The company utilizes third-party manufacturers to produce THB335 and future oral KIT inhibitor product candidates. These manufacturers are required to comply with regulatory standards, including current Good Manufacturing Practice (cGMP), and are subject to inspections by the FDA, EMA, and other regulatory authorities. Part of the manufacturing is outsourced to third parties in China, which exposes the company to risks related to political, economic, and trade policy changes that may disrupt supply or increase costs. Additionally, manufacturing challenges such as resource constraints, labor disputes, or unstable political conditions could affect the supply of product candidates for clinical trials and commercialization.
Third Harmonic Bio Inc's Comment on Supply Chain
The company utilizes third-party manufacturers to produce THB335 and future oral KIT inhibitor product candidates. These manufacturers are required to comply with regulatory standards, including current Good Manufacturing Practice (cGMP), and are subject to inspections by the FDA, EMA, and other regulatory authorities. Part of the manufacturing is outsourced to third parties in China, which exposes the company to risks related to political, economic, and trade policy changes that may disrupt supply or increase costs. Additionally, manufacturing challenges such as resource constraints, labor disputes, or unstable political conditions could affect the supply of product candidates for clinical trials and commercialization.
Sources:
Third Harmonic Bio 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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