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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
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751