The company utilizes contract manufacturers (CMOs) for the production of ZURZUVAE active drug substance, finished drug product, and packaging and labeling. Previously, contract manufacturers were used for ZULRESSO until its commercial availability in the U.S. was discontinued as of December 31, 2024. The company has a long-term supply agreement with a contract manufacturer for ZURZUVAE drug product and maintains inventory to mitigate supply risks. All commercial and clinical supplies are intended to be produced in compliance with current Good Manufacturing Practices (cGMP). Starting materials and key intermediates are produced by other CMOs. Currently, there are no long-term or redundant supply agreements for drug substances or products for other candidates, but the company plans to establish such agreements as development progresses. Supply risks are managed through inventory control and exploration of additional manufacturers. The syntheses of ZURZUVAE, SAGE-319, and SAGE-324 are considered reliable and suitable for large-scale manufacturing. The company intends to continue developing drug candidates compatible with cost-effective manufacturing at contract manufacturing facilities.
Sage Therapeutics Inc's Comment on Supply Chain
The company utilizes contract manufacturers (CMOs) for the production of ZURZUVAE active drug substance, finished drug product, and packaging and labeling. Previously, contract manufacturers were used for ZULRESSO until its commercial availability in the U.S. was discontinued as of December 31, 2024. The company has a long-term supply agreement with a contract manufacturer for ZURZUVAE drug product and maintains inventory to mitigate supply risks. All commercial and clinical supplies are intended to be produced in compliance with current Good Manufacturing Practices (cGMP). Starting materials and key intermediates are produced by other CMOs. Currently, there are no long-term or redundant supply agreements for drug substances or products for other candidates, but the company plans to establish such agreements as development progresses. Supply risks are managed through inventory control and exploration of additional manufacturers. The syntheses of ZURZUVAE, SAGE-319, and SAGE-324 are considered reliable and suitable for large-scale manufacturing. The company intends to continue developing drug candidates compatible with cost-effective manufacturing at contract manufacturing facilities.
Sources:
Sage 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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