The company utilizes a limited number of contract manufacturers to produce its commercial products in compliance with current Good Manufacturing Practice (cGMP) regulations, due to the extended lead times and costs associated with establishing additional manufacturing facilities. These third-party manufacturers operate a limited number of sites and may have limited experience producing the company's product candidates at commercial scale. They also serve other clients, which could impact their ability to perform work satisfactorily or on schedule. Contract manufacturers are subject to ongoing inspections by the FDA, the Drug Enforcement Administration when applicable, and state agencies to ensure compliance with cGMP and other regulations. Non-compliance by manufacturers may result in product recalls, destroyed inventory, production stoppages, and supply disruptions. Changes or additions to manufacturers require FDA and foreign regulatory approvals, including testing, submissions, and inspections, potentially causing delays. The limited number of potential manufacturers makes replacement challenging. The company anticipates continued reliance on contract manufacturing for future in-licensed or acquired products.
Tg Therapeutics Inc's Comment on Supply Chain
The company utilizes a limited number of contract manufacturers to produce its commercial products in compliance with current Good Manufacturing Practice (cGMP) regulations, due to the extended lead times and costs associated with establishing additional manufacturing facilities. These third-party manufacturers operate a limited number of sites and may have limited experience producing the company's product candidates at commercial scale. They also serve other clients, which could impact their ability to perform work satisfactorily or on schedule. Contract manufacturers are subject to ongoing inspections by the FDA, the Drug Enforcement Administration when applicable, and state agencies to ensure compliance with cGMP and other regulations. Non-compliance by manufacturers may result in product recalls, destroyed inventory, production stoppages, and supply disruptions. Changes or additions to manufacturers require FDA and foreign regulatory approvals, including testing, submissions, and inspections, potentially causing delays. The limited number of potential manufacturers makes replacement challenging. The company anticipates continued reliance on contract manufacturing for future in-licensed or acquired products.
Sources:
Tg 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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