USFDA gives nod for commercial production at Zydus Ahmedabad API unit
Ahmedabad: Pharma major Zydus Lifesciences has announced that the company has received Post Application Action Letter from the US Food and Drug Administration (USFDA) for the inspection conducted at the Ahmedabad API facility, 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 Enzylutamide from 14th to 22nd Dec 2023.
Enzalutamide is used for the treatment of prostate cancer.
Read also: USFDA issues 6 observations for Zydus Lifesciences Ahmedabad facility
Formerly known as Cadila Healthcare Limited, Zydus Lifesciences Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the production of generic drugs. Cadila was founded in 1952 by Ramanbhai Patel.
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