 2022.