The company utilizes multiple third-party suppliers and contract manufacturers (CMOs) for the provision of active ingredients, therapeutic units, and medical device development related to its product candidates. Ipsen, a partner, relies on contract research organizations (CROs), an active ingredient supplier, and a CMO for confirmatory trials and commercial supply of Iqirvo® (elafibranor). Several CMOs supply therapeutic units for the VS-01 Phase 2 trial. For G1090N, one supplier provides the active substance NTZ, while a pharmaceutical subcontractor manufactures the therapeutic units. Genoscience has supplied therapeutic units for GNS561 under a license agreement; following the acquisition of all intellectual property rights in early 2025, the company will contract directly with manufacturers for future supplies. Partners Seal Rock Therapeutics and Celloram support supply requirements for preclinical development of SRT-015 and CLM-022, with CMOs developing new injectable formulations. All manufacturing facilities are subject to regulatory inspections by the FDA, EU authorities, or other regulators. The company depends entirely on these third parties for compliance with manufacturing standards and regulatory requirements. Any default, bankruptcy, or dispute involving subcontractors, service providers, or collaborators such as Seal Rock Therapeutics or Celloram could disrupt supply.
Genfit S A's Comment on Supply Chain
The company utilizes multiple third-party suppliers and contract manufacturers (CMOs) for the provision of active ingredients, therapeutic units, and medical device development related to its product candidates. Ipsen, a partner, relies on contract research organizations (CROs), an active ingredient supplier, and a CMO for confirmatory trials and commercial supply of Iqirvo® (elafibranor). Several CMOs supply therapeutic units for the VS-01 Phase 2 trial. For G1090N, one supplier provides the active substance NTZ, while a pharmaceutical subcontractor manufactures the therapeutic units. Genoscience has supplied therapeutic units for GNS561 under a license agreement; following the acquisition of all intellectual property rights in early 2025, the company will contract directly with manufacturers for future supplies. Partners Seal Rock Therapeutics and Celloram support supply requirements for preclinical development of SRT-015 and CLM-022, with CMOs developing new injectable formulations. All manufacturing facilities are subject to regulatory inspections by the FDA, EU authorities, or other regulators. The company depends entirely on these third parties for compliance with manufacturing standards and regulatory requirements. Any default, bankruptcy, or dispute involving subcontractors, service providers, or collaborators such as Seal Rock Therapeutics or Celloram could disrupt supply.
Sources:
Genfit S a 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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