USFDA inspection: Zydus Lifesciences gets 4 observations for Ahmedabad plant
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-03-28 07:00 GMT | Update On 2024-03-28 07:00 GMT
Ahmedabad: Zydus Lifesciences has announced that the Company has 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.This cGMP USFDA inspection was conducted from March 18th to March 27th, 2024. "There were no Data Integrity related observations. The Company will closely...
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Ahmedabad: Zydus Lifesciences has announced that the Company has 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.
This cGMP USFDA inspection was conducted from March 18th to March 27th, 2024.
"There were no Data Integrity related observations. The Company will closely work with the USFDA to address the observations," Zydus said in a recent BSE filing.
Medical Dialogues team had earlier reported that the Company had received the EIR report from the USFDA for the inspection conducted at the API Ahmedabad facility.
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. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R&D.
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