REGULATORY INTELLIGENCE·Warning Letter
FDA Scrutiny: Lupin Pharmaceuticals Recalls Ramipril Over Unapproved API Sourcing, Signaling Broader CGMP Risks
Lupin Pharmaceuticals Inc. has initiated a Class II recall (D-0054-2025) of 357,414 bottles of Ramipril Capsules USP 10 mg due to sourcing active pharmaceutical ingredient from an unapproved vendor, a critical CGMP deviation. This event underscores the imperative for robust supplier qualification and continuous oversight in the global supply chain, directly impacting procurement strategies and regulatory compliance for generic drug manufacturers.
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