The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
The company will engage with the agency to resolve the import alert at the earliest.
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The certification follows an inspection conducted by the Malta Medicines Authority between January 29, 2026, and February 3, 2026
The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities
his marks the 12th formulation facility under Akums, and the second in Baddi, a strategic move with an aim to enhance Akums’ manufacturing capabilities.
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