Zydus gets USFDA EIR for Ankleshwar API facility
Ahmedabad: Zydus has announced that the company has received the Establishment Inspection Report (EIR) report from the US Food and Drugs Administration (US FDA) for the inspection conducted at its API manufacturing facility located at Ankleshwar.
This facility underwent an inspection from 10th to 14th March 2025, and the inspection has been classified as No Action Indicated (NAI). NAI means no objectionable conditions or practices were found during the inspection.
The USFDA has concluded that this inspection is “closed”.
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Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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