Zydus Lifesciences gets 2 USFDA observations for Ahmedabad transdermal manufacturing site
Ahmedabad: Zydus Lifesciences has received 2 observations from the US Food and Drug Administration (USFDA) at the closure of the inspection at the group's transdermal manufacturing site located at SEZ in Ahmedabad.
The inspection was conducted from July 15 to 19, 2024.
"The Company is confident of addressing the issues raised by the USFDA within the stipulated timeline, and is committed to resolving the same at the earliest," the Company stated.
Read also: USFDA nod to Zydus Lifesciences diabetes drug
Medical Dialogues team had earlier reported that had received four observations from the U.S. Food and Drug Administration (USFDA) at the closure of the inspection at the SEZ Onco Injectable manufacturing plant at Ahmedabad
Read also: USFDA inspection: Zydus Lifesciences gets 4 observations for Ahmedabad plant
Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
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