Zydus Lifesciences gets post application action letter for cGMP, PAI at Ahmedabad facility

07 Mar 2024 Evaluate

Zydus Lifesciences has received Post Application Action Letter from the USFDA for the inspection conducted at the Ahmedabad API facility of the company, confirming that the inspected facility has been considered as ready to commercially manufacture and supply the API. 

This facility underwent for-cause cGMP surveillance and Pre-Approval Inspection for manufacturing of drug substances Enzalutamide from December 14 to 22, 2023.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.


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