Cytokinetics Incorporated's Comment on Supply Chain
The company has established long-term commercial supply agreements with contract manufacturing organizations (CMOs) in Asia, North America, and Europe for raw materials, active pharmaceutical ingredients, finished drug products, and packaging for MYQORZO. These agreements currently depend on single sources of supply, which increases supply chain risk. To address this, the company is implementing a multi-phase program to introduce dual sourcing CMOs and sites globally, a process expected to take several years. Selected suppliers have multiple manufacturing sites and maintain rigorous quality control. The company is also increasing safety stock levels and identifying interchangeable suppliers. For small molecules, the company utilizes third-party contract manufacturers compliant with FDA current Good Manufacturing Practice (cGMP), EU Guidelines on Good Distribution Practice, and other regulatory requirements, subject to routine inspections. Additionally, the company complies with the Drug Supply Chain Security Act through serialization. Key registered starting materials for aficamten are sourced from manufacturers in China, with efforts underway to identify alternative geographically diverse suppliers to mitigate risks from global trade disputes or restrictive legislation.
Cytokinetics Incorporated's Comment on Supply Chain
The company has established long-term commercial supply agreements with contract manufacturing organizations (CMOs) in Asia, North America, and Europe for raw materials, active pharmaceutical ingredients, finished drug products, and packaging for MYQORZO. These agreements currently depend on single sources of supply, which increases supply chain risk. To address this, the company is implementing a multi-phase program to introduce dual sourcing CMOs and sites globally, a process expected to take several years. Selected suppliers have multiple manufacturing sites and maintain rigorous quality control. The company is also increasing safety stock levels and identifying interchangeable suppliers. For small molecules, the company utilizes third-party contract manufacturers compliant with FDA current Good Manufacturing Practice (cGMP), EU Guidelines on Good Distribution Practice, and other regulatory requirements, subject to routine inspections. Additionally, the company complies with the Drug Supply Chain Security Act through serialization. Key registered starting materials for aficamten are sourced from manufacturers in China, with efforts underway to identify alternative geographically diverse suppliers to mitigate risks from global trade disputes or restrictive legislation.
Sources:
Cytokinetics Incorporated'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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