CLINICAL & PIPELINE·Drug Approval
Amneal Pharmaceuticals' Tigecycline NDA: Supply Chain Diversification Amidst Compliance Scrutiny
Amneal Pharmaceuticals secured FDA approval for TIGECYCLINE (NDA211158) as a new manufacturer in August 2018, diversifying the supply of this critical intravenous antibacterial. While a recent labeling update in March 2025 confirms ongoing regulatory compliance, procurement and supply chain leaders must critically assess Amneal's documented history of high-severity CGMP risks and Metformin recalls, necessitating enhanced due diligence for TIGECYCLINE sourcing to mitigate potential supply disruptions.
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