The company currently utilizes Polpharma as its contract development and manufacturing organization (CDMO) for the production of clinical and commercial intravenous tramadol under current Good Manufacturing Practice (CGMP) requirements. Polpharma subcontracts certain activities to another manufacturer. The company plans to qualify a backup manufacturer and is contractually obligated to purchase a minimum quantity of final packaged drug product from Polpharma over five years following New Drug Application (NDA) approval. Payment terms include a fixed per-dose fee, a low single-digit royalty on net sales, and a $2.0 million milestone payment upon FDA approval.
For ATX-04, the company is establishing supply and manufacturing sources and anticipates engaging a CDMO for clinical and potential commercial supply under CGMP standards. The company’s manufacturers and subcontractors are subject to regulation and inspections by the FDA, DEA, and other agencies to ensure CGMP compliance. The company has limited control over third-party compliance beyond contractual agreements and audits. Any change in manufacturers after commercialization requires FDA and foreign regulatory approvals, including testing and inspections, which may result in delays. Additionally, identifying replacement manufacturers may be challenging due to limited availability.
The only supplier named in company filings is Polpharma.
Avenue Therapeutics Inc's Comment on Supply Chain
The company currently utilizes Polpharma as its contract development and manufacturing organization (CDMO) for the production of clinical and commercial intravenous tramadol under current Good Manufacturing Practice (CGMP) requirements. Polpharma subcontracts certain activities to another manufacturer. The company plans to qualify a backup manufacturer and is contractually obligated to purchase a minimum quantity of final packaged drug product from Polpharma over five years following New Drug Application (NDA) approval. Payment terms include a fixed per-dose fee, a low single-digit royalty on net sales, and a $2.0 million milestone payment upon FDA approval.
For ATX-04, the company is establishing supply and manufacturing sources and anticipates engaging a CDMO for clinical and potential commercial supply under CGMP standards. The company’s manufacturers and subcontractors are subject to regulation and inspections by the FDA, DEA, and other agencies to ensure CGMP compliance. The company has limited control over third-party compliance beyond contractual agreements and audits. Any change in manufacturers after commercialization requires FDA and foreign regulatory approvals, including testing and inspections, which may result in delays. Additionally, identifying replacement manufacturers may be challenging due to limited availability.
The only supplier named in company filings is Polpharma.
Sources:
Avenue Therapeutics Inc '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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