Kalvista Pharmaceuticals Inc's Comment on Supply Chain
The company utilizes third-party manufacturers and collaborators for the production, storage, and distribution of clinical trial and commercial supplies of EKTERLY (sebetralstat) and other product candidates. These third-party manufacturers are required to comply with current Good Manufacturing Practices (cGMP) and FDA regulations. The company does not exercise day-to-day control over these manufacturers but retains responsibility for compliance with applicable laws and regulations. Risks associated with third-party manufacturing include regulatory compliance issues, quality assurance challenges, potential breaches of agreements, misappropriation of proprietary information, and termination of agreements, which may result in regulatory sanctions and delays.
Kalvista Pharmaceuticals Inc's Comment on Supply Chain
The company utilizes third-party manufacturers and collaborators for the production, storage, and distribution of clinical trial and commercial supplies of EKTERLY (sebetralstat) and other product candidates. These third-party manufacturers are required to comply with current Good Manufacturing Practices (cGMP) and FDA regulations. The company does not exercise day-to-day control over these manufacturers but retains responsibility for compliance with applicable laws and regulations. Risks associated with third-party manufacturing include regulatory compliance issues, quality assurance challenges, potential breaches of agreements, misappropriation of proprietary information, and termination of agreements, which may result in regulatory sanctions and delays.
Sources:
Kalvista Pharmaceuticals 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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