USFDA issues EIR for Zydus Lifesciences Pharmez transdermal patch manufacturing facility
Ahmedabad: Zydus Lifesciences has received the EIR report from the U.S. Food and Drug Administration (USFDA) for the inspection conducted at its transdermal patch manufacturing facility located at Pharmez, Ahmedabad.
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated (VAI).
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
Medical Dialogues team had earlier reported that the Company had received 2 observations from the USFDA for the transdermal manufacturing site located at SEZ in Ahmedabad.
Zydus Lifesciences Ltd. is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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